volume IV

Document Number
17570
Parent Document Number
17564
Document File
Document

INTERNATIONAL COURT OF JUSTICE
____________________________________________

CASE CONCERNING
AERIAL HERBICIDE SPRAYING

(ECUADOR v. COLOMBIA)

REJOINDER OF THE

REPUBLIC OF COLOMBIA

VOLUME IV

ANNEXES 34 - 55

1 FEBRUARY 2012 LIST OF ANNEXES

VOLUME IV

Annex 34 Ministry for the Environment, Technical Opinion N° 1059,
24 Sep. 2003.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ▯. . . . . . . . . . . . . .1

Annex 35 Ministry of Health, Toxicological Opinion N° LP – 0173 – 93,
2 Apr. 1993; Toxicological Opinion N° MP – 12118 – 2001,
5 Nov. 2001; Toxicological Opinion N° LP – 12499 – 2002,

29 Apr. 2002 ................................................. 13

Annex 36 Note N° SPD 338 from the Colombian Agriculture and Livestock
Institute to the Ministry for the Environment enclosing water
samples analysis results from Catatumbo region, 18 July 2002 ..........21

Annex 37 Note N° 00118, from the Colombian Agriculture and Livestock
Institute to the National Narcotics Directorate enclosing water
samples analysis results from Caquetá region, 10 Jan. 2003. ...........29

Annex 38 Records of Water Samples Analyses Results 2005-2007 in the
framework of the Program for the Eradication of Illicit Crops by
Aerial Spraying with Glyphosate (PECIG). ......................... 35

Annex 39 Records of Soil Samples Analyses Results 2005-2008 in the

framework of the Program for the Eradication of Illicit Crops by
Aerial Spraying with Glyphosate (PECIG). ......................... 53

Annex 40 Note N° 2400-2.139140 from the Ministry for the Environment
and Sustainable Development, to the Ministry of ForeignAffairs of

Colombia, enclosing the List of Orders issued by the Ministry for the
Environment regarding control and follow up of the Environmental
Management Plan of the Program for the Eradication of Illicit Crops
byAerial Spraying with Glyphosate (PECIG), 3 Nov. 2011. ............ 67

Annex 40-A: Ministry for the Environment, Order N° 2282 whereby

a monitoring of the execution of the Environmental
Management Plan of the Program for the Eradication
of Illicit Crops by Aerial Spraying with Glyphosate
(PECIG) is carried out, 21 Dec. 2005. .................... 73

iii Annex 40-B: Ministry for the Environment,Order NN° 2283 whereby
a monitoring of the execution of the Environmental
Management Plan of the Program for the Eradication
of Illicit Crops by Aerial Spraying with Glyphosate

(PECIG) is carried out, 21 Dec. 2005. .................... 87

Annex 41 List of External Environmental Audits by the National Narcotics
Directorate (DNE): ............................................ 95

Annex 41-A: Inter-Agency Commission for the Verification of

Eradicated Crops (DNE, DIRAN, and foreign experts
from USDA/ARS and INL-Washington), Report on the
environmental audit for the eradication of illicit crops,
Bogotá, 26 Mar. 1997. ................................ 107

Annex 41-B: Environmental Audit on the eradication of illicit crops,
Report on Activities, Program for the Eradication of
Illicit Crops byAerial Spraying with Glyphosate. Period
1-30 Sep. 2000, 18 Oct. 2000. .......................... 135

Annex 41-C: Environmental Audit on the eradication of illicit crops,
Report on Activities, Program for the Eradication of
Illicit Crops byAerial Spraying with Glyphosate. Period
10 Nov. to 9 Dec. 2003, 18 Dec. 2003. ................... 143

Annex 41-D: Audit to the Program for the Eradication of Illicit Crops,
Report on Activities, Program for the Eradication of
Illicit Crops byAerial Spraying with Glyphosate.Audited
period: 5. Nov. to 4 Dec.2004, 7 Dec. 2004. ............... 155

Annex 41-E: Audit to the Program for the Eradication of Illicit Crops
by Aerial Spraying with Glyphosate Herbicide, Report
No. 3. Audited period: 19 Dec. 2006 to 18 Jan. 2007,
Jan. 2007. .......................................... 159

Annex 42 Note N° 3111-2- 14218 from the Ministry for the Environment in

response to Note 10945 of 22 July 1998 from the National Narcotics
Directorate (DNE), 28 July 1998. ................................ 235

Annex 43 Minutes and Orders of prior consultation processes with indigenous
communities, in compliance with the Colombian Constitutional

Court’s ruling SU-0383. ....................................... 239

ivECUADORIAN OFFICIALDOCUMENTS

Annex 44 Ecuadorian Foreign Ministry Court Filing N° 937-2004,
22 Oct. 2004. ................................................ 287

Annex 45 Commission on Transparency and Truth for the Angostura Case,
Report, Quito, Dec. 2009. ...................................... 307

UNITED STATES OFFICIALDOCUMENTS

Annex 46 United States Embassy in Bogotá, Certification with regard to pilots’
training, from the NAS Director, James B. Story, to the Colombian
Ministry of ForeignAffairs, 27 Sep. 2011. .........................311

Annex 47 United States Interagency Committee forAviation Policy,Aviation
Resource Management Survey Team, Evaluative Arms Report of
the United States Department of State Bureau for International
Narcotics and LawAviation Division, ConductedAugust 24 through
September 2, 1998, DocumentA2A, 3 Sep. 1998. ................... 315

Annex 48 Memorandum from Peter P. Trent, INL/RM/ASD, PSC Bogota, to
Grant Harden, INL/RM/ASD, COR, Document G 16, 4 July 1996. ..... 319

Annex 49 Memorandum from INL/AD Safety – George C. Arzente to INL/
AD Operations – Paul O´Sullivan on Award Fee Input, Document

J-24, 16 June 1998. ........................................... 329

Annex 50 Memorandum from INL/C/ASD - David Johnson to INL/C/ASD
- Grant Harden on SafetyAward Fee Evaluation for October 1996,
Document G 50, 14 Nov. 1996. ................................. 333

Annex 51 United States Embassy Certification with regard to night spraying
tests and erroneous time data from Del Norte, from the NAS Director,
James B. Story, to the Colombian Ministry of Foreign Affairs,
27 Sep. 2011. ................................................ 337

Annex 52 Department of State Sample Contractor Evaluations, Documents G
93, L 16, L 26, L 34 and L 41. .................................. 341

vAnnex 53 Memoranda of Justification by the United States Department of State,
2002-2008: ................................................. 355

Annex 53-A: Department of State Memorandum of Justification
Concerning Determination on Health, Environmental,
and Legal Aspects of Coca Eradication in Colombia,
2002. ............................................. 357

Annex 53-B: Department of State Certification Related to Aerial
Eradication in Colombia Under theAndean Counterdrug
Initiative Section of the Foreign Operations, Export
Financing, and Related Programs Appropriations Act,
Division E, Consolidated Appropriation Resolution,

2003. ............................................. 421

Annex 53-C: Department of State Memorandum of Justification
Concerning the Secretary of State’s 2004 Certification of
Conditions Related to Aerial Eradication of Illicit Coca

and Opium Poppy in Colombia, 2004. ................... 483

Annex 53-D: Department of State Information Package on the
Certification of the Aerial Eradication of Illicit Coca and
Opium Poppy in Colombia, 2005. ....................... 517

Annex 53-E: Department of State Information Package on the
Certification of the Aerial Eradication of Illicit Coca and
Opium Poppy in Colombia, 2006. ....................... 529

Annex 53-F: Department of State Memorandum of Justification

Concerning the Secretary of State’s 2007 Certification of
Conditions Related to Aerial Eradication of Illicit Coca
in Colombia, 2007. .................................. 541

Annex 53-G: Department of State Memorandum of Justification

Concerning the Secretary of State’s 2008 Certification of
Conditions Related to Aerial Eradication of Illicit Coca
in Colombia, 2008. .................................. 553

Annex 54 United States Environmental Protection Agency (EPA), Office

of Pesticide Programs. Details of the 2003 Consultation for
the Department of State. Use of Pesticide for Coca and Poppy
Eradication Program in Colombia, June 2003. ...................... 577

Annex 55 Note from the Environmental ProtectionAgency (EPA) to the United

States Embassy in Colombia, enclosing answers and bibliography
of studies on glyphosate herbicide, 23 Sep. 2011. ................... 583
vi Annex 34

M inistry for teenvironMent, echnicalo pinion° 1059,

24 septeMber2003

(Archives of the Colombian Foreign Ministry)

12 Annex 34

REPUBLIC OF COLOMBIA
MINISTRY OF ENVIRONMENT, HOUSING AND TERRITORIAL
DEVELOPMENT

OPINION No: 1059 24 Sep 2003
FILE: 793

ENTITY: ANTI-NARCOTICS DIRECTORATE – DNE

PROJECT: Program for the Eradication of Illicit Crops by Aerial
Spraying with Glyphosate –PECIG

REF: MODIFICATION TECHNICAL CONCEPT No. 1015,
DATED SEPTEMBER 15, 2003

1. BACKGROUND

1.1 The Ministry of Environment, per Resolution No. 1065 of
November 26, 2001, ordered the National Narcotics
Directorate (DNE) to implement the ENVIRONMENTAL

MANAGEMENT PLAN for the Program for the Eradication
of Illicit Crops by Aerial Spraying with Glyphosate –PECIG.
1.2 Per Resolution No. 108 of January 31, 2002, the Ministry of
Environment confirmed Resolution No. 1065 of November
26, 2001, except Records

No. 4, 7 and 8 of the Environmental Management Plan, which
are described in the mentioned Resolution.
1.3 Per Resolution No. 099 of January 31, 2003, the Ministry for
Environment, (now Ministry for the Environment, Housing

and Territorial Development), amended in part Resolution
No. 1065 of November 26, 2001.
1.4 The National Narcotics Directorate, per communication filed
under No. 3111-1-12366 of August 12, 2003 submitted to the
Ministry an amendment to the Environmental Management

Plan ordered per Resolution No. 1065, 2001.

2. CONSIDERATIONS

2.1 General Considerations

The establishment of illicit crops, mainly developed in fragile
ecosystems and of biological diversity relevance for the country, is a

determinant in the processes of environmental damages faced by the

3Annex 34

country, m ainly du e t o land s uitability, an a ctivity a ssociated w ith
slash-and-burn of natural vegetation.
[Page 1]
The N ational Narcotics D irectorate h as i ndicated t hat t he A nti-

Narcotics Police, as executor of the Program for the Eradication of
Illicit C rops w ith G lyphosate, f aces p ermanent r isks in e radication
activities due to the presence of outlaw groups that harass and attack
aircraft during aerial applications of Glyphosate herbicide, which in
many c ases pr events t he ap propriate i mplementation of t he

environmental management Records.

This s ituation ha s be en ve rified b y th e M inistry dur ing E MPS´s
follow-up act ivities w here t he Eradi cation P rogram oper ates,
evidencing also the existence of strategies used by illicit growers to

avoid s praying of areas pl anted w ith c oca. A mong t hem i s t he
interspersing of lic it w ith illic it c rops, th e f ractionated pla nting of
illicit crops, the laying of wires between trees to snare aircraft as it
descends, an d t he p resence i n i solated t ree-plots of c onsiderable
height, with t he pu rpose of i mpeding t he m aneuverability of t he

aircraft performing the spray, being these last two situations, events
that endanger the lives of the pilots and in some cases force to change
the parameters of the operation of the program.

Taking into account that the Colombian government imple mented an
Illicit Crop Eradication Program with Glyphosate herbicide as a State
strategy t o f ight dr ug t rafficking a nd s top t he devastation t hat t he
implementation of illicit crops is causing in the country and that this
activity can generate effects on health and environment, the Ministry

ordered the National Narcotics Directorate (DNE) to implement the
Environmental M anagement P lan, t o pr event, m itigate, c ontrol,
compensate and co rrect an y negative en vironmental ef fects or
impacts.

The E nvironmental M anagement P lan or dered b y th e M inistry in
November, 2001 w as de signed and s ubmitted i n due t ime b y t he
National Narcotics Directorate. Its execution during this time, has
allowed DNE to prove the existence of some difficulties of technical

and lo gistical n ature, w hich limi t t he e ffective development of t he
activities contemplated in the programs proposed.

Since the Environmental Management Plan is a dynamic tool that can
be ad justed according t o t he ch aracteristics of the activity and t he

environmental conditions where i t is imp lemented, th e adjustment

4 Annex 34

document s ubmitted b y D NE p roposes a consistent s trategy i n t he
restructuring of t he 13 R ecords t hat c omprise t he c urrent
Environmental M anagement P lan, in s uch a w ay th at it a llows
effectiveness in execution and environmental control over the Program

for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate
–PECIG.

DNE´s pr oposal i s b ased on experience gained dur ing t he
implementation of t he Program a nd a pplication of e nvironmental

management records, which has allowed to identify that some of them
can be integrated, to the extent that they contain similar scope and
objectives; the integration and synthesis of the Records proposed by
DNE, will allow greater control in the development of environmental
management measures consistent with PECIG and the improvement of

the coordination relationships with the various entities involved in the
Program.

Additionally, DNE indicates that the characteristics of the activity to
eradicate illic it c rops r equires a d ynamic E MP th at f acilitates th e

effective i mplementation of pr oposed a ctivities, a ccording t o t he
various environmental, social and security conditions that arise in the
country.
[Page 2]

2.2 Comments on the content of the proposed Sheets

The in terdisciplinary technical r eview ma de to th e mo dification
proposal of t he E nvironmental M anagement P la n´s R ecords of
PECIG, l eads t o t he c onclusion t hat i t doe s not a lter t he ove rall

objective t o be pur sued, s uch a s pr evention, m itigation, c ontrol,
compensation a nd c orrection of pot ential effects or a dverse
environmental i mpacts t hat t he er adication act ivity m ay generate,
meaning the proposal as a logistical and technical adjustment to the
current plan.

However, t he review e nables t he M inistry t o make t he following
comments on each Record, including:

• RECORD 1. MANAGEMENT PROGRAM OF SPRAYING
OPERATIONS. Incorporates Records No. 1 - Management of
spraying operations with No. 6, I nspection, Verification and
Control pr ogram of s praying ope rations, ad justing s ome
objectives and activities of same.

5Annex 34

COMMENTS OF THE MINISTRY

The Ministry considers it desirable to unify these two Sheets,
as the objectives and activities proposed in the current EMP

are r elated, and t herefore, t he p roposed R ecords m eets t he
environmental requirement f or t he m anagement of s praying
operations.

1. Detection Measures

The de tection me asures a re dir ected at th e identification
process, characterization using geographical coordinates of the
areas affected b y i llicit cr ops an d ex clusion z ones of t he
Program; c haracterization w ill b e s upported with s atellite

imagery, aerial photography and mapping.

2. Operating Parameters

Based on t he o perating p arameters, D NE i n t hi s R ecord

modifies the maximum height of application, a situation that
could cause drift effects. T here are particular circumstances
that put pilots’ lives at risk, as well as ground conditions that
require hi gher s praying a nd e xplain t he a ction, w hen i t i s

strictly n ecessary. In t his s ense, ap plication p arameters as
droplet s ize i ncrease, pi lot e xperience, a djustment of
application s trip a nd l ow w ind s peeds s hould be i ssues t o
consider according to ICA´s recommendations to reduce this
effect, which although temporary, is negative.

3. Verification

In Paragraph 3.2.3. Verification, DNE states in this Record that
aerial spraying must be verified in order to prove its eficiency,

that is, whether it achieves its ultimate goal of destroying illicit
crops.

For t he pur poses of the e nvironmental m onitoring and

assessment which this Ministry requires, it will be necessary to
evaluate t he e fficiency an d e ffectiveness o f environmental
management measures.
[Page 3]
Regarding buf fer s trips, in vis its ma de b y this M inistry in

furtherance to the follow-up and verification of environmental

6 Annex 34

measures and quarterly reports of PECIG´s activities submitted

by DNE, it h as been observed that the drift effect is minimal
and no da mage ha s been c aused out side t hese s trips.
Therefore, we accept the amendment submitted by DNE in that
we welcome those indicated in Decree 1843 of 1991 of the
Ministry of Social Protection (formerly, Health Ministry).

• RECORD 2. COMPREHENSIVE SECURITY PRORAM IN
OPERATING BAS ES. Incorporates Records N o. 2 -

Glyphosate M anagement P rogram and i ts c oadjuvants in
operating bases, Record No. 3. F uels, Vehicles, Equipment
and Transportation Management Program, and Record No. 11
Comprehensive Se curity i n t he bas es of ope rations of t he
current plan.

COMMENTS OF THE MINISTRY

The Ministry considers it appropriate to integrate activities that
were distributed in the merged Sheets, to the extent that efforts

and resources are concentrated to better fulfill the proposed
objectives. T he implementation of this Sheet and others that
make up the Environmental Management Plan, must take into
account the regulation included in their content as well as that
which supplements or modifies same.

• RECORD 3. P ROGRAM FO R S OLID W ASTE
MANAGEMENT. Corresponds to current Record 4. Program
for Solid waste management.

CONSIDERATIONS OF THE MINISTRY

This R ecord ma intains its s tructure w ith r espect to c urrent
Record No. 4, Program for Solid Waste Management. T his

Program w illa pply r egulations s et f orth i n D ecree 1713 o f
2002, Resolution 2309 of 1986 and Decree 1843 of 1991.

• RECORD 4. WASTE WATER MANAGEMENT PROGRAM

IN PECIG´S BASES. Corresponds to current Record No. 5.
Wastewater Management Program.

7Annex 34

COMMENTS OF THE MINISTRY

This Record maintains the structure of Sheet No. 5 of current

EMP, W astewater M anagement P rogram. Discharge control,
provisions of de cree 15 41 of 1978 a nd 1594 of 1984 w ill
apply.

• RECORD 5 . E NVIRONMENTAL M ONITORING
PROGRAM Incorporates Record No. 7 – Research Program
in Representative and Demonstrative Plots and Record No. 8 –
Environmental Monitoring Program of current EMP.
[page 4]

CONSIDERATIONS OF THE MINISTRY

The objectives contained in Record No. 7 of the Plan to be
amended, as ar e t he s tudy of r egeneration an d eco logical

dynamics of sprayed areas and the determination of glyphosate
residues in soil and its damage on physical-chemical properties
of same, are include in the proposed Sheet to be implemented
in real conditions of soil in each nucleus of PECIG´s operation.
In this sense, this evaluation will be done simultaneously with

the e nvironmental m onitoring described i n the pr oposed
Record.

Record No. 8 – Environmental M onitoring o n w ater, s oil,
vegetation, land use and health of population components in

sprayed areas, aims to monitor the impacts caused on t hese
components.

The pr oposed Record contains i ndicators pr ovided f or In

Resolutions 1065/2001 and 108/2002 and complements with
others as follows:

Soil: p H, C ation-Exchange C apacity ( CEC), R atio of
exchangeable bases, nitrification (Nitrates, ammonium, nitrite),

Texture, Concentration of Glyphosate and AMPA , phosphate
solubilizers, Percentage of Organic Matter, Total and available
Phosphorous, N itrogen f asteners, ba cteria count, f ungi,
actinomycetes ( these l ast t hree ar e ad ditional). It ex cludes
earthworm analysis, taking account that toxicity of Glyphosate

active ingredient is mild, according to existing literature.

8 Annex 34

Water: Glyphosate and AMPA concentration, pH, electrical
conductivity, temperature, dissolved oxygen, chemical oxygen
demand, nitrification (Nitrates, ammonium, Nitrites), dissolved
phosphate, magnesium and calcium. Turbidity and color
parameters are excluded since they are not considered

representative for impact assessment of active ingredient:
Glyphosate.

Sediments: This Record excludes the analysis of this
component, sinc e taking of sample is time consuming and

requires complex equipment, which for reasons of security,
logistics and public order it is not possible to do. Given the
logistical issues and risks to personnel, this Ministry considers
it appropriate not to sample sediments.

The Ministry welcomes DNE´s proposal to conduct
regeneration and ecological dynamics studies of sprayed areas
and the determination of the residual glyphosate in soil and its
effect on the physical-chemical properties of same, under real
load conditions, for each PECIG´s operation nucleus.

The proposed Record includes the following activities and
people responsible for same:

1. Analysis of Plant Succession

• Aerial photography and videos by the Anti -Narcotics
Police, as part of the environmental monitoring whose
results will be submitted to the Ministry of Environment.

• Multitemporal analysis of vegetation, which is the
product of the SIMCI project (Illicit Crops Integrated
Monitoring System) led by the Ministry of Interior and
Justice wh ich will send results to the Ministry of
Environment.

2. Residue analysis of Glyphosate and AMPA

• Monitoring Planning: will be done with the participation
of the National Police, Anti-Narcotics Directorate, National
Health Institute and Agustín Codazzi Geographic Institute
of Colombia (IGAC).

9Annex 34

• Water and soil sampling and packing of same, by
IGAC´s technicians in soil and INS or by the entity
assigned by the INS for the purpose, in water resource.

• Submission of samples to laboratories by technicians

who collected the samples.

• Laboratory tests and results will be made by IGAC and
INS, in soils and water, respectively.

• Comparison of results for nucleus and frequencies
specified in the Record and submission to the Ministry of
Environment by DNE.

• RECORD. COMMUNICATION AND SOCIAL
MANAGEMENT PROGRAM. Incorporates Record No. 9
– Social management Program, Record No. 10, Education

and Communication Program, No. 12 Environmental
Management and Inter -institutional Coordination
Program.

COMMENTS OF THE MINISTRY

The Ministry authorizes the amendment and integration of
the Sheet proposed by the National Narcotics Directorate.

• RECORD 7. PUBLIC HEALTH PROGRAM.
Corresponds to Health care activities included in Sheet
No. 9 – Social Management Program of current EPM.
This Sheet is added to the EMP as a new Public Health

Program.

COMMENTS OF THE MINISTRY

This Record is included in the EMP document to be
evaluated as a new Program, which includes health care
activities included in Record No. 9 – Social Management

Program of current Plan. The content of this Record is the

10 Annex 34

result of an agreement reached by the Ministry of Social

Protection, DNE and DIRAN. It currently has a budget for
its implementation and is being developed by the National
Health Institute (INS). This Record is the responsibility of
the Ministry of Social Protection.

• RECORD 8. CONTINGENCY PLAN. Corresponds to
current Record No. 13. – PECIG´s Contingency Plan.

COMMENTS OF THE MINISTRY

This Sheet replaces current Sheet No. 13 of EMP which
also corresponds to PECIG´s Contingency Plan; it
maintains the structure of the previous plan and states
responsibilities in a more precise manner.

3. TECHNICAL OPINION

After an assessment made to the amendment document of the Program

for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate
-PECIG , the Ministry is of the opinion:

1. From the technical and environmental point of view, it is
viable to amend the Program for the Eradication of Illicit
Crops by Aerial Spraying with Glyphosate -PECIG - according
to the proposal submitted by the National Narcotics
Directorate (DNE) in the communication referred to above and

taking account of the following conditions:
a. The entities responsible for the compliance with the
Environmental Management Plan Record s must submit

semiannual reports describing all activities undertaken in the
EMP, including training programs developed during this
period, specifically detailing the activities undertaken to
comply with the buffer strips on environmental issues.

b. DNE must submit, within 60 days, the schedule and the
General Budget for the amended Program for the Eradication
of Illicit Crops by Aerial Spraying with Glyphosate –PECIG.

11Annex 34

c. The dosage authorized by ICA and accepted by the Ministry
per Resolution 099 of January 31, 2003 is maintained.

End of opinion

[Signed]
JOSE AGUSTIN ZEA PEREZ
[Signed] [Signed]
Contractor PAMELA OCAMPO DORA MARLEN VEGA

Contractor Contractor

Reviewed by:

[Signed] [Signed]

JAIRO HOMEZ SANCHEZ SERGIO ALBERTO CRUZ F
Counsel

Aproved

[Signed]

GUILLERMO ACEVEDO M

Advisor to Deputy Minister

12 Annex 35

Ministry ohealth,

toxicologicalopinionn° lp– 0173 – 93, pril1993;
toxicologicalopinionn° Mp– 12118 – 2001, 5oveMber 2001;

toxicologicalopinionn° lp– 12499 – 2002, 2pril2002

(Archives of the Colombian Foreign Ministry)

1314 Annex 35

REPUBLIC OF COLOMBIA

MINISTRY OF HEALTH

006882 SPT – 0173 – 93

2 APR 1993

Santafe de Bogota D.C.

March 17, 1993

Mr. CARLOS HERNAN RICO R.
Head of Agriculture Supplies Division

Colombian Agriculture Institute
Bogota

Dear Sir,
As regards the Health Regulations on Use and Handling of Pesticides under Decree 1843
of 1991 and ICA regulatory Resolutions 992 of 1992 and 10834 of the Ministry of Health,

THE MINISTRY OF HEALTH ISSUES THE
FOLLOWING PROVISIONAL TOXICOLOGY
OPINION, LP-0173-93

1. TOXICOLOGY CLASSIFICATION

ROUNDUP HERBICIDE, LIQUID CONCENTRATE WATER SOLUBLE PRODUCED BY
MONSANTO COLOMBIANA INC. WITH THE FOLLOWING COMPOSITION:

ACTIVE INGREDIENT(S) CONCENTRATION
Glyphosate 480 g/L

N-phosphonomethylglycine

ADDITIVE INGREDIENT(S) CONCENTRATION
Surfactant q.s. 1 Liter

THIS BELONGS IN TOXICOLOGY CATEGORY IV, SLIGHTLY TOXIC.

15Annex 35

2. USE PERMIT

ROUNDUP HERBICIDE, LIQUID CONCENTRATE WATER SOLUBLE produced
by MONSANTO COLOMBIANA INC. may be used in the country for
AGRICULTURE USE, provided that the established regulations are satisfied and
the necessary requirements are adopted to avoid health damages according to
CATEGORY IV, SLIGHTLY TOXIC.

3. This opinion supersedes the prior opinion: BP-4018-92

Sincerely,

(Signed and sealed) (Signed and sealed)

CARLOS CALDERÓN LLANTEN ALBA LUZ CASTRO MANCERA
Deputy Director Risk Factor Control Head Division Potentially Toxic
Substances

Cc. MONSANTO COLOMBIANA INC.
Atn. Eng. RUBEN GERMAN CRUZ K.

16 Annex 35

REPUBLIC OF COLOMBIA
MINISTRY OF HEALTH

Bogota D.C. CRQ-964-2001
Code 5050

Dr Carlos Augusto Villamizar-Quesada
Agricultural Materials Division
Colombian Agriculture Institute - ICA
Calle 37 No. 8-43 p. 4
Bogota

Dear Sir or Madam,

The Public Health Division of the Ministry of Health has conducted an
evaluation ordered by Decree 1843/1991, Chapter X, and issues the following
TOXICOLOGICAL OPINION MP 12118-2001

1. USE PERMIT

The herbicide FUETE SOLUBLE LIQUID of CIA AGRICOLA COLOMBIANA
LTDA whose composition is:

Active ingredients Concentration

Glyphosate 480 g/L
N- (phosponomethyl)glycine

Additive ingredients Concentration
Polyoxyethylene amine water to complete 1 L

May be used in Colombian territory in application of agricultural use, following
the current provisions of law and adopting measures necessary for the
protection of health in accordance with the following:

2. TOXICOLOGICAL CATEGORY
The herbicide FUETE SOLUBLE LIQUID of CIA AGRICOLA COLOMBIANA

LTDA, with the formulation expressed above, correspondence to toxicological
category III, Moderately Toxic, and therefore, the appropriate measures for
protection should be used, taking account of recommended practices in current
regulations.

17Annex 35

The holder of this Toxicological Opinion will comply with Law 430/98, Decree

1843/91, and Title F of Resolution 0822/98 of the Ministry of Development,
specifically, in the handling of waste and containers of pesticides

Note: THIS TOXICOLOGICAL OPINION SUPERSEDES THE PRIOR

OPINIONS MP-5230-94 AND LV-5026-94, DUE TO TOXICOLOGICAL
RECLASSIFICATION, AND MODIFICATION OF THE QUANTITATIVE
COMPOSITION

Cordially,

(signed)
Isabel Cristina Ruiz-Buitrago Ricardo Leon Vega-Aragon
Director General, Public Health Coordinator, Health Protection Group

(signed)

Ana Ruth Ramirez-Guzman
Professional, Chemical Risks

Copy: CIA AGRICOLA COLOMBIANA LTDA,
Calle 100 No. 7-33 Bogota

Reference number 1874 and 2081
Anna Ruth Ramirez- Guzman October 31, 2001

18The holder of this Toxicological Opinion will comply with Law 430/98, Decree

1843/91, and Title F of Resolution 0822/98 of the Ministry of Development,
specifically, in the handling of waste and containers of pesticides

Note: THIS TOXICOLOGICAL OPINION SUPERSEDES THE PRIOR

OPINIONS MP-5230-94 AND LV-5026-94, DUE TO TOXICOLOGICAL
RECLASSIFICATION, AND MODIFICATION OF THE QUANTITATIVE
COMPOSITION

Cordially,

(signed)
Isabel Cristina Ruiz-Buitrago Ricardo Leon Vega-Aragon
Director General, Public Health Coordinator, Health Protection Group

(signed)

Ana Ruth Ramirez-Guzman
Professional, Chemical Risks

Copy: CIA AGRICOLA COLOMBIANA LTDA,
Calle 100 No. 7-33 Bogota

Reference number 1874 and 2081
Anna Ruth Ramirez- Guzman October 31, 2001Annex 35

The bearer of this Opinion must comply with Law 430/98, Decree 1843/91 and
Title F of Resolution 6822/98 of the Ministry of Development, particularly in the

management of waste and pesticide containers.

The General Director of Public Health signs this Opinion, which was prepared
by Victor M. Varela M.

Sincerely,

(Signed)
ISABEL CRISTINA RUIZ BUITRAGO
General Public Health Office

(Signed)
RICARDO LEON VEGA ARAGON
Health Protection Coordinator

(Signed)
VICTOR MANUEL VARELA M.
University Professional

Cc. FERNANDO SILVA
CIA. AGRICOLA COLOMBIANA LTDA. Calle 100 No. 7-33, Of 1901 Bogota

File No. 459
Drafted by: Victor B. Varela B. 17-4-2002

20 Annex 36

N OTESPD338 FROM THEC OLOMBIANA GRICULTURE AND

LIVESTOCKINSTITUTE TO TMEINISTRY FOR TENVIRONMENT
ENCLOSING WATER SAMPLES ANALYSIS RESULTS FROMATUMBO
REGION,18JULY2002

(Archives of the Colombian Foreign Ministry)

21 REPUBLIC OF COLOMBIA

Ministry of Justice and Law

National Narcotics Directorate

Bogotá D.C. 18 JULY 2002

SPD - 338

JUAN MAYR MALDONADO

MINISTER FOR THE ENVIRONMENT

Ref: Analysis of water samples – Catatumbo Region

Dear Mr. Minister:

In response to the E nvironmental Monitoring activities referred to in
Environmental Management Plan, attached are the results of laboratory tests on water
samples that were collected in the Catatumbo region, under the sample codes No. IR - 29,
IR - 30, IR - 31 and IR - 32.

It was determined that in t he above results
samples.

Sincerely,

[Signed]
GABRIEL MERCHAN BENAVIDES

Director

Encl. 5 pages

SPD/asrjustes/Correspondencia Direccion/MMAanalisiscatatumbo.doc

Cra. 16 A #79-08 PBX 691-6770 – FAX 691-6690 – email: [email protected] Bogotá

22 Annex 36

REPUBLIC OF COLOMBIA

Ministry of Justice and Law

National Narcotics Directorate

Bogotá D.C. 18 JULY 2002

SPD - 338

JUAN MAYR MALDONADO
MINISTER FOR THE ENVIRONMENT

Ref: Analysis of water samples – Catatumbo Region

Dear Mr. Minister:

In response to the E nvironmental Monitoring activities referred to in the PECIG
Environmental Management Plan, attached are the results of laboratory tests on water

samples that were collected in the Catatumbo region, under the sample codes No. IR - 29,
IR - 30, IR - 31 and IR - 32.

It was determined that in t he above results there was no glyphosate present in the

samples.

Sincerely,

[Signed]
GABRIEL MERCHAN BENAVIDES
Director

Encl. 5 pages

C/pma ajustes/Correspondencia Direccion/MMAanalisiscatatumbo.doc
SPD/asr

Cra. 16 A #79-08 PBX 691-6770 – FAX 691-6690 – email: [email protected] Bogotá

23Annex 36

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

2.5.10

Mosquera (Cund.)

Acknowledge receipt

Ministry of Justice and the Law

National Narcotics Directorate
Attn. Dr. ALEXANDRA SHOONEWOLLFFROMERO
Deputy Director of Prevention and Development

Cra 16 A No. 79-08
Tel: 691-6770
Bogota

Ref: Analysis Results

For your information and relevant purposes, I am attaching the results of the glyphosate analysis in
four water samples that were collected in the Catatumbo region. The samples were encoded in the

lab as: IR - 29, IR - 30, IR – 31, and IR - 32.

Best regards,

[Signed ]
CARLOS A. SALCEDO SALAZAR
Coordinator, National Laboratory Group. Agricultural Supplies, LANIA

ICA – Tibaitata

“AGRICULTURAL PROTECTION
OUR COMMITMENT TO PEACE”

CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

24 Annex 36

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

AC-RC-20
L.A.N.I.A. TEST REPORT PAGE 1

CLIENT NATIONAL NARCOTICS LANIA CODE IR - 029
DIRECTORATE
DATE OF RECEPTION 02-JULY-2002 ISSUE DATE 04-JULY-2002

NAME BAG No. 2 WATER CATATUMBO REGION
Type of Material: Water
It is our pleasure to present the findings of the analysis requested by

SCOPE OF REPORT you. These results a re only applicable to the samples delivered and it
does not pertain to the Official Control to which ICA is bound.

Glyphosate: High efficiency liquid chromatography with post column
METHOD
derivatization and fluorescence detector, under Standard AR-NE-05

DATE OF ANALYSIS 04-JULY-2002

RESULTS

GLYPHOSATE: Undetected
Detection Limit: 7.0 μg/l

[Signed (p.p.)] [Signed]
CARLOS A. SALCEDO SALAZAR
Coordinator, National Laboratory Group. Agricultural CASTRO JIMENEZ PQ-0824
Supplies, LANIA Chemist

“AGRICULTURAL PROTECTION- OUR COMMITMENT TO PEACE”
CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

25Annex 36

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

AC-RC-20
L.A.N.I.A. TEST REPORT
PAGE 1

NATIONAL NARCOTICS
CLIENT DIRECTORATE LANIA CODE IR - 030

DATE OF RECEPTION 02-JULY-2002 ISSUE DATE 04-JULY-2002
BAG No. 3 WATER CATATUMBO REGION
NAME Type of Material: Water

It is our pleasure to present the findings of the analysis requested by
SCOPE OF REPORT you. These results are only applicable to the samples delivered and it
does not pertain to the Official Control to which ICA is bound.

METHOD Glyphosate: High efficiency liquid chromatography with post column
derivatization and fluorescence detector, under Standard AR-NE-05

DATE OF ANALYSIS 04-JULY-2002

RESULTS

GLYPHOSATE: Undetected
Detection Limit: 7.0 μg/l

[Signed (p.p.)] [Signed]
CARLOS A. SALCEDO SALAZAR RENE A. CASTRO JIMENEZ PQ-0824
Coordinator, National Laboratory Group. Agricultural
Supplies, LANIA Chemist

“AGRICULTURAL PROTECTION- OUR COMMITMENT TO PEACE”
CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

26 Annex 36

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

AC-RC-20
L.A.N.I.A. TEST REPORT PAGE 1

CLIENT NATIONAL NARCOTICS LANIA CODE IR - 031
DIRECTORATE
DATE OF RECEPTION 02-JULY-2002 ISSUE DATE 04-JULY-2002

NAME BAG No. 4 WATER CATATUMBO REGION
Type of Material: Water
It is our pleasure to present the findings of the analysis requested by

SCOPE OF REPORT you. These results are only applicable to the samples delivered and it
does not pertain to the Official Control to which ICA is bound.

Glyphosate: High efficiency liquid chromatography with post column
METHOD
derivatization and fluorescence detector, under Standard AR-NE-05

DATE OF ANALYSIS 04-JULY-2002

RESULTS

GLYPHOSATE: Undetected

Detection Limit: 7.0 μg/l

[Signed (p.p.)]
CARLOS A. SALCEDO SALAZAR [Signed]
Coordinator, National Laboratory Group. Agricultural CASTRO JIMENEZ PQ-0824
Chemist
Supplies, LANIA

“AGRICULTURAL PROTECTION- OUR COMMITMENT TO PEACE”
CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

27Annex 36

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

AC-RC-20
L.A.N.I.A. TEST REPORT PAGE 1

CLIENT NATIONAL NARCOTICS LANIA CODE IR - 032
DIRECTORATE
DATE OF RECEPTION 02-JULY-2002 ISSUE DATE 04-JULY-2002

NAME BAG No. 5 WATER CATATUMBO REGION
Type of Material: Water
It is our pleasure to present the findings of the analysis requested by

SCOPE OF REPORT you. These results are only applicable to the samples delivered and it
does not pertain to the Official Control to which ICA is bound.

Glyphosate: High ef ficiency liquid chromatography with post column
METHOD
derivatization and fluorescence detector, under Standard AR-NE-05

DATE OF ANALYSIS 04-JULY-2002

RESULTS

GLYPHOSATE: Undetected

Detection Limit: 7.0 μg/l

[Signed (p.p.)]
CARLOS A. SALCEDO SALAZAR [Signed]
Coordinator, National Laboratory Group. Agricultural CASTRO JIMENEZ PQ-0824
Chemist
Supplies, LANIA

“AGRICULTURAL PROTECTION- OUR COMMITMENT TO PEACE”
CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

28 Annex 37

N OTEN°00118,FROM THECOLOMBIAN AGRICULTURE AND

L IVESTOCKNSTITUTE TO THNATIONALN ARCOTICS
DIRECTORATE ENCLOSING WATER SAMPLES ANALYSIS RESULTS
FROMC AQUETÁ REGIO,10JANUARY 2003

(Archives of the Colombian Foreign Ministry)

29 MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

2.

Bogotá, 10 JAN2003

National Narcotics Directorate, When answering note File No.: E -2003-01184, Date: 2003/01/13; Time: 08:43:50; Area:
NATIONAL DIRECTOR

Col. ALFONSO PLAZAS VEGA ( Ret’d)

Director
National Narcotics Directorate
Carrera 16 A No. 79-08

Bogotá, D.C.

Dear Col Plazas:

I am submitting the results of water samples encoded as IR-052/053 for the analysis
of residues of glyphosate and its metabolite AMPA.

Sincerely,

[Signed]
ALVARO ABISAMBRA ABISAMBRA
General Manager

“AGRICULTURAL PROTECTION, OUR COMMITMENTTO PEACE”

ICA, “2001 National Award
for Executive Management”

CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

30 Annex 37

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

00118

2.

Bogotá, 10 JAN2003

National Narcotics Directorate, When answering note File No.: E -2003-01184, Date: 2003/01/13; Time: 08:43:50; Area:
NATIONAL DIRECTOR

Col. ALFONSO PLAZAS VEGA ( Ret’d)

Director
National Narcotics Directorate
Carrera 16 A No. 79-08

Bogotá, D.C.

Dear Col Plazas:

I am submitting the results of water samples encoded as IR-052/053 for the analysis
of residues of glyphosate and its metabolite AMPA.

Sincerely,

[Signed]
ALVARO ABISAMBRA ABISAMBRA
General Manager

“AGRICULTURAL PROTECTION, OUR COMMITMENTTO PEACE”

ICA, “2001 National Award
for Executive Management”

CALLE 37 No. 8-43 PISOS 4 Y 5 APARTADO AEREO 7984 FAX 285 4351 - 2882771
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

31Annex 37

National Police
Antinarcotics Division
Bogotá, 10 JAN 2003

No. 078 / DIRAN - DIREC

RE: Delivery of document

To: Doctor
ALFONSO PLAZAS VEGA

National Narcotics Director
Bogotá, D.C.

I am enclosing the laboratory results IR052 and IR053 performed on a
water sample. It should be noted that the spraying was done with a dose of 10.4 liters per
hectare, at a height of 27. 9 meters and the aircraft at a flight speed of 140 knots.

Sincerely,

[Signed]
Brigadier general JAIME AUGUSTO VERA GARAVITO
Antinarcotics Director

Encl. As announced

“I AM PROUD TO BE A POLICE OFFICER”
[email protected]

32 Annex 37

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

L.A.N.I.A. TEST REPORT AC-RC-20
PAGE 1

NATIONAL NARCOTICS DIRECTORATE
CLIENT LANIA CODE IR - 053
ILLICIT CROP ERADICATION AREA
DATE OF 08-JANUARY-
RECEPTION 30-DECEMBER-2002 ISSUE DATE 2003

WATER LENTIC BODY WELL MONTAÑITA LOCATION
NAME (CAQUETA);
DATE OF COLLECTION: 29-DEC-2002, TIME: 12:40

SCOPE OF It is our pleasure to present the findings of the analysis requested by you.
These results are only applicable to the samples deliveret does not
REPORT pertain to the Official Control to which ICA is bound.

METHOD Glyphosate: High efficiency liquid chromatography with post column
derivatization and fluorescence detector, under sample standard AR-NE-05

DATE OF ANALYSIS 08-JAN-2003

RESULTS

Active ingredient Results Recovery % DL (μg/L)

GLYPHOSATE: U 34.2 7.3
AMPA (aminomethylphosphonic acid) U 34.9 3.6

Yellow sample with the presence of suspended solids.

U: Undetected

DL: Detection Limit

[Signed (p.p.)]
CARLOS A. SALCEDO SALAZAR [Signed]
RENE A. CASTRO JIMENEZ PQ-0824
Coordinator, National Laboratory Group. Agricultural Chemist
Supplies, LANIA

“AGRICULTURAL PROTECTION- OUR COMMITMENT TO PEACE”

PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

[Translator’s note: There is a handwritten text at the top right that says: 3775
There is a seal on the chart that says: TOTAL OR PARTIAL TRANSCRIPTION IS PROHIBITED, National Laboratory

of Agricultural Supplies, ICA]

33Annex 37

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT When responding, include this number

L.A.N.I.A. TEST REPORT AC-RC-20
PAGE 1

CLIENT NATIONAL NARCOTICS DIRECTORATE LANIA CODE IR - 052
ILLICIT CROP ERADICATION AREA
DATE OF 08-JANUARY-
RECEPTION 30-DECEMBER-2002 ISSUE DATE 2003

CURRENT OF WATER; DATE OF COLLECTION: 29 -DEC-2002, TIME:
NAME 12:25; SAMPLE COLLECTION: MUNICIPALITY OF MONTAÑITA
(CAQUETA)

SCOPE OF It is our pleasure to present the findings of the analysed by you.
These results are only applicable to the samples delivered and it does not
REPORT pertain to the Official Control to which ICA is bound.

METHOD Glyphosate: High efficiency liquid chromatography with post column
derivatization and fluorescence detector, under sample standard AR-NE-05

DATE OF
08-JAN-2003
ANALYSIS

RESULTS

Active ingredient Results Recovery % DL (μg/L)

GLYPHOSATE: U 80.5 7.3
AMPA (aminomethylphosphonic acid) U 62.9 3.6

U: Undetected

DL: Detection Limit

[Signed (p.p.)]
CARLOS A. SALCEDO SALAZAR [Signed]
RENE A. CASTRO JIMENEZ PQ-0824
Coordinator, National Laboratory Group. Agricultural Chemist
Supplies, LANIA

“AGRICULTURAL PROTECTION- OUR COMMITMENT TO PEACE”
PBX 285 5520 – 258 4800 – 332 3700 e-mail: documentacion@ica gov.co BOGOTAD.C. COLOMBIA

[Translator’s note: There is a handwritten text at the top right that says: 3776

There is a seal on the chart that says: TOTAL OR PARTIAL TRANSCRIPTION IS PROHIBITED, National Laboratory
of Agricultural Supplies, ICA]

34 Annex 38

RECORDS OFW ATERSAMPLES ANALYSESR ESULTS2005-200IN

THE FRAMEWORK OF THEPROGRAM FOR THEERADICATION OF
ILLICIC ROPS BA ERIALSPRAYING WITG LYPHOSATE(PECIG).

(Archives of the Colombian Foreign Ministry)

35 CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING

Date Bogotá D.C. February 15, 2007
Company US EMBASSY – NAS OFFICE
Ordered by Mr. Gustavo Vargas

Fax -
Tel 383-2258
Address Carrera 45 No. 22D-45 Bogota
Analysis requested Analysis of Glyphosate and AMPA in water sample
Sample See Chart 1
Responsible for Sample Antinarcotics Division

Type of Sampling Specific
Date of Sampling January 30, 2007
Date of Entry February 2, 2007
Point of Sampling See Chart 1

l. Identification of Samples

The samples analyzed belong to two water samples taken for the Monitoring Program of
the US Embassy of glyphosate herbicide and its aminomethylphosphonic acid metabolite
(AMPA) in water. The samples were forwarded by the Antinarcotics Division of the

National Police to LAQMA LTDA.

Chart 1 Identification of samples

LAQMA Code Field Code
LQ6335 BAS-300107-LAR-ZANDRE-AGUA-DRENAJE
LQ6336 BAS-300107-LAR-LAGO-AGUA-TIEMPOO

2. MATERIALS AND EQUIPMENT

2.1 a) Reactives. Standard certificate of compound analyzed: Glyphosate N-
(phosphonomethylglycine) shows Dr. Ehrenstorfer Lot 40401, 98 ± 0.5% purity;

aminomethylphosphonic acid AMPA shows Dr. Ehrenstorfer Lot 21104, 98 ± 0.5% purity,
derivatization reagent. P- toluensulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,
lot 13224 EC.

b) Organic solvents for extraction, purification and mobile phase for HPLC reading were

all HPLC grade.

36 Annex 38

CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING

Date Bogotá D.C. February 15, 2007
Company US EMBASSY – NAS OFFICE
Ordered by Mr. Gustavo Vargas

Fax -
Tel 383-2258
Address Carrera 45 No. 22D-45 Bogota
Analysis requested Analysis of Glyphosate and AMPA in water sample
Sample See Chart 1
Responsible for Sample Antinarcotics Division

Type of Sampling Specific
Date of Sampling January 30, 2007
Date of Entry February 2, 2007
Point of Sampling See Chart 1

No. 1646/07
l. Identification of Samples

The samples analyzed belong to two water samples taken for the Monitoring Program of
the US Embassy of glyphosate herbicide and its aminomethylphosphonic acid metabolite
(AMPA) in water. The samples were forwarded by the Antinarcotics Division of the

National Police to LAQMA LTDA.

Chart 1 Identification of samples

LAQMA Code Field Code Date of Entry
LQ6335 BAS-300107-LAR-ZANDRE-AGUA-DRENAJE February 2007
LQ6336 BAS-300107-LAR-LAGO-AGUA-TIEMPOO

2. MATERIALS AND EQUIPMENT

2.1 a) Reactives. Standard certificate of compound analyzed: Glyphosate N-
(phosphonomethylglycine) shows Dr. Ehrenstorfer Lot 40401, 98 ± 0.5% purity;

aminomethylphosphonic acid AMPA shows Dr. Ehrenstorfer Lot 21104, 98 ± 0.5% purity,
derivatization reagent. P- toluensulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,
lot 13224 EC.

b) Organic solvents for extraction, purification and mobile phase for HPLC reading were

all HPLC grade.

37Annex 38

2.2 Equipment: Shimadzu Liquid Chromatograph Model LC-6A equipped with two high
pressure pumps. Sil 58 autoinjector, UV-160A UV detector variable wavelength: SCL-6B
system controller and C-R6A Chromatopac as a signal integrator.

3. METHODOLOGY FOR ANALYSIS AND TREATMENT OF THE SAMPLE

Chart 2 presents the methodology for the analysis of glyphosate and AMPA in water

samples.

Chart 2. Methodology of Analysis employed, preservatives and hold time.

Parameter Analysis technique Reference Method Preservation and Max

Hold time until
Analysis
Glyphosate/AMPA HPLC derivatization with J. Chrom. 540 14 days until
Herbicide P- toluensulfonyl (1991) 411-415 extraction/40 days

chloride after extraction

Identification of Glyphosate and AMPA. In order to identify Glyphosate and AMPA,
derivatization with p-toluensutfonil chloride was conducted, under alkaline conditions. 1 ml
extract was in alkaline conditions with phosphate buffer pH 11.2; 0.2 ml of reagent p-

toluensutfonil chloride was added and reaction was at 50° C for 5 minutes in thermostatic
bath.

Quantification of glyphosate and AMPA. Quantification was performed by external standard

method using calibration curve in the range of 10 to 30 ng/nl of the derivatives of glyphosate
paratoluensulfonyl chloride and AMPA - p- toluensulfonyl chloride prepared from certified standard
Dr. Ehrenstorfer GMBH.

HPLC Reading conditions. A Nucleoside column Cis 250 mm x 4.6 mm id was used, mobile phase
phosphate buffer pH 2.3 - acetonitrile 85:15 v/v. Flow 1.0 ml/min., Injection volume: 10-20 nL.
Reading wavelength of 235 nm.

4. RESULTS

Table 1 shows the results achieved in the analysis of Glyphosate and AMPA in the water
samples analyzed.

38 Annex 38

Table 1. Analysis Results of Glyphosate and AMPA in two (2) water samples. US Embassy –
NAS Office, January 2007

Identification of Sample Units Results Detection limit
LAQMA Client ID Glyphosate AMPA Glyphosate AMPA
Code mg/L mg/L
LQ6335 BAS-300107-LAR-ZANDRE- mg/L < 0.010 20.53 0.010 0.008
AGUA-DRENAJE
LQ6336 BAS- 3 00107 -LAR-LAGO-AGUA-g/L < 0.010 0.008 0.010 0.008
TIEMPOO

UNITS
mg/L Milligrams of the compound of interest per liter of sample analyzed or ppm
(parts per million)

U Non detectable to limit of detection of method employed

NOTE:
Report is valid for the described analysis; not to be reproduced without lab authorization.

5. COMMENTS TO RESULTS

No Glyphosate of AMPA found in the samples analyzed.

The samples were delivered to the lab by the client and were analyzed just as they were
received.

Sincerely,
[signed] [signed]

MARTHA CARPINTERO OMAR TRUJILLO
Chemist M.Sc. Environmental T.Q. - Chemical Analyst
PQ-0569 T.Q. 053

Technical Office

RESULTS OF THE ANALYSIS – CHEMICAL LABORATORY OF ENVIRONMENTAL
MONITORING
Report No. 1646/07 CRA 30 No. 90-33 Tel. 236-6178, Fax 621-9213

39Annex 38

CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING
RESULTS OF THE ANALYSIS

Date Bogotá D.C. November 10, 2006
Company US EMBASSY – NAS OFFICE
Ordered by Mr. Gustavo Vargas

Fax -
Tel 383-2258
Address Carrera 45 No. 22D-45 Bogota
Analysis requested Analysis of Glyphosate and AMPA in a water sample
Sample See Chart 1

Responsible for Sample Antinarcotics Division
Type of Sampling Specific
Date of Sampling SeeChart1
Date of Entry October 27, 2006
Point of Sampling Chart 1

No. 1513/06
l. Identification of Samples

The sample analyzed belong to one water sample taken for the Monitoring Program of the
US Embassy of glyphosate herbicide and its aminomethylphosphonic acid metabolite

(AMPA) in water. The samples were forwarded by IGAC to LAQMA LTDA. Table 1
identifies the sample analyzed.

Chart 1 Identification of samples

LAQMA Code Field Code Date of Entry
LQ-6012 VER-14-091006-1D167-AGUA-LOT October 27, 2006

2. MATERIALS AND EQUIPMENT

2.1 a) Reactives. Standard certificate of compound analyzed: Glyphosate N-
(phosphonomethylglycine) shows Dr. Ehrenstorfer Lot 40401, 98 ± 0.5% purity;
aminomethylphosphonic acid AMPA shows Dr. Ehrenstorfer Lot 21104, 98 ± 0.5% purity,
derivatization reagent. P- toluensulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,

lot 13224 EC.

b) Organic solvents for extraction, purification and mobile phase for HPLC reading were
all HPLC grade.

40 Annex 38

2.2 Equipment: Shimadzu Liquid Chromatograph Model LC-6A equipped with two high-
pressure pumps. Sil 58 autoinjector, UV-160A UV detector variable wavelength: SCL-6B
system controller and C-R6A Chromatopac as a signal integrator.

3. METHODOLOGY FOR ANALYSIS AND TREATMENT OF THE SAMPLE

Chart 2 presents the methodology for the analysis of glyphosate and AMPA in water
samples.

Chart 2. Methodology of Analysis employed, preservatives and hold time.

Parameter Analysis technique Reference Method
Preservation and Max
Hold time until
Analysis
Glyphosate/AMPA HPLC derivatization with J. Chrom. 540 14 days until

Herbicide P- toluensulfonyl (1991) 411-415 extraction/40 days
chloride after extraction

Identification of Glyphosate and AMPA. In order to identify Glyphosate and AMPA,

derivatization with p-toluensutfonil chloride was conducted, under alkaline conditions. 1
ml extract was in alkaline conditions with phosphate buffer pH 11.2; 0.2 ml of reagent p-
toluensutfonil chloride was added and reaction was at 50° C for 5 minutes in thermostatic
bath.

Quantification of glyphosate and AMPA. Quantification was performed by external standard
method using calibration curve in the range of 10 to 30 ng/nl of the derivatives of glyphosate
paratoluensulfonyl chloride and AMPA - p- tol uensulfonyl chloride prepared from certified

standard Dr. Ehrenstorfer GMBH.

HPLC Reading conditions. A Nucleoside column Cis 250 mm x 4.6 mm id was used, mobile
phase phosphate buffer pH 2.3 - acetonitrile 85:15 v/v. Flow 1.0 ml/min., Injection volume: 10-

20 nL. Reading wavelength of 235 nm.

4. RESULTS
Table 1 shows the results achieved in the analysis of Glyphosate and AMPA in the water

samples analyzed.

41Annex 38

Table 1. Analysis Results of Glyphosate and AMPA in one (1) water sample. US Embassy –
NAS Office, October 2006

Identification of Sample Units Results Detection limit
LAQMA Code Client ID Glyphosate AMPA Glyphosate AMPA mg/L
mg/L
LQ-6012 VER-14-091006- mg/L U U 0.010 0.008
1D167-AGUA-
LOT

UNITS
mg/L Milligrams of the compound of intest per liter of sample analyzed or ppm

(parts per million)
U Non detectable to limit of detection of method employed

NOTE:
Report is valid for the described analysis; not to be reproduced without lab authorization.

5. COMMENTS TO RESULTS

No Glyphosate of AMPA found in the samples analyzed.

The samples were delivered to the lab by the client and were analyzed just as they were
received

Sincerely,

[signed] [signed]
MARTHA CARPINTERO OMAR TRUJILLO
Chemist M.Sc. Environmental T.Q. - Chemical Analyst
PQ-0569 T.Q. 053

Technical Office

RESULTS OF THE ANALYSIS – CHEM LILABORATORY OF ENVIRONMENTAL

MONITORING
Report No. 1513/06 CRA 30 No. 90-33 Tel. 236-6178, Fax 621-9213, Page 3 of 3

42 Annex 38

CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING

RESULTS OF THE ANALYSIS

Date Bogotá D.C. August 22, 2006
Company US EMBASSY – NAS OFFICE
Ordered by Mr. Gustavo Vargas
Fax -

Tel 383-2258
Address Carrera 45 No. 22D-45 Bogota
Analysis requested Analysis of Glyphosate and AMPA in water samples
Sample Water (See Chart 1)
Responsible for Sample Unidentified

Type of Sampling Unidentified
Date of Sampling Unidentified
Date of Entry August 3, 2006
Point of Sampling See Chart 1

No. 1445/06

l. Identification of Samples

The samples analyzed belong to six (6) water samples taken for the Monitoring Program
of the US Embassy of glyphosate herbicide and its aminomethylphosphonic acid
metabolite (AMPA) in water. The samples were forwarded by IGAC to LAQMA LTDA.

Table 1 identifies the sample analyzed.

Chart 1 Identification of samples

LAQMA Code Field Code Date of Entry
L-5878 Monitoreo/2006/NorteSantander/60dias/Lotel August 3, 2006
L-5879 Monitoreo/2006/NorteSantander/60dias/Lote 2
L-5880 MONDECAL220606ID02ANTESAGUALOT
L-5881 MONDECAL220606ID02DESP-00AGUALOT

L-5882 MONDECAL220606ID01DESP-00AGUALOT
L-5883 MONDECAL220606ID01ANTESAGUALOT

2. MATERIALS AND EQUIPMENT

2.1 a) Reactives. Standard certificate of compound analyzed: Glyphosate N-
(phosphonomethylglycine) shows Dr. Ehrenstorfer Lot 40401, 98 ± 0.5% purity;

aminomethylphosphonic acid AMPA shows Dr. Ehrenstorfer Lot 21104, 98 ± 0.5% purity,

43Annex 38

derivatization reagent. P- toluensulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,
lot 13224 EC.

b) Organic solvents for extraction, purification and mobile phase for HPLC reading were all

HPLC grade.

2.2 Equipment: Shimadzu Liquid Chromatograph Model LC-6A equipped with two high-
pressure pumps. Sil 58 autoinjector, UV-160A UV detector variable wavelength: SCL-6B

system controller and C-R6A Chromatopac as a signal integrator.

3. METHODOLOGY FOR ANALYSIS AND TREATMENT OF THE SAMPLE

Chart 2 presents the methodology for the analysis of Glyphosate and AMPA in water
samples.

Chart 2. Methodology of Analysis employed, preservatives and hold time.

Parameter Analysis technique Reference Method Preservation and Max
Hold time until
Analysis

Glyphosate/AMPA HPLC derivatization with J. Chrom. 540 14 days until
Herbicide P- toluensulfonyl (1991) 411-415 extraction/40 days
chloride after extraction

Identification of Glyphosate and AMPA. In order to identify Glyphosate and AMPA,
derivatization with p-toluensutfonil chloride was conducted, under alkaline conditions. 1
ml extract was in alkaline conditions with phosphate buffer pH 11.2; 0.2 ml of reagent p-
toluensutfonil chloride was added and reaction was at 50° C for 5 minutes in thermostatic

bath.

Quantification of glyphosate and AMPA. Quantification was performed by external standard
method using calibration curve in the range of 10 to 30 ng/nl of the derivatives of glyphosate

paratoluensulfonyl chloride and AMPA - p- to luensulfonyl chloride prepared from certified
standard Dr. Ehrenstorfer GMBH.

HPLC Reading conditions. A Nucleoside column Cis 250 mm x 4.6 mm id was used, mobile
phase phosphate buffer pH 2.3 - acetonitrile 85:15 v/ v. Flow 1.0 ml/min., Injection volume: 10-

20 nL. Reading wavelength of 235 nm.

4. RESULTS
Table 1 shows the results achieved in the analysis of Glyphosate and AMPA in the water

samples analyzed.

44 derivatization reagent. P- toluensulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,
lot 13224 EC.

b) Organic solvents for extraction, purification and mobile phase for HPLC reading were all
HPLC grade.

2.2 Equipment: Shimadzu Liquid Chromatograph Model LC-6A equipped with two high-

pressure pumps. Sil 58 autoinjector, UV-160A UV detector variable wavelength: SCL-6B
system controller and C-R6A Chromatopac as a signal integrator.

3. METHODOLOGY FOR ANALYSIS AND TREATMENT OF THE SAMPLE

Chart 2 presents the methodology for the analysis of Glyphosate and AMPA in water
samples.

Chart 2. Methodology of Analysis employed, preservatives and hold time.

Parameter Analysis technique Reference Method Preservation and Max
Hold time until

Analysis
Glyphosate/AMPA HPLC derivatization with J. Chrom. 540 14 days until

Herbicide P- toluensulfonyl (1991) 411-415 extraction/40 days
chloride after extraction

Identification of Glyphosate and AMPA. In order to identify Glyphosate and AMPA,
derivatization with p-toluensutfonil chloride was conducted, under alkaline conditions. 1

ml extract was in alkaline conditions with phosphate buffer pH 11.2; 0.2 ml of reagent p-
toluensutfonil chloride was added and reaction was at 50° C for 5 minutes in thermostatic
bath.

Quantification of glyphosate and AMPA. Quantification was performed by external standard

method using calibration curve in the range of 10 to 30 ng/nl of the derivatives of glyphosate
paratoluensulfonyl chloride and AMPA - p- to luensulfonyl chloride prepared from certified
standard Dr. Ehrenstorfer GMBH.

HPLC Reading conditions. A Nucleoside column Cis 250 mm x 4.6 mm id was used, mobile
phase phosphate buffer pH 2.3 - acetonitrile 85:15 v/ v. Flow 1.0 ml/min., Injection volume: 10-

20 nL. Reading wavelength of 235 nm.

4. RESULTS
Table 1 shows the results achieved in the analysis of Glyphosate and AMPA in the water
samples analyzed.Annex 38

CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING

RESULTS OF THE ANALYSIS
Date Bogotá D.C. September 11, 2006

Company US EMBASSY – NAS OFFICE

Ordered by Mr. Gustavo Vargas
Fax -
Tel 383-2258
Address Carrera 45 No. 22D-45 Bogota

Analysis requested Analysis of Glyphosate and AMPA in water samples
Sample Water (SeeChart 1)
Responsible for Sample Antinarcotics División
Type of Sampling Specific

Date of Sampling August 25, 2006
Date of Entry August 28, 2006
Point of Sampling See Chart1

No. 1467/06
l. Identification of Samples

The samples analyzed belong to two (2) water samples taken for the Monitoring Program

of the US Em bassy of g lyphosate herbicide and its aminomethylphosphonic acid
metabolite (AMPA) in water. The samples were forwarded by IGAC to LAQMA LTDA.
Table 1 identifies the sample analyzed.

Chart1 Identification of samples

LAQMACode Field Code Date of Entry

L-5932 MON-DECAL-250806-ID01-DESP-60-AGUA-LOT August 28, 2006
L-5933 MON-DECAL-250806-ID02-DESP-60-AGUA-LOT

2. MATERIALS A ND EQUIP MENT

2.1 a) Reactives . Standard certificate of compound a nalyzed: Gl yphosate N-
(phosphonomethylglycine) s hows Dr. Ehr enstorfer Lot 4040 1, 98 ± 0.5 % purity;

aminomethylphosphonic acid AMPA shows Dr. Ehrenstorfer Lot 21104, 98 ± 0.5% purity,
derivatization reagent. P- toluensulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,
lot 13224 EC.

b) Organic solvents forextraction,purification andmobile phaseforHPLC readingwere
all HPLC grade.

46 Annex 38

2.2 Equipment: Shimadzu Liquid Chromatograph Model LC-6A equipped with two high-
pressure pumps. Sil 58 autoinjector, UV-160A UV detector variable wavelength: SCL-6B

system controller and C-R6A Chromatopac as a signal integrator.

3. METHODOLOGY FOR ANALYSIS AND TREATMENT OF THE SAMPLE

Chart 2 presents the methodology for the analysis of Glyphosate and AMPA in water
samples.

Chart 2. Methodology of Analysis employed, preservatives and hold time.

Parameter Analysis technique Reference Method Preservation and Max
Hold time until
Analysis

Glyphosate/AMPA HPLC derivatization with J. Chrom. 540 14 days until
Herbicide P- toluensulfonyl (1991) 411-415 extraction/40 days
chloride after extraction

Identification of Glyphosate and AMPA. In order to identify Glyphosate and AMPA,
derivatization with p-toluensutfonil chloride wa s conducted, under alkaline conditions. 1 mi

extract was in alkaline conditions with phosphate buffer pH 11.2; 0.2 mi of reagent p-
toluensutfonil chloride was added and reaction was at 50° C for 5 minutes in thermostatic
bath.

Quantification of glyphosate and AMPA. Quantification was performed by external standard
method using calibration curve in the range of 10 to 30 ng/^1 of the derivatives of glyphosate
paratoluensulfonyl chloride and AMPA - p- to luensulfonyl chloride prepared from certified
standard Dr. Ehrenstorfer GMBH.

HPLC Reading conditions. A Nucleoside column Cis 250 mm x 4.6 mm id was used, mobile
phase phosphate buffer pH 2.3 - acetonitrile 85:15 v/ v. Flow 1.0 ml/min., Injection volume: 10-
20 [iL. Reading wavelength of 235 nm.

4. RESULTS
Table 1 shows the results achieved in the analysis of Glyphosate and AMPA in the water
samples analyzed.

47Annex 38

Table 1. Analysis Results of Glyphosate and AMPA in two (2) water samples. US Embassy -
NAS Office, August 2006

Identification of Sample Units Results Detection limit
LAQMA Client ID GlyphosateAMPA GlyphosateAMPA
Code mg/L mg/L
L-5932 MON-DECAL-250806-ID01-DESP- mg/L <DL <DL 0.010 0.008
60-AGUA-LOT
L-5933 MON-DECAL-250806-ID02-DESP- mg/L <DL <DL
60-AGUA-LOT

UNITS
mg/L Milligrams of the compound of interest per liter of sample
analyzed or ppm

(parts per million)

NOTE:
Report is valid for the described analysis; not to be reproduced without lab

authorization.

5. COMMENTS TO RESULTS

No Glyphosate of AMPA found in the samples analyzed.

The samples were delivered to the lab by the client and were analyzed just as
they were received

Sincerely,

(signed) (signed)
MARTHA OMAR
CARPINTERO TRUJILLO

Chemist M.Sc. T.Q. -
Environmental Chemical

PQ- Analyst
0569Technical T.Q. 053

Office

RESULTS OF THE ANALYSIS – CHEMICAL LABORATORY OF ENVIRONMENTAL

MONITORING
Report No. 1467/06 CRA 30 No. 90-33 Tel. 236-6178, Fax 621-9213, Page 3 of 3

48 Annex 38

When responding, include this number.

L.A.N.I.A. TEST REPORT AC-RC-20 PAGE 1/1

CLIENT ACUATECNICA LTDA LANÍA CODE ER 078

DATE OF RECEPTION: OCTOBER 18, 2005 ISSUE DATE: DECEMBER 22, 2005

NAME LARANDIA LAKE WATER, SAMPLE 1 SURFACE RAW WATER,
SURFACE SAMPLING OF LARANDIA LAKE ÁREA OF INFLUENCE.

TYPE OF MATERIAL WATER

SCOPE OF REPORT It is our pleasure to present the findings of the analysis requested by
you. These results are only applicable to the samples delivered and it

does not pertain to the Official Control to which ICA is bound.

METHOD HPLC Liquid chromatography with derivatization post column and
fluorescence direction under internal regulation AR-NE-05.

DATE OF ANALYSIS December 22, 2005

RESULTS

Results (mg/L) DL (ng/L) %Recovery

GLYPHOSATE: 0.01
AMPA U 4

DL: Detection Limit
U: Undetected

(signed) (signed)

RENE A. CASTRO JIMENEZ HUGO A. RODRIGUEZ FAJARDO PQ-1495
Coordinator LANIA Group Chemist

Agricultural Protection- Our Commitment to Peace
C.I. Tibaitata Km 14 via a Mosquera, Laboratorio Nacional de Insumos Agrícolas - LANÍA
Pbx. 422-7371/21, direct line 422-7363/64, Fax 422-7363

49Annex 38

When responding, include this number.

L.A.N.I.A. TEST REPORT AC-RC-20 PAGE 1/1

CLIENT ACUATECNICA LTDA LANIA CODE ER 081

DATE OF RECEPTION: OCTOBER 18, 2005 ISSUE DATE: DECEMBER 22, 2005

NAME LARANDIA LAKE WATER, SAMPLE1 DEEP RAW WATER, DEEP
WATER SAMPLING OF LARANDIA LAK AREA OF INFLUENCE. TYPE
OF MATERIAL WATER

SCOPE OF REPORT It is our pleasure to preshe findings of the analysis requested by
you. These results are only applicable to the samples delivered and it
does not pertain to the Official Control to which ICA is bound.

METHOD HPLC Liquid chromatography with derivatization post column and

fluorescence direction under internal regulation AR-NE-05.

DATE OF ANALYSIS December 22, 2005

RESULTS
Results (mg/L) DL (μg/L) %Recoveiy
GLYPHOSATE: 0.01
AMPA U 4

DL: Detection Limit
U: Undetected

(signed) RENEA. (signed) HUGOA. RODRIGUEZ
CASTRO JIMENEZ FAJARDO PQ-1495 Chemist
Coordinator LANIA Group

Agricultural Protection- Our Commitment toCe.I. Tibaitata Km 14 via a
Mosquera, Laboratorio Nacional de Insumos Agrícolas Pbx. 422-7371/21,LANÍAct
line 422-7363/64, Fax 422-7363

50 Annex 38

When responding, include this number.

L.A.N.I.A. TEST REPORT AC-RC-20 PAGE 1/1

CLIENT NATIONAL NARCOTICS DIVISION LANIA CODE ER 105

DATE OF RECEPTION: DECEMBER 260,5 ISSUE DATE: DECEMBER 30, 2005

NAME ANTINARCOTICS DIVISION WATER SAMPLE, ERADICATION AREA,
SAMPLING CODE MDENAR-05 WATER 1D01AG.
INTERADMINISTRATIVE AGREEMEN FOR SERVICE 045 0F 2004.
TYPE OF MATERIAL: WATER

SCOPE OF REPORT It is our pleasure to prethe findings of the analysis requested by
you. These results are only applicable to the samples delivered and it
does not pertain to the Official Control to which ICA is bound.

Glyphosate: HPLC Liquid chromatography with derivatization post
METHOD
column and direction by fluorescence by direct injection.

DATE OF ANALYSIS December 30, 2005

RESULTS

Results (mg/L) DL (μg/L) %Recoveiy
GLYPHOSATE: U 7
AMPA U 4

DL: Detection Limit
U: Undetected

(signed) RUTE ANALIDA (signed) HUGO A.
BETANCOURTCASTROCoordinator RODRIGUEZ FAJARDO PQ-1495
LANIA Group Professional, Responsible for Residuals Area

Agricultural Protection- Our Commitment toe.I. Tibaitata Km 14 via a

Mosquera, Laboratorio Nacional de Insumos Agrícolas Pbx. 422-7371/21, direct
line 422-7363/64, Fax 422-7363

5152 Annex 39

RECORDS OFS OILSAMPLESA NALYSESRESULTS2005-2008IN THE

FRAMEWORK OF THE PROGRAM FOR THEE RADICATION OILLICIT
CROPS BYAERIAL SPRAYING WITHGLYPHOSATE (PECIG).

(Archives of the Colombian Foreign Ministry)

5354 Annex 39

Kappa Laboratories, Inc.
www.kappalabs.com
Mt. Sinai Medical Center • Biomedical Research

2577 N.W. 74th Avenue • Miami, Florida 33122 Pearlman Building 4300 Alton Road • Miami
Phone (305) 599-0199 • Fax (305) 592-1224 Beach, Florida 33140

LABORATORY REPORT

CLIENT:
Instituto Geografico
Carrera 30 No 48-51

Bogota Colombia

REPORT DATE: 5/2/2005

SOURCE: Soil- Meta Guaviare Nucleus
SAMPLE:DATE: 1/19/2005

SAMPLE RECEIVED: 1200 03/15/2005
SAMPLED BY: Client

JOB #: 340560-3
SAMPLE LOG #: F468

SAMPLE I.D. ID 150 Nariño Province

PARAMETER RESULT UNITS METHODS ANALYST
DETECTION DATE DATE
LIMIT EXT. ANALY.
Glyphosate U /-g/kg 547 250 04/20/05 04/20/05 IF
AMPA U /-g/kg 547 200 04/20/05 04/20/05 IF

Spike 57
Recovery- Percent
Glyphosate
Spike 72

Recovery- Percent
AMPA
U: Undetected

Kappa Laboratories has been inspected and is currently certified by the U.S. Department of

Agriculture (USDA Microbiology# 0093)
The Florida Dept of Health, Drinking Water, Including Microbiology, Pesticides and PCB’s

Environmental certification as Basic Environmental Laboratory (DOH # E86515) (FDEP
CompQAP [...]) Registered with the U.S. Food and Drug Administration (FDA # 1039389)
and is an FDA Accepted Laboratories for Impact Testing. Kappa Laboratory is currently a

Contract Laboratory to the U.S. Centers for Disease Control (CDC) Atlanta Georgia, Vessel
Sanitation Program.

Test results meet all Requirements of NELAC requirements.

Signed: (signed)
Denise Kmieck

Manager, Kappa Laboratories, Inc.

55Annex 39

Kappa Laboratories, Inc.
www.kappalabs.com
Mt. Sinai Medical Center • Biomedical Research
2577 N.W. 74th Avenue • Miami, Florida 33122 Pearlman Building 4300 Alton Road • Miami

Phone (305) 599-0199 • Fax (305) 592-1224 Beach, Florida 33140

LABORATORY REPORT
CLIENT:

Instituto Geografico
Carrera 30 No 48-51

Bogota Colombia

REPORT DATE: 5/2/2005

SOURCE: Soil-
SAMPLE:DATE: 1/19/2005
SAMPLE RECEIVED: 1200 03/15/2005

SAMPLED BY: Client

JOB #: 340560-3
SAMPLE LOG #: F469

SAMPLE I.D. ID 143 Nariño Province

PARAMETER RESULT UNITS METHODS DETECTION DATE DATE ANALYST

LIMIT EXT. ANALY.
Glyphosate U /-g/kg 547 250 04/20/05 04/20/05 IF
AMPA U /-g/kg 547 200 04/20/05 04/20/05 IF

Spike 57
Recovery- Percent
Glyphosate
Spike 72
Recovery- Percent

AMPA
U: Undetected

Kappa Laboratories has been inspected and is currently certified by the U.S. Department of

Agriculture (USDA Microbiology# 0093)
The Florida Dept of Health, Drinking Water, Including Microbiology, Pesticides and PCB’s
Environmental certification as Basic Environmental Laboratory (DOH # E86515) (FDEP

CompQAP [...]) Registered with the U.S. Food and Drug Administration (FDA # 1039389)
and is an FDA Accepted Laboratories for Impact Testing. Kappa Laboratory is currently a

Contract Laboratory to the U.S. Centers for Disease Control (CDC) Atlanta Georgia, Vessel

Sanitation Program.
Test results meet all Requirements of NELAC requirements.

Signed: (signed)
Denise Kmieck

Manager, Kappa Laboratories, Inc.

56 Annex 39

Kappa Laboratories, Inc.
www.kappalabs.com

Mt. Sinai Medical Center • Biomedical Research
2577 N.W. 74th Avenue • Miami, Florida 33122 Pearlman Building 4300 Alton Road • Miami
Phone (305) 599-0199 • Fax (305) 592-1224 Beach, Florida 33140

LABORATORY REPORT

CLIENT:
Instituto Geografico

Carrera 30 No 48-51
Bogota Colombia

REPORT DATE: 5/2/2005

SOURCE: Soil-
SAMPLE:DATE: 1/19/2005

SAMPLE RECEIVED: 1200 03/15/2005
SAMPLED BY: Client

JOB #: 340560-3

SAMPLE LOG #: F470
SAMPLE I.D. ID 140 Nariño Province

PARAMETER RESULT UNITS METHODS DETECTION DATE DATE ANALYST
LIMIT EXT. ANALY.
Glyphosate U /-g/kg 547 250 04/20/05 04/20/05 IF

AMPA U /-g/kg 547 200 04/20/05 04/20/05 IF
Spike 57
Recovery- Percent
Glyphosate

Spike 72
Recovery- Percent
AMPA

U: Undetected

Kappa Laboratories has been inspected and is currently certified by the U.S. Department of
Agriculture (USDA Microbiology# 0093)
The Florida Dept of Health, Drinking Water, Including Microbiology, Pesticides and PCB’s

Environmental certification as Basic Environmental Laboratory (DOH # E86515) (FDEP
CompQAP [...]) Registered with the U.S. Food and Drug Administration (FDA # 1039389)

and is an FDA Accepted Laboratories for Impact Testing. Kappa Laboratory is currently a

Contract Laboratory to the U.S. Centers for Disease Control (CDC) Atlanta Georgia, Vessel
Sanitation Program.

Test results meet all Requirements of NELAC requirements.

Signed: (signed)
Denise Kmieck
Manager, Kappa Laboratories, Inc.

57Annex 39

SOIL LABORATORY

RESULTS OF CHEMICAL ANALYSIS OF SOIL
RESULTS OF CHEMICAL ANALYSIS OF SOIL

Date: Day 22, Month 08, Year 2005
]Date: Day 22, Month 08, Year 2005

Province: Nariño Municipality: Location:
Province: Nariño Municipality: Location:
Sender: Environmental Monitoring Program PECIG Laboratory No. 3-59652 A 655
Sender: Environmental Monitoring Program PECIG Laboratory No. 3-59652 A 655

Field ID Granulometry Texture Gravel pH AI SAI Salinity P Organic
Field ID Granulometry classure %Gravel pH AI SAI Salinittotal P materialganic
Sand Lime Cía class % 1.1 1.2 [...] [...] ppin totaOC mNterial
Sand Cía 1.1 1.2 [...] [...] ppin OC N
% %ime y % [...] total
V12-05 SUELO ID - % % y % [...] total
V12-05 SUELO ID - 39.9 24.9 35.2 FA * 4.3 2.1 50.9 241 2.7 0.13
V184-AC -SUBÍID - 39.9 24.9 35.2 FA * 4.3 2.1 50.9 241 2.7 0.13
84-AC -SUB2 42.8 25.4 31.8 FA * 4.7 0.71 10.4 161 4.1 0.18
V12-05 SUELO ID -
84-AC -SUB2 42.8 25.4 31.8 FA * 4.7 0.71 10.4 161 4.1 0.18
V12-05 SUELO ID - 70.2 21.3 8.5 FA * 5.3 0.75 15.9 1057 4.2 0.25
V183-AC -SUBÍID - 70.2 21.3 8.5 FA * 5.3 0.75 15.9 1057 4.2 0.25
V12-05 SUELO ID - 68.9 22.8 8.3 FA * 4.5 1.9 78.2 1025 5.0 0.31
Exchange complex (meq /100 g) SB Trace elements (ppin) ppin
83-AC -SUB2 68.9 22.8 8.3 FA * 4.5 1.9 73.2 1026 5.0 0.31
[...] Exchange complex (meq /100 g) [...] SB Mag IrTrace elementsCop (ppin)o [...] [...] Suppin Phos
um esium sium ium nesi per n r phor
[...] Calci Magn Potas Sod [...] um Mag Iron Zinc Cop Boro [...] [...] Susfü Phos
um esium sium ium nesi per n r phor
17.8 1.2 0.38 0.27 0.11 2.0 11.3 um 33.5 20.7 2.2 us
27.1 4.8 0.95 0.33 0.06 6.1 22.7 49.9 29.6 1.4
33.8 2.1 0.638 1.127 0.1611 4.0.0 11.8.3 30.4 33.26.2 20.7 15.4 2.2
33.7 0.07 0.105 0.2233 0.1306 0.521 1.52.7 32.3 49.8.0 29.6 9.8 1.4
33.8 2.1 0.63 1.1 0.16 4.0 11.8 30.4 26.2 15.4
*33.7 SAMPLE0.07 NOT 0.10TER P0.22RLY:0.13 % OF 0.52 MAY BE1.5EATER 32.3 8.0 9.8

METHODS: […] texture, exchangeable acidity (EAw )ith KCI, electrical conductivity of the
* THE SAMPLE DID NOT SCATTER PROPERLY: THE % OF CLAY MAY BE GREATER
saturation extract. Organic carbon (OC), […] available phosphorus (P) […] carbon
METHODS: […] texture, exchangeable acidity (EAw )ith KCI, electrical conductivity of the
exchange capacity and exchange basis (calcium, magnesium, potassium and sodium. […]
saturation extract. Organic carbon (OC), […] available phosphorus (P) […] carbon
normal and neutral. Trace elements magnesium (Mg), iron (Fe) zinc (Zn) and copper (Cu)
exchange capacity and exchange basis (calcium, magnesium, potassium and sodium. […]
extraction with […] Boron (B) […]
normal and neutral. Trace elements magnesium (Mg), iron (Fe) zinc (Zn) and copper (Cu)
[…]
extraction with […] Boron (B) […]
[…]
[…]
[…]
[…]
[…]
[…]

[…]
Please communicate your suggestion, opinion or claim to telephone no.369-4016 or 369-

4000 ext 4016
Please communicate your suggestion, opinion or claim to telephone no.369-4016 or 369-

4000 ext 4016
Sincerely,

(Signed)
Sincerely,
Chemical Área Coordinator
(Signed)

Chemical Área Coordinator

58 Annex 39

SOIL LABORATORY

RESULTS OF CHEMICAL ANALYSIS OF SOIL

]Date: Day 22, Month 08, Year 2005

Province: Nariño Municipality: Location:

Sender: Environmental Monitoring Program PECIG Laboratory No. 3-59652 A 655

Field ID Granulometry Texture Gravel pH AI SAI Salinity P Organic
class % total material
Sand Lime Cía 1.1 1.2 [...] [...] ppin OC N

% % y % [...] total
V12-05 SUELO ID -
84-AC -SUBÍ 39.9 24.9 35.2 FA * 4.3 2.1 50.9 241 2.7 0.13
V12-05 SUELO ID -

84-AC -SUB2 42.8 25.4 31.8 FA * 4.7 0.71 10.4 161 4.1 0.18
V12-05 SUELO ID -
83-AC -SUBÍ 70.2 21.3 8.5 FA * 5.3 0.75 15.9 1057 4.2 0.25
V12-05 SUELO ID -
83-AC -SUB2 68.9 22.8 8.3 FA * 4.5 1.9 73.2 1026 5.0 0.31

Exchange complex (meq /100 g) SB Trace elements (ppin) ppin
[...] Calci Magn Potas Sod [...] Mag Iron Zinc Cop Boro [...] [...] Sulfü Phos

um esium sium ium nesi per n r phor
um us
17.8 1.2 0.38 0.27 0.11 2.0 11.3 33.5 20.7 2.2
27.1 4.8 0.95 0.33 0.06 6.1 22.7 49.9 29.6 1.4

33.8 2.1 0.63 1.1 0.16 4.0 11.8 30.4 26.2 15.4
33.7 0.07 0.10 0.22 0.13 0.52 1.5 32.3 8.0 9.8

* THE SAMPLE DID NOT SCATTER PROPERLY: THE % OF CLAY MAY BE GREATER

METHODS: […] texture, exchangeable acidity (EAw )ith KCI, electrical conductivity of the

saturation extract. Organic carbon (OC), […] available phosphorus (P) […] carbon

exchange capacity and exchange basis (calcium, magnesium, potassium and sodium. […]

normal and neutral. Trace elements magnesium (Mg), iron (Fe) zinc (Zn) and copper (Cu)

extraction with […] Boron (B) […]

[…]

[…]

[…]

[…]

Please communicate your suggestion, opinion or claim to telephone no.369-4016 or 369-

4000 ext 4016

Sincerely,

(Signed)

Chemical Área Coordinator

59Annex 39

CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING
RESULTS OF THE ANALYSIS

Date Bogotá D.C. April 2008
Company UNION TEMPORAL AUDITORIA PECIG

Ordered by Eng. Natalia Cadena Villarraga
Address Calle 73 No. 10-10 Of 506 Bogota D.C.
Fax/Tel […] 1570
E-mail […]
Analysis requested Identification of Glyphosate Aand physical chemical
characterization in soil

Sample LQ7 186, LQ7 187
Sampling Specific
Responsible for Sample Jenny Mendoza
Date of Sampling February 8, 2008
Date of Entry March 17, 2008

No. 1971/08
1. Identification of Samples

LAQMA Code Field Code Coordinates Date of Entry
LQ7 186 MON-DENAR-080208-IDO1-ANTES-SUELO 01°50’22 2’ N Marc2h0078,
78°29’59 9’ W

LQ7 187 MON-DENAR-080208-IDO1-DESPS -UELO 01°50’22 2’ N
78°29’59 9’ W

2. Methodology of Analysis and Treatment of the Sample

Chart 1 shows the methodology employed for the analysis of the samples.

Chart 1 Methodology of Analysis employed, preservatives and hold time

Parameter Reference Method Preservation and Max Hold
time until Analysis

Glyphosate/AMPA J AQAC int 1989, 72 No. 2 14 days until extraction/40
Herbicide 355 days after extraction

60 CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING

RESULTS OF THE ANALYSIS

Date Bogotá D.C. April 2008
Company UNION TEMPORAL AUDITORIA PECIG
Ordered by Eng. Natalia Cadena Villarraga

Address Calle 73 No. 10-10 Of 506 Bogota D.C.
Fax/Tel […] 1570
E-mail […]
Analysis requested Identification of Glyphosate Aand physical chemical

characterization in soil
Sample LQ7 186, LQ7 187
Sampling Specific
Responsible for Sample Jenny Mendoza
Date of Sampling February 8, 2008

Date of Entry March 17, 2008

No. 1971/08
1. Identification of Samples

LAQMA Code Field Code Coordinates Date of Entry
LQ7 186 MON-DENAR-080208-IDO1-ANTES-SUELO 01°50’22 2’ N Marc2h008,
78°29’59 9’ W
LQ7 187 MON-DENAR-080208-IDO1-DESPS -U-ELO 01°50’22 2’ N

78°29’59 9’ W

2. Methodology of Analysis and Treatment of the Sample

Chart 1 shows the methodology employed for the analysis of the samples.

Chart 1 Methodology of Analysis employed, preservatives and hold time

Parameter Reference Method Preservation and Max Hold
time until Analysis
Glyphosate/AMPA J AQAC int 1989, 72 No. 2 14 days until extraction/40
Herbicide 355 days after extractionAnnex 39

4. COMMENTS TO RESULTS

The samples were delivered to the lab by the client and were analyzed just as they were
received.

Sincerely,
(signed) (signed)
OMAR TRUJILLO
MARTHA CARPINTERO
Chemist M.Sc. Environmental T.Q. - Chemical Analyst
PQ-0569 T.Q. 053

RESULTS OF THE ANALYSIS..[.]
Report No. 1971/08 [...]

Calle 53 No. 13 -27 Bogotá D.C. Colombia PBX: 4870088

www.dne.gov.co

62 Annex 39

CHEMICAL LABORATORY FOR ENVIRONMENTAL MONITORING
RESULTS OF THE ANALYSIS

Date Bogotá D.C. April 7, 2008
Company US EMBASSY – NAS OFFICE
Ordered by Mr. Gustavo Vargas
Fax -
Tel 383-2258
Address Carrera 45 No. 22D-45 Bogota

Analysis requested Analysis of Glyphosate and AMPA in soil samples
Sample Soils (see Table 1)
Responsible for Sample Antinarcotics Division
Type of Sampling Specific
Date of Sampling February 8, 2008
Date of Entry March 12, 2008

Point of Sampling See Table 1

No. 1972/08
l. Identification of Samples

The samples analyzed belong to two soil samples taken by the Monitoring Program of the

US Embassy of glyphosate herbicide and its aminomethylphosphonic acid metabolite
(AMPA) in soils. Table 1 identifies the samples analyzed.

Table 1 Identification of samples

LAQMA Code Field Code Coordinates Date of Entry
LQ7 186 MON-DENAR-080208-IDO1-ANTES-SUELO March 12,
LQ7 187 MON-DENAR-080208-IDO1-DESP-O-SUELO 2008

2. MATERIALS AND EQUIPMENT

2.1 a) Reactives. Standard certificate of compound analyzed: Glyphosate N-
(phosphonomethylglycine) shows Dr. Ehrenstorfer Lot 40401, 98 ± 0.5% purity;
aminomethylphosphonic acid AMPA shows Dr. Ehrenstorfer Lot 21104, 98 ± 0.5% purity,
derivatization reagent. P- toluenesulfonyl chloride brand SIGMA-ALDRICH, 99.9% purity,
lot 13224 EC.

b) Organic solvents for extraction, purification and mobile phase for HPLC reading were
all HPLC grade.

63Annex 39

2.2 Equipment: Shimadzu Liquid Chromatograph Model LC-6A equipped with two high
pressure pumps. Sil 58 autoinjector, UV-160A UV detector variable wavelength: SCL-6B

system controller and C-R6A Chromatopac as a signal integrator.

3. METHODOLOGY FOR ANALYSIS AND TREATMENT OF THE SAMPLE

Table 2 presents the methodology for the analysis of glyphosate and AMPA in soil

samples.

Table 2. Methodology of Analysis employed, preservatives and hold time.

Parameter Analysis Reference Method Preservation and Max
technique Hold time until
Analysis
Glyphosate/AMPA Solid-liquid J AQAC int 1989, 72 14 days until
Herbicide extraction No. 2 355 extraction/40 days

after extraction

Preliminary pretreatment of samples. Prior to analysis, soil samples were homogenized,
sieved through sieve No. 5 (4.0 mm) ASTM series and took the moisture content below

10% at room temperature to avoid losses of the compounds of interest.

Extraction of glyphosate and AMPA in soil. The extraction treatment applied corresponds
to soil samples with high clay content and organic matter according to the classification of
texture samples sent by the IGAC. 25 grams of the samples were weighed, which were
subjected to extraction with 0.2 M KOH for 15 minutes; the sample was centrifuged at

1500 rpm and filtered through filter paper, glass fiber; the residue was resubmitted to the
extraction, centrifugation and filtration proce. he extract obtained was concentrated to
5 ml and passed through anion exchange column OH-form, the analyte of interest was
eluted with 0.5 M HCl; the extract obtained was dry and redissolved in 2 ml of mobile
phase used in reading by HPLC.

Later, in order to perform the identification of compounds of interest, Glyphosate and
AMPA, derivatization of the extract obtained was conducted.

Derivatization. Glyphosate and AMPA Standards as well as the sample extracts were

subjected to the process of derivatization with p-toluenesulfonyl chloride under alkaline
conditions. 1 ml extract was in alkaline conditions with phosphate buffer pH 11.2; 0.2 ml
of reagent p-toluensutfonil chloride was added and reaction was at 50° C for 5 minutes in
thermostatic bath.

Quantification of glyphosate and AMPA. Quantification was performed by external standard

method using calibration curve in the range of 10 to 30 nμ/1 of the derivatives

64 Annex 39

of glyphosate paratoluensulfonyl chloride and AMPA - p- toluensulfonyl
chloride prepared from certified standard Dr. Ehrenstorfer GMBH.

HPLC Reading conditions. A Nucleoside column C18 250 mm x 4.6 mm id was

used, mobile phase phosphate buffer pH 2.3 - acetonitrile 85:15 v/v. Flow 1.0
ml/min., Injection volume: 10μL. Reading wavelength of 235 nm.

4. RESULTS
Table 1 shows the results achieved in the analysis of Glyphosate and AMPA in

the soil
samples analyzed.

Table 1. Analysis Results of Glyphosate and AMPA in two (2) soil samples. US
Embassy – NAS Office, March 2008

Identification of Sample Units Results Detection limit
LAQMA Client ID Glyphosate AMPA Glyphosate AMPA
Code mg/kg mg/kg
LQ7 188 MON-DENAR-080208- mg/kg U U 0.8 0.4
IDOl-AN TES-SUELO
LQ7 189 MON-DENAR-080208- mg/kg 6.97 U

IDOl-DESP-O-SUELO

UNITS

mg/kg Milligrams of the compound of interest per kilogram of sample analyzed or
ppm (parts per million)

U Non detectable to limit of detection of method
employed
<MLD Less than minimum level of detection

NOTE:

Report is valid for the described analysis; not to be reproduced without laonauthorizati

5. COMMENTS TO RESULTS

The samples were delivered to the lab by the client and were analyzed just as
they were received.

Sincerely,
(signed) (signed)

MARTHA CARPINTERO OMAR TRUJILLO
Chemist M.Sc. Environmental T.Q. – Chemical Analyst
PQ-0569 T.Q. 053

RESULTS OF THE ANALYSIS – CHEMICAL LABORATORY OF ENVIRONMENTAL

MONITORING
Report No. 1972/08 CRA 30 No. 90-33 Tel. 236-6178, Fax 621-9213

6566 Annex 40

N OTE2400-2.1391FROM THE MINISTRY FOR TENVIRONMENT

ANDSUSTAINABLEDEVELOPMENT,TO THEM INISTRY FOREIGN
AFFAIRS OCOLOMBIA ENCLOSING THELIST OORDERS ISSUED BY
THEM INISTRY FOR TENVIRONMENT REGARDING CONTROL AND
FOLLOW UP OF THENVIRONMENTALM ANAGEMENT PLAN OF THE

PROGRAM FOR THE RADICATION OLLICITCROPS BYAERIAL
SPRAYING WITHGLYPHOSATE(PECIG),3NOVEMBER 2011

(Archives of the Colombian Foreign Ministry)

67 National Authority on Environmental Licenses
Republic of Colombia

2400-2. 139140

Bogotá, D.C, 03 Nov. 2011

Ms.

SONIA PEREIRA PORTILLA
Ambassador
Coordinator Internal Work Group

Affairs before the International Court of Justice
Carrera 5 No. 9-03 Edificio Marco Fidel Suarez

REFERENCE: Request for information on the follow-up by the Ministry for
the Environment and Sustainable Development on the

Program for the Eradication of Illicit Crops.

Dear Ms. Pereira:

Pursuant to the request made by your Coordinating Office on 20 Oct 2011, I am
submitting in an enclosed document, the different administrative decisions -
orders -ssued by the Ministry for the Environment, Housing and Territorial Development,

now the Ministry for the Environment and Sustainable Development, as part of the
control and follow-up on the environmental management plan of the program for the
eradication o f illicit crops by aerial spraying with glyphosate herbicide – PECIG, pursuant
provisions in article 5 of resolution 1054 of 2003.

To date, there are some Orders pending to be issued, corresponding to follow-up made
in September and October this year.

Sincerely,

LUZ HELENA SARMIENTO VILLAMIZAR
General Director

File: 0793 As announced in two (2) pages
Prepared by: José Agustín Zea, Contractor
Revised by: Camilo Rincón, Legal Advisor

Calle 37 No. 8 – 40 Bogotá, D. C.
Directo: 34 34 • 332 34 00 • Extensión: 2368
www.minambiente.gov.co

68 Annex 40

National Authority on Environmental Licenses
Republic of Colombia

2400-2. 139140

Bogotá, D.C, 03 Nov. 2011

Ms.

SONIA PEREIRA PORTILLA
Ambassador
Coordinator Internal Work Group

Affairs before the International Court of Justice
Carrera 5 No. 9-03 Edificio Marco Fidel Suarez

REFERENCE: Request for information on the follow-up by the Ministry for
the Environment and Sustainable Development on the

Program for the Eradication of Illicit Crops.

Dear Ms. Pereira:

Pursuant to the request made by your Coordinating Office on 20 Oct 2011, I am
submitting in an enclosed document, the different administrative decisions -
orders -ssued by the Ministry for the Environment, Housing and Territorial Development,

now the Ministry for the Environment and Sustainable Development, as part of the
control and follow-up on the environmental management plan of the program for the
eradication of illicit crops by aerial spraying with glyphosate herbicide – PECIG, pursuant
provisions in article 5 of resolution 1054 of 2003.

To date, there are some Orders pending to be issued, corresponding to follow-up made
in September and October this year.

Sincerely,

[Signed]
LUZ HELENA SARMIENTO VILLAMIZAR
General Director

File: 0793 As announced in two (2) pages
Prepared by: José Agustín Zea, Contractor
Revised by: Camilo Rincón, Legal Advisor

Calle 37 No. 8 – 40 Bogotá, D. C.
Directo: 34 34 • 332 34 00 • Extensión: 2368
www.minambiente.gov.co

69Annex 40

National Authority on Environmental Licenses

Republic of Colombia

ORDERS ISSUED BY THE MINISTRY FOR THE ENVIRONMENT, HOUSING AND TERRITORIAL
DEVELOPMENT, NOW THE MINISTRY FOR THE ENVIRONMENT AND SUSTAINABLE

DEVELOPMENT, AS PART OF THE CONTROL AND FOLLOW-UP ON THE ENVIRONMENTAL
MANAGEMENT PLAN OF THE PROGRAMME FOR THE ERADICATION OF ILLICIT CROPS BY

AERIAL SPRAYING WITH GLYPHOSATE HERBICIDE –PECIG, PURSUANT PROVISIONS IN
ARTICLE 5 OF RESOLUTION 1054 OF 2003.

ADMINISTRATIVE RULING DATE
Order 707 Of 26 July 2004.
Order 113 Of 03 February 2005.
Order 734 Of 10 May 2005.

Order 1542 Of 30 August 2005.
Order 1543 Of 30 August 2005.
Order 2282 Of 21 December 2005.

Order 2283 Of 21 December 2005.
Order 086 Of 23 January 2006.
Order 106 Of 23 January 2006.

Order 1172 Of 14 June 2006.
Order 1174 Of 14 June 2006.
Order 1175 Of 14 June 2006.
Order 1283 Of 10 July 2006.

Order 1606 Of 23 August 2006.
Order 1609 Of 23 August 2006.
Order 1627 Of 25 August 2006.

Order 1632 Of 25 August 2006.
Order 1653 Of 29 August 2006.
Order 1912 Of 18 September 2006.

Order 1967 Of 25 September 2006.
Order 2900 Of 15 December 2006.
Order 2901 Of 15 December 2006.

Order 2965 Of 22 December 2006.
Order 2970 Of 22 December 2006.
Order 0798 Of 29 March 2007.
Order 0897 Of 12 April 2007.

Order 0917 Of 13 April 2007.
Order 0918 Of 13 April 2007.
Order 0919 Of 13 April 2007.

Order 1152 Of 07 May 2007.
Order 1607 Of 26 June 2007.
Order 1609 Of 26 June 2007.

Order 1827 Of 16 July 2007.
Order 2018 Of 31 July 2007.
Order 2019 Of 31 July 2007.
Order 2242 Of 22 August 2007.

Calle 37 No. 8 – 40 Bogotá, D. C.
PBX: 332 34 34 • 332 34 00 • Extensión: 2368
Directo:
www.minambiente.gov.co

70 Annex 40

National Authority on Environmental Licenses

Republic of Colombia

Order 2409 Of 05 September 2007.
Order 2907 Of 25 October 2007.

Order 2940 Of 30 October 2007.
Order 3021 Of 08 November 2007.
Order 3236 Of 04 December 2007.

Order 3237 Of 04 December 2007.
Order 3454 Of 27 December 2007.
Order 0558 Of 25 February 2008.

Order 0991 Of 31 March 2008.
Order 1490 Of 07 May 2008.
Order 1564 Of 15 May 2008.

Order 1847 Of 11 June 2008.
Order 2091 Of 03 July 2008.
Order 2288 Of 25 July 2008.
Order 2313 Of 29 July 2008.

Order 2547 Of 15 August 2008.
Order 2781 Of 05 September 2008.
Order 2933 Of 22 September 2008.

Order 3309 Of 13 November 2008.
Order 3313 Of 13 November 2008.
Order 3491 Of 02 December 2008.

Order 3492 Of 02 December 2008.
Order 3496 Of 02 December 2008.
Order 0097 Of 23 January 2009.

Order 170 Of 30 January 2009.
Order 171 Of 30 January 2009.
Order 0389 Of 23 February 2009.

Order 0435 Of 25 February 2009.
Order 0542 Of 05 March 2009.
Order 0827 Of 25 March 2009.
Order 1240 Of 30 April 2009.

Order 1337 Of 11 May 2009.
Order 1520 Of 22 May 2009.
Order 1797 Of 16 June 2009.

Order 1798 Of 16 June 2009.
Order 1913 Of 25 June 2009.
Order 2126 Of 17 July 2009.

Order 2130 Of 17 July 2009.
Order 2342 Of 06 August 2009.
Order 2518 Of 28 August 2009.

Order 2545 Of 31 August 2009.
Order 2582 Of 03 September 2009.
Order 2731 Of 25 September 2009.

Order 2876 Of 09 October 2009.
Order 3470 Of 23 December 2009.
Order 3471 Of 23 December 2009.

Order 3473 Of 23 December 2009.

Calle 37 No. 8 – 40 Bogotá, D. C.
PBX: 332 34 34 • 332 34 00 • Extensión: 2368
Directo:
www.minambiente.gov.co

71Annex 40

National Authority on Environmental Licenses

Republic of Colombia

Order 0100 Of 20 January 2010.
Order 0209 Of 29 January 2010.

Order 0239 Of 04 February 2010.
Order 0415 Of 19 February 2010.
Order 0999 Of 06 April 2010.

Order 1556 Of 11 May 2010.
Order 2152 Of 11 June 2010.
Order 2634 Of 12 July 2010.

Order 3485 Of 16 September 2010.
Order 3734 Of 08 September 2010.
Order 3790 Of 15 October 2010.

Order 3862 Of 26 October 2010.
Order 3863 Of 26 October 2010.
Order 3864 Of 26 October 2010.
Order 3974 Of 05 November 2010.

Order 4573 Of 30 December 2010.
Order 0333 Of 07 February 2011.
Order 0336 Of 07 February 2011.

Order 0339 Of 07 February 2011.
Order 1121 Of 18 April 2011.
Order 1132 Of 18 April 2011.

Order 1220 Of 02 May 2011.
Order 1614 Of 31 May 2011.
Order 1746 Of 09 June 2011.

Order 2354 Of 22 July 2011.
Order 2864 Of 30 August 2011.
Order 2873 Of 30 August 2011.

Calle 37 No. 8 – 40 Bogotá, D. C.
PBX: 332 34 34 • 332 34 00 • Extensión: 2368
Directo:
www.minambiente.gov.co

72 Annex 40-A

M inistry for tenvironMent, rderN O. 228whereby a Monitoring
of the execution of ehnvironMentalManageMent plan of the

prograM for theeradication ollicitcrops byaerialspraying
withg lyphosate(pecig) is carried , 21 eceMber2005.

(Archives of the Colombian Foreign Ministry)

73 Ministry for the Environment, Housing and Territorial Development
Licenses, Permits and Environmental Procedures Division

[21 DEC 2005]

Bogota, D.C.

ORDER No. [2282]
“Performing a monitoring”

THE ADVISOR OF THE DEPUTY MINISTER FOR THE ENVIRONMENT
LICENSES, PERMITS AND ENVIRONMENTAL PROCEDURES DIVISION

In exercise of the powers under Resolution No. 1084 of August 9, 2005
Work and Minimum Requirements Handbook of the Ministry for the Environment, Housing
and Territorial Development, and

WHEREAS

BACKGROUND

This Ministry, by Resolution No. 1065 of November 26, 2001, enforced the Environmental
Management Plan for the activity called “Program for the Eradication of Illicit Crop s by

aerial spraying with glyphosate - PECIG” in the national territory.

The designated Environmental Management Plan as modified by this Ministry by
Resolution No. 1054 of September 30, 2003, to adjust the Sheets that comprise it and to

incorporate in its execution, in addition to
government entities such as Agustin Codazzi Geographical Institute
Institute of Health, the Anti-Narcotics Police and the Ministry of Interior and Justice.

By communication No. 2457 of September 12, 2005, the Coordinator of Grievance of the
Illicit Crop Eradication Area of the Anti -Narcotics Police, DIRAN, informed the Director of
the Sustainable Development Sector about conducting a field visit for veri
complaints in some municipalities of the

requested the appointment of an official of this
conducting the verification.

By communication No. 1610 of the ARECI -JEFAT of October 5, 2005, the Coordinator of
Grievance of the Illicit Crop Eradication Area of the Anti-Narcotics Police, DIRAN, informed

the Director of the Sustainable Development Sector of this Ministry about conducting a
field visit for verification of compl aints in some municipalities of the province of Norte de
Santander, and requested the appointment of an official of this Ministry to form the
technical team for conducting the verification.

[Page 1]

The Director of the Sustainable Development Sector together with the Department of

Licenses, Permits and Environmental Procedures of the Ministry, in exercise of the
functions assigned to control and monitoring assigned thereof

74 Annex 40-A

Ministry for the Environment, Housing and Territorial Development
Licenses, Permits and Environmental Procedures Division
Republic of Colombia

[21 DEC 2005]

Bogota, D.C.

ORDER No. [2282]
“Performing a monitoring”

THE ADVISOR OF THE DEPUTY MINISTER FOR THE ENVIRONMENT
LICENSES, PERMITS AND ENVIRONMENTAL PROCEDURES DIVISION

In exercise of the powers under Resolution No. 1084 of August 9, 2005 amending the
Work and Minimum Requirements Handbook of the Ministry for the Environment, Housing
and Territorial Development, and

WHEREAS

BACKGROUND

This Ministry, by Resolution No. 1065 of November 26, 2001, enforced the Environmental
Management Plan for the activity called “Program for the Eradication of Illicit Crop s by

aerial spraying with glyphosate - PECIG” in the national territory.

The designated Environmental Management Plan as modified by this Ministry by
Resolution No. 1054 of September 30, 2003, to adjust the Sheets that comprise it and to

incorporate in its execution, in addition to the National Narcotics Directorate, other
government entities such as Agustin Codazzi Geographical Institute - IGAC, National
Institute of Health, the Anti-Narcotics Police and the Ministry of Interior and Justice.

By communication No. 2457 of September 12, 2005, the Coordinator of Grievance of the
Illicit Crop Eradication Area of the Anti -Narcotics Police, DIRAN, informed the Director of
the Sustainable Development Sector about conducting a field visit for veri fication of
complaints in some municipalities of the provinces of Caquetá and Putumayo, and

requested the appointment of an official of this Ministry to form the technical team for
conducting the verification.

By communication No. 1610 of the ARECI -JEFAT of October 5, 2005, the Coordinator of
Grievance of the Illicit Crop Eradication Area of the Anti-Narcotics Police, DIRAN, informed

the Director of the Sustainable Development Sector of this Ministry about conducting a
field visit for verification of compl aints in some municipalities of the province of Norte de
Santander, and requested the appointment of an official of this Ministry to form the
technical team for conducting the verification.

[Page 1]

The Director of the Sustainable Development Sector together with the Department of

Licenses, Permits and Environmental Procedures of the Ministry, in exercise of the
functions assigned to control and monitoring assigned thereof , developed Technical

75Annex 40-A

Opinions No. 1753 of October 5, 2005 and No. 1823 of October 26, 2005, which stated the
following:
CONSIDERATIONS ON TECHNICAL OPINION No. 1753 of 2005

“This Technical Opinion is grounded on information obtained from the technical visits to
different areas where aerial spraying will take place (Environmental Monitoring) and areas
where spraying coca crops with glyphosate was performed (verification of complaints).

“Dates of verification and Environmental Monitoring: September 20-23, 2005

“Geographical Area for Environmental Monitoring and Verification: provinces of Caquetá
and Putumayo.

“Members of the Verification and Monitoring Commission:

Agustin Codazzi Geographical Institute (IGAC)
− David Rodriguez, engineer
− Jairo Pérez Ruiz, engineer National Narcotics Division (DNE)
− Luis Boada, engineer Colombian Agriculture Institute (ICA)
Coordinator, Complaints Group, Anti Narcotics Police
− Captain James Roa
(DIRAN)
− Captain Miguel Tunjano Coordinator, Verification Group, Anti Narcotics Police
(DIRAN)
Officer, NAS Office, US Embassy
− Lt Col (Ret) Carlos Narvaez
− José Agustín Zea, engineer Ministry of the Environment, Housing and Territorial
Development

“Materials and equipment:

• Two (2) helicopters and aircraft for transport between cities
• Satellite geopositioners

• Mapping of the areas to verify
• Laptops
• Digital cameras

• Elements for collecting water and soil samples

“Activities performed:

[Page 2]

“Verification of Complaints

“Verification of selected points was conducted by helicopter over flights around the

coordinate defined, by assessing the following aspects:

− Effects on the environment, identifying the effect on other coverages, drift and the
existence of housing or water bodies within the sprayed area.

− Additional observations, identifying the evidence or not of re seeding or pruning
activities, field conditions and those othersituations that may be consider ed of
interest for verification

76 Annex 40-A

For this purpose, the A rea of I llicit Crop Eradication screened the 52 complaints sites
located in the municipalities of Albania, Solita, Belén de los Andaquies, Cartagena del
Chaira, located in the province of Caquetá and in the municipalities of Villa Garzón, Puerto

Asís and Orito, located in the province of Putumayo.

“In summary, the number of plots subject to verification and the visit dates were as follows:

Municipalities Number of points Verification date 2005
Belén de los Andaquies, 27 September 21 and 22
Albania, Solita, Cartagena
del Chaira

Villa Garzón, Puerto Asís 19 September 22
and Orito
Total plots 46

“Of the total g eoreferenced points (52), the points listed below could not be visited due to
climatic conditions:

Municipality Number of points Verification date 2005
Cartagena del Chaira 06 Not verified
Total plots 06

“The arrival to each of the sites was done in helicopter , proceeding to locate the exact
coordinates of the area to verify, with the use of the satellite …

[Page 3]

…geopositioners. Once the site has been located, the helicopter pilot made double 360-
degree spins in both directions and at low altitude in order to have a better appreciation of
the lots to verify.

“Attached are Minutes 16 and 17 of 2005 signed by those present in this verification, the
routes and plans of the field visit ofthe complaints arising from the Program for the
Eradication of Illicit Crops with Glyphosate.

“Environmental Monitoring

“Environmental monitoring activities to be performed on the nucleus of illicit crops in
Putumayo - Caquetá, correspond to the sampling of water and soil for the phases before

and immediately after spraying, according to the research protocol established in the P lan
Environmental Management PECIG.

“For this pur pose, helic opter transport was performed from the military base in Villa

Garzón to an area near the border with Ec uador, where the PECIG is scheduled to begin
spraying to eradicate coca crops. We performed a total of three descents in sites that will
later be sprayed and the geographical coordinates of which are presented in the table
below, by taking samples of water, soil and plant material, according to protocol
established by the ICA.

77Annex 40-A

“These samples were properly packaged, labeled, refrigerated and then sent to Bogota for
the respective analysis.

Date Sample
Plot Soil Water North West

1 Before x x 0° 16.04’ 76° 46.24’
2 Before x x 0° 16.11’ 76° 47.56’
3 Before x x 0° 18.38’ 76° 53.38’

Sampling of the second phase (post -spraying) was not possible due to adverse weather
conditions which prevented conducting this activity which must be reprogramed again by
the Anti-Narcotics Police.

That taking into account the above the above opinion concluded that:

As a result of field observations conducted in the sites selected for verification, the
following considerations are made:

[Page 4]

1. Observations during the verification of complaints

The majority of the sprayed coca crops are located in areas suitable for forestry, which
have been continuously being taken over by the removal of natural vegetation, making
them suitable for installation of pastures and crops, including coca. Illicit crops are located
in areas of flat to undulating relief, characterized by poor soils, r egularly drained and
subject to erosion and denuded processes.

Some of the plots sprayed were subject to replanting practices, observing the practice of
intercropping of banana, fruit and yucc a plants in coca cultivation. Side effects from
spraying are caused by the effect of drift of the spray; in that sense there was no evidence

the loss of foliage in arboreal and bush species was not evidenced, in areas adjacent to
sprayed plots. No adverse effect to lawful economic activities was observed, other than
that which was inside the coca plots.

The monitoring allows showing the continuity of slash and burn practices for the adapting

of areas for agricultural activities or eventually, the planting of coca crops. Likewise, during
the course, coca seedlings and primary infrastructure for the processing of coca leaf were
observed.

In sprayed and abandoned sites, the natural regeneration processes are evident and they
are present in varying degrees, depending on the weather and soil conditions.

Practices of intercropping and fractioning of illicit with licit crops continues to occur in most
of the sites evaluated. The intercropping of coca is generally made with plantain, corn ,

yucca and fruit trees.

2. Environmental Monitoring Activity

78In sprayed and abandoned sites, the natural regeneration processes are evident and they
are present in varying degrees, depending on the weather and soil conditions. Annex 40-A

Practices of intercropping and fractioning of illicit with licit crops continues to occur in most
of the sites evaluated. The intercropping of coca is generally made with plantain, corn ,
yucca and fruit trees.

2. Environmental Monitoring Activity

Environmental Monitoring activities in water and soil in the Putumayo - Caquetá nucleus,
before spraying, was conducted in three (3) different p lots and was performed to

determine the behavior of residues of glyphosate and its metabolite AMPA, and its
possible relationship to physicochemical and biological properties thereof, taking several
samples in one same plot , in accordance with protocols approved by the Agustin Codazzi
Geographical Institute - IGAC and the Colombian Agricultural Institute - ICA, for sampling

of soil and water.

The purpose of the se analyses is to understand the dynamics of glyphosate and its
metabolite AMPA and their effect on physicochemical and biological properties of water
and soil and to assess the impact of the application, by comparing residues in sampled

plots before spraying, immediately thereafter, 60, 90 and 180 days after spraying, if
warranted.

