United States Prevention, Pesticides EPA 738-R95-019

Environmental Protection And Toxic Substances August 1995

Agency (7508W)

Reregistration

EligibilityDecision(RED)

Picloram
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

CERTIFIED MAIL

Dear Registrant:

I am pleased to announce that the Environmental Protection Agency has completed its

reregistration eligibility review and decisions on the pesticide chemical case Picloram which

includes the active ingredients triisopropanolamine picloram, isooctyl picloram, and potassium

picloram. The enclosed Reregistration Eligibility Decision (RED) contains the Agency's

evaluation of the data base of this chemical case, its conclusions of the potential human health

and environmental risks of the current product uses, and its decisions and conditions under

which these uses and products will be eligible for reregistration. The RED includes the data

and labeling requirements for products for reregistration. It may also include requirements for

additional data (generic) on the active ingredient(s) to confirm the risk assessments.

To assist you with a proper response, read the enclosed document entitled "Summary

of Instructions for Responding to the RED.” This summary also refers to other enclosed

documents which include further instructions. You must follow all instructions and submit

complete and timely responses. The first set of required responses are due 90 days from

receipt of this letter. The second set of required responses are due 8 months from the

date of this letter. Complete and timely responses will avoid the Agency taking the

enforcement action of suspension against your products.

If you have questions on the product specific data requirements or wish to meet with

the Agency, please contact the Special Review and Reregistration Division representative

Emily Mitchell at (703) 308-8583. Address any questions on required generic data to the

Special Review and Reregistration Division representative, Venus Eagle at (703) 308-8045.

Sincerely yours,

Lois A. Rossi, Director

Special Review and

 Reregistration Division

Enclosures

SUMMARY OF INSTRUCTIONS FOR RESPONDING TO

THE REREGISTRATION ELIGIBILITY DECISION (RED)

1. DATA CALL-IN (DCI) OR "90-DAY RESPONSE"--If generic data are required for

reregistration, a DCI letter will be enclosed describing such data. If product specific data

are required, a DCI letter will be enclosed listing such requirements. If both generic and

product specific data are required, a combined Generic and Product Specific DCI letter will

be enclosed describing such data. However, if you are an end-use product registrant only and

have been granted a generic data exemption (GDE) by EPA, you are being sent only the

product specific response forms (2 forms) with the RED. Registrants responsible for generic

data are being sent response forms for both generic and product specific data requirements (4

forms). You must submit the appropriate response forms (following the instructions

provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product

may be suspended.

2. TIME EXTENSIONS AND DATA WAIVER REQUESTS--No time extension requests

will be granted for the 90-day response. Time extension requests may be submitted only with

respect to actual data submissions. Requests for time extensions for product specific data

should be submitted in the 90-day response. Requests for data waivers must be submitted as

part of the 90-day response. All data waiver and time extension requests must be accompanied

by a full justification. All waivers and time extensions must be granted by EPA in order to go

into effect.

3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"--You must

submit the following items for each product within eight months of the date of this letter

(RED issuance date).

a. Application for Reregistration (EPA Form 8570-1). Use only an original

application form. Mark it "Application for Reregistration." Send your Application for

Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

b. Five copies of draft labeling which complies with the RED and current regulations

and requirements. Only make labeling changes which are required by the RED and current

regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation

changes, or labeling changes not related to reregistration) separately. You may, but are not

required to, delete uses which the RED says are ineligible for reregistration. For further

labeling guidance, refer to the labeling section of the EPA publication "General Information

on Applying for Registration in the U.S., Second Edition, August 1992" (available from the

National Technical Information Service, publication #PB92-221811; telephone number 703-

487-4650).

c. Generic or Product Specific Data. Submit all data in a format which complies

with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA

identifier (MRID) numbers. Before citing these studies, you must make sure that they meet

the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and

each alternate formulation. The labeling and CSF which you submit for each product must

comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal

concentration. You have two options for submitting a CSF: (1) accept the standard certified

limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis

of five batches. If you choose the second option, you must submit or cite the data for the five

batches along with a certification statement as described in 40 CFR §158.175(e). A copy of

the CSF is enclosed; follow the instructions on its back.

e. Certification With Respect to Data Compensation Requirements. Complete and

sign EPA form 8570-31 for each product. 

4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE--Comments

pertaining to the content of the RED may be submitted to the address shown in the Federal

Register Notice which announces the availability of this RED.

5. WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND

APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

Document Processing Desk (RED-SRRD-PRB)

Office of Pesticide Programs (7504C)

 EPA, 401 M St. S.W.

Washington, D.C. 20460-0001

By express:

Document Processing Desk (RED-SRRD-PRB)

Office of Pesticide Programs (7504C) 

Room 266A, Crystal Mall 2 

1921 Jefferson Davis Hwy. 

Arlington, VA 22202

6. EPA'S REVIEWS--EPA will screen all submissions for completeness; those which are not

complete will be returned with a request for corrections. EPA will try to respond to data

waiver and time extension requests within 60 days. EPA will also try to respond to all 8-

month submissions with a final reregistration determination within 14 months after the RED

has been issued. 
ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

SPECIAL REVIEW AND REREGISTRATION DIVISION

REREGISTRATION ELIGIBILITY DECISION

PICLORAM

LIST A

CASE 0096

TABLE OF CONTENTS

PICLORAM REREGISTRATION ELIGIBILITY DECISION TEAM ............ i

EXECUTIVE SUMMARY ......................................... v

I. INTRODUCTION .......................................... 1

II. CASE OVERVIEW ......................................... 2

A. Chemical Overview .................................... 2

B. Use Profile .......................................... 3

C. Estimated Usage of Pesticide .............................. 8

D. Data Requirements ..................................... 9

E. Regulatory History ..................................... 9

III. SCIENCE ASSESSMENT .................................... 10

A. Physical Chemistry Assessment ............................ 10

B. Human Health Assessment ............................... 11

1. Toxicology Assessment ............................. 11

a. Acute Toxicity ............................. 12

b. Subchronic Toxicity .......................... 13

c. Chronic Toxicity ............................ 15

d. Combined Chronic Toxicity and Carcinogenicity ...... 15

e. Developmental Toxicity ....................... 17

f. Reproductive Toxicity ........................ 19

g. Mutagenicity .............................. 19

h. Metabolism ............................... 21

i. Other Toxic Endpoints ........................ 22

j. Reference Dose ............................. 23

2. Exposure Assessment .............................. 23

a. Dietary .................................. 23

b. Occupational and Residential ................... 26

3. Risk Assessment ................................. 33

a. Dietary .................................. 33

b. Occupational and Residential ................... 36

C. Environmental Assessment ............................... 41

1. Environmental Fate .............................. 41

a. Environmental Chemistry, Fate and Transport ....... 41

b. Environmental Fate Assessment .................. 44

2. Ecological Effects ................................ 46

a. Ecological Effects Data ........................ 46

(1) Non-target Terrestrial Animals .............. 46

(2) Non-target Aquatic Animals ............... 49
(3) Non-Target Insects Data .................. 52

(4) Non-Target Plants Data .................. 53

(5) Adequacy of Toxicity Data ................ 57

b. Ecological Effects Risk Assessment ................ 58

(1) Calculation of Estimated Environmental

Concentrations ........................ 62

(2) Non-target Terrestrial Animals .............. 66

(3) Non-target Terrestrial Plants ............... 69

(4) Non-target Aquatic Plants ................. 72

(5) Non-target Aquatic Animals ............... 73

(6) Non-target Insects ...................... 76

IV. RISK MANAGEMENT AND REREGISTRATION DECISION ........... 76

A. Determination of Eligibility .............................. 76

1. Eligibility Decision ............................... 77

2. Eligible and Ineligible Uses ......................... 77

B. Regulatory Position ................................... 77

1. Tolerance Reassessment ............................ 77

2. Restricted Use Classification ......................... 80

3. State Management Plan ........................... 81

4. Reference Dose ................................. 81

5. Cancer Risk Assessment ........................... 82

6. Endangered Species Statement ....................... 82

7. Worker Protection ............................... 82

8. Spray Drift Advisory .............................. 86

9. Ground Water and Surface Water Advisories ............. 87

10. Phytotoxic Concerns .............................. 87

a. Risk Reduction Measures ................. 87

b. Monitoring and Other Programs ............ 88

c. Benefits ............................. 89

d. DowElanco's Stewardship ................. 89

V. ACTIONS REQUIRED BY REGISTRANTS ....................... 90

A. Manufacturing-Use Products ............................. 90

1. Additional Generic Data Requirements .................. 90

2. Labeling Requirements for Manufacturing-Use Products ...... 91

B. End-Use Products .................................... 92

1. Additional Product-Specific Data Requirements ............ 92

2. Labeling Requirements for End-Use Products ............. 93

a. Reduced Use Rates and Increased Intervals .......... 93

b. Other Labeling Requirements ................... 93

c. Spray Drift Labelling ......................... 95

d. Ground Water Statements ..................... 98

e. Surface Water Statements ...................... 98

f. Phytotoxicity Statements ....................... 98
C. Existing Stocks ...................................... 99

VI. APPENDICES ........................................... 101

APPENDIX A. Table of Use Patterns Subject to Reregistration ......... 103

APPENDIX B. Table of the Generic Data Requirements and Studies Used to

Make the Reregistration Decision ......................... 119

APPENDIX C. Citations Considered to be Part of the Data Base Supporting the

Reregistration of Picloram .............................. 149

APPENDIX D. List of Available Related Documents ................ 181

APPENDIX E. .......................................... 185

PR Notice 86-5 ..................................... 187

PR Notice 91-2 ..................................... 209

APPENDIX F. Combined Generic and Product Specific Data Call-In ..... 215

Attachment 1. Chemical Status Sheets ...................... 235

Attachment 2. Combined Generic and Product Specific Data Call-In

Response Forms (Form A inserts) Plus Instructions ........ 239

Attachment 3. Generic and Product Specific Requirement Status and

Registrant's Response Forms (Form B inserts) and Instructions

........................................... 245

Attachment 4. EPA Batching of End-Use Products for Meeting Data

Requirements for Reregistration ..................... 253

Attachment 5. EPA Acceptance Criteria .................... 257

Attachment 6. List of All Registrants Sent This Data Call-In Notice (insert)

........................................... 271

Attachment 7. Cost Share, Data Compensation Forms, Confidential

Statement of Formula Form and Instructions ............ 273

APPENDIX G. FACT SHEET ................................ 283
i

PICLORAM REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division

John Faulkner Economic Analysis Branch

George Keitt Biological Analysis Branch

James Saulmon Biological Analysis Branch

Thomas C. Harris Biological Analysis Branch

Environmental Fate and Effects Division

David Farrar Science Analysis and Coordination Staff

Kevin Poff Environmental Fate and Groundwater

Branch

Kevin Costello Environmental Fate and Groundwater

Branch

Estella Waldman Environmental Fate and Groundwater

Branch

Health Effects Division

Jane Smith Chemical Coordination Branch

Brian Dementi Toxicology Branch

William Smith Reregistration Support Chemistry Branch

Al Nielson Occupational and Residential Exposure

Branch

Shanaz Bacchus Occupational and Residential Exposure

Branch

John Bazuin Dietary Risk and Evaluation Section

Registration Division

Karen Hicks Fungicide-Herbicide Branch

Joanne Hayes Registration Support Branch

Special Review and Reregistration Division

Venus Eagle Reregistration Branch

Walter Waldrop Reregistration Branch

Carol Stangle Policy, Planning and Operations Branch
ii

Policy and Special Projects Staff

Jean Frane

Office of Compliance Monitoring

Phyllis Flaherty Office of Compliance Monitoring
GLOSSARY OF TERMS AND ABBREVIATIONS

iii

AE Acid Equivalent

a.i. Active Ingredient

ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).

ARC Anticipated Residue Contribution 

CAS Chemical Abstracts Service

CI Cation

CNS Central Nervous System

CSF Confidential Statement of Formula

DFR Dislodgeable Foliar Residue

DRES Dietary Risk Evaluation System

DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking

water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.

EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such

as a terrestrial ecosystem.

EP End-Use Product

EPA U.S. Environmental Protection Agency

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA Federal Food, Drug, and Cosmetic Act

GLC Gas Liquid Chromatography

GM Geometric Mean

GRAS Generally Recognized as Safe as Designated by FDA

HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other

organizations when emergency spills or contamination situations occur.

HDT Highest Dose Tested

LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to

cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or

volume of water, air or feed, e.g., mg/L, mg/kg or ppm.

LD Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the 50

test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a

weight of substance per unit weight of animal, e.g., mg/kg.

LD Lethal Dose-low. Lowest Dose at which lethality occurs lo

LEL Lowest Effect Level

LOC Level of Concern

LOD Limit of Detection 

LOEL Lowest Observed Effect Level

MATC Maximum Acceptable Toxicant Concentration

MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate

contaminants in drinking water under the Safe Drinking Water Act.

μg/g Micrograms Per Gram

mg/L Milligrams Per Liter

MP Manufacturing-Use Product

MPI Maximum Permissible Intake

MOE Margin of Exposure 

NOEC No effect concentration

MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.

N/A Not Applicable

NPDES National Pollutant Discharge Elimination System

NOEL No Observed Effect Level

OP Organophosphate
GLOSSARY OF TERMS AND ABBREVIATIONS

iv

OPP Office of Pesticide Programs

PADI Provisional Acceptable Daily Intake

PAG Pesticide Assessment Guideline

PAM Pesticide Analytical Method

PHED Pesticide Handler's Exposure Data 

PPE Personal Protective Equipment

ppb Parts Per Billion

ppm Parts Per Million

PRN Pesticide Registration Notice

Q The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model *

1

RBC Red Blood Cell

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose

RS Registration Standard

SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)

TC Toxic Concentration. The concentration at which a substance produces a toxic effect. 

TD Toxic Dose. The dose at which a substance produces a toxic effect.

TEP Typical End-Use Product

TGAI Technical Grade Active Ingredient

TMRC Theoretical Maximum Residue Contribution

TLC Thin Layer Chromatography

WP Wettable Powder

WPS Worker Protection Standard
v

EXECUTIVE SUMMARY

Background

This Reregistration Eligibility Decision document (RED) addresses the eligibility for

reregistration of pesticide products containing picloram acid and its derivatives; specifically it

includes triisopropanolamine picloram (TIPA-salt), isooctyl/ethylhexyl picloram (IOE) and

potassium picloram (K-salt). Hereafter, in this document, the term "picloram" refers to

picloram acid and these three derivatives. 

Picloram is a systemic herbicide used to control deeply rooted herbaceous weeds and

woody plants in rights-of-ways, forestry, rangelands, pastures and small grains. Picloram

salts and ester are manufactured by an integrated system from picloram acid. Picloram acid

has no end uses. TIPA-salt and K-salt have food/feed uses. The IOE of picloram is registered

for non-food uses only. TIPA-salt and K-salt are currently applied pre or postemergence as a

ground or aerial broadcast or spot treatment.

In March 1985, the Agency issued a Registration Standard for picloram. This

document required additional data and imposed a maximum level of hexachlorobenzene (HCB)

in the technical product of 200 ppm. It also required testing for nitrosoamines. The sole

registrant of picloram has complied with these requirements; no nitrosoamines were detected

in picloram products (< 1 ppm) and the level of HCB, an impurity that results from the

manufacturing process, has been certified to be less than 100 ppm. The picloram Final

Reregistration Standard and Tolerance Reassessment (FRSTR) was issued 5/18/88.