[Page 5]

1. With respect to the verification visit to the sites that were the subject of complaints by
spraying with glyphosate, the implementation of new coca crops were widely observed, in
some cases intercropped with subsistence crops and seedlings ready for planting new
coca areas; there were no side effects on forest vegetation near the sprayed plots ; also

noted were that the lots that had been abandoned show natural regeneration processes,
with herbaceous vegetation and shrubs.

In general and according to what was verified in all areas that contain illicit crops, the most

important impact to the environment is being caused by the effect of indiscriminate logging
and burning to which extensive areas of forest cover are being subjected, and putting at
risk the stability ofthe ecosystems and the environmental functions derived therefrom.
There, agricultural activities are established, both licit and illic, as are activities like
livestock, which further increase and enhance the deterioration of the natural environment.

Considering that Resolution No. 017 of 2001 of the National Narcotics Board has
delegated to the Anti- Narcotics Police, DIRAN, and to the National Narcotics Division,
DNE, the responsibility to conduct the p rocessing of complaints arising from the PECIG

operation, these will be the entities that will issuethe corresponding Opinion on the
findings of the field visit. In this regard, the Ministry verifies the performance of the activity
by the entities listed, as part of compliance with the measures set out in Sheet No. 6 of the
Environmental Management Plan.

2. As for the Environmental Monitoring, the first phase of this activity was held, according
to the protocol, pending the stages after spraying of plots, since due to bad weather it was
not possible to perform this activity, therefore being postponed and will be held as soon as
the Anti-Narcotics Police, DIRAN, schedules it.

The Environmental Monitoring Results for the Putumayo - Caquetá nucleus and
concerning the dynamics of glyphosate and its metabolite AMPA and their effect on the
physicochemical and biological characteristics of water and soil by comparing residues i n
sampled plots before spraying, i mmediately thereafter, sixty (60), ninety (90) an d one

hundred eighty (180) days after spraying, if warranted, will be delivered by the National
Narcotics Directorate in the semiannual report.

79Annex 40-A

In keeping with the purpose of the visit and the considerations submitted, this opinion does
not make additional or specific requirements to the other agencies responsible for
implementing the Environmental Management Plan.

3. The following documentation is part of this Technical Opinion:

Minutes No. 025/05, relating to the Environmental Monitoring (sampling of water and soil)

before the spraying operation, the Putumayo - Caquetá nucleus.
Minutes No. 16/05 with regard to the visit field for complaints from the program for the
eradication of illicit crops with glyphosate (PECIG) in the municipalities of O rito, Puerto
Asis and Villa Garzón, province of Putumayo.

Minutes No. 17/05 regarding the field visits by complaints from the program for the
Eradication of illicit crops with Glyphosate (PECIG) in the municipalities of Solita, Belén de
los Andaquíes, Albania and Cartagena del Chairá, Caqueta province.

Table of routes in the field visit in the province of Putumayo, along with the respective map
of location of verification points.

Charts and maps of the three (3) routes of field visit conducted in the Province of Caquetá

of the complaints of the verification activity.

Similarly, attached are some photographs on three (3) pages, taken during the field visit
conducted by this Ministry, which include both complaints verification activities and
environmental monitoring.

TECHNICAL OPINION CONSIDERATIONS No. 1823 of 2005

“The Technical Opinion was prepared based on information obtained from the technical

visits to different areas where spraying was performed on coca crops with glyphosate
(verification of complaints.)

“Dates of Verification of Complaints: 08 to 10 October 2005

“Geographic Area of Complaints Verification: Norte de Santander province

“Members of the Verification Committee:

− Jairo Pérez Ruiz, engineer Environmental Audit, National Narcotics Division (DNE)
− Luis Boada, engineer Colombian Agriculture Institute (ICA)
− Captain James Roa Coordinator, Complaints Group, Anti Narcotics Police
(DIRAN)

− Lt Luis Villarreal Official, Complaints Group, Anti Narcotics Police
(DIRAN)
− José Agustín Zea, engineer Ministry of the Environment, Housing and Territorial
Development

“Materials and equipment:

80− Lt Luis Villarreal Official, Complaints Group, Anti Narcotics Police
(DIRAN) Annex 40-A
− José Agustín Zea, engineer Ministry of the Environment, Housing and Territorial
Development

“Materials and equipment:

• Two (2) helicopters and aircraft for transport between cities
• Satellite geopositioners

• Mapping of the areas to verify
• Laptops
• Digital cameras

“Activities performed:

“Verification of Complaints

“Verification of selected points was conducted by helicopter over flights around the
coordinate defined, assessing the following aspects:

− Effects on the environment, identifying the effect on other coverages, drift and the

existence of housing or water bodies within the sprayed area.
− Additional observations, identifying the evidence or not of reseeding or pruning
activities, field conditions and those other situations that may be considered of
interest for verification

“For this purpose, the Area of Illicit Crop Eradication screened the 28 complaints sites
located in the municipalities of Cucuta, Sardinata and El Zulia, located in the province of
Norte de Santander.

“In summary, the number of plots subject to verification and the visit dates were as follows:

Municipalities Number of points Verification date 2005
Cucuta, Sardinata and El 26 October 09 and 10

Zulia
Total plots 26

“Of the total georeferenced points ( 28), the points listed below were where “Dumping”
occurred by the fumigation aircraft that was shot down by subversive organizations:

Municipality Number of points Verification date 2005

El Tarra 02 October 09
Total plots 02

“The arrival to each of the sites was done in helicopter, proceeding to locate the exact

coordinates of the area to verify, with the use of the satellite geopositioners. Once the site
has been located, the helicopter pilot made double 360-degree spins in both directions and
at low altitude in order to have a better appreciation of the lots to verify.

“Attached to this Opinion are the routes and coordinates of the field visit of the complaints

stemming from the Program for the Eradication of illicit crops with glyphosate.”

The aforementioned technical opinion considered the following:

“As a result of the observations in the field advanced to the sites selected for verification,
the following considerations are made:

81Annex 40-A

“Observations made in the Verification of Complaints

“The majority of the sprayed coca crops are located in areas suitable for forestry, which
have been continuously being taken over by the removal of natural vegetation, making
them suitable for installation of pastures and crops, including co ca. Illicit crops are located
in areas of flat to undulating relief, characterized by poor soils, regularly drained and

subject to erosion and denuded processes.

Some of the plots sprayed were subject to replanting practices, observing the practice of
intercropping of banana, fruit and yucc a plants in coca cultivation. Side effects from
spraying are caused by the effect of drift of the spray; in that sense there was no evidence

the loss of foliage in tree and shrub species in areas adjacent to the sprayed plots. In the
areas evaluated there was no indication of impact on licit economy, different from that
found in the coca plots.

“The monitoring allows showing the continuity of slash and burn practices for the adapting
of areas for agricultural activities or eventually, the planting of coca crops. Likewise, during
the course, coca seedlings and primary infrastructure for the processing of coca leaf were
observed.

“In sprayed and abandoned sites, the natural regeneration processes are evident and they
are present in varying degrees, depending on the weather and soil conditions.

“Practices of intercropping and fractioning of illicit with licit crops continues to occur in most

of the sites evaluated. The intercropping of coca is generally made with plantain, corn,
yucca fruit trees and pastures.

The Technical Opinion finishes with the following considerations:

“With respect to the verification visit to the sites that were the subject of complaints by
spraying with glyphosate, the implementation of new coca crops were widely observed, in
some cases intercropped with subsistence crops and seedlings ready for planting new
coca areas; there were no side effects on forest vegetation near the sprayed plots; also

noted were that the lots that had been abandoned show natural regeneration processes,
with herbaceous vegetation and shrubs.

“In general and according to what was verified in all areas that contain illicit crops, the

most important impact to the environment is being caused by the effect of indiscriminate
logging and burning to which extensive areas of forest cover are being subjected, which
put at risk the stability of the ecosystems and the environmental functions derived
therefrom. There, agricultural activities are established, both licit and illicit, as are livestock
activities, which further increase and enhance the deterioration of the natural environment.

“Taking into account that Resolution No. 017 of 2001 of the National Narcotics Board has
delegated to the Anti- Narcotics Police, DIRAN, and to the National Narcotics Division,
DNE, the responsibility to conduct the processing of complaints arising from the PECIG

operation, these will be the entities that will issue the corresponding opinion on the findings
of the field visit. In this regard, the Ministry verifies the performance of the activity by the
entities listed, as part of compliance with the measures set out in Sheet No. 6 of the
Environmental Management Plan.

82 Annex 40-A

“In keeping with the purpose of the visit and the considerations submitted, this opinion
does not make additional or specific requirements to the other agencies responsible for

implementing the Environmental Management Plan.

“The following documentation is part of this Technical Opinion:

Table of the coordinates of the verified sites , along with the respective map of location of
verification points.

Similarly, attached are some photographs on three (3) pages, taken during the field visit
conducted by this Ministry, which include both complaints verification activities and

environmental monitoring.”

LEGAL CONSIDERATIONS

In accordance with Article 8 of the Constitution it is the duty of thState and individuals to
protect the natural and cultural wealth of the nation. (Underlining outside of text).

Similarly, Article 79 ibidem enshrines the right to enjoy a healthy environment, community

participation, the State's duty to protect the diversity and integrity of the environment,
preserve ecologically important areas and to promote education to meet those objectives.

Article 95, paragraph 8 of the rule in question states that it is the duty of citizens to “Protect
the natural and cultural resources of the country and ensure the preservation of a healthy

environment.”

Article 5 paragraph 35 of Law 99 of 1993 states that among the functions of this Ministry is
the assessment, monitoring and control of environmental risk factors and of those that may

affect the occurrence of natural disasters and coordinate with other relevant authorities the
activities designed to prevent the emergence or prevent the spread of its effects.

Likewise the Ministry, under Article 33 of Decree 1220 of 2005 in force today, performs the
control and monitoring of licensed activities, which states: “Control and Monitoring. The

projects, w orks or activities subject to Environmental License or Environmental
Management Plan during its construction, operation, dismantling or abandonment are
controlled and monitored by the environmental authorities…”

Taking into account what is considered by t he technical staff of the Directorate for
Sustainable Sector Development, in relation to visitats conducted to the areas jurisdiction
of the municipality of Cucuta, Sardinata and El Zulia in Norte de Santander and areas of
the jurisdiction of the municipal ities of San Vicente del Caguan , Puerto Rico, Montañita
(Caquetá) and San José del Guaviare (Guaviare), this office will proceed to acknowledge

the Technical Opinions No. 1753 of October 5, 2005 and No. 1823 of October 26, 2005 at
the operative section of this administrative act.

Decree No.3266 of October 8, 2004 changing the structure of the Ministry of Environment,

Housing and Territorial Development, the Division of Licenses, Permits and Procedures of
the Ministry was created.

83Annex 40-A

In accordance with the provisions of Resolution No. 1084, 2005, the Advisor of the Deputy
Minister for the Environment, Division of Licenses, Permits and Environmental Procedures

has the authority to sign administrative acts related to requirements and additional
information to further the process of environmental licensing, permits and other
instruments of environmental management and control and to proceed in actions brought
against them.

In virtue of the foregoing,
DECIDES

ARTICLE ONE. To declare, that taking into account the purpose of the visit conducted and
what was established in the whereas section of this administrative document, to the effect
that there is no adverse effect on the environment, the agencies responsible for the
implementation for the Environmental Management Plan are not charged with any
additional or particular requirements.

ARTICLE TWO . To c ontinue with the obligations imposed by the Environmental
Management Plan.

ARTICLE THREE. Through the User Relations Group of the Section of Licenses, Permits
and Environmental Procedures of this M inistry, to serve notice of the contents of this
administrative act on the Legal Representative of the Anti -Narcotics Police DIRAN and/or
the duly appointed attorney

ARTICLE FOUR. Through the User Relations Group of the Section of Licenses, Permits
and Environmental Procedures of this M inistry, to serve notice of the contents of this
administrative act on the Legal Representative of the National Narcotics Directorate- DNE

and/or the duly appointed attorney

[Page 12]

ARTICLE FIVE. Through the User Relations Group of the Section of Licenses, Permits
and Environmental Procedures of this Ministry, serve notice of the contents of this
administrative act on the Legal Representative of FUNDEPUBLICO, Ms. CLAUDIA
SAMPEDRO TORRES and Mr. HECTOR SUAREZ, to CORPORACION APOYO and/or its

attorney duly constituted.

ARTICLE SIX. Through the User Relations Group of the Section of Licenses, Permits and
Environmental Procedures of this Ministry, serve notice of the contents of this
administrative act on the Legal Representative of the Office of the OMBUDSMAN and/or

its attorney duly constituted.

ARTICLE SEVEN. Through the User Relations Group the Section of Licenses, Permits
and Environmental Procedures of this Ministry, serve notice of the contents of this

administrative act on the Delegate Prosecutor for Environmental and Agricultural Affairs,
the ICA, the Ministry of Social Protection, the Ministry of Interior and Justice, the National
Narcotics Council, and the IGAC.

ARTICLE EIGHT. There is only recourse for reversal against this decision, and recourse
must be entered within five (5) days following service of this notice as provided for in
Articles 50, 51 and 52 of the Administrative Code.

84 Annex 40-A

BE THIS SERVED, COMMUNICATED AND OBEYED

[Signed]
VANESSA VELEZ CABAL

Advisor to the Deputy Minister of the Environment
Section of Licenses, Permits and Environmental Procedures

Exp. 793
Draft: Luisa Fernanda Olaya – Contract Attorney DLPTA

8586 Annex 40-B

M INISTRY FOR TENVIRONMENT,ORDER NO.2283WHEREBY A

MONITORING OF THE EXECUTION OF THEIRONMENTAL
M ANAGEMENT PLAN OF THPROGRAM FOR THEERADICATION OF
ILLICICROPS BYAERIALSPRAYING WITHGLYPHOSATE (PECIG)
IS CARRIED OUT1D ECEMBER2005

(Archives of the Colombian Foreign Ministry )

87 Ministry for the Environment, Housing and Territorial Development
Licenses, Permits and Environmental Procedures Division

[21 DEC 2005]

Bogota, D.C.

ORDER No. [2283]
“Deciding on requirements”

THE ADVISOR OF THE DEPUTY MINISTER FOR THE ENVIRONMENT
LICENSES, PERMITS AND ENVIRONMENTAL PROCEDURES DIVISION

In exercise of the powers under Resolution No. 1084 of August 9, 2005
Work and Minimum Requirements Handbook of the Ministry for the Environment, Housing
and Territorial Development, and

WHEREAS
BACKGROUND

This Ministry, by Resolution No. 1065 of November 26, 2001, enforced the Environmental

Management Plan for the activity called “Program for the Eradication of Illicit Crop s by
aerial spraying with glyphosate - PECIG” in the national territory.

The designated Environmental Management Plan as modified by this Ministry by
Resolution No. 1054 of September 30, 2003, to adjust the Sheets that comprise it and to

incorporate in its execution, in addition to
government entities such as Agustin Codazzi Geographical Institute
Institute of Health, the Anti-Narcotics Police and the Ministry of Interior and Justice.

In exercise of the powers of evaluation, control and monitoring established in Law 99 of
1993 and implementing regulations, the Division of Sustainable Sector Development of the
Ministry for the Environment, Housing and Territorial Development has monitored activities
currently underway in the Anti-Narcotics Police on environmental monitoring referred to in

Sheet 5 of the Environmental Management Plan for PECIG referring to sampling of water,
soil and vegetation in the Caquetá, Putumayo Nucleus of illicit crops.

The monitoring team of the Division of Sustainable Sector Development of the Ministry, in

the exercise of those powers, developed the Technical OPINION 1898 of November 17,
2005, which stated:

DEVELOPMENT OF ACTIVITIES

Date of Commission October 29 – 31, 2005

Geographic Visit Area Caquetá - Putumayo Nucleus of illicit crop

[Page 1]

88 Annex 40-B

Ministry for the Environment, Housing and Territorial Development
Licenses, Permits and Environmental Procedures Division
Republic of Colombia

[21 DEC 2005]

Bogota, D.C.

ORDER No. [2283]
“Deciding on requirements”

THE ADVISOR OF THE DEPUTY MINISTER FOR THE ENVIRONMENT
LICENSES, PERMITS AND ENVIRONMENTAL PROCEDURES DIVISION

In exercise of the powers under Resolution No. 1084 of August 9, 2005 amending the
Work and Minimum Requirements Handbook of the Ministry for the Environment, Housing
and Territorial Development, and

WHEREAS
BACKGROUND

This Ministry, by Resolution No. 1065 of November 26, 2001, enforced the Environmental

Management Plan for the activity called “Program for the Eradication of Illicit Crop s by
aerial spraying with glyphosate - PECIG” in the national territory.

The designated Environmental Management Plan as modified by this Ministry by
Resolution No. 1054 of September 30, 2003, to adjust the Sheets that comprise it and to

incorporate in its execution, in addition to the National Narcotics Directorate, other
government entities such as Agustin Codazzi Geographical Institute - IGAC, National
Institute of Health, the Anti-Narcotics Police and the Ministry of Interior and Justice.

In exercise of the powers of evaluation, control and monitoring established in Law 99 of
1993 and implementing regulations, the Division of Sustainable Sector Development of the
Ministry for the Environment, Housing and Territorial Development has monitored activities
currently underway in the Anti-Narcotics Police on environmental monitoring referred to in

Sheet 5 of the Environmental Management Plan for PECIG referring to sampling of water,
soil and vegetation in the Caquetá, Putumayo Nucleus of illicit crops.

The monitoring team of the Division of Sustainable Sector Development of the Ministry, in

the exercise of those powers, developed the Technical OPINION 1898 of November 17,
2005, which stated:

DEVELOPMENT OF ACTIVITIES

Date of Commission October 29 – 31, 2005

Geographic Visit Area Caquetá - Putumayo Nucleus of illicit crop

[Page 1]

89Annex 40-B

Participating Entities Colombian Agriculture Institute - ICA
National Narcotics Directorate - DNE
Anti-Narcotics Police - DIRAN

Aviation Area of the National Police - ARAVI
Ministry of Environment, Housing and Territorial Development

Prior to conducting field activities, a meeting was held in Larandia Military Base in the

province of Caqueta, with the participation of officials from the participating institutions and
Eradication and Aviation Areas of the National Police, to assess the security of the area
and to schedule the activities to be implemented during descents to the monitoring points.

In consideration of the difficult public order situation occurring in the area, the entry to the

monitoring sites required the support of eight armed helicopters, an air saving and rescue
helicopter, intelligence service aircraft and ten Jungle units of the National Police as well
as ground support by the National Army.

Advanced activity corresponds to the second phase of monitoring of this nucleus or post
aspersion replica, including sampling of soil , water and vegetation of two plots already
sprayed, as well as a control group that has not been spray ed, located within an
indigenous reserve. The analysis of these samples will assess the residuality of the

herbicide used by the Eradication Program for this particular nucleus in different periods of
time.

The plots are located in the municipality of Orito, Putumayo, on the border with Ecuador.
The geographical coordinates for each site are as follows:

Geographical Coordinate
Plot North West Spray Date
1 00° 16’ 06” 76° 46’ 24” July 14 - 2004

2 00° 16’ 11” 76° 47’ 57” July 14 - 2004
Control group in
3 00 ° 18’ 04” 76° 53’ 39” reservation area, not
sprayed

[Page 2]

The aforementioned technical opinion considered the following:

− The collection of water and soil samples was conducted in accordance with the ICA
protocols established for this purpose. These were properly packed, labeled and

refrigerated for later transport to Bogota, fulfilling the corresponding chain of
custody.

− The two lots sprayed show partial impact of the herbicide on the coca plantation,

inferring that the spraying was done only on one part of the cultivated area, and
that part of the sprayed underwent recovery practices such as looting.

− In the vicinity there are extensive plo ts with coca , mixed or intercropped with

plantain and yucca, as well as seedlings in full production of coca plantlets.

90 Annex 40-B

− The plot located within the reservation area has a coca plantation with bushes

surpassing 1.50 meters high, which indicates that the crop is older than one year;
the site is not subject to total cultural practices for weed control , showing only one
plating around each plant coca. The rest of the plot is covered with low growing
natural grass.

− In the treated plots there was no collateral damage from spraying . Water samples
were taken at points that are loc ated outside the sprayed plots given that within
these bodies there were no lotic or lentic waters.

− According to the monitoring protocol established in the Environmental Management
Plan, the next monitoring phase for this Nucleus must be within a period of 60
days. The results obtained from the analysis of these samples will be evaluated
comprehensively with the samples already taken and the remaining of the

monitoring process for this Nucleus.

− The process o f environmental monitoring for the de finition of the residuality of
glyphosate and its metabolite in the Caqueta - Putumayo illicit crop spraying

Nucleus continues in accordance with the guidelines of the Environmental
Management Plan - PECIG, following for these purposes, the protocols established
for this activity.

[Page 3]

LEGAL CONSIDERATIONS

In accordance with Article 8 of the Constitution, it is the responsibility of the State

and individuals to protect the natural and cultural wealth of the Nation (Underscore outside
of text)

Also, Article 79 ibid enshrines the right to enjoy a healthy environment, community
participation, the State’s duty to protect the diversity and integrity of the environment,

conserve ecologically important areas and promote education for these purposes.
Article 95, section 8 of the charter provides that it is the duty of citizens“To protect the
natural and cultural resources of the country and ensure t he conservation of a healthy
environment.”

Article 5 section 35 of Law 99 of 1993 states that within the functions of this Ministry is the
responsibility of the assessment, monitoring and control of environmental risk factors and
of those that may affect the occurrence of natural disasters and the coordination with other
authorities the activities designed to prevent the emergence or to prevent the spread of its

effects.

Also this Ministry, under Article 33 of Decree 1220 of 2005 in force today, performs the
control and monitoring of the activities licensed, which provides “Control and Monitoring.

The projects, works or activities subject to Environmental Licensing or Environmental
Management Plan during their construction, operation, dismantl ing or abandonment, are
subject to control and monitoring by the environmental authorities…”

91Annex 40-B

Taking into account what is considered by the technical team of the Sustainable Sector
Development Department, regarding the visit to the Caquetá - Putumayo Nucleus of illicit

crops, this office shall embrace the Technical Opinion No.1898 of November 17, 2005 in
the operative part of this administrative act.

By Decree No. 3266 of October 8, 2004 changing the structure of the Ministry of

Environment, Housing and Territorial Development, the Department of Licensing, Permits
and Procedures of the Ministry was created.

In accordance with provisions of Resolution No. 1084, 2005, the Advisor to the Deputy

Minister of the Environment, Department of Licenses, Permits and Environmental
Procedures has the authority t o sign the administrative acts related to requirements and
additional information to promote the environmental licensing procedure, permits and other
instruments …

[Page 4]

…for the environmental control and management, and to decide in actions brought against
them.

In virtue of the foregoing,
DECIDES

ARTICLE ONE. Declare that the environmental monitoring process for de fining the
residuality of glyphosate and its metabolite in the Caqueta - Putumayo nucleus of illicit
crop spraying continues forward in accordance with the guidelines of the Environmental
Management Plan PECIG, following fore these purposes, the established protocols for

such activity.

ARTICLE TWO. Require the Anti-Narcotics Police to comply with the protocol established
in the Environmental Management Plan for sampling, with respect to environmental

monitoring of the activity of the different nuclei where PECIG operates, for which it must
schedule and conduct the next monitoring phase for the Caqueta - Putumayo Nucleus,
corresponding to the replica 60 days after spraying.

ARTICLE THREE. To declare that in accordance with the purpose of the visit to the
Putumayo - Caqueta nucleus of illicit crops, and the considerations outlined in this
administrative act, there are no additional or particular requirements in regard to the
monitoring process established in the Environmental Management Plan –PECIG.

ARTICLE FOUR. Through the Section of Licenses, Permits and Environmental
Procedures of this Ministry, serve notice of the contents of this administrative act on the
Legal Representative of the Anti-Narcotics Police DIRAN and/or attorney duly constituted.

ARTICLE FIVE. Through the Section of Licenses, Permits and Environmental Procedures
of this M inistry, serve notice of the contents of this administrative act on the Legal
Representative of the National Narcotics Directorate -DNE and/ or its attorney duly
constituted.

ARTICLE SIX. Through the Section of Licenses, Permits and Environmental Procedures of
this Ministry, serve notice of the contents of this administrative act on the Legal

92 Annex 40-B

Representative of FUNDEPUBLlCO, to Dr. CLAUDIA TORRES SAM PEDRO and Dr.
HECTOR SUAREZ, to the CORPORACION APOYO and/or attorney duly constituted

[Page 5]

ARTICLE SEVEN. Through the Section of Licenses, Permits and Environmental
Procedures of this Ministry, serve notice of the contents of this administrative act on the
Legal Representative of the Office of the OMBUDSMAN and/or its attorney duly
constituted.

ARTICLE EIGHT . Through the Section of Licenses, Permits and E nvironmental
Procedures of this Ministry, serve notice of the contents of this administrative act on the
Delegate Prosecutor for Environmental and Agricultural Affairs, the ICA, the Ministry of
Social Protection, the Ministry of Interior and Justice, the National Narcotics Council, and

the IGAC.

ARTICLE NINE. There is only recourse for reversal against this decision, and recourse
must be entered within five (5) days following service of this notice as provided for in

Articles 50, 51 and 52 of the Administrative Code.

BE THIS SERVED, COMMUNICATED AND OBEYED

[Signed]
VANESSA VELEZ CABAL
Advisor to the Deputy Minister of the Environment
Section of Licenses, Permits and Environmental Procedures

Exp. 793
Draft: Luisa Fernanda Olaya – Contract Attorney DLPTA

[Page 6]

9394 Annex 41

LIST OE XTERNALENVIRONMENTAL AUDITS BY THNATIONAL
N ARCOTICSDIRECTORATE(DNE)

(Archives of the Colombian Foreign Ministry)

95 Ministry of Justice and Law
Republic of de Colombia

LIST OF EXTERNAL AUDITS – PROGRAMME FOR THE ERADICATION OF ILLICIT
CROPS BY AERIAL SPRAYING WITH GLYPHOSATE HERBICIDE

CONTRACTS DURATION
Report of activities carried out in the time period from 1 -
31 October 1994

Report of activities carried out in the time period from 1 -
30 November 1994
Report of activities carried out in the time period from 1 -

31 December 1994
Report of activities carried out in the time period from 1 -
31 January 1995

Report of activities carried out in the time period from 1 -
28 February 1995
Report of activities carried out in the time period from 1 -

October 01 31 March 1995
Contract 086 1994 to Report of activities carried out in the time period from 1 -
of1994 October 01 de 30 April 1995

1995 Report of activities carried out in the time period from 1 -
31 May 1995

Report of activities carried out in the time period from 1 -
31 June 1995
Report of activities carried out in the time period from 1 -
30 July 1995

Report of activities carried out in the time period from 1 -
31 August 1995

Report of activities carried out in the time period from 1 -
30 September 1995
Report of activities carried out in the time period from 1 -

19 October 1995
Report of activities carried out in the time period from 20
October - 17 November 1995

Report of activities carried out in the time period from 20
October 18 de November - 22 December 1995
Contract 065 1995 to Report of activities carried out in the time period from 1 -

of 1995 November 18 31 January 1996
1996 Report of activities carried out in the time period from 1 -
28 February 1996

Report of activities carried out in the time period from 1 -
31 March 1996

Carrera 9 No. 14-10 PBX. 4443100 www.mij.gov.co
Customer Service number 01 800 09 11170

96 Annex 41

Ministry of Justice and Law
Republic of de Colombia

LIST OF EXTERNAL AUDITS – PROGRAMME FOR THE ERADICATION OF ILLICIT
CROPS BY AERIAL SPRAYING WITH GLYPHOSATE HERBICIDE

CONTRACTS DURATION REPORTS
Report of activities carried out in the time period from 1 -
31 October 1994

Report of activities carried out in the time period from 1 -
30 November 1994
Report of activities carried out in the time period from 1 -

31 December 1994
Report of activities carried out in the time period from 1 -
31 January 1995

Report of activities carried out in the time period from 1 -
28 February 1995
Report of activities carried out in the time period from 1 -

October 01 31 March 1995
Contract 086 1994 to Report of activities carried out in the time period from 1 -
of1994 October 01 de 30 April 1995

1995 Report of activities carried out in the time period from 1 -
31 May 1995

Report of activities carried out in the time period from 1 -
31 June 1995
Report of activities carried out in the time period from 1 -
30 July 1995

Report of activities carried out in the time period from 1 -
31 August 1995

Report of activities carried out in the time period from 1 -
30 September 1995
Report of activities carried out in the time period from 1 -

19 October 1995
Report of activities carried out in the time period from 20
October - 17 November 1995

Report of activities carried out in the time period from 20
October 18 de November - 22 December 1995
Contract 065 1995 to Report of activities carried out in the time period from 1 -

of 1995 November 18 31 January 1996
1996 Report of activities carried out in the time period from 1 -
28 February 1996

Report of activities carried out in the time period from 1 -
31 March 1996

Carrera 9 No. 14-10 PBX. 4443100 www.mij.gov.co
Customer Service number 01 800 09 11170
Page1of 9

97Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
30 April 1996

Report of activities carried out in the time period from 1 -
31 May 1996
Report of activities carried out in the time period from 1 -
31 June 1996

Report of activities carried out in the time period from 1 -
31 July 1996
Report of activities carried out in the time period from 1 -

31 August 1996
Report of activities carried out in the time period from 1 -
30 September 1996

Report of activities carried out in the time period from 1 -
18 October 1996
Report of activities carried out in the time period from 20

October - 17 November 1996
Report of activities carried out in the time period from 1 -
31 December 1996

Report of activities carried out in the time period from 1 -
31 January 1997
Report of activities carried out in the time period from 1 -

28 February 1997
Report of activities carried out in the time period from 1 -
31 March 1997

Report of activities carried out in the time period from 1 -
30 April 1997
Report of activities carried out in the time period from 1 -
31 May 1997
05 December
Contract 082 1996 to Report of activities carried out in the time period from 1 -
of 1996 November 05 30 June 1997
1997
Report of activities carried out in the time period from 1 -
31 July 1997
Report of activities carried out in the time period from 1 -
31 August 1997

Report of activities carried out in the time period from 1 -
30 September 1997
Report of activities carried out in the time period from 1 -

31 October 1997
Report of activities carried out in the time period from 1 -
30 November 1997

Report of activities carried out in the time period from 1 -
31 December 1997

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98 Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
31 January 1998

Report of activities carried out in the time period from 1 -
28 February 1998
Report of activities carried out in the time period from 1 -
31 March 1998

Report of activities carried out in the time period from 1 -
30 April 1998
Report of activities carried out in the time period from 1 -

31 May 1998
Report of activities carried out in the time period from 1 -
30 June 1998

Report of activities carried out in the time period from 1 -
31 July 1998
Report of activities carried out in the time period from 1 -

31 August 1998
Report of activities carried out in the time period from 1 -
30 September 1998

08 January Report of activities carried out in the time period from 1 -
1998, plus 31 October 1998
Contract 001 addition of one Report of activities carried out in the time period from 1 -
of 1998 more month
30 November 1998
until 08 June Report of activities carried out in the time period from 1 -
2000. 31 December 1998

Report of activities carried out in the time period from 1 -
31 January 1999
Report of activities carried out in the time period from 1 -
28 February 1999

Report of activities carried out in the time period from 1 -
31 March 1999

Report of activities carried out in the time period from 1 -
30 April 1999
Report of activities carried out in the time period from 1 -
31 May 1999

Report of activities carried out in the time period from 1 -
30 June 1999
Report of activities carried out in the time period from 1 -

31 July 1999
Report of activities carried out in the time period from 1 -
31 August 1999

Report of activities carried out in the time period from 1 -
30 September 1999

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99Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
31 October 1999

Report of activities carried out in the time period from 1 -
30 November 1999
Report of activities carried out in the time period from 1 -

31 December 1999
Report of activities carried out in the time period from 1 -
31 January 2000

Report of activities carried out in the time period from 1 -
28 February 2000
Report of activities carried out in the time period from 1 -

31 March 2000
Report of activities carried out in the time period from 1 -
30 April 2000

Report of activities carried out in the time period from 1 -
31 May 2000
Report of activities carried out in the time period from 1 -

30 June 2000
Report of activities carried out in the time period from 1 -
31 July 2000

Report of activities carried out in the time period from 1 -
31 August 2000
28 July 2000
and the Report of activities carried out in the time period from 1 -
Contract 019 addition of 1,5 30 September 2000
of 2000 months, until 13
December Report of activities carried out in the time period from 1 -
31 October 2000
2000. Report of activities carried out in the time period from 1 -

30 November 2000
Report of activities carried out in the time period from 1 -
31 December 2000

Report of activities carried out in the time period from 1 -
31 January 2001
Report of activities carried out in the time period from 1 -

28 February 2001
Report of activities carried out in the time period from 1 -
4 January to 31 March 2001
Contract 001 22 September
of 2001 2001 Report of activities carried out in the time period from 1 -
30 April 2001
Report of activities carried out in the time period from 1 -

31 May 2001
Report of activities carried out in the time period from 1 -
30 June 2001

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100 Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
31 July 2001

Report of activities carried out in the time period from 1 -
31 August 2001
Report of activities carried out in the time period from 1 -

30 September 2001
Report of activities carried out in the time period from 1 -
31 October 2001
24 September
Contract 035 to 31 Report of activities carried out in the time period from 1 -
of 2001 December 30 November 2001
20011 Report of activities carried out in the time period from 1 -

31 December 2001
Report of activities carried out in the time period from 1 -
31 January 2002

Report of activities carried out in the time period from 1 -
28 February 2002
Report of activities carried out in the time period from 1 -

31 March 2002
Report of activities carried out in the time period from 1 -
Contract 001 1 January to 30 April 2002
of 2002 and an
addition 27 August 2002 Report of activities carried out in the time period from 1 -
31 May 2002
Report of activities carried out in the time period from 1 -

30 June 2002
Report of activities carried out in the time period from 1 -
31 July 2002

Report of activities carried out in the time period from 1 -
31 August 2002

30 August to Report of activities carried out in the time period from 1 -
Contract 026 29 October 30 September 2002
of 2002 Report of activities carried out in the time period from 1 -
2002 31 October 2002

Report of activities carried out in the time period from 1 -
30 November 2002

Report of activities carried out in the time period from 1 -
31 December 2002
Contract 033 21 November Report of activities carried out in the time period from 1 -
of 2002 2002 to 20 31 January 2003
April de 2003
Report of activities carried out in the time period from 1 -
28 February 2003

Report of activities carried out in the time period from 1 -
31 March 2003

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101Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
30 April 2003

Report of activities carried out in the time period from 1 -
31 May 2003
Report of activities carried out in the time period from 1 -

30 June 2003
Contract 019 7 May to 6 Report of activities carried out in the time period from 1 -
of 2003 September 31 July 2003
2003
Report of activities carried out in the time period from 1 -
31 August 2003
Report of activities carried out in the time period from 1 -

30 September 2003
Report of activities carried out in the time period from 1 -
31 October 2003

Report of activities carried out in the time period from 1 -
Contract 040 10 September 30 November 2003
of 2003 2003 to 9 Report of activities carried out in the time period from 1 -
January 2004
31 December 2003
Report of activities carried out in the time period from 1 -
31 January 2004

Report of activities carried out in the time period from 1 -
Contract 001 21 January to 28 February 2004
of 2004 21 March 2004 Report of activities carried out in the time period from 1 -

31 March 2004
Report of activities carried out in the time period from 1 -
30 April 2004

Report of activities carried out in the time period from 1 -
31 May 2004

Contract 013 5 April to 5 Report of activities carried out in the time period from 1 -
of 2004 August 2004 30 June 2004
Report of activities carried out in the time period from 1 -
31 July 2004

Report of activities carried out in the time period from 1 -
31 August 2004

Report of activities carried out in the time period from 1 -
30 September 2004

27 September Report of activities carried out in the time period from 1 -
Contract 033 31 October 2004
of 2004 2004 - 26 Report of activities carried out in the time period from 1 -
February 2005
30 November 2004
Report of activities carried out in the time period from 1 -
31 December 2004

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102 Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
31 January 2005

Report of activities carried out in the time period from 1 -
28 February 2005
Report of activities carried out in the time period from 1 -

31 March 2005
Contract 034 27 March 2005 Report of activities carried out in the time period from 1 -
of 2005 - 24 May 2005 30 April 2005

Report of activities carried out in the time period from 1 -
31 May 2005
Report of activities carried out in the time period from 1 -

30 June 2005
Report of activities carried out in the time period from 1 -
31 July 2005

Report of activities carried out in the time period from 1 -
31 August 2005
Report of activities carried out in the time period from 1 -

30 September 2005
Report of activities carried out in the time period from 1 -
31 October 2005

Report of activities carried out in the time period from 1 -
30 November 2005
25 May 2005 – Report of activities carried out in the time period from 1 -
25 February
Contract 015 2006, for two 31 December 2005
of 2005 additions it is Report of activities carried out in the time period from 1 -
extended until 31 January 2006
14 July 2006
Report of activities carried out in the time period from 1 -
28 February 2006

Report of activities carried out in the time period from 1 -
31 March 2006
Report of activities carried out in the time period from 1 -
30 April 2006

Report of activities carried out in the time period from 1 -
31 May 2006

Report of activities carried out in the time period from 1 -
30 June 2006
Report of activities carried out in the time period from 1 -
31 July 2006

Report of activities carried out in the time period from 1 -
Contract 027 9 October 2006 31 October 2006
of 2006 to 9 December
2006 Report of activities carried out in the time period from 1 -
30 November 2006

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103Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -
31 December 2006

Report of activities carried out in the time period from 1 -
31 January 2007
Report of activities carried out in the time period from 1 -

28 February 2007
Report of activities carried out in the time period from 1 -
31 March 2007

Report of activities carried out in the time period from 1 -
30 April 2007
Report of activities carried out in the time period from 1 -

17 January 31 May 2007
Contract 032 2007 to 16 Report of activities carried out in the time period from 1 -
of 2007 November 30 June 2007
2007
Report of activities carried out in the time period from 1 -
31 July 2007
Report of activities carried out in the time period from 1 -

31 August 2007
Report of activities carried out in the time period from 1 -
30 September 2007

Report of activities carried out in the time period from 1 -
31 October 2007
Report of activities carried out in the time period from 1 -

30 November 2007
Report of activities carried out in the time period from 1 -
31 December 2008

Report of activities carried out in the time period from 1 -
31 January 2009

Report of activities carried out in the time period from 1 -
28 February 2009
Report of activities carried out in the time period from 1 -
31 March 2009
9 December
Contract 051 2008 - 9 Report of activities carried out in the time period from 1 -
of 2008 December 30 April 2009
2009
Report of activities carried out in the time period from 1 -
31 May 2009
Report of activities carried out in the time period from 1 -
30 June 2009

Report of activities carried out in the time period from 1 -
31 July 2009

Report of activities carried out in the time period from 1 -
31 August 2009

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104 Annex 41

Ministry of Justice and Law
Republic of de Colombia

Report of activities carried out in the time period from 1 -

30 September 2009
Report of activities carried out in the time period from 1 -

31 October 2009
Report of activities carried out in the time period from 1 -
30 November 2009

Report of activities carried out in the time period from 1 -
31 December 2009

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Page9of 9

105106 Annex 41-A

inter-agency coMMission for theverification oeradicated crops
(dne, diran, and foreign experts frousda/ars and

inl-w ashington), epOrt ON the eNvirONmeNtal audit fOr the
eradicatiON Of illicit , ogotá , 26 arch 1997

(Archives of the Colombian Foreign Ministry)

107108 Annex 41-A

NATIONAL NARCOTICS DIRECTORATE
Special Administrative Unit
National Coordinating Entity

INTER-OF ERADICATED CROPS COMMISSION

ENVIRONMENTAL AUDIT REPORT
FOR ERADICATION OF ILLICIT CROPS

Santafé de Bogotá, D.C.Luis Eduardo Parra Rodríguez
Head of Environmental Audit

Santafe de Bogotá, D.C. April 15, 1997

AA-0140.97

Mr.
JOAQUIN POLO MONTALVO

National Narcotics Director

Bogotá

Dear Dr. Polo:

Please find enclosed the “Inter-Agency Verification Commission of Eradicated

Crops” report, conducted on February 26 and 27, 1997 on coca and poppy crops.

Cordially

[Signed]

LUIS EDUARDO PARRA RODRIGUEZ

Auditor

AUDITOR/A AMBIENTAL ERRAD/CACION DE
CULTIVO$ /LICITO$ Calle 24 No Te/, 3377181-
2682796Te/efax, Colombia3} Santafé de Bogotá O.C.

109Annex 41-A

PRESENTATION

This document is a continuation of the verification process on the effectiveness of

aerial spraying with glyphosate and eradication rates of illicit coca and poppy. The
report emphasizes field work done by the verification commission, and comprises,

as the previous reports, a technical memory and photographic record where the

results and conclusions of the verification process or procedure can be seen,

based on an agreed methodology.

The participation in such verification is part of the activities that mube complied

with by the Environmental Audit for the execution of Contract 082/96.

One of the major results seen by the Commission in this Verification, has to do with

the proven effectiveness of the glyphosate herbicide, applied under the technical

and environmental parameters set out for the aerial spraying for the eradication of

coca and poppy. This fact that was recognized by part of the foreign experts from
USDA/ARS and INL in Washington, particularly, from Dr. Charles Helling and John

McLaughlin.

As the methodology used in previous reports, the results, conclusions , and
considerations of this report are supported on a photographic sequence of

illustrative and proven character, which covers the different regions and/or verified

plots. Its biogeographic al context corresponds to the municipalities of Miraflores

and El Retorno (Guaviare), in the case of coca; and Planadas, Rioblanco and

Chaparral (Tolima) in the case of poppy. The Committee of national and foreign
experts conducted their work between February 25 and 27, 1997.

[Page 1]

110 Annex 41-A

Likewise, we mention that the verification process was conducted following the

“Joint Verification Procedure for the Control of Illicit Coca Crops” prepared in

October /96, and agreed between DIRAN, D.N.E. 1and for this purpose, the inter -

disciplinary participation was comprised by:

NAME TITLE ENTITY

Col. Carlos T. Ballesteros Under-Director Antinarcotics Police DIRAN

May. Francisco J. Yunis V Head of Illicit Crops Eradication Block DIRAN

Dr. Carlos Gallego Head of the Verification Division DIRAN

Dr. Susana Huffington Head of Internal Control D.N.E.

Mr. John McLaughlin INL – Washington US Dept. /USA

Mr Víctor Abeyta NAS Director USA Embassy

Dr. Charles Helling USDA Scientist USDA/ARS-USA

Eng. Luis Eduardo Parra Director of Environmental Audit Environmental Audit

[Page 2]

1This document was summarized and became the verification protocol signed between the Ministry of

Defense and the United States Embassy. The present process maintains the variable corresponding to the
randomized sample with a percentage of reliability.

111Annex 41-A

2. BACKGROUND AND JUSTIFICATION

Since its inception, the Program has practices and procedures for verification,

which have been improved and complemented until arriving to this procedure.

Past efforts and experiences are ver y important, since it has been possible to build

today´s model and practices.

Verification has been directed towards activities of: overall aerial reconnaissance,

detailed aerial reconnaissance and “in-situ” reconnaissance of sprayed plots and

regions.

The current procedure is explained by the need to establish an agreed mechanism

for assessing and quantifying eradication results by the glyphosate spraying

method, taking into account that statistics on 1995 and 1996 eradi cation had

differences. For these reasons, the governments of Colombia and the United

States developed a protocol to address the issue of eradication of illicit crops.

This verification was performed with the participation of Dr. Charles Helling, a

USDA/ARS weed expert scientist, and Mr. John McLaughlin, a Department of

State expert. With these scientists, the purpose was to verify the effectiveness of

the program based on a randomized sample, chosen by them, from the “Pathlink”

and/or “Satloc” registers delivered by Dyncorp.

[Page 3]

3. WORK DONE

The work undertaken for the implementation of the Verification is shown in detail in

the following table:

WORK DONE FOR VERIFICATION OF
ILLICIT COCA AND POPPY CROPS

DATE ACTIVITY REGION/ COMMENTS

MUNICIPALITY

26-02-97 Verification planning on cocaGuaviare Work done by DIRAN,
illicit crops, overflights, etc. DYNCORP and

112State expert. With these scientists, the purpose was to verify the effectiveness of

Annex 41-A
the program based on a randomized sample, chosen by them, from the “Pathlink”

and/or “Satloc” registers delivered by Dyncorp.

[Page 3]
Environmental Audit

Selection and determination of Guaviare Work done by NAS
through their “Pathlink”
coordinates of plots to 3. WORK DONE and “Satloc”2register
verified.
Commission work in 2
The work undertaken for the implementation of the Verification is shown iplots. Around Miraflores
Miraflores (Guaviare)
the following table: (1) and El Retorno (1)
27-02-97 Verification planning on poppy Tolima Work done by DIRAN,
WORK DONE FOR VERIFICATION OF
illicit crops, overflights, NAS and Environmental
displacementsILLICIT COCA AND POPPY CROPS Audit.

DATE DeterminatiACTIVITYordinates of TolimaREGION/ Work COMMENTSNAS and
plots to be verified. DIRAN from “Pathlink”
MUNICIPALITY register and spraying
notes.
26-02-97 Verification planning on coca Guaviare Work done by DIRAN,
illicit crops, overflights, etc. Rioblanco and DYNCORP andrification was
Chaparral (Tolima) done from the
Environmental Audit
heli3opter. Commission
Selection and determination of Guaviare work done by NAS
coordinates of plots to be through thei2 “Pathlink”
and “Satloc” register
verified.
“in-situ” verification [PagEl Retorno and Commission work in 2
plots. Around Miraflores
Miraflores (Guaviare) (1) and El Retorno (1)

27-02-97 Verification planning on poppy Tolima Work done by DIRAN,
illicit crops, overflights, NAS and Environmental

displacements, etc. Audit.
Determination of coordinates of Tolima Work done by NAS and

plots to be verified. DIRAN from “Pathlink”
register and spraying
notes.

“in-situ” verification Rioblanco and Detailed verification was
Chaparral (Tolima) done from the
helicopter. Commission
3
work

[Page 4]

2
Software used by NAS/USA through DYNCORP for aerial spraying control activities, aerial reconnaissance
and planning of eradication activities.
3Given the limitation of the operating capacity of the H1-UH helicopters to land on plots, it was decided to
make a detailed reconnaissance overflight on each pre-selected plot and PHOTO taking. This is possible on

illicit poppy crops given their evident death by aerial spraying with glyphosate.

113Annex 41-A

4. SELECTION AND REPRESENTATIVE QUALITY
OF THE SAMPLES TO BE VERIFIED

To establish this critical issue, the following criteria were taken into accowhich
form an integral part of the Verification Procedures, as follows:

1. Random selection of a sample of sprayed plots 128 and 227 days prior to

verification, in the case of coca, which represents approximately 3.45% of
total spray during July and October, 1996. In the case of poppy, sprayed
plots were selected 86, 77, 53, 31, 21 and 5 days before , corresponding to
the months of December 1996, January and February 1997.

2. Determination of plots to verify from computer records established by the
“Pathlink, Analyzer” and “SATLOC” system and provided by
NAS/DYNCORP.

3. Estimation of eradicated areas, based on the opinion of experts on damage
assessment which disable coca plantations for drug production, at least for
1 year. In the case of poppy, the criterion is that it is out of production for
one harvest.

4. The results expressed on the effectiveness of aerial spraying were made in
terms of percentage of damage to the plot, with an inherent margin of error
(experts estimate).

The above criteria are expressed in the results shown in TABLES No. 4.1 and 4.2

[Page 5]

114 Annex 41-A

TABLE NO. 4.1

SPRAYED AREA IN THE PERIOD AND PERCENTAGE OF SAMPLE –
COCA-LEAF

DEPARTMENT MUNICIPALITY SPRAYED AREA (ha) SAMPLE
JULY OCTOBER AREA %
(1)
(ha)
Guaviare El Retorno - 1447.34 4 0.3
Miraflores 635.0 - 20 3.15

TOTAL 635.0 1447.34 24 ∑ 3.45
(1) The sample area is the sum of average of estimated areas in each plot and selected by USA experts
- This verification was made in the presence of a USDA/ARS scientist Washington-
expert.

TABLE NO. 4.2

SPRAYED AREA IN THE PERIOD AND PERCENTAGE OF SAMPLE –
OPIUM POPPY

DEPARTMENT MUNICIPALITY SPRAYED AREA (ha) SAMPLE (1)

DECEMBER JANUARY FEBRUARY AREA %
(ha)
Tolima Planadas - 130 100 125 54.34
Rioblanco 69 50 150 119 44.23
Chaparral 100 - - 46 46.0

TOTAL 169 180 250 290 48.41*
(1) The coca sample is large since all sprayed nucleus was overflown.
* This percentage results from comparing total sample area with total sprayed area during this
quarter.

[Page 6]

115Annex 41-A

5. CONCLUSIONS AND RECOMMENDATIONS

5.1 COCA ERADICATION

In general terms, conclusions and recommendations, based on verification
conducted in this period, are similar to the previous, as follows:

• Overall reliability criteria set out in the agreed procedure were observed
with the greatest scientific rigor. Under these conditions, coca eradication,

on a sample of 3.45% of the sprayed universe, showed an eradication rate
of 90%-100%, according to field observations, as shown in Table No. 5.1

• The invasion of natural vegetation (grasses and herbaceous ) of forests

destroyed, is abundant and aggressive, especially in those plots that were
not subjected to indiscriminate and uncontrolled use of agrochemicals
during the cultivation process (herbicides, foliar fertilizers, insecticides, etc.)

• Arboreal vegetation and shrubs were observed surrounding sprayed plots,
without any adverse effect. Likewise, the presence of entomological fauna
on the upper soil layer was observed (arthropods, termites, annelids and
arachnids)

5.2 POPPY ERADICATION

As for the case of coca, verification results on Program efficiency on poppy crops
re the following:

[Page 7]

116 Annex 41-A

• Poppy eradication, on a sample of 48.41% of the sprayed universe, showed

an eradication rate between 90% a4d 100% according to the range
estimated by the Commission The observations are shown in Table 5.2

• According to these eradication estimates, it can be said that all sprayed
poppy was eradicated.

• In general, there was a significant decrease in the area with illicit poppy
crops in the verified area. In turn, these areas have been destined to
extensive cattle raising, an inappropriate activity in this type of soil, thus

creating pastured Andean cloud forest.

• [Page 8]

4
This sample is as high as possible, since the verification process is based mainly on detailed aerial
reconnaissance, taking into account landing difficulties. This procedure helps the quick wilting of poppies
(maximum 8 days after spraying), a situation that makes death evident

117Annex 41-A

TABLE NO. 5.1

VERIFICATION OF EFFECTIVE DEATH OF ILLICIT COCA-LEAF CROPS BY AERIAL SPRAYING IN THE
DEPARTMENT OF GUAVIARE

(2) (3) (4)
SPRAYI(1) SITE OR SITE OR PATHLINK COORDINATES FIELD COORDINATES PLOT SIZE DEATH PERC(5)AGE
DATE PLOT REGION (HA) (%)
MIN RANGE MAX
RANGE

08/07/96 1 Mraflores N 01°25,09' W 71° 58,73' N 01°24,230' W 71° 58,703' 15 - 20 85 95
18/10/96 2 El Retorno N 02°16,17' W 72° 33,37' N 02°16,609' W 72° 33,530' 4 95 100

TOTALS - - - - 19-24 90.0 97.5

______________
(1) Dated recorded in “Pathlink” listings
(2) Coordinates taken directly from “Pathlink” listings

(3) Coordinates taken with GP.S., manual. Its precision is high and is based where the helicopterlands.
(4) Sizes estimated by experts in field (NAS advisor pilot, Colombian pilots and engineers from Environmental Audit), based on aerial
reconnaissance in helicopter and visual appreciation “in-situ”
(5) Estimate based on wilting and total death of plants in overall plot

TABLE NO. 5.2

VERIFICATION OF EFFECTIVE DEATH OF ILLICIT POPPY CROPS BY AERIAL SPRAYING IN THE
DEPARTMENT OF TOLIMA

(2) (3) (4)
SPRAYI(1) SITE OR SITE OR PATHLINK COORDINATES FIELD COORDINATES PLOT SIZE DEATH PERC(5)AGE
DATE PLOT REGION (HA) (%)
MIN RANGE MAX
RANGE
(6)
04/12/96 1 Chaparral N 03°39,38' W 75° 39,30' N 03°39,380' W 75° 39,300' 46 85 95
12/12/96 2 Rioblanco N 03°26,80' W 75° 54,1' N 03°27,100' W 75° 50,600' 46 90 95
12/12/96 3 Rioblanco N 03°20,10' W 75° 48,5' N 03°20,100' W 75° 43,500' 23 85 95

05/01/97 4 Rioblanco N 03°27,55' W 75° 49,19' N 03°27,550' W 75° 45,190' 50 90 95
20/01/97 5 Planadas N 03°03,59' W 75° 42.01' N 03°03,590' W 75° 42,010' 50 90 95
06/02/97 6 Planadas N 02°59,80' W 75° 45,30' N 02°59,00' W 75° 40,44' 50 90 95
22/02/97 7 Planadas N 02°58,24' W 75° 46,48' N 02°58,240' W 75° 46,480' 25 90 95

TOTALS - - - - 290 88.57 95.0

______________
(1) Dated recorded in “Pathlink” listings
(2) Coordinates taken directly from “Pathlink” listings
(3) Coordinates taken with GP.S., manual. Its precision is high and is based where the helicopter lands.
(4) Sizes estimated by experts in field (NAS advisor pilot, Colombian pilots and engineers from Environmental Audit), based on aerial

reconnaissance in helicopter and visual appreciation “in-situ”
(5) Estimation based on wilting and total death of plants in overall plot
(6) Plot size was taken based on sprayed area on fumigation date, since an overflight was made on all sprayed area.

118 Annex 41-A

PLOT NO. 1

PHOTO NO. VC 10 ROLL: RVC 137

LOCATION: N 01° 24,230 W 71° 58,703' Miraflores – Guaviare

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 227 days

COMMENTS: • Plot sprayed on 08/07/96 in the Miraflores area, with an extension of 15-20 ha.

• Death of plot was considered by USDA/ARS expert in at least 90%
• Note the invasion of natural vegetation (pastures and herbaceous). It can be
observed that some plats have some non-productive leaves and their stem is
completely necrotic (death)

119Annex 41-A

PLOT NO. 1

PHOTO NO. VC 11 ROLL: RVC 137

LOCATION: N 01° 24,230 W 71° 58,703' Miraflores – Guaviare

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 227 days

COMMENTS: • Plot located in Miraflores-Guaviare. This plot was selected by US experts for
verification.

• Approximate size: 15 – 20 ha

• Note US expert inspecting effective death of coca plants and of overall plot

• This plot was assigned 90% control according to US members of the
commission

120 Annex 41-A

PLOT NO. 1

PHOTO NO. VC 16 ROLL: RVC 137

LOCATION: N 01° 24,230 W 71° 58,703'

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 227 days

COMMENTS: • Plot located in Miraflores-Guaviare. Approximate size 15-20 ha, sprayed on
08/07/96

• Observe flight (1) Some sectors were not sprayed due to radial method and no
overlapping of flight lines

• Note coca plant completely dead in foreground. 90% plot control. The
Commission considered this plot out of production and observed completely
abandoned.

• See woody vegetation, with no damage.

121Annex 41-A

PLOT NO. 2

PHOTO NO. VC 19 ROLL: RVC 137

LOCATION: N 02° 16,609 W 72° 33,530' El Retorno

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 128 days

COMMENTS: • See Mr. John McLaughlin (INL-Washington) examining aerial spraying results

with glyphosate

• Coca is completely dead and control was 100% in sprayed plot. Note invasion
of grass and herbaceous species in plot.

122 Annex 41-A

PLOT NO. 2

PHOTO NO. VC 20 ROLL: RVC 137

LOCATION: N 02° 16,609 W 72° 33,530'

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 128 days

COMMENTS: • Note completely necrotic (dead tissue) logs and branches.

123Annex 41-A

PLOT NO. 2

PHOTO NO. VC 21 ROLL: RVC 121

LOCATION: N 02° 16,609 W 72° 33,530'

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 128 days

COMMENTS: • See Dr. Charles Helling (USDA Scientist) descending from helicopter to
examine coca crop sprayed with glyphosate

• See coca is completely dead. 100% control.

124 Annex 41-A

PLOT NO. 2

PHOTO NO. VC 22 ROLL: RVC 137

LOCATION: N 02° 16,609 W 72° 33,530'

VERIFICATION DATE: 26/02/97 SPRAYING TIME: 128 days

COMMENTS: • Plot sprayed with glyphosate on 18/10/96.

• See members of the USDA/ARS mission and Department of State inspecting
foliar and woody material of a coca plant sprayed with glyphosate, which is

necrotic, rosette and with no possibilities of being used for cocaine production
• See coca plot, completely death

• Some signs of leaves are twisted, chlorotic and non-productive.

125Annex 41-A

PLOT NO. 1

PHOTO NO. VC 27 ROLL: RVC 137

LOCATION: N 03° 39,380 W 75° 39,300'

VERIFICATION DATE: 26/02/97 SPRAYING TIME: + 86 days

COMMENTS: • Plot located in Chaparral-Tolima, towards San José de las Hermosas.

• See 90% of poppy planted area was eradicated

• See natural forest unaffected by aerial spraying.

126 Annex 41-A

PLOT NO. 1

PHOTO NO. VC 29 ROLL: RVC 137

LOCATION: N 03° 39,380 W 75° 39,300' Chaparral

VERIFICATION DATE: 26/02/97 SPRAYING TIME: + 86 days

COMMENTS: • See tree vegetation undamaged by aerial spraying with
glyphosate.

• See rabbit or small area of poppy crop left unsprayed; however, crop was
abandoned because probably this small area did not yield any profit.

127Annex 41-A

PLOT NO. 2

PHOTO NO. VC 31 ROLL: RVC 137

LOCATION: N 03° 27,100 W 75° 50,600'

VERIFICATION DATE: 26/02/97 SPRAYING TIME: + 77 days

COMMENTS: • Plot located in the jurisdiction of Rioblanco – Tolima.

• See flight trail (1) effective for the eradication of illicit coca crop
• Note that eradicated areas are destined for extensive cattle raising, an
inadequate activity in this type of soils and physiography.

• In (2) plots which in previous years were sprayed and are in the process of
natural regeneration or restoration.

128 Annex 41-A

PLOT NO. 3

PHOTO NO. VC 32 ROLL: RVC 137

LOCATION: N 03° 20,100 W 75° 48,600' Rioblanco - Tolima

VERIFICATION DATE: 27/02/97 SPRAYING TIME: 77 days

COMMENTS: • Observe destruction of cloud forest for illicit crops which, after being eradicated,

are abandoned leaving only a forest cemetery.

• Coca illicit crop was completely eradicated.

129Annex 41-A

PLOT NO. 4

PHOTO NO. VC 35 ROLL: RVC 137

LOCATION: N 03° 27,550 W 75° 45,190' Rioblanco - Tolima

VERIFICATION DATE: 27/02/97 SPRAYING TIME: + 53 days

COMMENTS: • Observe maize crop (1) undamaged and eradicated poppy.

• See that the trend in establishing illicit crops is to look for areas towards higher

elevations.

130 Annex 41-A

PLOT NO. 4

PHOTO NO. VC 36A ROLL: RVC 137

LOCATION: N 03° 27,550 W 75° 45,190' Rioblanco

VERIFICATION DATE: 27/02/97 SPRAYING TIME: + 53 days

COMMENTS: • Destruction, slash and burn, and deforestation are common in illicit crops.

• (1) See total poppy destruction.

• (2) See newly planted poppy, not more than 30 - 45 days.

131Annex 41-A

PLOT NO. 5

PHOTO NO. VC 4 ROLL: RVA 138

LOCATION: N 03° 03,590 W 75° 42,010' Planadas / Tolima

VERIFICATION DATE: 27/02/97 SPRAYING TIME: 37 days

COMMENTS: • Nucleus completely eradicated. Its approximate area was 50 ha (100).

• Observe recent poppy in among the remains of the trees.

132 Annex 41-A

PLOT NO. 6

PHOTO NO. VC 14 ROLL: RVC 138

LOCATION: N 03° 59' W 75° 40,44' Planadas / Tolima

VERIFICATION DATE: 27/02/97 SPRAYING TIME: 21 days

COMMENTS: • See over 90% eradication of cultivated land. Nucleus was 75 ha.

133Annex 41-A

PLOT NO. 7

PHOTO NO. VA 15 ROLL: RVC 138

LOCATION: N 02° 58,240' W 75° 46,480' Planadas / Tolima

VERIFICATION DATE: 27/02/97 SPRAYING TIME: 5 days

COMMENTS: • Observe plot few days after spraying.

• See yellowish color of plants, indicating their evident death *100% control.

134142154 Annex 41-E

AUDIT TO THEPROGRAM FOR THE ERADICATION OFILLICITCROPS
BY AERIALSPRAYING WITH GLYPHOSATE HERBICIDE. REPORTNO .

3. UDITED PERIOD:19 DECEMBER 2006TO 18JANUARY 2007,
JANUARY 2007

(Archives of the Colombian Foreign Ministry)

159 Audit Report No. 3
Dec 19, 2006 to Jan 18, 2007
“Audit of the eradication of illicit crops by aerial

spraying with glyphosate”

NATIONAL NARCOTICS DIRECTORATE - DNE

AUDIT CONTRACT No. 027 OF 2006

AUDIT OF THE PROGRAM FOR ERADICATION OF ILLICIT CROPS BY AERIAL
SPRAYING WITH GLYPHOSATE

REPORT No. 3
AUDIT PERIOD: 19 DECEMBER 2006 TO 18 JANUARY 2007

CONTRACTOR: UNIÓN TEMPORAL AUDITORÍA PMA

BOGOTA D.C., JANUARY 2007

160 Annex 42

NOTE3111-2-1421FROM THEM INISTRY FOR TENVIRONMENT

IN RESPONSE TOOTE10945OF22J ULY1998FROM THENATIONAL
N ARCOTICSDIRECTORATE(DNE),28JULY1998

(Archives of the Colombian Foreign Ministry)

235236 Annex 42

REPUBLIC OF COLOMBIA

MINISTRY FOR THE ENVIRONMENT
Sustainable Development Division

Licenses Section

28 Jul 1998 3111-2-

14218
Santafe de Bogota, D.C.

Ms.
IVONNE ALCALA AREVALO

Dirtector
National Narcotics Directorate

Reference: Note 10945 dated 22 July 1998

Dear Ms.:

In reply to your note in the reference, I respectfully inform you that

this Section has established the date 30 July 1998, at 10:00 a.m. for
submission of the Environmental Management Plan for the
application of glyphosaste herbicide for eradication of illicit crops.

Sincerely,

GUILLERMO ACEVEDO MANTILLA
Assistant Director Environmental Licenses

c.c. File No. 793

PGA/WORD-GLIFOF1/28-JUL-98

237238 Annex 43

MINUTES ANDO RDERS OF PRIOR CONSULTATION PROCESSES WITH

INDIGENOUS COMMUNITIESIN COMPLIANCE WITH THECOLOMBIAN
CONSTITUTIONALC OURT’S RULINSU-0383.

(Archives of the Colombian Foreign Ministry)

239 NOTE OF AGREEMENT OF THE CONSULTATION PROCESS WITH

AUTHORITIES AND INDIGENOUS ORGANIZATIONS OF THE COLOMBIAN
AMAZONIA ON POLICIES OF ERADICATION OF ILLICT CROPS AS ORDERED
BY THE CONSTITUTIONAL COURT IN DECISION SU-383 / 2003

In compliance with mandate of Decision SU -383 / 2003 of the Constitutional Court,
this formalization note of Consultation between authorities and organizations of
indigenous communities of the Colombian Amazonia and the Colombian
Government represented by Dr. Juan Carlos Vives -Menotti, Ministry of Interior and

Justice (a.i.), in representation of the National Narcotics Council
Minute of August 1, 2003, and Mrs. Maria Inés Restrepo-
Alternative Development Plan Program of the Office of the President, in
representation of the Office of the President, per Resolution 1823 of September 12,
2003.

In furtherance of this process, it was agreed to conduct regional workshops
regarding information of mandate ordered in decision for c
the Government of President Álvaro Uribe- Vélez, on eradication of illicit crops in

the Colombian Amazonia, defining participation of indigenous authorities in
representation of their communities in the areas of illicit crops, in order to inform
effectively and efficiently the decision of the Constitutional Court and
Government´s policies, with full observance of principles and regulations contained
in Agreement 169 of ILO, approved by Law 21 / 1991 and procedure established in

that decision and meeting of a national meeting with delegates of the Colombian
Amazonia departments to make the consultation, in accordance with above
mentioned decision.

Whereas

The policy of eradication illicit crops is a State policy approved and ratified by
National Development Plan 2003- 2006 of President, Álvaro Uribe- Vélez, “Towards
a Community State” approved by Law 812 of June 26, 2003.

An essential component of this policy is to fight the problem of illicit drugs and
organized crime, oriented “towards the dismantling of the process of production,
trade and consumption of drugs, by means of forced and voluntary eradication of
crops and the development in depressed areas and conflict through the
implementation of an alternative development program that generates alternatives

for subsistence and the generation of short-term income.
For many indigenous communities of the Colombian Amazonia, the consumption of

coca leaf has had a traditional use rooted in its ancestral culture and which makes
an integral part of their daily life, being essential in the life of every individual and
its community.

The Colombian state protects the ethnical and cultural diversity of the Nation and in
this constitutional framework respects the traditional use that the indigenou
peoples make of the coca leaf a fundamental of their culture, and its commitment is

240 Annex 43

NOTE OF AGREEMENT OF THE CONSULTATION PROCESS WITH

AUTHORITIES AND INDIGENOUS ORGANIZATIONS OF THE COLOMBIAN
AMAZONIA ON POLICIES OF ERADICATION OF ILLICT CROPS AS ORDERED
BY THE CONSTITUTIONAL COURT IN DECISION SU-383 / 2003

In compliance with mandate of Decision SU -383 / 2003 of the Constitutional Court,
this formalization note of Consultation between authorities and organizations of
indigenous communities of the Colombian Amazonia and the Colombian
Government represented by Dr. Juan Carlos Vives -Menotti, Ministry of Interior and

Justice (a.i.), in representation of the National Narcotics Council (CNE), as per
Minute of August 1, 2003, and Mrs. Maria Inés Restrepo- Cañón, director of the
Alternative Development Plan Program of the Office of the President, in
representation of the Office of the President, per Resolution 1823 of September 12,
2003.

In furtherance of this process, it was agreed to conduct regional workshops
regarding information of mandate ordered in decision for c onsultation policies of
the Government of President Álvaro Uribe- Vélez, on eradication of illicit crops in

the Colombian Amazonia, defining participation of indigenous authorities in
representation of their communities in the areas of illicit crops, in order to inform
effectively and efficiently the decision of the Constitutional Court and
Government´s policies, with full observance of principles and regulations contained
in Agreement 169 of ILO, approved by Law 21 / 1991 and procedure established in

that decision and meeting of a national meeting with delegates of the Colombian
Amazonia departments to make the consultation, in accordance with above
mentioned decision.

Whereas

The policy of eradication illicit crops is a State policy approved and ratified the
National Development Plan 2003- 2006 of President, Álvaro Uribe- Vélez, “Towards
a Community State” approved by Law 812 of June 26, 2003.

An essential component of this policy is to fight the problem of illicit drugs and
organized crime, oriented “towards the dismantling of the process of production,
trade and consumption of drugs, by means of forced and voluntary eradication of
crops and the development in depressed areas and conflict through the
implementation of an alternative development program that generates alternatives

for subsistence and the generation of short-term income.
For many indigenous communities of the Colombian Amazonia, the consumption of

coca leaf has had a traditional use rooted in its ancestral culture and which makes
an integral part of their daily life, being essential in the life of every individual and
its community.

The Colombian state protects the ethnical and cultural diversity of the Nation and in
this constitutional framework respects the traditional use that the indigenou s
peoples make of the coca leaf a fundamental of their culture, and its commitment is

1

241Annex 43

to preserve, strengthen and develop the legal and constitutional characteristics of
the indigenous territories of the Colombian Amazonia.

IT IS AGREED THAT:

The eradication of illicit crops in indigenous territories of the Colombian Amazonia
will be made in a concerted and verifiable manner, between the indigenous
authorities and organizations and competent entities.

The consultation must establish times, verification and support mechanisms for the
execution of alternative development programs consistent with the cultural and
environmental characteristics of indigenous peoples and territories.

Regarding all other protected rights, the following is agreed:

• The Government will establish a “Regional Amazonia Working Group” with
representatives of the indigenous organizations and authorities of the
Amazonia and other State, regional and local entities, as a standing
consultation forum for the formulation of a regional and integr al policy of

sustainable development.
• In consultation with indigenous authorities and organizations of the

Colombian Amazonia, the Government undertakes to formulate and
promote the approval of a policy document – Conpes – to contain
economic, cultural, po litical environmental and investment aspects in the
indigenous reservations and communities in this region. The Conpes
document must include the following components, amongst others:

1. Support to the formulation and financing of life plans.

2. Guidelines to encourage indigenous territorial order in the conformation
perspective of Indigenous Territorial Entities.

3. Procedure to define health attention models of the Amazonia indigenous
communities in furtherance of Article 22 of Law 691 /2001 and Articles
24 and 25 of Law 21 /1991.

4. Definition of policies for indigenous communities in the border in the
context of binational relations and foreign policy defined by the
Government.

5. Implementation of a strategy for the management of international
cooperation funds for financing development proposals agreed by the
Regional Amazonia Working Group.

6. Definition of a specific component in the context of the National
Guidelines for the Prevention and Attention of Indigenous Forced
Displacement.

7. Definition of an alternative s ubstitution and development program
adapted to their cultural particularities and procurement of funds for its
implementation.

2

242 Annex 43

8. In the context of President Alvaro Uribe´s Government, to continue
compliance with agreements signed between the Government and t he

indigenous communities of the Colombian Amazonia for the manual
eradication of illicit crops. (Mutual Agreement and Standing Committee
of Cofán).

9. Support to bilingual and intercultural education programs proposed by
the indigenous communities and authorities.

OTHER COMMITMENTS
The Government commits its political will to promote the Ley Orgánica de

Ordenamiento Territorial (Organic Law of Territorial Order) filed on July 20, 2003 at
the Congress, which develops the constitutional mandate for the creation of
Indigenous Territorial Entities.

The Government will promote the definition of certain political principles regarding
Human Rights for indigenous peoples of the Colombian Amazonia.

In the context of the National Development Plan, the Government will ad vance to
define a policy for the agreed management of protected areas overlapped with
indigenous territories in the Amazon region.

The Government will effect consultations to regulate Article 7 of Law 30 / 1986 to
guarantee the traditional use of coca and other plants from which narcotics
substances can be produced, used for cultural purposes.

The Parties agree a term of 6 months to regulate and implement the Regional
Amazonia Working Group and the Conpes formulation agreed here. The
Government, through the Ministry of Interior and Justice will procure the necessary
funds to guarantee indigenous interaction, to be made with a commission of 10

delegates formed by representatives of the departments and members of the
OPIAC´s executive committee.

In the contex t of President Uribe´s government policies, the Government and the
subscribing entities of the Acuerdo Mutuo para la sustitución de cultivos de uso
ilícito de coca en el departamento de Putumayo” ( Mutual Agreement for the
substitution of illicit use of coc a in the department of Putumayo), “Plan Integral
Raíz por Raíz por la pervivencia de los pueblos indígenas ” (Integral Plan Root by

Root for the survival of indigenous peoples ) “Mesa Permanente del Pueblo Cofán ”
(Standing Committee of Cofán)”, agree to meet with the representative institutions
of the Indigenous peoples of Putumayo to evaluate and execute same, but only in
matters consistent with guidelines and eradication programs of illicit crops and the
Government´s National Development Plan.

The Parties express their will to reach to a common agreement, and as needed,
the international accompaniment of international organizations to guarantee the

development to guarantee the development and compliance of this agreement
In witness whereof, this agreement is signed in Bogotá on November 14, 2003 by:

3

243Annex 43

For the Colombian Government

Minister (a.i.) of Interior and Justice in representation of the National Narcotics
Council

Director of the Presidential Program: Alternative Development Plan

1. Department of Amazonas

2. Department of Caquetá

4

244 Annex 43

3. Department of Guanía

4. Department of Guaviare

President Regional Indigenous Council of Guaviare – CRIGUA II

5. Department of Putumayo

President Awa Community

President, Indigenous Zonal Organization of Putumayo, OZIP

5

245Annex 43

Coordinator Standing Committee Cofan Community

6. Department of Vaupés

Organization of Indigenous Peoples of the Colombian Amazonia

President Secretary General

NOTE: List of captains and indigenous authorities of the Colombian Amazonia
present in the meeting attached:

Witnesses:

6

246 Annex 43

LIST OF INDIGENOUS AUTHORITIES OF THE COLOMBIA AMAZONIA
PRESENT AT THE CONSULTATION PROCESS OF THE GOVERNMENT´S

SPRAYING POLICIES
Bogotá, D.C. November 14, 2003

NAME COMMUNITY TITLE

7

247Annex 43

LIST OF INDIGENOUS AUTHORITIES OF THE COLOMBIA AMAZONIA
PRESENT AT THE CONSULTATION PROCESS OF THE GOVERNMENT´S

SPRAYING POLICIES
Bogotá, D.C. November 14, 2003

NAME COMMUNITY TITLE

8

248 Annex 43

LIST OF INDIGENOUS AUTHORITIES OF THE COLOMBIA AMAZONIA
PRESENT AT THE CONSULTATION PROCESS OF THE GOVERNMENT´S

SPRAYING POLICIES
Bogotá, D.C. November 14, 2003

NAME COMMUNITY TITLE

9

249Annex 43

LIST OF INDIGENOUS AUTHORITIES OF THE COLOMBIA AMAZONIA
PRESENT AT THE CONSULTATION PROCESS OF THE GOVERNMENT´S

SPRAYING POLICIES
Bogotá, D.C. November 14, 2003

NAME COMMUNITY TITLE

10

250 Annex 43

LIST OF INDIGENOUS AUTHORITIES OF THE COLOMBIA AMAZONIA
PRESENT AT THE CONSULTATION PROCESS OF THE GOVERNMENT´S

SPRAYING POLICIES
Bogotá, D.C. November 14, 2003

NAME COMMUNITY TITLE

11

251Annex 43

NOTE OF FORMALIZATION OF PRIOR CONSULTATION –ERADICATION OF
ILLICIT CROPS WITH INDIGENOULS AUTHORITIES OF PUTUMAYO (PUERTO
LEGUÍZAMO)

December 20 and 21, 2006

In compliance with Decision SU-373/ 2003 and Agreement signed on
November 14, 2003 between the Colombian Government andthe Indigenous
Authorities of the Colombian Amazonia, prior consultation process was
conductedas follows:

Installation – (December 20/2006)

Opening of Prior Consultation Process

(Ministry of Interior and Justice –Ethnic Directorate)

As provided for by Law, the Ethnic Directorate makes a presentation of what
is, how does operate and the importance of the prior consultation process,

compliance with Decision SU-383 and all other legal provisions.

Then, the introduction of participant officers, invitees and indigenous
authorities present is made.

The indigenous authorities present, taking advantage of the various officers
of Official en tities described their concerns regarding the process. These

concerns were answered to and the Agenda to continue was established for
the following day.

Socialization of the Process (December 20, 2006)

The indigenous authorities headed by senior partici pants with knowledge of
the matter, Liborio Muñoz (JHRIJIRI), Dapid Perdomo-Hernández (Santa Rita),
Héctor Yaiguaje (Gaoya) and Jorge Torres (indigenous reservation of KICHWA

ALTO NAPORUNA) made the presentation on the meaning of coca plant,
tobacco and Ya gé for the indigenous community, according to the
knowledge inherited by their ancestors.

1

252 Annex 43

The say that coca is life image of the Creator, the Image of Christ delivered at
the High Throne, which means the life plans of the indigenous jurisdictions

(reservation), coca is the intelligence that God gives us as a gift.
Unfortunately, today it has taken two paths: that of the ancestral use and
that which departs from it , used for interests other than the welfare and

health of the communities.

Likewise, regarding tobacco and yagé, it is said that these are plants that give

them force, redirectioning of life, organization, work, respect, food, clothing,
health and life increase, amongst others.

2

253Annex 43

PRESENTATION OF GENERAL POLICY –ANTI-DRUGS
(National Narcotics Directorate-DNE)

Dr. Elena Ramos ma de a detailed explanation of the Drugs Policy which is
included in the National Development Plan with emphasis on strategies set
out by the State to fight illicit drugs, stressing the need of break up drug

production processes, processing, traffic and consumption. Also, emphasis is
made regarding compliance with decision of Article of the Constitutional
Court, with due respect of the ancestral consumption by indigenous
communities and implementing State prog rams for the eradication of illicit

crops not used for this purpose.

PRESENTATION OF THE OPERATING PART OF PROCEDURE AND FORMS OF
ERADICATION

(Anti-Narcotics Police)

Maj. Miguel Antonio Tunjano explained the diagnostics of illicit crops of coca
in areas of indigenous reservations in Putumayo.

He presented the legal, technical and environmental framework for the
development of aerial and manual eradication operations.

Additionally, eradication mechanisms, taking account detection processes,
aerial spraying, manual eradication and verification.

TECHNICAL ANALYSIS OF POLICE PRESENTATION
(Colombian Agriculture and Livestock Institute – ICA)

Dr. Jorge Arturo Rodríguez mentioned the commitment of the Institute with
the eradication program of illicit crops, such as to guarantee the application
of the herbicide under parameters approved by the Group of Agricultural

inputs. He also mentions how glyphosate is a freely traded product in
Colombia and in 96% of total Colombian sales of the molecule, has been used
in various licit crops. Finally, he reported on the technical advantages of using
the coadjuvant product. COSMOFLUX, also approved by ICA and freely traded

in Colombia.

3

254 Annex 43

ENVIRONMENTAL IMPACTS

MINISTRY FOR THE ENVIRONMENT, HOUSING AND TERRITORIAL
DEVELOPMENT

Eng. José Agustín Zea presented the Environmental Management Plan of the
Eradication Program of illicit Crops, amended by Resolution 1054 / 2003,
made up of 8 sheets.

He gave details of follow -up processes to the various activities described in
the Environmental Management Sheets.

NOTE OF THE TRANSLATOR: Page hand-numbered (536) missing.
….. who grants them and Puerto Leguízamo is not included. The Government

presents the Forest Ranger Families proposal which includes the
implementation of productive processes. He says that besides ADAM there
are other entities that grant international cooperation funds.

Carlos Sáenz, Head of the Nature Park LA PAYA program, says that the
purpose of the Park is to maintain the biological and cultural diversity found
within it and for this reason, regarding spraying and manual eradication there

is a series of procedures defined by Resolution No. 105 / 2005, which
establishes the steps for making eradication without damaging flora and
fauna. In the eradication process, it must be taken into account that this is

an economic situation where communities live. There was an experience in
Leguízamo of another eradication process approximately 5 years ago, where,
although economic alternatives were given, no follow-up was madeon it, and
after some years, funds were spent because projects were not viable in

economic and social terms. Therefore, when mounting an eradication
operation, economic alternatives must be presented, and these must be
viable at economic, social and envi ronmental levels. Regarding parks we
have been working in the search of productive alternatives in the Park areas

with sustainable systems projects for participatory conservation and
restoration, developed in the buffer zone and inside the Park, respectiv ely.
We consider that what is being done from the parks could be worked
complementarily with the eradication program proposal. In Parks, we will be

attentive that the protection of biological and cultural diversity is complied
with.

4

255Annex 43

The Kichwas Governors claim recognition of their ethnic group before the

Ministry and say that no agreement can be reached when their territories
have not been even been recognized as Indigenous Reservations.

The communities have been informed of the eradication and PLANTE 5years
ago, and the results were negative because funds were diverted by the NGOs
responsible for the projects at the time. In fact, there is no credibility in

Government policies and demand that the Government guarantees
compliance of the process.

PROPOSALS

Abraham López, President of ACILAPP, read the proposal that includes 3
strategic lines, which forms part of this Note, for the same to be sent to the
competent authorities for their consideration and execution.

Luis Marina Garzón explained that this proposal presented by ACILAPP is not
the way in which the Government handles the eradication of illicit crops. The

Government´s proposal corresponds to Forest Ranger Families and it will lead
to possible projects such as food security, FAMILIES IN ACTION,
infrastructure, COMPUTERS FOR EDUCATION, and training at SENA.

She referred to the methodology of the proposal presented by the

indigenous communities, and said that no reference can be made to costs, or
of the magnitude of such petitions. If the program e nters the community
with the support of social and technical environmental accompaniment and
the program itself, they will look for the solution of the major problems of

the communities.

Eighteen of the 34 indigenous communities are formed as reservations, 8 of
these overlap with the La Paya Park area; 4 are under study to be established
as a reservation since four years ago, but no answer has yet been received.

Therefore, the communities that could make part of the Family Rangers
Family would be only 10 o f the 34 and this would not be a solution for the
community; it is suggested that the Government reviews the proposal.

AGREEMENT

The communities define the time for manual eradication of 45 days, that is,
that by the first week of February, the illicit co ca crops would be eradicated
in the indigenous communities of Puerto Leguízamo and the number of

plants contemplated for exclusion for traditional use is the following:

5

256 Annex 43

MAMBEADORES MALOQUEROS

10 mts x 10 mts for IYAIMA EIMUE 20 mts x 50 mts for N+MA+RAMA

In turn, the Government headed by the Ethnic Directorate will take the

necessary steps before the competent authorities for them to offer support
to the indigenous community of Puerto Leguízamo in Putumayo, including
those located inside the LA PAYAPark.

FOLLOW-UP COMMITTEE

The following will be the follow-up committee:

FOR THE COMMUNITY THE GOVERNORS

FOR THE INDIGENOUS COUNCILS-ACILAPP THE PRESIDENT OR HIS DELEGATE
FOR OZIP THE OFFICE OF THE PROCURATOR OR THE

OMBUDSMAN
FOR THE PUBLIC MINISTRY THE ETHNIC DIRECTORATE

FOR THE National Narcotics DirectorateDELEGATE
DNE

FOR THE PRESIDENT OF THE REPUBLIC DELEGATE

MINISTRY OF THE ENVIRONMENT, DELEGATE
HOUSING AND DEVELOPMENT

Colombian Agriculture and Livestock DELEGATE
Institute (ICA)

ADMINISTRATIVE UNIT OF NATURE PARKS HEAD OF PARK OR TECHNICAL
SUBDIRECTORATE

Proposal and list of attendees attached.

In witness, this Note is signed on December 21, 2006

6

257Annex 43

PRIOR CONSULTATION –ERADICATION OF ILLICIT CROPS WITH THE
INDIGENOUS AUTHORITIES OF PUTUMAYO (PUERTO LEGUÍZAMO)

DECEMBER 20 AND 21, 2006

In compliance with Decision SU -383 / 2003 and agreement signed on

November 14, 2003 between the Government and the Indigenous
Authorities of the Colombian Amazonia.

PARTICIPATING INDIGENOUS AUTHORITIES

ENTITY SIGNATURE
ADOLFO CABEZAS – AGUAS NEGRAS GOVERNOR

JESUS RIVADENEIRA – LA QUEBRADITA GOVERNOR
LUCY MAR SAN JUAN – KICHWA GOVERNOR, URBAN DISTRICT

RODOLFO RODRIGUEZ – MURUL COUNCIL GOVERNOR – URBAN
DISTRICT

FABIO RIVADENEIRA – NARINO MAYOR

ADOLFO MASICAYA - TUKUNARE GOVERNOR
ENOC FAUSTO MONAGA – TABLERO GOVERNOR

FABIO LARRARTE GIL – EL REFUGIO ADVISER

CAMILO TOVAR – TERRITORIAL AREA – ACILAPP

OLIVER ALEXANDER CHARRI – BELLAVISTA GOVERNOR
DOMITILA REMUY – COMUYA AMENA COUNCIL- GOVERNESS

NILSON ANDOQUE – SAMARITANA GOVERNOR
JESÚS ALVARADO – PINUNA NEGRO GOVERNOR

GUSTAVO SERILLAMA - EL PROGRESO GOVERNOR

JUAN GOMEZ – LAGARTO COCHA GOVERNOR

MARCIAL MACHACURY – CECILIA COCHA GOVERNOR
LORENZO PIANDA – ALTO NAPORUNA GOVERNOR

7

258 Annex 43

PRIOR CONSULTATION –ERADICATION OF ILLICIT CROPS WITH THE
INDIGENOUS AUTHORITIES OF PUTUMAYO (PUERTO LEGUÍZAMO)

DECEMBER 20 AND 21, 2006

In compliance with Decision SU -383 / 2003 and agreement signed on
November 14, 2003 between the Government and the Indigenous
Authorities of the Colombian Amazonia.

PARTICIPATING INDIGENOUS AUTHORITIES

ENTITY SIGNATURE
ELIECER MUÑOZ – JIRI-JIRI GOVERNOR

JESUS RIVADENEIRA – LA QUEBRADITA GOVERNOR
ELSA NIDIA RIVADENEIRA - PUERTO PUNTALES – GOVERNESS

FREDDY ALVARADO – EL HACHA GOVERNOR

BERNARDINO COCA – TAITA EL HACHA

HECTOR YAIGUAJE COCA
TAITA – SIONA GAO YA
RODRIGO JITUYAMA
CACIQUE MURUI URBAN DISTRICT

LIBORIO MUÑOZ – CACIQUE JIRI – JIRI

JULIO CÉSAR LOPEZ – CACIQUE UMANCIA

JORGE TORRES – TAITA ALTO NAPORUNA
MARCELIANO COBETTE –CACIQUE TUKUNARE

CÉSAR ORTEGA PAYAGUAJE – TRADTIONAL PRACTITIONER
BAJO CASACUNTE

JESÚS ALVARADO – PINUNA NEGRO GOVERNOR
ADELMO CUELLAR – TRADITIONAL PRACTITIONER - KICHWA

JUAN GOMEZ – LAGARTO COCHA GOVERNOR

MARCIAL MACHACURY – CECILIA COCHA GOVERNOR

LORENZO PIANDA – ALTO NAPORUNA GOVERNOR

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259Annex 43

PRIOR CONSULTATION –ERADICATION OF ILLICIT CROPS WITH THE

INDIGENOUS AUTHORITIES OF PUTUMAYO (PUERTO LEGUÍZAMO)

DECEMBER 20 AND 21, 2006

In compliance with Decision SU -383 / 2003 and agreement signed on

November 14, 2003 between the Government and the Indigenous
Authorities of the Colombian Amazonia.

PARTICIPATING INDIGENOUS AUTHORITIES

ENTITY SIGNATURE

LUIS HURTADO – BAJO CASACUNTE GOVERNOR
SIEON GASCA – CONSARA GOVERNOR

DEMSE GUZMAN – REFUGIO GOVERNOR

LUIS GUAMAN – LA PLAYA GOVERNOR

CALISTO NUNEZ – LA PLAYA GOVERNOR
RAQUEL HERNANDEZ- TRADITIONAL PRACTITIONER– SANTA RITA

JOSE DARIO GUTIERREZ – COREGUAJU LEADER – URBAN DISTRICT

JESUS MARIN OLAYA – PUERTO RICO GOVERNOR

WILLIAM YAIGUAJE – SIONA COUNCIL GOVERNOR – URBAN
DISTRICT

PEDRO HERNAN COTE –HUMAN RIGHTS – ACILAPP

CLAUDIO SANCHEZ – INDIGENOUS COORDINATOR
ABRAHAM CESAR LOPEZ – ACILAPP PRESIDENT

LUIS LOPEZ JAMIOY – OZIP PRESIDENT

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260 Annex 43

PRIOR CONSULTATION –ERADICATION OF ILLICIT CROPS WITH THE
INDIGENOUS AUTHORITIES OF PUTUMAYO (PUERTO LEGUÍZAMO)

DECEMBER 20 AND 21, 2006

In compliance with Decision SU -383 / 2003 and agreement signed on
November 14, 2003 between the Government and the Indigenous

Authorities of the Colombian Amazonia.

PARTICIPATING INDIGENOUS AUTHORITIES

ENTITY SIGNATURE
ROSA ELENA RAMOS - National Narcotics Directorate DNE

EDGAR ALONSO DIAZ - MINISTRY OF INTERIOR AND JUSTICE –
ETHNIC DIRECTORATE
MY. MIGUEL ANTONIO TUNJANO - National Narcotics Directorate
DNE.

JORGE ARTURO RODRIGUEZ – ICA
JORGE HERNAN BOTERO TOBON – NATIONAL HEALTH INSTITUTE

JOSE AGUSTIN ZEA PÉREZ – MINISTRY OF THE ENVIRONMENT,
HOUSING AND TERRITORIAL DEVELOPMENT

LUIS ENRIQUE DELGADO-CIFUENTES- TEMPORARY UNION – EMP-
DEN audit.
LUIS MARINA GARZON – OFFICE OF THE PRESIDENT - PCI

CARLOS NARVAEZ – ENVIRONMENTAL PROGRAM OFFICER – US
EMBASSY

NOHORA ROCIO GALLEGO -SALAS – MINISTRY OF INTERIOR AND
JUSTICE -

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261Annex 43

LIST OF ATTENDANCE OF THE PRIOR CONSULTATION PROCESS–

ERADICATION OF ILLICIT CROPS WITH INDIGENOUS AUTHORITIES OF
PUTUMAYO (PUERTO LEGUÍZAMO) –20 AND 21 DECEMBER 2006

In compliance with Decision SU -383 / 2003 and agreement signed on

November 14, 2003 between the Government and the Indigenous
Authorities of the Colombian Amazonia.

NAME ID TITLE COMMUNITY RESERVATION

NOTE OF THE TRANSLATOR:

18 PAGES FOLLOW WITH ABOVE DETAILS IN HADWRITTEN FORM

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262 Annex 43

FIRST PRIOR CONSULTATION MEETING MINUTE –

ERADICATION OF ILLICIT CROPS WITH INDIGENOUS AUTHORITIES OF NARIÑO

(ACIESNA ORGANIZATION)

(SEPTEMBER 4 AND 5, 2007)

In compliance with Decision SU-383/ 2003 and Agreement signed on
November 14, 2003 between the Colombian Government andthe Indigenous
Authorities of the Colombian Amazonia, prior consultation process was

conductedas follows:

PLACE: DEPARTMENT OF NARIÑO –MUNICIPALITY OF OLAYA HERRERA

DATE: 4 AND 5 SEPTEMBER, 2007

AGENDA

1. Opening and introduction of attendees.
2. Appointment of translator (if necessary) and of persons to write
minutes.
3. Fundamentals and reasons of the prior consultation process – Ministry

of Interior and Justice (Ethnic Directorate).
Introduction of the Constitutional, legal and jurisprudence
fundamentals (Decision SU-383 / 2003 of the Constitutional Court) of
the Prior Consultation Process for the eradication of coca illicit crops in

indigenous territories.
4. Intervention by State entities:
 Presentation of the Policy of Fight against Drugs: Entities, political
and legal framework.

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263Annex 43

 Presentation of Strategies of eradication of illicit crops as measures

adopted by the Government to face this issue. Anti -Narcotics Police
Directorate.
 Presentation of the National Policy for Alternative Development.

Office of the President. Acción Social.

5. Space for authorities and members of indigenous communities

6. Proposals

7. Agreements

8. Designation of the Follow-up Committee
9. Reading and approval of Minutes

1. OPENING AND INTRODUCTION OF ATTENDEES

The Ethnic Directorate of the Ministry of Interior and Justice opened the

meeting introducing attendants of the various indigenous authorities or their
delegates and officers of the various State entities.

ATTENDANCE OF INDIGENOUS COMMUNITIES

NAME AUTHORITY OR RESERVATION- MUNICIPALITY
TITLE COMMUNITY
BENEDICTO TOVAR GOVERNOR SANQUIANGUITA OLAYA HERRERA
MARCIAL PETIARA GOVERNOR SANTIAGA OLAYA HERRERA

FIDELINO QUINTERO GOVERNOR SAN JOSE BACAO OLAYA HERRERA
EPIFANO GARABATO GOVERNOR QUEBRADA GRANDE SANTA BARBARA DE
ISCUANDE
JOSELINO CHIRIMIA GOVERNOR SAN JOSE BACAO OLAYA HERRERA

REINALDO MESA GOVERNOR SAN JUAN PAMPO LA TOLA
FLORINDO MALAGA GOVERNOR INTEGRATED EL CHARCO
COUNCIL
LUIS ALBERTO GARCIA GOVERNOR SAN AGUSTIN TUMACO

ERNESTO GONZALEZ GOVERNOR SAN JOSE BACAO OLAYA HERRERA
JOSE QUINTERO GOVERNOR INTEGRATED EL CHARCO
COUNCIL
LORENZO CHIRIMIA GOVERNOR MORRITO EL CHARCO

ARTURO BARQUEÑO GOVERNOR INTEGRATED OLAYA HERRERA
COUNCIL
OCTAVIO CAICEDO GOVERNOR SANQUIANGA EL CHARCO
RENE DURAN GOVERNOR INTEGRATED OLAYA HERRERA
2
COUNCIL
FRANCISCO GONZALEZ LEGAL SAN JOSE BACAO
REPRESENTATIVE-
ACIESNA

HIGINIO OBLISPO ONIC DELEGATE

264RENE DURAN GOVERNOR INTEGRATED OLAYA HERRERA

COUNCIL
FRANCISCO GONZALEZ LEGAL SAN JOSE BACAO
REPRESENTATIVE-
ACIESNA

HIGINIO OBLISPO ONIC DELEGATEAnnex 43

4. Intervention by State entities:

NATIONAL NARCOTICS DIRECTORATE (DNE)
PRESENTATION OF OVERALL ANTI-DRUG POLICY

Mrs. Rosa Elena Ramos -C. made a detailed explanation of the Overall Anti -
Drugs Policy, established in the National Development Plan, with emphasis in
State strategies to fight illicit drugs, stressing the need of dismantling
production processes, processing, traffic and drug consumption. Explanation

of the legal framework of Law 30 / 1986 and Law 599 / 200 of the Criminal
Code, where coca-leaf, opium poppy and marihuana crops are established as
illegal. Also, stress is made on compliance with decision of Article 4 of the
Constitutional Court, respecting ancestral consumption of indigenous

communities and implementing State policies for the eradication of illicit
crops not used for this purpose.

PRESENTATION OF THE OPERATING PART OF PROCEDURE AND FORMS OF

ERADICATION.
NATIONAL NARCOTICS DIRECTORATE (DNE)

My. Miguel Antonio Tunjano explained th e diagnosis and problems of illicit

coca-leaf crops in indigenous reservations of Nariño.
He introduced the legal, technical and environmental framework for the

development of forcible eradication operations, both aerial and manual.
Additionally, eradication mechanisms taking account of detection processes,

aerial spraying, manual eradication and verification.
He also explained the procedure for lodging claims for possible damage to

licit crops in the context of the Program for the Eradication of Illicit Crops by
Aerial Spraying under Resolution No. 008 / 2007.

He stressed the fact that the police has not undertaken eradication
operations of illicit crops within indigenous reservations areas, in accordance
with official cartographic information provided by IGAC ( Agustín Codazzi
Geographic Institute of Colombia) and INCODER.

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266 Annex 43

5. SPACE FOR AUTHORITIES AND MEMBERS OF INDIGENOUS COMMUNITIES
Regarding presentation made by the Police, the indigenous communities said

that the nine reservations present, equiva lent to 15 communities, have had
spraying tests with no presence of coca in the indigenous territory where the
aerial spraying occurred; My Tunjano explained in more detail the claims
procedure, mentioning the competent authority and the 20 -days term

allowed to file a claim, as of the date of spraying.
Additionally they say that if eradication is conducted correctly, it could be

advantageous since it would be eradicating the curse of drug -trafficking, but
they claim that since the moment spraying begins, ai rcraft do not close their
valves until completing operations, thus causing damage to the communities,
their crops, fauna and flora and soil, the source of their livelihood.

In the case of Casa Grande and Tórtola, claims were filed immediately to the
municipal authorities, and no reply has been received so far.

The existing procedures for claims are difficult, said the mayor of the Olaya
Herrera municipality, even more so for river communities. Some people have

a video showing the damage caused by aerial s praying to biodiversity in
general, and have handed it to the National Narcotics Directorate (DNE) as a
claim, but no reply has been so far to this claim for damage caused by
glyphosate spraying.

In view of this array of claims, the agencies requested tha t dates and names
should be provided of the individuals who could potentially been affected,

for verification.
Additionally, the community expressed its concern for some loans that they

obtained from Banco Agrario, for crops which, according to them, were
affected by the aerial spraying. Here, the agencies again requested
information in order to verify the situation and thus, be able to effect follow-
up of the claims filed. Also, the Anti -Narcotics Police stressed that no

spraying has been conducted in indigenous reservations.
Regarding the reservation´s dispute about mapping, it was suggested that the

community might consider the possibility of sending a “right of petition” to
INCODER, for it to provide plans with the location of existing reservations in
the region in order to be able to unify official information and information
existing in the communities.

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267Annex 43

The community made some observations regarding its ancestral wisdom
regarding medicine and food, and spoke against logging and spraying; What
has the Ministry of the Environment thought in the ambit of its responsibility

for the protection of biodiversity as World Heritage, understanding the world
view as an equal relationship of man with nature?

Regarding this appreciation, the Ministry of the Environment argued that it
strictly follows the Environmental Management Plan, both as to the
verification of spraying operations and as to claims filed under the context of
the Plan.

The indigenous community expressed its concern for the presence of a
person who does not belong to the Prior Consultation process, who arrived in

the second group of the Commission with unknown intentions; and that the
indigenous communities were not consulted on the matter, this person made
an unauthorized tour within the community and tried to engage in an activity

that the community knew absolutely nothing about.
The agencies replied that this person was making surveys and effectively, he
was told not to interact with the community in the course of this task.

The community describe their life plan, “LET US RESUME OUR PATHS” (tachi
ode t´tadama) and with concerns such as health problems and basic

sanitation (according to the needs of the SIA culture), education (according to
SIA culture), land titles and clearance of reservations (they ask the
Commission to be introduced to Incoder), uncontrolled exploitation of timber

resources, lack of strategies of territorial order, contamination of rivers and
timber exploitation, amongst others.
Reassuming the objective of Prior Consultation, apart from coca for ancestral,

traditional and medicinal use, the community has started an alternative
option of productive projects, there is no coca in their territories and what
the Police has presented is a previous map; today, there are no coca -leaf

crops, since aerial spraying has finished with them; there are just a few plants
in the mountain but they are dying; the community is engaged in the
implementation of crops for their living and development. This is different
from the crops of persons w ho do not belong to the indigenous community

and who may have illicit coca-leaf crops.

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268 Annex 43

The representative of Acción Social explained the measures that INCODER
must take against occupiers of indigenous reservations who might have illicit
crops.

Regarding these projects, except for the Forest Ranger Families (familias
guardabosques) other Ministries should participate to support the Plan of

Life, and therefore, they request the Plan to be sent to the Ministries which
could support them and not to leave this situation alone, but to make the
expectations of participant communities a reality.

6. PROPOSALS
The community requested the Commission to secure State support to
strengthen their Plan of Life, clarifying that the communities decided
autonomously before prior consultation, that they would effect the voluntary

eradication of their illicit coca -leaf crops that are currently in their territory.
Regarding illicit crops of settlers, that is, persons who do not belong to the
indigenous communities but live inside the indigenous territory and who may
own illicit coca -leaf crops, it is the State´s responsibility to eradicate these

crops by means of the eradication strategies it has available.
The community has exercised what is called “Social Control”, which they will

control themselves for “no more”.

7. AGREEMENTS

 The indigenous communities present will continue with the
voluntary manual eradication of coca illicit crops that exist inside their
reservations and of their property; this process could be verified in the

first week of December, when they will inform the number of coca
plants necessary for the preservation of their ancestral, cultural and
medicinal traditions.

 The National Narcotics Directorate (DNE) will request to the
National Narcotic s Council of Nariño a space to present the
Community´s Plan of Life. This presentation will be made during one of

the meetings of the Regional Narcotics Council with the Community
invited as invitee.

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269Annex 43

 Regarding illicit crops of settlers, that is, persons who do not belong

to the indigenous communities, the eradication of coca illicit crops is
responsibility of the State, to be dealt with under strategies authorized

for the purpose.

 The consultation team will ask INCODER to verify the legal situation
of the indigenous reservations, in particular, the situation of coca illicit

crops, for clearing purposes of their reservations.

Should there occur any adverse effects on food crops due to PECIG

application, the community will take recourse to Resolution No.008 of
the Narcotics Council for compensation of damages caused.

8. APPOINTMENT OF THE FOLLOW-UP COMMITTEE

FOR THE PUBLIC MINISTRY THE OFFICE OF THE GEN ERAL PROCURATOR
DELEGATE FOR HUMAN R IGHTS AND ETHNICAL

MATTERS)

FOR THE MINISTRY OF INTERIOR AND JUSTICE THE ETHNIC DIRECTORATE

THE NATIONAL NARCOTICS COUNCIL DELEGATE

OFFICE OF THE PRESIDE–ACCION SOCIAL DELEGATE
MINISTRY OF THE ENVIRONMENT , HOUSING AND DELEGATE

TERRITORIAL DEVELOPMENT

9. READING AND APPROVAL OF MINUTES

These minutes as read and signed by those who took part in it.

INDIGENOUS COMMUNITIES

NAME AUTHORITY OR RESERVATION MUNICIPALITY SIGNATURE
TITLE

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270 Annex 43

NAME AUTHORITY OR RESERVATION MUNICIPALITY SIGNATURE

TITLE

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271Annex 43

STATE AND ENFORCEMENT ENTITIES

NAME OFOFFICER ENTITY SIGNATURE
ROSA ELENA RAMOS C National Narcotics

Directorate DNE
MIGUEL ANTONIO TUNJANO National Narcotics

Directorate DNE
LUIS ALFREDO QUINTER-VELASQUEZ ICA

RICARDO MEDINA OFFICE OF THE PROCURATOR
ALFONSO HERNÁNDEZ MINISTRY OF THE ENVIRONMENT

LUISA MARINA GARZÓN OFFICE OF THE PRESID ENT –
ACCION SOCIAL

EDGAR ALONSO DIAZ ROJAS MINISTRY OF INTERIOR AND
JUSTIC– ETHNIC DIRECTORATE

NOHORA ROCIO GALLEGO SALAS MINISTRY OF INTERIOR AND
JUSTIC– ETHNIC DIRECTORATE

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272 Annex 43

[13 APR 2007]

Ministry for the Environment, Housing and Territorial Development
Licenses, Permits and Environmental Procedures Division
Republic of Colombia

Bogota, D.C.

ORDER No. [0917]

“Whereby a monitoring is performed and other decisions are made”

THE ADVISOR OF THE DEPUTY MINISTER FOR THE ENVIRONMENT
LICENSES, PERMITS AND ENVIRONMENTAL PROCEDURES DIVISION

In exercise of the powers under Resolution No. 802 of May 10, 2006, and

WHEREAS

By Resolution 1065 of November 26, 2001, the Ministry for the Environment , today the

Ministry for the Environment, Housing and Territorial Development , imposed the
Environmental Management Plan subm itted by the National Narcotics Directorate - DNE
for the activity called Program for the Eradication o f Illicit Crops by Aerial Spraying with
Glyphosate – PECIG in the country.

By Resolution 108 of January 31, 2002, this Ministry confirmed Resolution 1065 of
November 26, 2001, impos ing the Environmental Management Plan submitted by the
National Narcotics Directorate - DNE for the activity called Program for the Eradication of

Illicit Crops by Aerial Spraying with Glyphosate – PECIG in the country.

By Resolution 099 of January 30, 2003, the Ministry partially amended Resolution 1065 of
November 26, 2001, i n the sense of embracing the recommendation of the Col ombian

Agriculture and Livestock Institute - ICA, for the temporary increase in the dose of
commercial formulation of glyphosate used in the eradication of illicit crops, within the
framework of the eradication of illicit crops by aerial spraying.

By Resolution 1054 of September 30, 2003, the Minis try amended Resolutions 1065 of
November 26, 2001 and 108 of January 31, 2002, by which it imposed a n Environmental
Management Plan on the National Narcotics Directorate –DNE for the activity called
Program for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate – PECIG in

the country, in the sense of adjusting the Records of the Environmental Management Plan.

By Resolution 509 of May 6, 2004, the Ministry amended Resolution 099 of January 30,
2003, in the sense of granting an extension of one hundred twenty days (120) for delivery

of the required information by the decision under appeal.

By official letter No. OF106 - 30460 - DET - 1000, Dr. SORELLY PAREDES-VARGAS, of

the Office of Ethnic Affairs of the Ministry of The Interior and Justice, reported the

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273Annex 43

completion of consultation with indigenous communities in the municipality of Puerto Asis,
Putumayo within the framework of activities of the Program for the Eradication of Illicit

Crops by Aerial Spraying with Glyphosate - PECIG.

The Office of the Director of Licenses , Permits and Environmental Procedures Division of
the Ministry for the Environment, Housing and Territorial Development, in exercise of its

functions of monitoring and control and in order to verify compliance with Ruling SU-383 of
2003 of the Honorable Constitutional Court, accompanied the process of consultation with
indigenous communities in the municipality of Puerto Asis in the province of Putumayo,
within the framework of the activities of the Environmental Management Plan of Program

for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate - PECIG and issued
the Technical Opinion 26 on January 18, 2007, which stated:

DEVELOPMENT OF ACTIVITIES

“In development of the env ironmental monitoring process that the Ministry for the
Environment, Hous ing and Territorial Development performs on the various PECIG
activities and in compliance with Ruling SU- 383 of the Honorable Constitutional Court, the
consultation process with indigenous communities in the municipality of Puerto Asis,

Putumayo was conducted.

“For t his process the following were also summoned: the Anti -Narcotics Police, the
external audit of the eradication P rogram, the Municipal representative of Puerto Asis, the

National Narcotics Directorate - DNE, the Colombian Agriculture and Livestock Institute -
ICA, officials of Social Action of the Presidency of the Republic , and the National Health
Institute.

Consultation dates: 13 and 14 December 2006

Geographic Area of the Consultation: indigenous communities of the municipality of
Puerto Asis, province of Putumayo.

Members of the Commission:

- Doctor Gabriel Gutierrez Diaz: National Narcotics Directorate - DNE

- Diego Orozco Gómez, engineer: Colombian Agriculture and Livestock Institute - ICA
- Major Miguel Tunjano: Coordinator Verification Group, Anti-Narcotics Police -
DIRAN
- Lt. Colonel Luis Mendez: Anti-Narcotics Police - DIRAN
- Luis Delgado, engineer: External environmental audit

- Dr. Edgar Diaz: Ministry of the Interior and Justice - Office of Ethnic
Affairs
- Dr. Nohora Gallego: Ministry of the Interior and Justice - Office of Ethnic
Affairs

- José Agustín Zea, engineer: Ministry for the Environment, Housing and Territorial
Development
- Doctor Jorge Botero: National Health Institute
- Mrs. Courtney Beale: Environment Officer - U.S. Embassy

- Doctor Gustavo Vargas: Technical Advisor - U.S. Embassy
- Dr. Luz Bany Zambrano: Indigenous Affairs Promoter - Justice house, Puerto
Asis

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274 Annex 43

- Doctor Andres Gallego: Office of the High Commissioner for Social Action
- Dr. Uldarico Ramirez Advisor for Social Action

“In pursuance of the provision in Ruling SU- 383 of 2003 and the agreement signed on 14
November 2003 between the Government and the indigenous authorities of the Colombian
Amazon, the consultation process took place with indigenous communities in the
municipality of Puerto Asis, Putumayo ; the atten dance list appears in the formalization

record of the consultation, attached to the Technical Opinion 28 of January 20, 2007.

“The process took place between 13 and 14 December this year. O n the first day the
inauguration and opening of the consultation process occurred and the agenda was
established for the next day. The second day there was the socialization process, starting

with the presentation of the general drug policy by the National Narcotics Directorate .
Subsequently the DIRAN presented the spraying operation and procedure and forms of
illicit crop eradication in the country.

“The National Health Institute presented the health impact of the program for the
eradication of illicit crops,for which a protocol has been established for monitoring of
pesticide poisoning, ending this part of the socialization with the environmental impact of
the program for the eradication of illicit crops, with follow-up of the Environmental

Management Plan Records; finally the Office of Social Action of the Presidency of the
Republic presented the actions that are being developed concerning the Ranger family
program, International cooperation - AID, through the ADAM program and alternative
development programs.”

Finally the Department of Licenses, Permits and Environmental Procedures of this
Ministry, through the Technical Opinion 26 of January 18, 2007, concluded that:

“As a result of consultation with indigenous communities in the municipality of Puerto Asis,

Putumayo province, an Act was signed between the parties involved, that is, indigenous
authorities and entities of the state, where they agreed to a term of two (2) months to
arrange with their communities , and to present to the national government a proposal to
establish the method and the terms of the eradication of illicit crops, and two (2) months to
eradicate, that is, that by the first of May there should be no illicit cultivation in the

indigenous territory of Puerto Asis, Putumayo. Likewise, the exclusion areas for the
medicinal use of coca plants will be respected and a monitoring committee will be set up
comprising the Ministry of The Interior and Justice, Office of Ethnic Affairs, the Public
Ministry, the National Narcotics Directorate, two (2) delegates of the Indian community

(OCIMPA-OZIP), the Ministry for the Environment , Housing and Territorial Development
and the Anti-Narcotics Police.

The opinion issued by the Ministry concluded:

1. As a result of consultation with indigenous communities in the municipality of
Puerto Asis. Putumayo Province, a term of two (2) months was agreed to arrange
with their communities and to present the national government a proposal to
establish the method and terms of eradication of illicit crops in the indigenous

territory of Puerto Asis in Putumayo , and two (2) months to eradicate illicit crops,
that is, by the first of May there should be no illicit cultivation in indigenous territory
of Puerto Asis, Putumayo.

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275Annex 43

2. Similarly, it was agreed with the indigenous communities of the municipality of
Puerto Asis, Put umayo, that the Program for the Eradication of illicit cropswill

respect exclusion areas for the medicinal use of coca plants.

3. Given a Monitoring Committee was established of which is part the Ministry for the
Environment, Housing and Territorial Development, the Ministry of The Interior and

Justice-Office of Ethnic Affairs, the National Narcotics Directorate and the Anti-
Narcotics Police were recommended to timely inform this Ministry about the holding
of meetings of that committee, in order to achieve an effective accompaniment to
them.

4. “Part of t his Technical Opinion 28 of January 20, 2007 is the copy of the
formalization Minutes of the previous consultation - the eradication of illicit crops,
with the indigenous authorities of the municipality of Puerto Asis, Putumayo.

LEGAL CONSIDERATIONS

Article 8 of the Constitution states: “ It is the duty of the state and individuals to protect the
cultural and natural wealth of the Nation.”

Articles 79 and 80 of the Constitution enshrine the right of all to enjoy a healthy
environment, and to community participation in decisions that may affect it. It also
establishes that the State, among others, has the duty to protect biodiversity and

environmental integrity, as well as the State’ s obligation to plan for the management and
use of renewable natural resources to ensure sustainable development, conservation,
restoration and replacement.

Article 95 paragraph 8 of the rule cited above states that it is the duty of citizens to “protect
the natural and cultural resources of the country and ensure the preservation of a healthy
environment.”

Through the issuance of Law 99 of 1993, the Government created the Ministry for the
Environment (now Ministry for the Environment , Housing and Territorial Development),
reorganized the public sector responsible for the management and conservation of the
environment and renewable natural resources , organized the National Environmental

System - SINA, and issued other provisions.

Article 5 paragraph 35 of Law 99 of 1993 notes that within the functions of this Ministry is
the assessment, monitoring and control of environmental risk factors and those that may
affect the occurrence of natural disasters , and coordinate with other relevant authorities

the activities designed to prevent the emergence or impede the extent of their effects.

By the i ssuance of Decree 1220 of April 21, 2005, the Ministry for the Environment ,
Housing and Territorial Development regulated Title VIII of Law 99 of 1993.

Likewise, Decree 1220 of April 21, 2005 established in article 33 the duty of the
environmental authority to control and monitor projects, works or activities subject to
environmental permit or Environmental Management Plan during c onstruction, operation,

decommissioning or abandonment.