Supporting Rationales for Reregistration Decision

 A reference dose (RfD) for picloram was calculated to be 0.20 mg/kg/day based on a

NOEL of 20 mg/kg/day body-weight per day from a two-year rat chronic feeding study. An

uncertainty factor of 100 was used to account for the inter-species extrapolation and intraspecies variability. The picloram chronic dietary exposure/risk estimates are extremely low. 

For the United States population as a whole, the Theoretical Maximum Residue Contribution

(TMRC) is 0.9% of the RfD. For this same group, the Anticipated Residue Contribution

(ARC) is 0.5% of the RfD. Because the dietary exposure/risk is so low, about 1/200th of the

RfD, there are no concerns regarding chronic dietary exposure to picloram. 

The Agency has classified picloram as a Group E carcinogen (evidence of noncarcinogenicity for humans). Even though picloram was shown to be non-carcinogenic, a

cancer risk assessment was performed on the maximum HCB concentration since HCB has

been classified by the Agency as a Group B2 carcinogen. The refined, ARC dietary

carcinogenicity risk estimates for the United States population as a whole for the impurity,

HCB, is 7 x 10 , which is less than 1.0 x 10 point below which risk is generally considered -7 -6

to be negligible.
vi

Picloram IOE bears structural similarity to di(2-ethylhexyl)phthalate (DEHP) in that

both possess a 2-ethylhexyl moiety. DEHP and certain other substances containing the 2-

ethylhexyl moiety have been found to be carcinogenic in rodents. The Agency performed a

cancer risk assessment for workers and found that the risk associated with post-application

exposure is not a major concern since exposure to workers is minimal due to the use patterns

defined by the IOE labels and the cultural practices typically associated with a broad spectrum

herbicide of this type. The Agency is requiring that the restricted reentry intervals (REI) of

12 hours for all end use products containing picloram as required by the Worker Protection

Standard PR Notice for in-scope uses be retained. 

There is minimal concern for risk to fish and wildlife based on picloram's low toxicity

to avian and aquatic test species. However, potential phytotoxic risks to nontarget terrestrial

plants from exposure to picloram are very significant. Additionally, picloram is very mobile

and persistent which heightens the concern for exposure of nontarget plants since picloram is

highly toxic to a wide range of plant species. Picloram is occasionally transported from the

site of application and causes unintentional damage to crops and other nontarget plants. The

1992 Pesticides and Ground Water Database survey showed detects in groundwater in 10

states. 

Reregistration Decision

Picloram may pose a significant risk to on- and off-site endangered terrestrial, semiaquatic, and aquatic plant species and may also have adverse effects on other on and off-site

nontarget plants. In addition, the Agency is concerned about the potential for further ground

water contamination from registered uses of picloram. 

However, the Agency has determined that despite phytoxicity and ground water

concerns, all the uses of picloram are eligible for reregistration based on A) implementation of

risk reduction measures (reduced use rates and frequencies); B) registrant commitment to

better define the nature and scope of potential ground water contamination and nontarget plant

effects C) a cursory benefits analysis; D) the tightly controlled product distribution system that

has been put in place by the sole producer, DowElanco and; E) State regulation of picloram

(see section IV). 

The residual risks, with the modified use rates and frequencies, are not well understood

but could likely remain high. The additional information generated by the registrant's

commitment to a mapping program and a monitoring program, may be used to further refine

local restrictions and possible prohibitions of use in sensitive areas.

The Agency consulted with several state lead Agencies regarding use practices and

their regulatory experience with picloram. These consultations provided valuable guidance in

refinement of the reduction in application rates and timing of application.
vii

To further refine the risk assessments in this document, the Agency is requiring

additional ecotoxicity, phytoxicity and mixer/loader data for all three derivatives of picloram.

Before reregistering the products containing picloram acid and its derivatives, the

Agency is requiring that product specific data, revised Confidential Statements of Formula

(CSF) and revised labeling be submitted within eight months of the issuance of this document.

These data include product chemistry and acute toxicity testing for each registration . After

reviewing these data and any revised labels and finding them acceptable in accordance with

Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain

other active ingredients will be eligible for reregistration only when the other active

ingredients are determined to be eligible for reregistration.
1

I. INTRODUCTION

In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was

amended to accelerate the reregistration of products with active ingredients registered prior to

November 1, 1984. The amended Act provides a schedule for the reregistration process to be

completed in nine years. There are five phases to the reregistration process. The first four

phases of the process focus on identification of data requirements to support the reregistration

of an active ingredient and the generation and submission of data to fulfill the requirements.

The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the

Agency") of all data submitted to support reregistration.

FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether

pesticides containing such active ingredient are eligible for registration" before calling in data

on products and either reregistering products or taking "other appropriate regulatory action."

Thus, reregistration involves a thorough review of the scientific data base underlying a

pesticide's registration. The purpose of the Agency's review is to reassess the potential

hazards arising from the currently registered uses of the pesticide; to determine the need for

additional data on health and environmental effects; and to determine whether the pesticide

meets the "no unreasonable adverse effects" criterion of FIFRA.

This document presents the Agency's decision regarding the reregistration eligibility of the

registered uses of picloram (TGAI) and its derivatives: triisopropanolamine picloram (TIPAsalt), isooctyl/ethylhexyl picloram (IOE) and potassium picloram (K-salt). The document

consists of six sections. Section I is the introduction. Section II describes picloram and its

derivatives, their uses, data requirements and regulatory history. Section III discusses the

human health and environmental assessment based on the data available to the Agency. Section

IV presents the reregistration decision for picloram and its derivatives. Section V discusses the

reregistration requirements. Finally, Section VI is the Appendices which support this

Reregistration Eligibility Decision. Additional details concerning the Agency's review of

applicable data are available on request.
2

II. CASE OVERVIEW

A. Chemical Overview

The following active ingredient(s) are covered by this Reregistration Eligibility

Document:

(1) Picloram acid (TGAI)

Chemical Name: Picloram acid

CAS Registry Number: 1918-02-1

OPP Chemical Code: 005101

Empirical Formula: C6H3Cl3N2O2

Trade and Other Names: Manufacturing Use Only

Basic Manufacturer: DowElanco

(2) Picloram triisopropanolamine salt (TIPA)

Chemical Name: Picloram triisopropanolamine salt

CAS Registry Number: 6753-47-5

OPP Chemical Code: 005102 

Empirical Formula: C15H24Cl3N3O5

Trade and Other Names: Tordon 101 Mixture, Grazon P+D, Tordon 101R,

Tordon RTU, Pathway.

Basic Manufacturer: DowElanco

(3) Isooctyl Picloram (IOE) 

Chemical Name: Isooctyl Picloram, also known as ethylhexyl ester.

CAS Registry Number: 26952-20-5

OPP Chemical Code: 005103

Empirical Formula: C14H19Cl3N2O2

Trade and Other Names: Access

Basic Manufacturer: DowElanco

(4) Potassium Picloram (K-salt)

Chemical Name: Potassium Picloram

CAS Registry Number: 2545-60-0

OPP Chemical Code: 005104

Empirical Formula: C6H2Cl3KN2O2

Trade and Other Names: Tordon 22K, Tordon K, Grazon PC, Tordon 

K salt Liquor.

Basic Manufacturer: DowElanco
3

B. Use Profile

The following is a general use profile for the registered uses for picloram. A

detailed table of eligible uses as well as the methods, application rates, and use

restrictions is included in Appendix A.

1) Chemical: picloram acid 

Type of Pesticide: Herbicide

Formulation Types Registered: This is a manufacturing-use product

only.

2) Chemical: picloram, triisopropanolamine 

Type of Pesticide: Herbicide

Mode of action: pyridinecarboxylic acid herbicide,

auxin type

Use groups: Terrestrial feed crop--pastures, rangeland

Terrestrial nonfood crop--industrial areas (outdoor), nonagricultural

rights-of-way/fencerows/hedgerows, nonagricultural uncultivated

areas/soils

Forestry--forest plantings (reforestation program), forest trees, forest

roadsides

Pests: ailanthus, alder, aspen, birch, bitterweed, blackberry, bouncingbet,

brackenfern, broom snakeweed, buffalobur, bullnettle, bursage,

buttonbush, camphorweed, cedar, cherry, chicory, Chinese tallowtree,

clover, cocklebur, common broomweed, croton, dandelion, dock,

dogfennel, dogwood, Drummond's goldenweed, elm, field bindweed,

fir, fleabane, goldenrod, gorse, green ash, groundsel, gum, hawthorn,

hemlock, hickory, honeysuckle, hornbeam, horsenettle, knapweed,

kudzu, leafy spurge, loco, locust, maple, marshelder, mesquite,

milkweed, oak, persimmon, pine, plantain, poison oak, prickly lettuce,

pricklypear, ragweed, rose, rush skeletonweed, sassafras, serviceberry,

silverleaf nightshade, smartweed, sourwood, spruce, sumac, sunflower,

tansy ragwort, tasajillo, toadflax, tuliptree, upright prairie coneflower,

vetch, wild carrot, willow, yankeeweed 

Formulation

types: Emulsifiable concentrate--10.2% + 39.6% 2,4-D (0.54 lb AE

picloram/gal)

Soluble concentrate/liquid (water)--10.2% + 39.6% 2,4-D (0.54 lb AE

picloram/gal)
4

Liquid ready to use--5.4% + 20.9% 2,4-D (0.25 lb AE picloram/gal)

Methods and rates of application:

EMULSIFIABLE CONCENTRATE--to pastures or rangeland,

in spring or fall when target plants are actively growing,

broadcast foliar application at up to 0.54 lb acid

equivalent(AE)/acre by aircraft or ground sprayer.

SOLUBLE CONCENTRATE, LIQUID--to pastures or

rangeland, in spring or fall when target plants are actively

growing, broadcast foliar application at up to 0.54 lb acid

equivalent(AE)/acre by aircraft or ground sprayer.

--to forest sites:

•in preparation for reforestation, apply coarse foliar spray at up

to 1.62 lb AE/A by aircraft or ground sprayer, when target

plants are actively growing. 

•to forest roadsides, wildlife openings in forests, apply in spring

or late summer or fall, when target plants are actively growing:

• high volume leaf/stem/root collar treatment at up to 1.08 lb

AE/A by ground spray at up to 200 gal spray/A.

• low volume foliage treatment at up to 1.08 lb AE/A by ground

spray at up to 15 gal spray/A.

• cut surface treatment, at any season except when there is rapid

sap flow, apply 5.4 percent or 10.2 percent AE/A of soluble

concentrate/liquid, by injector, oil can or brush to cut surfaces of

injector wounds, frill/girdle cuts, or stump surfaces. About 10

ml. treats a tree 6 inches in diameter. 

•to naturally regenerated spruce and firs in Northeast U.S. for

strip thinning, apply up to 1.62 lb AE/A in bands, using 12-20

gal spray/A, by helicopter using Microfoil or Thru-Valve boom,

when trees are actively growing.

--to non-crop and industrial storage sites and rights-of-way

apply in spring or late summer or fall, when target plants are

actively growing:

• high volume leaf/stem/root collar treatment at up to 1.08 lb

AE/A by ground spray at up to 200 gal spray/A.

• low volume foliage treatment at up to 1.08 lb AE/A by ground

spray at up to 15 gal spray/A.

• cut surface treatment, at any season except when there is rapid

sap flow, apply 5.4 percent or 10.2 percent AE/A of soluble

concentrate/liquid, by injector, oil can or brush to cut surfaces of

injector wounds, frill/girdle cuts, or stump surfaces. About 10

ml. treats a tree 6 inches in diameter.

• broadcast stubble treatment, at up to 2.16 lb AE/A , using

ground sprayer, to cut stumps of mowed or hand-cut woody
5

species, before or during periods of active root growth, soon

after cutting, 

LIQUID READY TO USE (0.25 lb AE/gal)--to forest

and other non-crop sites such as fence row, roadsides

and rights-of-way, at any season (maples should not be

treated during spring sap flow), apply frill, girdle, or

stump treatment with paintbrush or sprayer, or injection

treatment with injection equipment at 0.008 to 0.0013 lb

AE/tree.

Use limitations: Do not apply through any type of irrigation system. Observe 30 days

preharvest interval for forage/fodder. Observe 7 days pregrazing

interval. Use only once per year.

3) Chemical: picloram, isooctyl/ethylhexyl esters 

Type of Pesticide: Herbicide

Mode of action: pyridinecarboxylic acid herbicide, auxin type

Use groups: Terrestrial nonfood crop--industrial areas (outdoor),

nonagricultural rights-of-way/fencerows/hedgerows,

nonagricultural uncultivated areas/soils

Forestry--forest trees

Pests: ash, aspen, birch, cherry, elm, hackberry, hickory, locust, maple,

multiflora rose, oak, oceanspray, pine, poplar, sassafras, tanoak

Formulation

types: Soluble concentrate/liquid (oil)--17.1% + 32.5% butoxyethyl triclopyr

Method and rate of application:

Basal bark and soil treatment, high volume (to stems less than 6 inches

diameter): Use low pressure knapsack, backpack, or power sprayer, at

0.02 lb acid equivalent (AE)/gal of oil spray (100 gal), or 0.02 to 0.03

lb AE/gal of oil/water emulsion spray when needed (best results are

obtained when applied during late dormant or active growing season). 

Basal bark and soil treatment, low volume (to stems less than 6 inches

diameter): Use backpack or knapsack sprayer at 0.2 to 0.3 lb AE/gallon

of oil spray when needed. (Best results are obtained when applied

during late dormant or active growing season.)

Thinline basal bark treatment, to stems less than 6 inches diameter,

apply as a thin stream around the trunk 0.0005 to 0.004 lb AE (2-15
6

ml) of undiluted product (1 lb AE/gal) per stem to be treated, using

equipment metered or calibrated to deliver these small amounts.

Use limitations: Do not contaminate water intended for irrigation or domestic purposes.

Do not apply to snow or frozen ground.

Do not apply near desirable trees if injury from potential transfer

through roots cannot be tolerated.

4) Chemical: picloram, potassium salt 

Type of Pesticide: Herbicide

Mode of action: pyridinecarboxylic acid herbicide, auxin type

Use groups: Terrestrial food + feed crop--agricultural fallow/idle land, barley, oats, wheat

Terrestrial feed crop--pastures, rangeland

Terrestrial nonfood crop--nonagricultural rights-of-way/fencerows/hedgerows,

nonagricultural uncultivated areas/soils, industrial areas (outdoor)

Pests: absinth wormwood, acacia, aspen, bitterweed, black henbane, blackberry,

bouncingbet, brackenfern, buffalobur, bullnettle, burroweed, bursage, buttonbush,

cactus, camelthorn, camphorweed, cedar, chaparral, chicory, Chinese tallowtree,

clover, cocklebur, common broomweed, common crupina, croton, dock,

dogwood, field bindweed, fleabane, fringed sagebrush, goldenrod, gorse,

granjeno, groundsel, guava, gum, hemlock, hickory, horsenettle, horseweed,

huisache, ironweed, java plum, juniper, knapweed, lambsquarters, lantana,

larkspur, leafy spurge, loco, locust, lupine, maple, marshelder, mesquite,

milkweed, oak, oxeye daisy, persimmon, pigweed, pine, poison oak, poplar,

prickly lettuce, pricklypear, rabbitbrush, ragweed, rush skeletonweed, St.