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276 Annex 43

In accordance with the considerations made by the Office of the Director of Licensing,
Permits and Environmental Procedures through Technical Opinion 26 of January 18, 2007,
it will be declared, through the operative part of this administrative act, that the Presidency

of the Republic, the Ministry of The Interior and Justice, the National Health Institute, the
Agriculture and Livestock Institute ICA, the National Narcotics Directorate and the
Antinarcotics Police - DlRAN, together with this Ministry, performed the process of prior
consultation with the Buenavista Reservation, La Italia Reservation, Pi nuna Blanco

Reservation, Santa Elena Town Council, Inga Town Council, Los Pastos Town Council ,
Moniya Amena Town Council and the Indigenous Zonal Organization - OZIP and the
OCIMPA Organization, located in the municipality of Puerto Asis in Putumayo province as
ordered by the Honorable Constitutional Court through SU -383 of 2003 Decision, in the
implementation of activities under the Program for the Eradication of Illicit Crops by Aerial

Spraying with Glyphosate - PECIG.

Notwithstanding the foregoing and in accordance with the considerations made by the
Department of Licenses, Permits and Environmental Procedures through the Technical

Opinion 26 of J anuary 18, 2007, it will be required, through the operative part of this
administrative act, of the Ministry of The Interior and Justice - Office of Ethnic Affairs, the
National Narcotics Directorate - DNE and the Anti Narcotics Police - DIRAN, to report
promptly and previously to this Ministry , the performance of meetings of the Monitoring

Committee set up to verify development of agreements with the Buenavista Reservation,
La Italia Reservation, Pinuna Blanco Reservation, Santa Elena Town Council, Inga Town
Council, Los Pastos Town Council, Moniya Amena Town Council and the Indigenous
Zonal Organization - OZIP and the OCIMPA Organization.

Decree 216 of February 3, 2003 defines the objectives, the structure of the Ministry for the
Environment, Housing and Territorial Development and other provisions. In its article 2, it
states that the Ministry for the Environment, Hous ing and Territorial Development will
continue to exercise powers under Law 99 of 1993.

By Article Three of Decree 3266 of October 8, 2004, the Ministry for the Environment ,
Housing and Territorial Development created the Department of Licenses, Permits and
Environmental Procedures, attached to the Office of the Deputy Minister for the
Environment.

According to the provisions of Decree 802 of May 10, 2006 of the Ministry for the
Environment, Housing and Territorial Development, it is the responsibility of the Advisor of
the Office of the Deputy Minister of Environment – Division to sign this administrative act.

In virtue of the foregoing,
DECIDES

ARTICLE ONE. To declare that the Presidency of the Republic, through the Social Action

Office, the Ministry of The Interior and Justice, this Ministry, the National Health Institute,
the Agriculture and Livestock Institute-ICA, the National Narcotics Directorate and
Antinarcotics Police - DIRAN together with the Ministry, undertook the process of prior
consultation with the Buenavista Reservation, La Italia Reservation, Pinuna Blanco

Reservation, Santa Elena Town Council, Inga Town Council, Los Pastos Town Council,
Moniya Amena Town Council and the Indigenous Zonal Organization - OZIP and the
OCIMPA Organization located in the municipality of Puerto Asis in Putumayo province, in
accordance with the order by the Honorable Constitutional Court through SU-383 Decision

5

277Annex 43

of 2003 in the implementation of activities under the Program for the Eradication of Illicit

Crops by Aerial Spraying with Glyphosate - PECIG, in accordance with what is stated in
the preamble of this administrative act.

ARTICLE TWO . To r equire the Ministry of The Interior and Justice - Office of Ethnic

Affairs, the National Narcotics Directorate -DNE and the Antinarcotics Police - DIRAN, to
report to this ministry promptly and prior to conducting meetings of the Committee for
Monitoring the agreements with the Buenavista Reservation, La Italia Reservation, Pinuna

Blanco Reservation, Santa Elena Town Council, I nga Town Council, Los Pastos Town
Council, Moniya Amena Town Council and the Indigenous Zonal Organization - OZIP and
the OCIMPA Organization in accordance with what i s discussed in the preamble of this
administrative act.

ARTICLE THREE . Through the Depar tment of Licenses, Permits and E nvironmental
Procedures of this Ministry, to serve notice of the contents of this administrative act on the
Legal Representatives of the Social Action Office of the Presidency of the Republic, the

Anti-Narcotics Police – DIRAN, the National Narcotics Directorate, the National Health
Institute, the Agriculture and Livestock Institute - ICA and/or the duly appointed attorneys.

ARTICLE FOUR . Through the Department of Licenses, Permits and E nvironmental

Procedures of this Ministry, to serve notice of the contents of this administrative act on the
Legal Representative of FUNDEPUBLICO, on Dr. Claudia Sampedro -Torres, Dr. Héctor
Suárez and/or the duly appointed attorneys.

ARTICLE FIVE . Through the Department of Licenses, Permits and Environmental
Procedures of this Ministry, to serve notice of the contents of this administrative act on the
Legal Representatives of the Ombudsman and/or the duly appointed attorney.

ARTICLE SIX. Through the Department of Licenses, Permits and E nvironmental
Procedures of this Ministry, to serve notice of the contents of this administrative act on the
Delegate Prosecutor for Environmental and Agricultural Affairs, the Ministry of Social

Protection, the National Narcotics Council -CNE and the Geographic Institute Agustín
Codazzi - IGAC.

ARTICLE SEVEN. There is recourse for reversal against this decision, by government
means, and recourse must be filed within five (5) days following service of this not ice and
with full compliance of Articles 50, 51 and 52 of the Administrative Code

BE THIS SERVED, COMMUNICATED AND OBEYED

[Signed]

NILBERCECE MACÍAS-FERNÁNDEZ
Advisor to the Deputy Minister for the Environment
Department of Licenses, Permits and Environmental Procedures

Draft: Camilo Rincon, professional contractor, Department of Licenses, Permits and Environmental Procedures
C/Mis Documentos/Culivos lIicitos/seguimiento CT26 del 18 de enero de 2007/ Exp 793

6

278 Annex 43

[Translator’s note:

The stamp that appears on the first page, 13 APR 2007, appears on pages 2, 3, 4, and 5;
The stamp that appears on the first page, 0917, appears on pages 2, 3, 4, 5, 6 and 7]

7

279Annex 43

[13 APR 2007]

Ministry for the Environment, Housing and Territorial Development
Licenses, Permits and EnvirRepublic of ColombiaDivision

Bogota, D.C.

ORDER No. [0918]

“Whereby a monitoring is performed and other decisions are made”

THE ADVISOR OF THE DEPUTY MINISTER FOR THE ENVIRONMENT
LICENSES, PERMITS AND ENVIRONMENTAL PROCEDURES DIVISION

In exercise of the powers under Resolution No. 802 of May 10, 2006, and

WHEREAS

By Resolution 1065 of November 26, 2001, the Ministry for the Environment , today the Ministry
for the Environment, Housing and Territorial Development , imposed the Environmental
Management Plan submitted by the National Narcotics Directorate - DNE for the activity called

Program for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate – PECIG in the
country.

By Resolution 108 of January 31, 2002, this Ministry confirmed Resolution 1065 of November

26, 2001, imposing the Environmental Management Plan submitted by the National Narcotics
Directorate - DNE for the activity called Program for the Eradication of Illicit Crops by Aerial
Spraying with Glyphosate – PECIG in the country.

By Resolution 099 of January 30, 2003, the Ministry partially amended Resolution 1065 of
November 26, 2001, in the sense of embracing the recommendation of the Col ombian
Agriculture and Livestock Institute - ICA, for the temporary increase in the dose of commercial
formulation of glyphosate us ed in the eradication of illicit crops, within the framework of the
eradication of illicit crops by aerial spraying.

By Resolution 1054 of September 30, 2003, the Ministry amended Resolutions 1065 of
November 26, 2001 and 108 of January 31, 2002, by which it imposed a n Environmental
Management Plan on the National Narcotics Directorate – DNE for the activity called Program

for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate –PECIG in the country ,
in the sense of adjusting the sheets of the Environmental Management Plan.

By Resolution 509 of May 6, 2004, the Ministry amended Resolution 099 of January 30, 2003,

in the sense of granting an extension of one hundred twenty days (120) for delivery of the
required information through the decision under appeal.

1

280 Annex 43

By official letter No. OF106 - 30460 - DET - 1000, filed in this Ministry under No. 4120- E1-634

of January 4, 2007, Ms . SORELLY PAREDES-VARGAS, of the Office of Ethnic Affairs of the
Ministry of the Interior and Justice, reported the completion of consultation with indigenous
communities in the municipality of Puerto Leguizamo, province of Putumayo within the
framework of activities of the Program for the Eradication of Illicit Crops by Aerial Spraying with
Glyphosate - PECIG.

Article Two of Ruling SU- 383 of 2003 of the Honorable Constitutional Court ordered the
President of the Republic, the Ministries of The Interior and Justice, and for the Environment,
Housing and Territorial Development, the National Narcotics Council and each of its members,

the National Narcotics Directorate and the National Police to consult effectively and efficiently
with indigenous and tribal peoples of the Colombian Amazon on decisions relating to the
Program for the Eradication of Illicit Crops that these entities conduct i n their territories, on the
issues for which each of these entities is responsible “in order to reach an agreement or be
granted approval of the proposed measures” in full compliance with the principles and rules

contained in the ILO Agreement 169, ratified by Law 21 of 1991.

The Office of the Director of Licenses , Permits and Environmental Procedures Division of the
Ministry for the Environment, Housing and Territorial Development, in exercise of its functions

of monitoring and control and in order to ver ify compliance with Ruling SU- 383 of 2003 of the
Honorable Constitutional Court, accompanied the process of consultation with indigenous
communities in the municipality of Puerto Leguizamo in the province of Putumayo, within the
framework of the activities of the Environmental Management Plan of Program for the
Eradication of Illicit Crops by Aerial Spraying with Glyphosate - PECIG and issued the

Technical Opinion 29 of January 2007, which stated:

1. DEVELOPMENT OF ACTIVITIES

“In development of the environmental monitoring process that the Ministry for the Environment,

Housing and Territorial Development performs on the various PECIG activities and in
compliance with Ruling SU-383 of the Honorable Constitutional Court, the consultation process
with indigenous communities in the municipality of Puerto Leguizamo , Putumayo was
conducted.

“For this process the following were also summoned: the Anti-Narcotics Police, the external
audit of the eradication Program, the Colombian Agriculture and Livestock Institute - ICA, the
National Narcotics Directorate - DNE, officials of Social Action of the Presidency of the
Republic, and the National Health Institute.

Consultation dates: 20 and 21 December 2006

Geographic Area of the Consultation: the municipality of Puerto Leguizamo , province of

Putumayo.

Members of the Commission:

2

281 Consultation dates: 20 and 21 December 2006
Annex 43

Geographic Area of the Consultation: the municipality of Puerto Leguizamo , province of
Putumayo.

Members of the Commission:

- Doctor Rosa Elena Ramos: National Narcotics Directorate - DNE

- Jorge Rodríguez, engineer: Colombian Agriculture and Livestock Institute -
ICA
- Major Miguel Tunjano: Coordinator Verification Group, Anti -Narcotics 2
Police - DIRAN
- Luis Delgado, engineer: External environmental audit

- Dr. Edgar Diaz: Ministry of the Interior and Justice - Office of
Ethnic Affairs
- Dr. Nohora Gallego: Ministry of the Interior and Justice - Office of
Ethnic Affairs

- José Agustín Zea, engineer: Ministry for the Environment, Housing and
Territorial Development
- Doctor Jorge Botero: National Health Institute
- Col Carlos Narvaez: Technical Advisor - U.S. Embassy
- Doctor Luz Marina Garzón: Office of the High Commissioner for Social Action

“In pursuance of the provision in Ruling SU- 383 of 2003 in connection with the prior
consultation with indigenous communities in the framework of the PECIG activities and the
agreement signed on 14 November 2003 between the Government and the indigenous

authorities of the Colombian Amazon, the consultation process took place with indigenous
communities of the municipality of Puerto Leguizamo, province of Putumayo; the attendance
list appears in the formalization record of the consultation, attached to the Opinion 29 of
January 20, 2007.

“The consultation process took place between 20 and 21 December this year. On the first day
the inauguration and opening of the consultation process occurred and the socialization
process started with each of the entities committed with the process. The National Narcotics
Directorate presented the general drug policy; subsequently the DIRAN presented the spraying
operation and procedure and forms of illicit crop eradication in the country.

“The National Health Institute presented the health impact of the program for the eradication of
illicit crops, for which a protocohas been established for monitoring of pesticide poisoning.
The officer of the Ministry for the Environment, Housing and Territorial Development presented

the environmental impact of the program for the eradication of illicit crops, with follow-up of the
Environmental Management Plan sheets; finally the Office of Social Action of the Presidency of
the Republic presented the actions that are being developed concerning the Ranger family
program, International cooperation - AID, through the ADAM program and alternative
development programs.”

Finally the Department of Licenses, Permits and Environmental Procedures of this Ministry,
through the Technical Opinion 29 of January 2007, concluded that:

“As a result of consultation with indigenous communities in the municipality of Puerto
Leguizamo, Putumayo province, an Act was signed between the parties involved, that is,
indigenous authorities and entities of the state, where they agreed to a term of forty -five (45)
days to eradicate the illicit crops, that is, that by the first week of February there should be no

3

282 Annex 43

illicit cultivation in theindigenous territory of Puerto Leguizamo – Putumayo. Likewise,

exclusion areas corresponding to medical use of coca plants will be respected and a follow -up
committee comprised of the Ministry of Interior and Justice, the national Narcotics Directorate,
two (2) delegates of the indigenous community (ACILAPP -OZIP), the Ministry for the
Environment, Housing, and Territ orial Development, the Anti -Narcotics Direction of the
National Police, and The Colombian Agriculture and Livestock Institute – ICA.”

The technical Opinion issued by this Ministry concluded:

1. “As a result of the consultation carried out with the indig enous communities of Puerto

Leguizamo Municipality, province of Putumayo, a 45- day term was agreed on to
eradicate coca crops, i.e., by the first week of February there will be no illicit crops in the
following indigenous reserves, located within the Puert o Leguizamo Municipality,
province of Putumayo:

1.1. “Coca- leaf Chewers Culture (Murui): Chewers culture (Murui): Piñuña Negro,
Aguas Negras, Tukunare, Lagarto Cocha, Samaritana, Santa Rita, Umancia, Progreso,
Nuevo Amanecer, Jiri-Jiri, Comuya Amena, Murui-urban center, Refugio, Puerto Nariño-
Murui, Bella Vista, Yarinal and La Primavera.

1.2. “Yage Culture (Kichua and Siona): Ato Naporuna, Calarcá, La Paya, Bajo
Remanso, Bajo Kasacunte, Puerto Rico, El Hacha, El Tablero, Cecilia Cocha, Inga
Kichwa, Puerto Nariño-Kichwa, Puntales, Consara, Nasakiwe, Nukanchipayata, Gaoya,
La Perecera and Quebradita.

2. “Likewise, it was agreed with the with the indigenous communities of Puerto
Leguizamo Municipality, province of Putumayo, that the Program for the Eradi cation of
Illicit Crops by Aerial Sp raying with Glyphosate –PECIG, will respect the exclusion
areas corresponding to medical use of coca plants, which, according to the Minute

signed, corresponds to an area of 10 by 10 meter for coca- leaf chewers and 20 by 50
meters for Yage users.

3. Given that a Follow -up committee was created, which the Ministry for the

Environment is part of, it is recommended to the Ministry of Interior and Justice, the
Anti-Nartics Direction of National Police to inform to this Mini stry about the meetings to
be held by such Committee in order to have an effective participation in those meetings.

4. A copy of the Prior Consultation Protocol Minute – eradication of illicit crops with

indigenous authorities of of Puerto Leguizamo Munic ipality, province of Putumayo, is
part of the Technical Opinion 29 of 20 January 2007.

LEGAL CONSIDERATIONS

Article 8 of the National Constitution states: “It is a duty of the State and its Citizens to protect
the cultural and natural richness of the Nation.”

4

283Annex 43

Articles 79 and 80 of the Constitution enshrine the right of all to enjoy a healthy environment,

and to community participation in decisions that may affect it. It also establishes that the State,
among others, has the duty to protect biodiversi ty and environmental integrity, as well as the
State’s obligation to plan for the management and use of renewable natural resources to
ensure sustainable development, conservation, restoration and replacement.

Article 95 paragraph 8 of the rule cited above states that it is the duty of citizens to “ protect the
natural and cultural resources of the country and ensure the preservation of a healthy
environment.”

Through the issuance of Law 99 of 1993, the Government created the Ministry for the
Environment (now Ministry for the Environment , Housing and Territorial Development),
reorganized the public sector responsible for the management and conservation of the
environment and renewable natural resources, organized the National Environmental System -
SINA, and issued other provisions.

Article 5 paragraph 35 of Law 99 of 1993 notes that within the functions of this Ministry is the
assessment, monitoring and control of environmental risk factors and th ose that may affect the
occurrence of natural disasters , and coordinate with other relevant authorities the activities

designed to prevent the emergence or impede the extent of their effects.

By the issuance of Decree 1220 of April 21, 2005, the Ministry for the Environment , Housing
and Territorial Development regulated Title VIII of Law 99 of 1993.

Likewise, Decree 1220 of April 21, 2005 established in article 33 the duty of the environmental
authority to control and monitor projects, works or activities subject to environmental permit or
Environmental Management Plan during c onstruction, operation, decommissioning or
abandonment.

In accordance with the considerations made by the Office of the Director of Licensing, Permits
and Environmental Procedures through Technical Opinion 29 of January 2007, it will be
declared, through the operative part of this administrative act, that the Presidency of the
Republic, the Ministry of The Interior and Justice, the National Health Institute, the Agriculture

and Livestock Institute ICA, the National Narcotics Directorate and the Antinarcotics Police -
DlRAN performed the process of prior consultation with the Coca-leaf Chewers culture (Murui):
Piñuña Negro, Aguas Negras, Tukunare, Lagarto Cocha, Samaritana, Santa Rita, Umancia,
Progreso, Nuevo Amanecer, Jiri -Jiri, Comuya Amena, Murui -urban center, Refugio, Puerto
Nariño-Murui, Bella Vista, Yarinal and Primavera and the Y agé culture (Kichwa and Siona):

Ato Naporuna, Calarcá, La Paya, Bajo Remanso, Bajo Kasacunte, Puerto Rico, El Hacha, El
Tablero, Cecilia Cocha, Inga Kichwa, Puerto Nariño- Kichwa, Puntales, Consara, Nasakiwe,
Nukanchipayata, Gaoya, La Perecera and Quebradit a, located in the municipality of Puerto
Leguizamo in the province of Putumayo as ordered by the Honorable Constitutional Court

through Ruling SU-383 of 2003, in the implementation of activities under the Program for the
Eradication of Illicit Crops by Aerial Spraying with Glyphosate - PECIG.

5

284 Annex 43

Notwithstanding the foregoing and in accordance with the considerations made by the

Department of Licenses, Permits and Environmental Procedures through the Technical
Opinion 29 of January 2007, it will be required, through the operative part of this administrative
act, of the Ministry of The Interior and Justice - Office of Ethnic Affairs, the N ational Narcotics
Directorate - DNE and the Anti Narcotics Police - DIRAN, to report promptly and previously to
this Ministry , the performance of meetings of the Monitoring Committee set up to verify

development of agreements with the Chewers culture (Murui) and the Yagé culture (Kichwa
and Siona).

Decree 216 of February 3, 2003 defines the objectives, the structure of the Mini stry for the

Environment, Housing and Territorial Development and other provisions. In its article 2, it
states that the Ministry for the Environment , Housing and Territorial Development will continue
to exercise powers under Law 99 of 1993.

By Article Three of Decree 3266 of October 8, 2004, the Ministry for the Environment , Housing

and Territorial Development created the Department of Licenses, Permits and Environmental
Procedures, attached to the Office of the Deputy Minister for the Environment.

According to the provisions of Decree 802 of May 10, 2006 of the Ministry for the Environment,

Housing and Territorial Development, it is the responsibility of the Advisor of the Office of the
Deputy Minister of Environment – Division to sign this administrative act.

In virtue of the foregoing,
DECIDES

ARTICLE ONE. To declare that the Presidency of the Republic, through the Social Action
Office, the Ministry of t he Interior and Justice, th is Ministry, the National Health Institute , the
Agriculture and Livestock Institute-ICA, the National Narcotics Directorate and Antinarcotics
Police – DIRAN, undertook the process of prior consultation with the the coca-leaf Chewers

culture (Murui): Piñuña Negro, Aguas Negras, Tukunare, Lagarto Cocha, Samaritana, Santa
Rita, Umancia, Progreso, Nuevo Amanecer, Jiri -Jiri, Comuya Amena, Murui -urban center,
Refugio, Puerto Nariño- Murui, Bella Vista, Yarinal and Primavera and the Yagé culture
(Kichwa and Siona): Ato Naporuna, Calarcá, La Paya, Bajo Remanso, Bajo Kasacunte, P uerto

Rico, El Hacha, El Tablero, Cecilia Cocha, Inga Kichwa, Puerto Nariño- Kichwa, Puntales,
Consara, Nasakiwe, Nukanchipayata, Gaoya, La Perecera and Quebradita, located in the
municipality of Puerto Leguizamo in the province of Putumayo as ordered by th e Honorable
Constitutional Court through Ruling SU- 383 of 2003, in the implementation of activities under
the Program for the Eradication of Illicit Crops by Aerial Spraying with Glyphosate - PECIG, in

accordance with what is stated in the preamble of this administrative act.

ARTICLE TWO. To require the Ministry of the Interior and Justice - Office of Ethnic Affairs, the
National Narcotics Directorate - DNE and the Antinarcotics Police - DIRAN, to report to this

ministry promptly and prior to conducting meetings of the Monitoring Committee in accordance
with what is discussed in the preamble of this administrative act.

6

285Annex 43

ARTICLE THREE . Through the Department of Licenses, Permits and Environmental
Procedures of this Ministry, to serve notice of the contents of this administrative act on the
Legal Representatives of the Social Action Office of the Presidency of the Republic, the Anti -
Narcotics Police – DIRAN, the National Narcotics Directorate, the National Health Institute, the

Agriculture and Livestock Institute - ICA and/or the duly appointed attorneys.

ARTICLE FOUR . Through the Department of Licenses, Permits and E nvironmental
Procedures of this Ministry, to serve notice of the contents of this administrative act on the

Legal Representative of FUNDEPUBLICO, on Dr. Claudia Sampedro- Torres, Dr. Héctor
Suárez and/or the duly appointed attorneys.

ARTICLE FIVE. Through the Department of Licenses, Permits and E nvironmental Procedures

of this M inistry, to serve notice of the contents of this administrative act on the Legal
Representatives of the Ombudsman and/or the duly appointed attorney.

ARTICLE SIX. Through the Department of Licenses, Permits and E nvironmental Procedures

of this M inistry, to serve notice of this administrative act on the Delegate Prosecutor for
Environmental and Agricultural Affairs, the Ministry of Social Protection, the National Narcotics
Council-CNE and the Geographic Institute Agustín Codazzi - IGAC.

ARTICLE SEVEN . There is recourse for rever sal against this administrative act , by
government means, and recourse must be filed within five (5) days following service of this
notice and with full compliance of Articles 50, 51 and 52 of the Administrative Code

BE THIS SERVED, COMMUNICATED AND OBEYED

[Signed]
NILBERCECE MACÍAS-FERNÁNDEZ

Advisor to the Deputy Minister for the Environment
Department of Licenses, Permits and Environmental Procedures

File 793
Draft: Camilo Rincon, professional contractor, Department of Licenses, Permits andEnvironmental Procedures
C/Mis Documentos/Culivos lIicitos/seguimiento CT29 de enero de 2007/ Exp 793

7

286 Annex 44

ECUADORIAN FOREIGNM INISTRC OURTFILINGNO .937-2004,
22 CTOBER 2004

(Ministry of Foreign Affairs of the Republic of Ecuador , pp. 6-7, 18-24, 31-40)

287288 Annex 44

REPUBLIC OF ECUADOR
MINISTRY OF FOREIGN AFFAIRS

Information Access Action No. 937-2004

[…]

Presidential Decree 1151 Official Gazette 238 of December 23, 2003

[…]

Art. 2: To create an Inter -Institutional Commission formed by the
ministries of the Env ironment, Public Health, Foreign Affairs, Agriculture and

Animal Husbandry, Govern ment and Nati onal Defense, representatives of the
provincial councils of the provinces of Sucumbíos, Orellana, Carchi, Imbabura
and Esmeraldas and a representative from each one of the municipalities of the
border populations.

Art. 3: The Inter -Institutional Commission shall have the following
powers:

a. To design an environm ental and health control and alert system
for avoi ding the use of chemical and biochemical

substances o r biological agents in the control and
eradication of marihuana, coca and poppy crops that could
affect the envi ronment, farmi ng production, fish-farming
production and public health of border populations of the

provinces of Sucumbíos, Orellana, Esmeraldas , Carchi and
Imbabura;
[Page 6]

b. To craft an early alert mechanism in said provinces for preventing

the potential risks from the use of chemical, biochemical or biological agents
harmful to the environment, farming production and fish-farming production or
the health of Ecuadorian populations;

c. To comp ile, systematize and analyze technical -scientific

information on the use of chemical, biochemical or biological agents as
fumigation mechanisms;

d. To organize campaigns for devel oping money-making legal crops

as a measure to discourage the border population from taking part in the
production of drug crops; and,

e. To spread information to the community on the potential impacts
of future fumigations.

...
[Page 7]

289Annex 44

[…]
Technical report on visit to the Province of Sucumbíos (border with

Colombia)
February 27-29, 2004

Gustavo Bernal
Soil Microbiologist Ph.D.

CCTE Commissioner

Recitals

With the knowledge that the Human Rights Commission of the Honorable
National Congress had programmed a visit to veri fy the existing problems of the
border populations of the Province of Sucumbíos, probably caused by residue
from glyphosate sprayed in Colombian territory, the engineer Oscar Izquierdo of
the Chancellor’s Office invited the members on the CCTE to join the

commission in its visit of the area, in accordance with the preestablished visit
agenda of the Human Rights Commission . Consequently, the agronomists
Gustavo Bernal Ph.D., Edwin Cáceres M.Sc. and Rubén Tamayo M.Sc.
accepted the invitation and participate d in the visit by the Human Rights
Commission of the Honorable National Congress during the period February 27

to 29, 2004.

Activities carried out at:

Puerto Mestanza

1) Samples of soil taken from the Puerto Mestanza area, following the
recommendations of the Soil Department Laboratory (DMSA) of the INIAP
Santa Catalina Station.

2) Samples of plants taken following the INIAP Plant Protection Department
(DNPV) laboratory. Mandarin leaves and fruits were collected and had the
following symptoms: curled leaves with light chlorotic spots and fruits with thick
surfaces and a wrinkled appearance.

Corazón Orense

3) Receipt of plant samples provided by community members. It is
necessary to emphasi ze that the plant samples were not collected directly by
the professional members on the CCTE. The samples were taken from

plantain, yucca, orange, lemon, cacao and maize plants.

[Page 18]

290 Annex 44

Santa Marianita

4) Receipt of vegetable samples provided by community members.

Furthermore, the samples taken from this place (plantain, yucca, orange, lemon
and cacao plants) were not collected directly by CCTE members.

5) Observation of symptoms or type of damage.

The plantain plants from both places had dark colored fruit , covered by a layer
of white and orange mycel ium. Necrosis was observed (black colored decay)
when cutting the fruit stalk.

The yucca was long and thin with white colored mycelium.

The orange plants had black spots on both sides of the leaves. There were
areas with light brown necrosis.

The lemon plant had abundant lichens.

The cacao had very dark spots gradually covering the entire bean surface.

The maize plants had deformed ear s, smaller than usual containing small,
irregular shaped grains.

Lab analysis

Both the soil samples and plant sampl es were taken to the DMSA and DNPV
laboratories at the INIAP Santa Catalina Station for analyses, following routine

procedures.

Analysis of soil samples

The soil taken to the lab was subjected to chemical analys es focusing on the

contents of macro nutrients: nitrogen (N); phosphorous (P), potassium (K),
sulfur (S); calcium (Ca), magnesium (Mg), and micro nutrients: zinc (Zn), copper
(Cu), iron (Fe), manganese (MN), boron (B). In addition, the following were
determined: sodium concentrations (Na), and al uminum (Al), soil ph (acidity),
cationic interchange capacity (CIC), and organic material content (MO).

Analysis of plant samples

The plant samples were subjected to microbiological analys es: Plant fragments
showing the described symptoms were taken and placed in appropriate culture

[Page 19]

means for growing fungi and bacteria. The routine procedure recommended by
the DNPV was followed.

Results and Discussion

291 [Page 19]
Annex 44
means for growing fungi and bacteria. The routine procedure recommended by
the DNPV was followed.

Results and Discussion

Analysis of soil samples collected from the Puerto Mestanza area.

Based on the (attached) analytical report, the soil lacks nutrients, showing an
imbalance thereof. The soil is acidic (pH 5.4), which is characteristic of the

Amazon area. The soil acidity makes absorption of major elements (Nutrients)
lower and complete inhibition possible. Complementarily, acidity increases
absorption of minor elements, such as iron (Fe). The report clearly shows a
high concentration of iron and aluminum, which are indicia of toxicity of these
elements, inhibiting the absorption of calcium and creating a low cationic
interchange capacity typifying deteriorated soil. Crops in these conditions fail to

grow normally and do not produce fruits in their normal shapes and sizes,
considerably reverberating on performance and productivity. A clear example is
maize with small ears of corn and small, irregular shaped grains, which are the
consequences of the soil’s poor nutritional value.

The soil also shows an excess of potassium with respect to other macro
nutrients of importance, such as ni trogen and phosphorous , causing an
imbalance for proper plant absorption. The results also show deficiencies of
Zinc and Boron, which are important micro nutrients for the proper functioning of
plant enzymes. The symptoms observed in f ruit plants, specifically mandarin,

are closely related with the soil’s deficient nutrients.

Finally, the organic matter content (1.40%) is very low, constituting yet another
indicator of the poor quality of the soil collected from the Mestanza area. Poor
soil, in organic matter terms, is a sig n of the physical, chemical and biological

deterioration of the soil. Under these conditions, and together with defi cient
and/or toxic nutrients, performance and productivity are severely affected,
yielding small and deformed fruit as in the case of maize and yucca.
Furthermore, the result is a weak and under developed crop that is largely
susceptible to damage by pathogenic microorganisms.

[Page 20]

Phytosanitary analyses

Crop Analyzed part Pathogens

Plantain Fruit Colletotrichum sp.
Verticillium sp.

Yucca Root Cladosporium sp.
Orange Leaves Phitomyces sp.
Endophragmia sp.
Lemon Leaves Cladosporium sp.
Cacao Fruit Phytophthora sp.

The phytosanitary analysis performed at the lab shows that the symptoms
observed in the crop samples provided by community members of the are as of
Corazón Orense and Santa Marianita are the result of fungal damage.
Generally, the fungi identified are crop pathogens. In the case of Cladosporium

292 Annex 44

sp in yucca, and Endophragmia sp in oranges, these are saprophytes which are
organisms that feed on dead plants.

Summary

The soil of the Puerto Mestanza area is poor, showing a nutritional imbalance
along with aluminum and iron toxicity.

The acidity of the soil from the Puerto Mestanza area make s it indispensable to
engage in fertility management practices thaneither increase soil acidity nor
deteriorate soil further.

The symptoms observed in cult ured mandarin at the Mestanza area are the

result of the soil’s nutritional imbalance (deficiencies and toxicities).

The symptoms observed in cultured maize from the Corazón Orense area are
also the result of the soil’s poor nutritional value.

The symptoms observed in the samples of plantain, yucca, oranges, lemons
and cacao, provided by the farmers of the Corazón Orense and San ta Marianita
areas, are the result of the damage caused by pathogenic fungi (see chart),
determined by laboratory procedures.

[Page 21]

INIAP
AUTONOMOUS NATIONAL INSTITUTE
OF FARMING RESEARCH

SANTA CATALINA EXPERIMENTAL STATION
NATIONAL PLANT PROTECTION DEPARTMENT

Telefax 690.693

PLANT DISEASE DIAGNOSIS

ENTRY INFORMATION
Diagnosis No. Type of Date of Entry Payment TIN No.
analysis Voucher No.

Mycologic 27-01-04

SENDER’S INFORMATION

Name of Sender:
Company:
Location:
Address: Telephone: Fax

CROP CHARACTERISTICS
Crop: Plantain, yucca, Variety: Age:

293Annex 44

orange, lemon, cacao
Development status: Prior crop:

Crop system:
Crop management

DESCRIPTION OF DISEASE
Plant parts affected:
Intensity of disease:
Distribution of disease:

Possible cause of
disease:

Symptoms or type of damage:

Plantain: dark colored rotting in the fruit, covered with a film of whitish and
orange mycelium. Black necrosis was observed when cutting the fruit stalk.

[Page 22]

Yucca: Whitish mycelium observed at the base of the yucca.

Orange: Black spots were observed on both sides of leaves. There were also
light brown necrotic areas.

Lemon: Abundant lichens present

Cacao: Extensive dark colored spots were observed in the fruit, progressively
covering the entire surface of the cocoa bean.

Additional observations:
Samples from crops located in the Amazon border with Colombia.

RESULTS

Crop Part Analyzed Pathogen (Fungi)
Plantain Fruit Colletotrichum sp
Verticillium sp

Yucca Roots Cladosporium sp
Orange Leaves Phitomyces sp
Endophragmia sp
Lemon Leaves Cladosporium sp
Cacao Fruit Phytophthora sp

Observations:
The identified fungi are generally crop pathogens, in the case of Cladosporium
sp in yucca and Endophragmia sp in orange the fungi are saprophytes.

294 Annex 44

[Page 23]

[…]

INIAP
“SANTA CATALINA” EXPERIMENTAL STATION

SOIL AND WATER MANAGEMENT LABORATORY

Km 14 ½ Panamericana Sur. Apdo 17-01-340
Quito-Ecuador Tel: 690-691/92/93 Fax: 690-693

SOIL ANALYTICAL REPORT

OWNER INFORMATION PROPERTY INFORMATION

Name: BORDER CONTAMINATION Name: PUERTO MESTANZA
Address: Province:
City: Canton:
Telephone: Parish:

Fax: Location: BORDER-COLOMBIA

LOT INFORMATION FOR LABORATORY USE
Current Crop: Report No.: 2,893

Prior Crop: (illegible) 0
Prior Fertilizer: Date of Sample:01/03/04
Surface: Entry Date: 01/03/04
Identification: JUNGLE BORDER Exit Date: 11/03/04

Nutrient Value Unit

N 37.00 ppm
P 9.00 ppm
S 6.90 ppm
K 1.30 meq/100 ml

Ca 2.90 meq/100 ml
Mg 1.10 meq/100 ml (graph)
LOW MEDIUM HIGH
Zn 2.50 ppm

Cu 4.50 ppm
Fe 197.00 ppm
Mn 5.40 ppm (graph)
LOW MEDIUM HIGH

B 0.40 ppm (graph)
LOW MEDIUM HIGH TOXIC
0 requires Cal 5.5 6.5 7.0 7.5 8.0
pH 5.40

Acid Slightly Acid Almost Neutral Sli.AlAlkaline
Acid Int. (Al+H) 3.70 meq/100 ml
Al meq/100 ml
Na 0.03 meq/100 ml (graph)

LOW MEDIUM TOXIC
CE 0.23 mmhos/cm (graph)
Not Saline Sli. SalinSaline Very Saline
MO 1.40 (graph)

LOW MEDIUM HIGH

Ca Mg Ca+Mg (meq/100ml) % ppm (%) Texture
Type
Mg K K Σ Base Ntot Cl Sand Slime Clay
2.6 0.8 3.1 9.0

(Signed) (Signed)
_____________________ _____________________
RESPONSIBLE LABORATORY LAB TECHNICIAN

295Annex 44

[Page 24]

ECUADORIAN ATOMIC ENERGY COMMISSION (CEEA)
ECOTOXICOLOGY
RESIDUE ANALYSIS LABORATORY

ANALYTICAL REPORT

Applicant: Ecuadorian Scientific-Technical Commission
(CCTE)
Samples of: Water

Sampled by: CEEA Ecotoxicology Lab.
Number of Samples: 4
Date of entrance into laboratory: 15 July 2004
Date of sample processing: 28 July – 2 August 2004
Date of Instrumental Analysis: 15 August 2004

Date of issuance of report: 16 August 2004

Sample Quantified Concentration
Code Glyphosate μg/L

Sample 1 No residue
La Chiquita found
Ravine

Sample 2 No residue
Chiquita found
Marshlands

Sample 3 No residue
Guadolito found
Affluent

Sample 4 No residue
Sabalera found
Marshlands

Quantification Limit:
Glyphosate 2 μg/L

[Page 31]

296 Annex 44

Notes:

1. The results of this report are exclusively for the analyzed samples

consisting of 4 samples of water taken at the Province of Esmerald as (San
Lorenzo – Mataje Zone) for Glyphosate residue analysis by CEEA technical
personnel on July 14, 2004.

2. The analysis method used is EPA 547 modified glyphosate residue analysis
confirmed in the laboratory. For the extraction, 200 ml of water was
concentrated in rotavapor up to two milliliters. The analysis was performed
using Vari an 9010 chromatograph liquid equipped with a post -column

derivatization PICKERING PCX 5200, SHIMADZU RF -551 fluorescence
detector and Hewlett Packard HP 3392 series II integrator. For
identification and quantification, analytical standards provided by Riedel de
Haën were followed.

3. Confidential document for use by the“Ecuadorian Scientific-Technical
Commission.” This document cannot be reproduced in whole or part
without authorization from the laboratory.

4. The samples referred to in this report shall remain in custody for 15 days
following the issuance of this report and will be discarded thereafter.
5. The laboratory is not liable for the interpretation of these results.
6. The data associated with this study (chromatograms, calibration curves,

etc.) will be kept under custody for a time period of six months following the
issuance of the report. The data will be subsequently discarded.
7. Analyzed Compound: Glyphosate

(Signed)
Laboratory Technician Responsible
for Residue Analysis
Chemist Ramiro Castro

LARPA-AC-136 R-16/08/04

(seal)
MINISTRY OF FOREIGN AFFAIRS
I HEREBY CERTIFY THAT THIS DOCUMENT IS AN
EXACT COPY OF THE ORIGINAL ON FILE AT THIS
MINISTRY.
(Signed)
AMBASSADOR EDWIN JOHNSON LOPEZ
VICE-MINISTER OF FOREIGN AFFAIRS
QUITO, OCTOBER 21, 2004

[Page 32]

297Annex 44

ECUADORIAN ATOMIC ENERGY COMMISSION (CEEA)
ECOTOXICOLOGY

RESIDUE ANALYSIS LABORATORY

ANALYTICAL REPORT

Applicant: Ecuadorian Scientific-Technical Commission
(CCTE)
Samples of: Water
Sampled by: CEEA Ecotoxicology Lab.
Number of Samples: Three

Date of entrance into laboratory: 24 April 2004
Date of sample processing: 27 April 2004
Date of Instrumental Analysis: 4 May June 2004
Date of issuance of report: 11 June 2004

Sample Quantified Concentration
Code Glyphosate μg/L

Mataje (1) No residue

Marshlands found

Mataje (2) No residue
River found

Mataje (3) No residue
(Potable water) found

Quantification Limit:
Glyphosate 2 μg/L

[Page 33]

298 Annex 44

Notes:

1. The results of this report are exclusively for the analyzed samples

consisting of 6 samples of water taken at the Province of Sucumbíos for
Glyphosate residue analysis by CEEA technical personnel on April 24,
2004.

2. The analysis method used is EPA 547 modified glyphosate residue analysi s
confirmed in the laboratory. For the extraction, 200 ml of water was
concentrated in rotavapor up to two milliliters. The analysis was performed
using Varian 9010 chromatograph liquid equipped with a post -column

derivatization PICKERING PCX 5200, SHIMA DZU RF -551 fluorescence
detector and Hewlett Packard HP 3392 series II integrator. For
identification and quantification, analytical standards provided by Riedel de
Haën were followed.

3. Confidential document for use by the “Ecuadorian Scientific-Technical
Commission.” This document cannot be reproduced in whole or part
without authorization from the laboratory.

4. The samples referred to in this report shall remain in custody for 15 days
following the issuance of this report and will be discarded thereafter.
5. The laboratory is not liable for the interpretation of these results.
6. The data associated with this study (chromatograms, calibration curves,

etc.) will be kept under custody for a time period of six months following the
issuance of the report. The data will be subsequently discarded.
7. Analyzed Compound: Glyphosate

(Signed)
Laboratory Technician Responsible
for Residue Analysis

LARPA-AC-123a R-11/06/04

(seal)
MINISTRY OF FOREIGN AFFAIRS
I HEREBY CERTIFY THAT THIS DOCUMENT IS AN
EXACT COPY OF THE ORIGINAL ON FILE AT THIS
MINISTRY.
(Signed)
AMBASSADOR EDWIN JOHNSON LOPEZ
VICE-MINISTER OF FOREIGN AFFAIRS
QUITO, OCTOBER 21, 2004

[Page 34]

299Annex 44

ECUADORIAN ATOMIC ENERGY COMMISSION (CEEA)
ECOTOXICOLOGY

RESIDUE ANALYSIS LABORATORY

ANALYTICAL REPORT

Applicant: Ecuadorian Scientific-Technical Commission
(CCTE)
Samples of: Water
Sampled by: CEEA Ecotoxicology Lab.
Number of Samples: Six

Date of entrance into laboratory: 15 May 2004
Date of sample processing: 20 May 2004
Date of Instrumental Analysis: 9 June 2004
Date of issuance of report: 11 June 2004

Sample Quantified Concentration
Code Glyphosate μg/L

AGOO1 No residue

Conejo River found

AG002 No residue
San Francisco found
1

AGOO3 No residue
San Miguel found
Bridge

AG004 No residue
La Punta found
Marshlands

AG005 No residue

Chone 1 found

AG006 No residue
Chone 2 found
Zancudo River

Quantification Limit:
Glyphosate 2 μg/L

[Page 35]

300 Annex 44

Notes:

1. The results of this report are exclusively for the analyzed samples

consisting of 6 samples of water taken at the Province of Sucumbíos for
Glyphosate residue analysis by CEEA technical personnel on May 14,
2004.

2. The analysis method used is EPA 547 modified glyphosate residue analysis
confirmed in the laboratory. For the extraction, 200 ml of water was
concentrated in rotavapor up to two milliliters. The analysis was performed
using Varian 9010 chromatograph liquid equipped with a post -column

derivatization PICKERING PCX 5200, SHIMADZ U RF -551 fluorescence
detector and Hewlett Packard HP 3392 series II integrator. For
identification and quantification, analytical standards provided by Riedel de
Haën were followed.

3. Confidential document for use by the “Ecuadorian Scientific-Technical
Commission.” This document cannot be reproduced in whole or part
without authorization from the laboratory.

4. The samples referred to in this report shall remain in custody for 15 days
following the issuance of this report and will be discarded thereafter.
5. The laboratory is not liable for the interpretation of these results.
6. The data associated with this study (chromatograms, calibration curves,

etc.) will be kept under custody for a time period of six months following the
issuance of the report. The data will be subsequently discarded.
7. Analyzed Compound: Glyphosate

(Signed)
Laboratory Technician Responsible
for Residue Analysis

LARPA-AC-123 R-11/06/04

(seal)
REPUBLIC OF ECUADOR
MINISTRY OF FOREIGN AFFAIRS
EXACT COPY OF THE ORIGINAL ON FILE AT THIS
MINISTRY.
(Signed)
AMBASSADOR EDWIN JOHNSON LOPEZ
VICE-MINISTER OF FOREIGN AFFAIRS

QUITO, OCTOBER 21, 2004

[Page 36]

301Annex 44

INIAP
AUTONOMOUS NATIONAL INSTITUTE

OF FARMING RESEARCH
SANTA CATALINA EXPERIMENTAL STATION
NATIONAL PLANT PROTECTION DEPARTMENT

Telefax 690.693

PLANT DISEASE DIAGNOSIS

ENTRY INFORMATION

Diagnosis No. Type of Date of Entry Payment TIN No.
analysis Voucher No.
Mycologic 27-01-04
and
Bacteriologic

SENDER’S INFORMATION
Name of Sender: Ecuadorian Chancellor’s Office

Company:
Location:
Address: Telephone: Fax

CROP CHARACTERISTICS
Crop: various Variety: Age:
Development status: Prior crop:
Crop system:

Crop management

DESCRIPTION OF DISEASE

Plant parts affected: leaves
Intensity of disease: medium
Distribution of disease: entire leaf
Possible cause of fungi

disease:

Symptoms or type of damage:

M1: Pasto (small plant) and

M2: Pasto (large plant) Reddish foliar necrosis was observed in both samples.

M3: Place La Cadena 8 Km from the border. Several black elongated spots
observed.

[Page 37]

302 Annex 44

M4: Place La Cadena 8 Km from the border: Small, dark, irregular spots
were observed o n the other plant. Some of the spots connecaffecting the

major part of the foliar lamina.

M5: Light brown necrosis on top and edges of leaves.

M6 (Labeled as sample 2 photo 7) Necrosis along the edges of leaves.

M7: Plantain: Slight necrosis

M8: Sample photo 5.

Additional observations:
Samples from crops located on the border with Colombia.

RESULTS

Crop Part Analyzed Pathogen (Fungi)
M1 Leaves ------
M2 Leaves ------

M3 Leaves ------
M4 Leaves Bypolaris sp
Heterosporium sp
M5 Leaves ------

M6 Leaves Helminthosporium sp
M7 Leaves Mycospherella sp
M8 Leaves ------
Observations:

Generally, identified fungi cause foliar spots.

DR. GUSTAVO BERNAL G. DR. MARIA LUISA INSUASTI A.
RESP. FOR PLANT PROTECTION DEPT. RESP. FOR LABORATORY
AREA

[Page 38]

303Annex 44

RESULTS

Methodology Analyzed Dilution Pathogen (Fungi) No. Colonies
(Medium) Sample
-4
PDA-CMA-EMA Soil 10 Penicillium sp 2
Cephalosporium sp 1
Cylindrocarpon sp 1
Methodology Analyzed Dilution Pathogen No. Colonies

(Medium) Sample -4 (Bacteria)
KB-SX-LPGA- Soil 10 Xanthomonas spp 2
CVP Bacterionema sp 2
Erwinia sp 0
Pseudomonas spp 2

Methodology Analyzed Dilution Pathogen (Fungi) No. Colonies
(Medium) Sample
PDA-CMA-EMA Water 10-4 ---------- ---------
Methodology Analyzed Dilution Pathogen No. Colonies

(Medium) Sample -4 (Bacteria)
KB-SX-LPGA- Water 10 Pseudomonas sp 1
CVP Xanthomonas sp 0
Erwinia sp 0

Observations:

DR. GUSTAVO BERNAL G. DR. MARIA LUISA INSUASTI
A.
RESP. FOR PLANT PROTECTION DEPT. RESP. FOR LABORATORY
AREA

[Page 39]

304 Annex 44

Discussion:

The plant analysis results (charts) show the presence of pathogenic fungi in

sample 4 (Bypolarys sp., and Heterosporium sp.). In sample No. 6 , the
presence of the fungus Helminthosporium sp. fungus was identified; and, in
sample 7, the Mycospherella sp. fungus was identified . All of the identified

fungi cause foliar spots.

There was symptomatology of small spots along leaf edges that did not show
pathogens. These samples were sent to the INIAP Soil Laboratory (Santa

Catalina Station) for foliar analysis and verification of deficiencies or toxicities of
nutrients in the foliar part of the samples (results to be issued). Part of the
samples was also sent to the Ecuadorian Atomic Energy Commission (CEEA)
for foliar analysis and to verif y the presence of any kind of agro -chemical

concentrations. These results must be forwarded by CEEA. Furthermore,
symptoms apparently provoked by hydric deficiency in crops were observed.
Following the analysis, soil pathogens were identified in the soil samples (see

chart) which cause radical diseases in crops such as bacteria genera Erwinia,
Xanthomonas, etc. The soil samples were also sent to CEEA for analysis and
detection of agro-chemicals.
With respect to these plant and soil samples, at present fi nal conclusions

cannot be issued until foliar and soil results are analyzed at CEEA, and all
results are analyzed as a whole. The symptomatology observed in the plant
samples may be the result of several causes: pathogens, toxicity ( e.g.,

“nutrients” or agro -chemicals) or nutritional deficiencies (to be verified) and
hydric stress.

(seal)
REPUBLIC OF ECUADOR
MINISTRY OF FOREIGN AFFAIRS
I HEREBY CERTIFY THAT THIS DOCUMENT IS AN
EXACT COPY OF THE ORIGINAL ON FILE AT THIS
MINISTRY. (Signed)
AMBASSADOR EDWIN JOHNSON LOPEZ
VICE-MINISTER OF FOREIGN AFFAIRS

QUITO, OCTOBER 21, 2004

[Page 40]

305306 Annex 45

COMMISSION ON TRANSPARENCY AND TRUTH FOR THE ANGOSTURA
CASE, REPORT, UITO, DECEMBER 2009

(Ministry of Foreign Affairs of the Republic of Ecuador , p.93, 95)

307308 Annex 45

Report of the Commission on Transparency and Truth for the
Angostura Case, Quito, December 2009

[Page 93]

“For example, nearby the geodesic line that connects the

Putumayo and San Miguel Rivers (border between the two
countries in the Sucumbios region) drug processing
laboratories, permanent and mobile camps, weapons and fuel
storage facilities have been established. Along that border, 42
illegal crosses can be found.”

“The Sucumbios Province is used as an operations center by
the FARC´s 48 and 32 fronts. Front 29 has influence in Carchi
and Esmeraldas. Whereas in Esmeraldas (Ecuadorian province
in the west of the common border) other groups emerging from
paramilitarism such as Los Rastrojos, Nueva Generación, Las

Aguilas Negras and Los Zorros fight with blood and iron for
control of precursors, weapons and drugs cargos.”

[Page 95]

As stated before, the efforts made to control smuggling and

drug-trafficking are still insufficient. Despite controls,
interinstitutional committees, citizens security boards, police
and army patrolling, customs check points, etc., smuggling and
drug-trafficking continue to increase.

As an example: in a day and night time monitoring of the main
and secondary access roads carried out by the investigation
team in the sector located between Puerto El Carmen as far as
river Access to Puerto Libre de San Lorenzo, activities such as
clandestine sale of white gasoline, caustic soda, drugs,
Liquefied petroleum gas, timber, irregular land ownership, late

records of displaced people, vehicles theft, paid- killing, etc.
were corroborated.”

309310 Annex 46

u nitedstatese Mbassy inbogotá , ertification with regard
to pilot’training,froM the nas d irector, aMes b. story,

to the coloMbian M inistry offoreigna ffair,
27 epteMber 2011

(United States Embassy in Bogotá, 2011)

311312 Annex 46

[Seal] Embassy of the United States of America

Bogotá, D.C.
27 September, 2011
Ambassador

Sonia Pereira
Coordinator Affairs before the International Court of Justice
Ministry of Foreign Affairs
San Carlos Palace
Bogotá, D.C.

Your Excellency:

We are pleased to greet you and wish you success at your
work.

In reply to your kind request, we inform you that the fixed- wing

pilots engaged in our program for eradication of illicit crops have
to take the Apart (Annual Proficiency And Readiness Test). This
test includes, besides the basic aerial skills, the aerial
operations tasks and the CRM (Crew Resource Management).

The assessment criteria are established based on knowledge of

the ATM (Aircrew Training Manual). The test is developed and
designed to keep an optimal training and performance level and
to standardize the technical procedures used by spray pilots.
Besides the aforementioned test, a skill test is applied without
prior notice at least once a year.

Likewise, an annual evaluation of spraying accuracy has been
implemented to ensure that pilots keep their capacity to apply
the chemical correctly from the aircraft. This is an evaluation
carried out in a simulated and controlled environment with the
highest criterion of real scenarios.

Additionally, every six months, training on the Environmental

Management Plan is given. During this training, required
parameters for optimal and environmentally safe application are
reviewed.

313Annex 46

With the training to the pilots group and its cor responding tests,

a greater awareness of the product application is guaranteed in
order to reduce likely causes that influence accuracy errors.

We avail of this opportunity to renew to you our high
consideration and respect.

Sincerely,

[Signed]
James B. Story
Director

Narcotics Affairs Section - NAS

314 Annex 47

UNITEDSTATESINTERAGENCYC OMMITTEE FORAVIATIONPOLIC,
AVIATIONRESOURCEM ANAGEMENT SURVEYTEAM ,EVALUATIVE

ARMS REPORT OF THUNITEDSTATESDEPARTMENT OFSTATE
BUREAU FORINTERNATIONALNARCOTICS ANL AWA VIATION
DIVISIO, ONDUCTEDA UGUST24THROUGH SEPTEMBER2,1998,
DOCUMENT A2A,3SEPTEMBER 1998

(United States Embassy in Bogotá, 2011, p. 1, 7)

315316 Annex 47

317Annex 47

318 Annex 48

M EMORANDUM FROM PETERP.TRENT,INL/RM/ASD,PSC
BOGOTA,TO GRANTH ARDEN,INL/RM/ASD,COR,

DOCUMENT G16,4JULY 1996

(United States Embassy in Bogotá, 2011)

319320 Annex 48

321Annex 48

322 Annex 48

323Annex 48

324 Annex 48

325Annex 48

326 Annex 48

327328 Annex 49

M eMoranduM froM inl/ad s afety– georgec.a rzente toinl/ad
operations– aul o´sullivan onaward feeinput, ocuMent J-24,
16 June1998

(United States Embassy in Bogotá, 2011)

329330 Annex 49

331332 Annex 50

M eMoranduM froMinl/c/asd - daviJohnson toinl/c/asd -
grant harden onsafetyaward feeevaluation fooctober1996,
docuMent g 50, 14oveMber 1996

(United States Embassy in Bogotá, 2011)

333334 Annex 50

335Annex 50

336 Annex 51

u nitedstateseMbassy inbogotá , ertification with regard to night
spraying tests and erroneous tiMe data fdel norte,froM the

nas d irector, aMesb. story,to thec oloMbianM inistry oforeign
a ffair, 27 epteMber2011

(United States Embassy in Bogotá, 2011)

337338 Annex 51

[Seal] Embassy of the United States of America

Bogotá, D.C.

27 September, 2011

Ambassador
Sonia Pereira
Coordinator Affairs before the International Court of Justice

Ministry of Foreign Affairs
San Carlos Palace
Bogotá, D.C.

Your Excellency:

We are pleased to greet you and wish you success at your work.

The Government of the United States with the cooperation of the Colombian
National Police carried out night spraying tests from February to April 2000 and

in January 2002. Once these tests were completed, it was concluded that night
operations would not be carried out.

Since the dates mentioned above, the Government of the United States has not

carried out night spraying operations. I am enclosing the map that shows the
areas sprayed at night during the aforementioned period of time; none of such
areas is within the 10 km of the border with the neighboring country , Ecuador

There are spray data submitted to Ecuador from Del Norte system which may
indicate night spraying operations after those dates. The information contained
in Del Norte data system is erroneous because the internal clock of the aircraft

used for spraying was never synchronized correctly.

The Government of the United States uses an additional form called Daily Flight
Summary, which shows the exact take- off and landing time for all aircraft

involved in aerial eradication missions. These forms have been shown to the
Government of Colombia previously and can be checked with for verification of

information. We especially appreciate to take into account the data contained in
these forms instead of the ones in Del Norte system, since the information
contained in them corresponds to the actual situation.

339Annex 51

Please accept our most sincere apologies for the confusion that this error may
have caused in the analysis of this case and we hope that this letter cl arifies the
discrepancies.

We avail of this opportunity to renew to you our high consideration and respect.

Sincerely,

[Signed]

James B. Story

Director
Narcotics Affairs Section - NAS

340 Annex 52

DEPARTMENT OF STATESAMPLE C ONTRACTOR EVALUATIONS,
D OCUMENTS G93, L 16,L 26,L AND L41

(United States Embassy in Bogotá, 2011)

341342 Annex 52

343Annex 52

344 Annex 52

345Annex 52

346 Annex 52

347Annex 52

348 Annex 52

349Annex 52

350 Annex 52

351Annex 52

352 Annex 52

353354 Annex 53

M EMORANDA OFJUSTIFICATION BY TUENITEDSTATES
DEPARTMENT OFS TATE,2002-2008

355356 Annex 53-A

departMent ofstateMeMoranduM of Justificaticoncerning
deterMination ohealth, nvironMenta,and legala spects

ofc ocaeradication icoloMbia, 2002

(U.S. Department of State)

357358 Annex 53-A

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2002 Aerial Eradication of Illicit Coca in
Colombia» 1 Memorandumof Justification

Memorandum of Justification Concerning Determination on Health,

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Environmental, and Legal Aspects of Coca Eradication in Colombia

The Kenneth M. Ludden Foreign Operations, Export Financing and Related Programs Appropriations Act, 2002

(P.L. 107-115) ("FOAA") lays out conditions under which assistance using funds appropriated under the FOAA
may be made available for the purchase of chemicals for the aerial eradication of coca in Colombia. The

legislati�n s requirements and the Administ�ation s summarized responses are below.

1. That the coca spraying is being carried out in accordance with regulatory controls required by the
Environmental Protection Agency as labeled for use in the United States:

Tab 2 of the report illustrates that the glyphosate formulation used to spray coca in Colombia is used in

accordance with theEPA label instructions for non-agricultural use. In Tab 3 of the report, a letter from EPA
Assistant Administrator JohnsonEPA confirms that application rates are within the parameters listed on U.S.

glyphosate labels.

2. That the coca spraying is in accordance with Colombian laws:

Tab 6 of the report includes a letter from the Ministry of Foreign Affairs of the Government of Colombia confirming
that the spraying is being carried out in accordance with each and every applicable Colombian law.

3. That the chemicals used in the coca spraying, in the manner in which they are applied, do not pose

unreasonable risks or adverse effects to humans or the environment:

USDA � S assessment (Tab 5) opines that the spray program poses no unreasonable health or environmental

risks. Upon examining the chemicals that used in Colombia, EPA notes the potential for acute eye toxicity, due

to an inert ingredient in the particular glyphosate formulation used by th� program. EPA s response points out
that the Department did not provide to the EPA the results of INL-commissioned toxicological tests performed on

the spray mixture, as promised in a briefing (note: these tests had not been completed at the time EPA

submitted its response). EPA replies that because of its inability to review such tests, it is unable to evaluate the

toxicity of the spray mixture that we are using in Colombia. In the absence of these testing results, EPA
recommended that the Department consider using an alternative glyphosate product with lower potential for

acute toxicity.

Until a lower toxicity glyphosate formulation could be made available for use in Colombia, we have continued to
spray with the higher toxicity glyphosate product. According to the EPA report, the risks of eye damage from the

current formulation are limited principally to the handlers and mixers of the concentrated formulation as opposed

to the general public. The concentrated glyphosate formulation is diluted when mixed with water for use in the

spray program; approximately 75 percent of the end use product is water. Furthermore, several safeguards are in
place to minimize human exposure to the spray mixture. Pilots are carefully selected and trained and are

instructed to avoid spraying near people, homes, or occupied buildings. The permissible spray parameters of

flight speed, aircraft height, and wind conditions are rigidly monitored and complied with. The Embassy is
working with the GOC to warn local citizens in areas where we spray (through radio and newspaper advisory

messages) to avoid the spray mist and inform them of precautions to take in case of possible incidental contact

with the spray mixture.

The Department now has the results of the eye irritation test of the spray mixture that would have bolstered
EPA � s analysis, but we did not receive these results in final form until af�er receipt of EPA s response. This

test determined that the spray mixture currently used in Colombia would be rated Categ�ry III on EPA s scale

of I-IV, with I being the most toxic. Congress is aware that this testing is underway and as we have notified in the
addendum to the report, we will provide the testing results as soon as all of the testing is completed.

359Annex 53-A

In addition, INL now has an alternative glyphosate product with lower potential for acute toxicity available for use

in Colombia. This formulation, registered in July 2002, is less toxic to the eyes because it uses a different inert

ingredient and is also known to have as low or lower toxicity ratings in all other categories, as well. Although this
alternative formulation has only recently been approved in Colombia, it has been extensively tested and widely

used elsewhere, and is registered for non-agricultural use in the U.S. by theEPA. Because this alternative

formulation addresses EP� s recommendation that the Department switch to a less toxic formulation, the
Department plans to switch to it for use in Colombia as soon as it can be manufactured, purchased, and

delivered. INL expects to place an order for the new product early in September 2002. The�Department s

notification to Congress will indicate our intention to make this switch, in re�ponse to EPA s concerns.

Based on the above information, we do not believe th�t EPA s reservation about the risk of eye irritation rises to
the threshold of "unreasonable risks" or "adverse effects" to humans or the environment identified in the statute.

4. That procedures are available to evaluate claims of local citizens that their crops were damaged by

such aerial coca fumigation, and to provide fair compensation for meritorious claims:

Tab 7 of the report outlines the procedures to evaluate claims of damage to legal crops from aerial eradication
and to provide fair compensation for meritorious claims. This includes an English language version of the

Colombian National Drug Counc�l s Resolution 0017, which formalized the new process. Complaints are being

received, logged, investigated, verified, and compensation is being allocated to cases with merit. Thus far only
two complaints have been deemed valid; compensation in these cases is pending and will be determined through

negotiation with the claimant.

5. That six months after FY 2002 FOAA enactment, funding from this act may not be made available for

chemicalsfor coca eradication unlessalternative development programshave been developed, in
consultation with communities and local authoritiesin the departments in which such aerial coca

fumigation is planned, and in the departments in which such aerial coca fumigation has been

conducted such programs are being implemented:

Tab 8 of the report illustrates that alternative development programs are being carried out in all but one of the

departments where we have sprayed in 2002. In this one department where a small amount of spraying took

place in February 2002, an alternative development program agreement has been negotiated and a contract for

the work signed. The GOC has agreed that no further spraying will take place in that department until an
alternative development program is actually being implemented.

Back to Top

The Office of Electronic Information, Bureau of Public Affairs, managesthissite asa portal for information from the U.S. State Department.

External linksto other Internet sitesshould not be construed asan endorsement of the vierein.privacy policiescontained the

360In addition, INL now has an alternative glyphosate product with lower potential for acute toxicity available for use

in Colombia. This formulation, registered in July 2002, is less toxic to the eyes because it uses a different inert

ingredient and is also known to have as low or lower toxicity ratings in all other categories, as well. Although this
alternative formulation has only recently been approved in Colombia, it has been extensively tested and widely

used elsewhere, and is registered for non-agricultural use in the U.S. by the EPA. Because this alternative

formulation addresses EP� s recommendation that the Department switch to a less toxic formulation, the
Department plans to switch to it for use in Colombia as soon as it can be manufactured, purchased, and

delivered. INL expects to place an order for the new product early in September 2002. The �epartment s

notification to Congress will indicate our intention to make this switch, in res�onse to EPA s concerns.

Based on the above information, we do not believe tha� EPA s reservation about the risk of eye irritation rises to Chemicals Used for the Aerial Eradication of Illicit Coca in Colombia and
the threshold of "unreasonable risks" or "adverse effects" to humans or the environment identified in the statute.
Conditions of Application

4. That procedures are available to evaluate claims of local citizens that their crops were damaged by

such aerial coca fumigation, and to provide fair compensation for meritorious claims:

The aerial spray mixture currently used in the U.S.-supported program of aerial eradication of coca in Colombia
Tab 7 of the report outlines the procedures to evaluate claims of damage to legal crops from aerial eradication contains three components: water, an EPA-registered formulation of the herbicide glyphosate, and a surfactant
and to provide fair compensation for meritorious claims. This includes an English language version of the
(Cosmo-Flux 411F). These components are mixed together into a spray mixture in the following percentages: 55
Colombian National Drug Counc�l s Resolution 0017, which formalized the new process. Complaints are being
percent water, 44 percent glyphosate formulation, and 1 percent Cosmo-Flux 411F (see Figure 1 below). This
received, logged, investigated, verified, and compensation is being allocated to cases with merit. Thus far only diluted mixture is applied to coca at the rate of 2.53 gallons per acre. This application rate is within the
two complaints have been deemed valid; compensation in these cases is pending and will be determined through
glyphosate manufacturer's recommendations for both the amount of concentrated formulation per acre and the
negotiation with the claimant.
amount of total spray volume per acre for woody plants and hard-to-control species. Coca is a hardy, woody

5. That six months after FY 2002 FOAA enactment, funding from this act may not be made available for bush that falls into this category.

chemicalsfor coca eradication unlessalternative development programshave been developed, in
consultation with communities and local authoritiesin the departments in which such aerial coca

fumigation is planned, and in the departments in which such aerial coca fumigation has been

conducted such programs are being implemented:

Tab 8 of the report illustrates that alternative development programs are being carried out in all but one of the

departments where we have sprayed in 2002. In this one department where a small amount of spraying took

place in February 2002, an alternative development program agreement has been negotiated and a contract for

the work signed. The GOC has agreed that no further spraying will take place in that department until an
alternative development program is actually being implemented.

Back to Top

Commercial glyphosate formulation:
The Office of Electronic Information, Bureau of Public Affairs, managesthissite asa portal for information from the U.S. State Department.
The commercial glyphosate formulation used in the spray mixture is registered with the U.S. Environmental
External linksto other Internet sitesshould not be construed asan endorsement of the viewrein.rivacy policiescontained the
Protection Agency (EPA) for sale in the United States for non-agricultural use and contains 41 percent

glyphosate salt and 59 percent inert ingredients. Approximately three fourths of the inert ingredient content are

water and the remainder is a surfactant blend. A surfactant is essentially a soap that enhances the ability of the
herbicide to penetrate the waxy cuticle of the leaf surface. Surfactants are commonly used with herbicide

formulations to improve the effectiveness of the product. This commercial glyphosate formulation used against

coca is registered, produced, and sold in Colombia, where the State Department s Bureau of International

Narcotics and Law Enforcement Affairs (INL) purchases it for the Government of Colombia (GOC) for use in the
GOC

proprietary and is retained by the manufacturer; it is not publicly available and the manufacturer has not provided

it to the Department. Figure 2 is a breakdown of the commercial glyphosate formulation by major components.Annex 53-A

Surfactant:

From the standpoint of coca control, properly selected surfactants make the glyphosate far more effective than if

the active ingredient were applied alone. Research by the United States Department of A�riculture s
Agricultural Research Service (USDA-ARS) has demonstrated that certain surfactants enhance glyphosate

penetration through the waxy cuticle on the coca leaf surface. Appropriate surfactants decrease the surface

tension of the adhering spray droplet (causing them to spread further on the leaf surface). Generally, this is good,

since the herbicide is less susceptible to runoff loss and greater surface coverage leads to more uptake of the
herbicide. The "right" surfactant may form a chemical shield around small clusters (micelles) of the herbicide and

enhance their penetration through the cuticle and into the leaf tissue.

In order to function, glyphosate must move from the site of application (the leaf surface) toward the actively
growing meristematic tissue - the new shoot tips and the new roots. Here, the herbicide glyphosate finally does

its job, blocking an enzyme that is essential for plant growth but absent from humans. Surfactants are a critical

component of the herbicide mixture, allowing the glyphosate to reach this actively growing tissue in the coca

plant. They may also stabilize the product droplets, reducing water evaporation, and thereby reducing spray drift.

The commercial glyphosate formulation used in the spray program contains 180g/l of surfactant as part of its

inert ingredients. As noted above, USDA-ARS research in the greenhouse and in the field (in Colombia, Panama,

and Hawaii) showed that commercial glyphosate formulations with surfactants performed better against coca
than other glyphosate without surfactants. Nevertheless, when coca ground-truth verification (see "Eradication

Oversight" section below) was first done in October 1997, ratings showed mean control of coca within aircraft

spray swaths to be about 70%. This was considered unacceptably low, since the goal was to eliminate the illicit
crop and force the growers to abandon further coca production. To improve swath control, USDA-ARS scientists

recommended two options, not mutually exclusive. One was to increase the level of glyphosate formulation in the

spray mixture. The second was to add an additional surfactant to boost control without necessarily requiring a

higher dose of herbicide. Previous USDA research had explored possible surfactants, not available in commercial
glyphosate formulations, that might enhance phytotoxicity against coca. Several candidates that enhanced

herbicide "efficacy" were selected by the GOC for further consideration.

In consultation with the G�C s Environmental Auditor to the spray program, USDA-ARS scientists
recommended that any product to be added to the herbicide tank mixture be acquired from a Colombian source,

if possible. This would ensure that it was a product already registered by the appropriate GOC regulatory

authority, the Colombian Farming and Livestock Institute (Instituto Colombiano Agropecuario, or ICA), and

almost certainly already used in Colombian agriculture. Cosmo-Flux 411F was selected as the additional
surfactant because it met the above requirements and most closely matched the most effective U.S. products

that had been tested by the USDA-ARS in Beltsville and Hawaii as additives to glyphosate for use against coca.

Cosmo-Flux 411F:

Cosmo-Flux 411F is manufactured in Colombia by a private company. Its use in Colombia is not limited to the

GOC � s eradication program - Cosmo-Flux 411F is often used as an additive to herbicide sprays for manual and

aerial application to crops. Cosmo-Flux 411F is approved for use with herbicides and is registered with the ICA
under ICA s lowest toxicological risk category, Category"lightly toxic." The Colombian Ministry of Health
� �
has also classified Cosmo-Flux 411F as "slightly toxic" (in opinion No. LP-0573/1993). The active components of

Cosmo-Flux 411F are polyol fatty acid esters and polyexothylated derivatives, which are seventeen percent of

the product. The remaining 83 percent is made up of inert liquid isoparaffins.

Cosmo-Flux 411F is produced, sold, and purchased for the GOC in Colombia but is not sold in the United

States. The EPA Office of Pesticide Programsdoes not regulate Cosmo-Flux 411F - or other adjuvant products

not labeled as pesticides.EPA, however, r egulates the use of such adjuvant chemicals if they are purposefully

362 formulated with and are a part of manufactured pesticide products for use in the U.S. - a common practice. INL

asked the EPA

411F to learn what EPA knew about the ingredients so that INL could better assess safety concerns related to

the use of this product in the spray program.EPA determined in September 2001 that all of the ingredients of
Cosmo-Flux 411F are exempt under 40 CFR 180.1001 from the requirement of tolerances when included in

pesticides applied to food, feeds, and livestock. That information reconfirmed the GOC s conclusion that

Cosmo-Flux 411F was appropriate for use against coca in Colombia. The Colombian manufacturer of Cosmo-

Flux 411F recommends its use in a dose ranging from 0.5 to 1.5 percent. The illicit crop eradication program s
use of a spray mixture that is 1 percent Cosmo-Flux 411F is thus within the manufacturer s recommendation.

Figure 3 illustrates the components of the final spray mixture by percentage. Water makes up approximately

three quarters of the mixture, a fact that substantially reduces the toxicity of the other ingredients. Glyphosate
salt (ispropylamine salt) is the second leading ingredient at 18% of the spray mix. Finally, the surfactants (those

within the commercial glyphosate formulation plus Cosmo-Flux 411F) make up approximately 8 percent of the
Surfactant:
mixture.

From the standpoint of coca control, properly selected surfactants make the glyphosate far more effective than if
the active ingredient were applied alone. Research by the United States Department of Ag�iculture s

Agricultural Research Service (USDA-ARS) has demonstrated that certain surfactants enhance glyphosate

penetration through the waxy cuticle on the coca leaf surface. Appropriate surfactants decrease the surface

tension of the adhering spray droplet (causing them to spread further on the leaf surface). Generally, this is good,
since the herbicide is less susceptible to runoff loss and greater surface coverage leads to more uptake of the

herbicide. The "right" surfactant may form a chemical shield around small clusters (micelles) of the herbicide and

enhance their penetration through the cuticle and into the leaf tissue.

In order to function, glyphosate must move from the site of application (the leaf surface) toward the actively

growing meristematic tissue - the new shoot tips and the new roots. Here, the herbicide glyphosate finally does

its job, blocking an enzyme that is essential for plant growth but absent from humans. Surfactants are a critical

component of the herbicide mixture, allowing the glyphosate to reach this actively growing tissue in the coca
plant. They may also stabilize the product droplets, reducing water evaporation, and thereby reducing spray drift.

The commercial glyphosate formulation used in the spray program contains 180g/l of surfactant as part of its

inert ingredients. As noted above, USDA-ARS research in the greenhouse and in the field (in Colombia, Panama, Spray mixing and handling:

and Hawaii) showed that commercial glyphosate formulations with surfactants performed better against coca
than other glyphosate without surfactants. Nevertheless, when coca ground-truth verification (see "Eradication The commercial glyphosate formulation, Cosmo-Flux 411F, and water are mixed at forward air bases by
mixers/loaders who are members of the Colombian National Police (CNP). The mixers/loaders are trained by the
Oversight" section below) was first done in October 1997, ratings showed mean control of coca within aircraft
CNP, the U.S. Embassy s spray advisor, and by designated spray pilots. They are trained on the relevant
spray swaths to be about 70%. This was considered unacceptably low, since the goal was to eliminate the illicit
precautions for handling the chemicals in the spray mixture, first aid, and use of personal protective equipment
crop and force the growers to abandon further coca production. To improve swath control, USDA-ARS scientists that applicators and other handlers of glyphosate in its concentrated formulation must wear. These include long-
recommended two options, not mutually exclusive. One was to increase the level of glyphosate formulation in the
sleeved shirts and long pants, waterproof gloves, shoes and so
spray mixture. The second was to add an additional surfactant to boost control without necessarily requiring a

higher dose of herbicide. Previous USDA research had explored possible surfactants, not available in commercial Storage and disposal of spray mixture:

glyphosate formulations, that might enhance phytotoxicity against coca. Several candidates that enhanced
herbicide "efficacy" were selected by the GOC for further consideration. Special care is taken in the management of the commercial glyphosate formulation, which is more concentrated
than the spray mixture. Appropriate measures are taken to ensure that glyphosate is not allowed to contaminate

In consultation with the G�C s Environmental Auditor to the spray program, USDA-ARS scientists water, foodstuffs, or natural areas through its storage or disposal. Storage is in manufacturer-approved plastic

recommended that any product to be added to the herbicide tank mixture be acquired from a Colombian source, barrels in covered areas with good ventilation, away from water sources. At the main spray bases, chemical
if possible. This would ensure that it was a product already registered by the appropriate GOC regulatory
storage is in a concrete storage shelter approximately 50 centimeters high with a 10-degree incline for the
authority, the Colombian Farming and Livestock Institute (Instituto Colombiano Agropecuario, or ICA), and collection of any residues. In addition, sawdust, sand, dirt, clay or other absorbent material is readily available for

almost certainly already used in Colombian agriculture. Cosmo-Flux 411F was selected as the additional immediate use in case of glyphosate spills. A drainagesystem, designed to prevent water contamination via run-

surfactant because it met the above requirements and most closely matched the most effective U.S. products off or leaching into the ground, collects water storage, mixing, and loading areas in trenches that carry it to a
that had been tested by the USDA-ARS in Beltsville and Hawaii as additives to glyphosate for use against coca.
stabilization pools, which are eventually discharged into a specially selected lot to facilitate natural degradation.

Cosmo-Flux 411F: Aircraft and spray equipment:

Cosmo-Flux 411F is manufactured in Colombia by a private company. Its use in Colombia is not limited to the Aviators currently spray coca with the single-engine T-65 "Thrush" aircraft built by the Ayers Corporation for

GOC � s eradication program - Cosmo-Flux 411F is often used as an additive to herbicide sprays for manual and agricultural spray operations and with the twin-engine OV-10D "Bronco" aircraft converted from a military
aerial application to crops. Cosmo-Flux 411F is approved for use with herbicides and is registered with the ICA
observation aircraft to an aerial spray aircraft. INL is currently taking delivery of a third type of spray aircraft, the
under ICA� s lowest toxicological risk category, Catego�y"lightly toxic." The Colombian Ministry of Health Air Tractor AT-802, which is a single-engine agricultural spray aircraft similar to the T-65.

has also classified Cosmo-Flux 411F as "slightly toxic" (in opinion No. LP-0573/1993). The active components of
The spray nozzles are standard, agricultural nozzles selected and adjusted to minimize the number of small
Cosmo-Flux 411F are polyol fatty acid esters and polyexothylated derivatives, which are seventeen percent of
the product. The remaining 83 percent is made up of inert liquid isoparaffins. droplets that can drift downwind from a sprayed coca field. These nozzles produce a volume mean diameter

(VMD) between 300-1,500 microns. This droplet size was reached after considerable INL and USDA testing and
Cosmo-Flux 411F is produced, sold, and purchased for the GOC in Colombia but is not sold in the United is consistent with the label instructions recommending coarse sprays that are less likely to drift. The aircraft

States. The EPA Office of Pesticide Programsdoes not regulate Cosmo-Flux 411F - or other adjuvant products spray systems are electronically calibrated to disperse a specified quantity of gallons of spray mix per hectare,

not labeled as pesticides.EPA, however, r egulates the use of such adjuvant chemicals if they are purposefully compensating for variances in ground speed. These are calibrated upon installation and are checked each dayAnnex 53-A

during the mechani� s daily inspection and the �ilot s preflight inspection. In addition, during actual spray

operations the pilot monitors the spraysystem by observing the readings of the spray pressureand the spray

flow rate gauges. Onboard computer and digital global positioningsystems (D/GPS)-driven equipment (SATLOC
and Del Norte) automatically record each aircraft s actual flight parameters, including differential-GPS track,

airspeed, altitude (mean sea level), application rate, and precise geographic location (longitude and latitude

coordinates) at the time of aspersion. This allows precise evaluation of each spray event in order to ensure that

spraying is conducted within proper target areas and within specified parameters. As part of the end-of-mission
check, the mission planner and pilots review the spray logs for any inconsistencies in the recorded spray data.

Spray pilots:

Eradication pilots must have approximately 3,000 total flight hours before they are considered for the spray

program and can receive preliminary training in illicit crop eradication. Most of these pilots also have at least
1,500 hours of commercial aerial application (crop dusting) experience. The INL Air Wing contractor trains the

spray pilots who are Colombians, third-country nationals, and U.S. citizens. Eradication training focuses

extensively on the visual identification of coca fields from the air as well as the technical aspects of crop
spraying.

Reconnaissance:

Detailed aerial reconnaissance of cultivation areas precedes all spray missions. Aerial reconnaissance is

performed using a multispectral digital imaging system (MDIS) thatdientifies crop type through the reflected
sunlight in the infrared portion of the electromagnetic spectrum. This airborne camera system is calibrated daily

and linked to global positioningsystems (GPS) equipment that enables fields to begeo-referenced and

accurately plotted onto aviation maps for mission planning purposes. As explained below, this equipment is for
mission planning and reconnaissance and is not in any way a substitute for positive visual identification of coca

fields by the spray pilot during the actual spray mission.

Most of Colombi� s coca crop is cultivated in the lowlands east of the Andes; here, the terrain is generally flat

or marked by gentle, rolling hills. The more agile T-65 is used for spraying in areas with steeper topography.
Coca is often grown in monocrop fields cut out of the triple canopy rainforest of the Amazon Basin. In this

context the precision of the pilots is crucial, as is the use of a herbicide mixture that allows for rapid restoration

of natural vegetation once the coca has been killed. The reemergence of native vegetation occurs very quickly

after glyphosate application, ensuring that soil erosion will be minimal.

Spray parameters:

Spraying is conducted in Colombia under rigid parameters laid out by t�e GOC s Environmental Auditor to the

spray program. Missions are cancelled if wind speed at the airport is greater than 10 m.p.h., if relative humidity
is below 75 percent, or if temperature is oveCelsius (90 Fahrenheit) - to avoid drift that might come from
� �
a temperature inversion. Spray missions are planned so as to avoid spraying wet coca; the goal is to have no

rain on the targeted fields from two hours before to four hours after the spraying. Spraying most often takes place

in the morning when weather conditions are favorable in the spraying area, although spraying can take place any
time of day when the above conditions are satisfied. Poor atmospheric conditions often are the cause of mission

cancellations. For example, in 1998 and 1999, spraying took place on an average of 125 days out of the year.

During the other 240 days, the spray planes were grounded, with the majority of cancellations due to bad
weather.

While flight lines are programmed using the reconnaissance procedures outlined above, pilots are instructed and

trained to activate their aircraft spraysystems only when they have poi entified coca directly in their

spray line. Spray planes are under continual risk from hostile ground fire, yet the pilots spray as low over the
coca fields as obstacles (e.g. trees) and security conditions will permit. The altitude above spray targets while

spraying is normally less than 100 feet. Under the conditions in which the aerial eradication program is carried

out in Colombia, spray pilots face great risks. Over the seven years of the aerial coca eradication program in

Colombia, three spray pilots have lost their lives by striking their aircraft against the ground or trees while trying
to spray as close to the illicit crop as possible.

The pilot of each eradication aircraft is responsible for deciding when damage to non-target foliage is likely to

occur and to take every measure to avoid such collateral damage and spray only within the boundaries of the
coca field. Pilots are licensed and trained to be conscious of wind direction and speed during spray operations to

avoid unintentional damage to any legal crops. According to Colombian law, food crops that are interspersed with

coca are subject to spraying. Nonetheless, great care is taken to avoid spray damage to legal crops and the

spraying of any area that does not contain coca. While every effort is made to minimize human and mechanical
mistakes, occasional errors are unavoidable. The GOC has implemented improved procedures to investigate

claims of spraying of legal crops and to compensate owners if damage is found to be credible.

364during the mechanic�s daily inspection and the pi�ot s preflight inspection. In addition, during actual spray

operations the pilot monitors the spraysystem by observing the readings of the spray pressureand the spray Spraying and human and environmental health:

flow rate gauges. Onboard computer and digital global positioningsystems (D/GPS)-driven equipment (SATLOC
Glyphosate is one of the most widely used agricultural herbicides in the world. It has been tested extensively in
and Del Norte) automatically record each air�raft s actual flight parameters, including differential-GPS track,
airspeed, altitude (mean sea level), application rate, and precise geographic location (longitude and latitude the United States, Colombia, and elsewhere.EPA approved glyphosate for general use in 1974 and re-registered
it in September 1993. In its latest comprehensive review of studies on glyphosate, theEPA concluded that
coordinates) at the time of aspersion. This allows precise evaluation of each spray event in order to ensure that
proper use of glyphosate, as permitted in the U.S., would not cause unreasonable adverse effects in humans or
spraying is conducted within proper target areas and within specified parameters. As part of the end-of-mission
the environment.
check, the mission planner and pilots review the spray logs for any inconsistencies in the recorded spray data.

Spray pilots: The product label advises that the concentrated formulation of the glyphosate product causes irreversible eye
damage, is harmful if swallowed or inhaled, and may cause skin irritation. These precautionary statements are

Eradication pilots must have approximately 3,000 total flight hours before they are considered for the spray determined according toEPA policy and are based on the results of testing on laboratory animals. INL does not

program and can receive preliminary training in illicit crop eradication. Most of these pilots also have at least believe that the spray program exposes humans who may be present in a sprayed field to such risks. This is
1,500 hours of commercial aerial application (crop dusting) experience. The INL Air Wing contractor trains the
because the irritation and toxicity potential of the individual ingredients are reduced when diluted during mixing
spray pilots who are Colombians, third-country nationals, and U.S. citizens. Eradication training focuses (the final product is approximately 75 percent water) and the mixture is dispersed when sprayed. Thus humans

extensively on the visual identification of coca fields from the air as well as the technical aspects of crop who may be present under the swath of the plane are not exposed to levels that approach the commercial

spraying. glyphosate formulation in its concentrated, undiluted form. The symptoms of such exposure are likely to be

Reconnaissance: short-term and reversible. Furthermore, any one individual field is unlikely to be sprayed more than one time in a
year, lowering the levels of repeated potential human exposure.

Detailed aerial reconnaissance of cultivation areas precedes all spray missions. Aerial reconnaissance is
To minimize human exposure to the spray mixture, pilots are instructed to avoid flights over towns and populated
performed using a multispectral digital imaging system (MDIS) thatdientifies crop type through the reflected
areas and, during spray missions, to avoid spraying near people, homes, or occupied buildings.
sunlight in the infrared portion of the electromagnetic spectrum. This airborne camera system is calibrated daily
and linked to global positioningsystems (GPS) equipment that enables fields to begeo-referenced and
Studies on livestock (cows, goats, and chickens) show livestock absorb limited amounts of glyphosate.
accurately plotted onto aviation maps for mission planning purposes. As explained below, this equipment is for Permitted levels of glyphosate in/on crops and livestock for human consumption are published in the Code of

mission planning and reconnaissance and is not in any way a substitute for positive visual identification of coca Federal Regulations, Title 40 (40 CFR), Section 180.364.EPA has concluded that consumption of crops treated

fields by the spray pilot during the actual spray mission. with glyphosate and livestock fed with forage treated with glyphosate in the U.S. does not pose a dietary concern

Most of Colombia�s coca crop is cultivated in the lowlands east of the Andes; here, the terrain is generally flat when residues are below these published tolerances. With respect to environmental impactE
based on required and available scientific studies, that glyphosate is not persistent in soil, does not build up after
or marked by gentle, rolling hills. The more agile T-65 is used for spraying in areas with steeper topography.
repeated use, and is biologically degraded over time by soil microbes. Because it binds tightly with the soil,
Coca is often grown in monocrop fields cut out of the triple canopy rainforest of the Amazon Basin. In this
glyphosate is unlikely to leach into underground drinking water. These qualities make glyphosate a well-suited
context the precision of the pilots is crucial, as is the use of a herbicide mixture that allows for rapid restoration herbicide for use against coca in Colombia.
of natural vegetation once the coca has been killed. The reemergence of native vegetation occurs very quickly

after glyphosate application, ensuring that soil erosion will be minimal. Studies have shown glyphosate itself to be "practically non-toxic" to fish, however some glyphosate end-

products may contain other ingredients that may increase the toxicity to fish when they are exposed. In
Spray parameters:
accordance with the instructions on the product label, pilots are instructed to avoid all bodies of water when
spraying coca.
Spraying is conducted in Colombia under rigid parameters laid out by the�GOC s Environmental Auditor to the
spray program. Missions are cancelled if wind speed at the airport is greater than 10 m.p.h., if relative humidity
Eradication oversight:
is below 75 percent, or if temperature is o�erCelsius (90� Fahrenheit) - to avoid drift that might come from

a temperature inversion. Spray missions are planned so as to avoid spraying wet coca; the goal is to have no Spray pilot oversight is carried out by several entities. Pilot performance is monitored by the GOC s
rain on the targeted fields from two hours before to four hours after the spraying. Spraying most often takes place
Environmental Auditor, the Colombian National Police (CNP), INL s Office of Aviation, the Narcotics Affairs
in the morning when weather conditions are favorable in the spraying area, although spraying can take place any Section (NAS) of the U.S. Embassy, Department of State contractor personnel, USDA weed scientists, and the

time of day when the above conditions are satisfied. Poor atmospheric conditions often are the cause of mission GOC �

cancellations. For example, in 1998 and 1999, spraying took place on an average of 125 days out of the year. personnel are continually on-site in the bases or airports from which the spray planes operate and in most cases
During the other 240 days, the spray planes were grounded, with the majority of cancellations due to bad
accompany the spray missions themselves. All of the above-mentioned offices actively participate in the ground
weather. truth verification of randomly selected, previously sprayed fields. These verifications usually take place twice a

year. During this process, one of the important elements is an assessment of potential overspray or non-target
While flight lines are programmed using the reconnaissance procedures outlined above, pilots are instructed and
drift, essential indicators of spray pilot (and herbicide) precision. These ground truth verification missions have
trained to activate their aircraft spraysystems only when they have posii entified coca directly in their
spray line. Spray planes are under continual risk from hostile ground fire, yet the pilots spray as low over the found very few instances of spray pilot error and have reported that pilot accuracy is excellent and overspray
minimal.
coca fields as obstacles (e.g. trees) and security conditions will permit. The altitude above spray targets while

spraying is normally less than 100 feet. Under the conditions in which the aerial eradication program is carried Unfortunately, human and mechanical error is possible and mistakes are made on occasion. In the past, many

out in Colombia, spray pilots face great risks. Over the seven years of the aerial coca eradication program in complaints of erroneous spraying of legal crops have proven groundless after subsequent investigation. However,
Colombia, three spray pilots have lost their lives by striking their aircraft against the ground or trees while trying
INL believes that the credibility of the spray program is enhanced by a speedy and fair review of all complaints
to spray as close to the illicit crop as possible. and by just compensation for any legal crops that were indeed sprayed in error. With support from the United

States, the GOC s process of investigating harm to legal crops has recently been improved to provide for faster
The pilot of each eradication aircraft is responsible for deciding when damage to non-target foliage is likely to
investigation and resolution of complaints.
occur and to take every measure to avoid such collateral damage and spray only within the boundaries of the
coca field. Pilots are licensed and trained to be conscious of wind direction and speed during spray operations to

avoid unintentional damage to any legal crops. According to Colombian law, food crops that are interspersed with

coca are subject to spraying. Nonetheless, great care is taken to avoid spray damage to legal crops and the Back to Top

spraying of any area that does not contain coca. While every effort is made to minimize human and mechanical
mistakes, occasional errors are unavoidable. The GOC has implemented improved procedures to investigate

claims of spraying of legal crops and to compensate owners if damage is found to be credible.Annex 53-A

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2002 Aerial Eradication of Illicit Coca in
Colombia» 3 EPA Response

Response from EPA Assistant Administrator Johnson to Secretary of

State, August 19, 2002 Subscribe to Updates

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES

The Honorable Colin L. Powell, Secretary

U.S. Department of State
Washington, D.C. 20520

Dear Secretary Powell:

We are enclosing our consultation review as per your request to Environmental Protection AgencyE(PA)
Administrator Christine Todd Whitman, for consultation on the potential human health and environmental effects

of the aerial coca eradication program in Colombia, pursuant to the Foreign Operations, Export Financing, and
Related Programs Appropriation Act (P.L 107-115). Administrator Whitman has asked me to respond on her

behalf because my office has primary oversight responsibility for pesticides, and the nature of this consultation

centers around the technical aspects of chemicals used in the aerial fumigation of coca.

The Foreign Operations, Export Financing, and Related Programs Appropriation Act specifically requires the

Department of State to consult with EPA on whether (1) "aerial coca fumigation is being carried out in

accordance with regulatory controls required by theEPA as labeled for use in the United States.... ; and (2)
whether the chemicals used in the aerial fumigation of coca, in the manner in which they are being applied, do

not pose unreasonable risks or adverse effects to humans or the environment..."

As part of our consultation review, we considered the full range of available scientific information from laboratory
and field testing and incident reports. Our consultation review evaluates the potential impact to human health and

the environment from the eradication program, based on information provided by Department of State, on the
pesticide used (glyphosate), inert ingredients, and the application rates and methods, In addition, Agency

scientists reviewed scientific studies on glyphosate, conducted a limited literature search for human health

incidents related to glyphosate use, and examined information on glyphosate use conditions in the United
States. We also considered information provided by non-governmental organizations, concerning effects

reportedly connected to coca eradication in Colombia.

Glyphosate is widely used in the United States. Based upon EPA reviews of domestic use cnditions,

glyphosate appears to be one of the most safely-used pesticides in the U.S. EPA's regulatory authority for

domestic pesticide use allows significant controls through pesticide labeling and compliance and enforcement
infrastructure implemented with the states and other federal agencies. Recognizing that these mechanisms are

not available to EPA in Colombia, the Agency has evaluated potential risks associated with the coca eradication

program and identified areas where Department of State should pay particular attention to minimize the potential
for adverse effects.

I trust that the attached document will assist you in preparing your response to Congress. Please let me know if

you have additional questions concerning this consultation review.

Sincerely,

Stephen L. Johnson

366 Annex 53-A

Assistant Administrator

U.S. Environmental Protection Agency Office of Pesticide Programs Details of the Consultation for
Department of State Use of Pesticide for Coca Eradication Program in Colombia, August 2002

Table of Contents

Executive Summary

1. Section 1.Description of Glyphosate Use in the U.S. For Comparison To Use in Colombia For Coca

Eradication

1. Use of Glyphosate in the United States Agricultural Use Sites

2. Non-Agricultural Uses Including Forestry
3. Properties of Glyphosate

4. Formulation of Glyphosate

5. Glyphosate Used With Surfactant For Foliar Absorption

2. Section 2.Human Health Risk Assessment For the Use of Glyphosate Herbicide As Part of the Aerial

Eradication Program of Coca in Colombia, S.A.

1. Hazard Identification

2. Dose Response Assessment
3. Exposure Assessment

3. Section 3.Review of Glyphosate Incident Reports With Special Reference To the Aerial Spraying Program

in Colombia

1. California Dat� 1982 Through 2000
2. Literature Review

3. A Study of Health Complaints Related To Aerial Eradication in Colombia

4. Conclusions

4. Section 4.Ecological Risk Assessment For the Use of Glyphosate Herbicide As Part of the U.S. Supported

Aerial Eradication Program of Coca in Colombia

1. Background

2. Ecological Risk Assessment
3. Potential Spray Drift of Glyphosate

4. Environmental Fate And Transport Assessment of Glyphosate

5. Risk Characterization

EXECUTIVE SUMMARY

CONSULTATION REVIEW OF THE USE OF PESTICIDE FOR COCA ERADICATION IN COLOMBIA

BACKGROUND

The Department of State currently assists the Government of Colombia with training, contractor support, financial

assistance, and technical and scientific advice for an aerial pesticide spraying program designed to eradicate

illicit crops (coca and poppy). In accordance with a provision in its 2002 Appropriations Bill, Department of State
has consulted with the U.S. Environmental Protection Agency (EPA) on two specificquestions: that fumigation

is "...being carried out in accordance with regulatory controls required by the Environmental Protection Agency

as labeled for use in the United States" and, that the chemicals being used "...in the manner they are being

applied, do not pose unreasonable ri ks or adverse effects to humans or the environment."

FINDINGS

EPA has reviewed information provided by Department of State concerning the pesticide formulation applied

(combination of the pesticide active ingredient, glyphosate, and inert ingredients), and application rates and
methods. According to the most recent figures (1999 sales and usage) glyphosate is the most widely used

conventional pesticide in the United States. The Agency evaluates all pesticides used in the U.S. to determine

whether they meet the U.S. safety standard of no unreasonable adverse effects. ConsequentlyE , PA has a

significant amount of information about glyphosate from a health and environmental standpoint because of our
reviews of use conditions in the U.S. In the U.S., the Agency can assure significant controls on use and

potential health and environmental impacts through the pesticide label, and through a state infrastructure which

governs label compliance to address issues such as drift and worker and bystander exposure.

367Annex 53-A

Based on a comparison of the glyphosate use pattern in Colombia, as described by the Department of State,
and use in the U.S., EPA determined that the most equivalent U.S. uses of glyphosate would be forestry or

rights-of-way. The glyphosate product which has been identified to us as used in Colombia is registered in both

the U.S. and Colombia, although it has never been marketed in the U.S. The Agency found application rates

described as used in Colombia to be within the parameters listed on U.S. labels. The addition of a spray adjuvant
(to facilitate the formulation adhering to and penetrating the coca plant) is also in keeping with U.S. practice.

While the specific spray adjuvant product identified as that used in Colombia is not sold in the U.S., similar

substances and products are commonly used. Most U.S. labels for forestry and right-of-way use of glyphosate

suggest application by helicopter. Since application in Colombia is done by fixed-wing aircraft, it is likely
conducted at a higher speed and from a greater altitude, than would be typical in the U.S. Department of State

has assured the Agency that mixers/loaders and applicators of the glyphosate formulation receive training

comparable to U.S. label requirements for glyphosate products including the use of personal protective

equipment such as gloves and goggles.

As for potential human health effects of the coca eradication program, there are no risks of concern for

glyphosate, per se, from dermal or inhalation routes of exposure, since toxicity is very low. There is concern for

acute eye toxicity due to an inert ingredient in the glyphosate formulated product used to treat coca. The

potential eye effects are related to an inert ingredient, not the glyphosate itself, and greatest potential for
exposure is expected for workers mixing and loading the concentrated glyphosate product. The components of

the spray adjuvant, Cosmoflux 411F, are substances with low oral and dermal toxicity that have been approved

for use in/on food by EPA and the Food and Drug Administration. There are no expected toxicological effects of

concern for acute (short-term) or chronic (long-term) dietary exposure through food and water from the coca
eradication program. Incident data from Colombia involving humans, livestock, mammals and birds, are based on

potential exposure to glyphosate from fumigation of poppy fields, which may differ from use of and exposure to

glyphosate from coca eradication, so conclusions should be made cautiously.

Relative to the potential environmental effects of the spraying program based on U.S. data, phytotoxicity to non-
target plants outside of the application zone would be expected, since glyphosate is a broad spectrum herbicide.

Given the application method described by Department of State, offsite exposure from spray drift is probable, as

it would be under similar uses in the U.S. This proposed use of glyphosate itself does not appear to pose a

significant direct risk to terrestrial or aquatic animals, although secondary adverse effects from the temporary
loss of habitat in the spray area could occur. EPA would not expect any risk to birdsand mammals, including

livestock, based on dietary exposure to the active ingredient glyphosate. Anticipated effects to animals are

based on an extrapolation of data related to North American species. Glyphosate does not have a high potential

to leach to ground water or reach surface water as dissolved runoff but does have potential to contaminate
surface water as a result of residues suspended in runoff water. A more refined assessment is difficult due to

uncertainty regarding the exact formulation of the spray solution.

As part of its consultation, EPA reviewed available scientific studiesand information on the human health and

environmental effects of glyphosate and the inert ingredients and on exposure pathways; conducted a literature

search for human health incidents related to glyphosate use in the U.S.; and summarized use patterns for
glyphosate in the U.S., including use sites, methods and rates of application, and differing formulations. In

addition, the Agency considered information, provided by non-governmental sources, concerning adverse effects

reportedly connected to the eradication program.

Details of the Agency�s findings are provided in the attached document.

SECTION 1. Description of Glyphosate Use in the U.S. for Comparison to Use in Colombia for Coca

Eradication

INTRODUCTION: The Biological and Economic Analysis Division( EAD) within the Office of Pesticide

Programs, Environmental Protection Agency, has been asked to describe the use of glyphosate within the
United States with a more detailed description of its use in forestry sites so that methods of use in the United

States may be used as a basis for comparison for coca eradication in Colombia (1).

SUMMARY: Glyphosate is the herbicide most widely used in the United States (2). In agriculture this popularity

is due, in large part, to the development of crops that are highly tolerant to broadcast applications of glyphosate

which allows growers to use this non-selective herbicide as their principal method of weed control in certain
crops. Growers have rapidly adopted glyphosate-based weed control programs with glyphosate tolerant crops

because they are simple and economical (3). In addition, due t� it s unique properties, glyphosate is also

widely used for non-agricultural weed control situations including home lawns and gardens, forestry and other

non-crop sites where total vegetation control is desired.

1
EPA �s(BEAD �s) biannual pesticide salesand usage report estimatesthat in 1999, glyphosate wasthe most used conventional

368Based on a comparison of the glyphosate use pattern in Colombia, as described by the Department of State,
and use in the U.S., EPA determined that the most equivalent U.S. uses of glyphosate would be forestry or

rights-of-way. The glyphosate product which has been identified to us as used in Colombia is registered in both

the U.S. and Colombia, although it has never been marketed in the U.S. The Agency found application rates

described as used in Colombia to be within the parameters listed on U.S. labels. The addition of a spray adjuvant

(to facilitate the formulation adhering to and penetrating the coca plant) is also in keeping with U.S. practice.
While the specific spray adjuvant product identified as that used in Colombia is not sold in the U.S., similar

substances and products are commonly used. Most U.S. labels for forestry and right-of-way use of glyphosate

suggest application by helicopter. Since application in Colombia is done by fixed-wing aircraft, it is likely

conducted at a higher speed and from a greater altitude, than would be typical in the U.S. Department of State
has assured the Agency that mixers/loaders and applicators of the glyphosate formulation receive training

comparable to U.S. label requirements for glyphosate products including the use of personal protective

equipment such as gloves and goggles.

As for potential human health effects of the coca eradication program, there are no risks of concern for
glyphosate, per se, from dermal or inhalation routes of exposure, since toxicity is very low. There is concern for

acute eye toxicity due to an inert ingredient in the glyphosate formulated product used to treat coca. The

potential eye effects are related to an inert ingredient, not the glyphosate itself, and greatest potential for

exposure is expected for workers mixing and loading the concentrated glyphosate product. The components of

the spray adjuvant, Cosmoflux 411F, are substances with low oral and dermal toxicity that have been approved
for use in/on food by EPA and the Food and Drug Administration. There are no expected toxicological effects of

concern for acute (short-term) or chronic (long-term) dietary exposure through food and water from the coca

eradication program. Incident data from Colombia involving humans, livestock, mammals and birds, are based on

potential exposure to glyphosate from fumigation of poppy fields, which may differ from use of and exposure to
glyphosate from coca eradication, so conclusions should be made cautiously.

Relative to the potential environmental effects of the spraying program based on U.S. data, phytotoxicity to non-

target plants outside of the application zone would be expected, since glyphosate is a broad spectrum herbicide.

Given the application method described by Department of State, offsite exposure from spray drift is probable, as
it would be under similar uses in the U.S. This proposed use of glyphosate itself does not appear to pose a

significant direct risk to terrestrial or aquatic animals, although secondary adverse effects from the temporary

loss of habitat in the spray area could occur. EPA would not expect any risk to birdsand mammals, including

livestock, based on dietary exposure to the active ingredient glyphosate. Anticipated effects to animals are

based on an extrapolation of data related to North American species. Glyphosate does not have a high potential
to leach to ground water or reach surface water as dissolved runoff but does have potential to contaminate

surface water as a result of residues suspended in runoff water. A more refined assessment is difficult due to

uncertainty regarding the exact formulation of the spray solution.

As part of its consultation, EPA reviewed available scientific studiesand information on the human health and
environmental effects of glyphosate and the inert ingredients and on exposure pathways; conducted a literature

search for human health incidents related to glyphosate use in the U.S.; and summarized use patterns for

glyphosate in the U.S., including use sites, methods and rates of application, and differing formulations. In

addition, the Agency considered information, provided by non-governmental sources, concerning adverse effects
reportedly connected to the eradication program.

Details of the Agenc� s findings are provided in the attached document.

SECTION 1. Description of Glyphosate Use in the U.S. for Comparison to Use in Colombia for Coca

Eradication

INTRODUCTION: The Biological and Economic Analysis Division ( EAD) within the Office of Pesticide
Programs, Environmental Protection Agency, has been asked to describe the use of glyphosate within the

United States with a more detailed description of its use in forestry sites so that methods of use in the United

States may be used as a basis for comparison for coca eradication in Colombia (1).

SUMMARY: Glyphosate is the herbicide most widely used in the United States (2). In agriculture this popularity

is due, in large part, to the development of crops that are highly tolerant to broadcast applications of glyphosate

which allows growers to use this non-selective herbicide as their principal method of weed control in certain
crops. Growers have rapidly adopted glyphosate-based weed control programs with glyphosate tolerant crops

because they are simple and economical (3). In addition, due t� it s unique properties, glyphosate is also

widely used for non-agricultural weed control situations including home lawns and gardens, forestry and other

non-crop sites where total vegetation control is desired.

1
EPA� s(BEAD� s) biannual pesticide salesand usage report estimatesthat in 1999, glyphosate wasthe most used conventionalAnnex 53-A

pounds of glyphosate were applied to soybeans alone (2) with over 60 percent of soybeans surveyed by

USDA � s National Agricultural Statistical Service treated with glyphosate (5).�Round-up , a glyphosate product

marketed for agricultural use is formulated with a surfactant during manufacture to facilitate foliar absorption. The

following table (Table Two) summarizes the use rates specified in label instructions for Roundup Original

product herbicide concentrate (12) which contains the isopropylamine salt of glyphosate for use in glyphosate-
tolerant soybeans.

Table Two. Allowed Rate of the Isopropylamine Salt of Glyphosate Per Application in Tolerant Soybeans

Maximum for Application Quarts of Pounds of Active Kilograms of Active

Timing Product/Acre Ingredient/Acre Ingredient/Hectare

For Entire Season 8 8 9

Before Crop Emergence 5 5 5.6

In Crop 3 3 3.4

Up to Two Weeks Prior to 1 1 1.1
Harvest

NON-AGRICULTURAL USES INCLUDING FORESTRY: BEAD has been asked to describe the use of

glyphosate in U.S. forestry sites since that use most closely corresponds to the use of glyphosate in Colombia

for coca control. For simplicity this document only refers to�Accord which is intended specifically for forestry

use (6). This product contains the isopropylamine salt of glyphosate (41.5%), and is labeled for non-agricultural
uses including Forestry Site Preparation and Utility Rights-of Way, Forestry Site Conifer and Hardwood Release,

and Wetland Sites in the U.S. Table Three describes the rates at which it may be used. It is recommended for

use in site preparation prior to planting any tree species, including Christmas tree and silvicultural nursery sites
(7). Specific methods of application for forestry uses include: aerial spraying; spraying from a truck, backpack or

hand-held sprayer; wipe application; frill treatment; cut stump treatment (7).

For forestry site preparation it may be applied using either ground or aerial equipment at rates from 2 to10

pounds glyphosate active ingredient per acre which is equivalent to 2.2-11.2 kilograms of active ingredient per
hectare (Table Three). It may also be applied using hand-held equipment. Product instructions specify that a

non-ionic surfactant be added to the spray mixture for all forestry uses at a rate of 0.5 to 1.5 percent by spray

volume (2 to 6 quarts of surfactant per 100 gallons of spray solution). It may also be combined with certain

residual herbicides to extend the period of weed control beyond that obtained with glyphosate alone.

The isopropylamine salt of glyphosate may also be used in forestry conifer and hardwood release as a directed

spray or by using selective equipment. This product may also be used in or around wetland sites generally at no

more than 5 quarts of product per acre (5 lbs isopropylamine salt of glyphosate per acre which is equal to 5.6
kg/ha) using over-water broadcast application (5).

Table Three. Rate of Isopropylamine Salt of Glyphosate Per Application For Certain Use Sites

Quarts of Pounds of Active Kilograms of Active

Use Site Product/Acre Ingredient/Acre Ingredient/Hectare

Forestry Site Preparation and 2-10 2-10 2.2-11.2

Utility Rights-of Way

Forestry Site Conifer and 2-10 2-10 2.2-11.2

Hardwood Release

Wetland Sites 2-5 2-5 2.2-5.6

PROPERTIES OF GLYPHOSATE: Glyphosate is a foliar-active herbicide; to exert herbicidal properties it must

enter the plant through foliage (or in some cases, the stem). Glyphosate applied to foliage is absorbed by leaves

370pounds of glyphosate were applied to soybeans alone (2) with over 60 percent of soybeans surveyed by

USDA � s National Agricultural Statistical Service treated with glyphosate (5).�Round-up , a glyphosate product

marketed for agricultural use is formulated with a surfactant during manufacture to facilitate foliar absorption. The

following table (Table Two) summarizes the use rates specified in label instructions for Roundup Original

product herbicide concentrate (12) which contains the isopropylamine salt of glyphosate for use in glyphosate-

tolerant soybeans.

Table Two. Allowed Rate of the Isopropylamine Salt of Glyphosate Per Application in Tolerant Soybeans

Maximum for Application Quarts of Pounds of Active Kilograms of Active

Timing Product/Acre Ingredient/Acre Ingredient/Hectare

For Entire Season 8 8 9

Before Crop Emergence 5 5 5.6

In Crop 3 3 3.4

Up to Two Weeks Prior to 1 1 1.1

Harvest

NON-AGRICULTURAL USES INCLUDING FORESTRY: BEAD has been asked to describe the use of

glyphosate in U.S. forestry sites since that use most closely corresponds to the use of glyphosate in Colombia
for coca control. For simplicity this document only refers to�Accord which is intended specifically for forestry

use (6). This product contains the isopropylamine salt of glyphosate (41.5%), and is labeled for non-agricultural

uses including Forestry Site Preparation and Utility Rights-of Way, Forestry Site Conifer and Hardwood Release,
and Wetland Sites in the U.S. Table Three describes the rates at which it may be used. It is recommended for

use in site preparation prior to planting any tree species, including Christmas tree and silvicultural nursery sites

(7). Specific methods of application for forestry uses include: aerial spraying; spraying from a truck, backpack or

hand-held sprayer; wipe application; frill treatment; cut stump treatment (7).

For forestry site preparation it may be applied using either ground or aerial equipment at rates from 2 to10

pounds glyphosate active ingredient per acre which is equivalent to 2.2-11.2 kilograms of active ingredient per

hectare (Table Three). It may also be applied using hand-held equipment. Product instructions specify that a

non-ionic surfactant be added to the spray mixture for all forestry uses at a rate of 0.5 to 1.5 percent by spray
volume (2 to 6 quarts of surfactant per 100 gallons of spray solution). It may also be combined with certain

residual herbicides to extend the period of weed control beyond that obtained with glyphosate alone.

The isopropylamine salt of glyphosate may also be used in forestry conifer and hardwood release as a directed

spray or by using selective equipment. This product may also be used in or around wetland sites generally at no
more than 5 quarts of product per acre (5 lbs isopropylamine salt of glyphosate per acre which is equal to 5.6

kg/ha) using over-water broadcast application (5).

Table Three. Rate of Isopropylamine Salt of Glyphosate Per Application For Certain Use Sites

Quarts of Pounds of Active Kilograms of Active

Use Site Product/Acre Ingredient/Acre Ingredient/Hectare

Forestry Site Preparation and 2-10 2-10 2.2-11.2

Utility Rights-of Way

Forestry Site Conifer and 2-10 2-10 2.2-11.2

Hardwood Release

Wetland Sites 2-5 2-5 2.2-5.6

PROPERTIES OF GLYPHOSATE: Glyphosate is a foliar-active herbicide; to exert herbicidal properties it must

enter the plant through foliage (or in some cases, the stem). Glyphosate applied to foliage is absorbed by leavesAnnex 53-A

(1) Description of Use of Glyphosate in Coca Eradication in Colombia in attachment to a letter from

Secretary of State Colin Powell to Environmental Protection Agency Administrator Governor Christine

Whitman.

(2) Donaldson, D., T. Kiely, and A. Grube. Pesticide Industry Sales and Usage, 1998 and 1999 Market
Estimates. June 2002. Biological and Economic Analysis Division, Office of Pesticide Programs, U.S.

Environmental Protection Agency.

(3) Gianessi, L.P., Silvers, C., Sankula, S., and Carpenter, J. Plant Biotechnology: Current and Potential

Impact for Improving Pest Management in U.S. Agriculture - An Analysis of 40 Case Studies. June 2002.
National Center for Food and Agricultural Policy.

(4) Glyphosate - Reregistration Eligibility Decision. United States Environmental Protection Agency.

September 1993.

(5) Agricultural Chemical Usage - 2000 Field Crops Summary. May 2001. United States Department of

Agriculture. National Agricultural Statistics Service.

(6) Accord� Herbicide Specimen Label. Available on-line from CDMS.

(7) Pesticide Fact Sheet. Prepared for the U.S. Department of Agriculture, Forest Service.

(8) D. Lantagne., M. Koelling, and D. Dickman. Effective Herbicide Use in Christmas Tree Plantations.

Michigan State University Extension.

(9) U.S. Environmental Protection Agency, Office of Pesticide Programs. Search of the Reference Files
System dated June 11, 2002.

(10)Miller, P., and P. Westra. Crop Series: Production. Colorado State University.

(11) EPA Proprietary Information

(12) Roundup Original Herbicide Supplemental Labeling for Postemergence Applications to Soybeans

with Roundup Ready � Gene. Available online from CDMS.

BEAD was asked to report on the use of glyphosate in forestry sites since it seemed similar to the use pattern

for coca eradication. However, it is not clear how closely this use approximates that for coca eradication.

Glyphosate is typically applied to forestry sites using helicopters at air speeds of 50-70 knots (about 60-80 miles

per hour). Application to forestry sites by fixed wing aircraft, if practiced at all, is extremely rare (1). The
recommended rate of application for pine release (conifer release) is 1.5 to 2 pounds active ingredient per acre.

Aerial application to other sites comprises less than one percent of the total amount of glyphosate applied in the

United States (3).

In addition to surfactants, drift control agents may be added to the spray mixture for forestry uses in an effort to

prevent drift to off target sites. BEAD has not investigated the prevalence of use or ivness of these

products.

BEAD estimates total gl obal use of glyphosate to be between 350 and 360 million pounds of glyphosate per
year. Annual use in the United States is approaches 100 million pounds of active ingredient and an estimated

250 to 260 million pounds of glyphosate is used outside of the United States. Use of glyphosate in Colombia

accounts for between four and five million pounds of this use. Primary sites in Colombia include coffee, bananas,
pasture-land and rice (3).

REFERENCES:

(1) Personal communication between Virginia Werling, United States Environmental Protection Agency

and John Taylor, United States Forest Service on August 9, 2002.

(2) Hamilton, R.A. "2002 North Carolina Agricultural Chemicals Manual - Chemical Weed Control In

Forest Stands" Extension Forest Resources Department, North Carolina State University. Available on-

line at http://ipm.ncsu.edu/agchem/chptr8/821.pdf

(3) United States Environmental Protection Agency Proprietary Data.