Johnswort, salmonberry, sassafras, Scotch broom, sea hibiscus, silverleaf

nightshade, smartweed, snakeweed, sourwood, spruce, sulphur cinquefoil, sumac,

sunflower, tansy ragwort, tasajillo, thistle, toadflax, trumpetcreeper, upright

prairie coneflower, wild buckwheat, wild carrot, wild licorice, wild parsnip,

willow, yankeeweed

Formulation

types: Soluble concentrate/liquid (water)--24.4% (can be used as invert emulsion)

Liquid--34.7% (Formulating intermediate)

Methods and rates of application:

EMULSIFIABLE CONCENTRATE (as invert emulsion): 

--to forest sites preparatory to reforestation, southern US, apply broadcast spray

at 1.5 lb AE/A by air or ground spray after foliage is well developed.
7

--to rangeland and permanent grass pasture (west of Mississippi R.), apply up

to 0.5 lb AE/A as low volume broadcast spray by air or ground equipment, when

target vegetation is actively growing.

SOLUBLE CONCENTRATE, LIQUID:

--to forest sites:

• preparatory to reforestation (Southern U.S.), apply broadcast spray at

1.5 lb.AE/A by air or ground spray after foliage is well developed.

•to forest roadsides, wildlife clearings, (southern U.S.), apply:

•low volume broadcast treatment, at 1 lb AE/A by air or ground sprayer,

in spring or late in summer or fall.

•high volume leaf/stem/root collar treatment at 1 lb AE/A by ground

sprayer.

•spot treatment at 0.5 to 2 lb AE/A/season by ground spray to foliage

when target plants are actively growing 

•spot concentrate application of up to 24 ml/tree of undiluted product

(0.013 lb AE/tree; max. limit of 0.5 lb AE/A/year) to soil under dripline

of Eastern red cedar, in spring or fall. 

•injector or frill/girdle treatment (Hawaii) using ca. 0.002 to 0.003 lb

AE/tree of product diluted 1:4 with water, applied when target trees are

actively growing.

--to rangeland and permanent grass pasture (west of Mississippi R.),

apply:

•low volume broadcast spray at up to 0.5 lb AE/A, by air or ground

equipment, when target vegetation is actively growing.

•high volume broadcast spray at up to 0.5 lb AE/A by ground sprayer,

when target vegetation is actively growing.

--to noncroplands, fencerows (southern U.S.), apply:

•low volume broadcast treatment, at 1 lb AE/A by air or ground sprayer,

in spring or late in summer or fall.

•high volume leaf/stem/root collar treatment at 1 lb AE/A by ground

sprayer.

•spot treatment at 0.5 to 2 lb AE/A/season by ground spray to foliage

when target plants are actively growing 

•spot concentrate application of up to 24 ml/tree of undiluted product

(0.013 lb AE/tree; max. limit of 0.5 lb AE/A/year) to soil under dripline

of Eastern red cedar, in spring or fall. 

•injector or frill/girdle treatment (Hawaii) using ca. 0.002 to 0.003 lb

AE/tree of product diluted 1:4 with water, applied when target trees are

actively growing.

Use limitations: Do not: apply through any type of irrigation system; graze or feed forage

from treated areas for 2 weeks after treatment; or harvest hay from treated

grain fields.
8

C. Estimated Usage of Pesticide

This section summarizes the best estimates available for the pesticide uses of

picloram and its derivatives. These estimates are derived from a variety of published and

proprietary sources available to the Agency. The data, reported on an aggregate and site

(crop) basis, reflect annual fluctuations in use patterns as well as the variability in using

data from various information sources.

The table below summarizes the pesticides use by site: 

ESTIMATED ANNUAL U.S. USAGE OF PICLORAM

SITE

 SITE ACRE SITE LB A.I.

ACREAGE TREATMENTS TREATED APPLIED

(000) (000) % (000)

Pasture & rangeland 530,000 2500 - 5000 < 1% 500 - 900 

Wheat 64,000 300 - 900 < 2% 25 - 35 

Barley 8,000 75 - 150 < 2% < 7 

Oats 6,000 < 1% < 2 < 25 

Cropland not used for 107,000 100 - 600 < 1% 50 - 100 

crops

Other crops/farmland 267,000 < 700 < 1% < 100 

Forestry (commercial) 482,000 25 - 100 < 1% 25 - 50 

Total Agriculture and

Forestry 1,464,000 3000 - 7475 < 1% 600 - 1194 

Rights-of-way

 Electric utilities

 Roadways

 Industrial facilities

 Railroads 2,200 15 - 35 < 2% 10 - 30

 Pipelines

Total Rights-of-Way

9,400 100 - 180 < 2% 80 - 140 

11,000 15 - 35 < 1% 10 - 30 

1,900 < 9 < 1% < 30 

1,100 < 6 < 1% < 6 

25,600 130 - 265 < 1% 100 - 236 

Total 1,489,600 3130 - 7740 < 1% 700 - 1430 

Sources:

 U.S. EPA proprietary sources

 Resources for the Future, Agriculture Usage Database, 1994

 DowElanco, Meeting with U.S. EPA, March 1, 1994
9

D. Data Requirements

Data requested in the revised September 30, 1988 Registration Standard for

picloram and its derivatives (triisopropanolamine picloram, isooctyl picloram, and

potassium picloram) included studies on product chemistry, ecological effects,

toxicology, environmental fate, and residue chemistry. These data were required to

support the uses listed in the Registration Standard. Appendix B includes all data

requirements identified by the Agency for currently registered uses needed to support

reregistration.

E. Regulatory History

Picloram and its derivatives were registered in the United States in 1964 for use

as a systemic herbicide to control woody plants and broadleaf weeds. In 1978 the

Agency classified picloram as a Restricted Use pesticide based on hazard to nontarget

organisms (specifically nontarget plants both crop and noncrop). Considerable

emphasis for restriction was based on recurring reports of phytotoxicity to such

economically important crops such as tomatoes, potatoes, and succulent ornamentals

caused by contaminated water supplies (1 part per billion [ppb]) range. This action

was taken by the Agency through regulations proposed in the September 1, 1977 (42

FR 44170) and finalized in the February 9, 1978 (43 FR 5782) issues of the

FEDERAL REGISTER.

On March 29, 1985, the Agency issued a Registration Standard for picloram. 

The Standard required: 1) precautionary label statements advising against the use of

picloram in very permeable soils such as karst limestone and loamy sands; 2) a

groundwater monitoring study; 3) retention of Restricted Use classification ; 4)

additional wildlife testing on the technical; 5) a field monitoring study to determine

concentrations of picloram in runoff water and sediment, leachate, groundwater, and in

water and sediment of receiving aquifers to complete a hazard evaluation of wildlife; 6)

development of analytical methods for metabolite residues in plant and animal samples;

7) storage stability data; 8) additional oncogenicity data; 9) limiting the level of

hexachlorobenzene (HCB) in the technical to a maximum of 200 parts per million

(ppm); 9) nontarget area phytoxicity data on the technical; and 10) testing for

nitrosamines and certification that the upper limit of nitrosamines occurring in the

technical is not greater than 1 ppm. 

The Agency has since received and reviewed the additional data and has revised

its scientific and regulatory conclusions in light of those data, other information on the

chemical, and expanded data requirements promulgated in 1984, at 40 CFR Part 158,

for registration and reregistration of pesticides under FIFRA. A revised Registration

Standard (issued 9-30-88), which supersedes the earlier Standard, is the Agency's

updated scientific assessment of the pesticide, and the data needed to support its
Cl

Cl

NH2 Cl

N

OH

O

Cl

Cl

NH2

Cl

N

ONH[CH2CH(OH)CH3]3

O

Cl

Cl N

O

OC8H17

Cl

NH2 Cl

Cl N

O

OK

Cl

NH2

10

continued registration. This Reregistration Eligibility Decision reflects a reassessment

of all data which were submitted in response to the revised Registration Standard.