SECTION 2. Human Health Risk Assessment for the Use of Glyphosate Herbicide as Part of the Aerial

Eradication Program of Coca in Colombia, S.A.

I INTRODUCTION

372 (1) Description of Use of Glyphosate in Coca Eradication in Colombia in attachment to a letter from
Secretary of State Colin Powell to Environmental Protection Agency Administrator Governor Christine

Whitman.

(2) Donaldson, D., T. Kiely, and A. Grube. Pesticide Industry Sales and Usage, 1998 and 1999 Market
Estimates. June 2002. Biological and Economic Analysis Division, Office of Pesticide Programs, U.S.

Environmental Protection Agency.

(3) Gianessi, L.P., Silvers, C., Sankula, S., and Carpenter, J. Plant Biotechnology: Current and Potential

Impact for Improving Pest Management in U.S. Agriculture - An Analysis of 40 Case Studies. June 2002.
National Center for Food and Agricultural Policy.

(4) Glyphosate - Reregistration Eligibility Decision. United States Environmental Protection Agency.

September 1993.

(5) Agricultural Chemical Usage - 2000 Field Crops Summary. May 2001. United States Department of
Agriculture. National Agricultural Statistics Service.

(6) Accor� Herbicide Specimen Label. Available on-line from CDMS.

(7) Pesticide Fact Sheet. Prepared for the U.S. Department of Agriculture, Forest Service.

(8) D. Lantagne., M. Koelling, and D. Dickman. Effective Herbicide Use in Christmas Tree Plantations.
Michigan State University Extension.

(9) U.S. Environmental Protection Agency, Office of Pesticide Programs. Search of the Reference Files

System dated June 11, 2002.

(10)Miller, P., and P. Westra. Crop Series: Production. Colorado State University.

(11) EPA Proprietary Information

(12) Roundup Original HerbicideM Supplemental Labeling for Postemergence Applications to Soybeans

with Roundup Ready � Gene. Available online from CDMS.

BEAD was asked to report on the use of glyphosate in forestry sites since it seemed similar to the use pattern

for coca eradication. However, it is not clear how closely this use approximates that for coca eradication.
Glyphosate is typically applied to forestry sites using helicopters at air speeds of 50-70 knots (about 60-80 miles

per hour). Application to forestry sites by fixed wing aircraft, if practiced at all, is extremely rare (1). The

recommended rate of application for pine release (conifer release) is 1.5 to 2 pounds active ingredient per acre.

Aerial application to other sites comprises less than one percent of the total amount of glyphosate applied in the
United States (3).

In addition to surfactants, drift control agents may be added to the spray mixture for forestry uses in an effort to

prevent drift to off target sites. BEAD has not investigated the prevalence of use or thivness of these

products.

BEAD estimates total gl obal use of glyphosate to be between 350 and 360 million pounds of glyphosate per

year. Annual use in the United States is approaches 100 million pounds of active ingredient and an estimated

250 to 260 million pounds of glyphosate is used outside of the United States. Use of glyphosate in Colombia
accounts for between four and five million pounds of this use. Primary sites in Colombia include coffee, bananas,

pasture-land and rice (3).

REFERENCES:

(1) Personal communication between Virginia Werling, United States Environmental Protection Agency
and John Taylor, United States Forest Service on August 9, 2002.

(2) Hamilton, R.A. "2002 North Carolina Agricultural Chemicals Manual - Chemical Weed Control In

Forest Stands" Extension Forest Resources Department, North Carolina State University. Available on-

line at http://ipm.ncsu.edu/agchem/chptr8/821.pdf

(3) United States Environmental Protection Agency Proprietary Data.

SECTION 2. Human Health Risk Assessment for the Use of Glyphosate Herbicide as Part of the Aerial

Eradication Program of Coca in Colombia, S.A.

I INTRODUCTIONAnnex 53-A

Committee (HIARC) met on March 26, 1998 and, again, on November 20, 2001. The most recent report of the

HIARC for glyphosate has the complete assessment of the endpoints selected for dietary exposure and

residential/occupational exposure. No endpoints were selected for the acute Reference Dose (RfD) since no
hazard attributed to a single dose was identified from the oral toxicity studies, and there are no concerns for

developmental or reproductive toxicity. In addition, the HIARC did not identify endpoints of concern for dermal and

inhalation exposures for any exposure period (short term 1-30 days, intermediate term- 1 to 6 months, or long

term- 6 months to lifetime) since no hazard was identified due to the low toxicity of glyphosate. HIARC did
identify an incidental oral endpoint for short- and intermediate-term exposure. The chronic dietary RfD of 1.75

mg/kg/day was based on diarrhea, nasal discharge, and mortality in a rabbit developmental toxicity study.

Glyphosate was not mutagenic in a full battery of assays. Based on the lack of evidence for carcinogenicity in

two acceptable studies in mice and rats, glyphosate is classified as a "Group E" chemical (no evidence of
carcinogenicity to humans).

EXPOSURE

An exposure and risk assessment is required for an active ingredient if: (1) certain toxicological criteria are
triggered and (2) there is potential for exposure. Upon review and analysis of the hazard database in total, the

Agency � s HIARC did not identify a hazard of concern for acute dietary, dermal, or inhalation exposures.

Therefore, quantitative estimates of risk for these exposure durations have not been conducted (TXR No.

0050428, W. Dykstra, 22-JAN-2002).

Acute dietary exposure is possible for persons consuming livestock or food crops which have been

inadvertently sprayed as a result of the aerial eradication program in Colombia. However, since glyphosate is a

contact herbicide that systemically kills plants after absorption thorugh leaves, dietary exposure due to
consumption of treated crops is expected to be limited. In addition, since an acute dietary endpoint was not

identified in the hazard database, no significant risk due to acute dietary food exposure to glyphosate residues is

expected. Based on the fact that a coca field is sprayed no more than twice to eradicate the crop, no chronic

food exposure is expected.

Handler (e.g., individuals mixing the concentrated formulated product to prepare the tank mix and

loading the tank mix in the aircraft) exposure is anticipated for short-term (1-30 days) and, possibly

intermediate-term (1-6 months) durations based on the frequency of application and duration of the spray

program.

Based on the use pattern described by the DoS, short-term dermal post-application exposures are expected

for persons pruning, or leaf pulling treated coca plants immediately after spray events. In cases such as

glyphosate, where the vapor pressure is negligible, OPP experience with post-application data suggests that
inhalation exposure is minimal and OPP does not quantitatively assess post-application inhalation exposure.

Intermediate- and long-term post-application exposures are not expected due in part to the fact that a coca field

is sprayed twice to eradicate the crop. Additionally, glyphosate is a translocated herbicide which is rainfast

within 48 hours after spraying. Therefore, potential exposure to dislodgeable residues of glyphosate after 48
hours is expected to be minimal.

DoS states that pilots are instructed not to spray fields where people are present. Therefore, incidental oral

exposure (hand-to-mouth) resulting from individuals being directly sprayed by glyphosate was not assessed.
Non-dietary incidental oral exposure was not quantitatively assessed for the use of glyphosate in Colombia.

There is potential for exposure to bystanders in areas near those targeted for spraying. However, the technology

and other safeguards described by DoS as being used in this program are consistent with common approaches

in the United States for reducinspray drift. Therefore, it is likely that drift is minimized in this program if all
procedures are adhered to and operational equipment is in working order.

From the review of Colombian glyphosate product human incident reports for poppy eradication, it should be

emphasized that the overwhelming majority (95%) of the illnesses reported are likely background incidents

unrelated to the spraying of herbicide to poppy. The remaining 5% increase could be due to a variety of causes
and do not support a conclusion that the spraying of the glyphosate tank mixture was responsible for these

complaints. Furthermore, the individual with the highest potential for exposure would be the mixer loader. They

are handling the concentrated glyphosate product and the tank mix. The incidence data that has been submitted
to the Agency by DoS, does not include any incident reports for those individuals. There are data to suggest that

the poppy spray eradication program could have resulted in minor skin, eye, or respiratory irritation, and perhaps

headache or other minor symptoms. However, the detailed information on timing of application, history of

exposure, and medical documentation of symptoms related to exposure to glyphosate tank mix were not
available. Given the limited amount of documentation, none of the data in the report from Colombia provide a

compelling case that the spraying of the glyphosate mixture has been a significant cause of illness in the region

374Committee (HIARC) met on March 26, 1998 and, again, on November 20, 2001. The most recent report of the studied. Prospective tracking of reports of health complaints, documenting times of exposure and onset of

HIARC for glyphosate has the complete assessment of the endpoints selected for dietary exposure and symptoms, are recommended during future spray operations to evaluate any potential health effects and

residential/occupational exposure. No endpoints were selected for the acute Reference Dose (RfD) since no ameliorate or prevent their occurrence.

hazard attributed to a single dose was identified from the oral toxicity studies, and there are no concerns for
developmental or reproductive toxicity. In addition, the HIARC did not identify endpoints of concern for dermal and A direct comparison of the epidemiological data in Colombia (which is from aerial application to poppy) to the
conditions of use, (as presented at the April 18, 2002 briefing for aerial application to coca by DoS to OPP risk
inhalation exposures for any exposure period (short term 1-30 days, intermediate term- 1 to 6 months, or long
assessors), would be limited. The briefing and the materials provided did not address the conditions of use for
term- 6 months to lifetime) since no hazard was identified due to the low toxicity of glyphosate. HIARC did
poppy. Nor was the Agency provided any human incident data for the coca eradication program. Subsequent to
identify an incidental oral endpoint for short- and intermediate-term exposure. The chronic dietary RfD of 1.75
mg/kg/day was based on diarrhea, nasal discharge, and mortality in a rabbit developmental toxicity study. the April 18 briefing HED received an e-mail communication from OPP/Field and External Affairs Division, stating
that DoS informed EPA that theapplication rate for poppy was lower than that for coca. According to the DoS,
Glyphosate was not mutagenic in a full battery of assays. Based on the lack of evidence for carcinogenicity in
the use pattern of the glyphosate mixture on poppy differs from the use on coca. Other details of the differences
two acceptable studies in mice and rats, glyphosate is classified as a "Group E" chemical (no evidence of
carcinogenicity to humans). between the two spray programs have not been supplied to the Agency. Specifically, the Agency has no
information as to the exact makeup of the tank mixture sprayed on poppy, or whether the same glyphosate

EXPOSURE product and adjuvants used in the coca eradication program were used in the poppy eradication program. The

Agency also has questions as to the geographical area differences, the frequency of repeated applications, and
An exposure and risk assessment is required for an active ingredient if: (1) certain toxicological criteria are
the size of the area treated on each spray mission. Therefore, generalized conclusions drawn from human
triggered and (2) there is potential for exposure. Upon review and analysis of the hazard database in total, the incident data as a result of application to opium poppy, in comparison to conditions of use for the coca
Agency s HIARC did not identify a hazard of concern for acute dietary, dermal, or inhalation exposures.
� eradication program should be made with caution.
Therefore, quantitative estimates of risk for these exposure durations have not been conducted (TXR No.

0050428, W. Dykstra, 22-JAN-2002). The glyphosate formulated productused in the coca eradication program in Colombia contains the active

ingredient glyphosate, a surfactant blend, and water. The acute toxicity test of theglyphosate technicalis
Acute dietary exposure is possible for persons consuming livestock or food crops which have been classified as toxicity category III for primary eye irritation and toxicity category IV for acute dermal and oral
inadvertently sprayed as a result of the aerial eradication program in Colombia. However, since glyphosate is a
toxicity, and skin irritation. It is not a dermal sensitizer. However, the surfactant used in theformulatedproduct
contact herbicide that systemically kills plants after absorption thorugh leaves, dietary exposure due to
reportedly can cause severe skin irritation and be corrosive to the eyes, as would be expected for many
consumption of treated crops is expected to be limited. In addition, since an acute dietary endpoint was not
surfactants. The label for theformulatedproduct used in the coca eradication program in Colombia includes the
identified in the hazard database, no significant risk due to acute dietary food exposure to glyphosate residues is "Danger" signal word. These findings suggest that any of the reports of toxicity to the eye may be due to the
expected. Based on the fact that a coca field is sprayed no more than twice to eradicate the crop, no chronic
surfactant, not glyphosate per se. The product has been determined to be toxicity category I for eye irritation,
food exposure is expected.
causing irreversible eye damage.

Handler (e.g., individuals mixing the concentrated formulated product to prepare the tank mix and
There may be a correlation between the ocular toxicity caused by the surfactant and reported incidents of ocular
loading the tank mix in the aircraft) exposure is anticipated for short-term (1-30 days) and, possibly effects. This is supported by data obtained from the California Pesticide Illness Surveillance Program (1982-
intermediate-term (1-6 months) durations based on the frequency of application and duration of the spray
2000). In 1992 the glyphosate product was reformulated in the US to reduce the amount of surfactant which
program.
posed a hazard to the eye. From 1982 through 1991, there were 221 illnesses involving the eye or 22.1 cases

Based on the use pattern described by the DoS, short-term dermal post-application exposures are expected per year. From 1994 (allowing 2 years for the product to be introduced into trade and widespread use) through
2000, there were 65 illnesses involving the eye or 9.3 cases per year, a decline of 58%. Therefore, these data
for persons pruning, or leaf pulling treated coca plants immediately after spray events. In cases such as
glyphosate, where the vapor pressure is negligible, OPP experience with post-application data suggests that support the finding that use of the reformulated glyphosate product since 1992, has resulted in a significant drop

inhalation exposure is minimal and OPP does not quantitatively assess post-application inhalation exposure. in illnesses. Overall, the total illnesses due to glyphosate declined by 39% from the 1982-1991 time period to the
1994-2000 time period, largely due to reduction in eye injuries.
Intermediate- and long-term post-application exposures are not expected due in part to the fact that a coca field
is sprayed twice to eradicate the crop. Additionally, glyphosate is a translocated herbicide which is rainfast
The greatest potential for
within 48 hours after spraying. Therefore, potential exposure to dislodgeable residues of glyphosate after 48
glyphosate product. There is also the potential for eye exposure as a result of entering treated fields after
hours is expected to be minimal.
treatment to perform pruning or harvesting activities.

DoS states that pilots are instructed not to spray fields where people are present. Therefore, incidental oral During an April 18 briefing, the Department of State agreed to supply the Agency with a full battery of the six
exposure (hand-to-mouth) resulting from individuals being directly sprayed by glyphosate was not assessed.
acute toxicity tests on the tank mix. To date this information has not been received. Until such information is
Non-dietary incidental oral exposure was not quantitatively assessed for the use of glyphosate in Colombia.
supplied to the Agency,EPA cannot evaluate the potential ocular or dermal toxicity resulting from direct contact

There is potential for exposure to bystanders in areas near those targeted for spraying. However, the technology with the tank mixture. Therefore, due to the acute eye irritation caused by the concentrated glyphosate
formulated product and the lack of acute toxicity data on the tank mixture, the Agency recommends that DoS
and other safeguards described by DoS as being used in this program are consistent with common approaches
in the United States for reducingspray drift. Therefore, it is likely that drift is minimized in this program if all consider using an alternative glyphosate product (with lower potential for acute toxicity) in future coca and/or

procedures are adhered to and operational equipment is in working order. poppy aerial eradication programs.

From the review of Colombian glyphosate product human incident reports for poppy eradication, it should be IIIBACKGROUND

emphasized that the overwhelming majority (95%) of the illnesses reported are likely background incidents EPA regulates pesticidesunder two statutes, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
unrelated to the spraying of herbicide to poppy. The remaining 5% increase could be due to a variety of causes
and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA provides the authority to register and review
and do not support a conclusion that the spraying of the glyphosate tank mixture was responsible for these
pesticides as well as the authority to suspend and cancel if use poses unreasonable risks. FFDCA provides
complaints. Furthermore, the individual with the highest potential for exposure would be the mixer loader. They
authority to set maximum residue levels (tolerances) for pesticides used in or on foods or animal feeds.
are handling the concentrated glyphosate product and the tank mix. The incidence data that has been submitted
to the Agency by DoS, does not include any incident reports for those individuals. There are data to suggest that Section 3 of FIFRA provides authority to register (license for sale and distribution) pesticide products. The label

the poppy spray eradication program could have resulted in minor skin, eye, or respiratory irritation, and perhaps of the pesticide product specifies the use (pest and crop/site), amount of product to be applied, frequency, timing

headache or other minor symptoms. However, the detailed information on timing of application, history of of use, restrictions, storage and disposal practices and precautionary statements. The active ingredient in a

exposure, and medical documentation of symptoms related to exposure to glyphosate tank mix were not pesticide product is the "ingredient which will prevent, destroy, repel, or mitigate any pest." The inert or other
available. Given the limited amount of documentation, none of the data in the report from Colombia provide a ingredient(s) in a pesticide product is "an ingredient which is not active." The registrant must provide data for the

compelling case that the spraying of the glyphosate mixture has been a significant cause of illness in the region Agency to assess potential environmental and human health risks. The data required to make a safety findingAnnex 53-A

are dependent on the intended use, e.g., food use vs non-food use. The data requirements for pesticides may be

found in 40 CFR Part 158. For human health risk assessment, data is required to permit characterization of

hazard and exposure.

Data requirements on the chemical identity and composition of the formulated pesticide product, may be found in

40 CFR 158.150. The list of ingredients for a pesticide product and the percent of each ingredient in the

formulation are contained in the confidential statement of formula (CSF). The CSF is FIFRA confidential business

information (CBI) and is entitled to treatment as trade secret or proprietary information. Agency risk
assessments do not typically contain this information.In finalizing the current document, FEAD and HED

consulted with OPP � s Information Resources and Services Division/Public Information and Records

Integrity Branch regarding CBI. It was determined that the document did contain some CBI and

therefore, some sectionshave been adapted .

Residue chemistry data required as per 40 CFR 158.240 support the ability of the Agency to estimate the

amount of pesticide that will result in food as a result of application of the pesticide according to the product

labels directions for use. The magnitude of the residue studies for crop field trials use the typical end use product
as the test material. The livestock feeding studies are required whenever a pesticide residue will be present in

livestock feed. The livestock feeding studies evaluate the magnitude of the resulting pesticide residue in meat,

milk, poultry, and eggs. The studies are conducted with the technical grade of the active ingredient or the plant

metabolites Residue chemistry data are also required to identify any potential metabolites of concern. These
data are used to determine the tolerances for the parent and or metabolites. Additional data is required on

environmental fate, degradation, metabolism, and dissipation.

Hazard data required for human health risk assessment are provided in 40 CFR 158.340. The use of the active
ingredient (i.e., food use or non-food use) will determine what studies are required. The acute toxicity data on the

technical grade of the active ingredient are used for classification and precautionary labeling for protective

clothing requirements, and worker reentry intervals. The only studies that are required to be conducted on the

manufacturing use product or end use product are the acute toxicity studies. The remaining toxicology studies
(e.g., developmental toxicity, reproduction, subchronic, chronic feeding, or carcinogenicity studies) require that

the test substance is the technical grade of the active ingredient. Subchronic toxicity studies provide data on

potential target organ toxicity and are also used to select dose levels for long term or chronic toxicity studies.

Chronic toxicity or carcinogenicity studies are conducted for food use chemicals to determine potential effects
following prolonged or repeated exposure that may have a latency period for expression. The test animals are

exposed orally for a significant portion of their life span. Developmental toxicity studies are required in two

species (usually the rat and rabbit) for food use chemicals. They are conducted to detect alterations in the
normal development of fetuses followingin utero exposure. The 2-generation rat reproductive toxicity study is

required to assess potential alterations in gonadal function, estrus cycles, mating, conception, birth, lactation,

weaning, as well as growth and development of offspring. The Agency also requires a battery of mutagenicity

studies to assess the potential induction of changes in the genetic material of cells. The above studies are
required for food use active ingredients. In general, less data is required for non-food use active ingredients and

inerts unless a concern has triggered additional testing.

The Agency conducts separate risk assessments for all pesticide active ingredients and has conducted risk

assessments for some inerts. The remaining inerts are cleared by the Agency. It should be understood that
whenever the inert ingredient was cleared, whenever the tolerance exemption was established, the inert met the

standards of the time. Inert ingredients, also known as "other ingredients," are the carrier for the active

ingredients which allow the product to deliver the active ingredient at a specific rate and ensure proper
distribution during application. Currently there are over 3200 inert ingredients cleared byEPA for use in various

domestic pesticides products. There are two major classifications: non-food use (such as lawn care products

and bathroom cleaners), and food-use, which require an exemption from the requirement of a tolerance and can

also be used in non-food products.

The Agency has a newly developed methodology for evaluating low or low/moderate toxicity chemical

substances by way of a screening process that incorporates elements of a tiered approach (US EPA, May

2002). Use of this process will permit the Agency to clear more chemicals of low to moderate toxicity for use in
pesticide products. The Agency is aware that some chemicals may be used as inert ingredients in some

formulations and as active ingredients in other formulations.EPA believes this methodology is appropriate for

evaluating some low toxicity chemicals regardless of whether they are categorized as active or inert ingredients.

The new process will permit the Agency to be able to conduct more in-depth evaluations of other ingredients that
are of potentially higher toxicity. Chemicals of higher toxicity that can not be appropriately addressed in the

lower tiers would be evaluated in a manner substantially similar to that of an active ingredient. Later as the

Agency begins to review chemical-specific or surrogate information in the open literature, the preliminary tier

determination may be revised (US EPA, May2002).

376are dependent on the intended use, e.g., food use vs non-food use. The data requirements for pesticides may be

found in 40 CFR Part 158. For human health risk assessment, data is required to permit characterization of

hazard and exposure.

Data requirements on the chemical identity and composition of the formulated pesticide product, may be found in
40 CFR 158.150. The list of ingredients for a pesticide product and the percent of each ingredient in the

formulation are contained in the confidential statement of formula (CSF). The CSF is FIFRA confidential business

information (CBI) and is entitled to treatment as trade secret or proprietary information. Agency risk

assessments do not typically contain this information.In finalizing the current document, FEAD and HED
consulted with OPP � s Information Resources and Services Division/Public Information and Records

Integrity Branch regarding CBI. It was determined that the document did contain some CBI and

therefore, some sectionshave been adapted .

Residue chemistry data required as per 40 CFR 158.240 support the ability of the Agency to estimate the

amount of pesticide that will result in food as a result of application of the pesticide according to the product

labels directions for use. The magnitude of the residue studies for crop field trials use the typical end use product

as the test material. The livestock feeding studies are required whenever a pesticide residue will be present in
livestock feed. The livestock feeding studies evaluate the magnitude of the resulting pesticide residue in meat,

milk, poultry, and eggs. The studies are conducted with the technical grade of the active ingredient or the plant

metabolites Residue chemistry data are also required to identify any potential metabolites of concern. These

data are used to determine the tolerances for the parent and or metabolites. Additional data is required on
environmental fate, degradation, metabolism, and dissipation.

Hazard data required for human health risk assessment are provided in 40 CFR 158.340. The use of the active

ingredient (i.e., food use or non-food use) will determine what studies are required. The acute toxicity data on the

technical grade of the active ingredient are used for classification and precautionary labeling for protective
clothing requirements, and worker reentry intervals. The only studies that are required to be conducted on the

manufacturing use product or end use product are the acute toxicity studies. The remaining toxicology studies

(e.g., developmental toxicity, reproduction, subchronic, chronic feeding, or carcinogenicity studies) require that

the test substance is the technical grade of the active ingredient. Subchronic toxicity studies provide data on
potential target organ toxicity and are also used to select dose levels for long term or chronic toxicity studies.

Chronic toxicity or carcinogenicity studies are conducted for food use chemicals to determine potential effects

following prolonged or repeated exposure that may have a latency period for expression. The test animals are

exposed orally for a significant portion of their life span. Developmental toxicity studies are required in two
species (usually the rat and rabbit) for food use chemicals. They are conducted to detect alterations in the

normal development of fetuses followingin utero exposure. The 2-generation rat reproductive toxicity study is

required to assess potential alterations in gonadal function, estrus cycles, mating, conception, birth, lactation,
weaning, as well as growth and development of offspring. The Agency also requires a battery of mutagenicity

studies to assess the potential induction of changes in the genetic material of cells. The above studies are

required for food use active ingredients. In general, less data is required for non-food use active ingredients and

inerts unless a concern has triggered additional testing.

The Agency conducts separate risk assessments for all pesticide active ingredients and has conducted risk

assessments for some inerts. The remaining inerts are cleared by the Agency. It should be understood that

whenever the inert ingredient was cleared, whenever the tolerance exemption was established, the inert met the

standards of the time. Inert ingredients, also known as "other ingredients," are the carrier for the active
ingredients which allow the product to deliver the active ingredient at a specific rate and ensure proper

distribution during application. Currently there are over 3200 inert ingredients cleared byEPA for use in various

domestic pesticides products. There are two major classifications: non-food use (such as lawn care products

and bathroom cleaners), and food-use, which require an exemption from the requirement of a tolerance and can
also be used in non-food products.

The Agency has a newly developed methodology for evaluating low or low/moderate toxicity chemical

substances by way of a screening process that incorporates elements of a tiered approach (US EPA, May

2002). Use of this process will permit the Agency to clear more chemicals of low to moderate toxicity for use in
pesticide products. The Agency is aware that some chemicals may be used as inert ingredients in some

formulations and as active ingredients in other formulations.EPA believes this methodology is appropriate for

evaluating some low toxicity chemicals regardless of whether they are categorized as active or inert ingredients.

The new process will permit the Agency to be able to conduct more in-depth evaluations of other ingredients that
are of potentially higher toxicity. Chemicals of higher toxicity that can not be appropriately addressed in the

lower tiers would be evaluated in a manner substantially similar to that of an active ingredient. Later as the

Agency begins to review chemical-specific or surrogate information in the open literature, the preliminary tier
determination may be revised (US EPA, May2002).Annex 53-A

resulted in evidence of appreciable parental toxicity. Glyphosate was not mutagenic in a full battery of assays.

Based on the lack of evidence for carcinogenicity in two acceptable studies in mice and rats, glyphosate is

classified as a "Group E" chemical (no evidence of carcinogenicity to humans).

Componentsof the Glyphosate Product

1. Polyoxyethylene alkylamine (POEA) . POEA is a compound that is used as a surfactant with many

glyphosate formulations. In a safety evaluation and risk assessment of glyphosate, the Roundup formulation and

the surfactant POEA, Williams et al.(2000) reported that POEA can cause severe skin irritation and be corrosive
to the eyes. In subchronic oral studies, POEA was mainly a gastrointestinal irritant in rats at high doses (~ 100

mg/kg/day) and in dogs at lower doses (30 mg/kg/day). In a developmental toxicity study in rats, POEA did not

cause any developmental effects up to 300 mg/kg/day, but did induce maternal toxicity at 100 and 300

mg/kg/day (Farmeret al., 2000). The concentrated formulated Roundup product can also be strongly irritating to
the eyes and slightly irritating to the skin (Williamset al., 2000).

2. (information not included as it may be entitled to confidential treatment) are substances that are not

highly toxic by oral or dermal routes and are not irritating to the skin. They may cause mild, transient eye
irritation. Many (information not included as it may be entitled to confidential treatmenta)re known not to be

sensitizers (study citation not included as it may be entitled to confidential treatment.)The molecular weight of a

(information not included as it may be entitled to confidential treatment)determines its biological properties, and,

thus, its toxicity. The lower molecular weight(information not included as it may be entitled to confidential
treatment)tend to be more toxic than the higher-weighted(information not included as it may be entitled to

confidential treatment)and are absorbed by the digestive tract and excreted in the urine and feces, while the

higher molecular weight(information not included as it may be entitled to confidential treatment)are absorbed
more slowly or not at all (study citation not included as it may be entitled to confidential treatment.)(information

not included as it may be entitled to confidential treatment)have low acute and chronic toxicity in animal

studies. No significant adverse effects have been noted in inhalation toxicology studies, carcinogen testing, or

mutagen assays. High oral doses have resulted in toxic effects to the kidneys and loose feces(study citation not
included as it may be entitled to confidential treatment.)Topical dermal application of(information not included

as it may be entitled to confidential treatment)to burn patients with injured skin has resulted in toxicity(study

citation not included as it may be entitled to confidential treatment.)

Cosmo - Flux 411F Adjuvant)

The Cosmo-Flux 411F adjuvant product used in the glyphosate tank mix is produced by a Colombian company

and is not sold in the U.S. The Agency is not in possession of toxicity data from direct dosing of test animals

with Cosmo-Flux 411F. However, the Agency has made a hazard assessment based on the toxicity of the
individual components. As stated above, sale or use of spray adjuvant products in the U.S. are generally not

regulated by EPA. However, the DoS has provd i ed the EPA with a copy of this product� s label and a

description of the product ingredients. To be able to provide an opinion on hazard characterization of the Cosmo-

flux ingredients, the EPA relied on available technical information from various sources. Cosmo-Flux 411F
consists mainly of (information not included as it may be entitled to confidential treatme) ith a nonionic

surfactant blend primarily composed of(information not included as it may be entitled to confidential treatment.)

All ingredients of this product are substances that are not highly toxic by oral or dermal routes. They may cause

mild eye and skin irritation. All components of the adjuvant have been approved for use in/on food byEPA (40
CFR 180.1001, Letter from R.Forrest/EPA, to R.Woolfolk/DoS, 7/30/2001).

Componentsof Cosmflux

1. (information not included as it may be entitled to confidential treatment). The (information not included as it
may be entitled to confidential treatment)can cause dermal and ocular irritation and, in high doses orally, can

cause significant toxicity. However, small amounts are not a concern and these substances have been approved

as food additives by the FDA and are exempt from tolerances byEPA on certain commodities.

2. (information not included as it may be entitled to confidential treatment). The other major component of
Cosmo-Flux 411F,(information not included as it may be entitled to confidential treatment,)is not considered

highly toxic. It may cause mild eye and skin irritation. The correspondinginformation not included as it may be

entitled to confidential treatment,) has low subacute, subchronic and chronic oral toxicity and is used as a direct
food additive and a component in cosmetics. The higher molecular weight(information not included as it may be

entitled to confidential treatment)is less likely to be absorbed orally or dermally and most likely of less

toxicological concern. The other minor components, are not known to be highly toxic compounds and would not

be of toxicological concern at the concentrations and conditions in which they are used.

VI DOSE RESPONSE ASSESSMENT

378resulted in evidence of appreciable parental toxicity. Glyphosate was not mutagenic in a full battery of assays.
Dose response analysis is the second step in the risk assessment process i.e.; characterization of the
Based on the lack of evidence for carcinogenicity in two acceptable studies in mice and rats, glyphosate is quantitative relationship between exposure (dose) and response based on studies in which adverse health effects

classified as a "Group E" chemical (no evidence of carcinogenicity to humans). have been observed. The objective is to identify endpoints of concern which correspond to the route and duration

of exposure based on the exposure patterns.
Componentsof the Glyphosate Product
HED selects doses and endpoints (effects of concern) for risk assessment via an internal peer review process.
1. Polyoxyethylene alkylamine (POEA) . POEA is a compound that is used as a surfactant with many
HED uses a standing Committee - the Hazard Identification Assessment Review Committee (HIARC), to
glyphosate formulations. In a safety evaluation and risk assessment of glyphosate, the Roundup formulation and
consider the available hazard data (studies required to be submitted by registrants in 40 CFR part 158 and open
the surfactant POEA, Williams et al.(2000) reported that POEA can cause severe skin irritation and be corrosive
peer reviewed literature) to identify endpoints for use in risk assessment.
to the eyes. In subchronic oral studies, POEA was mainly a gastrointestinal irritant in rats at high doses (~ 100
mg/kg/day) and in dogs at lower doses (30 mg/kg/day). In a developmental toxicity study in rats, POEA did not Ideally, each safety study identifies a dose level that does not produce a biologically or statistically significant

cause any developmental effects up to 300 mg/kg/day, but did induce maternal toxicity at 100 and 300 increased incidence of an adverse effect or no observable adverse effect level (NOAEL). The threshold dose is the

mg/kg/day (Farmeret al., 2000). The concentrated formulated Roundup product can also be strongly irritating to smallest dose required to produce a detectable effect. Below this dose, there is no detectable response.
the eyes and slightly irritating to the skin (Williamset al., 2000).
Glyphosate

2. (information not included as it may be entitled to confidential treatment) are substances that are not On

highly toxic by oral or dermal routes and are not irritating to the skin. They may cause mild, transient eye and identify dietary endpoints for Females 13-50 years old, as well as the General Population, the chronic

irritation. Many (information not included as it may be entitled to confidential treatmenta)re known not to be reference dose. The HIARC also considered toxicological endpoints for incidental oral exposure (on 20-NOV-01)
sensitizers (study citation not included as it may be entitled to confidential treatment.)The molecular weight of a
appropriate in residential exposure risk assessments.
(information not included as it may be entitled to confidential treatment)determines its biological properties, and,
The most recent report of the HIARC for glyphosate has the complete assessment of the endpoints selected for
thus, its toxicity. The lower molecular weight(information not included as it may be entitled to confidential
dietary and residential/occupational exposures (W. D
treatment)tend to be more toxic than the higher-weighted(information not included as it may be entitled to
confidential treatment)and are absorbed by the digestive tract and excreted in the urine and feces, while the (24 hour or single day) and chronic (continuous lifetime exposure) RfDs for the purposes of calculating dietary

higher molecular weight(information not included as it may be entitled to confidential treatment)are absorbed risk for food and drinking water. The RfD is calculated by dividing the appropriate no observed adverse effect level
by a ten fold factor for interspecies variability ("average" human sensitivities might be up to 10 times that of lab
more slowly or not at all (study citation not included as it may be entitled to confidential treatment.)(information
animals) and a ten fold factor for intraspecies variability (i.e., some individuals within a population might be 10
not included as it may be entitled to confidential treatment)have low acute and chronic toxicity in animal
studies. No significant adverse effects have been noted in inhalation toxicology studies, carcinogen testing, or times more sensitive than the "average" person).

mutagen assays. High oral doses have resulted in toxic effects to the kidneys and loose feces(study citation not
For glyphosate, no endpoints were selected for the acute RfD since no hazard attributed to a single dose was
included as it may be entitled to confidential treatment.)Topical dermal application of(information not included identified from the oral toxicity studies, and there are no specific concerns for toxic effects on the developing

as it may be entitled to confidential treatment)to burn patients with injured skin has resulted in toxicity(study fetus or infants and children. In addition, the HIARC did not identify endpoints of concern for dermal and
citation not included as it may be entitled to confidential treatment.)
inhalation exposures for any exposure period (short term- 1 to30 days, intermediate term- 1 to 6 months, or long
term- 6 months to lifetime) since no hazard was identified due to the low toxicity of glyphosate (TXR No.
Cosmo - Flux 411F Adjuvant)
0050428, W. Dykstra, 22-JAN-2002). The chronic dietary RfD of 1.75 mg/kg/day was based on diarrhea, nasal

The Cosmo-Flux 411F adjuvant product used in the glyphosate tank mix is produced by a Colombian company discharge, and mortality in a rabbit developmental toxicity study. A summary of doses and toxicological

and is not sold in the U.S. The Agency is not in possession of toxicity data from direct dosing of test animals endpoints selected for various relevant exposure scenarios are summarized in Table 1.
with Cosmo-Flux 411F. However, the Agency has made a hazard assessment based on the toxicity of the
Table 1. Glyphosate Endpoint Selection Table
individual components. As stated above, sale or use of spray adjuvant products in the U.S. are generally not

regulated by EPA. However, the DoS has provd i ed the EPA with a copy of this produ�t s label and a
description of the product ingredients. To be able to provide an opinion on hazard characterization of the Cosmo-

flux ingredients, the EPA relied on available technical information from various sources. Cosmo-Flux 411F

consists mainly of (information not included as it may be entitled to confidential treatm) ith a nonionic

surfactant blend primarily composed of(information not included as it may be entitled to confidential treatment.)
All ingredients of this product are substances that are not highly toxic by oral or dermal routes. They may cause

mild eye and skin irritation. All components of the adjuvant have been approved for use in/on food byEPA (40

CFR 180.1001, Letter from R.Forrest/EPA, to R.Woolfolk/DoS, 7/30/2001).

Componentsof Cosmflux

1. (information not included as it may be entitled to confidential treatment). The (information not included as it

may be entitled to confidential treatment)can cause dermal and ocular irritation and, in high doses orally, can

cause significant toxicity. However, small amounts are not a concern and these substances have been approved

as food additives by the FDA and are exempt from tolerances byEPA on certain commodities.

2. (information not included as it may be entitled to confidential treatment). The other major component of

Cosmo-Flux 411F,(information not included as it may be entitled to confidential treatment,)is not considered

highly toxic. It may cause mild eye and skin irritation. The correspondingnformation not included as it may be

entitled to confidential treatment,) has low subacute, subchronic and chronic oral toxicity and is used as a direct
food additive and a component in cosmetics. The higher molecular weight(information not included as it may be

entitled to confidential treatment)is less likely to be absorbed orally or dermally and most likely of less

toxicological concern. The other minor components, are not known to be highly toxic compounds and would not

be of toxicological concern at the concentrations and conditions in which they are used.

VI DOSE RESPONSE ASSESSMENTAnnex 53-A

Inhalation, Short-, Quantification of inhalation risk is not required because 1) no hazard was

Intermediate-, and identified in the 28 day inhalation toxicity study in rats - NOAE0.36mg/L
Long-Term (highest dose tested (HDT)); lowest observable adverse effect level (LOAEL) not

established based on 6 hours/day, 5 days/week for 4 weeks and 2) due to the

physical characteristics of the technical (wetcake), exposure to high levels of
the active ingredient is unlikely via the inhalation route, so there was no purpose

to test at higher doses.

Glyphosate Food Quality Protection Act (FQPA) Considerations

On August 3, 1996 the FQPA amended FIFRA and FFDCA. Section 408(b)(2)(C) of the Federal Food, Drug, and

Cosmetic Act addresses exposure of infants and children. Under this provisionEPA must apply the default 10X
safety factor when establishing, modifying, leaving in effect or revoking a tolerance or exemption for a pesticide

chemical residue, unless theEPA concludes, based on reliable data, that a different safety factor would protect

the safety of infants and children. Risk assessors, therefore presume that the default 10Xsafety factor applies

and should only recommend a different factor, based on an individualized assessment, when reliable data shows
that such different factor is safe for infants and children that it does not rely on a default value or presumption in

making decisions under Section 408 where reliable data are available that support an individualized

determination. The OPP FQPA Safety Factor Committee (SFC) makes specific case-by-case determinations as
to the need and size of the additional factor if reliable data permit. Determination of the magnitude of the overall

safety factor or margin of safety involves evaluating the completeness of the toxicology and exposure databases

and the potential for pre- or post-natal toxicity. Individualized assessments may result in the use of additional

factors greater or less than, or equal to 10X, or no additional factor at( PP Guidance Document on
Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment, 200)2

The HIARC addressed the potential enhanced sensitivity of infants and children from exposure to glyphosate as

required by the FQPA of 1996 at the March 26, 1998 meeting and reaffirmed the decision at the November 20,

2001 meeting. The HIARC concluded the following:

Based on the available data, there was no evidence of quantitative and qualitative increased susceptibility to

in utero and/or postnatal exposure to glyphosate in rats or rabbits.

Based on a weight of evidence consideration, the HIARC decided not to require the conduct of a
developmental neurotoxicity study with glyphosate to evaluate the potential for developmental neurotoxic

effects because there was no evidence of neurotoxicity and neuropathology in adult animals.

The FQPA SFC met on April 6, 1998 to evaluate the hazard and exposure data for glyphosate. The FQPA SFC

concluded that the safety factor of 10x be removed (reduced to 1x) since there is no evidence of quantitative or
qualitative increased susceptibility of the young demonstrated in the prenatal developmental studies in rats and

rabbits and pre/post natal reproduction study in rats. In addition the toxicology data base is complete, a

developmental neurotoxicity study is not required, and the dietary (food and drinking water) exposure
assessments will not underestimate the potential exposures for infants and children.

VII EXPOSURE ASSESSMENT

The exposure assessment is the third step in the risk assessment process. The objective is to determine the

source, type, frequency, magnitude, and duration of actual or hypothetical contact by humans with the agent of
interest. To conduct this assessment EPA relied upon the information provdied by DoS from two sources: (1)

Department of State (DoS) Presentation, DoS Coca Eradication Program, 4/18/02, (2) DoS document entitled

Chemicals Used for the Aerial Eradication of Illicit Coca in Colombia and Conditions of Application.These data

were used in accordance with standard policies and procedures used by the Agency in conducting pesticide
exposure assessments.

Dietary Food Exposure

Acute dietary exposure is possible for persons consuming livestock or food crops which have been inadvertently
sprayed as a result of the aerial eradication program in Colombia. However, since glyphosate is a contact

herbicide that systemically kills plants after absorption thorugh leaves, dietary exposure due to consumption of

treated crops is expected to be limited. Since a coca field is sprayed no more than twice to eradicate the crop,

no chronic food exposure is expected. Based on an evaluation of the hazard database, the Agency did not
identify a toxic effect attributed to a single oral dose. Therefore, an acute dietary risk assessment was not

performed (TXR No. 0050428, W. Dykstra, 22-JAN- 2002). No significant risk due to dietary exposure to

glyphosate residues is expected.

380 Inhalation, Short-, Quantification of inhalation risk is not required because 1) no hazard was

Intermediate-, and identified in the 28 day inhalation toxicity study in rats - NOAE0.36 mg/L
Long-Term (highest dose tested (HDT)); lowest observable adverse effect level (LOAEL) not

established based on 6 hours/day, 5 days/week for 4 weeks and 2) due to the

physical characteristics of the technical (wetcake), exposure to high levels of

the active ingredient is unlikely via the inhalation route, so there was no purpose
to test at higher doses.

Glyphosate Food Quality Protection Act (FQPA) Considerations

On August 3, 1996 the FQPA amended FIFRA and FFDCA. Section 408(b)(2)(C) of the Federal Food, Drug, and

Cosmetic Act addresses exposure of infants and children. Under this provisionEPA must apply the default 10X

safety factor when establishing, modifying, leaving in effect or revoking a tolerance or exemption for a pesticide
chemical residue, unless theEPA concludes, based on reliable data, that a different safety factor would protect

the safety of infants and children. Risk assessors, therefore presume that the default 10Xsafety factor applies

and should only recommend a different factor, based on an individualized assessment, when reliable data shows

that such different factor is safe for infants and children that it does not rely on a default value or presumption in
making decisions under Section 408 where reliable data are available that support an individualized

determination. The OPP FQPA Safety Factor Committee (SFC) makes specific case-by-case determinations as

to the need and size of the additional factor if reliable data permit. Determination of the magnitude of the overall

safety factor or margin of safety involves evaluating the completeness of the toxicology and exposure databases
and the potential for pre- or post-natal toxicity. Individualized assessments may result in the use of additional

factors greater or less than, or equal to 10X, or no additional factor at( PP Guidance Document on

Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment, 200)2

The HIARC addressed the potential enhanced sensitivity of infants and children from exposure to glyphosate as
required by the FQPA of 1996 at the March 26, 1998 meeting and reaffirmed the decision at the November 20,

2001 meeting. The HIARC concluded the following:

Based on the available data, there was no evidence of quantitative and qualitative increased susceptibility to
in utero and/or postnatal exposure to glyphosate in rats or rabbits.

Based on a weight of evidence consideration, the HIARC decided not to require the conduct of a

developmental neurotoxicity study with glyphosate to evaluate the potential for developmental neurotoxic

effects because there was no evidence of neurotoxicity and neuropathology in adult animals.

The FQPA SFC met on April 6, 1998 to evaluate the hazard and exposure data for glyphosate. The FQPA SFC

concluded that the safety factor of 10x be removed (reduced to 1x) since there is no evidence of quantitative or

qualitative increased susceptibility of the young demonstrated in the prenatal developmental studies in rats and

rabbits and pre/post natal reproduction study in rats. In addition the toxicology data base is complete, a
developmental neurotoxicity study is not required, and the dietary (food and drinking water) exposure

assessments will not underestimate the potential exposures for infants and children.

VII EXPOSURE ASSESSMENT

The exposure assessment is the third step in the risk assessment process. The objective is to determine the
source, type, frequency, magnitude, and duration of actual or hypothetical contact by humans with the agent of

interest. To conduct this assessment EPA relied upon the information provdied by DoS from two sources: (1)

Department of State (DoS) Presentation, DoS Coca Eradication Program, 4/18/02, (2) DoS document entitled

Chemicals Used for the Aerial Eradication of Illicit Coca in Colombia and Conditions of Application.These data
were used in accordance with standard policies and procedures used by the Agency in conducting pesticide

exposure assessments.

Dietary Food Exposure

Acute dietary exposure is possible for persons consuming livestock or food crops which have been inadvertently

sprayed as a result of the aerial eradication program in Colombia. However, since glyphosate is a contact

herbicide that systemically kills plants after absorption thorugh leaves, dietary exposure due to consumption of

treated crops is expected to be limited. Since a coca field is sprayed no more than twice to eradicate the crop,
no chronic food exposure is expected. Based on an evaluation of the hazard database, the Agency did not

identify a toxic effect attributed to a single oral dose. Therefore, an acute dietary risk assessment was not

performed (TXR No. 0050428, W. Dykstra, 22-JAN- 2002). No significant risk due to dietary exposure to

glyphosate residues is expected.Annex 53-A

140.6 (Iowa) days. Acceptable aerobic soil, aerobic aquatic and anaerobic aquatic metabolism studies

demonstrate that under those conditions at 25C in the laboratory glyphosate degrades rapidly with half-lives of

approximately 2, 7 and 8 days respectively. The reported half-lives (DT50) from the field studies conducted in the

coldest climates, i.e. Minnesota, New York. and Iowa, were the longest at 28.7, 127.8, and 140.6 days

respectively indicating that glyphosate residues in the field are somewhat more persistent in cooler climates as
opposed to milder ones (Georgia, California, Arizona, Ohio, and Texas) (Memo, J.Carleton, 10/26/98, D238931).

The climate in Colombia would favor a shorter half life than the colder regions of the US. Thereby, HED believes

glyphosate would not be persistent or be available for intermediate-term or long-term post-application exposures

in the Colombian climate.

A post-application exposure and risk assessment is required for an active ingredient if: (1) certain toxicological

criteria are triggered and (2) there is potential exposure. Upon review and analysis of the hazard database in

total, the Agenc� s HIARC did not identify a hazard of concern for these durations or routes of exposure.
Therefore, quantitative estimates of risk for short-term dermal and inhalation have not been conducted (TXR No.

0050428, W. Dykstra, 22-JAN-2002). No significant post-application risk due to glyphosate exposure is expected

as a result of this use.

Incidental Oral Exposure (Hand-to-Mouth)

Since DoS states that pilots are instructed not to spray fields where people are present, incidental oral exposure

(hand-to-mouth) resulting from being directly sprayed by glyphosate was not assessed. Non-dietary incidental

oral exposure was not quantitatively assessed for the use of glyphosate in Colombia.

As a point of comparison, screening level risk estimates for toddler incidental oral exposures (hand-to-mouth) to

the U.S. for registered residential turf uses of glyphosate have been calculated (D280831, Memo, W.Donovan,

20-FEB-2002). All resultingi ks for t oddler incidental oral exposure do not exce�d HED s level of concern. The

assumptions for toddler incidental oral exposures, (based on the maximum application rate of 1.62 lbs acid
equivalent (ae)/Acre), are expected to be conservative. For example, it is assumed that there is no dissipation of

transferable residues, so that toddlers areexposed to day of treatment residues for each day of exposure. Even

though the application rate for the coca eradication program is higher (3.3 lbs ae/Acre), using the same standard

screening level assumptions as used in the residential assessment for the U.S. registered turf use and taking
the higher application rate into account, the potential risk would not exce�d HED s level of concern.

As indicated in the turf assessment, glyphosate was directly applied to residential lawns and did not result in

exposures of concern to HED. Although spray drift is always a potential source of exposure to residents nearby
aerial spraying operations, AgDrif(a spray drift model) consistently predicts drift from applications is only a

fraction of the applied rate (lb ai/acre). Based on this assessment, HED believes that it is unlikely that there is a

higher potential for risk of exposure to spray drift from agricultural operations.

Eye Exposure

The greatest potential for eye exposure is expected for workers mixing and loading the concentrated glyphosate

product. Potential exposure is expected through 2 main pathways: (1) exposed hands transferring the

glyphosate product to the eye(s), (2) splashing of the liquid concentrated glyphosate product into the
workers eye(s). However, the label requires mixer/loaders to wear protective eyewear and this f PE isP

expected to mitigate the potential for eye exposure.

There is also the potential for eye exposure as a result of entering treated fields immediately after treatment to

perform pruning or harvesting activities. Specifically, persons dermally contacting treated foliage may transfer
residues from the hand to the eye. However, the Agency currently does not have a defined method or model to

assess quantitative eye exposures resulting from occupational or residential exposures to pesticides. For

products registered for use in the United States which have high acute toxicity to the eye, mitigation of exposure

to potential eye effects for post-application workers is done by lengthening restricted entry intervals (REI).

VIII SPRAY DRIFT

Due to spray drift, there is potential exposure for persons in areas near those targeted for spraying. Exposure

through drift is not expected to exceed that which is identified in the exposure characterization provided above.
The coca eradication program described by the Department of State has incorporated several features designed

to minimize the potential for off-target drift, provide quality assurance on a mission-by-mission basis, and

evaluate the performance of the program to the extent possible given current conditions. Three types of aircraft

are used in the program including the Ayres Corporation T65 Thrush, modified OV10D Bronco aircraft converted
from military observation use to spray aircraft, and the Air Tractor AT802. The T65 and AT802 are common to the

agricultural sector in the United States. The nozzles are Accu-Flow as described at the April 18, 2002 briefing to

the Agency. The droplet spectra characteristics, under use conditions for these nozzles, produce a very large

382140.6 (Iowa) days. Acceptable aerobic soil, aerobic aquatic and anaerobic aquatic metabolism studies

o
demonstrate that under those conditions at 25C in the laboratory glyphosate degrades rapidly with half-lives of
approximately 2, 7 and 8 days respectively. The reported half-lives (DT50) from the field studies conducted in the

coldest climates, i.e. Minnesota, New York. and Iowa, were the longest at 28.7, 127.8, and 140.6 days

respectively indicating that glyphosate residues in the field are somewhat more persistent in cooler climates as
opposed to milder ones (Georgia, California, Arizona, Ohio, and Texas) (Memo, J.Carleton, 10/26/98, D238931).

The climate in Colombia would favor a shorter half life than the colder regions of the US. Thereby, HED believes

glyphosate would not be persistent or be available for intermediate-term or long-term post-application exposures

in the Colombian climate.

A post-application exposure and risk assessment is required for an active ingredient if: (1) certain toxicological

criteria are triggered and (2) there is potential exposure. Upon review and analysis of the hazard database in

total, the Agenc� s HIARC did not identify a hazard of concern for these durations or routes of exposure.

Therefore, quantitative estimates of risk for short-term dermal and inhalation have not been conducted (TXR No.
0050428, W. Dykstra, 22-JAN-2002). No significant post-application risk due to glyphosate exposure is expected

as a result of this use.

Incidental Oral Exposure (Hand-to-Mouth)

Since DoS states that pilots are instructed not to spray fields where people are present, incidental oral exposure
(hand-to-mouth) resulting from being directly sprayed by glyphosate was not assessed. Non-dietary incidental

oral exposure was not quantitatively assessed for the use of glyphosate in Colombia.

As a point of comparison, screening level risk estimates for toddler incidental oral exposures (hand-to-mouth) to

the U.S. for registered residential turf uses of glyphosate have been calculated (D280831, Memo, W.Donovan,
20-FEB-2002). All resulting i ks for t oddler incidental oral exposure do not exceed�HED s level of concern. The

assumptions for toddler incidental oral exposures, (based on the maximum application rate of 1.62 lbs acid

equivalent (ae)/Acre), are expected to be conservative. For example, it is assumed that there is no dissipation of

transferable residues, so that toddlers areexposed to day of treatment residues for each day of exposure. Even
though the application rate for the coca eradication program is higher (3.3 lbs ae/Acre), using the same standard

screening level assumptions as used in the residential assessment for the U.S. registered turf use and taking

the higher application rate into account, the potential risk would not exceed�HED s level of concern.

As indicated in the turf assessment, glyphosate was directly applied to residential lawns and did not result in

exposures of concern to HED. Although spray drift is always a potential source of exposure to residents nearby

aerial spraying operations, AgDr�ft(a spray drift model) consistently predicts drift from applications is only a

fraction of the applied rate (lb ai/acre). Based on this assessment, HED believes that it is unlikely that there is a
higher potential for risk of exposure to spray drift from agricultural operations.

Eye Exposure

The greatest potential for eye exposure is expected for workers mixing and loading the concentrated glyphosate

product. Potential exposure is expected through 2 main pathways: (1) exposed hands transferring the
glyphosate product to the eye(s), (2) splashing of the liquid concentrated glyphosate product into the

workers� eye(s). However, the label requires mixer/loaders to wear protective eyewear and this levf PE is

expected to mitigate the potential for eye exposure.

There is also the potential for eye exposure as a result of entering treated fields immediately after treatment to
perform pruning or harvesting activities. Specifically, persons dermally contacting treated foliage may transfer

residues from the hand to the eye. However, the Agency currently does not have a defined method or model to

assess quantitative eye exposures resulting from occupational or residential exposures to pesticides. For

products registered for use in the United States which have high acute toxicity to the eye, mitigation of exposure
to potential eye effects for post-application workers is done by lengthening restricted entry intervals (REI).

VIII SPRAY DRIFT

Due to spray drift, there is potential exposure for persons in areas near those targeted for spraying. Exposure
through drift is not expected to exceed that which is identified in the exposure characterization provided above.

The coca eradication program described by the Department of State has incorporated several features designed

to minimize the potential for off-target drift, provide quality assurance on a mission-by-mission basis, and

evaluate the performance of the program to the extent possible given current conditions. Three types of aircraft
are used in the program including the Ayres Corporation T65 Thrush, modified OV10D Bronco aircraft converted

from military observation use to spray aircraft, and the Air Tractor AT802. The T65 and AT802 are common to the

agricultural sector in the United States. The nozzles are Accu-Flow as described at the April 18, 2002 briefing to

the Agency. The droplet spectra characteristics, under use conditions for these nozzles, produce a very largeAnnex 53-A

2000.

1.2 Morbidity and mortality in the municipality of El Tablon

The Narino Departmental Health Institute provided summary morbidity and mortality information for the El Tablon

De Gomez area and the Aponte settlement for the year 1999. Data for the year 2000 had not yet been officially
released, but estimates are provided. These data are reported here to provide an approximate description of

glyphosate tank mix exposure upon use on coca fields in Colombia. However, no quantitative conclusions can be

drawn from these data. Six illnesses likely to be related to pesticide exposure were identified and tabulated.

They include, acute diarrhea, acute respiratory infection, dermatitis, intoxication, conjunctivitis and headache.
The authors note that the first three illnesses listed (diarrhea, respiratory infection, and dermatitis) are likely to

be related to problems with inadequate nutrition, housing, and lack of health services. The basis for this listing of

symptoms is not specified, but it does agree with the list of symptoms likely to result from exposure to
glyphosate products based on Poison Control Center data, California surveillance reports, and the world

literature. Total morbidity for 1999 and estimated morbidity for 2000 are given in the Table below for El Tablon De

Gomez and the Aponte Settlement below. Note, however, that the overwhelming majority of these illnesses did

not occur at the time of spraying and, therefore, could not be related to spray exposure.

Table 2. Morbidity reported in the El Tablon De Gomez of Colombia in 1999 and estimated for 2000.

Pathology 1999 2000 Estimated

Acute diarrhea 146 186

Acute respiratory infection 568 506

Dermatitis 209 265

Poisoning/Intoxication 1 4

Conjunctivitis 75 85

Headaches 139 151

Total for 6 suspected illnesses 1,138 1,197

Table 3. Morbidity reported in the Aponte Settlement of Colombia in 1999 and estimated for 2000.

Pathology 1999 2000 Estimated

Acute diarrhea 181 190

Acute respiratory infection 199 222

Dermatitis 210 180

Poisoning/Intoxication 4 4

Conjunctivitis 87 104

Headaches 78 95

Total for 6 suspected illnesses 759 795

The Aponte settlement is contained within the El Tablon De Gomez area, where there has been a concern for

3842000. herbicide spraying-related health effects. Figures in the report are listed by five separate age groups. This reveals
that the majority of the cases of diarrhea and respiratory infection occurred in children less than five years old, as
1.2 Morbidity and mortality in the municipality of El Tablon
would be expected given known demographics of those health effects. Nationwide data show that 53% of

The Narino Departmental Health Institute provided summary morbidity and mortality information for the El Tablon intoxications are suicides or suicide attempts, but it is not clear how many of the four poisonings listed above

De Gomez area and the Aponte settlement for the year 1999. Data for the year 2000 had not yet been officially might be suicidal or, more importantly, are due to other products such as medications. In both Tables 2 and 3
there is an increase of 5% from 1999 to the estimate for 2000 for the total of the six suspected illnesses. Given
released, but estimates are provided. These data are reported here to provide an approximate description of
glyphosate tank mix exposure upon use on coca fields in Colombia. However, no quantitative conclusions can be that spraying is reported to have occurred in 2000 and not 1999, this suggests that the overwhelming majority

drawn from these data. Six illnesses likely to be related to pesticide exposure were identified and tabulated. (95%) of illnesses reported would be background incidence unrelated to the spraying of herbicide. The remaining

They include, acute diarrhea, acute respiratory infection, dermatitis, intoxication, conjunctivitis and headache. 5% increase could be due to a variety of causes and do not support a conclusion that the glyphosate tank
mixture was responsible for these complaints.
The authors note that the first three illnesses listed (diarrhea, respiratory infection, and dermatitis) are likely to
be related to problems with inadequate nutrition, housing, and lack of health services. The basis for this listing of
1.3 Epidemiological monitoring system and mandatory notification
symptoms is not specified, but it does agree with the list of symptoms likely to result from exposure to

glyphosate products based on Poison Control Center data, California surveillance reports, and the world In addition to the summary of general morbidity in the population, there is a mandatory health reportingsystem
literature. Total morbidity for 1999 and estimated morbidity for 2000 are given in the Table below for El Tablon De
in Colombia for 34 illnesses including pesticide poisonings. The review of these records found no reports of
Gomez and the Aponte Settlement below. Note, however, that the overwhelming majority of these illnesses did pesticide poisoning for the municipality of El Tablon in the year 2000 or the first 9 weeks of 2001. Weekly reports

not occur at the time of spraying and, therefore, could not be related to spray exposure. were examined to determine how many pesticide poisonings were reported each month. It did not appear that

the times of spraying correlated with reports of pesticide intoxication.
Table 2. Morbidity reported in the El Tablon De Gomez of Colombia in 1999 and estimated for 2000.

Table 4: Reports of Pesticide Intoxication provided to the Narino Department of Health Institute,
Epidemiology Section January 12, 2000 through March 7, 2001.
Pathology 1999 2000 Estimated

Acute diarrhea 146 186

Acute respiratory infection 568 506

Dermatitis 209 265

Poisoning/Intoxication 1 4

Conjunctivitis 75 85

Headaches 139 151

Total for 6 suspected illnesses 1,138 1,197

Table 3. Morbidity reported in the Aponte Settlement of Colombia in 1999 and estimated for 2000.

Pathology 1999 2000 Estimated

Acute diarrhea 181 190

Acute respiratory infection 199 222
Out of a total of 125 reported pesticide poisonings in 61 weeks, 15 occurred during 5 weeks when spraying

eradication occurred. Given the variation in the data, this could easily be due to chance and be unrelated to
Dermatitis 210 180
exposure from the spraying of the glyphosate tank mixture. More work is required to determine whether locations
of the 15 suspect poisoning matched the location and timing of spraying.

Poisoning/Intoxication 4 4
In 2000, the Narino Department of Health requested all municipalities to report the human health effects of

pesticide spraying. Ten municipalities supplied the reports. They are:

Conjunctivitis 87 104
Three municipalities including Tablon de Gomez, Barbacoas, and Magui reported no cases. However, the reports
were completed prior to the November spraying in Barbacoas and Magui and prior to (or perhaps during) the July

Headaches 78 95 and before the November spraying in Tablon de Gomez. Buesaco reported one patient with sore throat,

numbness in limbs, and conjunctivitis in June. In Tumaco, six case of patients with conjunctivitis and dermatitis

Total for 6 suspected illnesses 759 795 were reported as of October 6, 2000. In San Pablo, 50 cases of dermatitis, conjunctivitis, respiratory conditions,
and digestive problems were reported after as of October 6, 2000.

The Aponte settlement is contained within the El Tablon De Gomez area, where there has been a concern for In La Cruz, two cases of allergic rhinitis, two cases of dermatitis, and five cases of conjunctivitis were reportedAnnex 53-A

as of October 6, 2000. San Jose de Alban did not report any specific cases, but the scientific coordinator and
chief nurse noted an increase in gastrointestinal, dermatological and respiratory conditions. The exact quantity of

these conditions in relation to spray times was not given. El Rosario reported five cases of conjunctivitis and

rhinitis that might have been related to spraying carried out on July 31. San Pedro de Cartago reported an
increase in gastrointestinal symptoms but no quantitative relationship between illnesses and spray times was

provided.

The absence of any reports of pesticide poisoning combined with the information from the ten municipalities is

difficult to interpret. The glyphosate formulated product is known to cause irritation to the skin, eyes, mucous
membranes which may account for some of the reports of sore throat, conjunctivitis, dermatitis and other

conditions described above. However, it is not possible to evaluate these reports in any detail due to the lack of

any information on how many of these cases experienced exposure immediately prior to their illness and lack of

information on investigation of potential alternative causes. This anecdotal information does not provide any
substantial evidence of health effects due to the spraying of the glyphosate tank mixture in Colombia. Many of

the reports are consistent with exposure to glyphosate products by the dermal route, as reported in California

and the literature. So, it is possible that some cases could be related to the aerial eradication program.

To provide context for comparison, the California Pesticide Illness Surveillance Program (1982-2000) data for

glyphosate were reviewed for this risk assessment. Starting in 1992, the glyphosate product was reformulated in

the US to reduce the amount of surfactant which posed a hazard to the eye. From 1982 through 1991, there

were 221 illnesses involving the eye or 22.1 cases per year. From 1994 (allowing 2 years for the product to be
introduced into trade and widespread use) through 2000, there were 65 illnesses involving the eye or 9.3 cases

per year, a decline of 58%. Therefore, these data support the finding that the reformulated glyphosate product

used since 1992, have resulted in a significant drop in illnesses. Overall, the total illnesses due to glyphosate
declined by 39% from the 1982-1991 time period to the 1994-2000 time period, largely due to the reduction in

eye injuries.

2.2 Review of report of January 22, 2001 visit to the municipality of El Tablon de Gomez.

A commission visited the municipality of El Tablon on January 22, 2001 and spoke with Dr. Tordecilla and
reviewed health records of his patients. A number of records of skin conditions were noted for the months of

October, December 2000, and January 2001. The exact number of cases, selection criteria, and method of

analysis was not specified in the summary report. Nevertheless, the commission concluded "that the information

available permitted the commission to consider only the possibility of an association between exposure to
pesticides and the effects". The commission noted that it lacked the technical expertise, the data on dates and

locations of spraying, and therefore could not conclude whether the observed conditions were related to pesticide

exposure.

2.3 Interviewswith Narino department health officialsregarding the spraying

Employees of the Narino Department Health Institute were interviewed by Colombian authorities. A Fatima

Health Promoter thought children were most affected, suffering gastrointestinal problems and eye irritation. One

possible route of exposure was the village water fountains which supply some of the drinking water. The most
common symptoms in children, according to the Health Promoter, were stomach aches and vomiting, which

were different from the most common symptoms of glyphosate exposure reported by Lee et al. (2000), sore

throat and nausea. This inconsistency suggests that some cause other than glyphosate products was
responsible for the children s complaints. The Health Promoter reported one case of a boy with skin lesions

like sores after the spraying. The Health Promoter was particularly concerned that peasants receive more health

care from the government.

A nurse� s aide reported that three or four patients with burning eyes, headache, and dizziness were seen at her
health center. One boy with a respiratory infection was sent to another health center, later died. Medical records

were sought to substantiate this report but there was no clinical history, autopsy or other information to support

glyphosate spraying as a factor. She referred a patient with urinary problems to the hospital. Subsequent review

of the medical records of this case did not find reference to glyphosate tank mix exposure and suggested an
infectious origin. There were also cases of dermatitis, headache, abdominal pain and gastrointestinal symptoms,

but she could not say whether the symptoms were related to exposure to the spraying of glyphosate tank

mixture.

Another nurse s aide reported by telephone that her impression was that the number of dermatological

consultations had increased. However, there was no clear association with glyphosate tank mix exposure and

many of the reasons for the consultations were the same as in previous years when glyphosate was not used,

so no clear relationship between the spraying and these dermatological conditions was identified.

386as of October 6, 2000. San Jose de Alban did not report any specific cases, but the scientific coordinator and Reports of anecdotal evidence by nurse s aides and the health promoter have not established a link between
chief nurse noted an increase in gastrointestinal, dermatological and respiratory conditions. The exact quantity of the spraying of glyphosate tank mix and health effects. Follow-up to determine the timing and evidence of

these conditions in relation to spray times was not given. El Rosario reported five cases of conjunctivitis and exposure and examination of other potential causes of these effects was not performed. These interviews do not

rhinitis that might have been related to spraying carried out on July 31. San Pedro de Cartago reported an add significant evidence about the health rsi ks from the use of glyphosate tank mixture in Colombia.

increase in gastrointestinal symptoms but no quantitative relationship between illnesses and spray times was
provided. 2.5 Review of records of patients treated at Aponte Health Center - Sept. 2000 to Jan. 2001

There were 29 cases reported by Dr. Tordecelli and clinical records were obtained for 21 of them. Two other
The absence of any reports of pesticide poisoning combined with the information from the ten municipalities is
reports of skin lesions were sought but could not be confirmed. After careful review of the 21 records, it was
difficult to interpret. The glyphosate formulated product is known to cause irritation to the skin, eyes, mucous
determined that all but four cases were likely due to other causes. Most had skin conditions known to be related
membranes which may account for some of the reports of sore throat, conjunctivitis, dermatitis and other to bacteria or parasites, not chemical exposures and the onset of their symptoms did not correspond with the
conditions described above. However, it is not possible to evaluate these reports in any detail due to the lack of
times of spraying. There were seven patients whose symptoms started after spraying and three of these were
any information on how many of these cases experienced exposure immediately prior to their illness and lack of
conditions known to be caused by bacteria or parasites. For the remaining four cases possibly related to the
information on investigation of potential alternative causes. This anecdotal information does not provide any
substantial evidence of health effects due to the spraying of the glyphosate tank mixture in Colombia. Many of spraying of glyphosate tank mixture, one was an allergic reaction that had been seen in this patient before when
there was no spraying. A second and third case were contact eczema that is endemic in this region and thought
the reports are consistent with exposure to glyphosate products by the dermal route, as reported in California
to be more likely due to an infectious origin. One of these two cases did not initiate until 52 days after the last
and the literature. So, it is possible that some cases could be related to the aerial eradication program.
spraying. The fourth case was dermatitis on the thigh which would typically be protected by clothing and thereby

To provide context for comparison, the California Pesticide Illness Surveillance Program (1982-2000) data for protected from aerial spray applications. This reviewer agrees with the conclusion that "the twenty-one clinical
glyphosate were reviewed for this risk assessment. Starting in 1992, the glyphosate product was reformulated in histories . . . reveals that any relationship between aerial eradication with the herbicide glyphosate (tank mixture)

the US to reduce the amount of surfactant which posed a hazard to the eye. From 1982 through 1991, there and the skin conditions treated in Aponte is unlikely".

were 221 illnesses involving the eye or 22.1 cases per year. From 1994 (allowing 2 years for the product to be
In summary, the evidence collected and presented in this report cannot confirm that the glyphosate tank mixture
introduced into trade and widespread use) through 2000, there were 65 illnesses involving the eye or 9.3 cases
per year, a decline of 58%. Therefore, these data support the finding that the reformulated glyphosate product used in Colombia as the likely cause of illness in the surrounding community. There is suggestive evidence in
the form of reported increases of morbidity and reports from municipalities that some cases of relatively mild
used since 1992, have resulted in a significant drop in illnesses. Overall, the total illnesses due to glyphosate
complaints could have occurred in relation to the spraying eradication program. Some of the reports appear to be
declined by 39% from the 1982-1991 time period to the 1994-2000 time period, largely due to the reduction in
similar to those reported in the literature and by California. These cases report irritation to skin, eyes, and
eye injuries.
respiratory passages and suggest that the Cosmo-Flux 411F added to the glyphosate product in Colombia has
2.2 Review of report of January 22, 2001 visit to the municipality of El Tablon de Gomez. little or no effect on the overall toxicity of the formulated product.

A commission visited the municipality of El Tablon on January 22, 2001 and spoke with Dr. Tordecilla and Rather than review incomplete medical records, it would be better to collect information prospectively. For

reviewed health records of his patients. A number of records of skin conditions were noted for the months of example, if pesticide poisoning is a mandatory reporting condition, a form documenting the exposure, health
effects and medical data on each case could be designed and used to establish whether any particular
October, December 2000, and January 2001. The exact number of cases, selection criteria, and method of
analysis was not specified in the summary report. Nevertheless, the commission concluded "that the information conditions might be related to spraying the glyphosate tank mixture. Without prospective collection of data and

available permitted the commission to consider only the possibility of an association between exposure to follow up, it is difficult to evaluate potential health effects of the glyphosate tank mixture sprayed in Colombia.

pesticides and the effects". The commission noted that it lacked the technical expertise, the data on dates and Better records of the time of exposure relative to the onset of symptoms would also enhance interpretation of the
incidence data.
locations of spraying, and therefore could not conclude whether the observed conditions were related to pesticide
exposure.
X

2.3 Interviewswith Narino department health officialsregarding the spraying
Risk characterization combines the assessments of the first three steps to develop a qualitative or quantitative

Employees of the Narino Department Health Institute were interviewed by Colombian authorities. A Fatima estimate of the probability, that under the assumed conditions or variables of the exposure scenario, that harm
Health Promoter thought children were most affected, suffering gastrointestinal problems and eye irritation. One will result to an exposed individual. Risk is equal to hazard multiplied by exposure. For the scenarios that are

possible route of exposure was the village water fountains which supply some of the drinking water. The most relevant to the subject use, the Agency has not identified toxic effects attributable to a single oral exposure,

common symptoms in children, according to the Health Promoter, were stomach aches and vomiting, which short- or intermediate-term dermal, or short- or intermediate-term inhalation exposures (TXR No. 0050428, W.

were different from the most common symptoms of glyphosate exposure reported by Lee et al. (2000), sore Dykstra, 22-JAN-2002). Therefore, no quantification of exposure or risk was performed. Nonetheless, it is
throat and nausea. This inconsistency suggests that some cause other than glyphosate products was appropriate to qualitatively characterize the potential for risk concerns for this use.

responsible for the childr�n s complaints. The Health Promoter reported one case of a boy with skin lesions
From the review of glyphosate product incident reports for the use on poppy, it should be emphasized that the
like sores after the spraying. The Health Promoter was particularly concerned that peasants receive more health
spraying reported to have occurred in 2000 and not in 1999 suggests, that the overwhelming majority (95%) of
care from the government.
the illnesses reported would be background incidents unrelated to the spraying of herbicide. The remaining 5%
A nurse � s aide reported that three or four patients with burning eyes, headache, and dizziness were seen at her increase could be due to a variety of causes and do not support a conclusion that the spraying of the glyphosate

health center. One boy with a respiratory infection was sent to another health center, later died. Medical records tank mixture was responsible for these complaints. Furthermore, the individual with the highest potential for

were sought to substantiate this report but there was no clinical history, autopsy or other information to support exposure would be the mixer loader. They are handling the concentrated glyphosate product and the tank mix.

glyphosate spraying as a factor. She referred a patient with urinary problems to the hospital. Subsequent review The incident data that has been submitted to the Agency by DoS, does not include any incident reports for those
of the medical records of this case did not find reference to glyphosate tank mix exposure and suggested an individuals. There is some data to suggest that the poppy eradication program could have resulted in minor skin,

infectious origin. There were also cases of dermatitis, headache, abdominal pain and gastrointestinal symptoms, eye, or respiratory irritation, and perhaps headache or other minor symptoms. However, the detailed information

but she could not say whether the symptoms were related to exposure to the spraying of glyphosate tank on the use, timing of application, history of exposure, and medical documentation of symptoms related to
exposure to glyphosate tank mix were not available. The evidence collected and presented in the epidemiology
mixture.
report cannot confirm that the glyphosate tank mixture used in Colombia as the likely cause of a single illness.
Another nurse � aide reported by telephone that her impression was that the number of dermatological
There is suggestive evidence in the form of reported increases of morbidity and reports from municipalities that
consultations had increased. However, there was no clear association with glyphosate tank mix exposure and
some cases of relatively mild complaints could have occurred in relation to the spraying eradication program.
many of the reasons for the consultations were the same as in previous years when glyphosate was not used, Some of the reports appear to be similar to those reported in the literature and by California. These cases report

so no clear relationship between the spraying and these dermatological conditions was identified. irritation to skin, eyes, and respiratory passages and suggest that the Cosmo-Flux 411F added to the

glyphosate product in Colombia has little or no effect on the overall toxicity of the formulated product. TheAnnex 53-A

information so far collected indicates that any increase in health problems is likely to be relatively small at most

and the severity of those symptoms is likely to be minor to moderate at most. The Amazon Alliance and Earth

Justice submission provided little, if any, information on the number of persons affected, age and sex, symptoms

of illness, or diagnosis or treatment received. Without such informationEPA cannot even begin to characterize
the extent and pattern of the health effects claimed to result from glyphosate application. Given the limited

amount of documentation, none of the data in the report from Colombia provide a compelling case that the

spraying of the glyphosate mixture has been a significant cause of illness in the region studied. Prospective

tracking of reports of health complaints, documenting times of exposure and onset of symptoms, are
recommended during future spray operations to evaluate any potential health effects and ameliorate or prevent

their occurrence.

The glyphosate formulated productused in the coca eradication program in Colombia contains the active
ingredient glyphosate, a surfactant blend, and water. The acute toxicity test of theglyphosate technicalis

classified as category III for primary eye irritation and category IV for acute dermal and oral toxicity, and skin

irritation. It not a dermal sensitizer. However, the surfactant used in theformulatedproduct reportedly can cause

severe skin irritation and be corrosive to the eyes, as would be expected for many surfactants. The label for the
formulatedproduct used in the coca eradication program in Colombia includes the "Danger" signal word. The

product has been determined to be toxicity category I for eye irritation, causing irreversible eye damage. Some of

the findings reported in the incident data are in alignment with that, reports of toxicity to the eye due to the

surfactant, not glyphosate per se. This is supported by data obtained from the California Pesticide Illness
Surveillance Program (1982-2000). As stated previously, in 1992 the glyphosate product was reformulated in the

US to reduce the amount of surfactant which posed a hazard to the eye. From 1982 through 1991, there were

221 illnesses involving the eye or 22.1 cases per year. From 1994 (allowing 2 years for the product to be
introduced into trade and widespread use) through 2000, there were 65 illnesses involving the eye or 9.3 cases

per year, a decline of 58%. Therefore, these data support the finding that the use of the reformulated glyphosate

product since 1992, has resulted in a significant drop in illnesses. Overall, the total illnesses due to glyphosate

declined by 39% from the 1982-1991 time period to the 1994-2000 time period, largely due to the reduction in
eye injuries.

The acute toxicity of the undiluted glyphosate product is most pertinent to mixers and loaders, who are

potentially exposed to that form of the glyphosate product. On April 18, 2002, during a consultation with the
DoS, in preparation for the current risk assessment, the DoS agreed to supply the Agency with a full battery of

the six acute toxicity tests on the tank mix. To date, the Pesticide Program has not received this data. Until

such information is supplied to the Agency,EPA cannot evaluate any potential acute toxicity effects resulting

from direct contact with the tank mixture. Therefore, due to the acute eye irritation caused by the concentrated
glyphosate formulated product and the lack of acute toxicity data on the tank mixture, the Agency recommends

that an alternative glyphosate product (with lower potential for acute toxicity) be used in future coca and/or poppy

aerial eradication programs.

A direct comparison of the epidemiological data in Colombia (which is from aerial application to poppy) to the
conditions of use, (as presented at the April 18, 2002 briefing for aerial application to coca by DoS to OPP risk

assessors), would be limited. The briefing did not address the conditions of use for poppy. Subsequent to the

April 18 briefing HED received an e-mail communication from OPP/ Field and External Affairs Division, stating
that the application rate for poppy was lower than that for coca. According to the DoS, the use pattern of the

glyphosate mixture on poppy differs from the use on coca. Other details of the differences between the two spray

programs have not been supplied to the Agency. Specifically, the Agency has no information as to the exact

makeup of the tank mixture sprayed on poppy, or whether the same glyphosate product and adjuvants used in
the coca eradication program were used in the poppy eradication program. The Agency also has questions as to

the geographical area differences, the frequency of repeated applications, and the size of the area treated on

each spray mission. Therefore, generalized conclusions drawn from human incident data as a result of

application to opium poppy, in comparison to conditions of use for the coca eradication program should be made
with caution.

In summary, HED concludes that:

There are no risks of concern for glyphosate, per se, from the dermal or inhalation routes of exposure, since
toxicity is very low.

The identified components of the adjuvant Cosmoflux 411F are not highly toxic by the oral and dermal

routes; they have been approved for use in/on food by the Agency.

Glyphosate is not highly toxic. Based on the conditions of glyphosate use described by DoS, there is likely
minimal exposure or concern for acute and chronic dietary or incidental oral risks.

The incident data from Colombia based on the poppy use may differ from use of glyphosate as part of the

coca eradication program, so conclusions should be made with caution.

388information so far collected indicates that any increase in health problems is likely to be relatively small at most
and the severity of those symptoms is likely to be minor to moderate at most. The Amazon Alliance and Earth

Justice submission provided little, if any, information on the number of persons affected, age and sex, symptoms

of illness, or diagnosis or treatment received. Without such informationEPA cannot even begin to characterize
the extent and pattern of the health effects claimed to result from glyphosate application. Given the limited

amount of documentation, none of the data in the report from Colombia provide a compelling case that the

spraying of the glyphosate mixture has been a significant cause of illness in the region studied. Prospective
REFERENCES
tracking of reports of health complaints, documenting times of exposure and onset of symptoms, are
recommended during future spray operations to evaluate any potential health effects and ameliorate or prevent
HIARC Report for Glyphosate (TXR No. 0050428, W. Dykstra, 22-JAN-2002)
their occurrence.
Glyphosate in/on Pasture and Rangeland Grasses, Roundup Ready Wheat, and Nongrass Animal Feeds. (DP

The glyphosate formulated productused in the coca eradication program in Colombia contains the active Barcode: D280831, 20-FEB-2002)

ingredient glyphosate, a surfactant blend, and water. The acute toxicity test of theglyphosate technicalis
classified as category III for primary eye irritation and category IV for acute dermal and oral toxicity, and skin Farmer, D.R., T.A. Kaempfe, W.F. Heydens and W.R. Kelce. 2000. Developmental toxicity studies with

irritation. It not a dermal sensitizer. However, the surfactant used in theformulatedproduct reportedly can cause glyphosate and selected surfactants in rats. Teratology 61(6): 446.

severe skin irritation and be corrosive to the eyes, as would be expected for many surfactants. The label for the US Environmental Protection Agency, Office of Pesticide Programs May 9, 2002: Guidance Document on

formulatedproduct used in the coca eradication program in Colombia includes the "Danger" signal word. The Methodology for Determining the Data Needed and the Types of Assessments Necessary to Make FFDCA
product has been determined to be toxicity category I for eye irritation, causing irreversible eye damage. Some of
Section 408 Safety Determinations for Lower Toxicity Pesticide Chemicals.
the findings reported in the incident data are in alignment with that, reports of toxicity to the eye due to the

surfactant, not glyphosate per se. This is supported by data obtained from the California Pesticide Illness Williams, G.M., R. Kroes and I.C. Munro. 2000. Safety evaluation and risk assessment of the herbicide Roundup
and its active ingredient, glyphosate, for humans. Reg. Toxic. Pharm. 31: 117-165.
Surveillance Program (1982-2000). As stated previously, in 1992 the glyphosate product was reformulated in the
US to reduce the amount of surfactant which posed a hazard to the eye. From 1982 through 1991, there were
Certain references deleted for protection of CBI.
221 illnesses involving the eye or 22.1 cases per year. From 1994 (allowing 2 years for the product to be

introduced into trade and widespread use) through 2000, there were 65 illnesses involving the eye or 9.3 cases SECTION 3. Review of Glyphosate Incident Reportswith special reference to aerial spraying in

per year, a decline of 58%. Therefore, these data support the finding that the use of the reformulated glyphosate Colombia
product since 1992, has resulted in a significant drop in illnesses. Overall, the total illnesses due to glyphosate
BACKGROUND
declined by 39% from the 1982-1991 time period to the 1994-2000 time period, largely due to the reduction in

eye injuries. On May 8, 2002 the U. S. Department of State requested that the U.S. Environmental Protection Agency provide

The acute toxicity of the undiluted glyphosate product is most pertinent to mixers and loaders, who are consultation on the U.S.-supported aerial coca eradication program in Colombia. Specifically, the Department of
State requests advice on whether the aerial application program may pose unreasonable risks or adverse effects
potentially exposed to that form of the glyphosate product. On April 18, 2002, during a consultation with the
to humans or the environment. This review is part of a health risk assessment performed by the Health Effects
DoS, in preparation for the current risk assessment, the DoS agreed to supply the Agency with a full battery of
Division of the glyphosate product used in Colombia. This review will focus on reports of human health effects
the six acute toxicity tests on the tank mix. To date, the Pesticide Program has not received this data. Until
such information is supplied to the Agency,EPA cannot evaluate any potential acute toxicity effects resulting reported from the leading pesticide poisoning surveillance data sources in the United States, which include
Poison Control Centers and the California Pesticide Illness Surveillance Program. The California data source is
from direct contact with the tank mixture. Therefore, due to the acute eye irritation caused by the concentrated
especially useful for this review because of it s high quality, documentation going back to 1982, and because
glyphosate formulated product and the lack of acute toxicity data on the tank mixture, the Agency recommends
glyphosate is the second most widely used pesticide in California affording ample opportunity for unintentional
that an alternative glyphosate product (with lower potential for acute toxicity) be used in future coca and/or poppy
aerial eradication programs. exposures. The world scientific literature on glyphosate and a report from Colombia examining reports of the
adverse health effects are also reviewed.

A direct comparison of the epidemiological data in Colombia (which is from aerial application to poppy) to the
The aerial spray mixture used in Colombia consists of water, glyphosate formulation, and 1 percent Cosmo-Flux
conditions of use, (as presented at the April 18, 2002 briefing for aerial application to coca by DoS to OPP risk
411F. According to documentation supplied by the Department of State, this diluted mixture is applied to coca at
assessors), would be limited. The briefing did not address the conditions of use for poppy. Subsequent to the
April 18 briefing HED received an e-mail communication from OPP/ Field and External Affairs Division, stating the rate of 2.53 gallons per acre (U. S. Department of State 2002). "The commercial glyphosate formulation used
in the spray mixture is registered with U. S. Environmental Protection Agency (EPA) for sale in the United
that the application rate for poppy was lower than that for coca. According to the DoS, the use pattern of the
States for non-agricultural use and contains 41 percent glyphosate salt and 59 percent inert ingredients.
glyphosate mixture on poppy differs from the use on coca. Other details of the differences between the two spray
Approximately three fourths of the inert ingredient content are water and the remainder is a surfactant blend. A
programs have not been supplied to the Agency. Specifically, the Agency has no information as to the exact
makeup of the tank mixture sprayed on poppy, or whether the same glyphosate product and adjuvants used in surfactant is essentially a soap that enhances the ability of the herbicide to penetrate the waxy cuticle of the leaf
surface."(U. S. Department of State 2002).
the coca eradication program were used in the poppy eradication program. The Agency also has questions as to

the geographical area differences, the frequency of repeated applications, and the size of the area treated on This review will not be able to fully assess the formulation containing 1 percent Cosmo-Flux 411F because that

each spray mission. Therefore, generalized conclusions drawn from human incident data as a result of particular surfactant has not been used in the United States. Nevertheless, it will consider the summary of the
application to opium poppy, in comparison to conditions of use for the coca eradication program should be made
investigation in Colombia of the formulation which does contain this additional surfactant. Though all aspects of
with caution. glyphosate human poisoning data will be considered, this review will focus on one particular scenario, namely

the effects of dermal and inhalation exposure from spray drift or residues, that result from aerial application.
In summary, HED concludes that:

There are no risks of concern for glyphosate, per se, from the dermal or inhalation routes of exposure, since The following data bases have been consulted for the poisoning incident data on the active ingredient glyphosate
(PC Code: 103601):
toxicity is very low.

The identified components of the adjuvant Cosmoflux 411F are not highly toxic by the oral and dermal 1) Poison Control Centers - as the result of a data purchase by EPA, the Office of Pesticide Programs (OPP)

routes; they have been approved for use in/on food by the Agency. received Poison Control Center data covering the years 1993 through 1998 for all pesticides. Most of the national
Glyphosate is not highly toxic. Based on the conditions of glyphosate use described by DoS, there is likely
Poison Control Centers (PCCs) participate in a national data collection system, the Toxic Exposure Surveillance
minimal exposure or concern for acute and chronic dietary or incidental oral risks. System which obtains data from about 65-70 centers at hospitals and universities. PCCs provide telephone

The incident data from Colombia based on the poppy use may differ from use of glyphosate as part of the consultation for individuals and health care providers on suspected poisonings, involving drugs, household

coca eradication program, so conclusions should be made with caution. products, pesticides, etc. Note that Poison Control Center data does not have information on the type ofAnnex 53-A

application. So it is not possible to limit the review to the aerial application scenario or to limit it to only those

persons secondarily exposed to drift or residue. However, it will be possible to exclude oral exposures which are

inconsistent with the focus of the present review.

2) California Department of Pesticide Regulation - California has collected uniform data on suspected pesticide
poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences

of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers.

Information on exposure (worker activity), type of illness (systemic, eye, skin, eye/skin and respiratory),

likelihood of a causal relationship, and number of days off work and in the hospital are provided. The California
data permits assessing the risk of exposure both to handlers and to bystanders. The exposure of bystanders

and others to drift and residue will be a primary focus of this review.

3) Scientific Literature - A search was performed on Medline for scientific literature related to the human health
effects of glyphosate. All articles were retrieved and reviewed for relevance. Articles involving dermal or ocular

exposure are given priority because this fits with the primary scenario of concern for this review.

4) A report from the Department of Narino, Municipality of El Tablon De Gomez "A Study of Health Complaints

Related to Aerial Eradication in Colombia", Final Report dated September 2001 is reviewed. This document
addresses the specific exposure of interest and therefore will be given special attention.

GLYPHOSATE REVIEW

I. Poison Control Center Data - 1993 through 1998

Results for the years 1993 through 1998 are presented below for occupational cases, non-occupational involving

adults and older children, and for children under age six. Reports of intentional exposures (e.g., suicide

attempts) and exposures to multiple products are excluded. Cases where the outcome was determined to be

unrelated to the exposure were also excluded. Tables 1-4 present the hazard information for glyphosate
compared with all other pesticides on six measures: percent with symptoms, percent with moderate, major

(includes life-threatening or residual disability) outcome, percent with major outcome, percent of exposed cases

seen in a health care facility, and percent hospitalized and percent seen in a critical care facility. There were no

cases with a fatal outcome between 1993 and 1998. Table 1 reports the number of cases on which the data
derived in Tables 2-4 are based. Table 2 presents this information for occupational cases, Table 3 for non-

occupational cases involving adults and older children (six years or older), and Table 4 for children under age six.

Note that Table 2, involving occupational exposure, is of less relevance to this review because it is inconsistent
with the exposure scenario of interest in Colombia.

Table 1. Number of glyphosate exposures reported to the Toxic Exposure Surveillance SystemA(APCC),

number with determined outcome, number seen in a health care facility for occupational and non-occupational

cases (adults and children six years and older) and for children under six years of age only, 1993-1998 .

Subgroup Exposures Outcome Seen in Health Care
determined Facility

Occupational: adults and older children 875 663 263

Non-occupational: adults and older children 7491 5177 940

Children under age six 4897 3589 207

Table 2. Comparison between glyphosate and all pesticides for percent cases with symptomatic outcome

(SYM), moderate or more severe outcome (MOD), life-threatening or residual disability (LIFE-TH), seen in a
health care facility (HCF), hospitalized (HOSP), or seen in an intensive care unit (ICU) reported to Poison Control

Centers, 1993-1998 for occupational casesonly.

Pesticide SYM* MOD* LIFE-TH* HCF* HOSP* ICU*

Glyphosate 77.8% 7.54% 0.15% 30.0% 2.28% 0.76%

All Pesticides 86.0% 18.8% 0.62% 47.0% 6.08% 2.36%

390application. So it is not possible to limit the review to the aerial application scenario or to limit it to only those
persons secondarily exposed to drift or residue. However, it will be possible to exclude oral exposures which are

inconsistent with the focus of the present review.

2) California Department of Pesticide Regulation - California has collected uniform data on suspected pesticide

poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences

of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers.
Information on exposure (worker activity), type of illness (systemic, eye, skin, eye/skin and respiratory),

likelihood of a causal relationship, and number of days off work and in the hospital are provided. The California

data permits assessing the risk of exposure both to handlers and to bystanders. The exposure of bystanders

and others to drift and residue will be a primary focus of this review.

3) Scientific Literature - A search was performed on Medline for scientific literature related to the human health

effects of glyphosate. All articles were retrieved and reviewed for relevance. Articles involving dermal or ocular

exposure are given priority because this fits with the primary scenario of concern for this review.

4) A report from the Department of Narino, Municipality of El Tablon De Gomez "A Study of Health Complaints
Related to Aerial Eradication in Colombia", Final Report dated September 2001 is reviewed. This document

addresses the specific exposure of interest and therefore will be given special attention.

GLYPHOSATE REVIEW

I. Poison Control Center Data - 1993 through 1998

Results for the years 1993 through 1998 are presented below for occupational cases, non-occupational involving
adults and older children, and for children under age six. Reports of intentional exposures (e.g., suicide

attempts) and exposures to multiple products are excluded. Cases where the outcome was determined to be

unrelated to the exposure were also excluded. Tables 1-4 present the hazard information for glyphosate

compared with all other pesticides on six measures: percent with symptoms, percent with moderate, major
(includes life-threatening or residual disability) outcome, percent with major outcome, percent of exposed cases

seen in a health care facility, and percent hospitalized and percent seen in a critical care facility. There were no

cases with a fatal outcome between 1993 and 1998. Table 1 reports the number of cases on which the data

derived in Tables 2-4 are based. Table 2 presents this information for occupational cases, Table 3 for non-
occupational cases involving adults and older children (six years or older), and Table 4 for children under age six.

Note that Table 2, involving occupational exposure, is of less relevance to this review because it is inconsistent

with the exposure scenario of interest in Colombia.

Table 1. Number of glyphosate exposures reported to the Toxic Exposure Surveillance SystemA(APCC),

number with determined outcome, number seen in a health care facility for occupational and non-occupational
cases (adults and children six years and older) and for children under six years of age only, 1993-1998 .

Subgroup Exposures Outcome Seen in Health Care

determined Facility

Occupational: adults and older children 875 663 263

Non-occupational: adults and older children 7491 5177 940

Children under age six 4897 3589 207

Table 2. Comparison between glyphosate and all pesticides for percent cases with symptomatic outcome

(SYM), moderate or more severe outcome (MOD), life-threatening or residual disability (LIFE-TH), seen in a

health care facility (HCF), hospitalized (HOSP), or seen in an intensive care unit (ICU) reported to Poison Control

Centers, 1993-1998 for occupational casesnly.

Pesticide SYM* MOD* LIFE-TH* HCF* HOSP* ICU*

Glyphosate 77.8% 7.54% 0.15% 30.0% 2.28% 0.76%

All Pesticides 86.0% 18.8% 0.62% 47.0% 6.08% 2.36%Annex 53-A

0.35 for critical care. When oral exposures, common among children under age six, are excluded, there were
only 2 cases hospitalized and none required critical care treatment. Both of the children that were hospitalized

experienced seizures that were considered to be unknown if related to their exposure to glyphosate. Thus, even

in the most sensitive population, young infants, there was no strong evidence of serious effects from glyphosate.

II. California Data - 1982 through 2000

Detailed descriptions of 911 cases involving glyphosate, submitted to the California Pesticide Illness Surveillance

Program (1982-2000), were reviewed. In 675 of these cases, glyphosate was used alone or was judged to be

responsible for the health effects. These 675 cases include only those with a definite, probable or possible

relationship. Table 4 presents the types of illnesses reported by year. Table 5 gives the total number of workers
that took time off work as a result of their illness and how many were hospitalized and for how long.

Table 4. Cases Due to glyphosate in California Reported by Type of Illness and Year, 1982-2000.

Illness Type

a Eye Skin b c Total
Year Systemic Respiratory Combination

1982 7 27 12 - - 46

1983 4 24 22 - 2 52

1984 3 24 11 - - 38

1985 7 23 11 - 1 42

1986 6 20 6 - 1 33

1987 5 18 8 - - 31

1988 5 18 13 - 1 37

1989 7 18 12 - - 37

1990 6 21 18 1 3 49

1991 13 28 16 1 5 63

1992 11 18 12 - 4 45

1993 6 12 11 - 1 30

1994 5 12 6 - 2 25

1995 4 17 14 - 2 37

1996 6 8 7 - 5 26

1997 3 7 10 - 1 21

1998 4 8 6 2 3 23

3920.35 for critical care. When oral exposures, common among children under age six, are excluded, there were

only 2 cases hospitalized and none required critical care treatment. Both of the children that were hospitalized
experienced seizures that were considered to be unknown if related to their exposure to glyphosate. Thus, even

in the most sensitive population, young infants, there was no strong evidence of serious effects from glyphosate.

II. California Data - 1982 through 2000

Detailed descriptions of 911 cases involving glyphosate, submitted to the California Pesticide Illness Surveillance
Program (1982-2000), were reviewed. In 675 of these cases, glyphosate was used alone or was judged to be

responsible for the health effects. These 675 cases include only those with a definite, probable or possible

relationship. Table 4 presents the types of illnesses reported by year. Table 5 gives the total number of workers

that took time off work as a result of their illness and how many were hospitalized and for how long.

Table 4. Cases Due to glyphosate in California Reported by Type of Illness and Year, 1982-2000.

Illness Type

Systemic a Eye Skin Respiratoryb Combination c Total
Year

1982 7 27 12 - - 46

1983 4 24 22 - 2 52

1984 3 24 11 - - 38

1985 7 23 11 - 1 42

1986 6 20 6 - 1 33

1987 5 18 8 - - 31

1988 5 18 13 - 1 37

1989 7 18 12 - - 37

1990 6 21 18 1 3 49

1991 13 28 16 1 5 63

1992 11 18 12 - 4 45

1993 6 12 11 - 1 30

1994 5 12 6 - 2 25

1995 4 17 14 - 2 37

1996 6 8 7 - 5 26

1997 3 7 10 - 1 21

1998 4 8 6 2 3 23Annex 53-A

Direct Spray/Spill 1 6 - 1 - 8

Drift 12 4 2 2 3 23

Residue 2 3 2 - 2 9

Other and Unknown 8 2 2 - - 12

Total 112 316 206 8 33 675

a Category includescaseswhere skin, eye, or respiratory effectswere also reported.

b Category not used until 1990. Prior respiratory casesclassified assystemic.

c
Category includescombined irritative effectsto eye, skin, and respiratory system.

Table 6 shows that activities that involve direct handling of glyphosate account for over 90% of the illnesses. Only

43 illnesses, 6% of the total, could be ascribed to direct spray/spill, drift, or residue, scenarios that could

conceivably occur in Colombia as a result of the spray eradication program. Note that the 43 cases include 3

cases listed as unknown because the exposure could have been either direct spray, drift, or residue which could
not be determined. Among the 43 cases, 30 had a causal relationship classified as possible or 70% of the total.

Among all 675 cases, only 21% were classified as possible. Another 6 of the 43 cases were classified as having

a probable relationship between exposure and health effects and 7 had a definite relationship. Therefore, it should

be noted that the evidence for a causative relationship for the majority of cases involving drift or residue is often
lacking.

Of the 43 cases, 7 took one day off of work as a result of their illness and 2 people took off two days, and

another 2 people took off three days. A possible case picking plums did not know whether pesticides were

applied prior to picking, took five days off work. A possible case occurred in a teacher who reported headache,
nausea, fatigue, and vomiting after the glyphosate odor was sucked into her classroom by an air-conditioning

unit. The final case, a gardener, took 13 days off after pulling weeds and possibly exposed to residue which got

in his eyes, resulting in pain, burning sensations, and impaired vision.

Most of the symptoms reported in this group of 43 cases were relatively minor. Symptoms reported in four or
more individuals included eye irritation (includes itching, pain, burning), conjunctivitis, rash, swelling, skin

irritation (includes itching, blisters, pain, or numbness), throat irritation or burning, nasal congestion, headache,

nausea, shortness of breath or breathing difficulty, and asthmatic reactions. Note that these symptoms are

consistent with those specified in the fifth edition ofRecognition and Management of Pesticide Poisonings

(Reigart and Roberts 1999) which states that glyphosate is "irritating to the eyes, skin, and upper respiratory
tract".

Many of the 43 cases described in the California report involved heavier exposures than are likely to occur as a

result of aerial application. For example, most of the direct spray cases resulted when a bystander was

inadvertently sprayed by an applicator on the ground and was often drenched. Illnesses due to residue were often
the result of extensive contact with soil or foliage recently treated with glyphosate. Reports of illness from drift

from an aerial application were relatively rare, accounting for four of the 23 cases reported above.

Out of 1,384 incidents related to drift reported to the California Pesticide Illness Surveillance Program from 1982

through 1997, only 8 cases were related to glyphosate and suffered mild to moderate effects such as headache,
dizziness, coughing, sore throat and chest pain. Two individuals reported an allergic reaction which included

hives and rash. Glyphosate is second most widely applied pesticide in California (see Wilhoit et al. California

EPA web site: http://www.cdpr.ca.gov/docs/pur/purmain.htm) and unlike many other pesticides has never been

responsible for a large number of illnesses due to drift from a nearby application. California reported the number
of applications of glyphosate and all pesticides from 1991 through 1996 (see web site for data). There were 5,576

systemic poisonings (possible, probable, and definite) reported in this time period for all pesticides and 45

systemic poisoning reported for glyphosate. The number of poisonings per 1,000 applications was 0.6204 for all

pesticides and 0.0781, thus glyphosate had an estimated rate of systemic poisoning that was only 12% that of
all pesticides.

The review of California illness reports suggest that even diluted glyphosate can be a cause of skin, eye, or

throat irritation. These effects are almost always self limiting and do not require hospital admission for treatment.

Only one of the 675 California cases required hospitalization. This 1999 case occurred in an individual who had

394 Direct Spray/Spill 1 6 - 1 - 8

Drift 12 4 2 2 3 23

Residue 2 3 2 - 2 9

Other and Unknown 8 2 2 - - 12

Total 112 316 206 8 33 675

a Category includescaseswhere skin, eye, or respiratory effectswere also reported.

b Category not used until 1990. Prior respiratory casesclassified assystemic.

c
Category includescombined irritative effectsto eye, skin, and respiratory system.

Table 6 shows that activities that involve direct handling of glyphosate account for over 90% of the illnesses. Only

43 illnesses, 6% of the total, could be ascribed to direct spray/spill, drift, or residue, scenarios that could

conceivably occur in Colombia as a result of the spray eradication program. Note that the 43 cases include 3

cases listed as unknown because the exposure could have been either direct spray, drift, or residue which could
not be determined. Among the 43 cases, 30 had a causal relationship classified as possible or 70% of the total.

Among all 675 cases, only 21% were classified as possible. Another 6 of the 43 cases were classified as having

a probable relationship between exposure and health effects and 7 had a definite relationship. Therefore, it should

be noted that the evidence for a causative relationship for the majority of cases involving drift or residue is often
lacking.

Of the 43 cases, 7 took one day off of work as a result of their illness and 2 people took off two days, and

another 2 people took off three days. A possible case picking plums did not know whether pesticides were

applied prior to picking, took five days off work. A possible case occurred in a teacher who reported headache,
nausea, fatigue, and vomiting after the glyphosate odor was sucked into her classroom by an air-conditioning

unit. The final case, a gardener, took 13 days off after pulling weeds and possibly exposed to residue which got

in his eyes, resulting in pain, burning sensations, and impaired vision.

Most of the symptoms reported in this group of 43 cases were relatively minor. Symptoms reported in four or
more individuals included eye irritation (includes itching, pain, burning), conjunctivitis, rash, swelling, skin

irritation (includes itching, blisters, pain, or numbness), throat irritation or burning, nasal congestion, headache,

nausea, shortness of breath or breathing difficulty, and asthmatic reactions. Note that these symptoms are

consistent with those specified in the fifth edition ofRecognition and Management of Pesticide Poisonings

(Reigart and Roberts 1999) which states that glyphosate is "irritating to the eyes, skin, and upper respiratory
tract".

Many of the 43 cases described in the California report involved heavier exposures than are likely to occur as a

result of aerial application. For example, most of the direct spray cases resulted when a bystander was

inadvertently sprayed by an applicator on the ground and was often drenched. Illnesses due to residue were often
the result of extensive contact with soil or foliage recently treated with glyphosate. Reports of illness from drift

from an aerial application were relatively rare, accounting for four of the 23 cases reported above.

Out of 1,384 incidents related to drift reported to the California Pesticide Illness Surveillance Program from 1982

through 1997, only 8 cases were related to glyphosate and suffered mild to moderate effects such as headache,
dizziness, coughing, sore throat and chest pain. Two individuals reported an allergic reaction which included

hives and rash. Glyphosate is second most widely applied pesticide in California (see Wilhoit et al. California

EPA web site: http://www.cdpr.ca.gov/docs/pur/purmain.htm) and unlike many other pesticides has never been

responsible for a large number of illnesses due to drift from a nearby application. California reported the number
of applications of glyphosate and all pesticides from 1991 through 1996 (see web site for data). There were 5,576

systemic poisonings (possible, probable, and definite) reported in this time period for all pesticides and 45

systemic poisoning reported for glyphosate. The number of poisonings per 1,000 applications was 0.6204 for all

pesticides and 0.0781, thus glyphosate had an estimated rate of systemic poisoning that was only 12% that of
all pesticides.

The review of California illness reports suggest that even diluted glyphosate can be a cause of skin, eye, or

throat irritation. These effects are almost always self limiting and do not require hospital admission for treatment.

Only one of the 675 California cases required hospitalization. This 1999 case occurred in an individual who hadAnnex 53-A

file with the California Department of Pesticide Registration (CDPR), the 39% formulated product causes

moderate levels of irritation, a disparity probably due to irritant properties of surfactant(s) in the latter.

Virtually all of the cases of eye, skin, and respiratory irritation reported in California have occurred in
applicators of the formulated product, and residue is not known to produce skin reaction. In the CDPR

series, cases of skin irritation associated with glyphosate were often associated with contaminated work

clothing occluding the material directly against the skin."

O � Malley� s finding is supported by the California Pesticide Illness Surveillance Program, which is regarded as
the best, most comprehensive source of information on human pesticide exposure in the United States (U.S.

General Accounting Office 1993). This information and the earlier review of data from California, strongly support

the conclusion that the dermal risk of glyphosate, as formulated in the United States, is primarily to pesticide

handlers with very little or minor risk to others (e.g., bystanders) who may be exposed to glyphosate drift or
residue.

There was one recent case report in the literature of a 54 year-old man in Brazil who unintentionally sprayed

himself and developed skin lesions six hours later (Barbosa et al. 2001). He developed severe conjunctival
hyperemia (excess blood flow) and a rash which became blisters and persisted for 15 days. One month after the

exposure he developed symmetrical parkinsonian syndrome. The authors acknowledge that "it is not possible to

exclude the coincidence [idiopathic Parkins�n s disease] with exposure to glyphosate" and add that no other

report of parkinsonism induced by glyphosate has been reported. The authors propose a possible mechanism for
excitatory mechanisms but characterize their finding as a hypothesis. Other more detailed studies are underway

to determine whether pesticides might be related to Parkin�on s disease and any conclusions about the

potential involvement of glyphosate will have to await the results of those studies.

Williams et al. (2000) prepared an extensive risk assessment and safety evaluation of glyphosate, partly

supported by scientists with the manufacturer. They cite a study by Jauhiainen et al. (1991) which evaluated

short-term effects among five forest applicators. and compared results with pre-exposure baseline as well as to

data from a group of five controls. "There were no effects on hematology, clinical chemistry, ECG, pulmonary
function, blood pressure, or heart rate 1 week after application." They also cited California data as reviewed by

Pease et al. (1993) and noted that irritation of skin and eye effects were common, but not exceptional taking into

account the widespread product use. Reviewing the Temple and Smith (1992) report (reviewed above), Williams

et al. suggest that the systemic symptoms r eported (e.g., headache, fast pulse, slight nausea) "probably
represent a nonspecific response related to pain associated with eye and/or skin irritation." Other studies cited

by Williams related to dermal effects have already been reviewed above.

Ocular effects

Acquavella et al. (1999) reviewed ocular effects reported to the American Association of Poison Control Centers

in the United States from 1993 through 1997. They identified 1513 records involving ocular or dermal/ocular

exposure. Information from patient notes kept by at least one Poison Center were also reviewed. More than 80%

of the exposures were residential and about 15% were occupational. Only 5% of the calls involved concentrated
product. "Approximately 70% of callers had minor effects, primarily transient irritations, attributed to exposure.

Ninety-nine percent of those with minor effects complained of eye pain, 3% complained of lacrimation (watery

eyes), and 3% complained of blurred vision." Those exposed to more concentrated formulations (>2%

glyphosate, >1%Polyethoxylated tallow amine) were more likely to report lacrimation but not blurred vision,
however, there was little evidence of a trend between concentration categories and lacrimation. A total of 30

callers (2%) were classified as having a moderate medical outcome, such as persistent irritations, low grade

corneal burns or abrasions. There was one caller (0.1%) with a major effect - scarring of the upper palpebral
conjunctiva. This patient was wearing extended wear contact lenses that were rinsed and replaced right after the

exposure. Over the next 17 days the patient had a corneal abrasion and conjunctivitis which resolved as the

vision returned to its pre-exposure state. The additional information on this case suggests the case should be

reclassified as moderate because the scarring of the tear duct system, which washtought to be permanent, did
heal. There were 95 calls lost to follow-up where medical outcome remained undetermined. In summary, there

was some temporary injury in about 2% of the reported cases, but no case of permanent damage.

Inhalation exposure

Jamison et al. (1986) conducted a study of pulmonary function in workers handling flax which had previously had

the fibers softened and separated and either wetted or treated with glyphosate 6 weeks prior to harvest. The

authors concluded that workers had a significant decrease in pulmonary function which was likely due to

exposure to the dust. Though there was very little residue of glyphosate at the end of the six weeks, the authors
stated that glyphosate could not "be excluded as a cause of the increase pulmonary function impairment

observed." However, Williams et al. (2000) took issue with this view, noting that the levels of glyphosate would be

very low, "if present at all, and could not be responsible for the altered pulmonary function observed." They felt

396 file with the California Department of Pesticide Registration (CDPR), the 39% formulated product causes the production of dust particles and/or different microorganisms during the process were a more likely

moderate levels of irritation, a disparity probably due to irritant properties of surfactant(s) in the latter. explanation.

Virtually all of the cases of eye, skin, and respiratory irritation reported in California have occurred in
Pushnoy et al. (1998) reported on a 42 year-old mechanic who cleaned and repaired a spray rig in a confined
applicators of the formulated product, and residue is not known to produce skin reaction. In the CDPR
series, cases of skin irritation associated with glyphosate were often associated with contaminated work space. He reported to the emergency department complaining of shortness of breath, irritative cough, dizziness,
discomfort in the throat, and coughing up blood. He was admitted to the hospital and diagnosed with acute
clothing occluding the material directly against the skin."
chemical pneumonitis. The authors suggested that the polyoxyethylene amine surfactant was largely

O � Malley� s finding is supported by the California Pesticide Illness Surveillance Program, which is regarded as responsible for irritant effects on the mucosal lining and lung tissue, and therefore, the likely cause of the

the best, most comprehensive source of information on human pesticide exposure in the United States (U.S. pneumonitis. Goldstein et al. (1999, 5 authors with industry and one with Yale University) took issue with the
General Accounting Office 1993). This information and the earlier review of data from California, strongly support findings of Pushnoy et al. They argued that neither glyphosate nor any compound in the finished product could

the conclusion that the dermal risk of glyphosate, as formulated in the United States, is primarily to pesticide vaporize sufficiently even in a poorly ventilated space to cause such an exposure. They added that occupational

handlers with very little or minor risk to others (e.g., bystanders) who may be exposed to glyphosate drift or pneumonitis had never been reported in connection with glyphosate products. The original authors replied that a
residue. longer presentation of the circumstances surrounding this case would have permitted Goldstein et al. to reject

the alternative exposures (e.g., chlorinated solvent, diesel fuel, welding) they suggested. They further state that
There was one recent case report in the literature of a 54 year-old man in Brazil who unintentionally sprayed
even though the vapor pressure of glyphosate was low "we have concluded that the patient s clinical
himself and developed skin lesions six hours later (Barbosa et al. 2001). He developed severe conjunctival
symptomatology resulted from exposure and inhalation of a mixture of vapor and air-borne droplets containing
hyperemia (excess blood flow) and a rash which became blisters and persisted for 15 days. One month after the glyphosate . . . that part of the parenchymal reaction was due to the effect of a surfactant (such as
exposure he developed symmetrical parkinsonian syndrome. The authors acknowledge that "it is not possible to
polyoxyethylene amine) on the alveolar lining". However, the authors acknowledge that the effect of the
exclude the coincidence [idiopathic Parkinso� s disease] with exposure to glyphosate" and add that no other
surfactant, though it seems plausible, is "based just on clinical evidence".
report of parkinsonism induced by glyphosate has been reported. The authors propose a possible mechanism for

excitatory mechanisms but characterize their finding as a hypothesis. Other more detailed studies are underway Oral exposure
to determine whether pesticides might be related to Parkinson s disease and any conclusions about the
� Inadvertent oral exposure to glyphosate sprayed on coca plants in Colombia is extremely unlikely. Therefore, the
potential involvement of glyphosate will have to await the results of those studies.
review of the scientific literature on oral exposure will be cursory. In a letter to Lancet Sawada et al. (1988)

Williams et al. (2000) prepared an extensive risk assessment and safety evaluation of glyphosate, partly reported on 56 ingestions of glyphosate product. They found that the average dose among fatal cases was 104

supported by scientists with the manufacturer. They cite a study by Jauhiainen et al. (1991) which evaluated ml and 206 ml among fatal cases. They describe the clinical picture as one of hypovolaemic shock likely due to
short-term effects among five forest applicators. and compared results with pre-exposure baseline as well as to the 15% polyoxyethylene amine surfactant. Of the 56 cases reviewed, 48 cases were attempted suicides, 3

data from a group of five controls. "There were no effects on hematology, clinical chemistry, ECG, pulmonary unintentional (all infants), and 5 with unknown intent. Jackson (1988 with Monsanto) responded to the Sawada et

function, blood pressure, or heart rate 1 week after application." They also cited California data as reviewed by al. report and stated that there were no reports of deaths following accidental ingestion.