III. SCIENCE ASSESSMENT

A. Physical Chemistry Assessment

This structure of picloram acid and its derivatives are presented below:

Picloram acid Picloram triisopropanolamine salt (TIPA)

Empirical Formula: C6H3Cl3N2O2 Empirical Formula: C H Cl N O

Molecular Weight: 241.5 Molecular Weight: 432.6

CAS Registry No.: 1918-02-1 Shaughnessy No.: 005102

Shaughnessy No.: 005101

15 24 3 3 5

Picloram isooctyl ester (IOE aka EHE) Picloram potassium salt (K-salt)

Empirical Formula: C14H19Cl3N2O2 Empirical Formula: C H Cl KN O

Molecular Weight: 353.5 Molecular Weight: 280.6

Shaughnessy No.: 005103 Shaughnessy No.: 005104

6 2 3 2 2

IDENTIFICATION OF ACTIVE INGREDIENT

The picloram acid technical is an off-white to brown powder which decomposes

at 215°C, photodegrades, and is non-volatile. The acid is only slightly soluble in

water at 430 ppm at 25°C, and is more soluble in ethanol, acetone, and methanol. The

picloram salt derivatives are water soluble; the isooctyl ester is not water soluble.
11

MANUFACTURING-USE PRODUCTS

There are two picloram manufacturing-use products (MPs) registered to

DowElanco Company: the 72% picloram acid technical (T; EPA Reg. No. 62719-

179) and the 34.7% picloram K-salt formulation intermediate (FI; EPA Reg. No.

62719-30). There are no registered MPs for the TIPA and IOE; TIPA and IOE enduse products (EPs) are manufactured by integrated systems.

At the time of the Registration Standard dated 10/84 and the Final Registration

Standard and Tolerance Reassessment (FRSTR) dated 5/18/88, the only registered MP

was the 34.7% K-salt FI. The 72% T was registered in 1990, following issuance of

the FRSTR. The DowElanco 72% T and the 34.7% K-salt FI are the only MPs subject

to a reregistration eligibility decision.

REGULATORY BACKGROUND

The Picloram FRSTR dated 5/18/88 required that all new data be submitted in

support of the reregistration of picloram and its salts and ester. After the 72% T was

registered, the product chemistry database submitted since the FRSTR was reevaluated. Additional MP data were required for the now registered picloram acid

technical, and data were required for the "practical equivalent of the technical grade of

the active ingredient" for the picloram salts and ester manufactured by integrated

systems.

The Picloram Registration Standard dated 3/29/85 required the limiting of the

level of hexachlorobenzene (HCB) in the technical to a maximum of 200 ppm and also

required testing for nitrosoamines in picloram products. The sole registrant of

picloram products has complied with these requirements; no nitrosoamines were

detected in picloram products (<1 ppm) and the level of HCB has been certified to be

less than 100 ppm.

B. Human Health Assessment

1. Toxicology Assessment

The toxicological data base in support of the food uses for picloram (the

acid, potassium salt, isooctyl ester, and triisopropanolamine salt) is adequate

and will support reregistration eligibility.
12

a. Acute Toxicity

Table I: Acute Toxicity - Picloram, Acid (94.1% a.i.)

Test Result Category

Oral LD (rat) 4012 mg/kg (females) III 50

1

> 5000 mg/kg (males) IV

Dermal LD (rabbit) > 2000 mg/kg (both sexes) III 50

2

Inhalation LC (rat) > 0.035 mg/L (both sexes) I

50

3

Eye Irritation Moderate eye irritant III 4

Dermal Irritation Non irritant IV 5

Dermal Sensitization Non sensitizer N/A 6

Delayed Neurotoxicity N/A

1-6 MRID#s 404794-13 thru -18; HED Document Number 006787

* Note: Data pertaining to acute eye irritation, dermal irritation, dermal sensitization and delayed neurotoxicity are not required to support the

reregistration of the picloram acid. These data are presented for informational purposes.

Table II: Acute Toxicity - Picloram Potassium Salt (38.8% a.i.)

Test Result Category

Oral LD (rat) 3536 mg/kg (females) III 50

7

> 5000 mg/kg (males) IV

Dermal LD (rabbit) > 2000 mg/kg (both sexes) III 50

8

Inhalation LC (rat) > 1.63 mg/L (both sexes) II 50

9

Eye Irritation Moderate eye irritant III 10

Dermal Irritation Non irritant IV 11

Dermal Sensitization Positive skin sensitizer N/A 12

Delayed Neurotoxicity N/A

7-12 MRID#s 404794-01 thru -06; HED Document Number 006787
13

Table III: Acute Toxicity - Picloram, Isooctyl ester (IOE) (85.9% a.i.)

Test Result Category

Oral LD (rat) > 3500 mg/kg (both sexes) III 50

13

Dermal LD (rabbit) > 2000 mg/kg (both sexes) III 50

14

Inhalation LC (rat) >0.35 mg/L (both sexes) II 50

15

Eye Irritation Moderate eye irritation III 16

Dermal Irritation Mild dermal irritation III 17

Dermal Sensitization Positive skin sensitizer N/A 18

Delayed Neurotoxicity N/A

13-18 MRID#s 404794-07 thru -12; HED Document Number 006787

Table IV: Acute Toxicity - Picloram, Triisopropanolamine Salt (61% a.i.) 

Test Result Category

Oral LD50 (rat) > 5000 mg/kg (both sexes) IV 19

Dermal LD (rabbit) > 2000 mg/kg (both sexes) III 50

20

Inhalation LC (rat) > 0.07 mg/L (both sexes) II 50

21 

Eye Irritation Minimal irritant (both sexes) III 22

Dermal Irritation Not an irritant (males) IV 23

Slight irritant (females)

Dermal Sensitization Positive N/A 24

Delayed Neurotoxicity N/A

19-24 MRID#s 413812-01 thru -06; HED Document Number 010173 

b. Subchronic Toxicity

In a 90-day oral toxicity study, picloram acid was administered

via the diet to groups of 15 F344 rats/sex/dose at dosage levels of 0, 15,

50, 150, 300 or 500 mg/kg/day. Based upon liver weight changes and

minimal microscopic changes in the liver, the systemic LOEL is 150

mg/kg/day. The NOEL is 50 mg/kg/day. (MRID# 001105-37)

In a 1982 6-month dog dietary study, picloram acid was

evaluated at dosage levels of 0, 7, 35 or 175 mg/kg/day. The systemic

NOEL is 35 mg/kg/day and the LOEL is 175 mg/kg/day based on

decreases in the following: body weight gain, food consumption, liver

weights (relative), alkaline phosphatase and alanine transaminase. 
14

Increased liver to body weight ratios and absolute weights were observed

in only two males at the 35 mg/kg/day dosage level. (MRID# 001105-

34).

In a 21-day dermal toxicity study, the potassium salt of picloram

was administered dermally to groups of five New Zealand white rabbits

of each sex at doses of 0 (vehicle control), 75.3, 251 or 753 mg/kg/day

(0, 65, 217 or 650 mg/kg/day picloram acid equivalents) for a total of

15 applications over the 21-day period. The NOEL is greater than or

equal to 753 mg/kg/day for both sexes: hence, a LOEL was not

established for either sex. Although the limit dose of 1000 mg/kg/day

was not achieved, practical difficulties precluded administering more test

material. The study revealed the non-systemic effects of dermal

irritation and very slight to well defined edema and/or erythema in both

sexes at all dose levels. (MRID# 413849-01)

In a 13-week oral toxicity study in the F344 rat, picloram

isooctyl ester was evaluated by dietary administration at dosage levels of

0, 22, 73, 220 or 733 mg/kg/day (0, 15, 50, 150 or 500 mg/kg/day

picloram acid equivalents). There were 10 rats/sex/group employed in

the study. The LOEL is 220 mg/kg/day, where the findings were

increased liver weights in both sexes accompanied by slight/very slight

hepatocellular hypertrophy and increased kidney weight in males only. 

The NOEL is 73 mg/kg/day. (MRID# 422970-01)

In a 21-day dermal toxicity study in the rabbit, picloram isooctyl

ester (89.9% purity) was evaluated at dosage levels of 0 (vehicle control)

250, 500 or 1000 mg/kg/day. There were 5 rabbits/sex in each of the

study groups. The LOEL is 500 mg/kg/day based upon increased

bilirubin (males) and increased BUN (males/females). The NOEL is

250 mg/kg/day. There were dermal responses at the site of application,

at all doses, but such do not constitute findings of systemic toxicity. 

There were no dose related histopathologic findings. (MRID#s 421716-

01; 428707-01)

In a 21-day dermal toxicity study the triisopropanolamine salt of

picloram was administered dermally to groups of five New Zealand

white rabbits of each sex at doses of 0 (vehicle control), 132, 440 or

1320 mg/kg/day (0, 73.8, 246 or 738 mg/kg/day picloram acid

equivalents) for a total of 15 applications over the 21-day study period. 

The NOEL is greater than or equal to 1320 mg/kg/day for both sexes;

hence, a LOEL was not established for either sex. The study revealed

dermal irritation and very slight to well defined edema and/or erythema

among animals of both sexes at all doses. (MRID# 413849-02)
15

In a 13-week oral toxicity study in the F344 rat, picloram,

triisopropanolamine salt was evaluated by dietary administration at

dosage levels of 0, 25, 90, 550 or 1800 mg/kg/day. There were 10

rats/sex/group employed in the study. The LOEL is 550 mg/kg/day

based on hepatocellular hypertrophy observed in males at 550 and 1800

mg/kg/day with a dose-response relationship. Hepatocellular

hypertrophy and increased liver and kidney weights were observed in

females at 1800 mg/kg/day. There was decreased body weight gain in

both sexes at 1800 mg/kg/day. The NOEL is 90 mg/kg/day. (MRID#

414427-01)

c. Chronic Toxicity

In a 1988 1-year chronic feeding study in the dog, picloram acid

was administered orally via the diet at dosage levels of 0, 7, 35 or 175

mg/kg/day. The LOEL is 175 mg/kg/day based on increased liver

weight (absolute and relative). The NOEL is 35 mg/kg/day. (MRID#

408343-01) 

d. Combined Chronic Toxicity and Carcinogenicity

The following studies were submitted prior to the Picloram

Registration Standard (1988) under the same identifier (MRID#

00081275) and were referenced in the Registration Standard.

In a study performed for the NTP by Gulf South Research 

Institute (GSRI), Osborne-Mendel rats were fed picloram (technical

grade 90% pure with 130 ppm HCB) at dosages corresponding to time

weighted average (TWA) dosages of 372 mg/kg/day (7437 ppm) and

747 mg/kg/day (14,875 ppm) for 80 weeks. At the highest dose, 747

mg/kg/day, an carcinogenic effect (neoplastic nodules) was seen in

females. This study was considered supplementary since the matched

control groups were not adequate size, the study was conducted for a

shorter than 2-year lifetime exposure limit, and the supporting data to

determine if the maximum tolerated dose (MTD) was attained at 747

mg/kg/day was not provided. (MRID# 00081275)

In a second NTP study, B6C3F1 mice were fed picloram

(technical grade 90% pure with 130 ppm HCB) at dosages of 357 or 714

mg/kg/day for 79 weeks and allowed to recover for 10 weeks prior to

sacrifice. Picloram did not show a carcinogenic response up to 714

mg/kg/day for 79 weeks. This study was considered deficient since

available information did not assure that an MTD was attained. (MRID#

00081275)
16

The following studies were submitted in response to the

deficiencies cited in the Registration Standard.

In a chronic toxicity/carcinogenicity feeding study conducted in

the F344 rat, picloram acid (technical grade 93% containing 197 ppm

hexachlorobenzene as an impurity) was evaluated at 0, 20, 60 or 200

mg/kg/day for 2 years. The chronic toxicity LOEL was 60 mg/kg/day

as evidenced by altered size and tinctorial properties of centrilobular

hepatocytes and increased absolute and/or relative liver weights in both

sexes. The NOEL was 20 mg/kg/day. The study was negative for

carcinogenicity, but due to concerns that a MTD may not have been

achieved and the fact that the test material contained 197 ppm

hexachlorobenzene impurity, the study was not considered to fulfill

adequately the carcinogenicity testing requirement. (MRID# 001559-40)

In response to the deficiencies cited in the study above, an

additional 2-year dietary chronic/carcinogenicity study was conducted

(in 1992) using F344 rats administered picloram acid at dosage levels of 

0, 250 or 500 mg/kg/day for 104 weeks. Chronic toxicity was observed

at 250 mg/kg/day among males only (increased incidence and severity of

glomerulonephritis, blood in urine, decreased specific gravity of urine,

increased size of hepatocytes that often had altered staining properties). 

Among females there were chronic effects only at 500 mg/kg/day

(increased glomerulonephropathy, increased absolute and relative kidney

weight). There was no evidence of carcinogenicity in this study. It

should be noted that use of the Osborne-Mendel rat was waived due to

lack of availability of the strain of rat. In addition, the level of

hexachlorobenzene in the test material employed in this study was 12

ppm. These two studies (MRID# 001559-40, 426193-02) fulfill the

guidelines 83-1(a) and 83-2(a) for rats.

In a 1992 2-year dietary carcinogenicity study in B6C3F1 mice,

picloram acid was evaluated at doses of 0, 100, 500 or 1000 mg/kg/day. 

The systemic NOEL in this study is 500 mg/kg/day based on a

significant increase in absolute and relative kidney weights in males (at

the high dose level). No histopathological lesions were found to

corroborate these changes. There was no evidence of carcinogenicity. 

(MRID# 426193-01)

The dose levels tested in the 1992 carcinogenicity studies in rats

and mice were considered adequate for carcinogenicity testing. The

treatment did not alter the spontaneous tumor profile in mice or different

strains of rats tested under the testing conditions. The chemical was

classified as a "Group E - Evidence of non-Carcinogenicity for
17

humans." This classification applies to the picloram acid and potassium

salt forms for which acceptable carcinogenicity studies were available 

for review by the HED Carcinogenicity Peer Review Committee

(5/26/88). Carcinogenicity studies had not been required for the other

forms of picloram. However, subsequent to the carcinogenicity peer

review meeting, it was reported that 2-ethylhexanol was detected as a

metabolite of the picloram ethylhexyl ester in Fisher 344 rats. This

metabolite is thought to play a role in the ability of di-(2-

ethylhexyl)phthalate (DEHP) to act as a peroxisome proliferator and it

has been suggested that peroxisome proliferation might be the/an

underlying mechanism in DEHP carcinogenicity. Based on this

information the Agency decided it was appropriate to use a Q for di-(2- 1

*

ethylhexyl) phthalate and perform an initial assessment of possible risk

to workers from potential exposure to picloram ethylhexyl ester.

e. Developmental Toxicity

The HED RfD Peer Review Committee concluded that there was

no evidence, based on the available data, that picloram and its salts and

ester were associated with significant reproductive or developmental

toxicity under the testing conditions.

In the following developmental toxicity studies, the dose levels

that appear in parenthesis are picloram acid equivalents where the

conversion factors employed were 0.86, 0.68 and 0.56 as applied to

doses of potassium salt, isooctyl ester and triisopropanolamine salt,

respectively.