Pease et al. (1993) and noted that irritation of skin and eye effects were common, but not exceptional taking into
account the widespread product use. Reviewing the Temple and Smith (1992) report (reviewed above), Williams Kageura et al. (1988) reported on the death of a 26 year old woman who ingested glyphosate in a suicide. They
attributed the death to inhalation of vomitus into the lungs causing asphyxiation. Talbot et al. (1991) reviewed 93
et al. suggest that the systemic symptoms r eported (e.g., headache, fast pulse, slight nausea) "probably
cases of glyphosate exposure reported to the emergency room in Taiwan from 1974 through September 30,
represent a nonspecific response related to pain associated with eye and/or skin irritation." Other studies cited
1989. Cases involving exposures to other products were excluded. The majority of these cases were suicidal and
by Williams related to dermal effects have already been reviewed above.
involved oral exposures. Those cases where the amount ingested was not recorded were also excluded. They
Ocular effects noted that some cases had only moderate effects even after ingestion of up to 500 ml and death had resulted

from ingestion of concentrate in amounts above 85 ml. Oral ingestions by mistake in seven cases was usually of
Acquavella et al. (1999) reviewed ocular effects reported to the American Association of Poison Control Centers
a small amount and "resulted in only minor mouth discomfort". The authors concluded that "the data suggest
in the United States from 1993 through 1997. They identified 1513 records involving ocular or dermal/ocular that those over 40 years of age, who ingest more than 100 ml, are at the highest risk of a fatal outcome."
exposure. Information from patient notes kept by at least one Poison Center were also reviewed. More than 80%

of the exposures were residential and about 15% were occupational. Only 5% of the calls involved concentrated Tominack et al. (1991) reported on 97 telephone consultations with the Taiwan National Poison Center involving

product. "Approximately 70% of callers had minor effects, primarily transient irritations, attributed to exposure. ingestion of glyphosate-surfactant herbicide concentrate from January 1986 through September 1988. Eighty-

Ninety-nine percent of those with minor effects complained of eye pain, 3% complained of lacrimation (watery eight cases were suicidal, five unintentional, and four with uncertain intention. Non-fatal cases ingested an
eyes), and 3% complained of blurred vision." Those exposed to more concentrated formulations (>2% average of 120 ml (range 5-500 ml) and fatal cases averaged 263 ml (range 150-500 ml). Of these 97, 12 were

glyphosate, >1%Polyethoxylated tallow amine) were more likely to report lacrimation but not blurred vision, asymptomatic, 28 had mild, 33 had moderate, and 16 had severe symptoms. Increasing dose and increasing

however, there was little evidence of a trend between concentration categories and lacrimation. A total of 30 age were significant predictors of fatality. It should be noted that 10 of the 97 cases ingested another substance

callers (2%) were classified as having a moderate medical outcome, such as persistent irritations, low grade in addition to glyphosate. They found that ingestion of a mouthful of concentrate or more was capable of
corneal burns or abrasions. There was one caller (0.1%) with a major effect - scarring of the upper palpebral producing symptoms including gastrointestinal mucosal injury, pulmonary edema, decreased or absent urine

conjunctiva. This patient was wearing extended wear contact lenses that were rinsed and replaced right after the output, metabolic acidosis, leukocytosis, fever, and hypotension that possibly could develop into shock. Similar

exposure. Over the next 17 days the patient had a corneal abrasion and conjunctivitis which resolved as the to the paper cited above, a dose of 150 ml or more and age of 40 years or more were found to be at highest risk

vision returned to its pre-exposure state. The additional information on this case suggests the case should be of fatal outcome.
reclassified as moderate because the scarring of the tear duct system, which washtought to be permanent, did
Menkes et al. (1991) reported on four cases of suicidal ingestion of glyphosate, one of them fatal. Two of the
heal. There were 95 calls lost to follow-up where medical outcome remained undetermined. In summary, there
cases experienced massive fluid and electrolyte loss, probably due to tubular necrosis. After considering all of
was some temporary injury in about 2% of the reported cases, but no case of permanent damage.
the evidence concerning the glyphosate and the surfactant the authors stated "it seems unlikely that toxicity can

Inhalation exposure be ascribed solely to the surfactant."

Jamison et al. (1986) conducted a study of pulmonary function in workers handling flax which had previously had Temple and Smith (1992) reviewed a series of cases reported to the New Zealand National Poisons Information

the fibers softened and separated and either wetted or treated with glyphosate 6 weeks prior to harvest. The Centre. The majority of these cases were unintentional. Three ingestions are described, two of them fatal. The

authors concluded that workers had a significant decrease in pulmonary function which was likely due to authors concluded "Small ingestions (less than 5 ml of the concentrate in adults) pose little problem and simple

exposure to the dust. Though there was very little residue of glyphosate at the end of the six weeks, the authors dilution to minimize gastrointestinal irritation should suffice."
stated that glyphosate could not "be excluded as a cause of the increase pulmonary function impairment
Hung et al. (1997) reviewed 53 cases reported between 1992 and 1996 in Taiwan to assess laryngeal injury. Of
observed." However, Williams et al. (2000) took issue with this view, noting that the levels of glyphosate would be
these, 36 reported significant laryngeal injury was strongly correlated with aspiration pneumonitis (reported in 8
very low, "if present at all, and could not be responsible for the altered pulmonary function observed." They feltAnnex 53-A

cases). The average amount ingested in such cases was 300 ml.

Lin et al. (1999) reported on a suicide case who drank 150 ml of concentrate (41% isopropylamine salt of

glyphosate, 15% polyoxyethylene amine). This 26 year-old man experienced cardiogenic shock which may have
been due to transient suppression of the cardiac conductionsystem and contractility, rather than intravascular

hypovolemia.

Chang et al. (1999) reported on 50 patients with suicidal glyphosate-surfactant ingestions and evaluated their

upper gastrointestinal tract injuries. Esophageal injury was seen in 68% of patients, gastric injury in 72%, and
duodenal injury in 16%. The authors considered these injuries "minor in comparison with those by other strong

acids."

Lee et al. (2000) reviewed 131 cases of glyphosate ingestion seen in their emergency department in Taiwan over

a seven year period. There were 11 fatalities (mortality rate 8.4%). The most common presentations included
sore throat (80%), nausea (74%), vomiting, and fever (41%). The most common laboratory abnormalities were

leukocytosis (68%), low bicarbonate (48%), acidosis (36%), elevated AST, hypoxemia (28%), and elevated BUN.

Of the 81 cases receiving an electrocardiogram, 15 were abnormal, mainly sinus tachycardia and nonspecific
ST-T changes. Twenty-two of 105 patients who had chest x-rays had abnormal infiltrates or patches. Three

patients with renal failure all died. Poor outcome was predicted by respiratory distress, renal dysfunction,

abnormal CXR, shock, and ingestion of 200 ml or more, altered consciousness, hyperkalemia, and pulmonary

edema. The 11 cases that died ingested an average of 330 ml which was higher than the previous reports by
Sawada et al. (1988) and Tominack et al. (1991). The authors propose that direct damage to the airway passage

is an important factor in severe poisoning.

Reproductive effects

There were two studies located that evaluated reproductive outcome in farmers handling pesticides that

specifically analyzed for the effects of glyphosate. However, these studies are both retrospective, subject to

numerous biases and confounders, and only suggest associations rather than causative relationships. Thus any

of these finding would require replication and further evaluation before they could become established. These
studies are summarized below.

Savitz et al. (1997) examined male pesticide exposure three months before conception and through conception

in relation to pregnancy outcome in an Ontario farm population. The risk for miscarriage was not statistically

significant, though somewhat elevated for glyphosate users. This finding was true for both use of glyphosate on
crops (17 cases) and in yards (13 cases). A similar result was found for preterm delivery based on 5 cases

involving crop use of glyphosate. On the other hand, there was no statistical significance or elevation of risk for

small for gestational age infants. The authors acknowledge that the lengthy recall interval may have reduced the
quality of information collected on exposure and health outcome. They advise "Replication of these findings in

other geographic settings in a study of similar quality would be of value; however, to improve on our strategy, the

availability of unusually detailed source of historical exposure data would be necessary."

Arbuckle and Mery (2001) evaluated the risk of spontaneous abortion in the same Ontario farm population
examined by Savitz et al. (1997). In this refined analysis they found that late abortions were statistically

associated with preconception exposure to glyphosate (odds ratio = 1.7, 95% confidence interval 1.0-2.9). This

finding is only just marginally significant. The authors state their findings have "several limitations . . . Because
dose information was not available, misclassification of exposure is likely." Finally they state their "analyses

were designed to generate, not to test, hypotheses". Due to the fact that multiple comparisons were conducted

some findings may be due to chance.

IV. A Study of Health Complaints Related to Aerial Eradication in Colombia

This report, prepared by the Department of Narino, Municipality of El Tablon De Gomez, makes a concerted

effort to identify any health problems that might be related to use of glyphosate in aerial eradication programs.

The study was commissioned by the U.S. Embassy in Bogota and conducted independently by Dr. Camillo

Uribe, Director of Clinica Uribe Cualla, the national poison control center. Sections of this report are summarized
below with the sections numbed in bold as in the original report.

1.1 Description of studied area

This report primarily concerns the area around the municipality of El Tablon in southern Colombia. The total
population is given as 16,770, of which 89% is categorized as rural. The main crops in this area include coffee,

corn, wheat, oats, potatoes, and illicit opium poppy. It is known that a variety of other more toxic pesticides are

used on these crops. The municipality has three health centers, including Aponte, which is the focus of this

report. The Aponte health center is staffed by a medical doctor, a nurse, and a nur�e s aide. From July 2000 to

398cases). The average amount ingested in such cases was 300 ml.

Lin et al. (1999) reported on a suicide case who drank 150 ml of concentrate (41% isopropylamine salt of

glyphosate, 15% polyoxyethylene amine). This 26 year-old man experienced cardiogenic shock which may have

been due to transient suppression of the cardiac conductionsystem and contractility, rather than intravascular
hypovolemia.

Chang et al. (1999) reported on 50 patients with suicidal glyphosate-surfactant ingestions and evaluated their

upper gastrointestinal tract injuries. Esophageal injury was seen in 68% of patients, gastric injury in 72%, and

duodenal injury in 16%. The authors considered these injuries "minor in comparison with those by other strong
acids."

Lee et al. (2000) reviewed 131 cases of glyphosate ingestion seen in their emergency department in Taiwan over

a seven year period. There were 11 fatalities (mortality rate 8.4%). The most common presentations included
sore throat (80%), nausea (74%), vomiting, and fever (41%). The most common laboratory abnormalities were

leukocytosis (68%), low bicarbonate (48%), acidosis (36%), elevated AST, hypoxemia (28%), and elevated BUN.

Of the 81 cases receiving an electrocardiogram, 15 were abnormal, mainly sinus tachycardia and nonspecific

ST-T changes. Twenty-two of 105 patients who had chest x-rays had abnormal infiltrates or patches. Three
patients with renal failure all died. Poor outcome was predicted by respiratory distress, renal dysfunction,

abnormal CXR, shock, and ingestion of 200 ml or more, altered consciousness, hyperkalemia, and pulmonary

edema. The 11 cases that died ingested an average of 330 ml which was higher than the previous reports by

Sawada et al. (1988) and Tominack et al. (1991). The authors propose that direct damage to the airway passage
is an important factor in severe poisoning.

Reproductive effects

There were two studies located that evaluated reproductive outcome in farmers handling pesticides that

specifically analyzed for the effects of glyphosate. However, these studies are both retrospective, subject to
numerous biases and confounders, and only suggest associations rather than causative relationships. Thus any

of these finding would require replication and further evaluation before they could become established. These

studies are summarized below.

Savitz et al. (1997) examined male pesticide exposure three months before conception and through conception
in relation to pregnancy outcome in an Ontario farm population. The risk for miscarriage was not statistically

significant, though somewhat elevated for glyphosate users. This finding was true for both use of glyphosate on

crops (17 cases) and in yards (13 cases). A similar result was found for preterm delivery based on 5 cases

involving crop use of glyphosate. On the other hand, there was no statistical significance or elevation of risk for
small for gestational age infants. The authors acknowledge that the lengthy recall interval may have reduced the

quality of information collected on exposure and health outcome. They advise "Replication of these findings in

other geographic settings in a study of similar quality would be of value; however, to improve on our strategy, the
availability of unusually detailed source of historical exposure data would be necessary."

Arbuckle and Mery (2001) evaluated the risk of spontaneous abortion in the same Ontario farm population

examined by Savitz et al. (1997). In this refined analysis they found that late abortions were statistically

associated with preconception exposure to glyphosate (odds ratio = 1.7, 95% confidence interval 1.0-2.9). This
finding is only just marginally significant. The authors state their findings have "several limitations . . . Because

dose information was not available, misclassification of exposure is likely." Finally they state their "analyses

were designed to generate, not to test, hypotheses". Due to the fact that multiple comparisons were conducted

some findings may be due to chance.

IV. A Study of Health Complaints Related to Aerial Eradication in Colombia

This report, prepared by the Department of Narino, Municipality of El Tablon De Gomez, makes a concerted

effort to identify any health problems that might be related to use of glyphosate in aerial eradication programs.

The study was commissioned by the U.S. Embassy in Bogota and conducted independently by Dr. Camillo
Uribe, Director of Clinica Uribe Cualla, the national poison control center. Sections of this report are summarized

below with the sections numbed inbold as in the original report.

1.1 Description of studied area

This report primarily concerns the area around the municipality of El Tablon in southern Colombia. The total
population is given as 16,770, of which 89% is categorized as rural. The main crops in this area include coffee,

corn, wheat, oats, potatoes, and illicit opium poppy. It is known that a variety of other more toxic pesticides are

used on these crops. The municipality has three health centers, including Aponte, which is the focus of this
report. The Aponte health center is staffed by a medical doctor, a nurse, and a nurse s aide. From July 2000 to
�Annex 53-A

of diarrhea and respiratory infection occurred in children less than five years old, as would be expected given the

known demographics of those diseases. Nationwide data show that 53% of intoxications are suicides or suicide

attempts, but it is not clear how many of the 13 poisonings listed above might be suicidal or, more importantly,

are due to other products such as medications. In both Tables 7 and 8 there is an increase of 5% from 1999 to
the estimate for 2000. Given that spraying is reported to have occurred in 2000 and not in 1999, this suggests

that the overwhelming majority (95%) of illnesses reported would be background incidence unrelated to the

spraying of herbicide. The remaining 5% increase could be due to a variety of causes and do not support a

conclusion that glyphosate was responsible for these complaints.

1.3 Epidemiological monitoring system and mandatory notification

In addition to the summary of morbidity, there is a mandatory health reporting system in Colombia for 34

illnesses including pesticide poisonings. The review of these records found no reports of pesticide poisoning for

the municipality of El Tablon in the year 2000 or the first 9 weeks of 2001. Weekly reports from Attachment 5
were examined to determine how many pesticide poisonings were reported each month. It was not clear whether

the dates on each report represented the starting date or ending date for a reporting period. Regardless of which

is correct, it did not appear that the times of spraying correlated with reports of pesticide intoxication.

Table 9. Reports of Pesticide Intoxication provided to the Narino Department of Health Institute, Epidemiology
Section January 12, 2000 through March 7, 2001.

Month in Number of Month in 2000 Number of Poisonings occurring at time

2000 Poisonings or 2002 poisonings of spraying

January 0 July 11 9

February 0 August 6

March 8 September 12

April 13 October 8

May 7 November 13* 6*

June 15 December 2

-- - Jan. 2001 7

-- - Feb. 2001 19

-- - Mar. 2001 0

*Reportsfor weeksnumber 43 and 44 in the first half of November were missing.

Out of a total of 121 reported pesticide poisonings in 61 weeks, only 15 occurred during 5 weeks when spraying

eradication occurred. This given the variation in the data, this could easily be due to chance and be unrelated to
glyphosate exposure. More work would be required to determine whether locations of the 15 suspect poisoning

matched the location and timing of spraying.

In 2000, the Narino Department of Health requested all municipalities to report on the effects of spraying on

human health. Ten municipalities supplied the following reports:

Three municipalities including Tablon de Gomez, Barbacoas, and Magui reported no cases. However, the reports

were completed prior to the November spraying in Barbacoas and Magui and prior to (or perhaps during) the July

and before the November spraying in Tablon de Gomez.

Buesaco reported one patient with sore throat, numbness in limbs, and conjunctivitis in June.

In Tumaco, six case of patients with conjunctivitis and dermatitis were reported.

400of diarrhea and respiratory infection occurred in children less than five years old, as would be expected given the
In San Pablo, 50 cases of dermatitis, conjunctivitis, respiratory conditions, and digestive problems were reported
known demographics of those diseases. Nationwide data show that 53% of intoxications are suicides or suicide after spraying.

attempts, but it is not clear how many of the 13 poisonings listed above might be suicidal or, more importantly,
In La Cruz, two cases of allergic rhinitis, two cases of dermatitis, and five cases of conjunctivitis were reported.
are due to other products such as medications. In both Tables 7 and 8 there is an increase of 5% from 1999 to
the estimate for 2000. Given that spraying is reported to have occurred in 2000 and not in 1999, this suggests
San Jose de Alban did not report any specific cases, but the scientific coordinator and chief nurse noted
that the overwhelming majority (95%) of illnesses reported would be background incidence unrelated to the increase in gastrointestinal, dermatological and respiratory conditions. The exact quantity of these conditions in

spraying of herbicide. The remaining 5% increase could be due to a variety of causes and do not support a relation to spray times was not given.

conclusion that glyphosate was responsible for these complaints.
El Rosario reported five cases of conjunctivitis and rhinitis that might have been related to spraying carried out on
1.3 Epidemiological monitoring system and mandatory notification
July 31.

In addition to the summary of morbidity, there is a mandatory health reporting system in Colombia for 34 San Pedro de Cartago reported an increase in gastrointestinal symptoms but no quantitative relationship

illnesses including pesticide poisonings. The review of these records found no reports of pesticide poisoning for between illnesses and spray times was provided.

the municipality of El Tablon in the year 2000 or the first 9 weeks of 2001. Weekly reports from Attachment 5
were examined to determine how many pesticide poisonings were reported each month. It was not clear whether The absence of any reports of pesticide poisoning combined with the information from the ten municipalities is

the dates on each report represented the starting date or ending date for a reporting period. Regardless of which difficult to interpret. Glyphosate is known to cause irritation to the skin, eyes, mucous membranes which may
account for some of the reports of sore throat, conjunctivitis, dermatitis and other conditions described above.
is correct, it did not appear that the times of spraying correlated with reports of pesticide intoxication.
However, it is not possible to evaluate these reports in any detail due to the lack of any information on how many

Table 9. Reports of Pesticide Intoxication provided to the Narino Department of Health Institute, Epidemiology of these cases experienced exposure immediately prior to their illness and lack of information on investigation of
Section January 12, 2000 through March 7, 2001.
potential alternative causes. This anecdotal information does not provide any substantial evidence of health
effects due to glyphosate spraying in Colombia. Many of the reports are consistent with exposure to glyphosate

Month in Number of Month in 2000 Number of Poisonings occurring at time by the dermal route, as reported in California and the literature. So, some number of cases (impossible to

2000 Poisonings or 2002 poisonings of spraying estimate) could be related to the aerial eradication program.

2.2 Review of report of January 22, 2001 visit to the municipality of El Tablon de Gomez.
January 0 July 11 9
A commission visited the municipality of El Tablon on January 22, 2001 and spoke with Dr. Tordecilla and

reviewed health records of his patients. A number of records of skin conditions were noted for the months of

February 0 August 6 October, December 2000, and January 2001. The exact number of cases, selection criteria, and method of
analysis was not specified in the summary report. Nevertheless, the commission concluded "that the information

available permitted the commission to consider only the possibility of an association between exposure to
March 8 September 12
pesticides and the effects". The commission noted that it lacked the technical expertise, the data on dates and

locations of spraying, and therefore could not conclude whether the observed conditions were related to pesticide
April 13 October 8 exposure.

2.3 Interviewswith Narino department health officialsregarding the spraying
May 7 November 13* 6*

Employees of the Narino Department Health Institute were interviewed. According to a Fatima Health Promoter,

June 15 December 2 he/she thought the children were most affected, suffering gastrointestinal problems and eye irritation. One
possible route of exposure was the village water fountains that were reportedly sprayed and that water could

reach the water that supplies the settlement. The most common symptoms in children, according to the Health

-- - Jan. 2001 7 Promoter, were stomach aches and vomiting, which were different from the most common symptoms reported by

Lee et al. (2000) which were sore throat and nausea. This suggests that some cause other than glyphosate was
responsible for the children s complaints. He/she reported one case of a boy with skin lesions like sores after
-- - Feb. 2001 19
the spraying. He/she was particularly concerned that peasants receive more health care from the government.

He/she also noted that he lost a considerable sum of money when most of his peas were affected by the
-- - Mar. 2001 0
spraying in June. He/she claimed to have a tape made during the spraying by pilots where they were heard to
say they would dump the remainder of their herbicide in a field because they had too much quantity.

*Reportsfor weeksnumber 43 and 44 in the first half of November were missing.
A nurse

Out of a total of 121 reported pesticide poisonings in 61 weeks, only 15 occurred during 5 weeks when spraying health center. One boy with a respiratory infection was sent to another health center where he arrived dead.

eradication occurred. This given the variation in the data, this could easily be due to chance and be unrelated to Medical records were sought to substantiate this report but there was no clinical history, autopsy or other
glyphosate exposure. More work would be required to determine whether locations of the 15 suspect poisoning information to support it. She referred a patient with urinary problems to the hospital. Subsequent review of the

matched the location and timing of spraying. medical records of this case did not find reference to glyphosate exposure and suggested an infectious origin.

She said there had been cases of dermatitis, headache, abdominal pain and gastrointestinal symptoms, but
In 2000, the Narino Department of Health requested all municipalities to report on the effects of spraying on could not say whether the symptoms were related to glyphosate exposure. She also was concerned that the

human health. Ten municipalities supplied the following reports: government supply aid to this needy population, especially better health services.

Three municipalities including Tablon de Gomez, Barbacoas, and Magui reported no cases. However, the reports
Another nurse�
were completed prior to the November spraying in Barbacoas and Magui and prior to (or perhaps during) the July
consultations had increased. She admitted her impression was subjective and that the reasons for the
and before the November spraying in Tablon de Gomez. consultations were the same as in previous years, so she would not commit to there being a relationship

between the spraying and these dermatological conditions.
Buesaco reported one patient with sore throat, numbness in limbs, and conjunctivitis in June.

In Tumaco, six case of patients with conjunctivitis and dermatitis were reported. Reports of anecdotal evidence by nurse s aides and the health promoter have little value for establishing any

link between the spraying of glyphosate and health effects. Only with follow-up to substantiate the suspicionsAnnex 53-A

could a more substantial case be made. These interviews do no add significant evidence about the health risks

of glyphosate used in Colombia.

2.4 Video

Some videos made by reporters were reported at the Aponte Health Center. One of these videos was located and

reviewed. It purported to show spraying on November 3, 2000 which caused unspecified "calamities". However,

specific evidence of health complaints in humans was, apparently, not provided.

This video does provides opinion but does not add substantive information about the potential health effects of

glyphosate used in Colombia.

2.5 Review of records of patients treated at Aponte Health Center - Sept. 2000 to Jan. 2001

There were 29 cases reported by Dr. Tordecelli and clinical records were obtained for 21 of them. Two other
reports of skin lesions were sought but could not be confirmed. After careful review of the 21 records, it was

determined that all but four cases were likely due to other causes. Most had skin conditions known to be related

to bacteria or parasites, not chemical exposures and the onset of their symptoms did not correspond with the
times of spraying. There were seven patients whose symptoms started after spraying and three of these were

conditions known to be caused by bacteria or parasites. For the remaining four cases possibly related to

glyphosate spraying, one was an allergic reaction that had been seen in this patient before when there was no
spraying. A second and third case were contact eczema that is endemic in this region and thought to be more

likely due to an infectious origin. One of these two cases did not initiate until 52 days after the last spraying. The

fourth case was dermatitis on the thigh which would typically be protected by clothing and thereby protected

from aerial spray applications. This reviewer agrees with the conclusion that "the twenty-one clinical histories . . .
reveals that any relationship between aerial eradication with the herbicide glyphosate and the skin conditions

treated in Aponte is unlikely".

In summary, the evidence collected and presented in this report cannot confirm the glyphosate used in Colombia
as the likely cause of a single illness. There is suggestive evidence in the form of reported increases of morbidity

and reports from municipalities that some cases of relatively mild complaints could have occurred in relation to

the spraying eradication program. Some of the reports appear to be similar to those reported in the literature and

by California. These cases report irritation to skin, eyes, a respiratory passages and suggesting that the Cosmo-
Flux 411F added to the glyphosate in Colombia has little or no effect on the overall toxicity of the formulated

product. If true, this would mean that the evaluation of glyphosate, as used in the United States and elsewhere,

would be expected to have the same toxicologic properties and effects as glyphosate formulated in Colombia.

Rather than review incomplete medical records, it would be better to collect information prospectively. For

example, if pesticide poisoning is a mandatory reporting condition, a form documenting the exposure, health

effects and medical data on each case could be designed and used to establish whether any particular

conditions might be related to spraying glyphosate. Without prospective collection of data and follow up it is
difficult to evaluate potential health effects of glyphosate.

V. Conclusions

There is some data to suggest that the spray eradication program could have resulted in minor skin, eye, or
respiratory irritation, and perhaps headache or other minor symptoms. However, the detailed information on

timing of application, history of exposure, and medical documentation of symptoms related to glyphosate

exposure were not available. Thus, not a single case of the reported symptoms can be confirmed as caused by
the spray applications. The information so far collected gives the impression that any increase in health

problems is likely to be relatively small at most and the severity of those symptoms is likely to be minor to

moderate at most. Given the limited amount of documentation, none of the data in the report from Colombia

provide a compelling case that glyphosate spraying has been a significant cause of illness in the region studied.
Some of the reports in Colombia, potentially related to glyphosate, are similar to those reported in the literature

and by California. These cases report irritation to skin, eyes, a respiratory passages and suggesting that the

Cosmo-Flux 411F added to the glyphosate in Colombia has little or no effect on the overall toxicity of the
formulated product. Colombia. Prospective tracking of reports of health complaints, documenting times of

exposure and onset of symptoms, are recommended during future spray operations to evaluate any potential

health effects and ameliorate or prevent their occurrence.

References

Acquavella JF, Weber JA, Cullen MR, Cruz OA, Martens MA, Holden LR, Riordan S, Thompson M, Farmer D.

1999. Human ocular effects from self-reported exposures to Roundup herbicides. Hum Exp Toxicol.18(8):479-86.

Arbuckle TE, Lin Z, Mery LS. 2001. An exploratory analysis of the effect of pesticide exposure on the risk of

402could a more substantial case be made. These interviews do no add significant evidence about the health risks spontaneous abortion in an Ontario farm population. Environ Health Perspect 109(8):851-7.

of glyphosate used in Colombia.
Barbosa ER, Leiros da Costa MD, Bacheschi LA, Scaff M, Leite CC. 2001. Parkinsonism after glycine-derivate

2.4 Video exposure. MovDisord. 16(3):565-8.

Some videos made by reporters were reported at the Aponte Health Center. One of these videos was located and Chang CY, Peng YC, Hung DZ, Hu WH, Yang DY, Lin TJ. 1999. Clinical impact of upper gastro-intestinal tract
reviewed. It purported to show spraying on November 3, 2000 which caused unspecified "calamities". However, injuries in glyphosate-surfactant oral intoxication. Hum Exp Toxicol. 18(8):475-8.

specific evidence of health complaints in humans was, apparently, not provided.
Goldstein DA, Johnson G, Farmer DR, Martens MA, Ford JE, Cullen MR. 1999. Pneumonitis and herbicide

This video does provides opinion but does not add substantive information about the potential health effects of exposure. Chest. 116(4):1139-40.

glyphosate used in Colombia.
Hindson TC, Diffey B. 1984a. Phototoxicity of glyphosate in a weedkiller. Contact Dermatitis. 10(1):51-2.
2.5 Review of records of patients treated at Aponte Health Center - Sept. 2000 to Jan. 2001
Hindson TC, Diffey BL. 1984b. Toxicity of a weedkiller: a correction. Contact Dermatitis. 11(4):260.

There were 29 cases reported by Dr. Tordecelli and clinical records were obtained for 21 of them. Two other
Hung DZ, Deng JF, Wu TC. 1997. Laryngeal survey in glyphosate intoxication: a pathophysiological
reports of skin lesions were sought but could not be confirmed. After careful review of the 21 records, it was
determined that all but four cases were likely due to other causes. Most had skin conditions known to be related investigation. Hum Exp Toxicol. 16(10):596-9.

to bacteria or parasites, not chemical exposures and the onset of their symptoms did not correspond with the Jackson JR. 1988. Toxicity of herbicide containing glyphosate. Lancet. Feb 20;1(8582):414.

times of spraying. There were seven patients whose symptoms started after spraying and three of these were
Jamison JP, Langlands JH, Lowry RC. 1986. Ventilatory impairment from pre-harvest retted flax. Br J Ind Med.
conditions known to be caused by bacteria or parasites. For the remaining four cases possibly related to
glyphosate spraying, one was an allergic reaction that had been seen in this patient before when there was no 43(12):809-13.

spraying. A second and third case were contact eczema that is endemic in this region and thought to be more
Jauhiainen A, Rasanen K, Sarantila R, Nuutinen J, Kangas J. 1991. Occupational exposure of forest workers to
likely due to an infectious origin. One of these two cases did not initiate until 52 days after the last spraying. The glyphosate during brush saw spraying work. Am Ind Hyg Assoc J 52:61-64.

fourth case was dermatitis on the thigh which would typically be protected by clothing and thereby protected
from aerial spray applications. This reviewer agrees with the conclusion that "the twenty-one clinical histories . . . Kageuka M, Hieda Y, Hara K, Takamoto M, Fukuma Y, Kashimura S. 1988. Analysis of glyphosate and

reveals that any relationship between aerial eradication with the herbicide glyphosate and the skin conditions (aminomethyl) phosphonic acid in a suspected poisoning case. Nippon Hoigaku Zasshi. 42(2):128-32.

treated in Aponte is unlikely".
Lee HL, Chen KW, Chi CH, Huang JJ, Tsai LM. 2000. Clinical presentations and prognostic factors of a
glyphosate-surfactant herbicide intoxication: a review of 131 cases. Acad Emerg Med. 7:906-10.
In summary, the evidence collected and presented in this report cannot confirm the glyphosate used in Colombia
as the likely cause of a single illness. There is suggestive evidence in the form of reported increases of morbidity
Lin CM, Lai CP, Fang TC, Lin CL. 1999. Cardiogenic shock in a patient with glyphosate-surfactant poisoning. J
and reports from municipalities that some cases of relatively mild complaints could have occurred in relation to
Formos Med Assoc. 98(10):698-700.
the spraying eradication program. Some of the reports appear to be similar to those reported in the literature and

by California. These cases report irritation to skin, eyes, a respiratory passages and suggesting that the Cosmo- Maibach HI. 1986. Irritation, sensitization, photoirritation and photosensitization assays with a
Flux 411F added to the glyphosate in Colombia has little or no effect on the overall toxicity of the formulated
glyphosate herbicide. Contact Dermatitis. 15(3):152-6.
product. If true, this would mean that the evaluation of glyphosate, as used in the United States and elsewhere,

would be expected to have the same toxicologic properties and effects as glyphosate formulated in Colombia. Menkes DB, Temple WA, Edwards IR. 1991. Intentional self-poisoning with glyphosate-containing herbicides.

Hum Exp Toxicol. 10(2):103-7.
Rather than review incomplete medical records, it would be better to collect information prospectively. For
example, if pesticide poisoning is a mandatory reporting condition, a form documenting the exposure, health
O
effects and medical data on each case could be designed and used to establish whether any particular 220. Philadelphia, Hanley & Belfus, Inc.

conditions might be related to spraying glyphosate. Without prospective collection of data and follow up it is
difficult to evaluate potential health effects of glyphosate. Pease WS Morello-Frosch RA, Albright DS, Kyle AD, Robinson JC. 1993. Preventing Pesticide-Related Illness

in California Agriculture. California Policy Seminar, University of California, Berkeley, CA.
V. Conclusions
Pushnoy LA, Avnon LS, Carel RS. 1998. Herbicide (Roundup) pneumonitis. Chest. 114(6):1769-71.

There is some data to suggest that the spray eradication program could have resulted in minor skin, eye, or
Reigart JR, Roberts JR. 1999. Recognition and Management of Pesticide Poisonings, Fifth EditionE
respiratory irritation, and perhaps headache or other minor symptoms. However, the detailed information on
timing of application, history of exposure, and medical documentation of symptoms related to glyphosate 98-003. U.S. Environmental Protection Agency, Washington, D.C.

exposure were not available. Thus, not a single case of the reported symptoms can be confirmed as caused by
Savitz DA, Arbuckle T, Kaczor D, Curtis KM. 1997. Male pesticide exposure and pregnancy outcome. Am J
the spray applications. The information so far collected gives the impression that any increase in health Epidemiol. 146(12):1025-36.

problems is likely to be relatively small at most and the severity of those symptoms is likely to be minor to
moderate at most. Given the limited amount of documentation, none of the data in the report from Colombia Sawada Y, Nagai Y, Ueyama M, Yamamoto I. 1988. Probable toxicity of surface-active agent in commercial

provide a compelling case that glyphosate spraying has been a significant cause of illness in the region studied. herbicide containing glyphosate. Lancet. Feb 6;1(8580):299.

Some of the reports in Colombia, potentially related to glyphosate, are similar to those reported in the literature
Talbot AR, Shiaw MH, Huang JS, Yang SF, Goo TS, Wang SH, Chen CL, Sanford TR. 1991. Acute poisoning
and by California. These cases report irritation to skin, eyes, a respiratory passages and suggesting that the with a glyphosate-surfactant herbicide ('Roundup'): a review of 93 cases. Hum Exp Toxicol. 10(1):1-8.
Cosmo-Flux 411F added to the glyphosate in Colombia has little or no effect on the overall toxicity of the

formulated product. Colombia. Prospective tracking of reports of health complaints, documenting times of Temple WA, Smith NA. 1992. Glyphosate herbicide poisoning experience in New Zealand. N Z Med J.

exposure and onset of symptoms, are recommended during future spray operations to evaluate any potential 105(933):173-4.

health effects and ameliorate or prevent their occurrence.
Tominack RL, Yang GY, Tsai WJ, Chung HM, Deng JF. 1991. Taiwan National Poison Center survey of
References glyphosate--surfactant herbicide ingestions. J Toxicol Clin Toxicol. 29(1):91-109.

Acquavella JF, Weber JA, Cullen MR, Cruz OA, Martens MA, Holden LR, Riordan S, Thompson M, Farmer D. U. S. Department of State. 2002. Letter to Christine Todd Whitman, Administrator, Environmental Protection

1999. Human ocular effects from self-reported exposures to Roundup herbicides. Hum Exp Toxicol.18(8):479-86. Agency from Colin L. Powell. and attachment "Chemicals Used for the Eradication of Illicit Coca in Colombia and

Arbuckle TE, Lin Z, Mery LS. 2001. An exploratory analysis of the effect of pesticide exposure on the risk of Conditions of Application.Annex 53-A

U.S. General Accounting Office. 1993. Pesticides on Farms: Limited capability exists to monitor occupational

illnesses and injuries. Report to the Chairman, Committee on Agriculture, Nutrition, and Forestry, U.S. Senate,

December 1993. GAO/PEMB-94-6.

Wester RC, Melendres J, Sarason R, McMaster J, Maibach HI. 1991. Glyphosate skin binding, absorption,
residual tissue distribution, and skin decontamination. Fundam Appl Toxicol. 16(4):725-32.

Williams GM, Kroes R, Munro IC. 2000. Safety evaluation and risk assessment of the herbicide Roundup and its

active ingredient, glyphosate, for humans. Regul Toxicol Pharmacol. 31(2 Pt 1):117-65.

SECTION 4. Ecological Risk Assessment for the use of Glyphosate Herbicide as Part of the U.S.
Supported Aerial Eradication Program of Coca in Colombia.

I Introduction

At the request of the Department of State (DoS), the Office of Pesticide Programs (OPP) of the U.S.
Environmental Protection Agency has developed an ecological risk assessment for the aerial coca eradication

program in Colombia. The DoS met with members of OPP on April 18, 2002 to provide information on exposure

and use of the glyphosate tank mixture for aerial eradication of illicit coca in Colombia. This assessment is

based on the information provided in that meeting and in the appendix included in the formal request from the
Secretary of State. The eradication program includes the use of a spray mixture of a glyphosate formulation, an

adjuvant (Cosmo-Flux 411F) and water. The glyphosate tank mixture is applied aerially as a foliar application in

certain provinces within Colombia.

II Background

Approach to Environmental Fate and Ecological Risk Assessments of Pesticides

Before a pesticide can be sold in the United States, the Agency requires pesticide companies which request

product registrations in the U.S. to perform certain required environmental fate and ecological effects studies and
to submit the resulting data. OPP uses the environmental fate studies to assess potential environmental

exposure; data requirements are listed in the regulations (4� CFR 158.290). The ecological effects studies are

used to assess potential toxicity to non-target organisms; data requirements are established in 40 CFR
158.490 (Terrestrial and aquatic organisms data requirements), 158.540 (Plant protection data
� �
requirements), an� 158.590 (Nontarget insect data requirements).

All non-target terrestrial and aquatic animal toxicity studies, and aquatic plant studies, are performed using the

technical grade active ingredient (TGAI). Non-target terrestrial plant toxicity tests are performed with pesticide in
a formulated product (as sold to users). Aquatic fish and invertebrate toxicity studies using formulated product

are also required if the use of the formulation is expected to lead to transport to water bodies, either directly or

through runoff. The potential exposure and toxicity of each pesticide are considered to characterize the potential

of ecological risk.

The present environmental fate assessment is based on regulatory environmental fate studies submitted to the

Agency to support the registration of glyphosate salts and their formulated pesticide products. These studies

were conducted under Good Laboratory Practices (GLP), as required under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). The studies used in the assessment have been deemed acceptable and have

served to generate previous environmental and ecological risk assessments for glyphosate.

The number and types of environmental fate studies required for each pesticide depends on its proposed use

pattern (terrestrial, aquatic, forestry, indoors, greenhouse). The required studies consist of a series of core
laboratory studies for all pesticides and field dissipation studies for pesticides used on outdoor crops

(terrestrial/aquatic), non-crops (terrestrial/aquatic), and forestry. Each study provides specific data that, together

with the physical and chemical properties of the pesticide, are then combined to produce an integrated
environmental fate assessment and to identify the potential of the pesticide to leach to groundwater, and/or reach

surface water, and/or bioaccumulate in aquatic organisms. The data are also used as input parameters in

models to estimate exposure concentrations in the environment. Monitoring data, if available, are also

incorporated into the assessment.

The limited number of species and environmental systems tested can introduce a degree of uncertainty when

attempting to extrapolate the data outside the experimental conditions of the studies, such as different soils,

geographical regions, and ecosystems. As part of the overall risk characterization of a pesticgencythe A

also identifies uncertainties associated with the available data and those introduced by the assumptions needed
to estimate concentrations using models.

III Ecological Risk Assessment

404U.S. General Accounting Office. 1993. Pesticides on Farms: Limited capability exists to monitor occupational
illnesses and injuries. Report to the Chairman, Committee on Agriculture, Nutrition, and Forestry, U.S. Senate,

December 1993. GAO/PEMB-94-6.

Wester RC, Melendres J, Sarason R, McMaster J, Maibach HI. 1991. Glyphosate skin binding, absorption,
residual tissue distribution, and skin decontamination. Fundam Appl Toxicol. 16(4):725-32.

Williams GM, Kroes R, Munro IC. 2000. Safety evaluation and risk assessment of the herbicide Roundup and its

active ingredient, glyphosate, for humans. Regul Toxicol Pharmacol. 31(2 Pt 1):117-65.

SECTION 4. Ecological Risk Assessment for the use of Glyphosate Herbicide as Part of the U.S.
Supported Aerial Eradication Program of Coca in Colombia.

I Introduction

At the request of the Department of State (DoS), the Office of Pesticide Programs (OPP) of the U.S.

Environmental Protection Agency has developed an ecological risk assessment for the aerial coca eradication
program in Colombia. The DoS met with members of OPP on April 18, 2002 to provide information on exposure

and use of the glyphosate tank mixture for aerial eradication of illicit coca in Colombia. This assessment is

based on the information provided in that meeting and in the appendix included in the formal request from the

Secretary of State. The eradication program includes the use of a spray mixture of a glyphosate formulation, an
adjuvant (Cosmo-Flux 411F) and water. The glyphosate tank mixture is applied aerially as a foliar application in

certain provinces within Colombia.

II Background

Approach to Environmental Fate and Ecological Risk Assessments of Pesticides

Before a pesticide can be sold in the United States, the Agency requires pesticide companies which request

product registrations in the U.S. to perform certain required environmental fate and ecological effects studies and

to submit the resulting data. OPP uses the environmental fate studies to assess potential environmental
exposure; data requirements are listed in the regulations (40 CFR 158.290). The ecological effects studies are

used to assess potential toxicity to non-target organisms; data requirements are established in 40 CFR

� 158.490 (Terrestrial and aquatic organisms data requirements�, 158.540 (Plant protection data

requirements), and� 158.590 (Nontarget insect data requirements).

All non-target terrestrial and aquatic animal toxicity studies, and aquatic plant studies, are performed using the

technical grade active ingredient (TGAI). Non-target terrestrial plant toxicity tests are performed with pesticide in

a formulated product (as sold to users). Aquatic fish and invertebrate toxicity studies using formulated product

are also required if the use of the formulation is expected to lead to transport to water bodies, either directly or
through runoff. The potential exposure and toxicity of each pesticide are considered to characterize the potential

of ecological risk.

The present environmental fate assessment is based on regulatory environmental fate studies submitted to the

Agency to support the registration of glyphosate salts and their formulated pesticide products. These studies
were conducted under Good Laboratory Practices (GLP), as required under the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA). The studies used in the assessment have been deemed acceptable and have

served to generate previous environmental and ecological risk assessments for glyphosate.

The number and types of environmental fate studies required for each pesticide depends on its proposed use
pattern (terrestrial, aquatic, forestry, indoors, greenhouse). The required studies consist of a series of core

laboratory studies for all pesticides and field dissipation studies for pesticides used on outdoor crops

(terrestrial/aquatic), non-crops (terrestrial/aquatic), and forestry. Each study provides specific data that, together

with the physical and chemical properties of the pesticide, are then combined to produce an integrated
environmental fate assessment and to identify the potential of the pesticide to leach to groundwater, and/or reach

surface water, and/or bioaccumulate in aquatic organisms. The data are also used as input parameters in

models to estimate exposure concentrations in the environment. Monitoring data, if available, are also
incorporated into the assessment.

The limited number of species and environmental systems tested can introduce a degree of uncertainty when

attempting to extrapolate the data outside the experimental conditions of the studies, such as different soils,

geographical regions, and ecosystems. As part of the overall risk characterization of a pesticidegency A
also identifies uncertainties associated with the available data and those introduced by the assumptions needed

to estimate concentrations using models.

III Ecological Risk AssessmentAnnex 53-A

Aquatic

Laboratory studies indicate glyphosate is slightly toxic to fish, invertebrates and aquatic plants. The lowest
resulting acute LC values (concentrations at which half the test animals died) were in parts-per-million (ppm)
50
for active ingredient glyphosate. For instance, the most sensitive freshwater fish (fathead minnow) had an LC
50
of 85 ppm, while chronic effects were not seen in another study at the highest test concentration of 26 ppm. The

EC 50 (level at which adverse effects are seen in half the test animals) for the freshwater invertebrateDaphnia

magna was 134 ppm, and the chronic NOEL 50 ppm.

OPP exposure models indicate that surface-water exposure in the parts-per-billion could be expected from the

use on coca. OPP also considered a more conservative exposure scenario of the direct application of 3.75 lb
2
acid eq./acre of glyphosate to a 1-acre, 6-foot deep pond The calculated maximum concentration of 230 ppb is

well below the glyphosate toxicity values measured for aquatic organisms in the laboratory. Therefore, aquatic
organisms should not be at risk from exposure to glyphosate. The environmental fate assessment which is the

basis of this exposure calculation is described in the following section.

2Saltsof glyphosate (isopropylamine, diamine, and trimesium) are registered in the United Statesfor ural andariety of agricult

non-agricultural uses. All of the saltsof glyphosate generate the "free acid of glyphosate" (glypicide-active, the actual herb

chemical. The glyphosate acid equivalentsvary from salt to salt to salt, asit dependson the ratio thethe molecular weight of

glyphosate free acid to that of the salt. For thisreason, application ratesare generally expresseid equivalents"lyphosate ac

when estimating exposure concentrationsof glyphosate in water and soil. The ratio of glyphosate acid ylamineglyphosate isoprop

salt is0.75. Thus, each pound of thissalt isequivalent to 0.75 poundsof glyphosate acid (or 1 g o 0.75 g of thequivalent t

acid)

It is possible that much greater exposure could occur from direct overspray of water bodies much smaller than a
1-hectare, 6-foot deep pond, but such simulation is not a standard component of Agency risk assessments. The

product label of the specific glyphosate product DoS indicates is being used against coca, and the DoS

application guidelines, prohibit direct overspray of water bodies. It is possible that some ecologically important

water bodies too small to appear on maps could be sprayed directly in a project as large as the coca eradication

program. EPA has registered other glyphosate products for directapplication to aquatic sites to kill undesirable
vegetation.

Freshwater aquatic plants also seem unlikely to be at risk from exposure to active ingredient glyphosate.

Submitted studies resulted in EC50 values of 12.5 ppm for green algae (Selenastrum capricornatum), 21.5 ppm

for duckweed (Lemna gibba)and 38.6 ppm for the freshwater diatomNavicula pelliculosa. These values are well

beyond the 230 ppb exposure calculated for direct overspray in the pond simulation described above.

Risk Specific to Formulations of Glyphosate

Ecological toxicity studies submitted to EPA for some of the formulations of yhosate products thatEPA has

registered have shown them to be more toxic than glyphosate alone. The results of these studies indicate that

the formulations will pose a risk primarily to non-target plants, as described above. For instance, the minimum

bluegill sunfish 50 of 5.8 ppm reported for a 41.8% glyphosate formulation in EPA � glyphosate reregistration

eligibility document (RED, 1993) is 20 times more toxic than the bluegill sunfish50C observed for technical

glyphosate, but is still much higher than exposure levels expected in the environment. The bluegill sunfis50LC

for a test with surfactant MONO818 by itself was 1.0 ppm.

The risk to non-target terrestrial and aquatic animals from formulated glyphosate used for coca eradication is

uncertain because the Agency does not have relevant toxicity data for the Colombian formulation, nor for the

adjuvant Cosmo-Flux 411F. An adjuvant is a subsidiary ingredient or additive in a mixture that adds to the

effectiveness of the primary or active ingredient. Adjuvants are most commonly added to tank mixes of pesticide
products before they are applied. Further discussion is provided in the Health Effects Division s assessment of

the coca eradication program.

Potential Spray Drift of Glyphosate

The AgDrift model (version 2.01) was used to estimate downwind deposition of aerial applications of herbicide

sprays during coca eradication efforts. The aerial part of the AgDrift model, which was used in this assessment,
was developed from USDA Forest Service models designed to estimate deposition of forestry applications. The

3
model has been the subject of a Scientific Advisory Panel( AP) meeting and showed a good correlation with

field trial data of downwind deposition. Reviews and descriptions of AgDrift have been published.

AgDrift uses a number of input parameters associated with the application equipment and the meteorology

406Aquatic

Laboratory studies indicate glyphosate is slightly toxic to fish, invertebrates and aquatic plants. The lowest
resulting acute LC values (concentrations at which half the test animals died) were in parts-per-million (ppm)
50
for active ingredient glyphosate. For instance, the most sensitive freshwater fish (fathead minnow) had an LC
50
of 85 ppm, while chronic effects were not seen in another study at the highest test concentration of 26 ppm. The

EC 50 (level at which adverse effects are seen in half the test animals) for the freshwater invertebrateDaphnia

magna was 134 ppm, and the chronic NOEL 50 ppm.

OPP exposure models indicate that surface-water exposure in the parts-per-billion could be expected from the

use on coca. OPP also considered a more conservative exposure scenario of the direct application of 3.75 lb

acid eq./acre of glyphosate to a 1-acre, 6-foot deep pond . The calculated maximum concentration of 230 ppb is

well below the glyphosate toxicity values measured for aquatic organisms in the laboratory. Therefore, aquatic

organisms should not be at risk from exposure to glyphosate. The environmental fate assessment which is the
basis of this exposure calculation is described in the following section.

2Saltsof glyphosate (isopropylamine, diamine, and trimesium) are registered in the United Statesfor a ural andiety of agricult

non-agricultural uses. All of the saltsof glyphosate generate the "free acid of glyphosate" (glyphosicide-activehe actual herb

chemical. The glyphosate acid equivalentsvary from salt to salt to salt, asit dependson the ratio of the molecular weight of

glyphosate free acid to that of the salt. For thisreason, application ratesare generally expressed id equivalents"phosate ac

when estimating exposure concentrationsof glyphosate in water and soil. The ratio of glyphosate acid to ylaminephosate isoprop

salt is0.75. Thus, each pound of thissalt isequivalent to 0.75 poundsof glyphosate acid (or 1 g ofo 0.75 g of theivalent t

acid)

It is possible that much greater exposure could occur from direct overspray of water bodies much smaller than a

1-hectare, 6-foot deep pond, but such simulation is not a standard component of Agency risk assessments. The

product label of the specific glyphosate product DoS indicates is being used against coca, and the DoS
application guidelines, prohibit direct overspray of water bodies. It is possible that some ecologically important

water bodies too small to appear on maps could be sprayed directly in a project as large as the coca eradication

program. EPA has registered other glyphosate products for directapplication to aquatic sites to kill undesirable

vegetation.

Freshwater aquatic plants also seem unlikely to be at risk from exposure to active ingredient glyphosate.
Submitted studies resulted in EC values of 12.5 ppm for green algae (Selenastrum capricornatum), 21.5 ppm
50
for duckweed (Lemna gibba)and 38.6 ppm for the freshwater diatomNavicula pelliculosa. These values are well

beyond the 230 ppb exposure calculated for direct overspray in the pond simulation described above.

Risk Specific to Formulations of Glyphosate

Ecological toxicity studies submitted to EPA for some of the formulations of glyhosate products thatEPA has

registered have shown them to be more toxic than glyphosate alone. The results of these studies indicate that
the formulations will pose a risk primarily to non-target plants, as described above. For instance, the minimum

bluegill sunfish LC of 5.8 ppm reported for a 41.8% glyphosate formulation in EPA s�glyphosate reregistration
50
eligibility document (RED, 1993) is 20 times more toxic than the bluegill sunfish LC observed for technical
50
glyphosate, but is still much higher than exposure levels expected in the environment. The bluegill sunfish L50

for a test with surfactant MONO818 by itself was 1.0 ppm.

The risk to non-target terrestrial and aquatic animals from formulated glyphosate used for coca eradication is

uncertain because the Agency does not have relevant toxicity data for the Colombian formulation, nor for the

adjuvant Cosmo-Flux 411F. An adjuvant is a subsidiary ingredient or additive in a mixture that adds to the
effectiveness of the primary or active ingredient. Adjuvants are most commonly added to tank mixes of pesticide

products before they are applied. Further discussion is provided in the Health Effects Divisi�n s assessment of

the coca eradication program.

Potential Spray Drift of Glyphosate

The AgDrift model (version 2.01) was used to estimate downwind deposition of aerial applications of herbicide
sprays during coca eradication efforts. The aerial part of the AgDrift model, which was used in this assessment,

was developed from USDA Forest Service models designed to estimate deposition of forestry applications. The

model has been the subject of a Scientific Advisory Panel S( AP) meeting and showed a good correlation with

4
field trial data of downwind deposition. Reviews and descriptions of AgDrift have been published.

AgDrift uses a number of input parameters associated with the application equipment and the meteorologyAnnex 53-A

target site may vary but 75% was used as the best available input

Relative humidity 75% for modeling.

Reference (1) p.6 states missions are canceled if temperature

measured at the airport is above 90 degree F. Temperature at the

target site may vary but 90 degree F was used as the best
Temperature 90 degrees F available input for modeling.

Reference (1) p. 6 states the altitude above spray targets is

normally less than 100 feet. This value was used as the best

Release height 100 ft available input for modeling.

Based on video of spraying operations with multiple aircraft, the

Spray lines 4 number of spray lines used in modeling was 4.

(1) Chemicals Used for the Aerial Eradication of Illicit Coca in Colombia and Conditions of Application. An

undated, unsigned, 9-page document provided to OPP by the State Department.

In addition to the general uncertainties above, there are also uncertainties associated with the inputs used for

modeling the spray applications. Droplet size is one of the most important parameters affecting drift of

pesticides. There is uncertainty as to the droplet size spectrum used in aerial coca spraying. Documentation

supplied by the DoS describes the droplet size used in terms of the volume median diameter (VMD) which is

the droplet size for which half of the volume of spray is contained in droplets with smaller diameter and half of the
spray is contained in droplets of larger diameter. The VMD was stated to range from 300 to 1500 microns which

is a wide range. In the DoS presentation the VMD was stated to be 200 to 300 microns during application

conditions. In addition to the wide range of VMD values presented, VMD is not a good descriptor of droplet size

spectra for estimating spray drift. Spray drift is predominately associated with finer sprays and VMD does not
define the amount of small droplets contained in spray. Although specific data on droplet size under application

conditions was not provided, it is unlikely that very coarse sprays would be achievable due to shearing effects of

releasing droplets at high airspeeds. Large droplets released into the turbulence created by an aircraft traveling in

excess of 120 mph tend to break into smaller more driftable droplets.

6ChemicalsUsed for the Aerial Eradication of Illicit Coca in Colombia and Conditionsof Application. An ugeated, unsigned, 9-pa

document provided to OPP by the State Department.

Other uncertainties associated with inputs include inputs for meteorology and release height. AgDrift modeling

requires site-specific inputs for meteorology. In coca eradication efforts (as well as agricultural applications in the
US) wind speed, temperature and humidity are measured at the airport which may not be representative of these

parameters at the application site. The applicator is ultimately given the responsibility of determining if conditions

at the target site are acceptable. DoS reports that the coca eradication program selects experienced applicators

for spray missions with the expectation they will better be able to identify unacceptable conditions and make
applications within specified parameters.

In order to capture the range of deposition values expected during coca eradication applications, AgDrift was run

with two droplet size spectra and at two wind speeds. The droplet size spectra were extremely coarse to very
coarse and medium. The definitions refer to the American Society of Agricultural EngineeringA(SAE) Standard

572 definition of droplet size spectra. The wind speeds used were 3 mph and 10 mph. AgDrift was run in tier 3 to

estimate downwind depositions shown in Figure 1 below.

408 target site may vary but 75% was used as the best available input

Relative humidity 75% for modeling.

Reference (1) p.6 states missions are canceled if temperature

measured at the airport is above 90 degree F. Temperature at the

target site may vary but 90 degree F was used as the best
Temperature 90 degrees F available input for modeling.

Reference (1) p. 6 states the altitude above spray targets is
normally less than 100 feet. This value was used as the best

Release height 100 ft available input for modeling.

Based on video of spraying operations with multiple aircraft, the

Spray lines 4 number of spray lines used in modeling was 4.

(1) Chemicals Used for the Aerial Eradication of Illicit Coca in Colombia and Conditions of Application. An

undated, unsigned, 9-page document provided to OPP by the State Department.

In addition to the general uncertainties above, there are also uncertainties associated with the inputs used for
modeling the spray applications. Droplet size is one of the most important parameters affecting drift of

pesticides. There is uncertainty as to the droplet size spectrum used in aerial coca spraying. Documentation

supplied by the DoS describes the droplet size used in terms of the volume median diameter (VMD) which is

the droplet size for which half of the volume of spray is contained in droplets with smaller diameter and half of the

spray is contained in droplets of larger diameter. The VMD was stated to range from 300 to 1500 microns which

is a wide range. In the DoS presentation the VMD was stated to be 200 to 300 microns during application
conditions. In addition to the wide range of VMD values presented, VMD is not a good descriptor of droplet size

spectra for estimating spray drift. Spray drift is predominately associated with finer sprays and VMD does not

define the amount of small droplets contained in spray. Although specific data on droplet size under application

conditions was not provided, it is unlikely that very coarse sprays would be achievable due to shearing effects of
releasing droplets at high airspeeds. Large droplets released into the turbulence created by an aircraft traveling in

excess of 120 mph tend to break into smaller more driftable droplets.

6ChemicalsUsed for the Aerial Eradication of Illicit Coca in Colombia and Conditionsof Application. An ugeated, unsigned, 9-pa

document provided to OPP by the State Department.

Other uncertainties associated with inputs include inputs for meteorology and release height. AgDrift modeling

requires site-specific inputs for meteorology. In coca eradication efforts (as well as agricultural applications in the

US) wind speed, temperature and humidity are measured at the airport which may not be representative of these

parameters at the application site. The applicator is ultimately given the responsibility of determining if conditions
at the target site are acceptable. DoS reports that the coca eradication program selects experienced applicators

for spray missions with the expectation they will better be able to identify unacceptable conditions and make

applications within specified parameters.

In order to capture the range of deposition values expected during coca eradication applications, AgDrift was run
with two droplet size spectra and at two wind speeds. The droplet size spectra were extremely coarse to very

coarse and medium. The definitions refer to the American Society of Agricultural EngineeringA(SAE) Standard

572 definition of droplet size spectra. The wind speeds used were 3 mph and 10 mph. AgDrift was run in tier 3 to

estimate downwind depositions shown in Figure 1 below.Annex 53-A

Molecular formula C3 8NO P5

Molecular weight 169.07

Solubility in water 12,000 mg/L 25ΕC (very soluble)

Vapor pressure 4.3 x 1010, mmHg at 25 Ε (doesn t readily

volatilize)
-10
1.8 x 10 , mmHg at 45 Ε

Henry s Law Constant 9.6 x 1017 atm-m /mole, estimated at 25 C
, Ε

n-Octanol-water partition coefficient (Kow) -4.0
(as log Kow)

pK a Glyphosate is a zwitterion
pK 2.6
a1=
pK 5.6
a2
pKa3 10.6

Transformation, persistence and transport in soils

The major route of transformation of glyphosate in soils is microbial degradation. In laboratory studies in soils

incubated under aerobic conditions,4 C-labeled glyphosate degraded with half-lives ranging from 1.85 to 5.4

days in two sandy loam soils, and 2.06 days in a silt loam. These studies were conducted in the absence of

light and at 2Ε C. The major degradate that formed in these soils was aminomethyl phosphonic acid (AMPA),

which reached a maximum of ca. 29% at 40 days, but declined afterwards. After 1 yea∃, 70% of the applied
14
radioactivity was found as CO 2 indicating that the ultimate fate of glyphosate and AMPA is mineralization

(i.e., formation of 2O and inorganic carbonates and bicarbonates). Photolysis on soil is not a degradation route

for glyphosate, as the half-lives under both irradiated and dark conditions were 6.6 days and any degradation that
occurred during the studies was likely to be microbial.

Batch-equilibrium adsorption studies in a wide range of soils and sediments from the US and United Kingdom

have shown that glyphosate and AMPA adsorbed strongly to soils, with adsorption coefficientsads) ranging

from 9.4 to 700 mL/g. Therefore, glyphosate has a low potential to leach to groundwater or reach surface water
by runoff, but may enter surface water through soil erosion.

Terrestrial field dissipation studies conducted with a formulation of the non-radiolabeled isopropylamine salt at an

application rate of 10.7 lb of salt/acre (7.95 lb acid equivalent/acre) showed that dissipation (i.e., transformation

plus transport) was slower in colder than in warmer climates. The reported half-lives at each site were 2.9 days in
Texas, 13 to 20 days in Georgia, California and Arizona, 127 days in New York, and 140 days in Iowa.

Glyphosate and AMPA were found predominantly in the 0 to 6 inch layers, indicating that they are not potential

leachers. All of these studies were conducted with the formulation applied directly to soil in bare ground plots.

Glyphosate is a foliar herbicide that is not applied directly to soils and would only reach soil by wash-off from
foliage. Therefore, direct application to soils in bare ground plots represent a worse case of gluse.sate

The low vapor pressure of glyphosate (4.3 x 100,mmHg at 25 C and 1.8 x 10-10,mmHg at 45 C) suggests
Ε Ε
that it has low potential to volatilize from soils.

Transformation, persistence, and transport in water

Laboratory studies suggest that abiotic hydrolysis (i.e., hydrolysis in the absence of microorganisms) is not a
primary degradation pathway for glyphosate. Glyphosate remained stable for at least 30 days in sterile aqueous

buffered solutions of pH 5, 7 and 9 that were kept in the darkΕat 25 C. Buffered solutions of glyphosate were

stable to sunlight, suggesting that direct photolysis is not a likely degradation pathway for glyphosateE.PA has

no data at this time to assess any contribution of indirect photolysis in natural waters.

410 The half-life of glyphosate in a silty clay loam sediment incubated under anaerobic conditions (flooded plus a
nitrogen atmosphere) was estimated as 8.1 days and 199 days in a water-clay loam sediment system. Most of
Molecular formula C3 8NO P5
applied radioactivity was found in the sediment phase. The major metabolite was AMPA, which also remained

associated with the sediment. The observed half-live in an aerobically incubated silty clay loam sediment was 7
Molecular weight 169.07 days.

Aquatic field dissipation data showed that the half-life of glyphosate in water used as irrigation source was 7.5
Solubility in water 12,000 mg/L 25 Ε (very soluble)
days (farm pond in Missouri, 408816-01). In Michigan, Georgia, and Oregon pond and stream water systems,

glyphosate dissipated rapidly immediately after treatment. Accumulation was higher in the pond than in the
stream sediments (415528-01).
Vapor pressure 4.3 x 1010, mmHg at 25 Ε (doesn t readily

volatilize) The low Henry
-10
1.8 x 10 , mmHg at 45 Ε Given the strong adsorption to sediments, glyphosate is most likely to be associated with the sediment. The

very low n-octanol -water partition coefficient is indicative that glyphosate is not likely to bioaccumulate in
aquatic organisms
Henry s Law Constant 9.6 x 1017 atm-m /mole, estimated at 25 C
, Ε
Dissipation in a forestry environment

n-Octanol-water partition coefficient (Kow) -4.0 Residues of an aerially applied glyphosate product at a rate of 3.75 lb of acid equivalents/acre declined rapidly
(as log Kow)
from tree foliage in less than 1 day at the Michigan and Georgia sites and less than 14 days at a site in Oregon.
The rate of dissipation in the foliage (wash-off) correlated with the amount of rainfall and leaf drop, which also

determines the movement of glyphosate and AMPA through the forest ecosystem. The average half-life for overall
pKa Glyphosate is a zwitterion
pK 2.6 dissipation from the forest ecosystem was 100 days for glyphosate (35 to 158 days) and 118 days for AMPA (71
a1=
pK 5.6 to 165 days). In all cases, the maximum combined residue of glyphosate and AMPA in soil was less than 5 ppm
a2 , but the amount of residues declined with time (MRID 415528-01).
pKa3 10.6

VI. Risk Characterization

Transformation, persistence and transport in soils
The ongoing use of a glyphosate spray for coca eradication is likely to pose a risk to non-target plants.

The major route of transformation of glyphosate in soils is microbial degradation. In laboratory studies in soils Vegetative vigor toxicity laboratory tests performed using a formulated glyphosate product (glyphosate acid WP
48.3%) on North American crops indicated toxicity to terrestrial plants with applications of less than 1.0 lb of
incubated under aerobic conditions,4 C-labeled glyphosate degraded with half-lives ranging from 1.85 to 5.4
active ingredient per acre (lb ai/acre) (Table I). The State Department proposes to use a rate of 3.34 lb acid
days in two sandy loam soils, and 2.06 days in a silt loam. These studies were conducted in the absence of
equivalents/acre for direct, aerial application to coca. A second application is possible if fields are replanted, or
light and at Ε5 C. The major degradate that formed in these soils was aminomethyl phosphonic acid (AMPA), the first is determined after 3 to 6 months to have been inadequate. The product reported by DoS as used in

which reached a maximum of ca. 29% at 40 days, but declined afterwards. After 1 year∃ 70% of the applied Colombia has a formulation which matches the formulation of a product that is registered, but not used, in the
14
radioactivity was found as CO 2 indicating that the ultimate fate of glyphosate and AMPA is mineralization United States.

(i.e., formation of 2O and inorganic carbonates and bicarbonates). Photolysis on soil is not a degradation route
AgDrift modeling of potential spray drift indicates that non-target plants hundreds of feet away may be exposed
for glyphosate, as the half-lives under both irradiated and dark conditions were 6.6 days and any degradation that to a fraction of this glyphosate application. Based on the toxicity data for North American crops, AgDrift
occurred during the studies was likely to be microbial.
indicates the possibility that 50% of young plant crops would be expected to show measurable reductions in dry

Batch-equilibrium adsorption studies in a wide range of soils and sediments from the US and United Kingdom weight from 150 to nearly 600 feet downwind (depending on spray droplet size and wind conditions). As detailed

have shown that glyphosate and AMPA adsorbed strongly to soils, with adsorption coefficientsads) ranging below, there are several hundred non-target terrestrial plant incident reports in the Agency s Ecological Incident
Information System (EIIS) database connected with the use of glyphosate products.
from 9.4 to 700 mL/g. Therefore, glyphosate has a low potential to leach to groundwater or reach surface water
by runoff, but may enter surface water through soil erosion.
There is uncertainty whether crops or other plants in Colombia, whether similar to crops tested in the United

Terrestrial field dissipation studies conducted with a formulation of the non-radiolabeled isopropylamine salt at an States or not, would be affected similarly at the same exposure levels. However, since glyphosate is an effective,

application rate of 10.7 lb of salt/acre (7.95 lb acid equivalent/acre) showed that dissipation (i.e., transformation broad spectrum herbicide, risk to non-target plants outside of the application zone would be expected. The
Agency
plus transport) was slower in colder than in warmer climates. The reported half-lives at each site were 2.9 days in
Texas, 13 to 20 days in Georgia, California and Arizona, 127 days in New York, and 140 days in Iowa. States attributed to use of glyphosate.

Glyphosate and AMPA were found predominantly in the 0 to 6 inch layers, indicating that they are not potential
This use of the active ingredient glyphosate itself would not pose a significant direct risk to terrestrial or aquatic
leachers. All of these studies were conducted with the formulation applied directly to soil in bare ground plots.
animals, although temporary secondary adverse effects from the loss of habitat in the spray area may occur.
Glyphosate is a foliar herbicide that is not applied directly to soils and would only reach soil by wash-off from Neither acute nor chronic adverse effects were observed in mammalian and avian laboratory toxicity tests using
foliage. Therefore, direct application to soils in bare ground plots represent a worse case of gluse.sate
the active ingredient alone. Mortality was observed in fish and aquatic invertebrate studies. However, the resulting

The low vapor pressure of glyphosate (4.3 x 100,mmHg at 25 C and 1.8 x 10-10,mmHg at 45 C) suggests acute LC
Ε Ε
that it has low potential to volatilize from soils. effects, were in parts-per-million. Toxicity endpoints for aquatic plants also ranged from 0.85 to 39.9 ppm.
Considerably lower surface-water exposure, in the parts-per-billion, could be expected from the use on coca

Transformation, persistence, and transport in water using runoff simulations from Agency exposure models. The Agency considered an even more conservative

scenario, estimating the concentration that would result from the direct application of 3.75 lb acid eq./acre of
Laboratory studies suggest that abiotic hydrolysis (i.e., hydrolysis in the absence of microorganisms) is not a
primary degradation pathway for glyphosate. Glyphosate remained stable for at least 30 days in sterile aqueous glyphosate to a 1-acre, 6-foot deep pond. The calculated maximum concentration of 230 ppb is well below the
toxicity values measured for aquatic organisms in the laboratory.
buffered solutions of pH 5, 7 and 9 that were kept in the darkΕat 25 C. Buffered solutions of glyphosate were

stable to sunlight, suggesting that direct photolysis is not a likely degradation pathway for glyphosateE.PA has It is possible that much greater exposure could occur from direct overspray of water bodies much smaller than a

no data at this time to assess any contribution of indirect photolysis in natural waters. 1-acre, 6-foot deep pond, but such simulation is not a standard component of Agency risk assessments. It is

possible that some ecologically important water bodies too small or ephemeral to appear on maps could beAnnex 53-A

sprayed directly in a project as large as the coca eradication program.

There are several aspects of an ecological risk assessment which, while included as a regular part of the U.S.

registration process, are not relevant to the use of glyphosate on coca. In considering the risk of a chemical to
terrestrial or aquatic animals in the United States, the Agency has set levels of concern (LOCs) at between 5 to

20% of the acute toxicological endpoints for further consideration of risk to endangered species, or eligibility of a

chemical for Restricted Use (application permitted only by Certified Pesticide Applicators.) Our document does

not include endangered species because the Agency lacks information on the species which might be present in
areas of spraying. In addition, the Health Effects Division determined that results of mammalian toxicology

studies did not warrant the establishment of a chronic toxicological endpoint for the calculation of a Reference

Dose (RfD, a reference endpoint for human health risk assessment ) for glyphosate. Since there is not a chronic

endpoint, a drinking water exposure assessment is not necessary for the use of glyphosate on coca.

Although the measured toxicity and estimated exposure indicate that only non-target plants are likely to be

adversely affected by the use on coca, there are important uncertainties that should be considered. One of

these, which was emphasized by the Amazon Alliance in a memo to the Agency, is the extrapolation of North
American data to the conditions and wildlife found in Colombia. The toxicity of a pesticide to different classes of

animals and plants can vary widely among species within an individual ecosystem. The Agency uses the test

species as surrogates for other North American species not tested, but has little experience with tropical flora

and fauna. Similarly, laboratory and field estimates of the environmental fate of pesticides, including potential
surface- water contamination, are performed with North American soils, hydrology and climate data.

The potentially most important uncertainty in this risk assessment concerns differences in the formulation and

tank mix for use in Colombia from those used in the United States. Toxicity studies indicate that U.S.
formulations of glyphosate are more toxic to non-target animals than the technical product alone, but not toxic at

levels of expected exposure. However, none of the ecological effects studies submitted to or encountered by the

Agency for glyphosate were performed with the formulation that the DoS has indicated is used in Colombia,

which may contain different types of cationic surfactants than those in formulations for which the Agency has
data. Consultant Jeremy Bigwood presented a literature search of over 200 citations to the Ecuadorian Minister

of the Environment in March 2002, stating that (t)here have been NO scientific investigations on the past or

present formulations being used in Colombia.

In addition, the Agency does not have ecological toxicity information on adjuvant Cosmo-Flux 411F, which is
neither manufactured nor sold in the United States. There is some inconsistency in the description of Cosmo-

Flux in the two available labels, in Spanish and in English. However, all of the individual ingredients (surfactants)

which comprise the adjuvant are substances with low oral and dermal mammalian toxicity. The toxicity of the
blend of these surfactants is not known; although the Agency often requires formulation toxicity data for non-

target plants and aquatic organisms, tank-mix adjuvants are not required to be included in these studies.

ReportsFrom External Sources

The effect of Cosmo-Flux 411F or its individual ingredients on non-target organisms is unknown, although Mr.
Bigwood suggests some possible effects in his report to the government of Ecuador. Mr. Bigwood cites studies

from the Western Australia Department of Environmental Protection (WADEP) as indicating that a formulation

equivalent to that which the Department of State has indicated is used in Colombia can be acutely toxic to
adult frogs and tadpoles at the recommended application rates (1.8 to 5.4 kg/ha). The Agens tox database

cites LC50 values for two Australian frog species (Crinia insigniferaand Litoria moorei) of 40 and 8 ppm,

respectively, presumably from the same studies. Such concentrations are greater than those likely to occur from

transport of glyphosate in runoff to ponds. These concentrations might be possible for frogs exposed by direct

overspray, such as tree frogs. However, the Agency does not have a method for estimating the possible dietary
intake of pesticides for tree frogs; the A�ency s model for dietary exposure of terrestrial animals is based on

agricultural field data collected in the United States. Extrapolation of toxicity to Australian frog species to

Colombian species includes significant uncertainty.

Suggestions of risk to other organisms in Mr. Bigwood s report are less specific. This report states that

(t)oxicity of glyphosate formulations in riverine systems is not merely limited to fish, but also to amphibians,

insects, crawfish and water fleas, and undoubtedly to other species found in rivers and other bodies of water.

This is followed by a discussion of toxicity values for a surfactant other than Cosmo-Flux 411F . As described
above, while aquatic exposure to glyphosate itself (or U.S. formulations) is not likely to pose a risk to aquatic

animals and plants, data on the toxicity of tank- mix adjuvant Cosmo-Flux 411F to these organisms would be

required to assess formulation and tank-mix rsi ks. Tank-mix ecological toxicity data are not routinely provdied in

the U.S. pesticide registration process.

The Agency would need to obtain and review literature studies cited in Mr. Bi�wood s report in order to

412sprayed directly in a project as large as the coca eradication program.

There are several aspects of an ecological risk assessment which, while included as a regular part of the U.S.

registration process, are not relevant to the use of glyphosate on coca. In considering the risk of a chemical to
comment on other suggested risks. Mr. Bigwood suggests that glyphosate enhances the growth of pathogenic
terrestrial or aquatic animals in the United States, the Agency has set levels of concern (LOCs) at between 5 to
20% of the acute toxicological endpoints for further consideration of risk to endangered species, or eligibility of a fungi according to several research papers. Based on the titles of the papers, most of the studies cited concern
the effect of fusarium fungi on glyphosate efficacy. The Agency cannot comment on the magnitude of this effect
chemical for Restricted Use (application permitted only by Certified Pesticide Applicators.) Our document does
without reviewing the data, nor on the potential for risk from this effect. The effects of pesticide applications on
not include endangered species because the Agency lacks information on the species which might be present in
microbiota is not a standard component of the Agency s risk assessments.
areas of spraying. In addition, the Health Effects Division determined that results of mammalian toxicology
studies did not warrant the establishment of a chronic toxicological endpoint for the calculation of a Reference
Incident data
Dose (RfD, a reference endpoint for human health risk assessment ) for glyphosate. Since there is not a chronic
US Incident Data
endpoint, a drinking water exposure assessment is not necessary for the use of glyphosate on coca.

There are several hundred non-target terrestrial plant incident reports in the Agency s Ecological Incident
Although the measured toxicity and estimated exposure indicate that only non-target plants are likely to be
adversely affected by the use on coca, there are important uncertainties that should be considered. One of Information System database connected with the use of glyphosate products. This is consistent with the risk

these, which was emphasized by the Amazon Alliance in a memo to the Agency, is the extrapolation of North assessment above, which suggests that the efficacy of glyphosate is such that non-target plants hundreds of
feet away could be at risk from glyphosate in spray drift. The variety of crops, ornamentals and trees included in
American data to the conditions and wildlife found in Colombia. The toxicity of a pesticide to different classes of
the EIIS reflect the wide spectrum of glyphosate efficacy.
animals and plants can vary widely among species within an individual ecosystem. The Agency uses the test

species as surrogates for other North American species not tested, but has little experience with tropical flora There are a small, limited number of reported incidences to fowl, fish and a dog allegedly resulting from label use
and fauna. Similarly, laboratory and field estimates of the environmental fate of pesticides, including potential
of glyphosate products. Further analysis of the data on the actual incidence report forms indicates that other
surface- water contamination, are performed with North American soils, hydrology and climate data. factors or other pesticides may explain the adverse effects. For instance, one incident was apparently due to

overstock and improper oxygen levels in a catfish pond, and another to a spill of several barrels of Roundup
The potentially most important uncertainty in this risk assessment concerns differences in the formulation and
directly into a creek. Another fish kill was more likely attributable to diuron runoff into a pond than to glyphosate
tank mix for use in Colombia from those used in the United States. Toxicity studies indicate that U.S.
formulations of glyphosate are more toxic to non-target animals than the technical product alone, but not toxic at exposure. Although glyphosate was associated with these incidents, the fact that other conditions or pesticides
were likely responsible is consistent with the fact that glyphosate has very low mammalian, avian and aquatic
levels of expected exposure. However, none of the ecological effects studies submitted to or encountered by the
acute and chronic toxicity.
Agency for glyphosate were performed with the formulation that the DoS has indicated is used in Colombia,

which may contain different types of cationic surfactants than those in formulations for which the Agency has Only one incident appears to be attributable to glyphosate, involving 2 iguanas that ate dandelions apparently
data. Consultant Jeremy Bigwood presented a literature search of over 200 citations to the Ecuadorian Minister
sprayed with a Roundup product. However, the reptiles exhibited signs of neurological effects (shock, depression
of the Environment in March 2002, stating that (t)here have been NO scientific investigations on the past or and tremor) which are not generally associated with glyphosate toxicity and which may be due to the inert

present formulations being used in Colombia. ingredients in the formulation. The Agency does not have any test protocols nor does it require toxicity testing on

reptiles for any pesticide. Thus, information on this class of animals in general is an uncertainty.
In addition, the Agency does not have ecological toxicity information on adjuvant Cosmo-Flux 411F, which is
neither manufactured nor sold in the United States. There is some inconsistency in the description of Cosmo-
Central and South American Incidents
Flux in the two available labels, in Spanish and in English. However, all of the individual ingredients (surfactants)

which comprise the adjuvant are substances with low oral and dermal mammalian toxicity. The toxicity of the Mr. Bigwood s report for the Government of Ecuador states that exposure to a dried formulation containing both
glyphosate and a surfactant in Roundup (the commercial product being used) caused the death of over 50% of
blend of these surfactants is not known; although the Agency often requires formulation toxicity data for non-
target plants and aquatic organisms, tank-mix adjuvants are not required to be included in these studies. several beneficial insect species. The report does not indicate the level of exposure or the nature of the dried

formulation that caused these effects. Therefore, the Agency cannot comment on the relevance of these data to
ReportsFrom External Sources
aerial spray of the formulation. Mr. Bigwood cites a Los Angeles Times article in which Guatemalan farmers
contend that the discontinued poppy eradication program has devastated the areas traditional agricultural base,
The effect of Cosmo-Flux 411F or its individual ingredients on non-target organisms is unknown, although Mr.
particularly tomatoes and bees. Honeybee oral and contact toxicity tests provided to the Agency using technical
Bigwood suggests some possible effects in his report to the government of Ecuador. Mr. Bigwood cites studies
from the Western Australia Department of Environmental Protection (WADEP) as indicating that a formulation glyphosate (active ingredient only, not the formulated product) could not establish an LC at concentrations up

equivalent to that which the Department of State has indicated is used in Colombia can be acutely toxic to to 100 micrograms per bee. However, these studies cannot be used to rule out the possible toxicity of the
Colombian formulation and tank mix to beneficial insects.
adult frogs and tadpoles at the recommended application rates (1.8 to 5.4 kg/ha). The Age�cs tox database

cites LC50 values for two Australian frog species (Crinia insigniferaand Litoria moorei) of 40 and 8 ppm, The Amazon Alliance provided the Agency with a list of incidents in Colombia which report adverse effects to

respectively, presumably from the same studies. Such concentrations are greater than those likely to occur from crops and domesticated animals from the use of glyphosate on illicit crops. The Agency cannot comment on the
transport of glyphosate in runoff to ponds. These concentrations might be possible for frogs exposed by direct
reliability of these incident reports, because sufficient information isn't included for each incident. The plant
overspray, such as tree frogs. However, the Agency does not have a method for estimating the possible dietary incidents are not inconsistent with the body of plant incidents in the Agency's Ecological Incident Information

intake of pesticides for tree frogs; the A�ency s model for dietary exposure of terrestrial animals is based on System database. However, the large animal incidents reported by the Amazon Alliance do not appear to be

agricultural field data collected in the United States. Extrapolation of toxicity to Australian frog species to consistent with glyphosate and glyphosate formulation toxicity data submitted to and reviewed by the Agency.
Colombian species includes significant uncertainty.

Suggestions of risk to other organisms in Mr. Bigwo�d s report are less specific. This report states that

(t)oxicity of glyphosate formulations in riverine systems is not merely limited to fish, but also to amphibians,

insects, crawfish and water fleas, and undoubtedly to other species found in rivers and other bodies of water.
This is followed by a discussion of toxicity values for a surfactant other than Cosmo-Flux 411F . As described

above, while aquatic exposure to glyphosate itself (or U.S. formulations) is not likely to pose a risk to aquatic

animals and plants, data on the toxicity of tank- mix adjuvant Cosmo-Flux 411F to these organisms would be

required to assess formulation and tank-mix rsi ks. Tank-mix ecological toxicity data are not routinely provdied in
the U.S. pesticide registration process.

The Agency would need to obtain and review literature studies cited in Mr. Bi�wood s report in order toAnnex 53-A

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Colombia» 8 Addendum to Report

Department of State's Comments on EPA August 19, 2002 Letter

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The Department wishes to respond to three concerns raised by the EPA in its August 19 response to Secretary

Powell. First, EPA expressed concern about the level of eye toxicity of the glyphosate formulated product which

the Department has been using in the aerial spray program in Colombia (e.g. , EPA Response at pp. 2, 33).
Secondly, EPA replied that it could not evaluate the toxicity of the tank mixture (glyphosate formulation, water,

surfactant) as sprayed in Colombia because the Department did not supply toxicity tests on that mixture (e.g. ,

EPA Response at pp. 2, 33). These two concerns prompted EPA to recommend "that DOS consider using an
alternative glyphosate product (with lower potential for acute toxicity) in future coca and/or poppy aerial

eradication programs." (EPA Response at p. 12) Finally, EPA raised questions regarding the potential for spray

drift to legitimate crops from aerial eradication (e.g., EPA Response at p. 59).

Glyphosate formulation:

As this report was being prepared, the Department has worked with its supplier of glyphosate to identify a

slightly different formulation that is less of an eye irritant because it uses a different inert surfactant. This

formulation is also known to have as low or lower toxicity ratings in all other categories as well. Although this

alternative formulation has only recently been registered in Colombia, it has been extensively tested and widely
used elsewhere, including the U.S., and is registered for non-agricultural use in the U.S. by theEPA.

This alternative formulation addresses EPA � concern in its response to the Department of State. The

Department plans to switch to this alternative formulation for use in the aerial spray program in Colombia as soon
as the alternative formulation can be manufactured, purchased, and delivered.

Toxicity tests:

EPA indicated that it could not verify the potential toxicity of the spray mixture: the glyphosate formulation

diluted with water and fortified with additional surfactant. The Department has commissioned toxicity tests of the
spray mixture being used in Colombia. The most relevant portion of the studies has been completed; it confirms

that the risk of eye irritation is low to persons not handling or mixing the concentrated glyphosate formulation.

The Department also expects the full tests to demonstrate that this mixture poses no health risk for humans.
The EPA-certified laboratory that is performing the studies is doing so in a professional, scientific manner, which

has required a considerable amount of time. The results will be forwarded to the Committees, and to theEPA, as

soon as the Department receives final copies of the studies.

The Department has also commissioned toxicity tests for the spray mixture using the alternative glyphosate
formulation discussed above. These will be performed as soon as that formulation is available for mixing in field

conditions.

Spray drift:

The EPA used a computer model to indicate a possibility that non-target plants hundreds of feet away might be
exposed to a fraction of the glyphosate application, depending on spray droplet size and wind conditions. USDA

scientists and the Colombian Environmental Auditor to the spray program regularly look for evidence of spray drift

as part of ground truth verification missions. These experts, who actually go to the fields, have concluded
consistently that evidence of spray drift is rare. Post-spray field visits indicate that if this drift occurs, it is most

often in trace amounts that have no observable adverse consequences on non-target plants.

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414The Office of Electronic Information, Bureau of Public Affairs, managesthissite asa portal for information from the U.S. State Department.

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Colombia» 5 Colombian Embassy Diplomatic Notes

Letter from Colombian Ambassador to the U.S. Luis Alberto Moreno

with Attached Diplomatic Note from the Ministry of Foreign Affairs of
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the Government of Colombia

EMBAJADA DE COLOMBIA

WASHINGTON, D.C.

March 22, 2002

The Honorable

RANDY BEERS

Assistant Secretary for International
Narcotics and Law Enforcement

U. S. Department of State

Washington D. C.

Dear Secretary Beers:

I hereby enclose the Verbal Note sent by the Ministry of Foreign Affairs of Colombia to the United States

Embassy in Bogota, certifying that our two Governments have been conducting consultations regarding the U.S.-
supported aerial coca eradication program in Colombia and that this program is being carried out in accordance

with Colombian laws.

Cordially,

LUIS IS ALBERTO MORENO

Ambassador

REPUBLICA DE COLOMBIA

MINISTERIO DE RELACIONES EXTERIORES

VRE.CEC No. 11355

El Ministerio de Relaciones Exteriores, saluda muy atentamente a la Honorable Embajada de los Estados

Unidos de A�rica con oc�sn de informar que el Gobierno de Colombia, se encuentra desarrollando el
Programa de Erradicaci n de Cultivos Ilicitos por rea con el Herbicida Glifosato (PECIG),
� � �
atendiendo las normas colombianas aplicables en la material.

Que en aten�n al programa PECIG, viene implementando un plan de manejo ambiental aprobado por el
Ministerio del Medio Ambiente, a trav s de n No.1065 de 2001 y precisada mediante Resoluci n
� � �
No. 0108 de 2002.

Que desde el comienzo del Programa de E�radicaci n de Cultivos Il�cit�srea con elsi n A

Herbicida Glifosato (PECIG), este ha contado con una auditoria ambiental.

A la Honorable

EMBAJADA DE ESTADOS UNIDOS DE AMERICA

Ciudad

REPUBLICA DE COLOMBIA

MINISTERIO DE RELACIONES EXTERIORES

416 Annex 53-A

En este sentido de acuerdo con las consultas sostenidas entre los Gobiernos de Colombia y los Estados
Unidos en asuntos relacionados con la fumigacrea de cultivos ilegales de coca en Colombia, por este
� �
medio el gobierno de Colombia certifica que el programa�de �urea apoyado por los Estados Unidos

se es� llevando a cabo de acuerdo con todas y cada una de las leyes colombianas aplicables en la materia.

El Ministerio de Relaciones Exteriores se vale de la oportunidad para reiterar a la Honorable Embajada de los
Estados Unidos de A� rica las seguridades de�su m s distinguida co�sideraci n.

Bogot� D. C., 21 de marzo de 2002

U.S. Department of State
Office of Language Services

Translating Division

LS No. 07-2002-0012

KFC/JF
Spanish

Republic of Colombia

Ministry of Foreign Relations

VRE.CEC No. 11355

The Ministry of Foreign Relations presents its compliments to the Embassy of the United States and would like

to inform it that the Government of Colombia is implementing the IProgram to Eradicate Illicit Crops by Aerial

Spraying of the Herbicide Glyphosate (PECIG), in accordance with applicable Colombian regulations.

Under the PECIG program, an environmental management plan is being implemented that was approved by the

Ministry of Environment, through decision No. 1065 of 2001, and outlined further in decision No. 0108 of 2002.

The PECIG program has, moreover, been subject from the outset to an environmental audit.

Embassy of the United States,

Bogot� .

Therefore, in accordance with the consultations held between the Governments of Colombia and the United

States on matters related to the aerial spraying of illegal coca crops in Colombia, the Government of Colombia
hereby certifies that the aerial spraying program supported by the United States is being carried out in

accordance with each and every applicable Colombian law on the matter.

[Complimentary close.]

Bogota, March 21, 2002
[Initialed]

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417Annex 53-A

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Colombia» 7 Aerial Eradication, Alternative Development, and Chart

Aerial Eradication and Alternative Development

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The Kenneth M. Ludden Foreign Operations, Export Financing, and Related Programs Appropriations Act, 2002

(P.L. 107-115) (the FY 2002 FOAA) stipulates that

"� such funds may not be made available for such purposes after six months from the date of

enactment of this Act unless alternative development programs have been developed, in

consultation with communities and local authorities in the departments in which such aerial

fumigation is planned, and in the departments in which such aerial fumigation is has been
conducted such programs are being implement�d "

The attached chart denotes, by department, where aerial spraying of coca has taken place or is anticipated

during calendar year 2002. In each of those departments except Antioquia, alternative development programs
have been developed in consultation with communities and local authorities in those departments. In the

department of Antioquia, the alternative development project is under negotiation. In February 2002 spray planes

treated approximately 1,620 hectares of coca in Antioquia. The Embassy and the Colombian National Police
have agreed that no further spraying will take place until an alternative development project is being implemented.

The executing agency for each alternative development program is listed in column four. In the departments

where the majority of the spraying has taken place in 2002 - Putumayo, Caqueta, Norte de Santander and

Nar� o - multiple alternative development projects are currently being implemented simultaneously.

Colombia: Aerial Eradication and Alternative Development

by Department

Department Spraying 2002 AD Program AD Executing Organization

Amazonas

Antioquia X X PADF

Arauca

Atlantico

Bolivar X X PNDA, FIP - "Campo en Accion," PADF

Boyaca

418 Annex 53-A

Caldas

Caqueta X X PNDA, ODCCP, ACDI/VOCA

Casanare

Cauca X X PNDA, FIP - "Campo en Accion," ACDI/VOCA

Cesar X X FIP - "Campo en Accion"

Choco

Cordoba X X Red de Solidaridad Social (RSS)

Cundinamarca X X FIP - "Campo en Accion" (approved)

Guainia X X PNDA

Guaviave X X PNDA

Huila X X PNDA, ACDI/VOCA

La Guajira

Magdalena

Meta X X PNDA, FIP - "Campo en Accion," ODCCP

PNDA, FIP - "Campo en Accion," ODCCP,
Narino X X
ACDI/VOCA

Norte de Santander X X PNDA, FIP - "Campo en Accion"

Putumayo X X PNDA, FIP - "Campo en Accion," USACE

Quindio

Risaralda

Santander X X FIP - "Campo en Accion"

Sucre X FIP - "Campo en Accion" (approved)

Tolima X X PNDA, FIP - "Campo en Accion," ACDI/VOCA

Valle de Cauca X FIP - "Campo en Accion" (approved)

Vaupes

Vichada X X PNDA

419Annex 53-A

PNDA (formerly PLANTE): GOC's National Plan of Alternative Development

FIP - "Campo en Accion" (GOC's Popular Investment Fund: "Countryside in Action")

ODCCP (Office of Crime Controland Crime Prevention - formerly UN Drug Control Program): livestock

program

ACDI/VOCA (Agricultural Cooperative Development International/Volunteer Overseas Cooperation in

Agriculture): specialty coffee program

PADF (Panamerican Development Foundation): income generation program (under negotiation)

USACE (U.S. Army Corps of Engineers): infrastructure development

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420 Annex 53-B

departMent ofstatecertificatiorelated toaerialeradication in
c oloMbiaunder thea ndeancounterdrug nitiativsection of the

foreigno peration, xportfinancingand relatedp rograMsa ppropriations
act, divisie, consolidatedappropriatioresolution, 2003

(U.S. Department of State)

421422 Annex 53-B

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Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2003 » Certification Related to Aerial
Eradication in Colombia

Certification Related to Aerial Eradication in Colombia Under the
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Andean Counterdrug Initiative Section of the Foreign Operations,

Export Financing, and Related Programs Appropriations Act, Division E,

Consolidated Appropriations Resolution, 2003, (P.L. 108-7)

Report on Issues Related to the Aerial Eradication of Illicit Coca in Colombia

BUREAU OF INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS
December 2003

Pursuant to the authority vested in me as Secretary of State, including under the Andean Counterdrug Initiative

section of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, Division E,
Consolidated Appropriations Resolution, 2003, (P.L. 108-7� (the �O), I hereby determine and certify that:

(1) the herbicide mixture is being used in accordance withEPA label requirements for comparable use in the

United States and any additional controls recommended by EPA for this program, and with the Colombian
Environmental Management Plan for aerial fumigation; (2) the herbicide mixture, in the manner it is being used,

does not pose unreasonable risks of adverse effects to humans or the environment; (3) complaints of harm to

health or licit crops caused by such fumigation are evaluated and fair compensation is being paid for meritorious
claims; and programs are being implemented by the United States Agency for International Development, the

Government of Colombia, or other organizations, in consultation with local communities, to provide alternative

sources of income in areas where security permits for small-acreage growers whose illicit crops are targeted for
fumigation.

This Certification shall be published in the Federal Registerand copies shall be transmitted to the appropriate

committees of Congress.

______________ ______________________

Date Colin L. Powell

Secretary of State

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423Annex 53-B

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Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2003 » Memorandumof Justification
Concerning the Aerial Eradication of Coca and OpiumPoppy in Colombia

Memorandum of Justification Concerning the Aerial Eradication of Coca

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and Opium Poppy in Colombia

Report on Issues Related to the Aerial Eradication of Illicit Coca in Colombia

BUREAU OF INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

December 2003

The Andean Counterdrug Initiative section of the Foreign Operations, Export Financing, and Related Programs

Appropriations Act, Division E, Consolidated Appropriations Resolution, �003, (�) lays out ( FOAA

conditions under which assistance using funds appropriated under the FOAA may be made available for the
procurement of chemicals for use in aerial eradication of illicit crops. In particular, the FOAA provides:

That not more than 20 percent of the funds appropriated by this Act that are used for the procurement of

chemicals for aerial coca and poppy fumigation programs may be made available for such programs
unless the Secretary of State, after consultation with the Administrator of the Environmental Protection

Agency (EPA), certifies to the Committees on Appropriations that (1) the herbicide mixture is being used

in accordance withEPA label requirements for comparable use in the United States and any additional

controls recommended by EPA for this program, and with the Colombian Eanagementtal M
Plan for aerial fumigation; (2) the herbicide mixture, in the manner it is being used, does not pose

unreasonable risks of adverse effects to humans or the environment; (3) complaints of harm to health or

licit crops caused by such fumigation are evaluated and fair compensation is being paid for meritorious

claims; and such funds may not be made available for such purposes unless programs are being
implemented by the United States Agency for International Development, the Government of Colombia, or

other organizations, in consultation with local communities, to provide alternative sources of income in

areas where security permits for small-acreage growers whose illicit crops are targeted for fumigation.

This memorandum lays out the justification for the Secretary of State s Determination that the conditions in

The Andean Counterdrug Initiative section have been met as required.

On April 9, 2003, the Secretary of State wrote U.S. Environmental Protection AgencyE(PA) Administrator

Whitman to request written consultation concerning the U.S.-supported Colombia eradication program. This
letter is included as Attachment 1. Specifically, EPA was asked to advise the Department of State about

whether the herbicide mixture is being used in accordance with EPAalbel requirements for comparable use in

the United States and any additional controls recommended by EPA for this program; and about the risks of

adverse effects to humans or the environment from the herbicide mixture, in the manner it is being used.

In 2002, EPA provided the Department of State a thorough technical review of the�Department of State s

glyphosate use in the Government of C�lombia s coca spray program. The Department of State and EPA

determined that EPA should use th� EPA s 2002 analysis as a foundation for the 2003 consultation. The
Department s working level consultations with EPA preceded the Secretary s letter and continued into June.
� �
The Department met withEPA to brief EPA on c hanges in the eradication program since the 2002EPA Analysis

and to discuss opium poppy eradication, which Congress did not askEPA to address in 20�2. The Secretary s

April 9 letter provided EPA with a written�dDepartment of State Updated Report on Chemicals used
in the Colombian Aerial Eradication�P-- that provided further information on the issues discussed in the

briefing. This document is included as Attachment 2.

On June 9, EPA Assistant Administrator Stephen Johnson responded to the Secretary of State on behalf of EPA
Administrator Whitman with the results of EPA s consultation review. That letter, and the attached document

� Office of Pesticide Programs Details of the 2003 Consultation for the Department of State Use of Pesticide for

Coca and Poppy Eradication Program in Co� �bEPA 2003 Analysi� ) are included as Attachment 3.

424 Annex 53-B

1. (A) The herbicide mixture is being used in accordance with EPA label requirements for comparable

use in the United States

EPA does not draft the label requirements for pesticide use in the United States, although it reviews and

approves recommendations for use that are written by pesticide manufacturers. The aerial spray mixtures
currently used in the U.S.-supported program of aerial eradication of both coca and opium poppy in Colombia

contain three components: water, anEPA-registered formulation of the herbicide glyphosate, and a surfactant

(Cosmo-Flux 411F).

The commercial glyphosate formulation used in the spray mixture is registered withEPA for sale in the United
States for non-agricultural use. Although EPA dorgulate the use of adjuvant products not labeled as

pesticides, EP� s Office of Pesticide Programs reviewed the complete chemical constituents of Cosmo-Flux

411F, at the request of the Department of State, in 2001. This allowed the Department of State to better assess
safety concerns related to the use of this product in the spray program. EPA determinedr001 thatmbe2

all of the ingredients of Cosmo-Flux 411F are exempt under 40 CFR 180.1001 from the requirement of tolerances

when included in pesticides applied to food, feeds, and livestock.

During 2003 consultations withEPA, the Department of State reported to EPA the breakdown of the spray
mixtures used for spraying coca and opium poppy and the application rates used in each operation (Attachment

2, p. 5). EPA responded t�aEPA has determined that application rates for both coca and opium poppy

eradication in Colombia are within the parameters listed on�U.S. labels (Attachment 3, Executive Summary).
This determination meets the criteria for the Secretary to certify that the herbicide mixture is being used in

accordance withEPA label requirements for comparable use in the United States.

1. (B) The herbicide mixture is being used in accordance with any additional controls recommended

by the EPA for this program

The Government of Colombia and the Department of State have implemented several changes in the program to

address issues raised by the 2002 EPAanalysis. For reference, the 2002EPA analysis,�Office of

Pesticide Programs Details of the Consultation for Department of State: Use of Pesticide for Coca Eradication

Program in Colombi� � 2002 EPA Analysi� ) is enclosed as Attachment 4. The 2002 EPA
recommendations and the Department of State responses are outlined below.

EPA recommendation to change glyphosate product used by the program:

The EPA made one direct recommendation to the Department of State related to spray program controls in the
2002 EPA Analysis. EPA recomm ended (Attachment 4, p. 12) t...due to the acute eye irritation caused by

the concentrated glyphosate formulated product and the lack of acute toxicity data on the tank mixture, the

Agency recommends that DoS consider using an alternative glyphosate product (with lower potential for acute

toxicity) in future coca and/or poppy aerial eradicati�n programs. The Department of State believes that this
recommendation was meant as a precaution for those persons filling spray tanks on the airplane who risked

splashing the full-strength glyphosate into the eyes or onto the skin. The Department of State does not believe

that the recommendation was intended to indicate any potential risk to persons exposed to the spray mixture as
actually applied by the spray aircraft.

At the time that the EPA m ade this recommendation, there were no suitable replacement glyphosate

formulations registered for sale and use in Colombia that offered lower potential for acute eye irritation. The

Department of State worked with the pr�gram s glyphosate supplier to identify and to register for sale and use
in Colombia a formulation of glyphosate with reduced potential for eye irritation. As soon as that product could be

registered for sale and use in Colombia, the Department of State began to purchase it for use in the spray

program beginning in September 2002, and it is the formulation used today.

Like the previous formulation, the new formulation is also registered with the EPA for sale in the United States for
non-agricultural use. It also contains 41 percent glyphosate salt and 59 percent inert ingredients. Like the

previous formulation, the formulation now used is made from a base material (glyphosate technical) that is

produced by a manufacturing plant in the United States. The glyphosate formulation now used is mixed with
water and surfactant in the same proportions as the previous formulation to form the coca spray mixture.

The difference between the old and new formulations is that the current full strength product has an overall

category III toxicological �ating ( mi�d) on the scale used by the EPA, whereas the previously used

glyphosate formulation was rated categ�ry I ( hig�l) in its full, undiluted strength. The toxicity reduction
is due to a change in the surfactant used in the glyphosate formulation. Of course, these ratings refer to the

toxicological profile of the glyphosate formulations in their point of sale, undiluted form, and not the spray mixture

(water, glyphosate formulation, and surfactant) that exits the spray aircraft.

425Annex 53-B

EPA � s 2003 analysis offered the following assessment of the implications �f the spray program s switch to
the new herbicide formulation for spraying of coca and opium pop�y in Colombia: As for human health

concerns, EPA concludes there ari ks of concern from dietaryl ader/applicator or field workers, or

bystanders (including children). The concerns for mixer/loader eye irritation �iscussed in the Agency s 2002
findings have been mitigated by switching to the lower toxicity product (Attachment 3, Executive Summary, p.

ii).

EPA advice regarding tracking reported health complaints:

EPA � s 2002 analysis (Attachment 4, p. 32) also �t(p)rospective tracking of reports of health
complaints, documenting times of exposure and onset of symptoms, are recommended during future spray

operations to evaluate any potential health effects and ameliorate or pre�ent their occurrence. The Department

of State has increased its efforts to track reported health complaints and to investigate any possible connection

between verified spraying of illicit crops and damages purported in any such complaints.

The spray program tracks human health complaints in several ways. The first is to initiate an immediate

investigation, often including clinical evaluation of the patient(s), upon notice to the U.S. Embassy of a problem.

The Embassy� s Narcotics Affairs Section (NAS) learns about cases through letters directed to the Embassy or

Government of Colombia (GOC) entities, from local counternarcotics base commanders, from the members of
the media, and from non-governmental organizations. To investigate complaints of toxic exposure allegedly

caused by spraying, NAS retains the services of two of Colombia's leading toxicologists, including the director of

Colombia�s national poison control center, the Uribe Cualla Centro de Ases�ramiento Toxicol gico.

Since submission to Congress of the F� Report on Issues Related to the Eradication of Illicit Coca in
Colombia� four such complaints have been reported to the U.S. Embassy. Details of these complaints and of

follow-up medical evaluations are included below.

In September 2002, the Embassy received a complaint of multiple cases of poisoning from spraying of coca in

Puerto A� s (Putumayo Department). A visit to the hospital and interviews with doctors there by a Colombian
toxicologist under contract to the State Department revealed no cases of poisoning or illness attributable to

spray chemicals. The toxicologist learned of two hospitalized children who could have been the source of the

complaint, and he reviewed their cases. One of those children was suffering from poisoning by an
organophosphate insecticide. The other child was suffering from asthma. An English language version of the

toxicolog�ss report from this investigation is enclosed as Attachment 2, Tab B.

In February 2003, a news report in �hdaily�El Tiemp� attributed the spread of tuberculosis and

cases of harelip and cleft palate in newborns to aerial spra�ing of coca in Tib (Norte de Santander department).
A toxicological review (Attachment 5) showed cleft palate and harelip to be genetically inherited defects that have

never been reported in humans as a result of exposure to any chemical substance. Tuberculosis is an infectious

disease passed from person to person, and is also unrelated to any potential exposure to spray chemicals.

During a March 2003 visit to Pas�o, Nari o, Embassy Public Affairs personnel were told that the local hospital
had cases of children suffering health problems from spraying. A NAS officer followed up on this case and spoke

with a hospital doctor who explained that there were no sick children in the hospital, but that he was tracking a

number of children with birth defects whose mothers allegedly were exposed to spray chemicals. The doctor

offered to let an Embassy-contracted Colombian toxicologist review the case files. A NAS letter to fileergarding
this case is enclosed as Attachment 6.

On July 2, 2003, a news broadcast on Caracol TV reported the death of a coca leaf harvester allegedly exposed

to spray chemicals. The man had been hospitalized in San Pablo, Bolivar department. Investigation revealed that

the man suffered a serious infectious disease that went undiagnosed until it was too late. Officials in San Pablo
eventually transferred the man to a better-equipped hospital in Bucaramanga, Santander department, where he

later died. An autopsy confirmed that the man had died from pneumonia and meningial infection. A screen for

chemicals in his lung tissue was negative. The�toxicologist s report from this investigation is enclosed as

Attachment 7.

The Government of Colombia and the U.S. Embass� Bhave also taken a proactive approach to

investigating human health concerns manifest in areas where the spraying takes place. Both governments have

collaborated to create a robust Medical Civic Action Program (Medcap) to search out cases of harm to health
allegedly caused by the spraying. These public health interventions are timed to take place in areas where coca

eradication has recently taken place. U.S. Embassy-contracted Colombian toxicologists talk to patients as well

as to local medical personnel, looking for spray-related cases. As outlined in the chart below, a total of 4,779

patients made themselves available for Medcap medical personnel, had their medical conditions assessed, and
received complimentary health care. Although Medcap personnel have encountered cases that were claimed to

426EPA � s 2003 analysis offered the following assessment of the implications o� the spray program s switch to
the new herbicide formulation for spraying of coca and opium pop�y in Colombia: As for human health

concerns, EPA concludes there ari ks of concern from dietary,l ader/applicator or field workers, or

bystanders (including children). The concerns for mixer/loader eye irritation d�scussed in the Agency s 2002
findings have been mitigated by switching to the lower toxicity product (Attachment 3, Executive Summary, p.

ii).

EPA advice regarding tracking reported health complaints:

EPA � s 2002 analysis (Attachment 4, p. 32) also s�(p)rospective tracking of reports of health
complaints, documenting times of exposure and onset of symptoms, are recommended during future spray

operations to evaluate any potential health effects and ameliorate or prev�nt their occurrence. The Department

of State has increased its efforts to track reported health complaints and to investigate any possible connection

between verified spraying of illicit crops and damages purported in any such complaints.

The spray program tracks human health complaints in several ways. The first is to initiate an immediate

investigation, often including clinical evaluation of the patient(s), upon notice to the U.S. Embassy of a problem.

The Embassy� s Narcotics Affairs Section (NAS) learns about cases through letters directed to the Embassy or

Government of Colombia (GOC) entities, from local counternarcotics base commanders, from the members of
the media, and from non-governmental organizations. To investigate complaints of toxic exposure allegedly

caused by spraying, NAS retains the services of two of Colombia's leading toxicologists, including the director of

Colombi� s national poison control center, the Uribe Cualla Centro de Aseso�amiento Toxicol gico.

Since submission to Congress of the F� Report on Issues Related to the Eradication of Illicit Coca in
Colombia� four such complaints have been reported to the U.S. Embassy. Details of these complaints and of

follow-up medical evaluations are included below.

In September 2002, the Embassy received a complaint of multiple cases of poisoning from spraying of coca in

Puerto A� s (Putumayo Department). A visit to the hospital and interviews with doctors there by a Colombian
toxicologist under contract to the State Department revealed no cases of poisoning or illness attributable to

spray chemicals. The toxicologist learned of two hospitalized children who could have been the source of the

complaint, and he reviewed their cases. One of those children was suffering from poisoning by an
organophosphate insecticide. The other child was suffering from asthma. An English language version of the

toxicolog�ss report from this investigation is enclosed as Attachment 2, Tab B.

In February 2003, a news report in �hedail�tEl Tiemp� attributed the spread of tuberculosis and

cases of harelip and cleft palate in newborns to aerial spray�ng of coca in Tib (Norte de Santander department).
A toxicological review (Attachment 5) showed cleft palate and harelip to be genetically inherited defects that have

never been reported in humans as a result of exposure to any chemical substance. Tuberculosis is an infectious

disease passed from person to person, and is also unrelated to any potential exposure to spray chemicals.

During a March 2003 visit to Pas�o, Nari o, Embassy Public Affairs personnel were told that the local hospital
had cases of children suffering health problems from spraying. A NAS officer followed up on this case and spoke

with a hospital doctor who explained that there were no sick children in the hospital, but that he was tracking a

number of children with birth defects whose mothers allegedly were exposed to spray chemicals. The doctor

offered to let an Embassy-contracted Colombian toxicologist review the case files. A NAS letter to fileergarding
this case is enclosed as Attachment 6.

On July 2, 2003, a news broadcast on Caracol TV reported the death of a coca leaf harvester allegedly exposed

to spray chemicals. The man had been hospitalized in San Pablo, Bolivar department. Investigation revealed that

the man suffered a serious infectious disease that went undiagnosed until it was too late. Officials in San Pablo
eventually transferred the man to a better-equipped hospital in Bucaramanga, Santander department, where he

later died. An autopsy confirmed that the man had died from pneumonia and meningial infection. A screen for

chemicals in his lung tissue was negative. The �oxicologist s report from this investigation is enclosed as

Attachment 7.

The Government of Colombia and the U.S. Embassy�Bhave also taken a proactive approach to

investigating human health concerns manifest in areas where the spraying takes place. Both governments have

collaborated to create a robust Medical Civic Action Program (Medcap) to search out cases of harm to health
allegedly caused by the spraying. These public health interventions are timed to take place in areas where coca

eradication has recently taken place. U.S. Embassy-contracted Colombian toxicologists talk to patients as well

as to local medical personnel, looking for spray-related cases. As outlined in the chart below, a total of 4,779

patients made themselves available for Medcap medical personnel, had their medical conditions assessed, and
received complimentary health care. Although Medcap personnel have encountered cases that were claimed toAnnex 53-B

The first of these steps was to reinforce the environmental safety component of spray pilot training. A NAS

Environmental Advisor and aviation experts from the Department �f State s Air Wing designed a curriculum for

pilots on the potential negative impact that spraying may have on the environment and techniques to minimize
potential collateral damage to legal crops and the environment.

Pilots received this briefing in December 2002 and again in June 2003. All pilots, both fixed wing spray pilots and

rotary wing escort helicopter pilots, will receive these briefings, which will be conducted semi-annually (a third

session is on track for December 2003). Briefings emphasize the unique aspects of the Colombian operational
theatre, and will solicit feedback from pilots on techniques to maximize application effectiveness and avoid

damage to non-target vegetation. An outline of this briefing is included as Attachment 2, Tab C.

Search and rescue helicopter crews that accompany each spray flight have also been directed to monitor drift

patterns from above. They now assist in ensuring that spray does not drift beyond target crops and notify the
spray aircraft flight lead when conditions might merit canceling a spray flight. A copy of the directive from the

Department of Stat� s Bureau of International Narcotics and Law Enforcement Affairs (INL) Office of Aviation to
the eradication contractor that formalizes these new spray regulations is included as Attachment 2, Tab D.

EPA noted in 2003 that (t)he Agency believes that the potential for spray drift phytotoxicity is still a factor for

both coca and poppy spraying.EPA recognizes that the Department of State is employing Best Management

Practices to minimize drift and encourages them to continue thes� efforts. (Attachment 3, Executive
Summary, p. ii).

The Department will continue drift control efforts asEPA recomm ends. Based on response� to EPA s 2002

and 2003 recommendations on herbicide use, human health tracking, and spray drift, the Department of State

believes that the herbicide mixture is being used in accordance with any additional controls recommended by the
EPA for this program.

1. (C) The herbicide mixture is being used in accordance with the Colombian Environmental

Management Plan for aerial fumigation

The GOC �s Environmental Management Plan for aerial eradication (EMP) was drafted and implemented by the

Ministry of the Environment (MINAMB) in 2001. The EMP was designed to be a living document, and it was
modified by several MINAMB resolutions at the end of the previous administration. As written, the EMP was

impossible to execute and lacked clear lines of responsibility for the GOC line agencies that were required to

carry out aspects of the EMP.

In 2003, the GOC recognized that further refinement was necessary to achieve greater efficiencies, and formed

an inter-institutional technical committee to revise the EMP. This committee, which first met on May 8, 2003,

was composed of representatives from the Ministry of the Environment (MINAMB), the National Directorate for
Dangerous Drugs (DNE), the Antinarcotics Police (DIRAN), the Ministry of Health, the Ministry of Agriculture

(ICA), MINAMB's laboratory (IDEAM), and the U.S. Embassy Bogota Narcotics Affairs Section (NAS).

The revisions recommended by the committee were briefed to Colombian environmental groups following formal

publication. After a fifteen-day period, during which no adverse comments were received, the revisions were
incorporated into the EMP by MINAMB Resolution 1054 on September 30, 2003. An English language version of

the revised EMP is enclosed as Attachment 8.

The most significant change in the EMP is the inclusion of multiple agencies in the monitoring process. Under

the EMP as modified, environmental monitoring is an inter-agency process, with clear roles and responsibilities
for each party. INL technical and equipment assistance provided to a wide range of EMP participants has given

these agencies an ability to actively participate in monitoring of the spray program and to carry out the roles
required of them. With Department of State-donated laboratory equipment, the GOC Institute of Geography will

conduct soil sampling and the Ministry of Health will conduct water sampling to determine the persistence of

glyphosate in sprayed areas. Similarly, with assistance from the Department of Stat�, the GOC s Ministry of
Health is training health care providers in areas where spraying takes place to recognize different forms of

chemical poisoning. Once trained, they will be able to differentiate between glyphosate-derived illness and the

other forms of chemical poisoning that commonly afflict people who process raw materials into finished drugs in
their homes. NAS has allocated $3 million from the eradication budget for environmental improvements ranging

from physical upgrades at bases to the provision of training and equipment to GOC line agencies for EMP

purposes.

INL Principal Deputy Assistant Secretary Paul Simons visited Bogota during November 5-7 to meet with NAS
Bogota and participating GOC EMP agencies to discuss their roles under the new EMP. All of these agencies

were appreciative of the Department of �tate s assistance that is now allowing them a seat at the table under a

functioning EMP. In addition to providing assistance to �olombia s EMP agencies, NAS Bogota has hired four
personnel to strengthen oversight of the eradication program and related initiatives to ensure continued

428The first of these steps was to reinforce the environmental safety component of spray pilot training. A NAS
Environmental Advisor and aviation experts from the Department�of State s Air Wing designed a curriculum for

pilots on the potential negative impact that spraying may have on the environment and techniques to minimize

potential collateral damage to legal crops and the environment.

Pilots received this briefing in December 2002 and again in June 2003. All pilots, both fixed wing spray pilots and

rotary wing escort helicopter pilots, will receive these briefings, which will be conducted semi-annually (a third

session is on track for December 2003). Briefings emphasize the unique aspects of the Colombian operational
theatre, and will solicit feedback from pilots on techniques to maximize application effectiveness and avoid

damage to non-target vegetation. An outline of this briefing is included as Attachment 2, Tab C.

Search and rescue helicopter crews that accompany each spray flight have also been directed to monitor drift

patterns from above. They now assist in ensuring that spray does not drift beyond target crops and notify the
spray aircraft flight lead when conditions might merit canceling a spray flight. A copy of the directive from the

Department of Sta�e s Bureau of International Narcotics and Law Enforcement Affairs (INL) Office of Aviation to

the eradication contractor that formalizes these new spray regulations is included as Attachment 2, Tab D.

EPA noted in 2003 tha� (t)he Agency believes that the potential for spray drift phytotoxicity is still a factor for
both coca and poppy spraying.EPA recognizes that the Department of State is employing Best Management

Practices to minimize drift and encourages them to continue the�e efforts. (Attachment 3, Executive

Summary, p. ii).

The Department will continue drift control efforts asEPA recomm ends. Based on respon�es to EPA s 2002
and 2003 recommendations on herbicide use, human health tracking, and spray drift, the Department of State

believes that the herbicide mixture is being used in accordance with any additional controls recommended by the

EPA for this program.

1. (C) The herbicide mixture is being used in accordance with the Colombian Environmental
Management Plan for aerial fumigation

The GOC s Environmental Management Plan for aerial eradication (EMP) was drafted and implemented by the

Ministry of the Environment (MINAMB) in 2001. The EMP was designed to be a living document, and it was

modified by several MINAMB resolutions at the end of the previous administration. As written, the EMP was
impossible to execute and lacked clear lines of responsibility for the GOC line agencies that were required to

carry out aspects of the EMP.

In 2003, the GOC recognized that further refinement was necessary to achieve greater efficiencies, and formed

an inter-institutional technical committee to revise the EMP. This committee, which first met on May 8, 2003,
was composed of representatives from the Ministry of the Environment (MINAMB), the National Directorate for

Dangerous Drugs (DNE), the Antinarcotics Police (DIRAN), the Ministry of Health, the Ministry of Agriculture

(ICA), MINAMB's laboratory (IDEAM), and the U.S. Embassy Bogota Narcotics Affairs Section (NAS).

The revisions recommended by the committee were briefed to Colombian environmental groups following formal
publication. After a fifteen-day period, during which no adverse comments were received, the revisions were

incorporated into the EMP by MINAMB Resolution 1054 on September 30, 2003. An English language version of

the revised EMP is enclosed as Attachment 8.

The most significant change in the EMP is the inclusion of multiple agencies in the monitoring process. Under
the EMP as modified, environmental monitoring is an inter-agency process, with clear roles and responsibilities

for each party. INL technical and equipment assistance provided to a wide range of EMP participants has given

these agencies an ability to actively participate in monitoring of the spray program and to carry out the roles
required of them. With Department of State-donated laboratory equipment, the GOC Institute of Geography will

conduct soil sampling and the Ministry of Health will conduct water sampling to determine the persistence of

glyphosate in sprayed areas. Similarly, with assistance from the Department of St�te, the GOC s Ministry of
Health is training health care providers in areas where spraying takes place to recognize different forms of

chemical poisoning. Once trained, they will be able to differentiate between glyphosate-derived illness and the

other forms of chemical poisoning that commonly afflict people who process raw materials into finished drugs in
their homes. NAS has allocated $3 million from the eradication budget for environmental improvements ranging

from physical upgrades at bases to the provision of training and equipment to GOC line agencies for EMP
purposes.

INL Principal Deputy Assistant Secretary Paul Simons visited Bogota during November 5-7 to meet with NAS

Bogota and participating GOC EMP agencies to discuss their roles under the new EMP. All of these agencies

were appreciative of the Department of�State s assistance that is now allowing them a seat at the table under a
functioning EMP. In addition to providing assistance to Colombia s EMP agencies, NAS Bogota has hired four

personnel to strengthen oversight of the eradication program and related initiatives to ensure continuedAnnex 53-B

Field verification is extremely dangerous and resource intensive and this is a slow-moving process. Because of

the risks involved for the Embassy personnel, agronomists, lawyers, DNE representatives, CNP officials, and

ombudsman � representatives that accompany site visits, the primacy of security will dictate the pace of
investigations in the future. Although logistical considerations (security concerns, personnel availability, and

helicopter resources) are part of the reason that complaints cannot be resolved in the field more quickly, the

greatest logjam in this system is the number of false complaints that overwhelm the ability of field investigators
to close more cases.

False complaint� cases in which growers complained that their legitimate crops were sprayed, but

investigators who reached the fields in question found them to be coca or legitimate crops interspersed with coca

� waste resources that otherwise might be used in the service of the farmers who really deserve compensation.
Of the 1,200 complaints investigated in the field, only five have been deemed credible. In other words, less than

half of one percent of the cases that have been visited by complaint verification teams to date have merited
compensation. Nevertheless, Embassy Bogota has taken steps to make sure that the complaint resolution is

swifter and continues to pursue field verifications when security, weather, and logistical considerations permit.

The Colombian Ministry of Justice is in the process of refining the claims procedures to further streamline the

process. These will include a warning that a complainant found to have coca growing in fields that he claims
were legal crops will be subject to prosecution under violation of a Colombian law prohibiting false claims.

Presumably, this will deter the overwhelming number of false claims that have flooded the system, making

investigation of and restitution for genuine claims very difficult.

3. (B) Such funds may not be made available for such purposes unless programs are being
implemented by the USAID, the GOC, or other organizations in consultation with local communities, to

provide alternative sources of income in areas where security permits for small-acreage growers

whose illicit crops are targeted for spraying

Thus far in calendar year 2003, the Colombian aerial eradication program has sprayed coca in the departments
of Putumayo, Nari o, Guaviare, Meta, Bolivar, Cauca, Norte de Santander, Vichada, Antioquia, Vaupes,

Cordoba, and Arauca and opium poppy in the departments of Cauca, Huila, Toli�a, Nari o, Cesar, and La

Guajira. In each of these areas, USAID, the GOC, and/or other organizations are implementing alternative
development programs to provide legal income generating opportunities to illicit crop growers who agree to

accept benefits after eradicating their crops of coca or opium poppy.

For the purposes of this report, the Department of State interpret� the�teas a Colombian

department. This is consistent with the way that the Colombian spray program records and reports spray
activity. It is also the most appropriate definition because Department of State and USAID experience has shown

that while alternative development programs should be (and are) coordinated with spraying, these two

components should not always be implemented in every location.

Alternative development is not appropriate in many locations where illicit crops are grown. Coca and opium
poppy are often grown in remote, difficult to reach areas with limited infrastructure to support legal crops that

have less value and higher transport costs than illegal merchandise. Dispersing development activities to remote
areas raises costs while reducing impact. Furthermore, many drug-producing regions have nutrient-poor and

fragile tropical soils, inappropriate for large-scale farming activity and unsuitable for increased human habitation.

As reflected in the language of Public Law 108-7, guerilla and paramilitary groups operate in many illicit crop-
growing zones and make alternative development inadvisable in these locations. These narcoterrorist groups reap

immense profit from the illegal trade and pose grave security rsiks for development personnel and slow down the

implementation progress.

Despite these obstacles to alternative development in Colombia, USAID and the GOC are implementing a robust
alternative development program in coca and opium producing areas. Now in the fourth year of Plan Colombia

alternative development coordination with the GOC and the third year of project implement�tion, USAIDs

alternative development (AD) program has supported a total of 24,549 hectares of licit crops and completed 260
infrastructure projects in coca and poppy growing areas through March 31, 2003. These efforts have benefited a

total of 22,829 families. These achievements in each category have surpassed program goals. Equally important,

USAID has strengthened a total of 30 NGOs, cooperatives, and national institutions so that alternative
development and community building activities will be more sustainable.

The alternative development projects being carried out by USAID and GOC organizations in each area where the

spray program eradicates illicit crops are described below.

Antioquia

A $9.1 million project through the Pan-American Development Foundation (PADF) for short-term production

430 activities for immediate income and employment needs; longer term crops such as natural rubber and cacao to
Field verification is extremely dangerous and resource intensive and this is a slow-moving process. Because of
the risks involved for the Embassy personnel, agronomists, lawyers, DNE representatives, CNP officials, and provide sustainability; and complementary productive infrastructure. Also operating in south of Bolivar

ombudsman s�representatives that accompany site visits, the primacy of security will dictate the pace of Department.

investigations in the future. Although logistical considerations (security concerns, personnel availability, and
helicopter resources) are part of the reason that complaints cannot be resolved in the field more quickly, the A $8.5 million project through Land O Lakes (LOL) to promote sustainable dairy production, processing and
marketing involving small farmers. Also operating in Nari o.
greatest logjam in this system is the number of false complaints that overwhelm the ability of field investigators
to close more cases.
Aid to Artisans (ATA)is carrying out a $4.3 million project to strengthen local capacity for production and

False complaints cases in which growers complained that their legitimate crops were sprayed, but marketing of crafts. Also operating in Atlantico, Boyaca, Caldas, Cauca, Cesar, Codoba, Huila, Magdalena,

investigators who reached the fields in question found them to be coca or legitimate crops interspersed with coca Narino, Quindio, Santander, Sucre, and Tolima.

� waste resources that otherwise might be used in the service of the farmers who really deserve compensation. The $20 million Colombia Agribusiness Partnership Program (C
Of the 1,200 complaints investigated in the field, only five have been deemed credible. In other words, less than
Development (ARD) is promoting private sector agricultural production. In Antioquia, the program supports small
half of one percent of the cases that have been visited by complaint verification teams to date have merited
farmers in producing fruit for processing into pulp and African palm. Also operates in Atlantico, Bolivar, Caldas,
compensation. Nevertheless, Embassy Bogota has taken steps to make sure that the complaint resolution is
swifter and continues to pursue field verifications when security, weather, and logistical considerations permit. Casanare, Cauca, Cesar, Cordoba, Guajira, Huila, Magdalena, Narino, Quindio, Risaralda, Santander, Sucre,
Tolima, and Valle del Cauca.

The Colombian Ministry of Justice is in the process of refining the claims procedures to further streamline the
The $12 million Colombia Enterprise Development (CED) project to support small and medium enterprise
process. These will include a warning that a complainant found to have coca growing in fields that he claims
development in secondary cities. Also operating in Atlantico, Caldas, Quindio, Risaralda, Santander, Valle del
were legal crops will be subject to prosecution under violation of a Colombian law prohibiting false claims.
Presumably, this will deter the overwhelming number of false claims that have flooded the system, making Cauca, and Tolima.

investigation of and restitution for genuine claims very difficult. The $22.7 million Colombia Forestry Development Project (CFDP) to support: forest policy changes and

improved production, processing and marketing of forest and wood products to increase incomes. Will also
3. (B) Such funds may not be made available for such purposes unless programs are being
operate in Choco, Magdalena, and Narino.
implemented by the USAID, the GOC, or other organizations in consultation with local communities, to

provide alternative sources of income in areas where security permits for small-acreage growers The Colombian Government s Investment Fund for Peace (FIP), a $32.2 million investment, is generating
whose illicit crops are targeted for spraying employment through infrastructures, licit crop production (coffee rehabilitation, agro forestry), skills training, and

education/nutrition aid to poor families.
Thus far in calendar year 2003, the Colombian aerial eradication program has sprayed coca in the departments

of Putumayo, Nar� o, Guaviare, Meta, Bolivar, Cauca, Norte de Santander, Vichada, Antioquia, Vaupes,
Arauca
Cordoba, and Arauca and opium poppy in the departments of Cauca, Huila, Tolim�, Nari o, Cesar, and La
Guajira. In each of these areas, USAID, the GOC, and/or other organizations are implementing alternative
The $2.4 million effort under the GOC s FIP generates employment through infrastructure and road
development programs to provide legal income generating opportunities to illicit crop growers who agree to improvements, equipment and infrastructure for local government and community organizations, and

accept benefits after eradicating their crops of coca or opium poppy. education/nutrition assistance to poor families.

For the purposes of this report, the Department of State interpret� the �eas a Colombian Bolivar
department. This is consistent with the way that the Colombian spray program records and reports spray

activity. It is also the most appropriate definition because Department of State and USAID experience has shown PADF is supporting short cycle production activities to address immediate income and employment

that while alternative development programs should be (and are) coordinated with spraying, these two requirements; longer term crops such as natural rubber and cacao to provide sustainability; and complementary
components should not always be implemented in every location.
productive infrastructure.

Alternative development is not appropriate in many locations where illicit crops are grown. Coca and opium
CAPP is also promoting private sector involvement with farmers to porduce cacao, African palm, and yucca
poppy are often grown in remote, difficult to reach areas with limited infrastructure to support legal crops that
have less value and higher transport costs than illegal merchandise. Dispersing development activities to remote (cassava).

areas raises costs while reducing impact. Furthermore, many drug-producing regions have nutrient-poor and
The GOC
fragile tropical soils, inappropriate for large-scale farming activity and unsuitable for increased human habitation. infrastructure and road improvement projects, licit crop production (rubber, reforestation, corn, beans), equipment
As reflected in the language of Public Law 108-7, guerilla and paramilitary groups operate in many illicit crop-
and infrastructure for local governments and community organizations, skills training, forest guardian families
growing zones and make alternative development inadvisable in these locations. These narcoterrorist groups reap
program, and education/nutrition assistance to poor families.
immense profit from the illegal trade and pose grave security rsiks for development personnel and slow down the
implementation progress.
Caqueta

Despite these obstacles to alternative development in Colombia, USAID and the GOC are implementing a robust

alternative development program in coca and opium producing areas. Now in the fourth year of Plan Colombia Chemonics -- Colombia Alternative Development (CAD) project is investing $4.5 million and fostering short-term

alternative development coordination with the GOC and the third year of project implementa�ion, USAIDs crop production for food security and longer-term income generation through rubber production.
alternative development (AD) program has supported a total of 24,549 hectares of licit crops and completed 260

infrastructure projects in coca and poppy growing areas through March 31, 2003. These efforts have benefited a The Amazon Conservation Team is assisting Colombian indigenous communities in food security, health and

total of 22,829 families. These achievements in each category have surpassed program goals. Equally important, local governance/land management (total investment $1.8 million). Activities under this program are also being
USAID has strengthened a total of 30 NGOs, cooperatives, and national institutions so that alternative
carried out in the Departments of Putumayo and Vaupes.
development and community building activities will be more sustainable.

The alternative development projects being carried out by USAID and GOC organizations in each area where the The GOC

spray program eradicates illicit crops are described below. projects, licit crop production (coffee rehabilitation, sugarcane, rubber planters, livestock), equipment and
infrastructure for local governments and community organizations, and education/nutrition assistance to poor

Antioquia families with resources amounting to $2.0 million.

A $9.1 million project through the Pan-American Development Foundation (PADF) for short-term production
CaucaAnnex 53-B

Chemonics-CAD activities, totaling $3.9 million, to improve forest management/production, processing and

marketing chains as well as supporting small scale irrigation for the production and marketing of short-season,

high-value crops.

ACDI/VOCA is also promoting specialty coffee production, processing and marketing �n Cauca s illicit crop
growing areas.

The CAPP project is supporting private sector investments in hot peppers, jute, and cacao.

Aid to Artisans project is enhancing local capacity for production and marketing of crafts as licit income
generating alternatives.

The GOC �s FIP is supporting employment generation activities through infrastructure and road improvement
projects, licit crop production (coffee rehabilitation, fruit trees, forestry, yucca, vegetables, and livestock),

equipment and infrastructure for local governments and community organizations, and education/nutrition

assistance to poor families with resources totaling $8.6 million.

Cesar

Aid to Artisans project is carrying out activities to strengthen the production and marketing of crafts.

The ARD/CAPP program is supporting private sector investments with small farmers producing crops such as

cacao, fruits and African palm.

The GOC �s FIP is supporting employment generation activities through infrastructure and road improvement

projects, licit crop production (cacao, coffee rehabilitation, forestry), equipment and infrastructure for local
governments and community organizations, and education/nutrition assistance to poor families totaling $3.8

million.

Cordoba

Aid to Artisans project is supporting the strengthening of local capacity to produce and market crafts by artisans

in the Department.

ARD/CAPP program is supporting private sector activities in cacaoand passion fruit production.

The GOC s FIP is providing $8.6 million for employment generation activities involving road improvement

projects, and education/nutrition assistance to poor families.

La Guajira

The CAPP is s upporting private sector activities in crops such as passion fruit and cacao.

The GOC s FIP is providing $0.7 million to support employment generation through infrastructure activities,

equipment and infrastructure for local governments and community organizations, and education/nutrition

assistance to poor families.

Guaviare

The GOC �s FIP is providing $0.8 million to support employment generation activities through road improvement

projects. A FIP road improvement program involving Guaviare and Meta is providing $3.4 million for the two

departments.

Huila

Chemonics - CAD project is supporting a $0.6 million activity to promote production and marketing of passion

fruit.

ACDI/VOCA is promoting specialty coffee production, processing and marketing in poppy growing areas.

ARD/CAPP is s upporting cacao and fruits production.

The Aid to Artisans project is promoting production and marketing of crafts.

432 The GOC
Chemonics-CAD activities, totaling $3.9 million, to improve forest management/production, processing and and infrastructure for local governments and community organizations, and education/nutrition assistance to poor

marketing chains as well as supporting small scale irrigation for the production and marketing of short-season, families with $7.5 million in GOC resources.

high-value crops.
Meta

ACDI/VOCA is also promoting specialty coffee production, processing and marketin� in Cauca s illicit crop

growing areas. The GOC
projects, equipment and infrastructure for local governments and community organizations, and

The CAPP project is supporting private sector investments in hot peppers, jute, and cacao. education/nutrition assistance to poor families totaling $3.6 million. In addition, a road improvement program

involving Guaviare and Meta is providing $3.4 million to the two departments.
Aid to Artisans project is enhancing local capacity for production and marketing of crafts as licit income

generating alternatives. The ARD/CAPP program is promoting private sector investments with small farmers to porduce African palm.

The GOC � s FIP is supporting employment generation activities through infrastructure and road improvement Nari�

projects, licit crop production (coffee rehabilitation, fruit trees, forestry, yucca, vegetables, and livestock),
ACDI/VOCA is promoting specialty coffee production, processing and marketing in illicit crop growing areas of
equipment and infrastructure for local governments and community organizations, and education/nutrition
assistance to poor families with resources totaling $8.6 million. Narino.

Cesar The United Nations Office on Drugs and Crime (UNODC) is implementing a $1.2 million activity to encourage
annual crops, agro forestry, and dual purpose livestock production. An agro-forestry management activity totaling

Aid to Artisans project is carrying out activities to strengthen the production and marketing of crafts. $1.8 million is scheduled to begin in December.

The ARD/CAPP program is supporting private sector investments with small farmers producing crops such as Land O

cacao, fruits and African palm.
ARD/CAPPprogram is supporting small farmer, private sector projects in cacao and African palm production.

The GOC � s FIP is supporting employment generation activities through infrastructure and road improvement
Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in Narino.
projects, licit crop production (cacao, coffee rehabilitation, forestry), equipment and infrastructure for local
governments and community organizations, and education/nutrition assistance to poor families totaling $3.8
The $22.7 million Chemonics Colombia Forestry Development Project will be supporting forest policy changes
million.
and carry out activities for the improved production, processing and marketing of forest and wood products in
Narino as well as in Antioquia, Choco and Magdalena.
Cordoba

The GOC
Aid to Artisans project is supporting the strengthening of local capacity to produce and market crafts by artisans
projects, support for licit crop production (coffee rehabilitation, fruit trees, corn, beans), equipment and
in the Department.
infrastructure for local governments and community organizations, and education/nutrition assistance to poor
families with resources totaling $8.2 million.
ARD/CAPP program is supporting private sector activities in cacaoand passion fruit production.

Norte de Santander
The GOC � s FIP is providing $8.6 million for employment generation activities involving road improvement
projects, and education/nutrition assistance to poor families.

A Chemonics-CAD $6.4 million activity in cooperation with FIP is promoting cacao and African palm production,
La Guajira
processing and marketing.

The CAPP is s upporting private sector activities in crops such as passion fruit and cacao. The GOC
production (rubber, cacao, plantains), equipment and infrastructure for local governments and community

The GOC � s FIP is providing $0.7 million to support employment generation through infrastructure activities, organizations, and education/nutrition assistance to poor families totaling $6.0 million.
equipment and infrastructure for local governments and community organizations, and education/nutrition

assistance to poor families. Putumayo

Guaviare Chemonics-CAD project is providing $44.7 million in Putumayo for: short and medium-term crop production with

farmers and indigenous groups, hearts of palm production, processing and marketing; rubber production,

The GOC � s FIP is providing $0.8 million to support employment generation activities through road improvement processing and marketing; forest management and value added processing and utilization of forest and wood
projects. A FIP road improvement program involving Guaviare and Meta is providing $3.4 million for the two
products; infrastructure projects, including bridge construction and road improvements, schools, and health
departments. facilities. As part of the development of production and marketing chains, support is being provided for the private

sector involvement in processing plants and marketing for cassava chips, black pepper and plantain; tropical

Huila flowers and foliage, vanilla production, as well as for medicinal plants and essential oils.

Chemonics - CAD project is supporting a $0.6 million activity to promote production and marketing of passion The U.S. Army Corp of Engineers

fruit. water treatment activities that are generating employment.

ACDI/VOCA is promoting specialty coffee production, processing and marketing in poppy growing areas.
The Amazon Conservation Team s $1.8 million project is supporting Colombian indigenous communities in food
security, health and local governance/land management.
ARD/CAPP is s upporting cacao and fruits production.

The GOC
The Aid to Artisans project is promoting production and marketing of crafts.
projects, the forest guardian families program, equipment and infrastructure for local governments andAnnex 53-B

community organizations, and education/nutrition assistance to poor families totaling $8.5 million.

Tolima

Chemonics-CAD project is supporting a $1.1 million activity to increase annual crop production for food security

and to increase income and employment generation in the longer term through forestry, livestock and cold

climate fruit production.

ACDI/VOCA is promoting specialty coffee production, processing and marketing in illicit crop growing areas of

Tolima.

The $12.0 million Colombia Enterprise Development project implemented by CARANA Corpowill be
supporting small and medium enterprise development in Colombia s secondary cities including those in Tolima.

Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the

Department.

ARD/CAPP is s upporting private sector projects in fruits and cacao production.

The GOC � s FIP is supporting the forest guardian families program, equipment and infrastructure for local

governments and community organizations, and education/nutrition assistance to poor families with resources
totaling $10.2 million.

Vaupes

The Amazon ConservationTeam � s project is supporting traditional healers and helping to strengthen indigenous

community organizations that are also involved in managing indigenous lands.

Vichada

The GOC � s FIP is providing $200,000 in employment generation activities through infrastructure projects,

equipment and infrastructure for local governments and community organizations, and education/nutrition

assistance to poor families.

Back to Top

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External linksto other Internet sitesshould not be construed asan endorsement of the vrein.r privacy policiescontained the

434community organizations, and education/nutrition assistance to poor families totaling $8.5 million.

Tolima

Chemonics-CAD project is supporting a $1.1 million activity to increase annual crop production for food security

and to increase income and employment generation in the longer term through forestry, livestock and cold

climate fruit production.

ACDI/VOCA is promoting specialty coffee production, processing and marketing in illicit crop growing areas of

Tolima.

The $12.0 million Colombia Enterprise Development project implemented by CARANA Cowill beon

supporting small and medium enterprise development in C�lombia s secondary cities including those in Tolima. Updated Report on Chemicals Used in the Colombian Aerial Eradication

Program
Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the
Department.

Report on Issues Related to the Aerial Eradication of Illicit Coca in Colombia
ARD/CAPP is s upporting private sector projects in fruits and cacao production.
BUREAU OF INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS
December 2003
The GOC � s FIP is supporting the forest guardian families program, equipment and infrastructure for local

governments and community organizations, and education/nutrition assistance to poor families with resources On September 4, 2002, the Department of State submitted to Congress the Secretary of State s determination

totaling $10.2 million. and report to Congress on issues related to the eradication of illicit coca in Colombia in accordance with the FY

2002 Foreign Operations, Export Financing, and Related Programs Appropriations Act (P.L. 107-115). That
Vaupes document contained an explanation of the chemicals and methods used for the eradication of coca in Colombia

and the safeguards in place to minimize the risk of harm to human health and the environment. It also contained
The Amazon ConservationTeam� s project is supporting traditional healers and helping to strengthen indigenous
community organizations that are also involved in managing indigenous lands. the results of the Department of State s consultations with the United States Environmental Protection Agency
(EPA), including EPA

Vichada coca eradication.

The Government of Colombia and the Department of State have implemented several changes in the program to
The GOC � s FIP is providing $200,000 in employment generation activities through infrastructure projects,
address concerns raised by theEPA analysis. The first section of this document reviews the Department of
equipment and infrastructure for local governments and community organizations, and education/nutrition State response to EPA s 2002 recommendation for additional controls for the spray program. Sections two and
assistance to poor families.
three explain the changes introduced by the Government of Colombia and the Department of State to respond to

EPA and Congressional concerns about other aspects of aerial eradication in Colombia. A fourth section

describes the changes in chemical composition and spraying methods since the Department of State s 2002
Back to Top report. The final section reviews the chemicals and methods used for opium poppy eradication in Colombia, a

part of the program that Congress did not ask the Department of State or EPA toaddress in FY 2002.

1. EPA Recommendation to Change Glyphosate Product Used by the Program
The Office of Electronic Information, Bureau of Public Affairs, managesthissite asa portal for information from the U.S. State Department.
External linksto other Internet sitesshould not be construed asan endorsement of the rein.or privacy policiescontained the
The EPA made one direct recommendation to the Department of State related to spray program controls in its

Eradication Program in Colombia.

eye irritation caused by the concentrated glyphosate formulated product and the lack of acute toxicity data on

the tank mixture, the Agency recommends that DoS consider using an alternative glyphosate product (with lower
potential for acute toxicity) in future coca and/or poppy aerial eradication programs. This was addressed to the

possible risk of splashing the full-strength glyphosate into the eyes or onto the skin of persons filling the spray

tanks on the airplane. It was not directed at potential risk to persons exposed to the spray mixture as actually

applied by the planes.

At the time that EPA m ade this recommendation, there were no suitable replacement glyphosate formulations

registered for sale and use in Colombia that offered lower potential for acute eye irritation. The Department of

State worked with the program s glyphosate supplier to identify and to register for sale and use in Colombia a
formulation of glyphosate with reduced potential for eye irritation. As soon as that product could be registered for

sale and use in Colombia, the Department of State began to purchase it for use in the spray program and it

remains the formulation used today.

Like the previous formulation, the new formulation is also registered with the EPA for sale in the United States for
non-agricultural use. It also contains 41 percent glyphosate salt and 59 percent inert ingredients. Like the

previous formulation, the formulation now used is made from a base material (glyphosate technical) that is

produced by a manufacturing plant that is registered in the United States even though the formulation is

produced and sold in Colombia. The glyphosate formulation now used is mixed with water and surfactant in the
same proportions as the previous formulation to form the coca spray mixture.Annex 53-B

The difference between the formulations is that the current product has an overall category III toxicological rating
� mildly to�) on the scale used by the EPA, whereas the previously used glyphosate formulation was rated

category�I ( highly�t). The toxicity reduction is due to a change in the surfactant used in the glyphosate

formulation. Of course, these ratings refer to the toxicological profile of the glyphosate formulations in their point
of sale, undiluted form, and not the spray mixture (water, glyphosate formulation, and surfactant) that exits the

spray aircraft.

The Department of State took these steps in part to address public concerns about the toxicity of the spray

mixture and allegations that the combination of glyphosate and surfactant would pose a threat to human and
environmental health. In that regard, the Department of State also contracted with an independent United States

laboratory to determine the toxicity of the spray mixture (e.g., the glyphosate formulation with water and

surfactant added), exactly as it is mixed in the field. Because final drafts of those toxicology tests were not

completed in time fo� EPA s assessment in 2002, copies of the toxicology tests on the spray mixture currently
used for coca eradication are enclosed as Attachment A. These tests show that the spray mixture rates a

category �II ( mildl�) for eye irritation and cate�oslightly t�xiin all other categories (e.g.,

acute oral, acute dermal, acute inhalation, skin irritation, sensitization).

2. EPA Advice Regarding Tracking Reported Health Complaints

EPA� � Office of Pesticide Programs Details of the Consultation for Department of State: Use of Pesticide for

Coca Eradication Program in Co�oalso advised (on page 32� (p)rospective tracking of reports of

health complaints, documenting times of exposure and onset of symptoms, are recommended during future

spray operations to evaluate any potential health effects and ameliorate or �revent their occurrence. Although
this recommendation is not related to spray program controls, the Department of State has increased its efforts

to track reported health complaints and to investigate any possible connection between any such complaints

and the eradication of illicit crops.

The spray program tracks human health complaints in two ways. The first is to initiate an immediate
investigation, often including clinical evaluation of the patient(s), upon notice to the U.S. Embassy of a problem.

The Embass� s Narcotics Affairs Section (NAS) learns about cases through letters directed to the Embassy or

GOC entities, from local counternarcotics base commanders, and from the members of the media. To investigate
complaints of toxic exposure allegedly caused by spraying, NAS retains the services of two of Colombia's

leading toxicologists, including the direc�or of Colombia s national poison control center, the Uribe Cualla

Centro de Asesoramiento T�xicol gico.

Since submission to Congress of the�FReport on Issues Related to the Eradication of Illicit Coca in
Colombia, two such complaints have been reported to the U.S. Embassy. In September 2002, the Embassy

received a complaint of multiple cases of poisoning from spraying �f coca in Puerto As s (Putumayo

department). A visit to the hospital and interviews with doctors there revealed no cases of poisoning or illness

attributable to spray chemicals. The toxicologist learned of two hospitalized children who could have been the
source of the complaint, and he reviewed their cases. One of those children was suffering from poisoning by an

organophosphate insecticide. The other child was suffering from asthma. An English language version of the

toxicolo�is report from this investigation is enclosed as Attachment B.

In February 2003, a news report in�tdail�gEl Tiemp� attributed the spread of tuberculosis and
cases of harelip and cleft palate in newborns to aerial spr�ying of coca in Tib (Norte de Santander department).

A toxicological review showed cleft palate and harelip to be a genetically inherited defect that has never been

reported in humans as a result of exposure to any chemical substance. Tuberculosis is an infectious disease

passed from person to person, and is also unrelated to any potential exposure to spray chemicals.

The Government of Colombia and the U.S. Embas�yhave also taken a proactive approach to

investigating any human health concerns manifest in areas where the spraying takes place. Both governments

have collaborated to create a robust Medical Civic Action Program (Medcap) to search out cases of harm to

health allegedly caused by the spraying. During these public health interventions that are timed to take place in
areas where coca eradication has recently taken place, U.S. Embassy-contracted toxicologists talk to patients

and talk to local medical personnel, looking for spray-related cases. As outlined in the chart below, a total of

1,029 patients made themselves available for Medcap medical personnel, had their medical conditions
assessed, and received complimentary health care. Although Medcap personnel have encountered cases that

were claimed to be spray-related, reviews of these cases have determined that events unrelated to eradication

spraying had caused them. Through Medcap and other medical investigations, the U.S. Embassy has never

found an instance of spray-related harm to human health. This is an ongoing program and the next Medcap is
planned for the end of April in Caquet , a few weeks into the spray campaign in that region.

436The difference between the formulations is that the current product has an overall category III toxicological rating Place and Date
(�mildly tox�c) on the scale used by the EPA, whereas the previously used glyphosate formulation was rated

category � ( highly �o). The toxicity reduction is due to a change in the surfactant used in the glyphosate
Cartagena del Chair�
formulation. Of course, these ratings refer to the toxicological profile of the glyphosate formulations in their point
of sale, undiluted form, and not the spray mixture (water, glyphosate formulation, and surfactant) that exits the (Caquet

spray aircraft. May 11, 2002

The Department of State took these steps in part to address public concerns about the toxicity of the spray
Solano (Caquet )
mixture and allegations that the combination of glyphosate and surfactant would pose a threat to human and August 7, 2002
environmental health. In that regard, the Department of State also contracted with an independent United States

laboratory to determine the toxicity of the spray mixture (e.g., the glyphosate formulation with water and
Santa Ana (Putumayo)
surfactant added), exactly as it is mixed in the field. Because final drafts of those toxicology tests were not
September 21, 2002
completed in time for�EPA s assessment in 2002, copies of the toxicology tests on the spray mixture currently
used for coca eradication are enclosed as Attachment A. These tests show that the spray mixture rates a

category I�I ( mildly�t) for eye irritation and categ�rslightly to�iin all other categories (e.g., Puerto As

acute oral, acute dermal, acute inhalation, skin irritation, sensitization). November 9, 2002

2. EPA Advice Regarding Tracking Reported Health Complaints
San Vicente del Cagu n
EPA � � Office of Pesticide Programs Details of the Consultation for Department of State: Use of Pesticide for (Caquet

Coca Eradication Program in Col�mbalso advised (on page 32)�t(p)rospective tracking of reports of February 1, 2003

health complaints, documenting times of exposure and onset of symptoms, are recommended during future

spray operations to evaluate any potential health effects and ameliorate or prev�nt their occurrence. Although To further address public and Congressional concerns about the possibility of human health and environmental
this recommendation is not related to spray program controls, the Department of State has increased its efforts
harm potentially caused by spraying, the Department of State is working with the Government of Colombia and
to track reported health complaints and to investigate any possible connection between any such complaints Garzon Ingenieros Asociados Ltda, an accredited Colombian laboratory, to analyze water taken from areas

and the eradication of illicit crops. where the spray program operates. Technology for monitoring soil is not available in Colombia, so the

Department of State is working with the Government of Colombia and the U.S. Department of Agriculture
The spray program tracks human health complaints in two ways. The first is to initiate an immediate
investigation, often including clinical evaluation of the patient(s), upon notice to the U.S. Embassy of a problem. Agricultural Research Service to analyze soil samples at the USDA/ARS laboratory at the University of
Mississippi. The Department of State is paying for technicians from two Colombian government laboratories and
The Embassy� s Narcotics Affairs Section (NAS) learns about cases through letters directed to the Embassy or
the Ministry of the Environment to travel to Mississippi in April to learn how to perform the analysis. The soil and
GOC entities, from local counternarcotics base commanders, and from the members of the media. To investigate
complaints of toxic exposure allegedly caused by spraying, NAS retains the services of two of Colombia's water analyses will determine the degree of persistence of glyphosate and its byproducts in Colombian soil and

leading toxicologists, including the director�of Colombia s national poison control center, the Uribe Cualla water, in the unlikely event there is something unique about Colombian soil and water that would invalidate the
many studies done on the residual effects of glyphosate in other parts of the world. The Department of State, the
Centro de Asesoramiento Tox�col gico.
Government of Colombia and a private Colombian university (Universidad de Los Andes) are developing

Since submission to Congress of the F�2Report on Issues Related to the Eradication of Illicit Coca in demonstration plots in the five distinct environmental regions of the country to study glyphosate persistence and
Colombia, two such complaints have been reported to the U.S. Embassy. In September 2002, the Embassy
� the regeneration of natural vegetation and other ecological dynamics following aerial eradication of illicit crops.
received a complaint of multiple cases of poisoning from spraying of c�ca in Puerto As s (Putumayo
3. EPA Comment Regarding Spray Drift
department). A visit to the hospital and interviews with doctors there revealed no cases of poisoning or illness

attributable to spray chemicals. The toxicologist learned of two hospitalized children who could have been the Although not addressed to the Department of State as a recommendation,EPA also noted in its consultation
source of the complaint, and he reviewed their cases. One of those children was suffering from poisoning by an
with the Department of State some concern for spray drift and the potential for non-targeted, desirable vegetation
organophosphate insecticide. The other child was suffering from asthma. An English language version of the
to suffer from the spraying of nearby coca (or opium poppy). Informed of EPA s and Congressional concern, the
toxicolog�ss report from this investigation is enclosed as Attachment B. Department of State and the Government of Colombia have incorporated several measures into the spray

program to assist us with evaluation and control of spray drift.
In February 2003, a news report in t�edaily� El Tiemp� attributed the spread of tuberculosis and
cases of harelip and cleft palate in newborns to aerial sprayi�g of coca in Tib (Norte de Santander department).
The first of these steps was to reinforce the environmental safety component of spray pilot training. All pilots,
A toxicological review showed cleft palate and harelip to be a genetically inherited defect that has never been both fixed wing spray pilots and rotary wing escort helicopter pilots, will receive briefings on the potential negative

reported in humans as a result of exposure to any chemical substance. Tuberculosis is an infectious disease impact that spraying may have on the environment and techniques to minimize potential collateral damage to

passed from person to person, and is also unrelated to any potential exposure to spray chemicals. legal crops and the environment. These briefings will be conducted semi-annually, will emphasize the unique

The Government of Colombia and the U.S. Embassy �ohave also taken a proactive approach to aspects of the Colombian operational theatre, and will solicit feedback from pilots on techniques to maximize
application effectiveness and avoid damage to non-target vegetation. An outline of this briefing is included as
investigating any human health concerns manifest in areas where the spraying takes place. Both governments
Attachment C. Search and rescue helicopter crews that accompany each spray flight have also been directed to
have collaborated to create a robust Medical Civic Action Program (Medcap) to search out cases of harm to
monitor drift patterns from above. They now assist in ensuring that spray does not drift beyond target crops and
health allegedly caused by the spraying. During these public health interventions that are timed to take place in
areas where coca eradication has recently taken place, U.S. Embassy-contracted toxicologists talk to patients notify the spray aircraft flight lead when conditions might merit canceling a spray flight. A copy of the directive
from the Department of State s Bureau of International Narcotics and Law Enforcement Affairs (INL) Office of
and talk to local medical personnel, looking for spray-related cases. As outlined in the chart below, a total of
Aviation to the eradication contractor that formalizes these new spray regulations is included as Attachment D.
1,029 patients made themselves available for Medcap medical personnel, had their medical conditions
assessed, and received complimentary health care. Although Medcap personnel have encountered cases that
The Department of State s Assistant Secretary for INL also directed the team of United States Department of
were claimed to be spray-related, reviews of these cases have determined that events unrelated to eradication
Agriculture (USDA) and Government of Colombia scientists, responsible for the ground truth verification
spraying had caused them. Through Medcap and other medical investigations, the U.S. Embassy has never missions, to incorporate an analysis and quantification of overspray into ground truth verification exercises. While

found an instance of spray-related harm to human health. This is an ongoing program and the next Medcap is past verification missions sought out and noted cases of overspray, documenting the existence and extent of
planned for the end of April in Caquet , a few weeks into the spray campaign in that region.
� any damage to crops or foliage not targeted for eradication, this is now a formal component of the ground truthing

exercise. The most recent ground truth verification mission (December 9-20, 2002) found that incidences ofAnnex 53-B

overspray were minor. The USDA Agricultural Research Service report from this verification exercise has not yet

been completed, and INL will forward a complete copy toEPA as soon as the Department of State receives the

report.

4. Changes in Chemical Composition and Spraying Methods Since 2002 Report

Apart from changing to a more benign formulation of glyphosate spray mixture, as discussed earlier, there have

been no changes to any of the components of the spray mixture. For some time in 2002, the Government of

Colombia lowered the application rate of glyphosate for coca eradication from the traditional application rate of
10.4 liters per hectare to 8.0 liters per hectare. After extensive ground truth evaluation, it was determined that the

lower rate was ineffective for killing coca. Thus the application rate was returned to its former rate of 10.4 liters

per hectare, which was the rate reported in the Dep�rtment s Report on Issues Related to the Eradication of

Illicit Coca in Colombia in 2002 -- the rate that EPA evaluated when analyzing the potential for risks of adverse
effects on human health and the environment posed by the coca eradication program.

The only changes in the methodology used to spray coca since the time of the last report is the addition of a

new type of spray aircraft to the spray fleet. Four Air Tractor Model 802 (AT-802) aircraft are currently being used
to spray coca, and another four will be delivered this year. These aircraft are manufactured in the United States

for agricultural crop spraying and utilize the identical nozzles (same brand and diameter) in the identical

configuration (nozzle angle, droplet size, calibration methods) as the OV-10 and T-65 spray aircraft. AT-802 flight

speed during eradication operations is 165 m.p.h.

5. DifferencesBetween Opium Poppy Spraying and Coca Spraying

The Secretary of State was not required to determine and report to Congress on any aspects of the opium poppy
eradication program in FY2002, and thus the Department did not provide information toEPA on the chemicals

and methodology of poppy spraying. Like the coca spray mixture described�in the Report on Issues Related to

the Eradication of Illicit Coca in C�lothe opium poppy spray mixture contains three components: water,

an EPA-registered formulation of the herbicide glyphosate, and a surfactant (Cosmo-Flux 411F). Because the
opium poppy is not a woody, hard-to-control species like the coca bush, opium poppy eradication uses a spray

mixture with a substantially lower glyphosate content than the spray mixture used for coca eradication (see

Attachment E). For opium poppy spraying, water, formulated glyphosate, and surfactant are combined into a

spray mixture in the following percentages: 94 percent water, 5 percent glyphosate formulation, and 1 percent
Cosmo-Flux 411F. This diluted mixture is applied to opium poppy at the rate of 50.0 liters/hectare (or 5.46

gallons per acre). This application rate is within the glyphosate manufacturer's label recommendations for both

the amount of concentrated formulation per acre and the amount of total spray volume per acre.

Opium poppy spraying differs from coca spraying in several ways. Because Colombia cultivates much less

opium poppy than coca and spray program resources are limited, aircraft spray much more coca than opium

poppy, therefore expending more spray chemicals in coca growing areas than in areas where opium poppy is

cultivated. For example, in 2002, eradication aircraft sprayed totals of 122,700 hectares of coca and 3,000
hectares of opium poppy. Opium poppy is generally cultivated in plots that are smaller than the average coca

field. While difficult to quantify precisely, opium poppy fields generally range from 0.5 to 5 hectares. Opium

poppy is ordinarily cultivated at a higher altitude than coca, and thus opium poppy often is cultivated and sprayed

in hilly to mountainous terrain. For these reasons, the T-65 is the only aircraft used to spray opium poppy
because it has a smaller wingspan (and spray swath) than the OV-10 or AT-802 and because it is a more agile

aircraft capable of staying close to the ground in more steeply graded, rugged terrain.

Because of the challenges of mountain spraying, pilots undergo an extended training program before they are
qualified to perform actual opium poppy spray operations in Colombia. As the Department of State reported in

2002, coca eradication pilots must have approximately 3,000 total flight hours before they are considered for the

spray program and can receive preliminary training in illicit crop eradication. Most of these pilots also have at

least 1,500 hours of commercial aerial application (crop dusting) experience. In addition to these requirements,
opium poppy spray pilots must undergo 40 hours of follow-on training specific to the topography, wind conditions,

and cloud cover that they will experience in their area of operations.

Attachments

A.Toxicological testing results for coca spray mixture (Purity Analysis for Glyphosate, Acute Oral Toxicity

Study, Acute Dermal Toxicity Study, Acute Nose-Only Inhalation Toxicity Study, Primary Eye Irritation

Study, Primary Skin Irritation Study, Dermal Sensitization Study).

B. � Investigative Report on Cases of Possible Human Health Effects in Pu� �o AJorge Hern� n

Botero Tob�n, M.D. Bogot� , Colombia, September 19, 2002.

438overspray were minor. The USDA Agricultural Research Service report from this verification exercise has not yet

been completed, and INL will forward a complete copy toEPA as soon as the Department of State receives the

report.
C.

4. Changes in Chemical Composition and Spraying Methods Since 2002 Report
D.
Apart from changing to a more benign formulation of glyphosate spray mixture, as discussed earlier, there have

been no changes to any of the components of the spray mixture. For some time in 2002, the Government of

Colombia lowered the application rate of glyphosate for coca eradication from the traditional application rate of E.

10.4 liters per hectare to 8.0 liters per hectare. After extensive ground truth evaluation, it was determined that the
lower rate was ineffective for killing coca. Thus the application rate was returned to its former rate of 10.4 liters

per hectare, which was the rate reported in the Depar�ment s Report on Issues Related to the Eradication of

Illicit Coca in Colombia in 2002 -- the rate that EPA evaluated when analyzing the potential for risks of adverse
effects on human health and the environment posed by the coca eradication program.
Back to Top

The only changes in the methodology used to spray coca since the time of the last report is the addition of a

new type of spray aircraft to the spray fleet. Four Air Tractor Model 802 (AT-802) aircraft are currently being used

to spray coca, and another four will be delivered this year. These aircraft are manufactured in the United States
for agricultural crop spraying and utilize the identical nozzles (same brand and diameter) in the identical

configuration (nozzle angle, droplet size, calibration methods) as the OV-10 and T-65 spray aircraft. AT-802 flight

speed during eradication operations is 165 m.p.h.

5. DifferencesBetween Opium Poppy Spraying and Coca Spraying

The Secretary of State was not required to determine and report to Congress on any aspects of the opium poppy

eradication program in FY2002, and thus the Department did not provide information toEPA on the chemicals

and methodology of poppy spraying. Like the coca spray mixture described i� the Report on Issues Related to
the Eradication of Illicit Coca in Col�mthe opium poppy spray mixture contains three components: water,

an EPA-registered formulation of the herbicide glyphosate, and a surfactant (Cosmo-Flux 411F). Because the

opium poppy is not a woody, hard-to-control species like the coca bush, opium poppy eradication uses a spray

mixture with a substantially lower glyphosate content than the spray mixture used for coca eradication (see
Attachment E). For opium poppy spraying, water, formulated glyphosate, and surfactant are combined into a

spray mixture in the following percentages: 94 percent water, 5 percent glyphosate formulation, and 1 percent

Cosmo-Flux 411F. This diluted mixture is applied to opium poppy at the rate of 50.0 liters/hectare (or 5.46

gallons per acre). This application rate is within the glyphosate manufacturer's label recommendations for both
the amount of concentrated formulation per acre and the amount of total spray volume per acre.

Opium poppy spraying differs from coca spraying in several ways. Because Colombia cultivates much less

opium poppy than coca and spray program resources are limited, aircraft spray much more coca than opium
poppy, therefore expending more spray chemicals in coca growing areas than in areas where opium poppy is

cultivated. For example, in 2002, eradication aircraft sprayed totals of 122,700 hectares of coca and 3,000

hectares of opium poppy. Opium poppy is generally cultivated in plots that are smaller than the average coca

field. While difficult to quantify precisely, opium poppy fields generally range from 0.5 to 5 hectares. Opium
poppy is ordinarily cultivated at a higher altitude than coca, and thus opium poppy often is cultivated and sprayed

in hilly to mountainous terrain. For these reasons, the T-65 is the only aircraft used to spray opium poppy

because it has a smaller wingspan (and spray swath) than the OV-10 or AT-802 and because it is a more agile

aircraft capable of staying close to the ground in more steeply graded, rugged terrain.

Because of the challenges of mountain spraying, pilots undergo an extended training program before they are

qualified to perform actual opium poppy spray operations in Colombia. As the Department of State reported in

2002, coca eradication pilots must have approximately 3,000 total flight hours before they are considered for the

spray program and can receive preliminary training in illicit crop eradication. Most of these pilots also have at
least 1,500 hours of commercial aerial application (crop dusting) experience. In addition to these requirements,

opium poppy spray pilots must undergo 40 hours of follow-on training specific to the topography, wind conditions,

and cloud cover that they will experience in their area of operations.

Attachments

A. Toxicological testing results for coca spray mixture (Purity Analysis for Glyphosate, Acute Oral Toxicity

Study, Acute Dermal Toxicity Study, Acute Nose-Only Inhalation Toxicity Study, Primary Eye Irritation

Study, Primary Skin Irritation Study, Dermal Sensitization Study).

B. � Investigative Report on Cases of Possible Human Health Effects in Pue� � As Jorge Her� n

Botero Tob�n, M.D. Bogot� , Colombia, September 19, 2002.Annex 53-B

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BUREAU OF INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS
December 2003

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440 Annex 53-B

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

DETAILS OF THE 2003 CONSULTATION

FOR THE DEPARTMENT OF STATE

USE OF PESTICIDE FOR COCA AND POPPY

ERADICATION PROGRAM IN COLOMBIA

JUNE 2003

441Annex 53-B

TABLE OF CONTENTS

EXECUTIVE SUMMARY

I. PESTICIDE USE ASSESSMENT ...........................................................
..................1

A. Introduction ........................................................................
............................. 1
B. Summary ........................................................................
.................................. 1
C. Background ........................................................................
.............................. 1

D. Opium Poppy Eradication ........................................................................
...... 2
E. Conclusions ........................................................................
............................... 3

II. HUMAN HEALTH RISK ASSESSMENT............................................
..................... 5

A. Introduction ........................................................................
.............................. 5
B. Background ........................................................................
............................... 9
C. Historical Regulatory Background ................................................................12
D. Hazard Identification ........................................................................
..............13

E. Dose Response Assessment ........................................................................
......14
F. Exposure Assessment ........................................................................
...............17
G. Potential Exposure From Spray Drift ............................................................22
H. Incident Data Review: A Study of Health Complaints Related to Aerial

Eradication of Poppy in Colombia .................................................................23
I. Updated Incident Data Review .......................................................................2
9
J. Risk Characterization...................................................................
....................31
K. Summary Conclusions.....................................................
.................................33

III. ECOLOGICAL RISK ASSESSMENT..............................................
.........................35

A. Introduction............................................................
...........................................35
B. Ecological Risk Characterization...................................................................
.35

442 Annex 53-B

EXECUTIVE SUMMARY

CONSULTATION REVIEW OF THE USE OF PESTICIDES FOR
COCA AND POPPY ERADICATION IN COLOMBIA (2003)

BACKGROUND

The Department of State continues to assist the Government of Colombia with training,
contractor support, financial assistance, and technical and scientific advice for an aerial pesticide
spraying program designed to eradicate illicit crops (coca and poppy). The Department of State
has again consulted with the Environmental Protection Agency (EPA) on whether “the herbicide

mixture is being used in accordance with EPA label requirements for comparable use in the
United States” and that “the herbicide mixture, in the manner it is being used, does not pose
unreasonable risks or adverse effects to humans health or the environment.”

Similar to this year, in 2002 EPA conducted a review of coca eradication ac
tivities in
Colombia. The Agency has determined that its findings from 2002 remain relevant to the current
coca eradication activities in Colombia. For 2003, EPA was asked to also consider the opium
poppy eradication program.

2002 REVIEW OF COCA ERADICATION PROGRAM

Last year, EPA reviewed the coca eradication program in Colombia and concluded that
there was no evidence of significant human health or environmental risks from the spraying.

The Agency did recommend that the Department of State switch to an herbicide product with
lower toxicity due to a potential for hazard to the eyes of pesticide mixers/loaders. EPA also
requested the Department of State to conduct field investigations of health complaints associated
with coca eradication. The Agency further concluded that spray drift wa
s likely to cause
phytotoxicity downwind of coca fields. The final primary conclusion was that EPA could not

verify the product formulation because the product was being manufactured outside of the U.S.

2003 FINDINGS

The Department of State followed EPA’s 2002 recommendation by beginning use of a
lower toxicity glyphosate product in its coca and poppy eradication prog
rams and implementing
a program to investigate health complaints. As with coca eradication, the use of glyphosate for
opium poppy eradication is done aerially. Based on information provided by the Department of
State, several conclusions may be reached concerning poppy eradication: total area sprayed is

less than for coca eradication, individual poppy sites are smaller and located at higher elevations,
and the rate of glyphosate for poppy eradication is lower than that for coca. Based on a
comparison of the glyphosate use pattern in Colombia, as described by the Department of State,
and use in the U.S., EPA has determined that application rates for both coca and poppy
eradication in Colombia are within the parameters listed on U.S. labels.

443Annex 53-B

ii

As for human health concerns, EPA concludes there are no risks of concern from dietary,
mixer/loader/applicator or field workers, or bystanders (including children). The concerns for

mixer/loader eye irritation discussed in the Agency’s 2002 findings hav
e been mitigated by
switching to the lower toxicity product. The Department of State and the Government of
Colombia initiated two programs to investigate health complaints. Of those cases investigated to
date in Colombia, no findings directly link adverse health effects to the spraying.

In regard to potential environmental effects from the coca and poppy eradication
programs, EPA concludes that the switch to a lower toxicity product will pose l
ess risk of acute
poisoning to wildlife. The Agency believes that the potential for spray drift phytotoxicity is still

a factor for both coca and poppy spraying. EPA recognizes that the Department of State is
employing Best Management Practices to minimize drift and encourages them to continue these
efforts.

EPA cannot verify the quality of the product manufactured, since the actual formulation
is done in Colombia. The Agency did, however, review toxicity testing conducted on the s
pray
mixture solution being applied in Colombia and did not find any irregularities.

For 2003, EPA recommends that the Department of State continue programs for
investigating health complaints. The Agency also requests that Department of State improve its
definition of glyphosate poisoning, provide further documentation of its investigations and how
they are conducted, and standardize data collection.

Details of EPA’s findings are provided in the attached document.

444 Annex 53-B

-1-

I. PESTICIDE USE ASSESSMENT

A. Introduction

The Biological and Economic Analysis Division (BEAD) in the Office of Pesticide Programs
within the Environmental Protection Agency (EPA) has augmented the 2002 EPA assessment
and description of the use of glyphosate in the United States (1) as a
basis for comparison to

glyphosate use in Colombia for coca eradication with a discussion of changes in the program for
2003. This request has come from the Department of State (DoS) which is required to consult
with the EPA before reporting to Congress on the use of glyphosate for the Andean counter drug
initiative. This year DoS is required to include glyphosate for control
of opium poppy in its

consultation. This document compares the described use on opium poppy and coca to use
within the US.

B. Summary

The use of glyphosate for control of opium poppy is conducted at 1 lb ai/acre (0.8 lb a.e/acre)
and at a spray mixture (product + water diluent + Cosmoflux 411F surfactant) volume of about
5.5 gallons per acre (50 liters/hectare). This application rate is wi
thin the label recommendations

for the amount of concentrated formulation per acre and the amount of total spray volume per
acre for application for glyphosate products registered for use in the U
S.

C. Background

Glyphosate is the most widely used herbicide in the US (1). It is non-selective in action
and is
used where total vegetation control is desired. It is used on a variety
of sites including
agricultural crops, lawns, gardens, forests and utility grounds. Applic
ation is made to the target

plant’s foliage, and after being absorbed, glyphosate circulates with
in the plant, exerting
herbicidal activity systemically. Glyphosate and its use within the US were described in the
2002 EPA assessment. In its assessment report, EPA described the use of glyphosate in the US
in the following paragraph:

“Glyphosate may be used on over 400 crop and non-crop sites. The largest agricultural use sites include
soybeans, cotton and field corn. In addition to agricultural use, EPA estimates that 16-22 million pounds of
the technical grade active ingredient were applied to non-agricultural sites in 1999 (this is the most recent
year for which adequate data are available). This estimate includes both home owner and professional
applications as well as use on forested lands. Based on EPA data for 1999, an estimated 1-2 million pounds
of glyphosate was applied to forest acres, with more than 650,000 forest acres treated.”

In 2002, a description of glyphosate use in forestry sites in the US was included since use for

coca eradication would be most similar to the US labeled use for broad-spectrum post-emergence
weed control for forestry site preparation and utility rights-of-way. For coca eradication,
glyphosate is sprayed from fixed wing aircraft at speeds around 165 mph at 4.4 pounds active
ingredient (isopropylamine salt) per acre in about two gallons of spray mixture per acre.

445Annex 53-B

-2-

Aerial application of the glyphosate product to non-crop, non-timber, industrial and rights-of-
way areas in the US is allowed using fixed wing aircraft and helicopter
to control annual and

perennial weeds and woody brush and trees. Although application may be made at up to 10 lb
ai/year per acre in the US, the typical use rate per application is much lower, averaging less than
one pound per acre on major agricultural sites (EPA has no data on average application rate to

forest sites). In addition, product labeling recommends application at 3 to 15 gallons of total
spray mixture volume per acre for aerial application to forestry sites.

D. Opium Poppy Eradication

Glyphosate used for the opium poppy eradication program is also applied aerially, however its
use differs in several ways from the coca eradication program:

1. Total area sprayed is much smaller for poppy eradication. The State Department explains
that:

“Because Colombia cultivates much less opium poppy than coca and spray resources are limited, aircraft
spray much more coca than poppy, therefore expending more spray chemicals in coca growing areas than in
areas where opium poppy is cultivated. For example, in 2002, eradication aircraft sprayed totals of 122,700
hectares of coca [about 303,000 acres] and 3,000 hectares [about 7400 acres] of opium poppy.”

2. Individual poppy spray sites are smaller and located at higher elevations. The State

Department states:

“While difficult to quantify precisely, opium poppy fields generally range from 0.5 to 5 hectares. Opium
poppy is ordinarily cultivated at a higher altitude than coca, and thus opium poppy often is cultivated and
sprayed in hilly to mountainous terrain.”

3. The rate (or dose) of glyphosate for poppy eradication is lower th
an that for coca eradication.
The State Department states:

“Because the opium poppy is not a woody, hard-to-control species like the coca bush, opium
poppy

eradication uses a spray mixture with a substantially lower glyphosate content than the spray mixture used
for coca eradication.”

The Department of State described the concentrate formulation for use in 2003 as containing 41
percent glyphosate salt and 59 percent inert ingredients. The same concentrate formulation is

being used for both coca and opium poppy eradication (1). Other similar products with this
proportion of active to inert ingredients are registered with the US Env
ironmental Protection
Agency for use in the US on forestry and utility rights-of-way sites. A surfactant is added to the

diluted spray mixture prior to spraying. This practice improves absorption of the herbicide by
the plant and is standard practice for applying glyphosate to forestry s
ites in the US.

For opium poppy spraying, water, formulated glyphosate, and surfactant are combined in a spray

mixture in the following percentages: 94 percent water, 5 percent glyphosa
te formulation, and 1
percent surfactant. This diluted spray mixture is applied to opium poppy at the rate of 50.0

446 Annex 53-B

-3-

liters/hectare (or 5.5 gallons per acre) (1). This is equivalent to
1 lb ai/A isopropylamine salt (or
0.8 a.e.)/acre as illustrated in the calculation below.

Calculation of rate of application for opium poppy:

(50 liters spray mixture/1 hectare) (5% glyphosate product/1 liter spray mixture) (4 lbs. ai isopropylamine glyphosate
salt/1 gallon formulated product gallon/3.78 liter) (1 hectare/2.47 acres) = 1.1 lb ai/acre

In contrast, the Department of State reports glyphosate use for coca eradication at 10.4 l/ha of
glyphosate product which is equivalent to 4.4 lb a.i./acre of glyphosate
isopropylamine salt (3.3

a.e./acre) as illustrated in the calculation below.

Calculation of rate of application for coca eradication:

1
(10.4 liter spray mixture/1 hectare) (4 lbs ai isopropylamine glyphosate salt/1 gallon glyphosate product )
(1gallon/3.78 liter) (1 hectare/2.47 acres) = 4.4 lb ai/acre

Although glyphosate is applied aerially to wooded sites, the rate of app
lication is more similar to
that for agricultural uses than for forestry uses. Agricultural use of
glyphosate is common at

rates lower than 0.5 lb ai/A. In contrast, product labels for the use o
f glyphosate for forestry
sites start at rates of 2 lbs ai/A.

E. Conclusions

This application rate for opium poppy eradication is within the glyphosate manufacturer’s label
recommendations for both the amount of concentrated formulation per acre and the amount of

total spray volume per acre . The Department of State informed EPA that the coca use is the
same as described in the 2002 assessment, except for a change in product.

REFERENCES

(1) U.S. Environmental Protection Agency, Office of Pesticide Programs, Details of the
Consultation for Department of State, Use of Pesticide for Coca Eradication Program in

Colombia, August 2002.

(2) Department of State Updated Report on Chemicals Used in the Columbian Aerial Eradication

Program. Attachment to a letter from Secretary of State, Colin Powell, to Environmental
Protection Agency Administrator, Governor Christine Whitman, April 9, 2003.

(3) Donaldson, D., T. Kiely, and A. Grube. Pesticide Industry Sales a
nd Usage, 1998 and 1999

Market Estimates. June 2002. Biological and Economic Analysis Division, Office of Pesticide
Programs, U.S. Environmental Protection Agency.

(4) Agricultural Chemical Usage - 2000 Field Crops Summary. May 2001. US Department of
Agriculture. National Agricultural Statistics Service.

447Annex 53-B

-4-

448 Annex 53-B

-5-

II. HUMAN HEALTH RISK ASSESSMENT

A. Introduction

In April 2003, the DoS requested that EPA provide a human health risk assessment for the aerial

eradication of coca and poppy in Colombia. To facilitate this request, in addition to the
information provided for the previous assessment, the DoS provided a report entitled,
Department of State Updated Report on Chemicals used in the Colombian Aerial Eradication
Program and submitted acute toxicity tests for the spray mixture used in the coca eradication
program assessed previously.

Unless otherwise specified, all information pertaining to the coca and poppy e eradication
program s in Colombia was provided to the Agency from three sources: (1) DoS Presentation,
DoS Coca Eradication Program, 4/18/02, (2) DoS document entitled Chemicals Used for the

Aerial Eradication of Illicit Coca in Colombia and Conditions of Application. (3) DoS report
entitled Department of State Updated Report on Chemicals used in the Colombian Aerial
Eradication Program.

USE PATTERN

The glyphosate tank mixture is applied as an over the top aerial foliar application to coca in
certain provinces within Columbia. The tank mixture sprayed for eradication of coca in
Columbia contains 55% water, 44% of glyphosate herbicide product, and 1% adjuvant (Cosmo-
Flux 411F). Up to two applications of the glyphosate tank mixture are sprayed over coca crops

at a maximum of 1.25 gallons of product/acre.

According to updated information provided by the DoS, “Apart from changing to a more benign
formulation of glyphosate spray mixture, there have been no changes to any of the components
of the spray mixture.” The only changes in the methodology used in the spray program is the use

of a new aircraft, the Four Air Tractor Model 802 (AT-802). These airc
raft utilize the identical
nozzles (same brand and diameter) in the identical configuration (nozzle angle, droplet size,
calibration methods) as the aircraft evaluated in the previous assessment.

The opium poppy spray mixture contains the same cm oponents as the spray mixture used in the coca

eradication program. According to information provided by DoS, the spray mixture used in the
opium poppy eradication program contains a substantially lower concentration of glyphosate than
the spray mixture used for coca eradication(.11 gallons glyphosate/A for coca versus 0.27 gallons
glyphosate /A for poppy). This application rate is within the manufacturer's product label

recommendations.

The poppy eradication program differs from the coca eradication program in several ways.
According to the DoS report, poppy fields are generally smaller than coca fields, ranging from
0.5 to 5 hectares. Also, poppy is often cultivated and sprayed in more mountainous terrain than

coca.

449Annex 53-B

-6-

As for the previous assessment, in order to assess the hazard of what was sprayed in Columbia,
the components of the mixture were evaluated separately.

HAZARD ASSESSMENT
The Cosmo-Flux 411F adjuvant used in the glyphosate tank mix is produced by a Colombian

company and is not sold domestically. All ingredients of this product are substances that are not
highly toxic by oral or dermal routes. They may cause mild eye and skin irritation. Cosmo-Flux
411F consists mainly of (information not included as it may be entitled to confidential treatment
)
with a nonionic surfactant blend primarily composed of (information not included as it may be
entitled to confidential treatment).

The available hazard data base on experimental animals indicates that the glyphosate technical
grade active ingredient (TGAI) has low acute toxicity via the oral and
dermal routes. It is a mild
eye irritant and a slight dermal irritant. It is not a dermal sensitizer. The requirement for an

acute inhalation study was waived since no respiratory or systemic toxicity was seen following
subchronic inhalation exposure in rats. In the subchronic and chronic oral toxicity studies (1-
year dog, 24-month mouse, 2-year chronic/carcinogenicity rat, and 2-generation rat
reproduction), systemic toxicity manifested most commonly as clinical signs, decreases in body
weight and/or body weight gain, decreased food consumption, and/or liver and kidney toxicity at

doses equal to or above the limit dose (1000 mg/kg/day). No dermal or systemic toxicity was
seen following repeated dermal exposures. There was no quantitative or qualitative evidence for
increased susceptibility in fetuses following in utero exposure to rats and rabbits in
developmental toxicity studies or following pre/post-natal exposure to rats in t
he 2-generation

reproductive toxicity study in rats. Effects in the offspring were observed only at or above
treatment levels which resulted in evidence of appreciable parental toxicity.
The Food Quality
Protection Act (FQPA) Safety Factor Committee (SFC) concluded that the safety factor, to
protect infants and children, of 10x be removed (reduced to 1x). The Hazard Identification
Assessment Review Committee (HIARC) met on March 26, 1998 and, again, on November 20,

2001. The most recent report of the HIARC for glyphosate has the complete assessment of the
endpoints selected for dietary exposure and residential/occupational exposure. No endpoints
were selected for the acute Reference Dose (RfD) since no hazard attr
ibuted to a single dose
was identified from the oral toxicity studies, and there are no concerns for developmental or

reproductive toxicity. In addition, the HIARC did not identify endpoints of concern for dermal
and inhalation exposures for any exposure period (short term 1 to30 days, intermediate term 1 to
6 months, or long term 6 months to lifetime) since no hazard was identified due to the low
toxicity of glyphosate. HIARC did identify an incidental oral endpoint for short- and
intermediate-term exposure. The chronic dietary RfD of 1.75 mg/kg/day was based on diarrhea,

nasal discharge, and mortality in a rabbit developmental toxicity study. Glyphosate was not
mutagenic in a full battery of assays. Based on the lack of evidence for
carcinogenicity in two
acceptable studies in mice and rats, glyphosate is classified as a “Group E” chemical (no
evidence of carcinogenicity to humans).

450 Annex 53-B

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EXPOSURE
An exposure and risk assessment are required for an active ingredient if: (1) certain toxicologica
l
criteria are triggered and (2) there is potential for exposure. Upon
review and analysis of the
hazard database in total, the Agency’s HIARC did not identify a hazard of concern for acute
dietary, dermal, or inhalation exposures. Therefore, quantitative estimates of risk for these

exposure durations have not been conducted.

Acute dietary exposure is possible for persons consuming livestock or food crops which have
been inadvertently sprayed as a result of the aerial eradication program
in Columbia. However,
since glyphosate is a contact herbicide that systemically kills plants after absorption through

leaves, dietary exposure due to consumption of treated crops is expected to be limited. In
addition, since an acute dietary endpoint of concern was not identified
in the hazard database, no
significant risk due to acute dietary food exposure to glyphosate residues is expected. Based on
the fact that a poppy field is sprayed no more than twice to eradicate the crop, no chronic food

exposure is expected.

Handler (e.g., individuals mixing the concentrated formulated product to prepare the tank mix
and loading the tank mix in the aircraft) exposure is anticipated for short-term (1-30 days) and,
possibly intermediate-term (1-6 months) durations based on the frequency of application and

duration of the spray program.

Based on the use pattern described by the DoS, short-term dermal post-application exposures are
expected for persons re-entering treated coca and poppy fields immediately after spray events.

In cases such as glyphosate, where the vapor pressure is negligible, OPP
experience with post-
application data suggests that inhalation exposure is minimal and does not quantitatively assess
post-application inhalation exposure. Intermediate and long-term post-application exposures are
not expected due in part to the fact that coca and poppy fields are spra
yed no more than twice to
eradicate the crop. Additionally, glyphosate is a translocated herbicid
e which is rain fast within

48 hours after spraying. Therefore, potential exposure to dislodgeable
residues of glyphosate
after 48 hours is expected to be minimal.

DoS states that pilots are instructed not to spray fields where people are present. Therefore,

incidental oral exposure (hand-to-mouth) resulting from individuals being directly sprayed by
glyphosate was not quantitatively assessed. Also, it is not current Age
ncy policy to
quantitatively assess toddler hand-to-mouth exposure resulting from spray drift. Additionally,
HED does not currently perform exposure assessments for toddler non-dietary oral exposures for
agricultural scenarios. As a point of comparison, screening level risk estimates for toddler

incidental oral exposures (hand-to-mouth) to the U.S. registered residential turf uses of
glyphosate have been calculated. Using the same standard screening level assumptions as used
in the residential assessment for the U.S. registered turf use and taking the higher application r
ate
into account, the potential risks form incidental oral exposure due to the spraying of glyphosate
as part of the coca and poppy eradication program would not exceed HED’s level of concern.

451Annex 53-B

-8-

There is potential for exposure to persons in nearby areas to those targ
eted for spraying.
However, the technology and other safeguards used in this program are consistent with common
approaches in the US for reducing spray drift. Therefore, it is likely that drift is minimized in
this program if all procedures are adhered to and operational equipment is in working order.

From the review of Colombian glyphosate product human incident reports for poppy
eradication (evaluated in the previous assessment), it should be emphasized that the
overwhelming majority (95%) of the illnesses reported are likely background incident
s unrelated
to the spraying of herbicide on poppy. The remaining 5% increase could be due to a variety of

causes and do not support a conclusion that the spraying of the glyphosa
te tank mixture was
responsible for these complaints. Furthermore, the individual with the highest potential for
exposure would be the mixer loader. They are handling the concentrated glyphosate product and
the tank mix. The incidence data that has been submitted to the Agency by DoS, does not
include any incident reports for those individuals. There are data to
suggest that the poppy

spray eradication program could have resulted in minor skin, eye, or respiratory irritation, and
perhaps headache or other minor symptoms. However, the detailed information on timing of
application, history of exposure, and medical documentation of symptoms related to exposure to
glyphosate tank mix were not available. Given the limited amount of documentation, none of the
data in the report from Colombia provide a compelling case that the spraying of the glyphosate

mixture has been a significant cause of illness in the region studied. Prospective tracking of
reports of health complaints, documenting times of exposure and onset of symptoms, are
recommended during future spray operations to evaluate any potential health effects and
ameliorate or prevent their occurrence.

The glyphosate formulated product used in the coca eradication program in Colombia contains
the active ingredient glyphosate, a surfactant blend, and water. The ac
ute toxicity test of the
glyphosate technical is classified as toxicity category III for primary eye irritation and toxicity
category IV for acute dermal and oral toxicity, and skin irritation. It is not a dermal sensitizer.

The product currently used in the coca and poppy aerial eradication prog
ram is classified as
toxicity category III for primary eye irritation and toxicity category IV for acute dermal and oral
toxicity, and skin irritation and is not a dermal sensitizer. The label for the formulated product
used in the poppy eradication program in Colombia uses “Caution” as the signal word.

The overall conclusion from the earlier review stated that “There is some data to suggest that the
spray eradication program could have resulted in minor skin, eye, or respiratory irritation, and
perhaps headache or other minor symptoms. However, the detailed information on timing of
application, history of exposure, and medical documentation of symptoms related to glyphosate

exposure were not available. Thus, the reported symptoms cannot be confirmed to be a result of
the spray applications. The information collected gives the impression that any increase in
health problems is likely to be relatively small, and the severity of those symptoms is likely to be
minor to moderate. Given the limited amount of documentation, none of the data in the report
from Colombia provide a compelling case that glyphosate spraying has been a significant cause

of illness in the region studied. Some of the reports in Colombia, potentially related to
glyphosate tank mix exposure, are similar in nature to those reported in the literature and by

452 Annex 53-B

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California. These cases report irritation to skin, eyes, and respirator
y passages. This suggests
that the Cosmo-Flux 411F added to the glyphosate in Colombia has little or no effect on the
overall toxicity of the formulated product. Prospective tracking of reports of health complaints,
documenting times of exposure and onset of symptoms, are recommended during future spray
operations to evaluate any potential health effects and ameliorate or prevent occurrence.”

In the 2002 assessment the DoS requested advice on whether the aerial application program may
pose unreasonable risks or adverse effects to humans or the environment. The current (2003)
assessment considers recent exposure information provided to the Agency for the DoS
Colombia poppy eradication program in light of the 2002 assessment. Current information

indicates that the Government of Colombia and the U.S. Embassy Bogota have adhered to the
EPA advice . . . “Prospective tracking of reports of health complaints, documenting times of
exposure and onset of symptoms, are recommended during future spray operations to evaluate
any potential health effects and ameliorate or prevent occurrence.” The 2003 submission from

the “Department of State Updated Report on Chemicals used in the Colombian Aerial
Eradication Program” to the EPA indicates that “A visit to the hospital and interview
s with
doctors there revealed no cases of poisoning or illness attributable to spray chemicals.” U.S.
Embassy-contracted toxicologists talked to patients and talked to local medical personnel,
looking for spray-related cases. . . The report concluded that “Throu
gh Medical Civic Action

Program (Medcap) and other medical investigations, the U.S. Embassy has never found an
instance of spray-related harm to human health.”. Missing from their account was a clearly
stated case definition for what would constitute a glyphosate-related po
isoning. A case
definition is required if the conclusion that they have “never found an instance of spray-related

harm to human health” is to be supported.
During April 18 briefing, the Department of State agreed to supply the Agency with a full
battery of the six acute toxicity tests on the tank mix used in the coca aerial eradication program.
That information has been received and reviewed. In summary, the acute toxicity of the spray
mixture is category III for eye irritation and category IV for skin irrita
tion and acute dermal, oral

and inhalation exposure and is negative for dermal sensitization.

B. Background

EPA regulates pesticides under two statutes, the Federal Insecticide, Fu
ngicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA provides the
authority to register and review pesticides as well as the authority to
suspend and cancel if use
poses unreasonable risks. FFDCA provides authority to set maximum residue levels (tolerances)
for pesticides used in or on foods or animal feeds.

Section 3 of FIFRA provides authority to register (license for sale and distribution) pesticide
products. The label of the pesticide product specifies the use (pest a
nd crop/site), amount of
product to be applied, frequency, timing of use, restrictions, storage and disposal practices and
precautionary statements. The active ingredient in a pesticide product is the “ingredien
t which

will prevent, destroy, repel, or mitigate any pest.” The inert or other ingredient(s) in a pesticide
product is “an ingredient which is not active.” The registrant mu
st provide data for the Agency

453Annex 53-B

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to assess potential environmental and human health risks. The data required to make a safety
finding are dependent on the intended use, e.g., food use vs non-food use. The data requirements
for pesticides may be found in 40 CFR Part 158. For human health risk assessment, data is
required to permit characterization of hazard and exposure.

Data requirements on the chemical identity and composition of the formulated pesticide product,
may be found in 40 CFR 158.150. The list of ingredients for a pesticide product and the percent
of each ingredient in the formulation are contained in the confidential statement of formula
(CSF). The CSF is FIFRA confidential business information (CBI) and is entitled to treatment
as trade secret or proprietary information. Agency risk assessments do not typically contain this

information.

Residue chemistry data required as per 40 CFR 158.240 support the ability of the Agency to
estimate the amount of pesticide that will result in food as a result of application of the pesticide

according to the product labels directions for use. The magnitude of the residue studies for crop
field trials use the typical end use product as the test material. The livestock feeding studies are
required whenever a pesticide residue will be present in livestock feed. The livestock feeding
studies evaluate the magnitude of the resulting pesticide residue in meat, milk, poultry, and eggs.
The studies are conducted with the technical grade of the active ingred
ient or the plant

metabolites Residue chemistry data are also required to identify any potential metabolites of
concern. These data are used to determine the tolerances for the parent and/or metabolites.
Additional data is required on environmental fate, degradation, metabolism, and dissipation.

Hazard data required for human health risk assessment are provided in 40 CFR 158.340. The
use of the active ingredient (i.e., food use or non-food use) will det
ermine what studies are
required. The acute toxicity data on the technical grade of the active
ingredient are used for
classification and precautionary labeling for protective clothing requirements, and worker
reentry intervals. The only studies that are required to be conducted on
the manufacturing use

product or end use product are the acute toxicity studies. The remaining toxicology studies (e.g.,
developmental toxicity, reproduction, subchronic, chronic feeding, or carcinogenicity studies)
require that the test substance is the technical grade of the active ing
redient. Subchronic toxicity
studies provide data on potential target organ toxicity and are also use
d to select dose levels for

long term or chronic toxicity studies. Chronic toxicity or carcinogenicity studies are conducted
for food use chemicals to determine potential effects following prolonged or repeated exposure
that may have a latency period for expression. The test animals are exposed orally for a
significant portion of their life span. Developmental toxicity studies are required in two species
(usually the rat and rabbit) for food use chemicals. They are conducted to detect alterations in

the normal development of fetuses following in utero exposure. The 2-generation rat
reproductive toxicity study is required to assess potential alterations
in gonadal function, estrus
cycles, mating, conception, birth, lactation, weaning, as well as growth and deve
lopment of
offspring. The Agency also requires a battery of mutagenicity studies to assess the potential
induction of changes in the genetic material of cells. The above studies are required for food use

active ingredients. In general, less data is required for non-food use
active ingredients and inerts
unless a concern has triggered additional testing.

454 Annex 53-B

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The Agency conducts separate risk assessments for all pesticide active ingredients and has
conducted risk assessments for some inerts. The remaining inerts are cleared by the Agency. It
should be understood that whenever the inert ingredient was cleared, wh
enever the tolerance
exemption was established, the inert met the standards of the time.

Inert ingredients, also known as “other ingredients,” are the carr
ier for the active ingredients
which allow the product to deliver the active ingredient at a specific r
ate and ensure proper
distribution during application. Currently there are over 3200 inert ingredients cleared by EPA
for use in various domestic pesticides products. There are two major classifications: non-food
use (such as lawn care products and bathroom cleaners), and food-use, which require an

exemption from the requirement of a tolerance and can also be used in non-food products.

The Agency has a newly developed methodology for evaluating low or low/moderate toxicity
chemical substances by way of a screening process that incorporates elements of a tiered

approach . Use of this process will permit the Agency to clear more chemicals of low to
moderate toxicity for use in pesticide products. The Agency is aware tha
t some chemicals may
be used as inert ingredients in some formulations and as active ingredients in other formulations.
EPA believes this methodology is appropriate for evaluating some low toxicity chemicals
regardless of whether they are categorized as active or inert ingredient
s. The new process will

permit the Agency to be able to conduct more in-depth evaluations of other ingredients that are
of potentially higher toxicity. Chemicals of higher toxicity that cannot be appropriately
addressed in the lower tiers would be evaluated in a manner substantially similar to that of an
active ingredient. Later as the Agency begins to review chemical-specific or surrogate

information in the open literature, the preliminary tier determination may be revised.

Inert ingredients that are exempt from tolerance are listed in 40 CFR 180.1001 (c). The inert
ingredients in the glyphosate formulation have been approved by the Agency. The components
of the adjuvant (Cosmo-Flux 411F) that have been sprayed on coca plants in Colombia, have

also been determined to be approved for use on food by the Agency.

The two federal statutes for regulating pesticides in the US give EPA li
mited authority to
regulate the sale, or use of adjuvants in the US. EPA has authority to
regulate an adjuvant if it is

purposely included in the manufacturing process of a pesticide product in which case the
chemical would be regarded as an inert ingredient. In the US as with all co
untries, adjuvants are
commonly used and added to pesticides as wetting agents, spreaders. emulsifiers, antifoamers,
and penetrants. These may contain surfactants, solvents, or other types of chemicals to achieve
the desired purpose.

An adjuvant is a subsidiary ingredient or additive product added to a pe
sticide in a mixture that
aids the effectiveness of the primary or active ingredient. Adjuvants are most commonly added
to tank mixes of pesticide products prior to application to the site to be treated
. Adjuvants are
not subject to FIFRA registration, as no pesticidal claims are made. Pesticide manufacturers

choose whether or not to address on their product labels the use of adju
vants with their
product(s). However, when added to a tank mix for application to a food or feed crop/site, the

455Annex 53-B

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individual components must be cleared under FFDCA. While adjuvant products are not
registered on the federal level, they are subject to registration under
some state laws. The states
of Washington and California are two states that register adjuvants. The adjuvant (Cosmo-Flux
411F) used in the glyphosate tank mix is produced by a Colombian company and is not sold

domestically. The Department of State has agreed to provide the Agency with acute toxicity
data performed on the actual tank mix that has been sprayed in Colombia.

C. Historical Regulatory Information

The glyphosate product currently used in the Colombian aerial eradication program was
registered in August 1994. It was intended to replace the glyphosate pr
oducts on the market that
were in toxicity category I and II for eye irritation with a product tha
t was category III for eye
irritation. The currently used product also offered improves rain fastness and is currently one of

the major glyphosate products used in agriculture in the US. In August 2002,
the registrant
submitted a label for ground and aerial application to kill undesirable vege
tation in a variety of
non-agricultural sites.

D. Hazard Identification

Hazard identification is the first step in the risk assessment process. The objective is to
qualitatively characterize the inherent toxicity of a chemical. Scientific data are evaluated to

establish a causal relationship between the occurrence of adverse health
effects and exposure to a
chemical. Because high quality controlled toxicology studies on humans are frequently
unavailable, regulatory scientists rely on animal data to estimate hazard to support regulatory
decision making. Prior to and subsequent to initial registration, the Agency has
required the

registrants of glyphosate products to submit appropriate studies according to contemporary study
requirements and testing protocol requirements.

Glyphosate Technical

The available hazard data base on experimental animals indicates that glyphosate has low acute
toxicity via the oral and dermal routes with LD 50> 5000 mg/kg. It is a mild eye irritant and a
slight dermal irritant. It is not a dermal sensitizer. The requirement for an acute inhalation
study was waived since no respiratory or systemic toxicity was seen following subchronic

inhalation exposure in rats. In the subchronic and chronic oral toxicity studies (1-year dog, 24-
month mouse, 2-year chronic/carcinogenicity rat, and 2-generation rat reproduction), systemic
toxicity manifested most commonly as clinical signs, decreases in body weight and/or body
weight gain, decreased food consumption, and/or liver and kidney toxicity at doses equal to or

above the limit dose (1000 mg/kg/day). No dermal or systemic toxicity was seen following
repeated dermal exposures. There was no quantitative or qualitative evidence for inc
reased
susceptibility in fetuses following in utero exposure to rats and rabbits in developmental toxicity
studies or following pre/post-natal exposure to rats in the 2-generation
reproductive toxicity

study in rats. Effects in the offspring were observed only at or above treatment levels which
resulted in evidence of appreciable parental toxicity. Glyphosate was n
ot mutagenic in a full

456 Annex 53-B

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battery of assays. Based on the lack of evidence for carcinogenicity in
two acceptable studies in
mice and rats, glyphosate is classified as a “Group E” chemical (no evidence of carcinogenicity
to humans).

Components of the Glyphosate Product

1. Polyoxyethylene alkylamine (POEA). POEA is a compound that is used as a surfactant
with many glyphosate formulations. In a safety evaluation and risk assessment of glyphosate,
the Roundup formulation and the surfactant POEA, Williams et al. (2000) reported that POEA
can cause severe skin irritation and be corrosive to the eyes. In subc
hronic oral studies, POEA

was mainly a gastrointestinal irritant in rats at high doses (~ 100 mg/kg/day) and in dogs at lower
doses (30 mg/kg/day). In a developmental toxicity study in rats, POEA did not cause any
developmental effects up to 300 mg/kg/day, but did induce maternal toxicity at 100 and 300
mg/kg/day (Farmer et al., 2000). The concentrated formulated Roundup product can also be

strongly irritating to the eyes and slightly irritating to the skin (Williams et al., 2000).

2. (information not included as it may be entitled to confidential treatment). (information not
included as it may be entitled to confidential treatment) are substances that are not highly toxic
by oral or dermal routes and are not irritating to the skin. They may cause mild, transient eye

irritation. Many (information not included as it may be entitled to confidential treatment) are
known not to be sensitizers (information not included as it may be entitled to confidential
treatment). The molecular weight of a (information not included as it may be entitled to
confidential treatment) determines its biological properties, and, thus, its toxicity. The lower

molecular weight (information not included as it may be entitled to confidential treatment
) tend
to be more toxic than the higher-weighted (information not included as it may be entitled to
confidential treatment) and are absorbed by the digestive tract and excreted in the urine and
feces, while the higher molecular weight (information not included as it may be entitled to
confidential treatment) are absorbed more slowly or not at all (information not included as it

may be entitled to confidential treatment). (information not included as it may be entitled to
confidential treatment) have low acute and chronic toxicity in animal studies. No significant
adverse effects have been noted in inhalation toxicology studies, carcinogen testing, or mutagen
assays. High oral doses have resulted in toxic effects to the kidneys and loose feces (information

not included as it may be entitled to confidential treatment). Topical dermal application of
(information not included as it may be entitled to confidential treatment
) to burn patients with
injured skin has resulted in toxicity. (information not included as it may be entitled to
confidential treatment).

Cosmo - Flux 411F (Adjuvant)

The Cosmo-Flux 411F adjuvant product used in the glyphosate tank mix is produced by a
Colombian company and is not sold in the U.S. The Agency is not in possession of toxicity data

from direct dosing of test animals with Cosmo-Flux 411F. However, the Agency has made
safety findings based on the toxicity of the individual components. As stated above, sale or use
of spray adjuvant products in the U.S. are generally not regulated by EPA. However, the DoS

457Annex 53-B

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has provided the EPA with a copy of this product’s label and a description of the product
ingredients. To be able to provide an opinion on hazard characterization of the Cosmoflux
ingredients, the EPA relied on available technical information from various sources. Cosmo-
Flux 411F consists mainly of (information not included as it may be entitled to confidential
treatment) with a nonionic surfactant blend primarily composed of (information not included as

it may be entitled to confidential treatment). All ingredients of this product are substances that
are not highly toxic by oral or dermal routes. They may cause mild eye and skin irritation. All
components of the adjuvant have been approved for use in/on food by EPA (4
0 CFR 180.1001.

Components of CosmoFlux (Considered as CBI)

1. (information not included as it may be entitled to confidential treatment). The (information
not included as it may be entitled to confidential treatment) can cause dermal and ocular
irritation and, in high doses orally, can cause significant toxicity. However, small amounts are

not a concern and these substances have been approved as food additives by the FDA and are
exempt from tolerances by EPA on certain commodities.

2. (information not included as it may be entitled to confidential treatment). The other major
component of Cosmo-Flux 411F, (information not included as it may be entitled to confidential

treatment), is not considered highly toxic. It may cause mild eye and skin irritation. The
corresponding monoester, (information not included as it may be entitled to confidential
treatment), has low subacute, subchronic and chronic oral toxicity and is used a
s a direct food
additive and a component in cosmetics. The higher molecular weight triester is less likely to be

absorbed orally or dermally and most likely of less toxicological concern. The other minor
components, are not known to be highly toxic compounds and would not be of toxicological
concern at the concentrations and conditions in which they are used.

E. Dose Response Assessment

Dose response analysis is the second step in the risk assessment process i.e.; characterization of
the quantitative relationship between exposure (dose) and response bas
ed on studies in which
adverse health effects have been observed. The objective is to identify endpoints of concern

which correspond to the route and duration of exposure based on the exposure patterns.

HED selects doses and endpoints (effects of concern) for risk assessment via an internal peer
review process. HED uses a standing Committee - the Hazard Identification Assessment Review
Committee (HIARC), to consider the available hazard data (studies require
d to be submitted by

registrants in 40 CFR part 158 and open peer reviewed literature) to id
entify endpoints for use in
risk assessment.

Ideally, each safety study identifies a dose level that does not produce
a biological or statistically

significant increased incidence of an adverse effect or no observable ad
verse effect level
(NOAEL). The threshold dose is the smallest dose required to produce a detectable effect.
Below this dose, there is no detectable response.

458 Annex 53-B

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On March 26, 1998 and, again, on November 20, 2001 the HED HIARC met to examine the
hazard data base and identify dietary endpoints for Females 13-50 years old, as well as the
General Population, the chronic reference dose. The HIARC also considered toxicological
endpoints for incidental oral exposure appropriate in residential exposu
re risk assessments.

The most recent report of the HIARC for glyphosate has the complete assessment of the
endpoints selected for dietary and residential/occupational exposures.
OPP calculates acute (24
hour or single day) and chronic (continuous lifetime exposure) RfDs for the purposes of
calculating dietary risk for food and drinking water. The RfD is calculated by dividing the
appropriate no observed adverse effect level by a ten fold factor for interspecies variability

(“average” human sensitivities might be up to 10 times that of lab animals) and a ten fold factor
for intraspecies variability (i.e., some individuals within a population might be 10 times more
sensitive than the “average” person).

For glyphosate, no endpoints were selected for the acute RfD since no hazard attributed to a
single dose was identified from the oral toxicity studies, and there are no specific concerns for
toxic effects on the developing fetus or infants and children. In addition, the HIARC did not
identify endpoints of concern for dermal and inhalation exposures for any exposure period (short
term- 1 to30 days, intermediate term- 1 to 6 months, or long term- 6 months to lifetime) since no

hazard was identified due to the low toxicity of glyphosate. The chronic dietary RfD of 1.75
mg/kg/day was based on diarrhea, nasal discharge, and mortality in a rabbit developmental
toxicity study. A summary of the doses and toxicological endpoints selected for various relevant
exposure scenarios are summarized in Table 1.

459Annex 53-B

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Table 1. Glyphosate Endpoint Selection Table
EXPOSURE DOSE ENDPOINT STUDY
SCENARIO (mg/kg/day)

An effect of concern attributable to a single dose was not identified fr
om the oral

Acute Dietary toxicity studies; there are no concerns for developmental or reproductive toxicity.
(24 hour or single
exposure)

Maternal toxicity based on clinical signs Developmental
Chronic Dietary NOAEL = (diarrhea and nasal discharge)resulting in toxicity -Rabbit

(continuous lifetime 175 mortality of some dams at 350 mg/kg/day
exposure) uncertainty
factor (UF) = Chronic RfD = 2.0 mg/kg/day
100

Incidental Oral, NOAEL= Maternal toxicity based on clinical signs Developmental
Short- (1-30 days), 175 (diarrhea and nasal discharge)resulting in toxicity -Rabbit
and Intermediate-(1- mortality of some dams at 350 mg/kg/day
6 months) Term

Dermal, No hazard was identified, therefore quantification of dermal risk is not required.
Short-, No systemic toxicity was seen at the Limit Dose (1000 mg/kg/day) following

Intermediate-and repeated dermal applications to New Zealand White rabbits.
Long-Term

Inhalation, Short-, Quantification of inhalation risk is not required because 1) no hazard was
Intermediate-, and identified in the 28 day inhalation toxicity study in rats - NOAEL = 0.36 mg/L
Long-Term (highest dose tested (HDT)); lowest observable adverse effect level (LOAEL) not

established based on 6 hours/day, 5 days/week for 4 weeks and 2) due to the
physical characteristics of the technical (wetcake), exposure to high
levels of the
active ingredient is unlikely via the inhalation route, so there was no
purpose to
test at higher doses.

Glyphosate Food Quality Protection Act (FQPA) Considerations

On August 3, 1996 the FQPA amended FIFRA and FFDCA. Section 408(B)(II)(C) of FFDCA

addresses exposure of infants and children. Under this provision EPA must apply the default 10X
safety factor when establishing, modifying, leaving in effect or revoking a tolerance or exemption
for a pesticide chemical residue, unless the EPA concludes, based on reliable data, that a d
ifferent
safety factor would protect the safety of infants and children. Risk assessors, therefore presume
that the default 10X safety factor applies and should only recommend a different factor, based on

an individualized assessment, when reliable data shows that such different factor is safe for
infants and children that it does not rely on a default value or presumption in making decisions
under Section 408 where reliable data are available that support an indi
vidualized determination.

460 Annex 53-B

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The OPP FQPA Safety Factor Committee (SFC) makes specific case-by-case determinations as to
the need and size of the additional factor if reliable data permit. Determination of the magnitude
of the overall safety factor or margin of safety involves evaluating the completeness of the
toxicology and exposure databases and the potential for pre- or post-natal toxicity. Individualized
assessments may result in the use of additional factors greater or less than, or equa
l to 10X, or no

additional factor at all. (OPP Guidance Document on Determination of the Appropriate FQPA
Safety Factor(s) in Tolerance Assessment, 2002)

The HIARC addressed the potential enhanced sensitivity of infants and children from exposure to
glyphosate as required by the FQPA of 1996 at the March 26, 1998 meeting and reaffirmed the

decision at the November 20, 2001 meeting. The HIARC concluded the following:

••Based on the available data, there was no evidence of quantitative and qualitative increased
susceptibility to in utero and/or postnatal exposure to glyphosate in rats or rabbits.

••Based on a weight of evidence consideration, the HIARC decided not to require the conduct of
a developmental neurotoxicity study with glyphosate to evaluate the potential for
developmental
neurotoxic effects because there was no evidence of neurotoxicity and neuropathology in adult
animals.

The FQPA SFC met on April 6, 1998 to evaluate the hazard and exposure data for glyphosate.
The FQPA SFC concluded that the safety factor of 10x be removed (reduced to 1x) since there is
no evidence of quantitative or qualitative increased susceptibility of the young demonstrated in

the prenatal developmental studies in rats and rabbits and pre/post natal reproduction study
in
rats. In addition the toxicology data base is complete, a developmental neurotoxicity study is not
required, and the dietary (food and drinking water) exposure assessments will not underestimate
the potential exposures for infants and children.

F. Exposure Assessment

The exposure assessment is the third step in the risk assessment process. The objective is to
determine the source, type, frequency, magnitude, and duration of actual or hypothetical contact

by humans with the agent of interest. To conduct this assessment EPA relied upon the
information provided by DoS from three sources: (1) Department of State (DoS) Presentation,
DoS Coca Eradication Program, 4/18/02, (2) DoS document entitled Chemicals Used for the
Aerial Eradication of Illicit Coca in Colombia and Conditions of Application. (3) DoS document
entitled Department of State Updated Report on Chemicals used in the Colombian Aerial

Eradication Program. These data were used in accordance with standard policies and procedur
es
used by the Agency in conducting pesticide exposure assessments.

Dietary Food Exposure

461Annex 53-B

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Acute dietary exposure is possible for persons consuming livestock or food crops which have
been inadvertently sprayed as a result of the aerial eradication program
in Colombia. However,
since glyphosate is a contact herbicide that systemically kills plants after absorption through
leaves, dietary exposure due to consumption of treated crops is expected to be limited. Since a
coca field is sprayed no more than twice to eradicate the crop, no chronic food exposure is

expected. Based on an evaluation of the hazard database, the Agency did not identify a toxic
effect attributed to a single oral dose. Therefore, an acute dietary risk assessment was not
performed. No significant risk due to dietary exposure to glyphosate residues is expected.

Occupational Handler and Post-application Exposure

Use Pattern Information

Use on coca for based on information supplied by DoS for the previous assessment on coca:

The tank mixture sprayed for eradication of coca in Colombia contains 55% water, 44% of
glyphosate herbicide product, and 1% adjuvant (Cosmo-Flux 411F). No more than two
applications of the glyphosate tank mixture are sprayed over coca crops at a maximum of 1.25
gallons/acre (equivalent to 1.1 gallons/Acre of glyphosate product, 0.03 gal/Acre of Cosmo-Flux
411F, and 0.12 gal/acre of water). DoS also stated that the average fi
eld size for coca in

Colombia is 3-5 hectares (approximately 7-12 acres). The program for aerial eradication of coca
treats a maximum of 1000 acres/day, during 3-5 missions/day.

Updated information for the use on coca and poppy (Department of State Updated Report on

Chemicals used in the Colombian Aerial Eradication Program).):

“4. Changes in chemical composition and spraying methods since 2002
report: Apart from
changing to a more benign formulation of glyphosate spray mixture, as discussed earlier, there
have been no changes to any of the components of the spray mixture. For some time in 2002, the

Government of Colombia lowered the application rate of glyphosate for coca eradication from the
traditional rate of 10.4 liters per hectare to 8.0 liters per hectare.
After extensive ground truth
evaluation, it was determined that the lower rate was ineffective for killing coca. Thus the
application rate returned to its former rate of 10.4 liters per hectare, which was the rate reported in

the Department’s Report on Issues Related to the Eradication of Illicit Coca in
Colombia in 2002
-- the rate that EPA evaluated when analyzing the potential for risks of
adverse effects on human
health and the environment posed by the coca eradication program. The only changes in the
methodology used to spray coca since the time of the last report is the addition of a new type of
spray aircraft to the spray fleet. Four Air Tractor Model 802 (AT-802) aircraft are currently being

used to spray coca, and another four will be delivered this year. These aircraft are manufactured
in the US for agricultural crop spraying and utilize the identical nozzles (same brand and
diameter) in the identical configuration (nozzle angle, droplet size, cali
bration methods) as the
OV-10 and T-65 spray aircraft. AT-802 flight speed during eradication operations is 165 m.p.h.

5. Differences between opium poppy spraying and coca spraying:

462 Annex 53-B

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The Secretary of State was not required to determine and report to Congress on any aspects of the
opium poppy eradication program in FY2002, and thusthe Department did not provide information
to EPA on the chemicals and methodology of poppy spraying. Like the coca spray mixture described
in the “Report on Issues Related to the Eradication of Illicit Coca in Colombia,” the opium poppy
spray mixture contains three components: water, an EPA-registered formulation of the herbicide

glyphosate, and a surfactant (Cosmo-Flux 411F ). Because the opium poppy is not a woody, hard-
to-control species like the coca bush, opium poppy eradication uses a spray mixture with a
substantially lower glyphosate content than the spray mixture used for coca eradication . For opium
poppy spraying, water, formulated glyphosate, and surfactant are combined into a spray mixture in
the following percentages: 94 percent water, 5 precent glyphosate formulation, and 1 percent Cosmo-

Flux 411F. This diluted mixture is applied toopium poppy at the rate of 50.0 liters/hectare (or 5.46
gallons per acre). This application rate is within the glyphosate manufacturer's label
recommendations for both the amount of concentratedformulation per acre and the amount of total
spray volume per acre.

Opium poppy spraying differs from coca spraying in several ways. Because Colombia cultivates
much less opium poppy than coca and spray program resources are limited, aircraft spray much
more coca than opium poppy, therefore expending more spray chemicals in coca growing areas
than in areas where opium poppy is cultivated. For example, in 2002, eradication aircraft sprayed

totals of 122,700 hectares of coca and 3,000 hectares of opium poppy. Opium poppy is generally
cultivated in plots that are smaller than the average coca field. While difficult to quantify
precisely, opium poppy fields generally range from 0.5 to 5 hectares. Opium poppy is ordinarily
cultivated at a higher altitude than coca, and thus opium poppy often is cultivated and sprayed in

hilly to mountainous terrain. For these reasons, the T-65 is the only aircraft us
ed to spray opium
poppy because it has a smaller wingspan (and spray swath) than the OV-10 or AT-802 and
because it is a more agile aircraft capable of staying close to the ground in more steeply graded,
rugged terrain.

Because of the challenges of mountain spraying, pilots undergo an extended training program
before they are qualified to perform actual opium poppy spray operations in Colombia. As the
Department of State reported in 2002, coca eradication pilots must have approximately 3,000 total
flight hours before they are considered for the spray program and can receive preliminary training

in illicit crop eradication. Most of these pilots also have at least 1,
500 hours of commercial aerial
application (crop dusting) experience. In addition to these requirements, opium poppy spray
pilots must undergo 40 hours of follow-on training specific to the topography, wind conditions,
and cloud cover that they will experience in their area of operations”
.

Handler Exposure

Exposure is expected for workers mixing and loading the glyphosate formulated product and tank
mix, and applicators applying the pesticidal mixture via fixed-wing aircraft. Mixers, loaders, and
applicators (handlers) have the potential for dermal exposure to the concentrate glyphosate

formulated product or tank mix from droplets contacting the skin. There is also the potential for
inhalation exposure to the concentrated glyphosate formulated product or mixed formulation from

463Annex 53-B

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breathing in aerosolized spray droplets.

According to the DoS, the mixer/loaders are trained on the label requirements for handling the
chemicals in the spray mixture, first aid, and use of personal protective equipment (PPE). The

required PPE according to the label includes long-sleeved shirts and lon
g pants, waterproof
gloves, shoes and socks, and protective eyewear. PPE is expected to mitigate potential exposure
to handlers.

Exposure to handlers is anticipated for short-term (1-30 days) durations. There also may be the
possibility for intermediate-term(1-6 months) handler exposure for individuals mixing, loading,
and applying the glyphosate mixture to multiple fields for more than 30 days. However, the
Agency does not have information pertaining to the duration of coca and poppy spray programs
or number of days spent mixing, loading, and applying the glyphosate mixture.

An occupational handler exposure and risk assessment is required for an active ingredient if: (1)
certain toxicological criteria are triggered and (2) there is potentia
l exposure to handlers (i.e.,
mixers, loaders, applicators, etc.) during use. Upon review and analysis
of the hazard database in

total, the Agency’s HIARC did not identify a hazard of concern for d
ermal or inhalation short-
and intermediate-term exposures. Therefore, quantitative estimates of risk for short-term dermal
and inhalation have not been conducted. No significant handler risk is
expected.

Post-application Exposure

According to the DoS, Colombian coca plants (Erythroxylum species) are woody perennial
shrubs native to the Andean region. Coca plants have leaves with waxy c
uticles which retard

herbicide uptake in the plant. The coca bushes grow to approximately chest level and are
harvested mainly by leaf pulling, 4 to 5 times per year. Coca plants grow from seedlings to a
harvestable plant in 12 to 18 months. Representatives from DoS indicated that, growers will prune
the coca plants, immediately after spraying, in order to salvage the coca crop. Specificall
y, since

glyphosate is a contact herbicide that works systemically to kill the plant after absorption through
the leaves, workers may enter fields immediately after spraying in order to prune or pull off the
coca leaves in order to prevent the coca plant from dying.

In the US, most uses of glyphosate are applied to kill weeds and other non-desirable

vegetation–annual and perennial grasses and herbaceous plants and woo
dy plants and trees on
crop and non-crop lands. In general, glyphosate is not applied in the U
S to destroy or kill the raw
agricultural commodity. The intended US uses are for undesired vegetation in and around
crop
fields, forests, industrial areas and residential areas.

DoS states that pilots are instructed not to spray fields where people are present. Therefore, based
on the use pattern described by the DoS, potential short-term dermal exposures are expected for
persons pruning, or leaf pulling treated coca plants immediately after spray events. These

activities are expected to result in dermal exposure from treated foliage contacting the skin. In
cases such as glyphosate, where the vapor pressure is negligible, HED ex
perience with post-

464 Annex 53-B

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application data suggests that inhalation exposure is minimal and therefore, HED does not
quantitatively assess post-application inhalation exposure. Since poppy
is sprayed at a much
lower application rate than coca, potential exposures related to re-ente
ring treated poppy field is
expected to be similar or lower than those associated with the use on coca.

Intermediate- and long-term post-application exposures are not expected due in part to the fact
that a coca and poppy fields are sprayed no more than twice. Additionally, glyphosate is a
translocated herbicide which is rainfast (unable to rinsed off by water
) within 48 hours after

spraying. Therefore, potential exposure to dislodgeable residues of gly
phosate after 48 hours is
expected to be minimal. Glyphosate has no residual soil activity. Results from the first 12 months
of bare ground field dissipation trials from eight sites show that the median half-life (DT50) for
glyphosate (Roundup) applied at maximum annual use rates (7.95 lb a.i./acre, 10.7 lb a.i./acre)
was 13.9 days with a range of 2.6 (Texas) to 140.6 (Iowa) days. Acceptable aerobic soil, aerobic
o
aquatic and anaerobic aquatic metabolism studies demonstrate that under those conditions at 25 C
in the laboratory glyphosate degrades rapidly with half-lives of approxi
mately 2, 7 and 8 days
respectively. The reported half-lives (DT50) from the field studies conducted in the coldest
climates, i.e. Minnesota, New York. and Iowa, were the longest at 28.7, 127.
8, and 140.6 days

respectively indicating that glyphosate residues in the field are somewhat more persistent in
cooler climates as opposed to milder ones (Georgia, California, Arizona, Ohio, and Texas). The
climate in Colombia would favor a shorter half life than the colder regions of the US. Thereby,
HED believes glyphosate would not be persistent or be available for inte
rmediate-term or long-

term post-application exposures in the Colombian climate.

A post-application exposure and risk assessment is required for an active ingredient if: (1) certain
toxicological criteria are triggered and (2) there is potential exposu
re. Upon review and analysis

of the hazard database in total, the Agency’s HIARC did not identify
a hazard of concern for
these durations or routes of exposure. Therefore, quantitative estimates of risk for short-term
dermal and inhalation have not been conducted. No significant post-applicat
ion risk due to
glyphosate exposure is expected as a result of this use.

Incidental Oral Exposure (Hand-to-Mouth)

Since DoS states that pilots are instructed not to spray fields where people are present, incidental
oral exposure (hand-to-mouth) resulting from being directly sprayed by glyphosate was not

assessed. Also, it is not current Agency policy to quantitatively asses
s toddler hand-to-mouth
exposure resulting from spray drift. Additionally, HED does not currently perform exposure
assessments for toddler non-dietary oral exposures for agricultural scenarios.
Therefore, non-
dietary incidental oral exposure was not quantitatively assessed for the use of glyphosate in

Colombia.

As a point of comparison, screening level risk estimates for toddler incidental oral exposures
(hand-to-mouth) to the U.S. registered residential turf uses of glyphosate have b
een calculated.

All resulting risks for toddler incidental oral exposure do not exceed HED’s level of concern.
The assumptions for toddler incidental oral exposures, (based on the maximum application rate of

465Annex 53-B

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1.62 lbs acid equivalent (ae)/acre), are expected to be conservative.
For example, it is assumed
that there is no dissipation of transferable residues, so that toddlers
are exposed to day of
treatment residues for each day of exposure. Even though the maximum application rate for the
aerial eradication program is higher (3.3 lbs ae/Acre), using the same standard screening level
assumptions as used in the residential assessment for the U.S. registered turf use and taking the

higher application rate into account, the potential risk would not excee
d HED’s level of concern.

As indicated in the turf assessment, glyphosate was directly applied to residential lawns and did
not result in exposures of concern to HED. Although spray drift is always a potential source of
exposure to residents nearby aerial spraying operations, AgDrift® (a
spray drift model)

consistently predicts drift from applications is only a fraction of the applied rate (lb ai/acre).
Based on this assessment, HED believes that it is unlikely that there is a higher potential
r risk
of exposure to spray drift from agricultural operations.

G. Potential Exposure From Spray Drift

Due to spray drift, there is potential exposure for persons in nearby ar
eas to those targeted for
spraying. Exposure through drift is not expected to exceed that which i
s identified in the
exposure characterization provided above and in the ecological risk asse
ssment below.

The coca eradication program operating in Colombia has incorporated several features designed
to minimize the potential for off-target drift, provide quality assurance on a mission-by-mission
basis, and evaluate the performance of the program to the extent possible given current

conditions. Three types of aircraft are used in the program including the Ayres Corporation T65
Thrush, modified OV10D Bronco aircraft converted from military observation use to spray
aircraft, and the Air Tractor AT802. The T65 and AT802 are common to the agricultural sector
in the US. The nozzles are Accu-Flow as described at the April 18, 2002 briefing to the Agency.
The droplet spectra characteristics, under use conditions for these nozz
les, produce a very large

droplet which has a volume median diameter (VMD) between 300 and 1500 microns. Use of
droplets this size is consistent with minimizing spray drift in agriculture in the US. A surfactant
(Cosmo-Flux 411F) is also used in the spray solution along with water and the
glyphosate
formulated product. The use of spray adjuvants (in this case Cosmo-Flux 411F) in pesticide

product formulations and/or the spray solution is also consistent with common agricultural
practices in the US.

The quality assurance standard operating procedures incorporated into th
e program are also
consistent with standard agricultural practices. These include reconnai
ssance of the spray sites,

use of global positioning satellite technology (GPS), and criteria for
aborting missions (e.g., based
on climatological conditions or presence of persons or livestock in the treatment areas).
Reconnaissance of spray sites is intended to define the treatment zones through the use of
sophisticated GPS mapping which is then overlaid with GPS spray records from missions to
evaluate performance. GPS technology is used for planning, assessments of mission

performance, and for archival purposes to evaluate potential claims against the program.

466 Annex 53-B

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Finally, to a limited extent where feasible, on-site ground inspections for spray efficac
y and
potential adverse effects are performed. Reports suggest approximately 90 percent efficacy in the
spray swath and minimal collateral damage to surrounding vegetation (e.g., aerial photos of
treated areas) based on information supplied by the DoS at the April 18, 2002 briefing.

The Agency did not complete a quantitative risk analysis of the drift potential of glyphosate in the
water/surfactant solution used in this program. However, the technology and other safeguards
used in this program are consistent with common approaches in the US for reducing spray drift.
Therefore, it is likely that drift is minimized in this program if all procedures are adhered to and
operational equipment is in working order. At the April 2002 briefing, it was indicated t
o the

Agency that quantitative spray drift studies had been completed by the DoS in conjunction with
the University of Georgia. These were not supplied to the Agency nor were they considered in
this evaluation. Additionally, it should be noted that the information considered by the Agency
were done so without review of the primary source (e.g., the method by which the VMD was

determined was not described, written application protocols describing target
site conditions
when applications would be aborted were not provided, and methods for scoring or measuring
off-target damage were not provided).

Based on information contained in the report provided to OPP in 2003 entitled Department of

State Updated Report on Chemicals used in the Colombian Aerial Eradication Program, it appears
that there are no differences in the method used for poppy eradication significant enough from the
coca eradication program, evaluated last year, that would show a cause for concern on drift
related issues. By all accounts, DoS is approaching drift reduction in
a systematic manner that is

based on the same kinds of recommendations that would commonly be used in agriculture. It is
also important to consider the drift issue in the context of concerns over human health. As
indicated above in the exposure discussion, a qualitative assessment for glyphosate indicated that
there were no risk concerns even for children playing in areas that have
been treated at rates
equivalent to those that would be expected within the treated areas. Spray drift would only lessen

these exposures, again, which are already not of concern. As such, the Agency has no concern for
spray drift from a human health perspective.

H. Incident Data Review: A Study of Health Complaints Related to Aerial Eradication

of Poppy in Colombia

The following incident data were evaluated as part of the 2002 assessment for the use of
glyphosate in the coca eradication program. Since the incidence data pertains to areas where
poppy was sprayed, it is considered pertinent to the current review and
is included below.

The report, prepared by the Department of Narino, Municipality of El Tablon De Gomez, makes a
concerted effort to identify any health problems that might be related to use of the glyphosate tank
mix in aerial eradication programs. The study was commissioned by the U.S. Embassy in Bogota
and conducted independently by Dr. Camillo Uribe, Director of Clinica Uribe Cualla, the national

poison control center. Sections of this report are summarized below with the sections numbered
in bold corresponding to the original report.

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An exact comparison of the epidemiological data in Colombia (which is from aerial application to
poppy) relative to the conditions of use, presented at the April 18, 20
02 briefing (for aerial
application to coca) by DoS to OPP risk assessors, would have limitations and uncertainties. The
briefing did not address the conditions of use for poppy. At that time DoS also did not provide
human incident data for the coca eradication program. Subsequent to this briefing DoS did

communicate that the application rate for poppy was lower than that for coca
. According to the
DoS, the use pattern of the glyphosate mixture on poppy also differs from the use on coca. Other
details of the differences between the two spray programs have not been supplied to the Agency.
Specifically, the Agency has no information as to the exact makeup of the tank mixture sprayed
on poppy, or whether the same glyphosate product and adjuvants used in the coca eradication

program were used in the poppy eradication program. Therefore, generalized conclusions drawn
from human incident data as a result of application to opium poppy, in comparison to conditions
of use for the coca eradication program should be made with caution.

1.1 Description of studied area

This report primarily concerns the area around the municipality of El Tablon in southern
Colombia. The total population is given as 16,770, of which 89% is categorized as rural. The
main crops in this area include coffee, corn, wheat, oats, potatoes, and illicit opium poppy. It is

known that a variety of other pesticides, more toxic than glyphosate, are used on these crops.
The municipality has three health centers, including Aponte, which is the focus of this report.
The Aponte health center is staffed by a medical doctor, a nurse, and a nurse’s aide. Aerial
eradication of the illicit opium poppy reportedly occurred in this region in June, July, and

November of 2000.

1.2 Morbidity and mortality in the municipality of El Tablon

The Narino Departmental Health Institute provided summary morbidity and mortality information

for the El Tablon De Gomez area and the Aponte settlement for the year 1999. Data for the year
2000 had not yet been officially released, but estimates are provided. These data are reported
here to provide an approximate description of glyphosate tank mix exposure upon use on coca
fields in Columbia. However, no quantitative conclusions can be drawn from these data. Six

illnesses likely to be related to pesticide exposure were identified and
tabulated. They include,
acute diarrhea, acute respiratory infection, dermatitis, intoxication, conjunctivitis and headache.
The authors note that the first three illnesses listed (diarrhea, respi
ratory infection, and dermatitis)
are likely to be related to problems with inadequate nutrition, housing, and lack of health services.
The basis for this listing of symptoms is not specified, but it does agree with the list of symptoms

likely to result from exposure to glyphosate products based on Poison Control Center data,
California surveillance reports, and the world literature. Total morbidity for 1999 and estimated
morbidity for 2000 are given in the Table below for El Tablon De Gomez and the Aponte
Settlement below. Note, however, that the overwhelming majority of these illnesses did not occur
at the time of spraying and, therefore, could not be related to spray exposure.

468 Annex 53-B

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Table 2. Morbidity reported in the El Tablon De Gomez of Colombia in 1999 and estimated for
2000.
Pathology 1999 2000 Estimated

Acute diarrhea 146 186

Acute respiratory infection 568 506

Dermatitis 209 265

Poisoning/Intoxication 1 4

Conjunctivitis 75 85

Headaches 139 151

Total for 6 suspected illnesses 1,138 1,197

Table 3. Morbidity reported in the Aponte Settlement of Colombia in 199
9 and estimated for 2000.

Pathology 1999 2000 Estimated

Acute diarrhea 181 190

Acute respiratory infection 199 222

Dermatitis 210 180

Poisoning/Intoxication 4 4

Conjunctivitis 87 104

Headaches 78 95

Total for 6 suspected illnesses 759 795

The Aponte settlement is contained within the El Tablon De Gomez area, where there has been a concern
for herbicide spraying-related health effects. The figures in the repor
t are listed by five separate age
groups. This reveals, that the majority of the cases of diarrhea and respiratory infection occurred in
children less than five years old, as would be expected given the known demographics of those health

effects. Nationwide data show that 53% of intoxications are suicides or
suicide attempts, but it is not clear
how many of the four poisonings listed above might be suicidal or, more importantly, are due to other
products such as medications. In both Tables 2 and 3 there is an increase of 5% from 1999 to the estimate
for 2000 for the total of the six suspected illnesses. Given that spray
ing is reported to have occurred in
2000 and not in 1999, this suggests that the overwhelming majority (95%) of illnesses reported would be

background incidence unrelated to the spraying of herbicide. The remaining 5% increase could be due to
a variety of causes and do not support a conclusion that the glyphosate
tank mixture was responsible for
these complaints.

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1.3 Epidemiological monitoring system and mandatory notification

In addition to the summary of general morbidity in the population, there is a mandatory health reporting
system in Colombia for 34 illnesses including pesticide poisonings. The review of these records found no
reports of pesticide poisoning for the municipality of El Tablon in the year 2000 or the first 9 weeks of

2001. Weekly reports were examined to determine how many pesticide poisonings were reported each
month. It did not appear that the times of spraying correlated with reports of pesticide intoxication.

Table 4: Reports of Pesticide Intoxication provided to the Narino Department of Health Institute,
Epidemiology Section January 12, 2000 through March 7, 2001.

Month/Year Number of Month/Year Number of Poisonings occurring at
Poisonings poisonings time of spraying

January 2000 0 July 2000 11 9

February 2000 0 August 2000 6

March 2000 8 September 2000 12

April 2000 13 October 2000 8

May 2000 7 November 2000 13 6

June 2000 15 December 2000 2

-- - Jan. 2001 7

-- - Feb. 2001 19

-- - Mar. 2001 0

Out of a total of 125 reported pesticide poisonings in 61 weeks, 15 occurred during 5 weeks when
spraying eradication occurred. Given the variation in the data, this co
uld easily be due to chance and be

unrelated to exposure from the spraying of the glyphosate tank mixture. More work is required to
determine whether locations of the 15 suspect poisoning matched the location and timing of spraying.

In 2000, the Narino Department of Health requested all municipalities to report the human health effects
of pesticide spraying. Ten municipalities supplied the reports. They are:

Three municipalities including Tablon de Gomez, Barbacoas, and Magui reported no cases. However, the
reports were completed prior to the November spraying in Barbacoas and Magui and prior to (or perhaps
during) the July and before the November spraying in Tablon de Gomez.

Buesaco reported one patient with sore throat, numbness in limbs, and conjunctivitis in June.

In Tumaco, six case of patients with conjunctivitis and dermatitis were reported as of October 6, 2000.

470 Annex 53-B

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In San Pablo, 50 cases of dermatitis, conjunctivitis, respiratory conditions, and digestive problems were
reported after as of October 6, 2000.

In La Cruz, two cases of allergic rhinitis, two cases of dermatitis, and five cases of conjunctivitis were
reported as of October 6, 2000.

San Jose de Alban did not report any specific cases, but the scientific coordinator and chief nurse noted an
increase in gastrointestinal, dermatological and respiratory conditions. The exact quantity of these
conditions in relation to spray times was not given.

El Rosario reported five cases of conjunctivitis and rhinitis that might have been related to spraying
carried out on July 31.

San Pedro de Cartago reported an increase in gastrointestinal symptoms but no quantitative relationship

between illnesses and spray times was provided.

The absence of any reports of pesticide poisoning combined with the information from the ten
municipalities is difficult to interpret. The glyphosate formulated product is known to cause irritation to
the skin, eyes, mucous membranes which may account for some of the reports of sore throat,

conjunctivitis, dermatitis and other conditions described above. However, it is not possibl
e to evaluate
these reports in any detail due to the lack of any information on how many of these cases experienced
exposure immediately prior to their illness and lack of information on investigation of potential alternative
causes. This anecdotal information does not provide any substantial evidence of health effects due to
the

spraying of the glyphosate tank mixture in Colombia. Many of the reports are consistent with exposure to
glyphosate products by the dermal route, as reported in California and the literature. So, it is possi
ble that
some cases could be related to the aerial eradication program.

To provide context for comparison, the California Pesticide Illness Surveillance Program (1982-2000)

data for glyphosate were reviewed for this risk assessment. This analysis demonstrated interesting
findings. Starting in 1992, the glyphosate product was reformulated in the US to reduce the amount of
surfactant which posed a hazard to the eye. From 1982 through 1991, there were 221 illnesses involving
the eye or 22.1 cases per year. From 1994 (allowing 2 years for the product to be introduced into trade

and widespread use) through 2000, there were 65 illnesses involving the
eye or 9.3 cases per year, a
decline of 58%. Therefore, these data support the finding that the refo
rmulated glyphosate product used
since 1992, have resulted in a significant drop in illnesses. Overall,
the total illnesses due to glyphosate
declined by 39% from the 1982-1991 time period to the 1994-2000 time period, largely due to the
reduction in eye injuries.

2.2 Review of report of January 22, 2001 visit to the municipality of El Tablon de Gomez.

A commission visited the municipality of El Tablon on January 22, 2001 and spoke with Dr. Tordecilla
and reviewed health records of his patients. A number of records of skin conditions were noted for the

months of October, December 2000, and January 2001. The exact number of cases, selection criteria, and
method of analysis was not specified in the summary report. Nevertheless, the commission concluded

471Annex 53-B

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“that the information available permitted the commission to consider only the possibility of an association
between exposure to pesticides and the effects”. The commission noted that it lacked the technical
expertise, the data on dates and locations of spraying, and therefore could not conclude whether the
observed conditions were related to pesticide exposure.

2.3 Interviews with Narino department health officials regarding the spraying

Employees of the Narino Department Health Institute were interviewed. A Fatima Health Promoter,
thought the children were most affected, suffering gastrointestinal problems and eye irritation. One
possible route of exposure was the village water fountains which supply some of the drinking water. The

most common symptoms in children, according to the Health Promoter, were stomach aches and vomiting,
which were different from the most common symptoms of glyphosate exposure reported by Lee et al.
(2000), sore throat and nausea. This inconsistency suggests that some
cause other than glyphosate
products was responsible for the children’s complaints. The Health Promoter reported one case of a boy

with skin lesions like sores after the spraying. The Health Promoter was particularly concerned that
peasants receive more health care from the government.

A nurse’s aide reported that three or four patients with burning eyes, headache, and dizziness were seen at
her health center. One boy with a respiratory infection was sent to anot
her health center, later died.

Medical records were sought to substantiate this report but there was no clinical history, autopsy or other
information to support glyphosate spraying as a factor. She referred a patient
with urinary problems to the
hospital. Subsequent review of the medical records of this case did not find reference to glyphosate tank
mix exposure and suggested an infectious origin. There were also cases of
dermatitis, headache,

abdominal pain and gastrointestinal symptoms, but she could not say whether the symptoms were related
to exposure to the spraying of glyphosate tank mixture.

Another nurse’s aide reported by telephone that her impression was that the number of dermatological
consultations had increased. However, there was no clear association with glyphosate tank mix exposure

and many of the reasons for the consultations were the same as in previous years when glyphosate was not
used, so no clear relationship between the spraying and these dermatological conditions was identified.

Reports of anecdotal evidence by nurse’s aides and the health promoter have not established a link

between the spraying of glyphosate tank mix and health effects. Follow-up to determine the timing and
evidence of exposure and examination of other potential causes of these effects was not performed. These
interviews do not add significant evidence about the health risks from the use of glyphosate tank mixture
in Colombia, more in depth study is needed.

2.5 Review of records of patients treated at Aponte Health Center - Sept. 2000 to Jan. 2001

There were 29 cases reported by Dr. Tordecelli and clinical records were
obtained for 21 of them. Two
other reports of skin lesions were sought but could not be confirmed. After careful review of the 21
records, it was determined that all but four cases were likely due to other causes. Most had
skin

conditions known to be related to bacteria or parasites, not chemical exposures and the onset of their
symptoms did not correspond with the times of spraying. There were seven patients whose symptoms

472 Annex 53-B

-29-

started after spraying and three of these were conditions known to be ca
used by bacteria or parasites. For
the remaining four cases possibly related to the spraying of glyphosate tank mixture, one was an allergic
reaction that had been seen in this patient before when there was no spraying. A second and third case
were contact eczema that is endemic in this region and thought to be more likely due to an infectious
origin. One of these two cases did not initiate until 52 days after the last spraying. The fourth case was

dermatitis on the thigh which would typically be protected by clothing and thereby protected from aerial
spray applications. This reviewer agrees with the conclusion that “the twenty-one clinical histories . . .
reveals that any relationship between aerial eradication with the herbic
ide glyphosate (tank mixture) and
the skin conditions treated in Aponte is unlikely”.

In summary, the evidence collected and presented in this report cannot confirm that the glyphosate tank
mixture used in Colombia as the likely cause of illness in the surrounding community. There is
suggestive evidence in the form of reported increases of morbidity and reports from municipalities that
some cases of relatively mild complaints could have occurred in relation to the spraying eradication

program. Some of the reports appear to be similar to those reported in the literature and by California.
These cases report irritation to skin, eyes, and respiratory passages an
d suggest that the Cosmo-Flux 411F
added to the glyphosate product in Colombia has little or no effect on the overall toxicity of the
formulated product.

Rather than review incomplete medical records, it would be better to collect information prospectively.
For example, if pesticide poisoning is a mandatory reporting condition, a form documenting the exposure,
health effects and medical data on each case could be designed and used to establish whether
any
particular conditions might be related to spraying the glyphosate tank mixture. Without prospective

collection of data and follow up, it is difficult to evaluate potential
health effects of the glyphosate tank
mixture sprayed in Colombia. Better records of the time of exposure relative to the onset of symptoms
would also enhance interpretation of the incidence data.

I. Updated Incident Data Review

The purpose of the current review is to consider recent exposure/inciden
t information provided to the
Agency for the DoS Colombia coca and poppy eradication program in light of the 2002 assessment of
reported health complaints. The “Department of State Updated Report on Chemicals used in the

Colombian Aerial Eradication Program” submitted this year, mentions two activities, quoted below:

“The spray program tracks human health complaints in two ways. The first is to initiate an
immediate investigation, often including clinical evaluation of the patient
(s), upon notice to the
U.S. Embassy of a problem . . . To investigate complaints of toxic exposure allegedly caused by

spraying, [the Embassy’s Narcotics Affairs Section] retains the services of two of Colombia’s
leading toxicologists, including the director of Colombia’s national poison control center, the
Uribe Cualla Centro de Asesoramiento Toxicologico . . . “. Subsequent to the 2002 EPA
assessment, “two complaints have been reported to the U.S. Embassy. In September 2002, the
Embassy received a complaint of multiple cases of poisoning from spraying coca in Puerto Asis

(Putumayo department). A visit to the hospital and interviews with doctors there reveal
ed no cases
of poisoning or illness attributable to spray chemicals.”

473Annex 53-B

-30-

A detailed report on this visit was provided in the 2003 submission: “Investigative report on cases of
possible human health effects in Puerto Asis” by Jorge Hernan Tobon, M.D., September 19, 2002.
Review of this report confirmed that only two hospitalized cases were located that could have been the
source of the complaint. One was a 13-year old child diagnosed as suffering from organophosphate
poisoning, not from glyphosate exposure. And the other was a three-year old child who developed

symptoms of asthma at some time after several sprayings near her village. However, the coincidental
development of symptoms without supporting evidence from other sources that glyphosate might be a
contributor to asthma, make this case an unlikely result of exposure to the herbicide. In the o
pinion of the
specialist treating the child, glyphosate was not the cause of her illne
ss.

The second prospective approach is quoted from “Department of State Updated Report on Chemicals used
in the Colombian Aerial Eradication Program”:

The Government of Colombia and the U.S. Embassy Bogota have also taken a proactive approach

to investigating any human health concerns manifest in areas where the spraying takes place. Both
governments have collaborated to create a robust Medcap to search out cases of
harm to health
allegedly caused by spraying. During these public health interventions
that are timed to take place
in areas where coca eradication has recently taken place, U.S. Embassy-contracted toxicologists
talk to patients and talk to local medical personnel, looking for spray-related cases. . . .

As a result of the effort described above 1,029 patients were interviewe
d by Medcap medical personnel,
had their medical conditions assessed, and received complimentary health care. None of the cases
reviewed were found to be related to the eradication spraying program. Tabular information shows that

between 120 and 260 patients were interviewed in relation to five separa
te spray operations. The report
concluded that “Through Medcap and other medical investigations, the U.S. Embassy has never found an
instance of spray-related harm to human health.”

The report also mentions a separate news report that attributed spread of tuberculosis an
d questioned

whether case of harelip and cleft palate in newborns might be related to spraying. Given the infectious
nature of tuberculosis and the known genetic factors associated with the two birth defects, the likelihood
of glyphosate having any role in these illnesses is extremely remote at best. The Agency is not aware of
any information linking glyphosate to cleft palate in rats or rabbits.

Conclusions Regarding Incident Reports

Current information indicates that the Government of Colombia and the U.S. Embassy Bogota have
adhered to the EPA advice ... “Prospective tracking of reports of hea
lth complaints, documenting times of

exposure and onset of symptoms, are recommended during future spray operations to evaluate any
potential health effects and ameliorate or prevent occurrence.” The 2003 submission from the
“Department of State Updated Report on Chemicals used in the Colombian Aerial Eradication Program”
to the EPA indicates that “A visit to the hospital and interviews wit
h doctors there revealed no cases of
poisoning or illness attributable to spray chemicals.” U.S. Embassy-contracted toxicologists talked to

patients and talked to local medical personnel, looking for spray-related cases... The report conclude
d that
“Through Medical Civic Action Program (Medcap) and other medical investigations, the U.S. Embassy

474 Annex 53-B

-31-

has never found an instance of spray-related harm to human health.”. Missing from their account was a
clearly stated case definition for what would constitute a glyphosate-related poisoning. A case definition
is required if the conclusion that they have “never found an instance of spray-related harm to human
health” is to be supported.

It would be useful to continue these efforts and further document the manner in which follow-up is
performed. Standardized collection of data on patients and their symptoms is recommended, so that future
analysis can look for patterns across patients not only to identify rela
ted cases, but perhaps identify new
effects previously unsuspected and that might be associated with low-level exposure to glyphosate spray
drift.

J. Risk Characterization

Risk characterization combines the assessments of the first three steps to develop a qualitative or

quantitative estimate of the probability, that under the assumed conditions or variables of the exposure
scenario, that harm will result to an exposed individual. Risk is equal to hazard multiplied by exposure.
For the scenarios that are relevant to the subject use, the Agency has n
ot identified toxic effects
attributable to a single oral exposure, short- or intermediate-term dermal, or short- or intermediate-term
inhalation exposures. Therefore, no quantitation of exposure or risk was performed. Nonetheless, it is

appropriate to qualitatively characterize the potential for risk concerns for this use.

From the review of glyphosate product incident reports for the use on poppy,
it should be emphasized that
the spraying reported to have occurred in 2000 and not in 1999 suggests,
that the overwhelming majority

(95%) of the illnesses reported would be background incidents unrelate
d to the spraying of herbicide. The
remaining 5% increase could be due to a variety of causes and do not suppor
t a conclusion that the
spraying of the glyphosate tank mixture was responsible for these complaints. Furthermore, the individual
with the highest potential for exposure would be the mixer loader. They are handling the concentrated
glyphosate product and the tank mix. The incident data that has been submitted to the Agency by DoS,

does not include any incident reports for those individuals. There is some data to suggest that the poppy
eradication program could have resulted in minor skin, eye, or respiratory irritation, and perhaps headache
or other minor symptoms. However, the detailed information on the use, timing of application, history of
exposure, and medical documentation of symptoms related to exposure to glyphosate tank mix were not

available. The evidence collected and presented in the epidemiology report cannot confirm that the
glyphosate tank mixture used in Colombia as the likely cause of a single illness. There is suggestive
evidence in the form of reported increases of morbidity and reports from municipalities that some cases of
relatively mild complaints could have occurred in relation to the spraying eradication progr
am. Some of
the reports appear to be similar to those reported in the literature and by California. These cases report

irritation to skin, eyes, and respiratory passages and suggest that the Cosmo-Flux 411F added to the
glyphosate product in Colombia has little or no effect on the overall toxicity of the formulated product.
The information so far collected indicates that any increase in health problems is likely to be relatively
small at most and the severity of those symptoms is likely to be minor to moderate at most.

The Amazon Alliance and Earth Justice submission in 2002 provided little, if any, information on the
number of persons affected, age and sex, symptoms of illness, or diagnosis or treatment received. Without

475Annex 53-B

-32-

such information EPA cannot even begin to characterize the extent and pattern of t
he health effects
claimed to result from glyphosate application. Given the limited amount of documentation, none of the
data in the report from Colombia provide a compelling case that the spraying of the glyphosate mixture
has been a significant cause of illness in the region studied. Prospective tracking of reports of health
complaints, documenting times of exposure and onset of symptoms, are recommended during future spray

operations to evaluate any potential health effects and ameliorate or prevent their occurrence.

Current information indicates that the Government of Colombia and the U.S. Embassy Bogota have
adhered to the advice provided by the Agency in 2002 ... “Prospective tracking of reports of health
complaints, documenting times of exposure and onset of symptoms, are recommended during future spray

operations to evaluate any potential health effects and ameliorate or prevent occurrence.” The 2003
submission from the “Department of State Updated Report on Chemicals used in the Colombian Aerial
Eradication Program” to the EPA indicates that “A visit to the hospital and interview
s with doctors there
revealed no cases of poisoning or illness attributable to spray chemicals.” U.S. Embassy-contracted

toxicologists talked to patients and talked to local medical personnel, looking for spray-related cases...
The report concluded that “Through Medical Civic Action Program (Medcap) and other medical
investigations, the U.S. Embassy has never found an instance of spray-related harm to human health.”.
Missing from their account was a clearly stated case definition for what would constitute a glyphosate-
related poisoning. A case definition is required if the conclusion that
they have “never found an instance

of spray-related harm to human health” is to be supported.

It would be useful to continue these efforts and further document the manner in which follow-up is
performed. Standardized collection of data on patients and their symptoms is recommended, so that future

analysis can look for patterns across patients not only to identify rela
ted cases, but perhaps identify new
effects previously unsuspected and that might be associated with low-level exposure to glyphosate spray
drift.

The glyphosate formulated product currently used in the coca eradication program in Colombia contains

the active ingredient glyphosate, a surfactant blend, and water. The ac
ute toxicity test of the glyphosate
technical and formulated product indicate that both are classified as category III for primary eye irritation
and category IV for acute dermal and oral toxicity, and skin irritation and are negative for dermal
sensitization. The label for the formulated product used in the eradication program in Colombia includes

the “Caution” signal word.

During April 18 briefing, the Department of State agreed to supply the Agency with a full battery of the
six acute toxicity tests on the tank mix used in the coca aerial eradication program. That information has
been received and reviewed. In summary, the acute toxicity of the spray mixture is category III for eye

irritation and category IV for skin irritation and acute dermal, oral and inhalation exposure and is negative
for dermal sensitization.

K. Summary Conclusions

• There are no risks of concern for glyphosate, per se, from the dermal or inhalation routes of
exposure, since toxicity is very low.

476 Annex 53-B

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• The components of the adjuvant Cosmoflux 411F are not highly toxic by the oral and dermal
routes; they have been approved for use in/on food by the Agency.
• Glyphosate is not highly toxic. Based on the conditions of glyphosate use described by DoS, there
is likely minimal exposure or concern for acute and chronic dietary or incidental oral risks.
• Due to the change of glyphosate product used in the Colombian Aerial Coca and Poppy

Eradication program and the submission of the acute toxicity tests for the tank mix, there is no
longer concern for acute eye toxicity.
• Based on the information received to date for the use on poppy, exposure is expected to be similar
or lower than the previously assessed use on coca.

REFERENCES

(information not included as it may be entitled to confidential treatment
).

HIARC Report for Glyphosate (TXR No. 0050428, 22-JAN-2002)

Glyphosate in/on Pasture and Rangeland Grasses, Roundup Ready® Wheat, and Nongrass Animal Feeds.
(DP Barcode: D280831, 20-FEB-2002)

Evaluation of 6 acute toxicity studies conducted on test material identified as Spray–Charlie.
(DP Barcode: D289806, 13-MAY-2003)

Farmer, D.R., T.A. Kaempfe, W.F. Heydens and W.R. Kelce. 2000. Developmental toxicity studies with
glyphosate and selected surfactants in rats. Teratology 61(6): 446.

(information not included as it may be entitled to confidential treatment
).

(information not included as it may be entitled to confidential treatment).

US Environmental Protection Agency, Office of Pesticide Programs May 9, 2002: Guidance Document
on Methodology for Determining the Data Needed and the Types of Assessments Necessary to Make

FFDCA Section 408 Safety Determinations for Lower Toxicity Pesticide Chemicals.

Williams, G.M., R. Kroes and I.C. Munro. 2000. Safety evaluation and risk assessment of the herbicide
Roundup and its active ingredient, glyphosate, for humans. Reg. Toxic. Pharm. 31: 117-165.

477Annex 53-B

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III. ECOLOGICAL RISK ASSESSMENT

A. Introduction

At the request of the Department of State (DoS), the Office of Pesticide Programs (OPP) of the U.S.
Environmental Protection Agency (EPA) provides here an ecological risk assessme
nt for the aerial coca

and poppy eradication programs in Colombia. The Environmental Fate and Effects Division (EFED)
performed a risk assessment for coca eradication in response to a similar request by DoS in 2002. That
assessment concluded that the active ingredient glyphosate itself would likely
pose little risk to non-target

terrestrial and aquatic animals, but that non-target terrestrial plants would likely be damaged some
distance from the intended spray area due to spray drift of glyphosate.

The proposed use of glyphosate on coca will be little changed from that described in 2002, with the
exception of the use of a different glyphosate product in 2003. This wil
l reduce the potential for eye
irritation, and therefore may provide some benefit to people and terrestrial animals exposed to the spray.

Other aspects of the proposed use remain the same, including the use of adjuvant CosmoFlux 411F.
Therefore, as detailed below, the expected risks and uncertainties in EP
A’s environmental risk assessment
remain essentially the same as described the previous year.

The request for a risk assessment for the use of glyphosate to control poppy production is new for 2003.
However, as described below, the expected risks and uncertainties corres
ponding to this use are nearly

identical to those for the coca use. The application rate of glyphosate
is less for poppies than for coca, and
therefore the risk to terrestrial animals is expected to be low. The potential for glyphosate runoff may be
much greater for poppies, since the sprayed fields can be located on mountainsides. However, as detailed

in the 2002 assessment for coca eradication, the concentration of active ingredient glyphos
ate that might
be derived even from direct application to a small pond should not result in significant risk to non-target
aquatic animals or plants. Therefore, runoff from the poppy or coca sprays would not be expected to pose

a significant risk to non-target aquatic organisms.

The primary risk that might be associated with the poppy eradication program is that from spray drift to

non-target terrestrial plants. As with coca applications, application to poppy fields will require application
at speeds and application heights greater than might be desirable for drift control, due to the safety
precautions needed for eradication sprays down a potentially forested mountainside. The added factor of

steep slopes make it likely that spray drift from the lower rate poppy sprays could extend a greater
distance than that from the coca eradication sprays which are understood to occur on more level terrain.

B. Ecological Risk Characterization

The following risk characterization for the coca eradication use is adapted from the 2002 ecological risk

assessment for the use of glyphosate herbicide as part of the U.S. supported ae
rial eradication program of
coca in Colombia:

The use of a glyphosate spray for coca and poppy eradication is unlikely
to cause adverse effects to

478 Annex 53-B

-35-

terrestrial or aquatic animals but is likely to pose a substantial risk to nearby non-target plants
. Vegetative

vigor toxicity laboratory tests performed using a formulated glyphosate product (glyphosate acid WP
48.3%) on North American crops indicated toxicity to terrestrial plants with applications of less than 1.0

lb of the isopropylamine salt of glyphosate per acre, which corresponds to 0.75 lb acid equiv
alents (a.e.)
per acre. The coca use rate is 1.11 gallons glyphosate/acre (3.34 lb acid equivalents/acre) for direct, aerial
application to coca. A second application is possible if fields are replanted, or the first is determined after

3 to 6 months to have been inadequate. Because poppies are reportedly more sensitive to glyphosate, a
lower application rate of 0.27 gallon/acre (0.8 lb a.e./acre) is used in spraying for poppy eradication. The

DoS reports that the spray mixture for poppy eradication would include 5% formulated glyphosate, 1%
Cosmo-Flux 411F, and 95% water (as opposed to 44%, 1% and 55%, respectively
for the coca spray). The

product claimed by the DoS to be used ib Colombia is widely used in the US on a variety of agricultural
commodities and non-agricultural sites.

EPA used the AgDRIFT model to estimate potential spray drift. The model suggests that non-target plants
hundreds of feet away may be exposed to a fraction of glyphosate applied to coca or poppy fields. Some

of the important application parameters for estimating spray drift levels from coca and poppy eradication
application are shown in Table 1.

Table 1. Important application parameters for defining off-target spray drift levels in coca and poppy
eradication.

Application parameter Coca spraying Poppy spraying Effect on off-target exposure

Application rate 3.34 lb a.e./acre 0.8 lb a.e./acre Lower application rates result in lower off-
target exposure

Flight speed during 200 mph 135-145 mph Lower flight speeds result in less secondary
application droplet break up, larger droplets, less drift,
and lower off-target exposure

Estimate wind speed 0-10 mph 0-4 mph Lower wind speeds results in less movement
range of spray droplets off-target (i.e. lower drift)

Estimated droplet size 300-1500 mm 300-1000 mm Larger droplets are less prone to be blown
range off-target

Estimated release <100 feet 30 -120 feet Lower release heights result in shorter fall

heights times for droplets and less opportunity to
be blown off-target

Boom width not available 70% of wingspan Narrow boom widths result in fewer droplet
being caught in wing tip vortices and lower
drift levels

Slope not available not available Drift can be carried farther when winds are
blowing down steeper slopes

479Annex 53-B

-36-

Figure 1.

Downwind Herbicide Deposition
Varying Droplet Size and Wind Speed
1.1

1.0 extremely coarse-very coarse spray, 3 mph wind
0.9

0.8 medium spray, 3 mph wind
0.7

0.6 extremely coarse-very coarse spray, adverse effect
10 mph wind
0.5 level for 50% of
0.4 young plants:
Deposition medium spray, 10 mph wind poppy spraying
0.3
0.2 coca spraying
(fraction of application rate)
0.1
0.0

0 200 400 600 800 1000

Downwind distance (ft)

Figure 1 shows the lowest levels of drift are associated with applications using the extremely coarse to
very coarse sprays at a 3 mph wind speed. The highest levels of drift are associated medium sprays at
wind speeds of 10 mph. Downwind deposition levels from coca and poppy spraying is likely to be
bounded by these estimates. The “effect level for 50% of young plants” is based of glyphosate toxicity

studies on ten young crop plants. Older plants are generally less sensi
tive to herbicides than young,
rapidly growing plants. At the level corresponding to approximately 11% and 44% of the coca and poppy
application rates, respectively, 50% of plants species would be expected
to show measurable reductions in

dry weight. With a 10 mph wind, plants would be expected to be exposed at this 50% affect level up to
200 feet downwind of poppy spraying and 550 feet downwind of coca spraying. Of the affected plants
some would likely recover while more sensitive plants may die, have reduced reproductive success, or
reduced yields (crop plants).

There is uncertainty whether crops or other plants in Colombia, whether similar to crops tested in the US
or not, would be affected similarly at the same exposure levels. However, since glyphosate is an effective,
broad spectrum herbicide, risk to non-target plants outside of the application zone would be expected. The

Agency’s Ecological Incidents Information Sytem (EIIS) database includes several hundred reports of
possible non-target plant incidents in the US attributed to use of glyph
osate.

The use of the active ingredient glyphosate itself in poppy and coca era
dication would not pose a

significant direct risk to terrestrial or aquatic animals, although secondary adverse effects from the loss of
habitat in the spray area are likely. Neither acute nor chronic adverse
effects were observed in mammalian
and avian laboratory toxicity tests submitted to the EPA by US industry, using the active ingredient alone.

480 Annex 53-B

-37-

Mortality was observed in fish and aquatic invertebrate studies. However, the resulting acute LC val50s
(concentrations at which half the test animals died), and lowest effect levels for chronic effects, were in
parts-per-million. Toxicity endpoints for aquatic plants also ranged from 0.85 to 39.9 ppm. Considerably
lower surface-water exposure, in the parts-per-billion, could be expecte
d from the use on coca or poppy

using runoff simulations from Agency exposure models PRZM and EXAMS. The Agency considered an
even more conservative scenario, estimating the concentration that would result from the direct
application of 3.75 lb acid eq./acre of glyphosate to a 1-acre, 6-foot deep pond. The calculated maximum
concentration of 230 ppb is well below the toxicity values measured for aquatic organisms in the

laboratory.

It is possible that much greater exposure could occur from direct overspray of water bodies much smaller
than a 1-acre, 6-foot deep pond, but such simulation is not a standard component of Agency risk
assessments. The product label for glyphosate prohibits such direct overspray o
f water bodies, but it is

possible that some ecologically important water bodies too small or ephemeral to appear on maps could be
sprayed directly in a project as large as the coca eradication program.

Although the measured toxicity and estimated exposure indicate that only non-target terrestrial plants are

likely to be adversely affected by the use on coca and poppy, there are
important uncertainties that should
be considered. One of these is the extrapolation of North American data to the conditions and wildlife
found in Colombia. The toxicity of a pesticide to different classes of animals and plants can vary widely
among species within an individual ecosystem. The Agency uses the test species as surrogates for other

North American species not tested, but has little experience with tropical flora and fauna. Similarly,
laboratory and field estimates of the environmental fate of pesticides, including potential surface-water
contamination, are performed with North American soils, hydrology and climate data. The uncertainty of
extrapolating North American exposure and effects data to this risk assessment would most effectively be

reduced by identification of characteristics which define sensitive tropical ecosystems.

An important uncertainty in this risk assessment concerns differences in the tank mix used in Colombia
from those used in the US. The Agency does not have ecological toxicity information on adjuvant Cosmo-
Flux 411F, which is neither manufactured nor sold in the US. However, all of the individual components

(surfactants) which comprise the adjuvant are substances with low oral and dermal mammalian toxicity.
The toxicity of the blend of these surfactants is not known; although the Agency often requires
formulation toxicity data for non-target plants and aquatic organisms, tank-mix adjuvants are not required
to be included in these studies.

481482 Annex 53-C

departMent os tateMeMoranduM of Justificaticnoncerning the
secretary ofstat´s2004 certification conditionsrelated ta erial

eradication oillicic oca andopiuMp oppy icoloMbia, 2004

(U.S. Department of State)

483484 Annex 53-C

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2004 » Memorandumof Justification

Concerning the Secretary of State's 2004 Certification of Conditions Related to the Aerial Eradication of Illicit Coca and Opmiu
Poppy in Colombia

Memorandum of Justification Concerning the Secretary of State's 2004
Subscribe to Updates
Certification of Conditions Related to the Aerial Eradication of Illicit

Coca and Opium Poppy in Colombia

Other Releases
BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC

2004

The Andean Counterdrug Initiative section of the Consolidated Appropriations Act, 2004 (Publ�c Law 108199)

lays out conditions under which assistance using funds appropriated under the Andean Counterdrug Initiative
may be made available for the procurement of chemicals for use in aerial eradication of illicit crops. In particular,

Public Law 108�199 provides:

"That not more than 20 percent of the funds appropriated by this Act that are used for the procurement of

chemicals for aerial coca and poppy fumigation programs may be made available for such programs
unless the Secretary of State, after consultation with the Administrator of the Environmental Protection

Agency (EPA), certifies to the Committees on Appropriations that: (1) the herbicide mixture is being used

in accordance withEPA label requirements for comparable use in the United States and any additional
controls recommended by theEPA for this program, and with the Colombian Environmental Management

Plan for aerial fumigation; and (2) the herbicide mixture, in the manner it is being used, does not pose

unreasonable risks or adverse effects to humans or the environment:Provided further, That such funds
may not be made available unless the Secretary of State certifies to the Committees on Appropriations

that complaints of harm to health or licit crops caused by such fumigation are evaluated and fair

compensation is being paid for meritorious claims:Provided further, That such funds may not be made

available for such purposes unless programs are being implemented by the United States Agency for
International Development, the Government of Colombia, or other organizations, in consultation with local

communities, to provide alternative sources of income in areas where security permits for small-acreage

growers whose illicit crops are targeted for fum�gation: ."

This memorandum provides justification for the Secretary o� State s determination and certification to Congress

that the above conditions have been met as required. In 2002 and 2003, the Secretary of State determined and

certified to Congress on similar conditions concerning human health and environmental safety issues related to
the Colombia spray program. These certifications were based on, among other information: all available scientific

data on glyphosate, the herbicide used by the program; toxicological tests of the spray mixture (water,

glyphosate, and a surfactant); active field verifications and complaint investigations; comprehensive human health
monitoring; and thorough verbal and written consultations on the spray program with USDA andEPA. Because

the Colombia aerial eradication program has not made any changes in the chemical formulation or application

methods used for eradication of coca and opium poppy since the Department of State last submitted documents

to EPA for the 2003 consultation (April 9, 2003), these prior certifications serve as the foundation for the 2004
certification. These certifications and attachments can be found on the Internet at the following address:

http://www.state.gov/p/inl/rls/rpt/aeicc/

On September 27, 2004 , the Secretary of State wrote U.S. Environmental Protection Agency (EPA)
Administrator Leavitt to request written consultation concerning the U.S.-supported Colombia eradication

program. This letter is includeAttachment 1 . Specifically, EPA was asked to advise the Department of

State about whether the herbicide mixture employed by the U.S.-supported program of aerial eradication of coca
and opium poppy in Colombia is being used in accordance withEPA label requirements for comparable use in

the United States and any additional controls recommended by the EPA for this program; whether the herbicide

485Annex 53-C

mixture is being used in accordance with the Colombian Environmental Management Plan for aerial fumigation;
and whether this herbicide mixture, in the manner it is being used, poses unreasonable risks or adverse effects

to humans or the environment.

The Department met withEPA on September 6, 2004 to brief EPA on the expanded monitoring of possible
environmental and human health issues related to the program since the 2003 EPA Analysis. The Secretary of

State� sSeptember 27, 2004 letter provided EPA a written document -- "2004 Department of State Report to

EPA on Human Health and Environmental Monitoring Related to the Colombian Illicit Crop Eradication Program"

-- with further information on the issues discussed in the briefing. This document isAttachment 2 .

On November 17, 2004 , EPA Administrator Michael O. Leavitt responded to the Secretary of State with the

results of EP� s consultation review. That letter and the attached document from the Office of Pesticide

Programs, "Details of the 2004 Consultation for the Department of State Use of Pesticide for Coca and Poppy
Eradication Program in Colombia" are included as . The next six sections directly address the
Attachment 3
requirements and concerns of Public Law 108-199.

1. The herbicide mixture is being used in accordance with EPA label requirementsfor comparable use
in the United States.

EPA told the Department of State in its recent2004 report that "Application rates for both coca and poppy

eradication in Colombia are within the parameters listed on labels of glyphosate products registered byEPA for

use in the United StatesAttachment 3, Section B ). This is the same finding they reached in the 2003 report,
when the EPA stated, "EPA has determi ed that application rates for both coca and poppy eradication in

Colombia are within the parameters listed on U.S. labels." This determination meets the criteria for the Secretary

to certify that the herbicide mixture is being used in accordance with EPAalbel requirements for comparable use
in the United States.

2. The herbicide mixture is being used in accordance with any additional controlsrecommended by

the EPA for this program.

The Government of Colombia and the Department of State have implemented several changes in the program to

address EPA � s recommendations made in the 2003EPA analysis as evidenced by the EPA�s statement in

its 2004 report, "The DoS and the Government of Colombia made modifications and enhancements to the spray

program as EPA recommended in its prior assessments." In 2003, the EPA recommended in its Executive
Summary, "that the Department of State continue programs for investigating health complaints. The Agency also

requested that the Department of State improve its definition of glyphosate poisoning, provide further

documentation of its investigations and how they are conducted, and standardize data collection."

The Department of State has expanded its efforts to track reported health complaints and to investigate any

possible connection between verified spraying of illicit crops and damages purported in any such complaints. The

U.S. Embassy conti nues to conduct immediate investigations in the field upon notice to the asy of as

problem. To date, no relation of reported human health problems to spraying has been substantiated by the
rigorous evaluations of toxicologists hired by the E�bassy s Narcotics Affairs Section (NAS).

The U.S. Embassy is aware of just one alleged human health related complaint since submission to Congress of

the FY 2003 Spray Certification. This complaint alleged human health (and legal crop) damage from spraying of
coca in Orito (Putumayo Department) and was reported in Colombia s leading daily newspaper, "El Tiempo" on

May 10, 2004. The Colombian National Police (CNP) and the U.S. Embassy immediately responded by sending

a verification team to Orito on May 11 to speak with the individuals interviewed in the newspaper article.

This team, composed of representatives from the CNP and NAS, an Embassy-hired toxicologist, the Government
of Colombi� s Alternative Development Agency (PDA), and local government representatives, found that the

allegations were unfounded and that interviewees misled the reporter to discredit the spray program and

discourage further law enforcement activity against illicit crops in the area. A May 12 letter from the PDA

Alternative Development Director to NAS thanking the Embassy for its rapid attention to this complaint is
included asAttachment 4 .

NAS is collaborating with the Colombian National Institute of Health (INS) on a program to identify health effects

of herbicides and pesticides, including glyphosate, in populations located in coca growing regions across
Colombia. A NAS-contracted toxicologist helped INS prepare and conduct training for physicians and

environmental health personnel who serve the populations of these areas.

The training consists of a weeklong workshop that covers toxicology, classification of pesticides, prevention,

diagnosis and recognition of pesticide poisoning, clinical management, epidemiological considerations and

486 procedures for the study of an outbreak, glyphosate toxicological facts, and a risk assessment of aerial
mixture is being used in accordance with the Colombian Environmental Management Plan for aerial fumigation;
and whether this herbicide mixture, in the manner it is being used, poses unreasonable risks or adverse effects application of glyphosate for people and the environment. In 2004, the following workshops took place, training a

to humans or the environment. total of 571 rural health care providers:

The Department met withEPA on September 6, 2004 to brief EPA on the expanded monitoring of possible

environmental and human health issues related to the program since the 2003 EPA Analysis. The Secretary of
State� sSeptember 27, 2004 letter provided EPA a written document -- "2004 Department of State Report to

EPA on Human Health and Environmental Monitoring Related to the Colombian Illicit Crop Eradication Program"

-- with further information on the issues discussed in the briefing. This documentAttachment 2 .s

On November 17, 2004 , EPA Administrator Michael O. Leavitt responded to the Secretary of State with the
results of EP� s consultation review. That letter and the attached document from the Office of Pesticide

Programs, "Details of the 2004 Consultation for the Department of State Use of Pesticide for Coca and Poppy

Eradication Program in Colombia" are includeAttachment 3. The next six sections directly address the
requirements and concerns of Public Law 108-199.

1. The herbicide mixture is being used in accordance with EPA label requirementsfor comparable use

in the United States.

EPA told the Department of State in its recent2004 report that "Application rates for both coca and poppy
The Department of State and the Government of Colombia are currently implementing the 2003 EPA
eradication in Colombia are within the parameters listed on labels of glyphosate products registered byEPA for
recommendations. The Department of State, in conjunction with the Government of Colombia s (GOC
use in the United StatesAttachment 3, Section B. This is the same finding they reached in the 2003 report, National Institute of Health, has improved its definition of glyphosate poisoning and standardized the process of

when the EPA stated, "EPA has deteri ed that application rates for both coca and poppy eradication in data collection. NAS Bogot
Colombia are within the parameters listed on U.S. labels." This determination meets the criteria for the Secretary
developed and distributed standardized data collection worksheets and a definition of glyphosate poisoning in the
to certify that the herbicide mixture is being used in accordance with EPAalbel requirements for comparable use
workshops referenced above.
in the United States.
The Government of Colombia and the U.S. Embassy Bogot

2. The herbicide mixture is being used in accordance with any additional controlsrecommended by investigating human health concerns manifested in areas where spraying takes place. Both governments have
the EPA for this program.
collaborated to create a robust Medical Civic Action Program (Medcap) to search out cases of harm to health
allegedly caused by the spraying. These public health interventions are timed to take place in areas where coca

The Government of Colombia and the Department of State have implemented several changes in the program to eradication has recently taken place and thus serve as a verification of the status of public health in areas where

address EPA �s recommendations made in the 2003EPA analysis as evidenced by the E�A s statement in the CNP sprays. U.S. Embassy-contracted Colombian toxicologists talk to patients as well as to local medical
its 2004 report, "The DoS and the Government of Colombia made modifications and enhancements to the spray
personnel, looking for spray-related cases.
program as EPA recommended in its prior assessments." In 2003, the EPA recommended in its Executive
As outlined in the chart below, 22,263 patients made themselves available for Medcap medical personnel, had
Summary, "that the Department of State continue programs for investigating health complaints. The Agency also
their medical conditions assessed, and received complimentary health care. Although Medcap personnel have
requested that the Department of State improve its definition of glyphosate poisoning, provide further
documentation of its investigations and how they are conducted, and standardize data collection." encountered several cases that were allegedly spray-related, their reviews of these cases have determined that,

in each case, the conditions were caused by events unrelated to aerial eradication. Through Medcap and other
The Department of State has expanded its efforts to track reported health complaints and to investigate any medical investigations, the U.S. Embassy has still not yetofund a single instance of spray-related harm to

possible connection between verified spraying of illicit crops and damages purported in any such complaints. The human health. This is an ongoing program and several Medcaps are planned for upcoming months.
U.S. Embassy conti nues to conduct immediate investigations in the field upon notice to tasy of aEmbs

problem. To date, no relation of reported human health problems to spraying has been substantiated by the

rigorous evaluations of toxicologists hired by the�Embassy s Narcotics Affairs Section (NAS).

The U.S. Embassy is aware of just one alleged human health related complaint since submission to Congress of
the FY 2003 Spray Certification. This complaint alleged human health (and legal crop) damage from spraying of

coca in Orito (Putumayo Department) and was reported in Col�mbia s leading daily newspaper, "El Tiempo" on

May 10, 2004. The Colombian National Police (CNP) and the U.S. Embassy immediately responded by sending

a verification team to Orito on May 11 to speak with the individuals interviewed in the newspaper article.

This team, composed of representatives from the CNP and NAS, an Embassy-hired toxicologist, the Government

of Colombi� s Alternative Development Agency (PDA), and local government representatives, found that the

allegations were unfounded and that interviewees misled the reporter to discredit the spray program and

discourage further law enforcement activity against illicit crops in the area. A May 12 letter from the PDA
Alternative Development Director to NAS thanking the Embassy for its rapid attention to this complaint is

included aAttachment 4 .

NAS is collaborating with the Colombian National Institute of Health (INS) on a program to identify health effects

of herbicides and pesticides, including glyphosate, in populations located in coca growing regions across
Colombia. A NAS-contracted toxicologist helped INS prepare and conduct training for physicians and

environmental health personnel who serve the populations of these areas.

The training consists of a weeklong workshop that covers toxicology, classification of pesticides, prevention,

diagnosis and recognition of pesticide poisoning, clinical management, epidemiological considerations andAnnex 53-C

22-23 May
Saravena 1,915 civilian patients

5 June 687 civilian patients
La Antioquena

12-13 June
3,493 civilian patients
Florencia

9-10 July 1,668 civilian patients

14-15 Aug 2,354 civilian patients

21-22 Aug 1,089 civilian patients

18-19 Sept 1,599 civilian patients

22,263 civilian patients
Totals
1,572 farm animals

The only changes suggested by theEPA in its 2004 report are minor and relate to improving the data collection
form used to collect information on reports of damage to human health. They are as follows:

General Data : Record date and contact information about the health care provider (who fills out the form) in

case follow-up consultation is needed

Characterization of the Exposure: Record more information about the location of exposure and any

description about the proximity to the spraying (how far away) or amount of exposure (e.g. amount of skin

exposed, eyes exposed, etc.).

The NAS in the U.S. Embassy in Bogota will be following up with the appropriate GOC officials to ensure that

these suggestions are incorporated into the overall Aerial Eradication Program.

3. The herbicide mixture is being used in accordance with the Colombian Environmental Management

Plan for aerial fumigation

On July 26, 2004 the Minister of the Environment, Housing, and Territorial Development, the Government of

Colombia entity charged with supervision of the Environmental Management Plan for aerial eradication (EMP),

ruled that the illicit crop eradication program is being conducted in compliance with the EMP. That Ruling No.
707, an English version of which is enclosedAttachment 5 , reads:

"The entities responsible for executing the Illicit Crop Eradication Program Using Aerial Spraying with the

Herbicide Glyphosate� PECIG � are currently complying with the measures established in the

Environmental Management Plan imposed by this Ministry, the purpose of which is preventing, mitigating,
controlling, offsetting, and correcting any possible negative environmental effects or impacts which might

result from eradicating illicit crops (p. 26)."

The Department of State providedEPA the English l anguage version of the EMP in late 2003.EPA responded to
the Department of State in a February 23, 2004 letter: "We believe the Plan contains appropriate types of

activities for a pesticide spray program. The information in the EMP is generally in agreement with information

provided to EPA for the previous consultations and discussed in�EPA s 2002 and 2003 written assessments."

This letter is found inAttachment 6.

The Government of Colombia� s Ministry of the Environment, Housing, and Territorial Devel�pment s ruling

meets the criteria for the Secretary to certify that the herbicide mixture is being used in accordance with the

Colombian Environmental Management Plan for aerial fumigation.

4. The herbicide mixture, in the manner it is being used, does not pose unreasonable risksor adverse

488 22-23 May
1,915 civilian patients
Saravena

5 June 687 civilian patients
La Antioquena

12-13 June
3,493 civilian patients
Florencia

9-10 July 1,668 civilian patients

14-15 Aug 2,354 civilian patients

21-22 Aug 1,089 civilian patients

18-19 Sept 1,599 civilian patients

22,263 civilian patients
Totals
1,572 farm animals

The only changes suggested by theEPA in its 2004 report are minor and relate to improving the data collection

form used to collect information on reports of damage to human health. They are as follows:

: Record date and contact information about the health care provider (who fills out the form) in
General Data
case follow-up consultation is needed

Characterization of the Exposure: Record more information about the location of exposure and any
description about the proximity to the spraying (how far away) or amount of exposure (e.g. amount of skin

exposed, eyes exposed, etc.).

The NAS in the U.S. Embassy in Bogota will be following up with the appropriate GOC officials to ensure that

these suggestions are incorporated into the overall Aerial Eradication Program.

3. The herbicide mixture is being used in accordance with the Colombian Environmental Management

Plan for aerial fumigation

On July 26, 2004 the Minister of the Environment, Housing, and Territorial Development, the Government of

Colombia entity charged with supervision of the Environmental Management Plan for aerial eradication (EMP),
ruled that the illicit crop eradication program is being conducted in compliance with the EMP. That Ruling No.

707, an English version of which is encloseAttachment 5 , reads:

"The entities responsible for executing the Illicit Crop Eradication Program Using Aerial Spraying with the

Herbicide Glyphosate� PECIG � are currently complying with the measures established in the
Environmental Management Plan imposed by this Ministry, the purpose of which is preventing, mitigating,

controlling, offsetting, and correcting any possible negative environmental effects or impacts which might

result from eradicating illicit crops (p. 26)."

The Department of State providedEPA the English l anguage version of the EMP in late 2003.EPA responded to
the Department of State in a February 23, 2004 letter: "We believe the Plan contains appropriate types of

activities for a pesticide spray program. The information in the EMP is generally in agreement with information

provided to EPA for the previous consultations and discussed i� EPA s 2002 and 2003 written assessments."
This letter is found inAttachment 6.

The Government of Colombia� s Ministry of the Environment, Housing, and Territorial Devel�pment s ruling

meets the criteria for the Secretary to certify that the herbicide mixture is being used in accordance with the
Colombian Environmental Management Plan for aerial fumigation.

4. The herbicide mixture, in the manner it is being used, does not pose unreasonable risksor adverseAnnex 53-C

based on exposure to residual glyphosate or AMPA in water bodies contiguous to or near coca crops."

For the 2003 Spray Certification, the Department had laboratory toxicity tests performed on the entire spray

mixture, which tested at an acceptable Category III for eye irritation and Category IV for all other categories (on
EPA's scale of I-IV with IV being the least toxic). Since that time, the spray program has increased its

environmental and human health monitoring program and the Government of Colombia�s Environmental Ministry

has determined that the spraying complies with the Ministry's Environmental Management Plan for aerial

eradication.

The Department of State believes that improvements over the last year have significantly decreased the likelihood

of adverse impacts of eradication program on humans and the environment and that theherbicide mixture, in the

manner it is being used, does not pose unreasonable rsi ks or adverse effects to humans or the environment.

5. Complaints of harm to health or licit crops caused by such fumigation are investigated, and fair
compensation isbeing paid for meritoriousclaims

The methodology for investigations into human health problems allegedly tied to spraying is covered in section 3
above. Therefore, this section focuses exclusively on complaints of spray damage to legal crops. The

Government of Colombia is investigating and resolving these complaints more swiftly than in past years and

continues to compensate all meritorious claims fairly.

On October 4, 2001, the GOC formally instituted a new process to compensate growers for legal crops sprayed
in error. Since that date, the Colombian National Police, Anti-Narcotics Directorate (DIRAN), the Government of

Colombia agency responsible for complaint investigations, has received 5,065 such complaints.

In 2004, the DIRAN�s complaint investigations unit and other GOC entities that play a role in complaint
investigations made substantial progress in eliminating the existing backlog of cases to be investigated and

resolved. In calendar year 2004, although only 632 new complaints were received (through October), 2,725

complaint investigations were completed. Of these investigations in 2004, only four complaints were found to be

valid and compensation payments were made, for a total of $3,846. Four more cases of compensation are due to
be paid in November. To date, the spray program has compensated growers in 12 cases for a total of $30,000 of

compensation.

Although most of the investigations of filed complaints have been completed, 1063 are currently being processed

and verified. Complaint resolution is a rolling process; on-site investigations continue, and compensation is being
paid to cases with merit. Typically, compensation hinges on the issues of whether planes sprayed in the vicinity

of a farm within a five-day window of the alleged date of spraying; whether the complainant owns the farm he/she

claimed was sprayed; whether the legal crop allegedly sprayed was intermixed with illegal crops; and whether
the affected crop suffered damage from the glyphosate, as opposed to fungus, insects, or other causes.

Police and agronomists from the Colombian Institute of Agriculture and Husbandry (ICA), Ministry of

Environment, and Office of Alternative Development conduct a site visit and the aviation computers are checked

for spray operations in the area. If the spray pilots have erred and accidentally sprayed licit crops, compensation
is paid to the farmer for the loss of the crop, based on current market value of the crop

Field verification is extremely dangerous and resource intensive; and it is a slow-moving process. Because of the

high risks involved for the Embassy personnel, agronomists, lawyers, DNE representatives, CNP officials, and
ombudsman s representatives who accompany on site visits, the primacy of security will dictate the pace of

investigations in the future. Although logistical considerations (security concerns, personnel availability, and

helicopter resources) are part of the reason why complaints cannot be resolved in the field more quickly, the

greatest logjam in this system is the number of false complaints which handicap the ability of field investigators
to close cases more quickly. During 2004 site investigations, some farmers related stories of armed narco-

terrorist groups forcing them to damage their own crops and falsifying complaints in order to publicly denounce

the aerial eradication program.

False complaints -- cases in which growers complained that their legitimate crops were sprayed, but
investigators who reached the fields in question found them to be coca or legitimate crops interspersed with coca

-- waste resources that otherwise might be used in the service of the farmers who really deserve compensation.

To date, less than half of one percent of the cases that have been visited by complaint verification teams has
merited compensation. Nevertheless, Embassy Bogot has taken steps to make sure that the overall complaint

resolution is swifter and continues to pursue rapid field verifications when security, weather, and logistical

considerations in individual cases permit.

The Colombian Ministry of Justice has refined the claims procedures, seeking to streamline the process and to
deter fraudulent claims. These procedures will include a warning that a complainant found to have coca growing

490based on exposure to residual glyphosate or AMPA in water bodies contiguous to or near coca crops."

For the 2003 Spray Certification, the Department had laboratory toxicity tests performed on the entire spray

mixture, which tested at an acceptable Category III for eye irritation and Category IV for all other categories (on

EPA's scale of I-IV with IV being the least toxic). Since that time, the spray program has increased its
environmental and human health monitoring program and the Government of Col�mbia s Environmental Ministry

has determined that the spraying complies with the Ministry's Environmental Management Plan for aerial

eradication.

The Department of State believes that improvements over the last year have significantly decreased the likelihood
of adverse impacts of eradication program on humans and the environment and that theherbicide mixture, in the

manner it is being used, does not pose unreasonable rsi ks or adverse effects to humans or the environment.

5. Complaints of harm to health or licit crops caused by such fumigation are investigated, and fair

compensation isbeing paid for meritoriousclaims

The methodology for investigations into human health problems allegedly tied to spraying is covered in section 3

above. Therefore, this section focuses exclusively on complaints of spray damage to legal crops. The
Government of Colombia is investigating and resolving these complaints more swiftly than in past years and

continues to compensate all meritorious claims fairly.

On October 4, 2001, the GOC formally instituted a new process to compensate growers for legal crops sprayed

in error. Since that date, the Colombian National Police, Anti-Narcotics Directorate (DIRAN), the Government of
Colombia agency responsible for complaint investigations, has received 5,065 such complaints.

In 2004, the DIRA� s complaint investigations unit and other GOC entities that play a role in complaint

investigations made substantial progress in eliminating the existing backlog of cases to be investigated and

resolved. In calendar year 2004, although only 632 new complaints were received (through October), 2,725
complaint investigations were completed. Of these investigations in 2004, only four complaints were found to be

valid and compensation payments were made, for a total of $3,846. Four more cases of compensation are due to

be paid in November. To date, the spray program has compensated growers in 12 cases for a total of $30,000 of

compensation.

Although most of the investigations of filed complaints have been completed, 1063 are currently being processed

and verified. Complaint resolution is a rolling process; on-site investigations continue, and compensation is being

paid to cases with merit. Typically, compensation hinges on the issues of whether planes sprayed in the vicinity

of a farm within a five-day window of the alleged date of spraying; whether the complainant owns the farm he/she
claimed was sprayed; whether the legal crop allegedly sprayed was intermixed with illegal crops; and whether

the affected crop suffered damage from the glyphosate, as opposed to fungus, insects, or other causes.

Police and agronomists from the Colombian Institute of Agriculture and Husbandry (ICA), Ministry of
Environment, and Office of Alternative Development conduct a site visit and the aviation computers are checked

for spray operations in the area. If the spray pilots have erred and accidentally sprayed licit crops, compensation

is paid to the farmer for the loss of the crop, based on current market value of the crop

Field verification is extremely dangerous and resource intensive; and it is a slow-moving process. Because of the
high risks involved for the Embassy personnel, agronomists, lawyers, DNE representatives, CNP officials, and

ombudsman s�representatives who accompany on site visits, the primacy of security will dictate the pace of

investigations in the future. Although logistical considerations (security concerns, personnel availability, and

helicopter resources) are part of the reason why complaints cannot be resolved in the field more quickly, the
greatest logjam in this system is the number of false complaints which handicap the ability of field investigators

to close cases more quickly. During 2004 site investigations, some farmers related stories of armed narco-

terrorist groups forcing them to damage their own crops and falsifying complaints in order to publicly denounce

the aerial eradication program.

False complaints -- cases in which growers complained that their legitimate crops were sprayed, but

investigators who reached the fields in question found them to be coca or legitimate crops interspersed with coca

-- waste resources that otherwise might be used in the service of the farmers who really deserve compensation.

To date, less than half of one percent of the cases that have been visited by complaint verification teams has
merited compensation. Nevertheless, Embassy Bog�t has taken steps to make sure that the overall complaint

resolution is swifter and continues to pursue rapid field verifications when security, weather, and logistical

considerations in individual cases permit.

The Colombian Ministry of Justice has refined the claims procedures, seeking to streamline the process and to
deter fraudulent claims. These procedures will include a warning that a complainant found to have coca growingAnnex 53-C

promotes forest policy reforms and improved production, processing and marketing of forest and wood products
to increase incomes. The program also oper�tes in A�lvar, Caldas, Casanare, Ca�ca, C sar,

C� rdoba, Guajira, Huila, Magdale�a, Nari�oo, Risaralda, Santander, Sucre, Tolima, and Valle del

Cauca.

The $23 million Colombia Forestry Development Program (CFDP), funded directly by USAID and implemented by

Chemonics, has a nucleus in Northeastern Antioquia where it is focusing on promoting pine plantations and

efficient industrial processing models. It has another nucleus along the Atrato River and Uraba region that

provides assistance to natural forests, agro forestry schemes, plantations and the Familias Guardabosques
nucleus in Turbo and Necocli. The estimated CFDP investment in Antioquia over the life of the project totals

$6,050,000. A portion of this assistance directly benefits indigenous communities in Mutata and Chigorodo.

USAID� s $12 million Colombia Enterprise Development (CED) project supports small and medium enterprise
development in secondary cities. CED is also operating in Atl ntico, Caldas, Quind o, Risaralda, Santander,
� �
Valle del Cauca, and Tolima.

The Colombian Governm�nt s Investment Fund for Peace (FIP), a $19.4 million investment, is generating

employment through infrastructures, licit crop production (coffee rehabilitation, agro forestry), skills training, and
education/nutrition aid to poor families.

Bolivar

The aforementioned CFDP, financed by USAID, has a nucleus along Magdalena River focusing mainly on
plantations such as Eucalyptus. CFDP investment in the nucleus totals approximately $2 million, of which an

estimated $1 million will go to Bolivar.

USAID� s alternative development program carried out by PADF is supporting short cycle production activities to
address immediate income and employment requirements; longer-term crops such as natural rubber and cacao

to provide sustainability; and complementary productive infrastructure. The project supports 2450 hectares of licit

crops benefiting 661 families.

ARD/CAPP is also promoting private sector involvement with farmers to porduce cacao, African palm, and yucca
(cassava).

The GOCis active in Bolivar supporting licit production activities such as palm oil and cassava production.

Caquet�

USAID� s centerpiece Colombia Alternative Development (CAD), implemented by Chemonics, is a $97.3 million

project fostering short-term crop production for food security and long-term income generation activities such as

rubber production. Similar activities are in operation in Cauca, Norte de Santander, Tolima and Putumayo.

USAID funds a $1.8 million Sustainable Development for Indigenous Colombian Communities project,

implemented by the Amazon Conservation Team (ACT) to assist Colombian indigenous communities in food

security, health, local governance, and land management. Activities under this program are also being carried

out in the departments of Putumayo a�d Vaup s. The GOC is also supporting institutional strengthening for
small-scale brown sugar producers and life plans (planes de vida) for indigenous communities.

Cauca

USAID s CAD activities support small-scale irrigation for the production and marketing of short-season, high-

value crops and value-added processing of wood products from tree plantations in indigenous areas.

The CFDP invested approximately $100,000 in natural forest management in the mu�icipality of Guapi Cauca

to benefit Afro-Colombian communities.

USAID Alternative Development activities also include a $9.8 million project, implemented by ACDI/VOCA, which

promotes specialty coffee production, processing and mark�ting in Cauca s illicit crop growing areas.

The CAPP project is supporting private sector investments in hot peppers, jute, and cacao.

The Aid to Artisans project is enhancing local capacity for production and marketing of crafts as licit income

generating alternatives.

The GOC is supporting fruit production and complementary activities for the coffee renewal program.

Caldas

492promotes forest policy reforms and improved production, processing and marketing of forest and wood products
to increase incomes. The program also opera�es in At� var, Caldas, Casanare, Cau�a, C sar,

C� rdoba, Guajira, Huila, Magdale�a, Nari �o, Risaralda, Santander, Sucre, Tolima, and Valle del

Cauca.

The $23 million Colombia Forestry Development Program (CFDP), funded directly by USAID and implemented by
Chemonics, has a nucleus in Northeastern Antioquia where it is focusing on promoting pine plantations and

efficient industrial processing models. It has another nucleus along the Atrato River and Uraba region that

provides assistance to natural forests, agro forestry schemes, plantations and the Familias Guardabosques

nucleus in Turbo and Necocli. The estimated CFDP investment in Antioquia over the life of the project totals
$6,050,000. A portion of this assistance directly benefits indigenous communities in Mutata and Chigorodo.

USAID� s $12 million Colombia Enterprise Development (CED) project supports small and medium enterprise

development in secondary cities. CED is also ope�ating in Atl ntic�, Caldas, Quind o, Risaralda, Santander,
Valle del Cauca, and Tolima.

The Colombian Governme�t s Investment Fund for Peace (FIP), a $19.4 million investment, is generating

employment through infrastructures, licit crop production (coffee rehabilitation, agro forestry), skills training, and

education/nutrition aid to poor families.

Bolivar

The aforementioned CFDP, financed by USAID, has a nucleus along Magdalena River focusing mainly on

plantations such as Eucalyptus. CFDP investment in the nucleus totals approximately $2 million, of which an
estimated $1 million will go to Bolivar.

USAID� s alternative development program carried out by PADF is supporting short cycle production activities to

address immediate income and employment requirements; longer-term crops such as natural rubber and cacao

to provide sustainability; and complementary productive infrastructure. The project supports 2450 hectares of licit
crops benefiting 661 families.

ARD/CAPP is also promoting private sector involvement with farmers to porduce cacao, African palm, and yucca

(cassava).

The GOCis active in Bolivar supporting licit production activities such as palm oil and cassava production.

Caquet�

USAID� s centerpiece Colombia Alternative Development (CAD), implemented by Chemonics, is a $97.3 million
project fostering short-term crop production for food security and long-term income generation activities such as

rubber production. Similar activities are in operation in Cauca, Norte de Santander, Tolima and Putumayo.

USAID funds a $1.8 million Sustainable Development for Indigenous Colombian Communities project,

implemented by the Amazon Conservation Team (ACT) to assist Colombian indigenous communities in food
security, health, local governance, and land management. Activities under this program are also being carried

out in the departments of Putumayo a�d Vaup s. The GOC is also supporting institutional strengthening for

small-scale brown sugar producers and life plans (planes de vida) for indigenous communities.

Cauca

USAID� s CAD activities support small-scale irrigation for the production and marketing of short-season, high-

value crops and value-added processing of wood products from tree plantations in indigenous areas.

The CFDP invested approximately $100,000 in natural forest management in the muni�ipality of Guapi Cauca
to benefit Afro-Colombian communities.

USAID Alternative Development activities also include a $9.8 million project, implemented by ACDI/VOCA, which

promotes specialty coffee production, processing and marke�ing in Cauca s illicit crop growing areas.

The CAPP project is supporting private sector investments in hot peppers, jute, and cacao.

The Aid to Artisans project is enhancing local capacity for production and marketing of crafts as licit income

generating alternatives.

The GOC is supporting fruit production and complementary activities for the coffee renewal program.

CaldasAnnex 53-C

agro forestry totaling $1.8 million. The project is financed by USAID and is scheduled to begin in December

2004, pending environmental assessment of activities.

The USAID Dairy Promotion program is promoting sustainable small farm dairy production, processing and
marketing, while the CAPPprogram is supporting small farmer, private sector projects in cacao and African palm

production.

Aid to Artisans project is carrying out activities to promote the production and marketing�of crafts in Nari o.

The CFDP will be supporting forest policy changes and carrying out activities for the improved production,
processing and marketing of forest and wood products �n Nari o, as well as in Anti�quia, Choc , and

Magdalena.

The GOCis supporting activities in coffee renewal and oil palm production.

Norte de Santander

The CAPP program is supporting private sector initiatives with small farmers in the production and processing of

African palm and Cacao.
The CAD project is promoting cacao and African palm production, processing, and marketing.

The USAID alternative development activities implemented through PAFD are working in association with

ASOHESAN (the Santa nder rubber produc�r s association) to support the cultivation of 1,652 hectares of

rubber that would benefit 411 families. The project includes as well the establishment of 826 hectares of short-
term crops and 137 food securitysystems (vegetable gardens, small animal husbandry).

The GOCis supporting palm oil crop production in the department.

Putumayo

The CAD project is supporting activities in Putumayo for short and medium-term crop production with farmers

and indigenous groups, hearts of palm production, processing and marketing; rubber production, processing and

marketing; forest management and value added processing and utilization of forest and wood products;
infrastructure projects, including bridge construction and road improvements, schools, and health facilities. As

part of the development of production and marketing chains, support is being provided for the private sector

involvement in processing plants and marketing for cassava chips, black pepper and plantain; tropical flowers
and foliage, vanilla production, as well as for medicinal plants and essential oils.

U.S. Army Corps of Enginee�s$6.7 million rural infrastructure project, funded by USAID, is carrying out road,

sewage and water treatment activities that are generating new employment in the region.

The Sustainable Development for Indigenous Colombian Communities project, implemented by the Amazon
Conservation Team, is supporting indigenous communities with improved food security, health, local governance,

and land management.

Santander

The GOCis supporting cocoa and oil palm production in this department.

The CAPP is s upporting private sector initiatives with small farmers in the production of cacao and African palm.

Tolima

The CAD project is supporting an activity to increase annual crop production for food security and to increase

income and employment generation in the longer term through forestry, livestock and cold climate fruit

production.

The Specialty Coffee activity is promoting specialty coffee production, processing and marketing in illicit crop

growing areas of Tolima.

The Colombia Enterprise Development (CED) project, funded by USAID and implemented by CARANA
Corporation,is supporting small and medium enterprise development in Colombia s secondary cities including

those in Tolima.

The Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the

department, while the ARD/CAPP is supporting private sector projects in fruits, natural rubber and cacao
production.

The GOCis supporting cacao and coffee activities.

494agro forestry totaling $1.8 million. The project is financed by USAID and is scheduled to begin in December

2004, pending environmental assessment of activities. Vaupes

The USAID Dairy Promotion program is promoting sustainable small farm dairy production, processing and The Sustainable Development for Indigenous Colombian Communities project is supporting traditional healers

marketing, while the CAPPprogram is supporting small farmer, private sector projects in cacao and African palm and helping to strengthen indigenous community organizations that are also involved in managing indigenous
production.
lands.

Aid to Artisans project is carrying out activities to promote the production and marketing of�crafts in Nari o.
Vichada

The CFDP will be supporting forest policy changes and carrying out activities for the improved production,
The GOCis providing institutional strengthening to indigenous community associations.
processing and marketing of forest and wood products in�Nari o, as well as in Antioqu�a, Choc , and
Magdalena.
The preceding six sections combined with the detailed attachments form the basis of the Justification for the

The GOCis supporting activities in coffee renewal and oil palm production. Secretary of State s 2004 Certification of Conditions Related to the Aerial Eradication of Illicit Coca and Opium

Poppy in Colombia.

Norte de Santander
Attachments
The CAPP program is supporting private sector initiatives with small farmers in the production and processing of
1. SecretaryPowell's September 27, 2004 Letter to EPAAdministrator Leavitt
African palm and Cacao.

The CAD project is promoting cacao and African palm production, processing, and marketing.
2. 2004 Department of State Report to EPA on Human Health and Environmental Monitoring Related to the
The USAID alternative development activities implemented through PAFD are working in association with Colombian Illicit Crop Eradication Program

ASOHESAN (the Santa nder rubber producer�s association) to support the cultivation of 1,652 hectares of

rubber that would benefit 411 families. The project includes as well the establishment of 826 hectares of short- 3. Letter and Consultation Report from EPA Administrator Leavitt

term crops and 137 food securitysystems (vegetable gardens, small animal husbandry).
4. Letter from Colombian Alternative Development Agency (PDA) Thanking the Embassy for its Rapid Attention to
The GOCis supporting palm oil crop production in the department.
a Human Health Complaint

Putumayo
5. Government of Colombia (GOC) Ruling No. 707 that States that the Illicit Crop Eradication Program is being
Conducted in Compliance with the GOC Environmental Management Plan (EMP)
The CAD project is supporting activities in Putumayo for short and medium-term crop production with farmers
and indigenous groups, hearts of palm production, processing and marketing; rubber production, processing and

marketing; forest management and value added processing and utilization of forest and wood products; 6. EPA letter confirming that information in the EMP is generally in agreement with information provided to EPA

infrastructure projects, including bridge construction and road improvements, schools, and health facilities. As for the previous consultations

part of the development of production and marketing chains, support is being provided for the private sector
involvement in processing plants and marketing for cassava chips, black pepper and plantain; tropical flowers

and foliage, vanilla production, as well as for medicinal plants and essential oils. Back to Top

U.S. Army Corps of Engineer� $6.7 million rural infrastructure project, funded by USAID, is carrying out road,
sewage and water treatment activities that are generating new employment in the region.

The Sustainable Development for Indigenous Colombian Communities project, implemented by the Amazon

Conservation Team, is supporting indigenous communities with improved food security, health, local governance,

and land management.

Santander

The GOCis supporting cocoa and oil palm production in this department.

The CAPP is s upporting private sector initiatives with small farmers in the production of cacao and African palm.

Tolima

The CAD project is supporting an activity to increase annual crop production for food security and to increase

income and employment generation in the longer term through forestry, livestock and cold climate fruit
production.

The Specialty Coffee activity is promoting specialty coffee production, processing and marketing in illicit crop

growing areas of Tolima.

The Colombia Enterprise Development (CED) project, funded by USAID and implemented by CARANA
Corporation,is supporting small and medium enterprise development in Col�mbia s secondary cities including

those in Tolima.

The Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the

department, while the ARD/CAPP is supporting private sector projects in fruits, natural rubber and cacao
production.

The GOCis supporting cacao and coffee activities.Annex 53-C

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2004 » Secretary Pow ell's Letter to EPA
Administrator Leavitt

Secretary Powell's Letter to EPA Administrator Leavitt

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BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC

September 27, 2004

Dear Mr. Leavitt:

I am writing to seek your assistance in preparing a certification required by the Consolidated Appropriations Act,

2004 (H.R.2673). The certification must be submitted to Congress before the Department of State can obligate a
portion of its FY 2004 funds for aerial eradication programs in Colombia.

Specifically, the Act states that the Secretary of State, in consultation with the Administrator of the

Environmental Protection Agency (EPA), must certify to the Committees on Appropriations that: "(1) the
herbicide mixture is being used in accordance withEPA label requirements for comparable use in the United

States and any additional controls recommended by the EPA for this program, and with the Colombian

Environmental Management Plan for aerial fumigation; and (2) the herbicide mixture, in the manner it is being

used, does not pose unreasonable risks or adverse effects to humans or the environment." I have enclosed the
relevant excerpt from the Consolidated Appropriations Act, 2004.

The Department of State�s Bureau of International Narcotics and Law Enforcement Affairs (INL) consults

regularly with EPA�s Office of Pesticide Programs to seek guidance on issues related to the chemicals applied
in the U.S.-supported aerial eradication program in Colombia. INL has provided Office of Pesticide Programs

personnel with comprehensive information about the methods used to apply these chemicals in Colombia to

eradicate coca and opium poppy. I have enclosed further information on human health and environmental

monitoring related to the U.S.-supported coca eradication program in Colombia to supplement information
provided to EPA in 2002 and 2003 during similar consultations.

Accordingly, I ask that you provide the Department of State with a written response to confirm that the

Department of State and the EPA have consulted concerning the U.S.-supported aerial coca eradication program
in Colombia. I also ask that you confirm that the herbicide mixture employed by the U.S.-supported program of

aerial eradication of coca and opium poppy in Colombia is being used in accordance withEPA label

requirements for comparable use in the United States and any additional controls recommended by theEPA for

this program; as well as with the Colombian Environmental Management Plan for aerial fumigation. Finally, I ask
that you confirm that this herbicide mixture, in the manner it is being used, does not pose unreasonablesriks to

or have adverse effects upon humans or the environment. I plan to submit your response as part of the

certification that the Consolidated Appropriations Act, 2004 requires me to submit to Congress, and would
appreciate your response on or before November 1, 2004.

INL Assistant Secretary Robert Charles and his staff stand ready to provide any further briefings you or other

concernedEPA personnel may need. Thank you for your assistance with this vital program to reduce the supply

of dangerous drugs into the United States.

Sincerely,

Colin L. Powell

Enclosures:

As stated.

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External linksto other Internet sitesshould not be construed asan endorsement of the viewsor privacrein.iciescontained the

496Back to Top

The Office of Electronic Information, Bureau of Public Affairs, managesthissite asa portal for information from the U.S. State Department.
External linksto other Internet sitesshould not be construed asan endorsement of the viewsor privarein.liciescontained theAnnex 53-C

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

DETAILS OF THE 2004 CONSULTATION FOR THE DEPARTMENT OF STATE

USE OF A HERBICIDE FOR COCA AND POPPY ERADICATION PROGRAM IN COLOMBIA
OCTOBER 2004

EXECUTIVE SUMMARY

CONSULTATION REVIEW OF THE USE OF A HERBICIDE FOR COCA AND POPPY ERADICATION IN

COLOMBIA, 2004

The Department of State (DoS) assists the Government of Colombia with training, contractor support, financial

assistance, and technical and scientific advice for aerial pesticide spraying activities designed to eradicate the

illicit crops coca and poppy in Colombia. The U.S. Environmental Protection AgencyE(PA) has completed an
assessment at the request of DoS, on whether the herbicide mixture, in the manner it is being used in Colombia

for coca and poppy eradication, does not pose unreasonable risks or adverse effects to human health or the

environment. The Agency has reviewed information provided to us by the DoS to confirm that the herbicide

mixture is being used according to EPA l bel requirements for comparable use in the United States, any
additional controls recommended byEPA for this program, and with the Colombian Environmental Management

Plan for aerial fumigation.

EPA concludes from its assessment of the submittedand available information on the spray program and the
herbicide glyphosate that there does not appear to be any evidence that glyphosate aerial spraying of coca or

poppy has resulted in any adverse human health effects among the population where this spraying occurs in

Colombia. There have been no substantive changes to the eradication program's method of aerial glyphosate

application or the spray formulation. Although the measured toxicity and estimated exposure indicate that only
nontarget terrestrial plants are likely to be adversely affected by the use on coca and poppy, important

uncertainties should be considered. The Agency findings from 2002 and 2003 remain relevant to the current coca

and poppy eradication activities in Colombia. The DoS and the Government of Colombia made modifications and

enhancements to the spray program asEPA recomm ended in its prior assessments. This is an interim finding
that may change as new information becomes available and followup is performed. Details of EPA findings are

provided in the attached document.

I. BACKGROUND

The Department of State (DoS) assists the Government of Colombia with training, contractor support, financial

assistance, and technical and scientific advice for an aerial pesticide spraying program designed to eradicate the

illicit crops coca and poppy. The eradication program includes the use of a spray mixture of a glyphosate

formulation, an adjuvant (Cosmo-Flux 411F), and water. The glyphosate tank mixture is applied aerially as a
foliar application in certain provinces of Colombia. As required by the Consolidated Appropriations Act, 2004

(H.R.2673), DoS has consulted with the U.S. Environmental Protection AgencyE(PA) to ensure that the

herbicide mixture, in the manner it is being used, does not pose unreasonable risks or adverse effects to human
health or the environment. As part of this effort,EPA has previously reviewed DoS eradication spray program

activities in 2002 and 2003. This review updates and comments on the progress of the Colombian government to

evaluate the effects of the glyphosate spray program on human health and the environment in areas where it has

been used to eradicate illicit crops, as requested by DoS, in a letter dated September 27, 2004.

II. SUMMARY OF PREVIOUS ASSESSMENTS

In 2002, EPA reviewed the coca eradication program in Colombia and concluded that there was no evidence of

significant human health or environmental risks from the spraying. EPA did recommend that DoS switch to a

herbicide product with lower toxicity due to a potential hazard to the eyes of pesticide mixers/l. PA also
asked DoS to conduct field investigations of health complaints associated with coca eradication. The Agency

further concluded that spray drift was likely to cause phytotoxicity downwind of sprayed coca fields. The Agency

reached its conclusions from a thorough review and assessment of the available scientific studies on glyphosate
and glyphosate-containing formulated products and their use in the United States and in conjunction with

information on the spray program in Colombia. The final conclusion was that EPA could not verify the porduct

formulation because the product was manufactured outside the United States and not registered by tEPA.

In 2003, DoS adoptedEPA's recomm endation and began using a lower-toxicity glyphosate product in its coca
and poppy eradication programs, and implemented a program to investigate health complaints. Based on a

comparison of the glyphosate use pattern in Colombia and approved use patterns of glyphosate products in the

United States, EPA determined thatapplication rates for both coca and poppy eradication in Colombia were
within the parameters listed on U.S. labels. The Agency could not verify the quality of the product since it is

formulated outside of the United States, but a review of toxicity testing on the spray mixture solution did not

498 Annex 53-C

uncover any irregularities.

EPA concluded in 2003 that there were no risks of concern from dietary exposures or from exposures to

mixer/loader/applicators or field workers, including bystanders. The concerns for mixer/loader eye irritation

discussed in EPA's 2002 review were mitigated in 2003 by switching to a lower-toxicity glyphosate product

registered by both EPA and the Government of Colombia.

The DoS and the Government of Colombia initiated two programs to investigate health complaints. Regarding

potential environmental effects from the eradication programs, EPA concluded that the switch to a lower-toxicity

product would present less risk of acute poisoning to wildlife, while potential phytotoxicity due to spray drift could
still be a factor in both coca and poppy spraying.EPA recomm ended that DoS continue programs for

investigating health complaints, and the Agency also asked DoS to develop a case definition for what would

constitute a glyphosate-related adverse effects exposure, provide further documentation of its investigations and

how they are conducted, and standardize data collection.

In February 2004, in response to a request from DoS,EPA reviewed the Environmental Management Plan for the

Illicit Crop Eradication Program in Colombia (EMP). DoS asked EPA to assess whether use of the herbicide

mixture in Colombia is in accordance with the EMP. The Plan described general descriptions of many activities

related to the spray program including references to Colombian laws that were to be followed. EPA conculded
that the Plan contained appropriate types of activities for a pesticide spray program. These activities include

spray application requirements and restrictions, training and safety precautions for personnel who handle and

apply the pesticide, handling of waste resulting from program operations, training public health workers to
recognize and treat pesticide poisoning, handling of health and environmental complaints, environmental

monitoring, and contingency plans for emergencies.EPA recognized that these types of activities were

appropriate for pesticide spray programs and generally reflect similar activities that can be included on pesticide

spray programs in the United States, depending on the specific pesticide, use conditions, known potentialsrki s,
and federal, state, or local laws.

EPA offered comments on two specific sections of the EMP. First, the Agency urged DoS to investigate

methods for properly disposing of pesticide containers rather than reusing them. The second comment was
regarding the statement in the EMP that there were no significant impacts to plants that surrounded the illicit

crops being sprayed. EPA reiterated its position previously stated in the consultations - that glpyhosate is highly

toxic to many plants and that some level of adverse effects is likely to occur to some nontarget plants as a result
of spray drift, as can be expected with herbicide applications. The Agency suggested an appropriate revision of

the wording in the EMP.

III. ASSESSMENT OF THE AERIAL SPRAY PROGRAM IN2004

In a letter dated September 27, 2004, to Michael O. Leavtit, Administrator of EPA, the Secretary of State

formally asked EPA for a written response to confirm that the DoS andEPA have consulted concerning the U.S.-

supported coca and poppy eradication program in Colombia. The Secretary askedEPA help certify that the
herbicide mixture is being used in accordance withEPA label requirements for comparable use in the United

States, any additional controls recommended byEPA for this program, and the Colombian Environmental

Management Plan for aerial fumigation. The Secretary also askedEPA to confirm that the herbicide mixture, in

the manner it is being used, does not pose unreasonable risks or adverse effects to humans or the environment.

EPA has reviewed the following reports, enclosed with the above letter, pertaining to humanhealth and the

environment:

1. Evaluation of the Effects of Glyphosate on Human Health in Illicit Crop Eradication Program Influence

Zones. Bogota, July 2003, National Health Institute.
2. Progress Report on the Illicit Crop Eradication Program Through Glyphosate Spraying (PECIG)

Environmental Management Plan by the National Institute of Health.

3. Survey to Evaluate the Effects of Glyphosate and Other Pesticides on Human Health in PECIG Influence
Zones.

4. A presentation entitled "Evaluation of the Effects of Glyphosate on Human Health in Areas of Influence of

the Illicit Crop Eradication Program (PECIG)" prepared by the Ministry of Social Protection and the National

Institute of Health.
5. Toxicologist's report on the investigation of the case of the death of a person exposed to spraying using a

glyphosate mixture, "Report on Issues Related to the Aerial Eradication of Illicit Coca in Colombia" by J. H.

B. Tobon, M.D., July 4, 2003.

6. Minister of the Environment, Housing and Regional Development Ruling No. 707, containing an evaluation of
compliance with the measures established in each of the specifications which make up the Environmental

499Annex 53-C

Management Plan, Bogota, July 26, 2004.

7. Interagency Soil and Water Sampling Field Study Report: Glyphosate Persistence in and Effects on the

Soil and Bodies of Water.
8. Soil and Water Sampling Protocols and Excel Spreadsheets of the Soil and Water Residue Sampling

Results.

9. July 23, 2004, Technical Opinion tram the Republic of Colombia Ministry of the Environment, Housing and

Regional Development evaluating the program's compliance with management measures established in the
Environmental Management Plan.

10. Glyphosate (10.4 L/HA) and Three Adjuvants, for the Control of Illicit Coca Crops, Erythoxium spp.:

Agronomic Efficacy Testing of Doses of Glyphosate in Illicit Crops, Bogota, July 2004.

A. REVIEW OF HUMAN HEALTH RISK

Evaluation of the Effects of Glyphosate on Human Health in Illicit Crop Eradication Program Influence Zones.

Bogota, July 2003, National Health Institute.

This document provides the protocol for conducting a descriptive case study to determine if there are any human

health risks associated with spraying glyphosate. The authors note that according to reports, glyphosate, along

with paraquat and 2,4-D, are widely used herbicides on land where coca crops are grown. An estimated 61

percent of the use on the land is due to paraquat and about 19 percent of the use is due to glyphosate
application by coca growers. Fungicides and insecticides also figure prominently in the cultivation of coca. Given

this widespread use of pesticides and exposures to other chemicals, there may be some health effects that

could be difficult to differentiate as to cause. The lack of technical knowledge by growers and surrounding
farmers is an important barrier to distinguishing the effects of aerial spraying from those of other pesticides.

The study protocol identifies the specific areas to be studied based on the prevalence of spraying for eradication

in those areas. Case definitions for suspected and probable cases are defined for individuals who seek health
care based on symptoms and signs of poisoning. A questionnaire was developed that evaluates signs and

symptoms, medical history, the person's exposure to pesticides and use of protective equipment, and types of

pesticides used. Biological monitoring was developed to assess exposure to glyphosate, organochlorines, and

cholinesterase-inhibiting insecticides. Procedures for collecting biological samples are clearly described. An
integral part of the study was a training course on diagnosis of pesticide intoxication for health professionals

residing in the area under study.

The protocol requires that "all subjects with a history of exposure to pesticides who have signs and symptoms

compatible with acute intoxication will be reported to the National Public Health Control System (SIVIGILA) using

the individual notification form." Duties for different individuals participating in collecting and monitoring the study

progress are specified. An Epi-Info program will be used to capture the information collected and to perform
analysis. Inclusion and exclusion criteria are specified to determine which individuals will be included in the final

analysis.

Progress Report on the Illicit Crop Eradication Program Through Glyphosate Spraying (PECIG) Environmental
Management Plan by the National Institute of Health.

The National Health Institute of Colombia acknowledged that there had been under-reporting and low coverage of
pesticide poisonings in the past. Four territories where spraying is most active were targeted for training of health

teams. A total of 284 environmental health professionals, technicians, and rural health providers received training

in recognition and reporting of pesticide poisoning between September 2003 and January 2004. An active search

for cases identified 39 possible cases of glyphosate intoxication from May to July 2004. Another four possible
cases were reported to the health units. Samples have been taken to determine the presence of glyphosate, its

metabolite, and other pesticides in urine. Telephone followup has been performed, and field investigations are

being considered to identify additional cases that may be occurring after spraying. An additional seven training

sessions are planned in the targeted areas.

Limitations in reporting and following up cases involving glyphosate are recognized and acknowledged in the

report by the National Institute of Health. These include:

repeated changes in weather conditions and spray schedules, which make planning and followup difficult;
trained health personnel are often transferred or leave the agency;

the community is reluctant to participate in the study and some have expressed concern that legal crops

have been affected by the glyphosate spraying activities;

the population is dispersed and difficult to access by telephone or other means; and

500 Annex 53-C

extreme weather conditions limit the research teams' mobility.

Survey to Evaluate the Effects of Glyphosate and Other Pesticides on Human Health in Pecig Influence Zones.

The survey form used to capture information in a standardized format includes sections for general data, patient's

data, medical exam data, characterization of exposure, occupational history, social background, attitude
towards the ICEPG, medical chart, and laboratory results. The questionnaire is fully responsive to the earlier

recommendations by EPA to "standardized collection of data on patients and their symptoms."

A presentation entitled "Evaluation of the Effects of Glyphosate on Human Health in Areas of Influence of the
Illicit Crop Eradication Program (PECIG)"

This presentation provides specific objectives for monitoring potential adverse effects of aerial glyphosate

application. Cases may be reported by persons consulting the Institute of Health directly, by an active search for

cases by the environmental health professionals and rural health providers, and by reporting from community
leaders and municipal ombudsmen. The presentation provides specific case definitions for a suspect, probable,

and confirmed case. It also advises on key procedures to follow to obtain biological specimens for determination

of glyphosate and its metabolite in urine. This presentation is appropriately targeted to identifying health effects

due to pesticides.

Toxicologist's report on the investigation of the case of the death of a person exposed to spraying using a

glyphosate mixture. "Report on Issues Related to the Aerial Eradication of Illict oca in Colombia" by J. H. B.

Tobon. M.D.. July 4.2003

This report describes the followup on a reported fatality associated with exposure to glyphosate application for

coca eradication. Information collected from the initial clinical files reported intense headaches, vomiting, fever,

and progressive deterioration of consciousness. The victim's spouse reported that the symptoms described

started ten days after the coca field where he had been working was sprayed. When hospitalized this patient
exhibited additional signs and symptoms of hypersecretion of saliva, contracted pupils, paleness, difficulty

breathing, excessive pulmonary secretions, profound depression of consciousness, and no response to stimuli.

Despite treatment, which included atropine for suspected organophosphate insecticide poisoning, the patient

died two hours later. Another physician reported that the patient had renal failure and his symptoms were
consistent with central nervous system infection or intoxication due to ogranophosphate or carbamate

insecticide. Dr. Tobon concluded that the signs "greatly suggest intoxication of a cholinesterase-inhibitor

chemical substance" and that "we are certain that the death cannot be attributed to exposure to glyphosate."
The Agency agrees with these findings based on the known toxicity of glyphosate as compared to other

pesticides.

Ministry of the Environment, Housing and Regional Development report on Ruling number 707 which includes a
public health program (specification number 7)

Consistent with the reports above, the public health program was designed "to develop risk management
measures for preventing, mitigating, correcting and offsetting effects on health which could be associated with

aerial spraying of glyphosate in areas where PECIG operates." The report notes an initial budget for this activity

of around 200 million pesos (about $80,000 in U.S. dollars). As reported above, 284 members of health teams in

the four targeted provinces "have received training in diagnosing, managing, preventing and supervising poisoning
caused by herbicides and in the research project execution methodology." The report submitted by the National

Health Institute found only three suspicious cases that have been reported since September 2003. An

international agreement is being put in place to permit analysis of samples, so that it can be established whether

glyphosate or other pesticides are present at levels that might be harmful to public health.

Comments on the Reports on Human Health

The reports submitted by DoS make clear that an aggressive program to identify glyphosate poisoning has been

implemented in the areas of Colombia where illicit crop eradication spraying programs are prevalent. A significant

number of health care providers have received training and additional training is under way or planned. PA had

earlier recommended case definitions and standardized collection of data. The submitted test protocol meets
those objectives. Trainees received specific information on being alert for digestive, dermal, ocular, and

respiratory symptoms. This is a comprehensive and appropriate approach for detecting ill effects of glyphosate.

The use of biological monitoring to further confirm exposure will help eliminate numerous cases of illness that are

likely to occur coincidently to aerial spraying, but are not, in fact, caused by the exposure to glyphosate.
Although there have been reports (about 43 in 2004), the majority were classified as possible or suspicious.

There were no cases classified as probable or confirmed, though a confirmed case would require verification from

501Annex 53-C

laboratory samples which, apparently, have not yet been processed or may not be available yet.

Despite an aggressive search for cases, there does not appear to be any evidence that glyphosate aerial

spraying has resulted in any adverse health effects among the population where this spraying takes place. This
is an interim finding that may change as new information becomes available and follow-up is performed. Since

efforts to obtain and gather such information are under way, one should be cautious and not over-interpret these

preliminary findings.

EPA also offers the following suggestions for the data collection form:

General Data : Record date and contact information about the health care provider (who fills out the form) in

case followup consultation is needed.

Characterization of the Exposure : Record more information about the location of exposure and any

description about the proximity to the spraying (how far away) or amount of exposure (e.g., amount of skin
exposed, eyes exposed, etc.).

EPA found the distinction between the suspect and probable case definitions somewhat difficult to follow. The

Agency suggests measuring the length of time between last exposure and effects and giving greater weight to
those effects that appear within 24 hours, when glyphosate effects would normally be expected.

The Agency provides these suggestions to assist the Colombian National Institute of Health in the efficient

analysis of information that comes as a result of its investigations. The Colombian Ministry of Social Protection

and the National Institute of Health are to be commended for their responsive and aggressive approach to
assessing the public health concerns associated with the use of pesticides. The Colombian agencies' scientific

protocol for identifying potential effects of glyphosate shows great care. Their approach is scientifically sound

and responsive to previous comments provided byEPA.

B. REVIEW OF ECOLOGICAL RISK

In 2002, EPA prepared an ecological risk assessment of the coca eradication program in Colombia. EPA

determined that spray drift was likely to cause phytotoxicity downwind of coca fields. The Agency was asked to

consider the opium poppy eradication program in 2003. As with coca eradication, the use of glyphosate for
opium poppy eradication is done aerially. Based on information provided by the DoS regarding poppy eradication,

the total area sprayed is less than for coca eradication, individual poppy sites are smaller and located at higher

elevations, and the rate of glyphosate application for poppy eradication is lower than that for coca. Application

rates for both coca and poppy eradication in Colombia are within the parameters listed on labels of glyphosate
products registered byEPA for use in the United States. Based on the results of the opiumpoppy eradication

assessment, EPA concluded that the potential for spray drift phytotoxicity conntiues to be a factor for coca

spraying. Spray drift and potential effects down wind of the target sites are common, universal factors in most if
not all pesticide applications from aerial or ground applications for all uses. In the United States, EPA

considered estimates of spray drift in its risk assessments of pesticide uses and registration decisions.

In addition to the documents submitted with the September 27, 2004, request, the DoS also indicated that there

have been no substantive changes to the eradication program's method of aerial glyphosate application or the
spray formulation. Based on a review of the submitted documents and current information indicating no changes

to the program's application methods, the Agency findings from 2002 and 2003 remain relevant to the current

coca and poppy eradication activities in Colombia. A review of the submitted information as it pertains to the

results of previous ecological assessments is provided below.

Soil and Water Residue Analysis

Interagency Soil and Water Sampling Field Study Report: Glyohosate Persistence in and Effects on the Soil and

Bodies of Water

Soil and Water Sampling Protocols and Excel Spreadsheets of the Soil and Water Residue Sampling Results

During November and December of 2003, a Government of Colombia interagency team collected and analyzed

soil and water samples to determine the persistence of glyphosate and its principal metabolite - amino-methyl

phosphonic acid (AMPA) - in Colombian soils and water following aerial application to illicit coca crops. A review
of the methods used to analyze the soil and water samples indicates that they are typical analytical chemistry

methods and recognized byEPA as acceptable to characterize glyphosate and AMPA in soil and water.

The results of the soil sampling showed no statistically significant differences between residual levels of

glyphosate and AMP A in the pre- and post-spraying soils. It appears that similar levels of glyphosate and

AMPA in pre- and post-spray soils may be the result of interception of the herbicide by the foliage. The toxic

effect of glyphosate to post-emergent plants is a result of aerial application of glyphosate onto the foliage of

502 Annex 53-C

nontarget species (i.e., plants other than coca, and poppy). Therefore, the soil data cannot be used to refine

environmental exposure concentrations for plants. Glyphosate levels on the foliage are expected to be much

higher than those in soil, and toxic effects are due to application of the herbicide directly to the postemergent

foliage rather than to soil uptake. The fraction of glyphosate that reaches the soil is a result of precipitation that
washes the herbicide from the plant leaves and stems into the soil, and/or attempts by growers to wash the

plants after spraying to salvage their crops. In addition, it appears that detected concentrations of AMPA in the

pre-spraying soil may be due to glyphosate usage by growers to control weeds and undesirable plants that
compete with the coca crop.

Pre-spraying concentrations of glyphosate and AMPA in bodies of water contiguous to or near coca crop plants

were negligible (i.e., less than detection limits) from the four sample sites. Maximum concentrations of

glyphosate and AMPA in water following spraying activities were 397 ppb and 0.18 ppb, respectively.
Comparison of the glyphosate monitoring data with modeled concentrations used in theEPA's ecological

assessments for glyphosate applications in the U.S. shows that the modeled surface water concentration of 230

ppb is lower than the maximum detected concentration of 397 ppb. The Agency's modeled concentration is
based on direct application of 3.75 lb acid eq./acre of glyphosate to a 1-acre, 6-foot deep pon, PA's standard

for modeling pesticide residues in water bodies. Although glyphosate was detected in water adjacent to coca

crops at a higher concentration than predicted by the Agency's previous assessments, the maximum detected

concentration of 397 ppb is well below acute and chronic effects levels (ppm) for fish, aquatic invertebrates, and
aquatic plants, species used for estimating rsi ks to species in the U.S. Therefore, similar to the results of

previous Agency assessments, no risks are predicted for aquatic animals and plants, based on exposure to

residual glyphosate or AMPA in water bodies contiguous to or near coca crops.

Maximum concentrations of glyphosate measured in surface water as part of the monitoring program were 397
ppb. According to data presented in theInteragency Soil and Water Sampling Field Study Report(Section 3.2),

pre- and post-spray glyphosate surface water samples were collected from only four sites. At two of the four

sites, post-spray glyphosate was not detected (detection limits were not provided). At the other two sites, post-
spray glyphosate was detected at concentrations of 0.998 and 397 ppb. Therefore the results of the water

sampling are highly variable and the limited number of samples allows for only-qualitative comparison and not a

quantitative statistical analysis of the water monitoring data.

Using runoff simulations from Agency exposure models PRZM and EXAMS, the concentration that may result
from direct application of 3.75 lb acid eq/acre of glyphosate to a 1-acre, 6-foot deep pond is 230 ppb, as noted

above. The coca use application rate is 4.4 lb a.i./acre or 3.3 lb acid eq/acre; therefore, use of 3.75 lb acid

eq/acre in modeling is a conservative estimate of exposure. It is possible that greater levels of exposure could
occur from direct overspray of water bodies much smaller than a 1-acre, 6-foot deep pond, but such simulation is

not a standard component of Agency risk assessments. The product label for glyphosate prohibits such direct

overspray of water bodies, but it is possible that some water bodies too small or ephemeral to appear on maps

could be sprayed directly in a project as large as the coca eradication program. U.S. EPAapproved uses of
certain glyphosate products do permit application to aquatic areas for vegetation control; for these uses EPA

would expect glyphosate and AMPA residues in water.

Colombia Ministry Technical Opinion and Efficacy Testing

July 23, 2004, Technical Opinion from the Republic of Colombia Ministry of the Environment, Housing and
Regional Development evaluating the program's compliance with management measures established in the

Environmental Management Plan

Glyphosate (10.4 L/HA) and Three Adjuvants, for the Control of Illicit Coca Crops, Erythoxium spp.: Agronomic

Efficacy Testing of Doses of Glyohosate in Illicit Crops, July 2004

A Technical Opinion was issued by Colombia's Ministry of the Environment, Housing and Regional Development
on July 23, 2004. The purpose of the Technical Opinion was to evaluate the program's compliance with

management measures established in the Environmental Management Plan (EMP). The EMP was created by

the Ministry to prevent, mitigate, control, offset, and correct any possible negative environmental effects or

impacts which might result from eradicating illicit crops. Based on the evaluation, the Ministry concluded that the
entities responsible for executing the crop eradication program are currently complying with the measures

established in the EMP. A summary of the compliance evaluations for the spray operation management program

and environmental monitoring program is discussed below.

The Ministry's evaluation of the spray operation management program shows that technical parameters

established in the EMP relating to flight altitude, maximum spray mix discharge, application rate, spray drift

control measures, droplet size, temperature, and wind speed are being followed. Operations records indicate that

503Annex 53-C

spray missions are cancelled for unfavorable weather conditions that could affect application efficiency and/or

adherence to meeting safety and environmental standards. A review of the spray systems fitted to aircraft shows

that they operate normally, and routine maintenance and calibration of all spray systems are conducted.

Spraying efficacy verifications and collateral effect evaluations were completed in 2004. Coca plant death

effectiveness figures of more than 85 percent were observed from spraying activities in different areas.
Phytotoxicity to border plants from spray drift of the glyphosate spray mixture were observed on a random basis,

and were described as temporary in nature and small in extent. This is expected and is from the mode of toxicity

and degradation of glyphosate commonly demonstrated in the United States from glyphosate applications. Drift

effects included partial defoliation of the canopy of high trees. No other collateral damage from spraying activities
was observed at the selected sites. In spray areas that were subsequently abandoned, it was noted that

vegetation, including grasses and herbaceous species, was beginning to grow again. In the case of plots that

had been completely abandoned (i.e., with no evidence of human activity), advanced vegetative succession,
including the presence of balsa wood and secondary forest, was observed.

The results of the glyphosate soil and water samples were discussed as part of the environmental management

program evaluation. In addition, the evaluation included a discussion of a current study on the dynamics of
vegetative succession based on existing satellite images of sprayed areas. Satellite images showed a spectral

response of stubble grass and low stubble three months after spraying; at less than three years following

spraying, secondary forest appeared, indicating significant signs of recovery in the vegetative structure.

Although the measured toxicity and estimated exposure indicate that only nontarget terrestrial plants are likely

to be adversely affected by the use on coca and poppy, important uncertainties should be considered. One of

these is the extrapolation of North American data to the conditions and wildlife found in Colombia. The toxicity of
a pesticide to different classes of animals and plants can vary widely among species in an individual ecosystem.

The Agency uses for its hazard and risk assessments of pesticides used in the United States, test North

American species as surrogates for other North American species not tested, but has limited experience with
tropical flora and fauna. Similarly, laboratory and field estimates of the environmental fate of pesticides, including

potential surface-water contamination, are performed with North American soils, hydrology, and climate data.

Identifying characteristics that define sensitive tropical systems would most effectively reduce the uncertainty

of extrapolating North American exposure and effects data.

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Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2004 » EPA Letter to INL Regarding the
Spray Program's Compliance w ith the Government of Colombia's Environmental Management Plan for Illicit Crop Eradication

EPA Letter to INL Regarding the Spray Program's Compliance with the

Government of Colombia's Environmental Management Plan for Illicit Subscribe to Updates

Crop Eradication

Other Releases

BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS
Washington, DC

February 23, 2004

United States Environmental Protection Agency

Washington, DC

20460

Office of Prevention, Pesticides and Toxic Substances

February 23, 2004

Mr. Thomas H. Martin, Director

INL Latin American Programs
Department of State

2201 C Street, NW

Room 7811
Washington, DC 20520

Dear Mr. Martin:

This is a response to the Department of S�ate s (DoS) request that the Environmental Protection ( PA)y E
review the Environmental Management Plan for the Illicit Crop Eradication Program in Colombia (EMP).

Specifically, DoS asked EPA to assess whether use of the herbicide mixture in Colombia is in accordance with

the EMP, as included in the Foreign Operations, Export Financing, and Related Programs Appropriations Act,
2002, (P.L. 108-7). As you know, in 2002, EPA was asked to consult regarding potential health and

environmental effects from use of the glyphosate pesticide spray mixture for coca eradication. In 2003, our

consultation considered both coca and poppy eradication efforts.

The Agency reviewed the EMP for comparison with applicable U.S. requirements for pesticide use and we

believe the Plan contains appropriate types of activities for a pesticide spray program. The information in the

EMP is generally in agreement with information provided to EPA for the previous consultations and discussed in

EPA � s 2002 and 2003 written assessments. The EMP provides additional information regarding the spray
program, such as requirements for environmental monitoring, waste management, and contingency plans.

The EMP gives general descriptions of many activities related to this spray program, including references to

relevant Colombian laws, which are to be followed. These activities include spray application requirements and
restrictions, training and safety precautions for personnel who handle and apply the pesticide, handling of waste

resulting from program operations, training public health workers to recognize and treat pesticide poisoning,

handling health and environmental complaints, environmental monitoring, and contingency plans for
emergencies. EPA recognizes that these types of activities are appropriate for pesticide spray programs and in

general reflect similar activities which can be included for pesticide spray programs in the U.S., depending on the

specific pesticide, use conditions, known potential risks, and Federal, state, or local laws. In general Federal

requirements and restrictions for handling and using pesticides in the U.S. are specific to individual licensed
pesticides for their permitted uses; requirements are stipulated on the labels of individual products.

There were two specific sections of the EMP that EPA would like to offer comments. First, according to the

505Annex 53-C

Domestic Solid Waste Management Program, empty pesticide containers may be used for collection of garbage

or for building barriers after containers are "completely washed and perforated." However, pesticide product

requirements in the U.S. prohibits reuse of containers and suggests disposal by appropriate means, unless the
containers are collected by the manufacturer for refilling. We would urge DoS to investigate with the manufacturer

or the Government of Colombia methods for properly disposing of these containers rather than reusing them. The

second specific comment relates to the Environmental Monitoring Program which states there is no significant
impact on plants that surround the illicit crops being sprayed. As our consultation documents of the past two

years have stated, glyphosate is highly toxic to many plants. Some levels of adverse effects are likely to occur

to some non-target plants as a result of spray drift, as can be expected with herbicide applications. The Agency

suggests an appropriate revision of this wording.

I hope this information is helpful. If you have additional questions, please let me know.

Sincerely,

Jay S. Ellenberger

Associate Director

Field and External Affairs Division

Office of Pesticide Programs

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506 Annex 53-C

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2004 » Protocol for Water Sampling for
Glyphosate and AMPA Residue Analysis

Protocol for Water Sampling for Glyphosate and AMPA Residue Analysis

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BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC

April 12, 2005

The Government of Colombia � s Institute of Agriculture and Husbandry (ICA)

Bogot� , 2003

Annex 1: Sampling Bodies of Water for Glyphosate and AMPA Residues Analysis (ICA)

1. OBJECTIVE

To do reliable, representative sampling in surface bodies of water to enable a quantitative determination of the

presence of glyphosate and AMPA residues.

2. GENERAL CONSIDERATIONS

1. Sample means the complete, homogenized accumulation of the various secondary samples taken from a

body of water, to analyze its properties and list them on the label.

2. Secondary Samplemeans the volume collected in the container for secondary samples in the body of water

under study.

2.1 Sampling Method

According to Su�rez (1), the most appropriate sampling method isrestricted samplingbecause it is limited to
the population; therefore, the sample constitutes a portion of the population. It is not possible to take an element

(sample) among many existing ones.

Said sampling procedure may be consideredstratified or territorial(1) based on the conditions at the sampling

points, so the samples are compound.

To illustrate: From a river, three different samples may be taken: one at the source, another in its stream, and

the third at the outlet. In other words: at a point before the crop under study, near the crop, and past the crop.

The sample taker must consider the points that he/she deems critical for the emission of the compound under
study as strategic sampling points (2). Such points are sampling sectors or strata.

A sample composed of secondary samples will be taken in each sector or stratum. We suggest collecting

secondary samples in points of turbulence (3).

The secondary samples will be mixed to obtain the sample.

3. GENERAL RECOMMENDATIONS

1. Rinse the secondary sample and sample containers several times (3 or 4) using the water to be sampled

(3,5).

2. For the sampling operation, be especially careful to not collect sediments (clay, mud, dirt, sand, etc.) along

with the water; to avoid doing so, do not submerge the container to the bottom of the body of water; we

suggest submerging it to an average depth.

3. After you collect the samples, store them until delivery in refrigerated devices or, if not, in a cool spot out of

the sun (5).

507Annex 53-C

4. To the extent possible, when collecting secondary samples, the container must be vertically submerged for

the water to flow freely inside. See Figure 1. It is essential to use gloves.

5. Use diluted sulfuric acid to obtain a pH range from 3 to 4 for your sample.

Figure 1

3.1 MaterialsRequired for Sampling

1. A 1-liter amber-tinted glass bottle with a cap (sample container)

2. 250-ml. wide-mouth secondary sample containers

3. A Styrofoam cooler with a lid, to transport the samples to the lab where they will be analyzed

4. A pair of gloves

5. Labels to mark the water samples with the following information:

Location refers to data regarding the region and zone where the body of water sampled is located.

Collection Siterefers to the location of the body of water per se, that is to say, at the source or at the
outlet of a river, on a farm, near a specific cr.p, etc

Collection Date and Time refers to the date and time when the secondary samples were collected from

the water body, to be later transferred to the sample container.

Number of Secondary Samples refers to the number of secondary samples collected from the body of
water, which were later transferred to the sample container (1-liter amber-tinted bottle).

Sample Taker � s Name refers to the name(s) of the person(s) who took the secondary samples and

transferred them to the sample container (1-liter amber-tinted bottles), including, if possible, his/her (their)

position(s) within the company in charge of collecting the sample.
Appearance refers to the visual inspection of the sample, determining sample characteristics such as

aspect, odor, turbidity, presence of foreign elements, grease or oil, gaseous emissions, color, et.c.. .

An example of a label appears below.

WATER SAMPLE

Glyphosate and AMPA Analysis

Location

Collection Site

Date Collected DAY MONTH YEAR Time Collected

Number of Secondary Samples Taken

Sample Taker � s (Takers�) Name(s

)

Appearance

Comments

Comments Here the sample taker adds any other information that he/she deems important regarding the

sample or the collection site and/or relevant for sample analysis.
6. Sulfuric acid and Pasteur pipette

508 Annex 53-C

7. pH measuring papers

3.2 Sampling Procedure

1. Visually determine the points where the secondary samples will be collected, taking them from mid-point in
the water and near the shore, in points of turbulence.

2. Wash secondary sample containers and sample containers with water from the sampling site (3 or 4 times)
(3,5).

3. Submerge each secondary sample container vertically so that water enters freely, until the complete

volume of the bottle volume is filled. See Figure 2.

4. Pour the full content of each secondary sample collected into the sample container (1 liter amber bottle).

5. Collect the next secondary sample, repeating steps 3 and 4.

6. Measure the pH, following the procedure established for that purpose.

7. Put the cap on the container, ensuring that there is no leakage.

8. Write the information required on the label and stick it on the sample container, using sufficient tape.

9. Store the container in a refrigerated device or at least in a cool spot out of the sun, until it is delivered to the

lab.

Send the samples out in the duly sealed Styrofoam refrigerator as soon as possible.
10.

a. Procedure for measuring pH

1. Make sure that your hands or the tool that you use to hold the pH measuring tape are completely clean.

2. Verify that the tape is not wet.

3. After firmly capping the sample container, shake it.

4. Uncap the container.

5. Submerge the tape, but not completely, into the water in the container.

6. Remove the tape from the container.

7. Find the color of the tape on the pH table supplied.

8. Repeat steps 5, 6 and 7.

9. The pH value must be the same the two times that you measure. If not, repeat the complete procedure.

10. Write on the label the pH value to which the color corresponds.

11. Acidulate the sample at a pH range from 3 to 4 using diluted sulfuric acid.

12. Write this pH value on the label.

BIBLIOGRAPHY

(1)SU � REZ, F. Fundamentos de Estad � stica. Aplicada al sector agropecuario. (Basic Statistics. Applied to
the Farming and Livestock Sector)Rojas Ederhard Editores. Bogota. Colombia. 1999.

(2)CEPIS. Manual de evaluaci� n y manejo de sustancias � xicas en aguas superficiales. Sec�i n 5.

Orientac� n para muestreo, monitoreo y a� lisis de datos. (Manual for Evaluating and Handling Toxic
Substances in Surface Bodies of Water. Section 5. Guide for Sampling, Monitoring and Data Analy) eru.

1991. pgs. 5,6.

509Annex 53-C

(3)SECRETAR A DE AGRICULTURA Y RECURSOS HIDR ULICOS. T cnicas de muestreo de aguas y
� � �
determinaciones en el campo. (AGRICULTURE AND HYDRUALIC RESOURCES SECRETARIATT.echniques

for Water Sampling and Field Determinations)1 st reprint of the 4th edition. 1986. 17 pgs.

(4)EPA. Pesticide Residue Analysis in Water. Training Manua.lEPA-430/1-79-013. USA. 1979.

(5)WATER QUALITY BRANCH, INLAND WATERS DIRECTORATES . ampling for water quality. Ottawa.

Canada. 1983. pgs. 3-9.

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Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2004 » Protocol for Soil Sampling for
Glyphosate and AMPA Residue Analysis

Protocol for Soil Sampling for Glyphosate and AMPA Residue Analysis

Subscribe to Updates

Other Releases
BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC

April 12, 2005

The Government of Colombia � s Ministry of the Environme�ts Institute of Hydrology, Meteorology

and Environmental Studies (IDEAM)

Bogot � , 2003

Soil Sampling for Glyphosate and AMPA Residue Analysis

INTRODUCTION

The Colombian Technical Standards Institute (ICONTEC), in 1994 NTC 3656 standard, sets forth the

methodologies for taking soil samples for the purpose of determining contamination and ensuring that lab
analysis can evaluate their quality and contamination level. The guidelines in this standard were taken into

account in the soil sampling proposal.

SAMPLING

The sampling unit will be one hectare in which 12 samples will be collected, 6 of which will be collected in one
sector of the lot and later compounded or joined to produce one sample; the other 6 samples will be collected in

the remaining sector of the hectare, to produce the second sample. These two compound samples will be used

to make physical-chemical, glyphosate and AMPA analyses.

The locations will be randomly selected in areas affected by the presence of illicit crops (the sampling obtained

prior to glyphosate spraying may be used as a reference pattern).

Sampling Methodology

Soil. In the selected areas, take samples in the central zones where a greater concentration of the applied
formula is believed to be found, using 12 sampling points selected at random (Figure 3). Collect minimum 1,000

g. from each site, at a depth of 20 cm. It is important to write down the soil temperature and moisture in situon

each lot.

Figure 3. Sample-taking Schema for Each Point Selected in Areas Sprayed with Glyphosate-based Formulas

Collect the soil samples in Kraft paper bags, then put them into large Ziploc plastic bags and properly label
(using a waterproof indelible marker). In addition, in each bag place a small identification format of the sample,

protected by a smaller bag, of those used in IDEAM Geomorphology and Soils Subdivision, and also separately

attach the field form (Annex 1).

For the physical-chemical and residue analysis of pesticides, create two samples from the initial 12, joining the

6 taken from one sector to make up one sample and the remaining six from the other sector to make up the

second sample, as indicated in Figure 4.

511Annex 53-C

Figure 4. Schema Indicating How to Make Up the Compound Mixes for physical-chemical and residue analyses

of pesticides.

Sampling Format

Geo-reference the collected samples and fill out the form supplied by IDEAM for soils. In the post-spraying

sample formats, remember to add additional information regarding the date, time, and operational and

environmental conditions of the aerial spraying (i.e. wind speed, application �eight, etc ); this data will be
supplied by the Anti-Narcotics Police and IDEAM.

Glyphosate and AMPA Residues

Soils. Send the soil samples, following the technical guidelines provided by the Canadian CTQ laboratory. Send
duly labeled 500 g. of soil with the corresponding identification form.

Soils. Collect the samples in quantities of 500 g. and put them in Kraft paper bags that will be later packed in

plastic bags and duly labeled, following the recommendations.

CUSTODY CHAIN PROTOCOL

One person will have the authority of being responsible for receiving and packing the samples, sealing and

opening the coolers after each sampling. This person will verify the presence and condition of all of the samples,

based on the forms on each cooler; this person will also verify the individual sample form. The team members
must constantly supervise and watch over the samples and coolers during sample taking, storage and

transportation.

Sample-taking

Soil.Collect the soil samples following the provisions in number 4.2.1, checking that the identification sheet

code matches the code on the bag. Also, the person in charge of custody must record on the forms if sampling

conditions were met as well as the sample condition. Once at the air base, in the presence of the individual in

charge of the custody chain and of witnessing (procedure that will be recorded on the forms), this person will
proceed to create the two samples out of the 12 secondary samples for analyzing pesticide (glyphosate)

residues and for physical-chemical analysis, taking from each bag approximately 100 grams; these new two

compound samples must be duly labeled, writing the codes of the mixed samples on the identification sheet.

Glyphosate and AMPA samples must be coded and stored following the Canada Laboratory guidelines and the

person in charge of custody will compound these samples to form two samples. The sample will be delivered to

Bogot� and handed over to the person who will act as Bogota-Canada custodian.

The samples must be transported from the sampling site to the air base. There the custodian
Transportation.
receives the samples and verifies the identification forms and the sample condition and then proceeds to

separate the samples for physical-chemical and residue analysis, clearly identifying the procedure followed on

the form. Once this process is done, the samples are stored in Styrofoam coolers with dry ice, or following the
procedure set forth by the Canadian lab. Then they are sealed in the presence of witnesses and immediately

taken to Bogota. In the lab, the person in charge of the Bogota-Canada custody and the authorized personnel at

the different labs open the samples, verify the forms, deliver the samples according to the analytes, sign the
delivery act writing down the condition, and seal the cooler again for its transfer to Canad.a

ANNEX 1

SOIL SAMPLE AND FIELD IDENTIFICATION FORMS

HYDROLOGY, METEOROLOGY, AND ENVIRONMENTAL STUDIES INSTITUTE

Diagonal 97 No 17 - 60 Bogota, D.C., Colombia.
PBX6356230 Web http://www.ideam.gov.co/

Geomorphology and Soils Subdivision

512 Annex 53-C

Tel. 6356049, Fax 6356130, Piso 3
Bogota, D. C.

Chemical Physiology Program

Oficinas Parque industrial de occidente (HB)
Cra. 129 # 29 - 57 Bodega 17 - 18

Tel: 4181181 - 4181215

SAMPLE IDENTIFICATION

Profile # Day Month Year

DATE

Provincial Department Settlement County

Coordinates LW: � ' '' LN: � ' ''

Altitude

Horizon Depth

Limits From cm. to cm.

Analysis Requested

Sample Counter-sample

Exploratory Monitoring

NOTE [NOT INCLUDED IN THE ORIGINAL TEXT]

This protocol has been modified in some technical aspects to adjust it to the difficult logistics and field

conditions encountered. These modifications have been granted approval by the Ministry of Agriculture and Rural
Development Colombian Framing and Livestock Institute (ICA), by Ministry of the Environment, Housing and

Territorial Development technicians who have been present when all of the samples were taken, as well as by

professional opinions from personnel at the �gust n Codazzi geographical Institute National Soils Laboratory.

These modifications are summarized below.

The samples are not packed in "Kraft" paper bags because the moisture in the soil dissolves this type of

paper, adding Boron (Br) and organic matter to the soil, altering the samples.

Samples are collected in two recyclable plasticbags (LDPE) with airtight sealing (Ziploc type). The double
bagging prevents losing the sample if the outside bag is punctured or if there is cross contact between

samples.

There are fewer secondary samples per area unit because there is little time from when the helicopter

descends to when it must take off again, due to the hostile presence of outlawed groups. However, the
samples are made up of several secondary samples (minimum 4) collected using the suggested

methodology.

Once taken, the samples are preserved in a portable cooler with ice, at temperatures below 4 degrees

centigrade, temperature below which there is no glyphosate metabolization. The ice in the cooler is kept in
airtight bags, so that, when it melts, the water does not enter into direct contact with the samples.

The glyphosate and AMPA analyses were made in a USDA-ARS laboratory at the University of Mississippi

(Oxford, Mississippi).

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513Annex 53-C

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2004 » EPA Letter to INL Regarding the
Spray Program's Compliance w ith the Government of Colombia's Environmental Management Plan for Illicit Crop Eradication

EPA Letter to INL Regarding the Spray Program's Compliance with the

Government of Colombia's Environmental Management Plan for Illicit
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Crop Eradication

Other Releases
BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC

February 23, 2004

United States Environmental Protection Agency

Washington, DC
20460

Office of Prevention, Pesticides and Toxic Substances

February 23, 2004

Mr. Thomas H. Martin, Director

INL Latin American Programs

Department of State

2201 C Street, NW
Room 7811

Washington, DC 20520

Dear Mr. Martin:

This is a response to the Department of S�ate s (DoS) request that the Environmental Protection ( PA)y E

review the Environmental Management Plan for the Illicit Crop Eradication Program in Colombia (EMP).

Specifically, DoS asked EPA to assess whether use of the herbicide mixture in Colombia is in accordance with
the EMP, as included in the Foreign Operations, Export Financing, and Related Programs Appropriations Act,

2002, (P.L. 108-7). As you know, in 2002, EPA was asked to consult regarding potential health and

environmental effects from use of the glyphosate pesticide spray mixture for coca eradication. In 2003, our
consultation considered both coca and poppy eradication efforts.

The Agency reviewed the EMP for comparison with applicable U.S. requirements for pesticide use and we

believe the Plan contains appropriate types of activities for a pesticide spray program. The information in the
EMP is generally in agreement with information provided to EPA for the previous consultations and discussed in

EPA � s 2002 and 2003 written assessments. The EMP provides additional information regarding the spray

program, such as requirements for environmental monitoring, waste management, and contingency plans.

The EMP gives general descriptions of many activities related to this spray program, including references to
relevant Colombian laws, which are to be followed. These activities include spray application requirements and

restrictions, training and safety precautions for personnel who handle and apply the pesticide, handling of waste

resulting from program operations, training public health workers to recognize and treat pesticide poisoning,
handling health and environmental complaints, environmental monitoring, and contingency plans for

emergencies. EPA recognizes that these types of activities are appropriate for pesticide spray programs and in

general reflect similar activities which can be included for pesticide spray programs in the U.S., depending on the
specific pesticide, use conditions, known potential risks, and Federal, state, or local laws. In general Federal

requirements and restrictions for handling and using pesticides in the U.S. are specific to individual licensed

pesticides for their permitted uses; requirements are stipulated on the labels of individual products.

There were two specific sections of the EMP that EPA would like to offer comments. First, according to the

514 Annex 53-C

Domestic Solid Waste Management Program, empty pesticide containers may be used for collection of garbage

or for building barriers after containers are "completely washed and perforated." However, pesticide product
requirements in the U.S. prohibits reuse of containers and suggests disposal by appropriate means, unless the

containers are collected by the manufacturer for refilling. We would urge DoS to investigate with the manufacturer

or the Government of Colombia methods for properly disposing of these containers rather than reusing them. The
second specific comment relates to the Environmental Monitoring Program which states there is no significant

impact on plants that surround the illicit crops being sprayed. As our consultation documents of the past two

years have stated, glyphosate is highly toxic to many plants. Some levels of adverse effects are likely to occur
to some non-target plants as a result of spray drift, as can be expected with herbicide applications. The Agency

suggests an appropriate revision of this wording.

I hope this information is helpful. If you have additional questions, please let me know.

Sincerely,

Jay S. Ellenberger

Associate Director

Field and External Affairs Division
Office of Pesticide Programs

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515516 Annex 53-D

d epartMent ostateinforMationp ackage on thc ertification of the

aeriale radication ollicitcoca ando piuMpoppy ic oloMbia, 2005

(U.S. Department of State)

517518 Annex 53-D

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»ia2005 » Information Package on the
Certification of the Aerial Eradication of Illicit Coca and OpiumPoppy in Colombia

Information Package on the Certification of the Aerial Eradication of

Illicit Coca and Opium Poppy in Colombia Subscribe to Updates

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BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC
April 22, 2005

Memorandum of Justification Concerning the Secretary of State � s 2005 Certification of Conditions

Related to the Aerial Eradication of IllicCoca and Opium Poppy in Colombia

The Andean Counterdrug Initiative sectionof the Foreign Operations, Export Financing and Related Programs

Appropriations Act, 2005 (Division D, P.L. 108-447) lays out conditions under which assistance using funds

appropriated under the heading Andean Counterdrug Initiative may be made available for the procurement of
chemicals for use in aerial eradication of illicit crops. In particular, the legislation provides:

"That not more than 20 percent of the funds appropriated by this Act that are used for the procurement of

chemicals for aerial coca and poppy fumigation programs may be made available for such programs
unless the Secretary of State certifies to the Committees on Appropriations that: (1) the herbicide mixture

is being used in accordance withEPA label requirements for comparable use in the United States and

with Colombian laws; and (2) the herbicide mixture, in the manner it is being used, does not pose

unreasonable risks or adverse effects to humans or the environment:Provided further, That such funds
may not be made available unless the Secretary of State certifies to the Committees on Appropriations

that complaints of harm to health or licit crops caused by such fumigation are evaluated and fair

compensation is being paid for meritorious claims:Provided further, That such funds may not be made
available for such purposes unless programs are being implemented by the United States Agency for

International Development, the Government of Colombia, or other organizations, in consultation with local

communities, to provide alternative sources of income in areas where security permits for small-acreage

growers whose illicit crops are targeted for fumi�ation ."

This memorandum provides justification for the Secretary of �tate s determination and certification to Congress

that the above conditions have been met as required. In 2002, 2003, and 2004, the Secretary of State determined

and certified to Congress on similar conditions concerning human health and environmental safety issues related
to the Colombia spray program. These certifications were based on, among other information: all available

scientific data on glyphosate, the herbicide used by the program; toxicological tests of the spray mixture (water,

glyphosate, and a surfactant); active field verifications and complaint investigations; comprehensive human health

monitoring; and thorough verbal and written consultations on the spray program with USDA andEPA. Because
the Colombia aerial eradication program has not made any changes in the chemical formulation or application

methods used for eradication of coca and opium poppy since the Secretary of State last certified to Congress on

the Colombia spray program (November 29, 2004), these prior certifications serve as the foundation for the 2005
certification. These certifications and attachments can be found on the Internet at the following address:

http://www.state.gov/p/inl/rls/rpt/aeicc/

1. The herbicide mixture is being used in accordance with EPA label requirementsfor comparable use

in the United States and with Colombian laws.

EPA told the Department of State in previous consultations that application rates for both coca and poppy

eradication in Colombia are within the parameters listed on labels of glyphosate products registered byEPA for

use in the United States. Since neither the application rates used by the Colombia eradication program nor the

519Annex 53-D

EPA-registered label recommendations have changed since 2004, the Secretary can certify to Congress that the

herbicide mixture continues to be used in accordance withEPA label requirements for comparable use in the

United States.

With respect to accordance with Colombian laws, the Colombian Minister of the Environment, Housing, and

Territorial Development determined in July 2004 that the illicit crop eradication program is being conducted in

compliance with the Environmental Management Plan for aerial eradication (EMP). Since that determination,
there have been no substantive changes in the execution of the illicit crop eradication or the EMP.

The spray program�s compliance with other Colombian laws governing aerial eradication was reconfirmed by

the October 19, 2004 final resolution of a class action suit filed in 2002 against the aerial eradication program on
environmental and human health grounds. The Colombian Administrative Tribunal, Col�mbia s highest

administrative court, upheld the Government of Colo�bia s appeal of a 2003 lower�court s ruling to halt aerial

eradication.

The Colombian Administrative Tribunal ruling (an English language translation of which is included as Attachment

1) concluded that:

It cannot be accurately inferred from the evidence outlined that glyphosate causes irreversible damage to

the environment when it is used for eradicating illicit crops; on the other hand, a number of facts lead to
the conclusion that sprayed areas regenerate in a relatively short period of time and that many hectares of

forest are destroyed when trees are felled by growers of illicit crops. (p. 10)

Accordingly, the Administrative Tribunal reversed a lowe� court s finding, and ordered that the Ministry of the
Environment, Housing and Regional Development, Ministry of Social Protection, and National Directorate of

Dangerous Drugs continue their oversight of the spray program. This finding represents a decisive legal

endorsement of the methods used for spraying illicit crops in Colombia and of the integrity of existing

environmental oversight mechanisms.

2. The herbicide mixture, in the manner it is being used, does not pose unreasonable risksor adverse

effects to humans or the environment

The Secretary of State determined and certified in 2002, 2003, and 2004 that the herbicide mixture, in the

manner it is being used, does not pose unreasonable rsi ks or adverse effects to humans or the environment.

After previous consultations with EPA, the Departmentand the Government of Colombia have incorporated all
EPA recommendations to strengthen spray program controls and ensure increased protection against adverse

effects to humans and the environment. The Department of State is not aware of any new evidence of risks or

adverse effects to humans or the environment that have surfaced since the 2004 certification. Included below is a

brief review of the conditions that allow the Secretary to recertify to Congress in 2005 that the herbicide mixture,
in the manner it is being used, does not pose unreasonable rsi ks or adverse effects to humans or the

environment.

In the 2004 EPA report, EPA offered the following assessment of human health concerns related to the spraying
of coca and opium poppy in Colombia: "Despite an aggressive search for cases, there does not appear to be any

evidence that glyphosate aerial spraying has resulted in any adverse health effects among the population where

this spraying takes place." EPA also col ded, "that an aggressive program to identify glyphosate poisoning
has been implemented in the areas of Colombia where illicit crop eradication spraying programs are prevalent." A

significant number of health care providers have received training and additional training is under way or planned.

As recognized in the 2003 report, the eradication program lowered its potential risks to wildlife and has
responded appropriately to minimize off target drift. However, in the 2004 report the Agency stated, "Spray drift

and potential side effect down wind of the target sites are common, universal factors in most if not all pesticide

applications from aerial or ground applications for all uses." In 2003,EPA recognized that the Department of

State was employing "Best Management Practices to minimize drift." The Department of State continues to
follow these Best Management Practices and is ever vigilant regarding the manner in which the herbicide is

applied.

The Government of Colombia regularly conducts studies to assess the spray program's environmental impact

through ground truth verifications to estimate spray drift and the accuracy of the spray mixture application, and

during verification of all legitimate complaints about alleged spraying of crops or vegetation that are not coca or

opium poppy. After one recent verification, the Government of Co�ombia s Ministry of Environment, Housing,
and Territorial Development characterized spray drift in the following fashion:

520 Annex 53-D

The drift effects that were observed in areas visited on a random basis were temporary in nature and small

in extent, and basically consisted of partial defoliation of the canopy of very high trees. No complementary

collateral damage from spraying activities was observed at the sites selected and verified. In sprayed

areas that were subsequently abandoned, it was noted that vegetation was starting to grow again, the
predominant types being grasses and a number of herbaceous species (Attachment 2)

The Department of State believes that the progr�m s rigid controls and operational guidelines have decreased

the likelihood of adverse impacts of the eradication program on humans and the environment and that

theherbicide mixture, in the manner it is being used, does not pose unreasonabriks or adverse effects to
humans or the environment.

This conclusion was recently confirmed by an objective, independent scientific study that evaluated the Colombia
illicit crop eradication program and its potential human health and environmental considerations. The Inter-

American Drug Abuse Control Commission (CICAD) section of theOrganization of American States (OAS)

commissioned a two-year risk assessment of human health and environmental effects related to aerial

eradication of illicit crops in Colombia. The final report to CICAD is enclosed as Attachment 3 and can also be
found at the following Internet Addrehttp://www.cicad.oas.org/en/glifosateFinalReport.pdfis study

examined not just the possible human health and environmental effects of glyphosate, but the specific manner in

which glyphosate is applied in Colombia to eradicate illicit crops, and reached the following conclusion: "(b)ased

on all evidence and information presented above, the Panel concluded that the risk to humans and human health
from the use of glyphosate and Cosmo-flux in the eradication of coca and poppy were minimal." (Conclusions,

6.1, p. 90). Similarly, with respect to potential risks to the Colombian environment, the panel concluded that "the

risks to the environment from the use of glyphosateand Cosmo-Flux in the eradication of coca and poppy in
Colombia were small in most circumstances." (Conclusions, 6.2, p. 90).

3. Complaints of harm to health or licit crops caused by such fumigation are investigated, and fair

compensation isbeing paid for meritoriousclaims

The Government of Colombia continues to compensate all meritorious claims fairly. On October 4, 2001, the

GOC formally instituted a new process to compensate growers for legal crops sprayed in error. From that date
through the end of March 2005, the Colombian National Police s Antinarcotics Directorate (DIRAN), the

Government of Colombia agency responsible for complaint investigations, has received 5,270 such complaints.

Since the Secretary�s 2004 spray certification to Congress, the DIRAN complaint investigations unit and other
GOC entities that participate in complaint investigations have made substantial progress in eliminating the

existing backlog of cases to be investigated and resolved. In October 2004, 1,063 cases were still under

investigation. By the end of March 2005, 208 new cases had been received, 925 cases were under investigation,

and 346 investigations had been completed. To date, of the 5,270 cases received, 4,345 investigations have been
completed. During 2004, only four complaints were found to be valid and compensation payments were made, for

a total of $3,846. The spray program has compensated a total of 12 cases, amounting to almost $30,000 in

compensation.

The 925 outstanding complaints are currently being processed and verified by an interagency group including the

DIRAN, agronomists from the Colombian Institute of Agriculture and Husbandry (ICA), the Ministry of

Environment, and the Office of Dangerous Drugs (DNE). Flight database and on-site investigations continue, and
compensation is being paid for all cases with merit after analysis of all considerations. Typically, compensation

hinges on very basic issues, such as whether planes sprayed in the vicinity of the compl�inant s property

within a five-day window of the alleged date of spraying; whether the complainant owns the allegedly sprayed

property; whether the legal crop sprayed was intermixed with illegal crops; and whether the affected crop suffered
damage from the spray mixture, as opposed to fungus, insects, or other causes. If the spray pilots have erred

and accidentally sprayed licit crops, compensation is paid to the farmer for the loss of the crop, based on current

market value of the crop.

Field verification is extremely dangerous and resource intensive; and it is an unavoidably methodical process.

Because of the high risks involved for all personnel who conduct site visits, the primacy of security will dictate

the pace of investigations in the future. Although logistical considerations (security concerns, personnel
availability, and helicopter resources) are part of the reason why complaints cannot be resolved in the field more

quickly, the greatest logjam in this system is the number of false complaints whichhandicap the ability of field

investigators to close cases more quickly. This was reconfirmed during several 2004 site investigations when

complainants related stories of narco-terrorist groups forcing them to damage their own crops and falsify
complaints in order to discredit the aerial spraying.

521Annex 53-D

The Department of State is investigating possibilities for improving the complaints resolution process through the

use of aircraft mounted imagery platforms that would make in situ verification safer, cheaper, and faster in the
future. The Colombian Ministry of Justice has also refined the claims procedures, seeking to streamline the

process and to deter fraudulent claims. These procedures will include a warning that a complainant found to have

coca growing on his/her property would be subject to prosecution for violations of Colombian law. The

Government of Colombia has also begun processes for seizure and forfeiture of property used for growing illicit
crops. Presumably, these steps will reduce the many false claims that have flooded the complainst ystem, and

facilitate investigation of and restitution for legitimate claims.

4. Programs are being implemented by the USAID, the GOC, or other organizations in consultation
with local communities, to provide alternative sources of income in areas where security permits for

small-acreage growerswhose illicit cropsare targeted for spraying

Thus far in calendar year 2005, the Colombian aerial eradication program has sprayed (or anticipates spraying)

coca in the departments of Putumayo, Na�i o, Guaviare, Meta, Bolivar, Cauca, Norte de Santander, Vichada,

Antioquia, Vaupes, Cordoba, Caldas, Arauca, Cesar, Valle del Cauca and La Guajira and opium poppy in the

departments of Cauca, Huila, Tolima, and N�ri o. In each of these areas, USAID, the GOC, and/or other
organizations are implementing alternative development programs to provide legal income generating

opportunities to illicit crop growers who agree to accept benefits after eradicating their crops of coca or opium

poppy.

For the purposes of this report, the Department of State interprets the term "area" as a Colombian department.

This is consistent with the way that the Colombian spray program records and reports spray activity. It is also

the most appropriate definition because Department of State and USAID experience has shown that while
alternative development programs should be (and are) coordinated with spraying, these two components cannot

always be co-implemented in every location.

Alternative development is not appropriate in many locations where illicit crops are grown. Coca and opium
poppy are often cultivated in remote, difficult to reach areas with limited infrastructure to support legal crops that

have less value and higher transport costs than those for illegal merchandise. Dispersing development activities

to remote areas often raises costs and security risks, while reducing impact. Furthermore, many drug-producing

regions have nutrient-poor and fragile tropical soils, inappropriate for large-scale farming activity and unsuitable
for increased human habitation. As reflected in the language of the 2005 Consolidated Appropriations Act, narco-

terrorist and paramilitary groups operate in many illicit crop-growing zones and make the presence of alternative

development projects inadvisable in such locations. These narco-terrorist groups reap immense profit from the
illegal trade, pose grave security risks for development personnel, and slow down project implementation.

Despite these obstacles to alternative development in Colombia, USAID and the GOC are moving forward with a

robust alternative development program in coca and opium producing areas. Now in the fourth year of Plan
Colombia alternative development coordination with the GOC and the fourth year of project implementation,

USAID's alternative development program has supported a total of 62,964 hectares of licit crops, 31,461 hectares

of forest land, and completed 918 infrastructure projects in coca and poppy growing areas through March 31,
2005. These efforts have benefited 54,780 families. These achievements in each category have surpassed

program goals. Equally important, USAID has strengthened a total of 281 NGOs, cooperatives, and national

institutions so that alternative development and community building activities will be more sustainable.

The alternative development projects being carried out by USAID and GOC organizations in each area where the
spray program eradicates illicit crops are described below.

Antioquia

An $18.5 million USAID project directed at alternative development, implemented by the Pan-American

Development Foundation (PADF), supports short-term production activities for immediate income and
employment needs. It also seeks to establish longer-term crops such as natural rubber (caucho) and cacao to

provide sustainability, as well as complementary productive infrastructure. Projects of cacao, caucho, and agro

forestry would cover an area of 2,017 hectares and would benefit 594 families in El Bajo Cauca.

An $8.5 million USAID Dairy project is carried out by Land O'Lakes (LOL) to promote sustainable dairy

production, processing and marketing involving small farmers. This program is also operati�g in Nari o.

USAID also funds an activity titled Aid to Artisans (ATA), which is carrying out a $4.3 million project to

strengthen local capacity for production and marketing of crafts. ATA is also opera�ing in Atl nt�c,, Boyac

522 Annex 53-D

Caldas, Cauca,�C sar� rdoba, Huila, Magdalena� Nari o,�Qo, Santander, Sucre, Tolima, and Valle

del Cauca.

USAID's successful $38 million Colombia Agribusiness PartnershAPP), implemented by
Associates in Rural Development (ARD), is to promote private sector involvement to help agricultural producers

and others involved in illicit products to shift into legal activities or remain uninvolved in illicit coca and poppy

production. The project targets rural families in coca/opium poppy regions and threatened zones and assists

them by supporting strategic alliances between agribusiness firms and these families. In Antioquia, the program
supports small farmers in producing fruit for processing into pulp, jute and African palm. The program also

operates in�Atl ntico�var, Caldas, Casanare, Cau�a, C s�rdoba, Guajira, Huila, Magdalena,

Nar� o, Norte de Santander, �uind o, Risaralda, Santander, Sucre, Tolima, and Valle del Cauca.

The USAID-funded Democratic Local Governance Program, also implemented by ARD, uses USAID funds to
support institutional strengthening activities in municipal-level development planning, municipal management,

public services, finance and revenue, public information, and project management. In Antioquia, the program

focuses on the Bajo Cauca region and has implemented projects to strengthen municipal administrations in
these areas. In addition, some funding has been invested in seven social infrastructure projects in the same

area. The program also operates in selected municipalities i� Putumayo, Nari o, Cauca, Valle del Cauca, Huila,

Tolima, and �ol var.

The $23 million Colombia Forestry Development Program (CFDP), funded directly by USAID and implemented by
Chemonics, has a nucleus in Northeastern Antioquia where it is focusing on promoting pine plantations and

efficient industrial processing models. The estimated CFDP investment in Antioquia over the life of the project

totals $6,050,000. A portion of this assistance directly benefits indigenous communities in Mutata and
Chigorodo. It has another nucleus along the Atrato River and Uraba region that provides assistance to natural

forests, agro forestry schemes, plantations and the Familias Guardabosques nucleus in Turbo and Necocli. In

Nar� o this program is directed at community-based natural forest management. In Cauca, CFDP has invested

in natural forest management in the municipality of Guapi to benefit Afro-Colombian communities.

USAID's $12 million Colombia Enterprise Development (CED) project supports small and medium enterprise

development in secondary cities. CED is also ope�ating in Atl ntic�, Caldas, Quind o, Risaralda, Santander,

Valle del Cauca, and Tolima.

The Colombian Government's Investment Fund for Peace (FIP), a $19.4 million investment, is generating
employment through infrastructure, licit crop production (coffee rehabilitation, agro forestry), skills training, and

education/nutrition aid to poor families.

Bolivar

The aforementioned CFDP, financed by USAID, has a nucleus along Magdalena River focusing mainly on

plantations such as Eucalyptus. CFDP investment in the nucleus totals approximately $2 million, of which an

estimated $1 million will go to Bolivar.

USAID's alternative development program carried out by PADF is supporting short cycle production activities to
address immediate income and employment requirements; longer-term crops such as natural rubber and cacao

to provide sustainability; and complementary productive infrastructure. The project supports 2450 hectares of licit

crops benefiting 661 families.

USAID s CAPP is also promoting private sector involvement with farmers to porduce cacao, African palm, and

yucca (cassava).

In Bolivar, the Democratic Local Governance Program works in southern Bolivar strengthening municipal

administrations in municipal management. In addition to this work, the program has invested USAID funds in 10
social infrastructure projects in Bolivar.

The GOC is active in Bolivar supporting licit production activities such as palm oil and cassava production.

Caquet�

USAID's centerpiece Colombia Alternative Development (CAD), implemented by Chemonics, is a $97.3 million

project; in Ca�uit is fostering a short-term crop production for food security and long-term income generation

activities such as rubber production.

USAID funds a $1.8 million Sustainable Development for Indigenous Colombian Communities project,
implemented by the Amazon Conservation Team (ACT) to assist Colombian indigenous communities in food

security, health, local governance, and land management. Activities under this program are also being carried

out in the departments of Putumayo a�d Vaup s. The GOC is also supporting institutional strengthening for

523Annex 53-D

small-scale brown sugar producers and life plans (planes de vida) for indigenous communities.

In Caque� , the Democratic Local Governance Program has implemented 16 social infrastructure projects. In

addition to this work, the program provided technical assistance and training to community leaders and public
officials in citizen participation and municipal management. The program completed its fieldwork in Caquet on

March 2004. However, field presence through governance strengthening activities, particularly in public services,

is expected to continue until December 2005.

Cauca

USAID's CAD activities support small-scale irrigation for the production and marketing of short-season, high-

value crops, including the growing, processing, and marketing of gourds for artisan and craft products and the

value-added processing of wood products from tree plantations in indigenous areas.

The CFDP invested approximately $100,000 in natural forest management in the municipality of Guapi -Cauca to

benefit Afro-Colombian communities.

USAID Alternative Development activities also include a $9.8 million project, implemented by ACDI/VOCA, which

promotes specialty coffee production, processing and marketing in Cauca's illicit crop growing areas.

The CAPP project is supporting private sector investments in hot peppers, jute, and cacao.

USAID Democratic Local Governance Program efforts in Cauca have focused on working with community leaders

and public officials to improve municipal management practices. As for social infrastructure projects, the program

funded the implementation of 52 projects that total approximately $1,880,000.

The Aid to Artisans project is enhancing local capacity for production and marketing of crafts as licit income

generating alternatives.

The Colombians Supporting Colombians program works in municipal development with emphasis on participatory
planning. This is put into practice with the construction of small-scale infrastructure projects with community

partnership and mayors involvement. The program also administers a credit fund, directly and via local

microfinance institutions, to offer microenterprises credit to invest in working capital and fixed assets to enhance

or expand their businesses.

The GOC is supporting fruit production and complementary activities for the coffee renewal program.

Caldas

USAID's Specialty Coffee program is also promoting specialty coffee production, processing, and marketing in
Caldas's illicit crop growing areas.

The CAPP activity is su pporting private sector initiatives with small farmers to produce and process tropical

fruits, jute, and peppers.

C� sar

The Aid to Artisans project is carrying out activities to strengthen the production and marketing of crafts.

The Colombia Agribusiness Partnership Program (CAPP) is supporting private sector investments for small
farmers producing crops such as cacao, fruits and African palm. The GOC is also supporting cacao and oil palm

production in this region.

C� rdoba

The Aid to Artisans project is supporting the strengthening of local capacity to produce and market crafts by
artisans in the department.

USAID �s CAPP is s upporting private sector activities in cacao and passion fruit production.

Guajira

USAID s CAPP is s upporting private sector activities in crops such as passion fruit and cacao.

Guaviare

The GOC is supporting rubber (caucho) production and agro forestry.

Guainia

The GOC is providing institutional strengthening to indigenous community associations.

524 Annex 53-D

Huila

USAID's Specialty Coffee project is promoting specialty coffee production, processing, and marketing in poppy

growing areas.

USAID � s CAD program is supporting the production and marketing of passion fruit.

The CAPP program is supporting cacao and fruit production, while the Aid to Artisans project is promoting the

production and marketing of crafts.

Democratic Local Governance Program work in Huila is focused on citizen participation, municipal management,
and public information. The program has also implemented 57 social infrastructure projects that total

approximately $1,997,000.

The GOC is supporting the strengthening of cultural values in indigenous communities, fruit production,

fishponds, and complementary activities for the coffee renewal program.

Magdalena

The CFDP has a forestry nucleus along the lower Magdalena River focusing mainly on plantations such as

Eucalyptus. CFDP investment in the nucleus totals approximately $2 million, of which an estimated $500,000

will go to Magdalena.

USAID's CAPP is also providing technicaland financial support in Magdalena to private sector initiatives to

produce African palm, banana, cacao, and exotic fruits.

Meta

The GOC is supporting activities in cacao, cassava, buffer zones in natural parks, and technical assistance for

local governments.

The USAID CAPP program is promoting private sector investments with small farmers to porduce African palm.

Nari� o

The Specialty Coffee project is promoting specialty coffee production, processing and marketing in illicit crop

growing areas of N�ri o.

CFDP has a forestry nucleus along three riversystems �no focusing mainly on community-based natural
forest management. CFDP investment in the nucleus totals approximately $1.8 million and directly benefits the

Afro-Colombian community.

The United Nations Office on Drugs and Crime (UNODC) plans to implement a USAID-funded $1.8 million

program that provides a range of agricultural and forestry projects.

In Na�io, the Democratic Local Governance Program is focused on development planning and finance and

revenue, particularly in assistance to municipal administrations in the formulation of tax codes. Forty-two (42)

social infrastructure projects, totaling approximately $1,322,000, have been implemented in this department.

The USAID Dairy Promotion program is promoting sustainable small farm dairy production, processing and

marketing, while the CAPP program is supporting small farmer, private sector projects in cacao and African palm

production.

Aid to Artisans project is carrying out activities to promote the production and marketin� of crafts in Nari o.

The CFDP will be supporting forest policy changes and carrying out activities for the improved production,

processing and marketing of forest and wood products�in Nari o, as well as in Ant�oquia, Choc , and

Magdalena.

The GOC is supporting activities in coffee renewal and oil palm production.

Norte de Santander

The USAID Colombia Agribusiness Partnership Program (CAPP) programspporting private sector initiatives

with small farmers in the production and processing of African palm and cacao.

The USAID alternative development activities implemented through PAFD are working in association with

ASOHESAN (the Santa nder rubber producer's association) to support the cultivation of 1,652 hectares of rubber

that would benefit 411 families. The project includes as well the establishment of 826 hectares of short-term
crops and 137 food securitysystems (vegetable gardens, small animal husbandry).

525Annex 53-D

The GOC is supporting palm oil crop production in the department.

Putumayo

The CAD project is supporting activities in Putumayo for short and medium-term crop production with farmers
and indigenous groups, hearts of palm production, processing and marketing; rubber production, processing and

marketing; forest management and value added processing and utilization of forest and wood products;

infrastructure projects, including bridge construction and road improvements, schools, and health facilities. As

part of the development of production and marketing chains, support is being provided for the private sector
involvement in processing plants and marketing for cassava chips, black pepper and plantain; tropical flowers

and foliage, vanilla production, as well as for medicinal plants and essential oils.

Democratic Local Governance Program work in Putumayo is focused on strengthening public service providers
and on enhancing municipal finance and revenue capabilities. A total of 20 Social Infrastructure (SIF) projects

have been implemented in this department. The program completed its fieldwork in Putumayo on March 2004.

However, field presence through governance strengthening activities, particularly in public services, is expected

to continue until December 2005.

U.S. Army Corps of Engineers' $6.7 million rural infrastructure project, funded by USAID, carried out road,

sewage, and water treatment activities that generated employment in the region. Current complementary work is

being carried out to improve the water treatment plant in Villa Garzon.

The Sustainable Development for Indigenous Colombian Communities project, implemented by the Amazon

Conservation Team, is supporting indigenous communities with improved food security, health, local governance,

and land management.

Santander

The GOC is supporting cocoa and oil palm production in this department.

The CAPP is s upporting private sector initiatives with small farmers in the production of cacao and African palm.

Tolima

The CAD project is supporting an activity to increase annual crop production for food security and to increase

income and employment generation in the longer term through forestry, livestock, pasture improvement, and

vegetable production.

The Specialty Coffee activity is promoting specialty coffee production, processing and marketing in illicit crop

growing areas of Tolima.

The Colombia Enterprise Development (CED) project, funded by USAID and implemented by CARANA
Corporation, is supporting small and medium enterprise development in Colombia's secondary cities including

those in Tolima.

The Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the

department, while the ARD/CAPP is supporting private sector projects in fruits, natural rubber and cacao
production.

Democratic Local Governance Program activities in Tolima focus on technical assistance in development

planning to community leaders and public officials. In addition, the program has provided funds totaling
approximately $747,000 for 18 social infrastructure projects.

The Colombians Supporting Colombians program works in municipal development with emphasis on participatory

planning. This is put into practice with the construction of small-scale infrastructure projects with community

partnership and mayor�s involvement. The program also administers a credit fund, directly and via local
microfinance institutions, to offer microenterprises credit to invest in working capital and fixed assets to enhance

or expand their businesses.

The GOC is supporting cacao and coffee activities.

Valle del Cauca

In Valle del Cauca, the Democratic Local Governance Program has focused on technical assistance in

development planning to public officials. Social infrastructure projects began April 2005.

The CAPP activity is su pporting private sector initiatives with small farmers to produce and process tropical

fruits, jute, and peppers.

Vaupes

526 Annex 53-D

The Sustainable Development for Indigenous Colombian Communities project is supporting traditional healers

and helping to strengthen indigenous community organizations that are also involved in managing indigenous
lands.

Vichada

The GOC is providing institutional strengthening to indigenous community associations.

The preceding four sections and attachments form the basis of the Justification for the Secretary of State s

2005 Certification of Conditions Related to the Aerial Eradication of Illicit Coca and Opium Poppy in.Colombia

Attachments:

1. Colombian Administrative Tribunal ruling of October 192,004, English la nguage version

2. Government of Colombia�s Ministry of Environment, Housing, and Territorial Development Ruling No. 707,
July 26, 2004, English la nguage version

3. Environmental and Human Health Assessment of the Aerial SprayProgram for Coca andoppy Control in
Colombia, a report prepared for the Inter-American Drug Abuse Control Commission (CICAD) section of the

OAS, March 31, 2005 [PDF format]

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527528 Annex 53-E

d epartMent ostateinforMationp ackage on thc ertification of the
aeriale radication ollicitcoca ando piuMpoppy ic oloMbia, 2006

(U.S. Department of State)

529530 Annex 53-E

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Certification of the Aerial Eradication of Illicit Coca and OpiumPoppy in Colombia

Information Package on the Certification of the Aerial Eradication of

Illicit Coca and Opium Poppy in Colombia Subscribe to Updates

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BUREAU FOR INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS

Washington, DC

August 22, 2006

Memorandum of Justification Concerning the Secretary of State � s 2006 Certification of Conditions Related to the

Aerial Eradication of Illicit Coca and Opium Poppy in Colombia

The Andean Counterdrug Initiative sectionof the Foreign Operations, Export Financing and Related Programs

Appropriations Act, 2006 (P.L. 109-102) lays out conditions under which assistance using funds appropriated under the

heading Andean Counterdrug Initiative maybe made available for the procurement of chemicals for use in aerial
eradication of illicit crops. In particular, the legislation provides:

"That not more than 20 percent of the funds appropriated bythis Act that are used for the procurement of

chemicals for aerial coca and poppyfumigation programs maybe made available for such programs
unless the Secretaryof State certifies to the Committees on Appropriations that: (1) the herbicide is

being used in accordance with EPAlabel requirements for comparable use in the United States and with
Colombian laws; and (2) the herbicide, in the manner it is being used, does not pose unreasonable

risks or adverse effects to humans or the environment including endemic species:ovided furtherThat

such funds maynot be made available unless the Secretaryof State certifies to the Committees on
Appropriations that complaints of harm to health or licit crops caused bysuch fumigation are evaluated

and fair compensation is being paid for meritorious claims:vided furtherThat such funds maynot be

made available for such purposes unless programs are being implemented bythe United States Agency
for International Development, the Government of Colombia, or other organizations, in consultation with

local communities, to provide alternative sources of income in areas where securitypermits for small-

acreage growers whose illicit crops are targeted for fumiga�i."

This memorandum provides justification for the Secretaryof St�ts determination and certification to Congress that

the above conditions have been met as required. In 2002, 2003, 2004, and 2005 the Secretaryof State determined and
certified to Congress on similar conditions concerning human health and environmental safetyissues related to the

Colombia sprayprogram. These certifications were based on, among other information: all available scientific data on

glyphosate, the herbicide used bythe program; toxicological tests of the spraymixture (water, glyphosate, and a
surfactant); active field verifications and complaint investigations; comprehensive human health monitoring; and

thorough verbal and written consultations on the sprayprogram with USDAand EPA.

Because the Colombia aerial eradication program has not made anychanges in the chemical formulation or

application methods used for eradication of coca and opium poppysince the Secretaryof State last certified to

Congress on the Colombia sprayprogram (July30, 2005), these prior certifications serve as the foundation for the
2006 certification. These certifications and attachments can be found on the Internet at the following address:

http://www.state.gov/p/inl/rls/rpt/aeicc/c15752.htm

1. The herbicide is being used in accordance with EPA label requirements for comparable use in the United States
and with Colombian laws.

EPAtold the Department of State in previous consultations that application rates for both coca and poppyeradication in
Colombia are within the parameters listed on labels of glyphosate products registered byEPAfor use in the United

States. Since neither the application rates used bythe Colombia eradication program nor the EPA-registered label

recommendations have changed since 2004, the Secretarycan certifyto Congress that the herbicide mixture continues
to be used in accordance with EPAlabel requirements for comparable use in the United States.

With respect to accordance with Colombian laws, the Colombian Minister of the Environment, Housing, and Territorial

531Annex 53-E

Development determined in July2004 that the illicit crop eradication program is being conducted in compliance with the

Environmental Management Plan for aerial eradication (EMP). Since that determination, there have been no substantive

changes in the execution of the illicit crop eradication or the EMP.

The sprayprogram � s compliance with other Colombian laws governing aerial eradication was reconfirmed bythe

October 19, 2004 final resolution of a class action suit filed in 2002 against the aerial eradication program on

environmental and human health grounds. The Colombian Administrative Tribunal, Colombia� s highest
administrative court, upheld the Government of Colomb�a s appeal of a 2003 lower cou�ts ruling to halt aerial

eradication.

The Colombian Administrative Tribunal ruling (an English-language translation of which is included as Attachment 1)
concluded that:

It cannot be accuratelyinferred from the evidence outlined that glyphosate causes irreversible damage to

the environment when it is used for eradicating illicit crops; on the other hand, a number of facts lead to
the conclusion that sprayed areas regenerate in a relativelyshort period of time and that manyhectares

of forest are destroyed when trees are felled bygrowers of illicit crops. (p. 10)

Accordingly, the Administrative Tribunal reversed a lower cos finding and ordered that the Ministryof the

Environment, Housing and Regional Development, Ministryof Social Protection, and National Directorate of Dangerous

Drugs continue their oversight of the sprayprogram. This finding represents a decisive legal endorsement of the
methods used for spraying illicit crops in Colombia and of the integrityof existing environmental oversight

mechanisms.

2. The herbicide, in the manner it is being used, does not pose unreasonable risks or adverse effects to humans or
the environment including endemic species.

The Secretaryof State determined and certified in 2002, 2003, 2004, and 2005 that the herbicide mixture, in the manner

it is being used, does not pose unreasonable risks or adverse effects to humans or the environment. After previous
consultations with EPA, the Department and the Government of Colombia have incorporated all EPArecommendations

to strengthen sprayprogram controls and ensure increased protection against adverse effects to humans and the
environment. The Department of State is not aware of anynew evidence of risks or adverse effects to humans or the

environment that have surfaced since the 2005 certification. Included below is a brief review of the conditions that allow

the Secretaryto recertifyto Congress in 2006 that the herbicide mixture, in the manner it is being used, does not pose
unreasonable risks or adverse effects to humans or the environment, including endemic species.

In the 2004 EPAreport, EPAoffered the following assessment of human health concerns related to the spraying of coca

and opium poppyin Colombia: "Despite an aggressive search for cases, there does not appear to be anyevidence that
glyphosate aerial spraying has resulted in anyadverse health effects among the population where this spraying takes

place." EPAalso concluded, "that an aggressive program to identifyglyphosate poisoning has been implemented in the

areas of Colombia where illicit crop eradication spraying programs are prevalent." Asignificant number of health care
providers have received training and additional training is under wayor planned.

As recognized in the 2003 report, the eradication program lowered its potential risks to wildlife and has responded

appropriatelyto minimize off target drift. However, in the 2004 report the EPAstated, "Spraydrift and potential side effect
down wind of the target sites are common, universal factors in most if not all pesticide applications from aerial or

ground applications for all uses." In 2003, EPArecognized that the Department of State was employing "Best
Management Practices to minimize drift." The Department of State continues to follow these Best Management

Practices and is ever vigilant regarding the manner in which the herbicide is applied.

The Government of Colombia regularlyconducts studies to assess the sprayprogram's environmental impact through
ground truth verifications to estimate spraydrift and the accuracyof the spraymixture application and during verification

of all legitimate complaints about alleged spraying of crops or vegetation that are not coca or opium poppy. After one

recent verification, the Government of Colom�is Ministryof Environment, Housing, and Territorial Development
characterized spraydrift in the following fashion:

The drift effects that were observed in areas visited on a random basis were temporaryin nature and

small in extent, and basicallyconsisted of partial defoliation of the canopyof veryhigh trees. No
complementarycollateral damage from spraying activities was observed at the sites selected and

verified. In sprayed areas that were subsequentlyabandoned, it was noted that vegetation was starting to
grow again, the predominant types being grasses and a number of herbaceous species (Attachment 2,

p. 4)

The Department of State believes that the progr�ms rigid controls and operational guidelines have decreased the
likelihood of adverse impacts of the eradication program on humans and the environment and that theherbicide

mixture, in the manner it is being used, does not pose unreasonable risks or adverse effects to humans or the

environment.

532 Annex 53-E

This conclusion was confirmed byan objective, independent scientific studythat evaluated the Colombia illicit crop

eradication program and its potential human health and environmental considerations. The Inter-American Drug Abuse

Control Commission (CICAD) section of the Organization of American States (OAS commissioned a two-year risk
assessment of human health and environmental effects related to aerial eradication of illicit crops in Colombia. The

final report to CICAD is enclosed as Attachment 3 and can also be found at the following Internet Address:

http://www.cicad.oas.org/en/glifosateFinalReport.pdf

This studyexamined not just the possible human health and environmental effects of glyphosate, but the specific

manner in which glyphosate is applied in Colombia to eradicate illicit crops, and reached the following conclusion: "

(b)ased on all evidence and information presented above, the Panel concluded that the risk to humans and human
health from the use of glyphosate and Cosmo-fluxin the eradication of coca and poppywere minimal." (Conclusions,

6.1, p. 90). Similarly, with respect to potential risks to the Colombian environment, the panel concluded that "the risks to
the environment from the use of glyphosate and Cosmo-Fluxin the eradication of coca and poppyin Colombia were

small in most circumstances." (Conclusions, 6.2, p. 90).

This studyalso concluded that the "Risks of direct effects in terrestrial wildlife such as mammals and birds were
judged to be negligible as were those to beneficial insects such as bees." (Conclusions, 6.2, p. 90). This is a far-

reaching and important judgment which addresses the risk from the sprayprogram faced byall terrestrial fauna

potentiallyexposed to the spray: not onlythose species endemic to Colombia, but anyintroduced species present as
well.

This does not mean that the spraying of glyphosate poses zero risk. The studygoes on to state that "Moderate risks to

some aquatic wildlife mayexist in some locations where shallow and static water bodies are located in close proximity
to coca fields and are accidentallyover-sprayed. However, when taken in the context of the environmental risks from

other activities associated with the production of coca and poppy, in particular, the uncontrolled and unplanned clearing

of pristine lands in ecologicallyimportant areas for the purposes of planting the crop, the added risks associated with
the sprayprogram are small." (Conclusions, 6.2, p. 91).

Despite the limited risk represented bythe sprayprogram, the Department of State, in consultation with Congress, is
supporting further CICAD research to better understand the level of risk that could be posed to Colombis aquatic

amphibians as a result of potential oversprayof amphibian habitat. Preliminaryresults of this continued studyconfirm

that the glyphosate mixture as used in Colombia has low toxicityfor aquatic amphibians. The Department will submit to
Congress a separate report on this work when the studyhas been completed.

These studies, as well as third-partyresearch on glyphosate, warrant a certification bythe Secretaryof State that the

sprayprogram does not pose unreasonable risks or adverse affects to Colombia � s endemic species.

3. Claims of harm to health or licit crops caused bysuch fumigation are investigated, and fair compensation is

being paid for meritorious claims

The Government of Colombia continues to compensate all meritorious claims fairly. On October 4, 2001, the
Government of Colombia formallyinstituted a new process to compensate growers for legal crops sprayed in error.

From that date through the end of March 2006, the Colombian National Police� s Antinarcotics Directorate (DIRAN), the
Government of Colombia agencyresponsible for complaint investigations, has received 5,974 such claims. Of these,

5,511 investigations were completed as of March 31, 2006.

Claims are processed and verified byan interagencygroup including the DIRAN, agronomists from the Colombian
Institute of Agriculture and Husbandry(ICA), the Ministryof Environment, and the Office of Dangerous Drugs (DNE). In

2005, 12 claims were found to be valid and $123,000 was paid as compensation. To date, the sprayprogram has paid

$160,000 compensation in 28 cases.

The 462 outstanding claims are being processed and verified bythe interagencyclaims investigations group. Flight

database and on-site investigations continue, and compensation is being paid for all cases with merit after analysis of

all considerations. Typically, compensation hinges on basic issues, such as whether planes sprayed in the vicinityof
the claimant's propertywithin a five-daywindow of the alleged date of spraying; whether the claimant owns the allegedly

sprayed property; whether the legal crop sprayed was intermixed with illegal crops; and whether the affected crop

suffered damage from the spraymixture, as opposed to fungus, insects, or other causes. If the spraypilots have erred
and accidentallysprayed licit crops, compensation is paid for the loss of the crop, based on current market value of the

crop.

Field verification is extremelydangerous and resource intensive; and it is an unavoidablymethodical process. Because

of the high securityrisks involved for all personnel who conduct site visits, the primacyof securitywill dictate the pace of

investigations in the future. Although logistical considerations (securityconcerns, personnel availability, and helicopter
resources) are part of the reason whyclaims cannot be resolved in the field more quickly, the greatest logjam is the

number of claims which turn out to be false. For example, in May2006, the claims investigations group spent three

days investigating some 75 claims that program pilots had sprayed African palm near Tumaco, Nari � o. The
eradication program spent over $100,000 in helicopter flight hours investigating these claims and found that in every

case coca was interspersed with the palm.

533Annex 53-E

The Department of State plans to improve the claims resolution process through aircraft mounted imageryplatforms to

make in situ verification safer, cheaper, and faster in the future. The Government of Colombia has also begun

processes for seizure and forfeiture of propertyused for growing illicit crops, although security-related and bureaucratic
hurdles are significant. We expect improvements in asset forfeiture in Colombia will reduce the manyfalse claims that

have flooded the complaint system and facilitate even more prompt investigation of and restitution for legitimate claims.

4. Programs are being implemented by the USAID, the Government of Colombia, or other organizations in
consultation with local communities, to provide alternative sources of income in areas where securitypermits for

small-acreage growers whose illicit crops are targeted for spraying.

In 2006, the Colombian aerial eradication program has sprayed (or anticipates spraying) coca in the departments of
Putumayo, Nari� o, Guaviare, Meta, Bolivar, Cauca, Norte de Santander, Vichada, Antioquia, Vaupes, Cordoba, Caldas,

Arauca, Cesar, Valle del Cauca and La Guajira and opium poppyin the departments of Cauca, Huila, Tolima, and

Nari� o. In each of these areas, USAID, the Government of Colombia, and/or other organizations are implementing
alternative development programs to provide legal income generating opportunities to illicit crop growers who agree to

accept benefits after eradicating their crops of coca or opium poppy.

For the purposes of this report, the Department of State interprets the term "area" as a Colombian department. This
designation is consistent with the waythat the Colombian sprayprogram records and reports sprayactivity. It is also

the most appropriate definition because Department of State and USAID experience has shown that while alternative

development programs should be (and are) coordinated with spraying, these two components cannot always be co-
implemented in everylocation.

Alternative development is not appropriate in manylocations where illicit crops are grown. Coca and opium poppyare

often cultivated in remote, difficult to reach areas with limited infrastructure to support legal crops that have less value
and higher transport costs than those for illegal merchandise. Dispersing development activities to remote areas often

raises costs and securityrisks, while reducing impact. Furthermore, manydrug-producing regions have nutrient-poor

and fragile tropical soils, inappropriate for large-scale farming activityand unsuitable for increased human habitation.
As reflected in the language of the 2005 Consolidated Appropriations Act, narco-terrorist and paramilitarygroups

operate in manyillicit crop-growing zones and make the presence of alternative development projects inadvisable in

such locations. These narco-terrorist groups reap immense profit from the illegal trade, pose grave securityrisks for
development personnel, and slow down project implementation.

Despite these obstacles to alternative development in Colombia, USAID and the Government of Colombia are moving
forward with a robust alternative development program in coca and opium producing areas. USAID's alternative

development program has supported 97,391 hectares of licit crops, 63,493 hectares of forest land, and completed

1,117 infrastructure projects in coca and poppygrowing areas through March 31, 2006. These efforts have benefited
75,638 families. These achievements in each categoryhave surpassed program goals. Equallyimportant, USAID has

strengthened a total of 1,265 small, medium or large private sector enterprises so that alternative development and

communitybuilding activities will be more sustainable.

The alternative development projects being carried out byUSAID and Government of Colombia organizations in each

area where the sprayprogram eradicates illicit crops are described below.

Antioquia

An $18.5 million USAID project directed at alternative development, implemented bythe Pan-American Development

Foundation (PADF), supports short-term production activities for immediate income and employment needs. It also

seeks to establish longer-term crops such as natural rubber (caucho) and cacao to provide sustainability, as well as
complementaryproductive infrastructure. Projects of cacao, caucho, and agro-forestrywillcover an area of 2,017

hectares and benefit 594 families in El Bajo Cauca.

An $8.5 million USAID Dairyproject is carried out byLand O'Lakes (LOL) to promote sustainable dairyproduction,
processing and marketing involving small farmers. This program is also operat�no.in Nari

USAID also funds an activitytitled Aid to Artisans (ATA), which is carrying out a $4.3 million project to strengthen local

capacityfor production and marketing of crafts. ATAis also opera�ntico, Boya� , Caldas, Cauca,�Csar,
C � rdoba, Huila, Magdalena, �ao, Quind�o, Santander, Sucre, Tolima, and Valle del Cauca.

USAID's successful $41.5 million Colombia Agribusiness Partnership Program (CAPP), implemented byAssociates in

Rural Development (ARD), is to promote private sector involvement to help agricultural producers and others involved in
illicit products to shift into legal activities or remain uninvolved in illicit coca and poppyproduction. The project targets

rural families in coca/opium poppyregions and threatened zones and assists them bysupporting strategic alliances

between agribusiness firms and these families. In Antioquia, the program supports small farmers in producing fruit for
processing into pulp, jute and African palm. The program also oper�tntico, B�lvar, Caldas, Casanare,

Cauca, C �sar, C�rdoba, Guajira, Huila, Magdalena,�No, Norte de Santander, Qu�no, Risaralda, Santander,

Sucre, Tolima, and Valle del Cauca.

The USAID-funded Democratic Local Governance Program and implemented byAssociates in Rural Development

534 Annex 53-E

(ARD), supports institutional strengthening activities relevant to municipal-level development planning, municipal
management, public services, finance and revenue, public information, and project management. In Antioquia, the

program focuses on the Bajo Cauca region and supports projects to strengthen municipal administrations in the

region. In addition, a total of $527,000 of USAID funds were invested in seventeen social infrastructure projects in the
same area, leveraging funds contributed from the Department, local governments, and communities of up to 54 percent

of the total cost. This region will be included under the new Areas for Municipal Level Alternative Development (ADAM)

program.

The $18.6 million Colombia ForestryDevelopment Program (CFDP), funded directlybyUSAID and implemented by

Chemonics, has a nucleus in Northeastern Antioquia where it is focusing on promoting pine plantations and efficient

industrial processing models. CFDP activities in Antioquia include plantations,rdabosquesand natural
forests. CFDP works closelywith thenizaci� n In� gena de Antioquiin Chigoro� and Muta� and

Cocomacia and Corpourab� en Vi� a del Fuerte to implement natural forestryprojects totaling approximately

$1,100,000.Familias Guardabosquesactivities are concentrated in�Neand Turbo and total approximately
$650,000. Plantation work is located in�Neand totals approximately$10,000.

USAID's $12 million Colombia Enterprise Development (CED) project supports small and medium enterprise

development in secondarycities. CED is also operatin�ntico, Caldas, Qui�do, Risaralda, Santander, Valle del
Cauca, and Tolima.

The Colombian Government's Investment Fund for Peace (FIP), a $19.4 million investment, is generating employment

through infrastructure, licit crop production (coffee rehabilitation, agro-forestry), skills training, and education/nutrition
aid to poor families.

Bolivar

The previouslymentioned ADAMprogram will support cacao, rubber and other alternative development activities in

selected municipalities along with municipal strengthening activities in these same municipalities.

CFDP supports plantation efforts in Bolivar in the following municipalities: Za�bn, Sabanas de San
Angel, Becerril and Agustin Codazzi totaling an estimated $400,000.

USAID's alternative development program carried out byPADF is supporting short cycle production activities to address

immediate income and employment requirements; longer-term crops such as natural rubber and cacao to provide
sustainability; and complementaryproductive infrastructure. The project supports 2450 hectares of licit crops benefiting

661 families.

USAID � CAPP is also promoting private sector involvement with farmers to produce cacao, African palm, and yucca
(cassava).

In Bolivar, the Democratic Local Governance Program worked in 7 municipalities in southern Bolivar strengthening

municipal administrations in the areas of transparencyand accountability. The municipalities of Santa Rosa and
Simi� are the main beneficiaries of the provided technical assistance package. Seven other municipalities received

punctual and specific techinical assistance and training. In total, the program invested $624,589 in USAID funds for

social infrastructure projects and leveraged a counterpart contribution of up to 53 percent of the total cost. This region
will be included under the new ADAMprogram.

The Government of Colombia supports licit production activities such as palm oil and cassava production in Bolivar.

Caquet�

USAID's centerpiece Colombia Alternative Development (CAD), implemented byChemonics, is a $97.3 million project;

in Caque� it is fostering short-term crop production for food securityand long-term income generation activities such

as rubber production.

USAID funds a $1.8 million Sustainable Development for Indigenous Colombian Communities project, implemented by

the Amazon Conservation Team (ACT) to assist Colombian indigenous communities in food security, health, local

governance, and land management. Activities under this program are also being carried out in the departments of
Putumayo and Vaup� s. The Government of Colombia is also supporting institutional strengthening for small-scale

brown sugar producers and life plans (planes de vida) for indigenous communities.

In Caquet , the Democratic Local Governance Program implemented 16 social infrastructure projects, investing

USAID funds for a total of $587,400 and leveraging 23 percent of total cost. In addition, the program provided technical

assistance and training to communityleaders and public officials in citizen participation and municipal management.
The program completed its activities in Caon March 2004. However, field presence through governance

strengthening activities, particularlyin public services, continued until December 2005, bysupporting the creation and

operation of a legacyinstitution ( de Administracion Publica Cooperati-EMCOOPCAQUETA. This enterprise
will provide on-going training and technical assistance in water and basic sanitation to municipalities and will fund

infrastructure investments. This region is not included under the new ADAMprogram.

535Annex 53-E

Cauca

USAID's CAD activities support small-scale irrigation for the production and marketing of short-season, high-value

crops, including the growing, processing, and marketing of gourds for artisan and craft products and the value-added
processing of wood products from tree plantations in indigenous areas.

CFDP is supporting Afro-Colombian communities in Guapi to manage their natural forestryresources. Technical

assistance is also provided to communities in Timb�q. CFDP� s investment in natural forestryin the department
totals approximately$420,000.

USAID Alternative Development activities also include a $9.8 million project, implemented bythe Agricultural
Cooperative Development International and Volunteer in Overseas Cooperative Assistance (ACDI/VOCA), which

promotes specialtycoffee production, processing and marketing in Cauca's illicit crop growing areas.

The CAPP project is supporting private sector investments in hot peppers, jute, and cacao.

USAID Democratic Local Governance Program efforts in Cauca have focused mainlyon working with community

leaders and public officials to improve municipal management practices. As for social infrastructure projects, the

program funded the implementation of 64 projects that total approximately$2,288,630 and leveraged 41 percent of the
total costs. This region will be included under the new ADAMprogram.

The Aid to Artisans project is enhancing local capacityfor production and marketing of crafts as licit income generating

alternatives.

The Colombians Supporting Colombians program works in municipal development with emphasis on participatory

planning. This objective is put into practice with the construction of small-scale infrastructure projects with community

partnerships and mayoral involvement. The program also administers a credit fund, directlyand via local microfinance
institutions, to offer microenterprises credit to invest in working capital and fixed assets to enhance or expand their

businesses.

The Government of Colombia is supporting fruit production and complementaryactivities for the coffee renewal

program.

Caldas

USAID's SpecialtyCoffee program is also promoting specialtycoffee production, processing, and marketing in

Caldas's illicit crop growing areas.

The CAPP activityis supporting private sector initiatives with small farmers to produce and process tropical fruits, jute,
and peppers.

C� sar

The ADAMprogram will be carrying out alternative development and municipal strengthening activities in selected

municipalities. The assessment of these activities is just beginning to be discussed with Departmental and local

government authorities, the private sector and potential beneficiaries.

The Aid to Artisans project is carrying out activities to strengthen the production and marketing of crafts.

The Colombia Agribusiness Partnership Program (CAPP) is supporting private sector investments for small farmers
producing crops such as cacao, fruits and African palm. The GOC is also supporting cacao and oil palm production in

this region.

C � rdoba

The ADAMproject will be assessing the possibilityof alternative development activities such as rubber and cacao as

well as local government strengthening activities in the Department.

The Aid to Artisans project is supporting the strengthening of local capacityto produce and market crafts byartisans in
the department.

USAID � CAPP is supporting private sector activities in cacao and passion fruit production.

Guajira

USAID � CAPP is supporting private sector activities in crops such as passion fruit and cacao.

Guaviare

The Government of Colombia is supporting rubber (ucho) production and agro forestry.

Guainia

536 Annex 53-E

The Government of Colombia is providing institutional strengthening to indigenous communityassociations.

Huila

The ADAMprogram, which will begin this year, is assessing alternative development and local government
strengthening activities with staff from the Department, municipalities, the private sector and beneficiaries.

USAID's SpecialtyCoffee project is promoting specialtycoffee production, processing, and marketing in poppy-growing

areas.

USAID � CAD program is supporting the production and marketing of passion fruit.

The CAPP program is supporting cacao and fruit production, while the Aid to Artisans project is promoting the
production and marketing of crafts.

Democratic Local Governance Program work in Huila is focused on citizen participation, municipal management, and

public information. The program has also implemented 57 social infrastructure projects that total approximately
$1,997,000.

The Government of Colombia is supporting the strengthening of cultural values in indigenous communities, fruit

production, fishponds, and complementaryactivities for the coffee renewal program.

Magdalena

CFDP supports Familias Guardabosques activities in the municipalityof Santa Marta totaling an estimated $650,000.

Plantation work is supported in San Angel, Algarrobo, San Sebastian, Guamal and �arbara de Pinto, totaling an
estimated $250,000.

USAID's CAPP is also providing technical and financial support in Magdalena to private sector initiatives to produce
African palm, banana, cacao, and exotic fruits.

Choco

CFDP supports Afro-Colombian communities in Docampad � to manage their natural forestryresources. �FsP
investment totals approximately$180,000.

Meta

The Government of Colombia is supporting activities in cacao, cassava, buffer zones in natural parks, and technical
assistance for local governments.

The USAID CAPP program is promoting private sector investments with small farmers to produce African palm.

Nari� o

The ADAMprogram, which will begin this year, is engaged in assessing alternative development and local government

strengthening activities with staff from the Department, municipalities, the private sector and beneficiaries. The program
will provide support for the expansion of dairyproduction, processing and marketing activities that were initiated bythe

Land O� Lakes program that recentlyended.

The SpecialtyCoffee project is promoting specialtycoffee production, processing and marketing in illicit crop growing
areas of Na�io.

CFDP supports the communitycouncil of Bajo Mira yFrontera, located in the municipalityof Tumaco, in managing its

natural forestryresources. CFDP has invested approximately$400,000.

The United Nations Office on Drugs and Crime (UNODC) is implementing a USAID-funded $1.8 million program that

provides a range of agricultural and forestryprojects.

In Nar� o, the Democratic Local Governance Program is focused on development planning and finance and revenue,
particularlyin assistance to municipal administrations in the formulation of taxcodes. Forty-two (42) social

infrastructure projects, totaling approximately$1,322,000, have been implemented in this department.

The USAID DairyPromotion program is promoting sustainable small farm dairyproduction, processing and marketing,

while the CAPP program is supporting small farmer, private sector projects in cacao and African palm production.

Aid to Artisans project is carrying out activities to promote the production and marketing�oo.crafts in Nari

The Government of Colombia is supporting various productive activities in coffee renewal and oil palm production.

Norte de Santander

The USAID Colombia Agribusiness Partnership Program (CAPP) program is supporting private sector initiatives with
small farmers in the production and processing of African palm and cacao.

537Annex 53-E

The USAID alternative development activities implemented through PAFD are working in association with ASOHESAN

(the Santander rubber producer's association) to support the cultivation of 1,652 hectares of rubber that would benefit

411 families. The project also includes the establishment of 826 hectares of short-term crops and 137 food security
systems (vegetable gardens, small animal husbandry).

The Government of Colombia is supporting palm oil crop production in the department.

Putumayo

The ADAMprogram will be supporting some activities that were developed under the Chemonics CAD project, such as

hearts of palm production, processing and marketing; forest management and value added processing and utilization
of forest and wood products; black pepper and plantain; tropical flowers and foliage, vanilla production, and medicinal

plants and essential oils. Local government strengthening activities will also be developed with selected municipalities

in Putumayo.

Democratic Local Governance Program work in Putumayo is focused on strengthening public service providers and on

enhancing municipal finance and revenue capabilities. Atotal of 20 Social Infrastructure (SIF) projects have been
implemented in this Department.

U.S. ArmyCorps of Engineers' $6.7 million rural infrastructure project, funded byUSAID, carried out road, sewage, and

water treatment activities that generated employment in the region. Current complementarywork is being carried out to
improve the water treatment plant in Villa Garzon.

The Sustainable Development for Indigenous Colombian Communities project, implemented bythe Amazon

Conservation Team, is supporting indigenous communities with improved food security, health, local governance, and
land management.

Santander

The ADAMprogram, which will begin this year, is engaged in assessing alternative development and local government

strengthening activities with staff from the Department, municipalities, the private sector and beneficiaries.

Tolima

The ADAMprogram, which will begin this year, is assessing alternative development and local government

strengthening activities with staff from the Department, municipalities, the private sector and beneficiaries.

The CAD project is supporting an activityto increase annual crop production for food securityand to increase income

and employment generation in the longer term through forestry, livestock, pasture improvement, and vegetable

production.

The SpecialtyCoffee activityis promoting specialtycoffee production, processing and marketing in illicit crop growing

areas of Tolima.

The Colombia Enterprise Development (CED) project, funded byUSAID and implemented byCARANACorporation, is
supporting small and medium enterprise development in Colombia's secondarycities including those in Tolima.

The Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the department,
while the ARD/CAPP is supporting private sector projects in fruits, natural rubber and cacao production.

Democratic Local Governance Program activities in Tolima focus on technical assistance in development planning to

communityleaders and public officials. In addition, the program has provided funds totaling approximately$747,000 for
18 social infrastructure projects.

The Colombians Supporting Colombians program works in municipal development with emphasis on participatory

planning. This objective is put into practice with the construction of small-scale infrastructure projects with community
partnerships and mayoral involvement. The program also administers a credit fund, directlyand via local microfinance

institutions, to offer microenterprises credit to invest in working capital and fixed assets to enhance or expand their
businesses.

The Government of Colombia is supporting cacao and coffee activities.

Valle del Cauca

The ADAMproject, which is expected to begin earlynext year, will begin assessing potential alternative development

and local government strengthening activities with the Departmental and local government authorities as well as
beneficiaries.

In Valle del Cauca, the Democratic Local Governance Program has focused on technical assistance in development

planning to public officials. Social infrastructure projects began April 2005.

The CAPP activityis supporting private sector initiatives with small farmers to produce and process tropical fruits, jute,

538 Annex 53-E

and peppers.

Vaupes

The Sustainable Development for Indigenous Colombian Communities project is supporting traditional healers and
helping to strengthen indigenous communityorganizations that are also involved in managing indigenous lands.

Vichada

The Government of Colombia is providing institutional strengthening to indigenous communityassociations.

USAID New Programs:

MIDAS

The new USAID initiative Mas Inversion para el Desarrollo Alternativo Sostenible (MIDAS) is a five-year, $160 million
program that has been recentlyawarded for implementation. MIDAS objective is to generate economic and social

alternatives to illicit crop production bypromoting market-driven, private sector-led business initiatives in selected
"economic corridors" of Colombia, and enhance the competitiveness of the Colombian economyto meet national and

international market demands, bypromoting economic policyand institutional reforms. The first year work plan is being

developed and implementation of activities is expected to begin around June 2006. MIDAS will provide technical and
financial support to design and implement private sector alternative development initiatives in the areas of

agribusinesses, commercial forestryand a wide arrayof rural and peri-urban activities through small and medium

sized enterprises (SME). As a complement, MIDAS will support the Government of Colombia with policyreforms and
institutional strengthening in the fiscal, financial, investment climate, trade and land market access areas, so as to

maximize employment generation and income growth in Colombia. The "economic corridors" where MIDAS resources

will be invested include the departments (states) of An�intico, B�l var, Caldas, Casanare, Cauc�,sar,
C� rdoba, Guajira, Huila, Magdalena,�No, Norte de Santander, Qu�no, Risaralda, Santander, Sucre, Tolima,

and Valle del Cauca.

ADAM

The new Areas for Municipal Level Alternative Development (ADAM) program, which is beginning implementation, will

be supporting alternative development and local government strengthening activities in selected municipalities by

helping farmers and others involved in illicit products to shift into licit activities or remain uninvolved in illicit crop
production. ADAMwill support institutional strengthening activities in these municipalities on development planning,

municipal management, public services, finance and revenues, citizen participation and transparency, and for social

and productive infrastructure projects. Linking these local government-strengthening activities with income generating
alternative development activities in a municipalityis expected to increase the impact and sustainabilityof alternative

development efforts. In Antioquia, the program will support cacao, rubber, and other alternative development activities

particularlyin the Bajo Cauca and northwest areas of the Department. The program also will operate in Bolivar, Cauca,
Cesar, Choco, Cordoba, Huila, Narino, Putumayo, Santander, Valle del Cauca and Toli�as first year results

will be reported in nex� s sprayand certification report.

Attachments:

1. Colombian Administrative Tribunal ruling of October 19, 2004, English language version

2.Government of Colombia� s Ministry of Environment, Housing, and Territorial Development Ruling No. 707,

July26, 2004, English la nguage version

3. Environmental and Human Health Assessment of the Aerial Spray Program for Coca and Poppy Control in

Colombia, a report prepared for the Inter-American Drug Abuse Control Commission (CICAD) section of the

OAS, March 31, 2005

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539540 Annex 53-F

departMent ofstateM eMoranduM ofJustificatioconcerning
thes ecretary ostates 2007 certification conditionsrelated

toaeriale radication ollicitcoca incoloMbia, 2007

(U.S. Department of State)

541542 Annex 53-F

Home» Under Secretary for Political Affairs» Bureau of International Narcotics and Law Enforcement Affairs» Remarks,

Statements, and Releases» Reports » Aerial Eradication of Illicit Coca in Colomb»iaMemorandumof Justification Concerning

the Secretary of State's 2007 Certification of Conditions Related to the Aerial Eradication of Illicit Coca in Colombia

Memorandum of Justification Concerning the Secretary of State's 2007

Certification of Conditions Related to the Aerial Eradication of Illicit Subscribe to Updates

Coca in Colombia

August 10, 2007

Bureau for International Narcotics and Law Enforcement Affairs
Washington, DC

August 10, 2007

The Andean Counterdrug Initiative sectionof the Foreign Operations, Export Financing and Related Programs
Appropriations Act, 2006 (P.L. 109-102) lays out conditions under which assistance using funds appropriated under the

heading Andean Counterdrug Initiative maybe made available for the procurement of chemicals for use in aerial

eradication of illicit crops. FY2006 conditions also applyfor FY2007 under the Revised Continuing Appropriations
Resolution, 2007 (P.L. 110-5)(CR). In particular, the legislation provides:

“That not more than 20 percent of the funds appropriated bythis Act that are used for the procurement of
chemicals for aerial coca and poppyfumigation programs maybe made available for such programs unless the

Secretaryof State certifies to the Committees on Appropriations that: (1) the herbicide mixture is being used in

accordance with EPAlabel requirements for comparable use in the United States and with Colombian laws;
and (2) the herbicide mixture, in the manner it is being used, does not pose unreasonable risks or adverse

effects to humans or the environment including endemic species: Provided further,That such funds maynot be
made available unless the Secretaryof State certifies to the Committees on Appropriations that complaints of

harm to health or licit crops caused bysuch fumigation are evaluated and fair compensation is being paid for

meritorious claims.”

This memorandum provides justification for the Secretaryof State’s determination and certification to Congress that the

above conditions have been met as required as well as a further condition imposed bythe legislation: “that such funds
maynot be made available for such purposes unless programs are being implemented bythe United States Agencyfor

International Development, the Government of Colombia, or other organizations, in consultation with local communities,

to provide alternative sources of income in areas where conditions exist for successful alternative development and
where securitypermits for growers and communities whose illicit crops are targeted for fumigation. In 2002, 2003,

2004, and 2005 the Secretaryof State determined and certified to Congress similar conditions concerning human

health and environmental safetyissues related to the Colombia sprayprogram. In 2006, the Secretaryof State
determined and certified to Congress identical conditions concerning human health and environmental safetyissues,

including endemic species. These certifications were based on, among other information: all available scientific data
on glyphosate, the herbicide used bythe program; toxicological tests of the spraymixture (water, glyphosate, and a

surfactant) as well as comparative soil and water samples before and after spray; active field verifications and

complaint investigations; comprehensive human health monitoring; and thorough verbal and written consultations on
the sprayprogram with USDAand EPA. Because the Colombia aerial eradication program has not made anychanges

in the chemical formulation or application methods used for eradication of coca since the Secretaryof State last
provided certification to Congress on the Colombia sprayprogram on August22, 2006, these prior certifications serve

as the foundation for the 2007 certification. The onlychange since previous certifications is that there has been no

aerial eradication of illicit poppycrops since August 2006, and there are no current plans to restart aerial eradication of
poppyin the coming year. These certifications and attachments can be found on the Internet at the following address:

http://www.state.gov/p/inl/rls/rpt/aeicc/

1. The herbicide mixture is being used in accordance with EPA label requirements for comparable use in the United
States and with Colombian laws.

EPAinformed the Department of State in previous consultations that application rates for coca eradication in Colombia

are within the parameters listed on labels of glyphosate products registered byEPAfor use in the United States. Since

543Annex 53-F

neither the application rates used bythe Colombia eradication program nor the EPA-registered label recommendations

have changed since 2004, the Secretarycertifies to Congress that the herbicide mixture continues to be used in

accordance with EPAlabel requirements for comparable use in the United States.

With respect to Colombian laws, the Colombian Minister of the Environment, Housing, and Territorial Development

determined in July2004 that the illicit crop eradication program is being conducted in compliance with the
Environmental Management Plan for aerial eradication (EMP). Since that determination, there have been no substantive

changes in the execution of the illicit crop eradication or the EMP.

The sprayprogram’s compliance with other Colombian laws governing aerial eradication was reconfirmed bythe

October 19, 2004 final resolution of a class action suit filed in 2002 against the aerial eradication program on
environmental and human health grounds. The Colombian Administrative Tribunal, Colombia’s highest administrative

court, upheld the Government of Colombia’s appeal of a 2003 lower court’s ruling to halt aerial eradication.

The Colombian Administrative Tribunal ruling (an English language translation of which is included as Attachment 1)
concluded that:

It cannot be accuratelyinferred from the evidence outlined that glyphosate causes irreversible damage to the

environment when it is used for eradicating illicit crops; on the other hand, a number of facts lead to the
conclusion that sprayed areas regenerate in a relativelyshort period of time and that manyhectares of forest are

destroyed when trees are felled bygrowers of illicit crops. (p. 10)

Accordingly, the Administrative Tribunal reversed a lower court’s finding, and ordered that the Ministryof the
Environment, Housing and Regional Development, Ministryof Social Protection, and National Directorate of Dangerous

Drugs continue their oversight of the sprayprogram.

On February21, 2007, the State Council upheld this decision in a ruling on a class action suit filed in May2006 against

the aerial eradication program on environmental grounds. The ruling (an English translation of which is included in
Attachment 2) concluded that the aforementioned case decided in 2004 was too similar to warrant a separate decision

on this case. The ruling states that:

In view of the foregoing, this Division shall declare proven theres judicata plea and shall reject the claims made
in the suit, in view of the fact that it was not feasible for the plaintiffs to pursue a new action in order to revive

petitions that have alreadybeen resolved. (p.5)

Both of these findings represent a decisive legal endorsement of the methods used for spraying illicit crops in
Colombia and of the integrityof existing environmental oversight mechanisms.

2. The herbicide mixture, in the manner it is being used, does not pose unreasonable risks or adverse effects to
humans or the environment, including endemic species.

The Secretaryof State determined and certified in 2002, 2003, 2004, 2005, and 2006 that the herbicide mixture, in the

manner it is being used, does not pose unreasonable risks or adverse effects to humans or the environment. After

previous consultations with EPA, the Department of State and the Government of Colombia have incorporated all EPA
recommendations to strengthen sprayprogram controls and ensure increased protection against adverse effects to

humans and the environment. The Department of State is not aware of anypublished scientific evidence of risks or

adverse effects to humans or the environment that have surfaced since the 2006 certification. Included below is a brief
review of the conditions that allow the Secretaryto recertifyto Congress in 2007 that the herbicide mixture, in the

manner it is being used, does not pose unreasonable risks or adverse effects to humans or the environment.

In the 2004 EPAreport, EPAoffered the following assessment of human health concerns related to the spraying of coca

in Colombia: “Despite an aggressive search for cases, there does not appear to be anyevidence that glyphosate aerial

spraying has resulted in anyadverse health effects among the population where this spraying takes place.” EPAalso
concluded “that an aggressive program to identifyglyphosate poisoning has been implemented in the areas of

Colombia where illicit crop eradication spraying programs are prevalent.” Asignificant number of health care providers
have received training and additional training is under wayor planned.

As recognized in the 2003 report, the eradication program lowered its potential risks to wildlife and has responded
appropriatelyto minimize off-target drift. However, in the 2004 report the Agencystated, “Spraydrift and potential side

effect down wind of the target sites are common, universal factors in most if not all pesticide applications from aerial or

ground applications for all uses." In 2003, EPArecognized that the Department of State was employing “Best
Management Practices to minimize drift.” The Department of State continues to follow these Best Management

Practices and is ever vigilant regarding the manner in which the herbicide is applied.

In 2003, 2004, 2005 and 2006, the U.S. Narcotics Affairs Section (NAS) and the Colombia National Police (CNP)

collected and analyzed a total of almost 80 water and 180 soil samples drawn from sprayed areas throughout

544 Annex 53-F

Colombia in order to determine the impact of glyphosate and AMPA(Amino-Methyl Phosphonic Acid) on the

environment. AMPAis a product of glyphosate degradation bynatural microbial and environmental activity. In

accordance with the Colombian Environmental Management Plan, these samples were taken before, immediately
after, and 60 days after sprayin two different fields during various aerial eradication campaigns. These studies (the

results of which are included as Attachment 3) determined that glyphosate and AMPAresidue did not adverselyimpact

the soil of the sprayed coca plots. Nor did the glyphosate or AMPAresidue adverselyimpact the water taken from
streams adjacent to sprayed coca crops.

In analyzing the soil and water samples, NAS and CNP (through private laboratories) use the High Pressure Liquid

Chromatography(HPLC) method of analysis for glyphosate and AMPA. The HPLC standards conform to EPA

standards, and this method is widelyaccepted as sufficientlyaccurate to measure and monitor the impact of
glyphosate on human health and the environment.

Soil analysis reveals a 108 dayhalf-life for glyphosate after sprayapplication, and a maximum persistence in the
environment of 217 days. This analysis does not differentiate between the glyphosate from the aerial sprayprogram

and that commonlyused bycoca growers. However, total residual levels in all these analyses were not found to be of

environmental concern. The maximum amount of glyphosate found was close to one part per million (1 mg of
glyphosate for each kilogram of drysoil).

Analysis reveals that glyphosate residue levels in water have never approached the “Maximum Contaminant Level”
(MCL) as set bythe US “Safe Drinking Water Act” at 700 micrograms per litre (0.7 milligrams per litre) for glyphosate

residuals.

The Government of Colombia regularlyconducts studies to assess the sprayprogram's environmental impact through

ground truth verifications to estimate spraydrift and the accuracyof the spraymixture application, and during verification
of all legitimate complaints about alleged spraying of crops or vegetation that are not coca. After one recent verification,

the Government of Colombia’s Ministryof Environment, Housing, and Territorial Development characterized spraydrift

in the following fashion:

The drift effects that were observed in areas visited on a random basis were temporaryin nature and small in

extent, and basicallyconsisted of partial defoliation of the canopyof veryhigh trees. No complementarycollateral

damage from spraying activities was observed at the sites selected and verified. In sprayed areas that were
subsequentlyabandoned, it was noted that vegetation was starting to grow again, the predominant types being

grasses and a number of herbaceous species (Attachment 4, p. 4)

The Department of State believes that the program’s rigid controls and operational guidelines have decreased the
likelihood of adverse impacts of the eradication program on humans and the environment and that theherbicide

mixture, in the manner it is being used, does not pose unreasonable risks or adverse effects to humans or the
environment, including endemic species.

This conclusion was confirmed byan objective, independent scientific studythat evaluated the Colombia illicit crop
eradication program and its potential human health and environmental considerations. The Inter-American Drug Abuse

Control Commission (CICAD) of the Organization of American States (OAS ) commissioned a two-year risk

assessment of human health and environmental effects related to aerial eradication of illicit crops in Colombia. The
final report to CICAD can be found at the following internet address:

http://www.cicad.oas.org/en/glifosateFinalReport.pdf .

In 2007, this studywas peer reviewed and published in volume 190 of the scientific journal Reviews of Environmental

Contamination and Toxicology.

This studyexamined not just the possible human health and environmental effects of glyphosate, but the specific

manner in which glyphosate is applied in Colombia and the specific glyphosate mixture used to eradicate illicit crops,
and reached the following conclusion: “(b)ased on all evidence and information presented above, the Panel concluded

that the risk to humans and human health from the use of glyphosate and Cosmo-fluxin the eradication of coca and

poppywere minimal.” (Conclusions, 6.1, p. 90). Similarly, with respect to potential risks to the Colombian environment,
the panel concluded that “the risks to the environment from the use of glyphosate and Cosmo-Fluxin the eradication of

coca and poppyin Colombia were small in most circumstances.” (Conclusions, 6.2, p. 90).

Although this conclusion broadlyapplies to Colombia’s endemic animal species, the CICAD report noted one area of

potential concern was that of the toxicityof the glyphosate mixture to Colombian amphibians. Astudywas therefore

submitted to Congress in August 2006 (“APreliminaryEvaluation of the Risk Posed to Colombia’s Amphibians and
Threatened Species bythe Government of Colombia’s U.S.-Supported Program of Aerial Eradication of Illicit Crops”)

pursuant to a request in Senate Report 109-96 accompanying the Department of State, Foreign Operations, and

Related Programs Appropriations Bill, 2006 (P.L. 109-102). This studyconcluded that worst case exposures of the
mixture as used in Colombia were sufficientlytoxic to the African clawed frog (which does not occur in Colombia but

545Annex 53-F

which served as an indicator species because it is the amphibian most sensitive to glyphosate) to justifyfurther studies
of its toxicityto Colombian frogs. The various components of the CICAD studies are ongoing, with an expected

completion date of December 2007. However, the August 2006 studynoted that the worst case exposure scenario used
in the studylikelywould be quite rare.

3. Complaints of harm to health or licit crops caused bysuch fumigation are investigated, and fair compensation is
being paid for meritorious claims.

The Government of Colombia continues to compensate all meritorious claims fairly. On October 4, 2001, the GOC

formallyinstituted a new process to compensate growers for legal crops sprayed in error. From that date through the
end of May2007, the Colombian National Police’s Antinarcotics Directorate (DIRAN), the Government of Colombia

agencyresponsible for complaint investigations, had received 6,778 such complaints. Of these, 6,344 investigations

were completed as of May31, 2007.

Complaints are processed and verified byan interagencygroup including the DIRAN, agronomists from the Colombian

Institute of Agriculture and Husbandry(ICA), the Ministryof Environment, and the Office of Dangerous Drugs (DNE). In
2006, 7 complaints were found to be valid and payments were made, for a total of $21,300 as compensation. From

Januarythrough May2007, nine complaints have been compensated for a total of $39,000. To date, the sprayprogram
has compensated a total of 43 cases, amounting to approximately$195,000 in compensation. The 431 outstanding

complaints (as of June 2007) are being processed and verified bythe interagencycomplaints investigations group.

Flight database and on-site investigations continue. Typically, compensation hinges on verybasic issues, such as
whether planes sprayed in the vicinityof the complainant’s propertywithin a five-daywindow of the alleged date of

spraying; whether the complainant owns the allegedlysprayed property; whether the legal crop sprayed was intermixed

with illegal crops; and whether the affected crop suffered damage from the spraymixture, as opposed to fungus,
insects, or other causes. If the spraypilots have erred and accidentallysprayed licit crops, compensation is paid to the

farmer for the loss of the crop, based on current market value of, and the start-up investment in, the crop.

Field verification is extremelydangerous and resource intensive; and it is an unavoidablymethodical process. Because

of the high risks involved for all personnel who conduct site visits, the primacyof securitywill dictate the pace of

investigations. Although logistical considerations (securityconcerns, personnel availability, and helicopter resources)
are part of the reason whycomplaints cannot be resolved in the field more quickly, the greatest contributor to the

backlog of cases is the number of false complaints which slow the progress of field investigators. For example, in May
2006, the complaints investigations group spent three days conducting field verification of some 75 cases alleging

sprayed African palm near Tumaco, Nariño. The eradication program spent over $100,000 in helicopter flight hours

alone investigating these claims and found that in everycase coca was interspersed with the palm.

The Government of Colombia has recentlyapproved a new resolution suggested bythe Department of State to

streamline the administration of the complaints process. We also plan to contribute to the improvement of the
complaints resolution process through aircraft mounted imageryplatforms to make in situ verification safer, cheaper,

and faster. The Government of Colombia has begun to seize propertyused for growing illicit crops, although security-

related and bureaucratic hurdles are significant. We expect this will reduce the number of false claims that have flooded
the complaint system, therebyfacilitating more prompt investigation of, and restitution for, legitimate claims.

4. Programs are being implemented by the USAID, the GOC, or other organizations in consultation with local
communities, to provide alternative sources of income in areas where security permits for small-acreage growers

whose illicit crops are targeted for spraying.

Thus far in calendar year 2007, the Colombian aerial eradication program has sprayed (or anticipates spraying) coca in

the departments of Putumayo, Nariño, Guaviare, Meta, Bolivar, Cauca, Norte de Santander, Vichada, Antioquia, Vaupes,

Cordoba, Caldas, Arauca, Cesar, Valle del Cauca, and La Guajira. In each of these areas, USAID, the GOC, and/or
other organizations are implementing alternative development programs to provide legal income generating

opportunities to small farm families who agree to accept benefits after verification byGOC and USAID implementing

partners that the farms are free of illicit crops.

For the purposes of this report, the Department of State interprets the term "area" as a Colombian department. This is

consistent with the waythat the Colombian sprayprogram records and reports sprayactivity. It is also the most
appropriate definition because Department of State and USAID experience has shown that while alternative

development programs should be (and are) coordinated with spraying, these two components cannot always be co-

implemented in everylocation.

Alternative development is not appropriate in manylocations where illicit crops are grown. Coca is often cultivated in
remote, difficult to reach areas with limited infrastructure to support legal crops that have less value and higher

transport costs than illegal crops. Dispersing development activities to remote areas often raises costs and security

risks, while reducing impact. Furthermore, manydrug-producing regions have nutrient-poor and fragile tropical soils,

546 Annex 53-F

inappropriate for large-scale farming activityand unsuitable for increased human habitation. As reflected in the

language of the 2005 Consolidated Appropriations Act, narco-terrorist and paramilitarygroups operate in manyillicit

crop-growing zones and make the presence of alternative development projects inadvisable in such locations. These
narco-terrorist groups reap immense profit from the illegal trade, pose grave securityrisks for development personnel,

and slow down project implementation.

Despite these obstacles to alternative development in Colombia, USAID and the GOC are moving forward with a robust

alternative development program in coca and opium producing areas. Now in the sixth year of Plan Colombia
alternative development coordination with the GOC and the fifth year of project implementation, USAID's alternative

development program has supported a total of 105,133 hectares of licit crops, 168,627 hectares of forest land, and

completed 1,130 infrastructure projects in coca growing areas through December 31, 2006. These efforts have
benefited 83,587 families. Equallyimportant, USAID has strengthened a total of 2,502 small, medium or large private

sector enterprises so that alternative development and communitybuilding activities will be more sustainable.

USAID New Programs:

MIDAS

The new USAID initiative Increased Investment for Sustainable Alternative Development (MIDAS) is a five-year, $180
million program. MIDAS’ objective is to generate economic and social alternatives to illicit crop production bypromoting

market-driven, private sector-led business initiatives in selected “economic corridors” of Colombia, and enhance the

competitiveness of the Colombian economyto meet national and international market demands, bypromoting
economic policyand institutional reforms. Implementation began during 2006. MIDAS will provide technical and

financial support to design and implement private sector alternative development initiatives in the areas of

agribusinesses, commercial forestryand a wide arrayof rural and peri-urban activities through small and medium
sized enterprises (SME). As a complement, MIDAS will support the Government of Colombia with policyreforms and

institutional strengthening in fiscal, financial, investment climate, trade, and land market access areas so as to

maximize employment generation and income growth in Colombia. The “economic corridors” where MIDAS resources
will be invested include the departments (states) of Antioquia, Atlántico, Bolívar, Caldas, Casanare, Cauca, César,

Córdoba, Guajira, Huila, Magdalena, Nariño, Norte de Santander, Quindío, Risaralda, Santander, Sucre, Tolima, and

Valle del Cauca.

ADAM

The new Alternative Development at the Municipal Level program (ADAM), which began implementation during 2006, is

supporting alternative development and local government strengthening activities in selected municipalities byhelping

farmers and others involved in illicit products to shift into licit activities or remain uninvolved in illicit crop production.
ADAMwill support institutional strengthening activities in these municipalities on development planning, municipal

management, public services, finance and revenues, citizen participation and transparency, and for social and

productive infrastructure projects. Linking these local government strengthening activities with income generating
alternative development activities in a municipalityis expected to increase the impact and sustainabilityof alternative

development efforts. In Antioquia, the program will support cacao, rubber, and other alternative development activities

particularlyin the Bajo Cauca and northwest areas of the Department. The program also will operate in Bolivar, Cauca,
Cesar, Choco, Cordoba, Huila, Narino, Putumayo, Santander, Valle del Cauca and Tolima. ADAM’s first year results will

be reported in next year’s spraycertification report.

Antioquia

An $18.5 million USAID project directed at alternative development, implemented bythe Pan-American Development

Foundation (PADF) supports short-term production activities for immediate income and employment needs. It also
seeks to establish longer-term crops such as natural rubber (caucho) and cacao to provide sustainability, as well as

complementaryproductive infrastructure. Projects of cacao, rubber, and agro forestrywould cover over 2,000 hectares

and benefit over 600 families in El Bajo Cauca.

An $8.5 million USAID dairyproject was carried out byLand O'Lakes (LOL) to promote sustainable dairyproduction,

processing and marketing involving small farmers. This program closed out in March 2006, but some activities are

being continued bythe USAID funded ADAMprogram. This program is also operated in Nariño.

USAID also funds an activitytitled Aid to Artisans (ATA), which is carrying out a $4.3 million project to strengthen local

capacityfor production and marketing of crafts. ATAis operating in Atlántico, Boyacá, Caldas, Cauca, César, Córdoba,

Huila, Magdalena, Nariño, Quindío, Santander, Sucre, Tolima, and Valle del Cauca.

USAID's successful $41.5 million Colombia Agribusiness Partnership Program (CAPP), implemented byAssociates in

Rural Development (ARD), was merged into the Increased Investment for Sustainable Alternative Development
Program (MIDAS) during June 2006 and continues to promote private sector involvement to help agricultural producers

and others involved in illicit products to shift into legal activities or remain uninvolved in illicit coca production. The

547Annex 53-F

project targets rural families in coca regions and threatened zones and assists them bysupporting strategic alliances

between agribusiness firms and these families. In Antioquia, the program supports small farmers in producing fruit for
processing into pulp, jute and African palm. The program also operates in Atlántico, Bolívar, Caldas, Casanare, Cauca,

César, Córdoba, Guajira, Huila, Magdalena, Nariño, Norte de Santander, Quindío, Risaralda, Santander, Sucre, Tolima,

and Valle del Cauca.

The USAID-funded Democratic Local Governance Program implemented byAssociates in Rural Development (ARD)

closed out in February2006, but the activities it supported - municipal-level development planning, municipal

management, public services, finance and revenue, public information, and project management - continue to be
implemented bythe Alternative Development at the Municipal Level (ADAM) and ARD.

The $18.6 million Colombia ForestryDevelopment Program (CFDP), funded directlybyUSAID and implemented by
Chemonics, promoted pine plantations and efficient industrial processing models in Northeastern Antioquia. This

program closed out in August 2006 and activities are being continued bythe MIDAS program.

USAID's $12 million Colombia Enterprise Development (CED) project supported small and medium enterprise
development in secondarycities in Antioquia. CED also operated in Atlántico, Caldas, Quindío, Risaralda, Santander,

Valle del Cauca, and Tolima. This program closed out in August 2006 and activities are being continued bythe MIDAS

program.

The Colombian Government's USD $19.4 million Investment Fund for Peace (FIP) is generating employment through

infrastructure, licit crop production (coffee rehabilitation, agro forestry), skills training, and education/nutritiooraid to p
families.

Bolivar

The previouslymentioned ADAMprogram is supporting cacao alternative development along with municipal
strengthening activities in selected municipalities.

CFDP supported plantation efforts totaling an estimated $400,000 in Bolivar in the following municipalities: Zambrano,
Fundación, Sabanas de San Angel, Becerril and Agustin Codazzi.

USAID's alternative development program carried out byPADF is supporting short cycle production activities to address

immediate income and employment requirements; longer-term crops such as natural rubber and cacao to provide
sustainability; and complementaryproductive infrastructure. The project supports 2450 hectares of licit crops benefiting

661 families.

USAID’s CAPP (now MIDAS) is also promoting private sector involvement with farmers to produce cacao, African palm,
and yucca (cassava).

In Bolivar, the Democratic Local Governance Program strengthened nine municipal administrations in southern Bolivar
in the areas of transparencyand accountability(TA). The municipalities of Santa Rosa and Simití are the main

beneficiaries of the provided technical assistance package, but seven other municipalities also received punctual and

specific TAtraining. In total, the program invested USAID funds of $624,589 in social infrastructure projects and
leveraged a counterpart contribution of up to 53 percent of the total cost. This program closed out and this region will be

included under the new ADAMprogram.

The GOC is active in Bolivar supporting licit production activities such as palm oil and cassava production.

Caquetá

USAID's centerpiece Colombia Alternative Development (CAD), implemented byChemonics, was a $97.3 million
project; in Caquetá it fostered short-term crop production for food securityand long-term income generation activities

such as rubber production. This program closed out in May2006.

The Sustainable Development for Indigenous Colombian Communities project, implemented bythe Amazon
Conservation Team (ACT), assisted Colombian indigenous communities in food security, health, local governance,

and land management. Activities under this program are also being carried out in the departments of Putumayo and

Vaupés. The GOC is also supporting institutional strengthening for small-scale brown sugar producers and life plans
for indigenous communities.

Cauca

CFDP started supporting Afro-Colombian communities in Guapi to manage their natural forestryresources. Technical

assistance is also provided to communities in Timbiquí. The CFDP closed out in August 2006 and the MIDAS

programs continued to support these communities.

USAID Alternative Development activities also include a $9.8 million project, implemented byACDI/VOCA, which

promotes specialtycoffee production, processing and marketing in Cauca's illicit crop growing areas.

The CAPP (Now MIDAS) project supported private sector investments in hot peppers, jute, and cacao.

548 Annex 53-F

USAID Democratic Local Governance Program efforts in Cauca have focused mainlyon working with community

leaders and public officials to improve municipal management practices. The program also funded the implementation

of 64 social infrastructure projects totaling approximately$2,288,630 and leveraged 41% of the total costs. This
program closed out in February2006 and ADAMwill continue this type of activityin Cauca.

USAID’s Aid to Artisans project is enhancing local capacityfor production and marketing of crafts as licit income
generating alternatives.

The Colombians Supporting Colombians Program works in municipal development with emphasis on participatory

planning. This is put into practice with the construction of small-scale infrastructure projects with community
partnership and mayoral involvement. The program also administers a credit fund, directlyand via local microfinance

institutions, to offer micro-credit for working capital and fixed assets to enhance or expand small businesses.

The GOC is supporting fruit production and complementaryactivities for the coffee renewal program.

Caldas

USAID's SpecialtyCoffee program is also promoting specialtycoffee production, processing, and marketing in
Caldas's illicit crop growing areas. The CAPP activityis supporting private sector initiatives with small farmers to

produce and process tropical fruits, jute, and peppers.

César

The ADAMprogram will be carrying out alternative development and municipal strengthening activities in selected

municipalities. The Aid to Artisans project is carrying out activities to strengthen the production and marketing of crafts.
The CAPP (now MIDAS) is supporting private sector investments for small farmers producing crops such as cacao,

fruits and African palm. The GOC is also supporting cacao and oil palm production in this region.

Choco

CFDP supports Afro-Colombian communities in Docampadó to manage their natural forestryresources. CFDP’s

investment totals approximately$180,000.

Guajira

USAID’s CAPP (now MIDAS) is supporting private sector activities in crops such as passion fruit and cacao.

Guainia

The GOC is providing institutional strengthening to indigenous communityassociations.

Guaviare

The GOC is supporting rubber production and agro forestry.

Huila

The ADAMprogram is supporting Passion Fruit and Blackberryproduction and local government strengthening

activities with staff from the Department and the municipalities.

USAID's SpecialtyCoffee project is promoting specialtycoffee production, processing, and marketing in poppygrowing
areas.

The CAPP (now MIDAS) program is supporting cacao and fruit production, while the Aid to Artisans project is promoting

the production and marketing of crafts.

Democratic Local Governance Program work in Huila is focused on citizen participation, municipal management, and

public information. The program has also implemented 57 social infrastructure projects that total approximately
$1,997,000. This program closed out in February2006 and LG activities are being continued bythe ADAMprogram.

The GOC is supporting the strengthening of cultural values in indigenous communities, fruit production, fishponds, and

complementaryactivities for the coffee renewal program.

Magdalena

CFDP supports Familias Guardabosques activities in the municipalityof Santa Marta totaling an estimated $650,000.

Plantation work is supported in San Angel, Algarrobo, San Sebastian, Guamal and Santa Bárbara de Pinto, totaling an
estimated $250,000.

USAID's CAPP is also providing technical and financial support in Magdalena to private sector initiatives to produce
African palm, banana, cacao, and exotic fruits.

Meta

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The GOC is supporting activities in cacao, cassava, buffer zones in natural parks, and technical assistance for local

governments.

The USAID CAPP (now MIDAS) program is promoting private sector investments with small farmers to produce African
palm.

Nariño

The ADAMprogram is supporting milk production activityand local government strengthening activities with staff from

the Department and municipalities.

The SpecialtyCoffee project is promoting specialtycoffee production, processing, and marketing in illicit crop growing
areas of Nariño.

CFDP supported the communitycouncil of Bajo Mira yFrontera, located in the municipalityof Tumaco, in managing its

natural forestryresources. CFDP invested approximately$400,000. The MIDAS program now supports this activity.

The United Nations Office on Drugs and Crime (UNODC) implemented a USAID-funded $1.8 million program that

provides a range of agricultural and forestryprojects.

The CAPP (now MIDAS) program is supporting small farmer, private sector projects in cacao and African palm

production.

Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in Nariño.

The GOC is supporting various productive activities in coffee renewal and oil palm production.

Norte de Santander

The CAPP (now MIDAS) program is supporting private sector initiatives with small farmers in the production and

processing of African palm and cacao.

The USAID alternative development activities implemented through PAFD are working in association with ASOHESAN
(the Santander rubber producer's association).

The GOC is supporting palm oil crop production in the department.

Putumayo

The ADAMprogram is supporting hearts of palm, vanilla and pepper production activities that were developed under the

Chemonics CAD.

U.S. ArmyCorps of Engineers' $6.7 million rural infrastructure project, funded byUSAID, carried out road, sewage, and

water treatment activities that generated employment in the region. Current complementarywork to improve the water

treatment plant in Villa Garzon was concluded in December 2006.

The Sustainable Development for Indigenous Colombian Communities project, implemented bythe Amazon

Conservation Team, is supporting indigenous communities with improved food security, health, local governance, and
land management.

Santander

The ADAMprogram is supporting cattle and cacao activities and local government strengthening activities with staff
from the Department and municipalities.

Tolima

The ADAMprogram is assessing alternative development and local government strengthening activities with staff from
the Department, municipalities, the private sector and beneficiaries which will begin this year.

The SpecialtyCoffee activityis promoting specialtycoffee production, processing and marketing in illicit crop growing
areas of Tolima.

The Colombia Enterprise Development (CED) project, funded byUSAID and implemented byCARANACorporation,

supported small and medium enterprise development in Colombia's secondarycities including those in Tolima. This
program closed out in August 2006.

The Aid to Artisans project is carrying out activities to promote the production and marketing of crafts in the department,
while the ARD/CAPP (now MIDAS) is supporting private sector projects in fruits, natural rubber and cacao production.

Democratic Local Governance Program activities in Tolima focus on technical assistance in development planning to

communityleaders and public officials. In addition, the program has provided funds totaling approximately$747,000 for
18 social infrastructure projects. This program closed out in February2006.

550 Annex 53-F

The Colombians Supporting Colombians Program works in municipal development with emphasis on participatory

planning, and also administers a credit fund as described above in Cauca Department.

The GOC is supporting cacao and coffee activities.

Valle del Cauca

The ADAMproject will begin assessing potential alternative development and local government strengthening activities
with the Departmental and local government authorities as well as beneficiaries which are expected to begin earlynext

year.

In Valle del Cauca, the Democratic Local Governance Program has focused on technical assistance in development
planning to public officials. This program closed out in February2006.

The CAPP (now MIDAS) activityis supporting private sector initiatives with small farmers to produce and process

tropical fruits, jute, and peppers.

Vaupes

The Sustainable Development for Indigenous Colombian Communities project is supporting traditional healers and
helping to strengthen indigenous communityorganizations that are also involved in managing indigenous lands.

Vichada

The GOC is providing institutional strengthening to indigenous communityassociations.

The preceding four sections and attachments form the basis of the Justification for the Secretaryof State’s 2006

Certification of Conditions Related to the Aerial Eradication of Illicit Coca in Colombia.

Attachments [not available online]:

1. Colombian Administrative Tribunal ruling of October 19, 2004, English language version

2. Colombian State Council ruling of February21, 2007, English language version

3. Results of Aerial Eradication Program Soil and Water Sampling

4. Government of Colombia’s Ministryof Environment, Housing, and Territorial Development Ruling No. 707, July26,

2004, English language version

5. Environmental and Human Health Assessment of the Aerial SprayProgram for Coca and PoppyControl in
Colombia, a report prepared for the Inter-American Drug Abuse Control Commission (CICAD) section of the OAS,

March 31, 2005

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External linksto other Internet sitesshould not be construed asan endorsement of the viewsor privacy policirein.tained the

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departMent ofstateM eMoranduM of Justificaticnoncerning the
secretary ostate´s2008 certification conditionsrelated to

aeriale radication illicitcoca incoloMbia, 2008

(U.S. Department of State)

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UNITEDSTATES ENVIRONMENTAL PROTECTIONAGENCY (EPA),
OFFICE OFPESTICIDPROGRAMS .DETAILS OF TH2003

CONSULTATION FOR THDEPARTMENT OFSTATE.U SE OF
PESTICIDE FOCOCA AND POPPYERADICATIONPROGRAM IN
COLOMBIA,JUNE 2003

(United States Environmental Protection Agency, p.10, 13, 14)

577 U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

DETAILS OF THE 2003 CONSULTATION
FOR THE DEPARTMENT OF STATE

USE OF PESTICIDE FOR COCA AND POPPY

ERADICATION PROGRAM IN COLOMBIA

JUNE 2003

578 Annex 54

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

DETAILS OF THE 2003 CONSULTATION

FOR THE DEPARTMENT OF STATE

USE OF PESTICIDE FOR COCA AND POPPY

ERADICATION PROGRAM IN COLOMBIA

JUNE 2003

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to assess potential environmental and human health risks. The data required to make a safety
finding are dependent on the intended use, e.g., food use vs non-food use. The data requirements
for pesticides may be found in 40 CFR Part 158. For human health risk assessment, data is
required to permit characterization of hazard and exposure.

Data requirements on the chemical identity and composition of the formulated pesticide product,
may be found in 40 CFR 158.150. The list of ingredients for a pesticide product and the percent
of each ingredient in the formulation are contained in the confidential statement of formula
(CSF). The CSF is FIFRA confidential business information (CBI) and is entitled to treatment
as trade secret or proprietary information. Agency risk assessments do not typically contain this

information.

Residue chemistry data required as per 40 CFR 158.240 support the ability of the Agency to
estimate the amount of pesticide that will result in food as a result of application of the pesticide

according to the product labels directions for use. The magnitude of the residue studies for crop
field trials use the typical end use product as the test material. The livestock feeding studies are
required whenever a pesticide residue will be present in livestock feed. The livestock feeding
studies evaluate the magnitude of the resulting pesticide residue in meat, milk, poultry, and eggs.
The studies are conducted with the technical grade of the active ingred
ient or the plant

metabolites Residue chemistry data are also required to identify any potential metabolites of
concern. These data are used to determine the tolerances for the parent and/or metabolites.
Additional data is required on environmental fate, degradation, metabolism, and dissipation.

Hazard data required for human health risk assessment are provided in 40 CFR 158.340. The
use of the active ingredient (i.e., food use or non-food use) will det
ermine what studies are
required. The acute toxicity data on the technical grade of the active
ingredient are used for
classification and precautionary labeling for protective clothing requirements, and worker
reentry intervals. The only studies that are required to be conducted on
the manufacturing use

product or end use product are the acute toxicity studies. The remaining toxicology studies (e.g.,
developmental toxicity, reproduction, subchronic, chronic feeding, or carcinogenicity studies)
require that the test substance is the technical grade of the active ing
redient. Subchronic toxicity
studies provide data on potential target organ toxicity and are also use
d to select dose levels for

long term or chronic toxicity studies. Chronic toxicity or carcinogenicity studies are conducted
for food use chemicals to determine potential effects following prolonged or repeated exposure
that may have a latency period for expression. The test animals are exposed orally for a
significant portion of their life span. Developmental toxicity studies are required in two species
(usually the rat and rabbit) for food use chemicals. They are conducted to detect alterations in

the normal development of fetuses following in utero exposure. The 2-generation rat
reproductive toxicity study is required to assess potential alterations
in gonadal function, estrus
cycles, mating, conception, birth, lactation, weaning, as well as growth and deve
lopment of
offspring. The Agency also requires a battery of mutagenicity studies to assess the potential
induction of changes in the genetic material of cells. The above studies are required for food use

active ingredients. In general, less data is required for non-food use
active ingredients and inerts
unless a concern has triggered additional testing.

580 Annex 54

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battery of assays. Based on the lack of evidence for carcinogenicity in
two acceptable studies in
mice and rats, glyphosate is classified as a “Group E” chemical (no evidence of carcinogenicity
to humans).

Components of the Glyphosate Product

1. Polyoxyethylene alkylamine (POEA). POEA is a compound that is used as a surfactant
with many glyphosate formulations. In a safety evaluation and risk assessment of glyphosate,
the Roundup formulation and the surfactant POEA, Williams et al. (2000) reported that POEA
can cause severe skin irritation and be corrosive to the eyes. In subc
hronic oral studies, POEA

was mainly a gastrointestinal irritant in rats at high doses (~ 100 mg/kg/day) and in dogs at lower
doses (30 mg/kg/day). In a developmental toxicity study in rats, POEA did not cause any
developmental effects up to 300 mg/kg/day, but did induce maternal toxicity at 100 and 300
mg/kg/day (Farmer et al., 2000). The concentrated formulated Roundup product can also be

strongly irritating to the eyes and slightly irritating to the skin (Williams et al., 2000).

2. (information not included as it may be entitled to confidential treatment). (information not
included as it may be entitled to confidential treatment) are substances that are not highly toxic
by oral or dermal routes and are not irritating to the skin. They may cause mild, transient eye

irritation. Many (information not included as it may be entitled to confidential treatment) are
known not to be sensitizers (information not included as it may be entitled to confidential
treatment). The molecular weight of a (information not included as it may be entitled to
confidential treatment) determines its biological properties, and, thus, its toxicity. The lower

molecular weight (information not included as it may be entitled to confidential treatment
) tend
to be more toxic than the higher-weighted (information not included as it may be entitled to
confidential treatment) and are absorbed by the digestive tract and excreted in the urine and
feces, while the higher molecular weight (information not included as it may be entitled to
confidential treatment) are absorbed more slowly or not at all (information not included as it

may be entitled to confidential treatment). (information not included as it may be entitled to
confidential treatment) have low acute and chronic toxicity in animal studies. No significant
adverse effects have been noted in inhalation toxicology studies, carcinogen testing, or mutagen
assays. High oral doses have resulted in toxic effects to the kidneys and loose feces (information

not included as it may be entitled to confidential treatment). Topical dermal application of
(information not included as it may be entitled to confidential treatment
) to burn patients with
injured skin has resulted in toxicity. (information not included as it may be entitled to
confidential treatment).

Cosmo - Flux 411F (Adjuvant)

The Cosmo-Flux 411F adjuvant product used in the glyphosate tank mix is produced by a
Colombian company and is not sold in the U.S. The Agency is not in possession of toxicity data

from direct dosing of test animals with Cosmo-Flux 411F. However, the Agency has made
safety findings based on the toxicity of the individual components. As stated above, sale or use
of spray adjuvant products in the U.S. are generally not regulated by EPA. However, the DoS

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has provided the EPA with a copy of this product’s label and a description of the product
ingredients. To be able to provide an opinion on hazard characterization of the Cosmoflux
ingredients, the EPA relied on available technical information from various sources. Cosmo-
Flux 411F consists mainly of (information not included as it may be entitled to confidential
treatment) with a nonionic surfactant blend primarily composed of (information not included as

it may be entitled to confidential treatment). All ingredients of this product are substances that
are not highly toxic by oral or dermal routes. They may cause mild eye and skin irritation. All
components of the adjuvant have been approved for use in/on food by EPA (4
0 CFR 180.1001.

Components of CosmoFlux (Considered as CBI)

1. (information not included as it may be entitled to confidential treatment). The (information
not included as it may be entitled to confidential treatment) can cause dermal and ocular
irritation and, in high doses orally, can cause significant toxicity. However, small amounts are

not a concern and these substances have been approved as food additives by the FDA and are
exempt from tolerances by EPA on certain commodities.

2. (information not included as it may be entitled to confidential treatment). The other major
component of Cosmo-Flux 411F, (information not included as it may be entitled to confidential

treatment), is not considered highly toxic. It may cause mild eye and skin irritation. The
corresponding monoester, (information not included as it may be entitled to confidential
treatment), has low subacute, subchronic and chronic oral toxicity and is used a
s a direct food
additive and a component in cosmetics. The higher molecular weight triester is less likely to be

absorbed orally or dermally and most likely of less toxicological concern. The other minor
components, are not known to be highly toxic compounds and would not be of toxicological
concern at the concentrations and conditions in which they are used.

E. Dose Response Assessment

Dose response analysis is the second step in the risk assessment process i.e.; characterization of
the quantitative relationship between exposure (dose) and response bas
ed on studies in which
adverse health effects have been observed. The objective is to identify endpoints of concern

which correspond to the route and duration of exposure based on the exposure patterns.

HED selects doses and endpoints (effects of concern) for risk assessment via an internal peer
review process. HED uses a standing Committee - the Hazard Identification Assessment Review
Committee (HIARC), to consider the available hazard data (studies require
d to be submitted by

registrants in 40 CFR part 158 and open peer reviewed literature) to id
entify endpoints for use in
risk assessment.

Ideally, each safety study identifies a dose level that does not produce
a biological or statistically

significant increased incidence of an adverse effect or no observable ad
verse effect level
(NOAEL). The threshold dose is the smallest dose required to produce a detectable effect.
Below this dose, there is no detectable response.

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n ote froM theenvironMentalp rotectionagency (epa) to

theu nitedstateseMbassy incoloMbia,enclosing answers
and bibliography of studies on glyphosate herb,cide
23septeMber 2011

(United States Environmental Protection Agency, United States Embassy in Bogotá)

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Document Long Title

volume IV

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