 

Picloram potassium salt was administered to New Zealand rabbits

by oral gavage at dosage levels of 0, 40, 200 and 400 mg/kg/day

(picloram acid equivalents) during days 6 to 18 of gestation. The

maternal NOEL is 40 (34) mg/kg/day, where the LOEL is 200 (172)

mg/kg/day based on reduced maternal weight gain during gestation. 

The developmental NOEL is 400 mg/kg/day and the LOEL was not

determined. (MRID# 410695-01, 001387-03, Accession# 252493)

The potassium salt of picloram was administered to CD rats by

gastric intubation at dosage levels of 0, 35 (30), 174 (150) and 347 (298)

mg/kg/day during day 6-15 of gestation. The test vehicle was distilled

water. There was no evidence of developmental toxicity at doses up to

and including the high dose of 347 (298) mg/kg/day. The maternal

LOEL is 347 (298) mg/kg/day based upon excessive salivation in the

dams of the high dose group. Hence, the developmental toxicity NOEL

is greater than or equal to 347 (298) mg/kg/day. The maternal toxicity
18

LOEL is 347 (298) mg/kg/day and NOEL is 174 (150) mg/kg/day. 

(MRID# 413825-02)

Picloram isooctyl ester was administered to New Zealand white

rabbits via oral gavage at dosage levels of 0, 20 (14), 100 (68) or 500

(340) mg/kg/day during days 7-19 of gestation. Developmental toxicity

was not observed at any dose level. Hence, the developmental toxicity

NOEL is greater than or equal to 500 (340) mg/kg/day. Maternal

toxicity was observed at 100 (68) mg/kg/day manifested as an increase

in the incidence of clinical signs (decreased feces at 500 (340)

mg/kg/day and decreased body weight gain at 100 (68) mg/kg/day and

above). Hence, for maternal toxicity, the LOEL is 100 (68) mg/kg/day

and the NOEL is 20 (14) mg/kg/day. (MRID# 421211-04)

Picloram isooctyl ester was evaluated in CD rats. The chemical

was administered via oral gavage at dosage levels of 0, 100 (68), 500

(340) or 1000 (680) mg/kg/day during days 6-15 of gestation. There

was no evidence of developmental toxicity at any dosage level; hence,

the developmental toxicity NOEL is greater than or equal to 1000 (680)

mg/kg/day. The maternal toxicity LOEL is 500 (340) mg/kg/day based

on decreased body weight gain during early gestation, days 6-9. The

maternal toxicity NOEL is 100 (68) mg/kg/day. (MRID# 422969-01)

Picloram triisopropanolamine salt was administered to New

Zealand white rabbits via oral gavage at dosage levels of 0, 180 (101),

538 (301) or 1,000 (560) mg/kg/day during days 7-19 of gestation

(phase 1) and at doses of 0, 54 (30), 180 (101), 538 (301) or 1,000

(560) mg/kg/day (phase II). Developmental toxicity was not observed at

any dose level in either of the two phases of the study. Hence, the

developmental toxicity NOEL is greater than or equal to 1000 (560)

mg/kg/day. Maternal toxicity was observed in both phases of the study

at greater than or equal to 180 (101) mg/kg/day manifested as increased

rate of abortions at 1000 (560) mg/kg/day; increased incidence of

clinical signs at 538 (301) and 1000 (560) mg/kg/day; and decreased

food consumption and body weight gain at 180 (101), 538 (301) and 00

(560) mg/kg/day. The maternal toxicity LOEL is 180 (101) mg/kg/day

and the NOEL is 54 (30) mg/kg/day. (MRID# 424609-01)

Picloram triisopropanolamine salt was administered to CD rats

by gastric intubation at dosage levels of 0, 100 (56), 500 (280) or 1000

(560) mg/kg/day during days 6-15 of gestation. The test vehicle was

distilled, deionized water. The picloram salt did not elicit evidence of

developmental toxicity at doses up to and including the high dose of

1000 (560) mg/kg/day. The developmental toxicity NOEL is 1000
19

(560) mg/kg/day. Maternal toxicity was observed at 1000 (560)

mg/kg/day manifested as excessive salivation, decreased body weight

gain and decreased food consumption. The maternal toxicity LOEL is

1000 (560) mg/kg/day and the NOEL is 500 (280) mg/kg/day. (MRID#

413825-04)

f. Reproductive Toxicity

Picloram acid was evaluated in a 2-generation reproduction study

in the CD rat. Dosage levels employed were 0, 20, 200 or 1000

mg/kg/day. The parental LOEL is 1000 mg/kg/day based on

histopathological lesions in the kidney of males of both generations and

some females. In males of both generations, blood in the urine,

decreased urine specific gravity, increased absolute and relative kidney

weight, and increased body weight gain was observed at the high dose. 

The parental LOEL is 1000 mg/kg/day and the NOEL is 200

mg/kg/day. The reproductive LOEL was not identified and the NOEL

is 1000 mg/kg/day. (MRID# 420787-01)

g. Mutagenicity

Picloram acid was evaluated in the Ames test using Salmonella

typhimurium. Doses ranged up to 5000 ug/plate, with and without

metabolic activation. The test substance did not produce a mutagenic

response either in the presence or absence of activation. (MRID#

414859-02)

Picloram acid was evaluated for gene mutation in mammalian

cells (HGPRT/CHO). As evaluated up to toxic levels (750 ug/ml

without metabolic activation; 1250 ug/ml with metabolic activation), the

compound was found to be negative for inducing forward mutation in

Chinese hamster ovary (CHO) cells. (MRID# 400726-01)

Picloram acid was evaluated for cytogenetic effects on bone

marrow cells of rats via intragastric administration at dosage levels of 0

(vehicle), 20, 200 or 2000 mg/kg. The test material did not produce

cytogenetic effects in the study. (MRID# 000983-22)

 

Picloram acid was evaluated for genotoxic potential as

administered to primary rat hepatocyte cultures at concentrations of 0

(vehicle), 10, 33.3, 100, 333.3 or 1000 ug/ml. The test material was

negative for unscheduled DNA synthesis (UDS, a measure of DNA

damage/repair) treated up to cytotoxic levels of (1000 ug/ml). (MRID#

415497-01)
20

Picloram isooctyl ester was evaluated in the Ames test using

Salmonella typhimurium. Dosages ranged from 16.7 to 1667 ug/plate in

studies with and without S9 activation. The test compound did not

induce a mutagenic response in the presence or absence of metabolic

activation. (MRID# 421211-06)

Picloram isooctyl ester was evaluated in two independent Chinese

Hamster Ovary Cell HGPRT forward gene mutation assays, one of these

with, and the other without, S9 activation. Concentrations of the

picloram isooctyl ester employed in the non-activated trial ranged 1.25

to 50 ug/ml as conducted in two assays of overlapping dosage range. 

The second trial, also conducted in two assays of overlapping dose and

including S9 activation, utlilzed dosages ranging from 2.50 to 200

ug/ml. Concentrations > 40 ug/ml in the non-activated trial and > 125

ug/ml in the activated trial were severely cytotoxic. There was no

evidence of a mutagenic response at any dosage level in either the S9

activated trial(s)/or the non-activated trial(s). (MRID# 424140-01)

Picloram isooctyl ester was evaluated in two independent rat

lymphocyte cytogenetic assays with and without S9 activation.

Concentrations ranging from 2.67 to 800 ug/ml +/-S9 were assayed in

Trial 1; severe cytotoxicity was observed at levels > 80 ug/ml +/-S9. 

In Trial 2, no cytotoxicity was seen in cells exposed to 8.04 or 17.4

ug/ml +/-S9 and harvested at 24 hours. However, reductions in the

mitotic index (MI) were observed in cells harvested 24 or 48 hours

postexposure to 26.8 ug/ml +/-S9. Although a number of minor

deficiencies rendered the purported negative results of this study

inadequate in initial review, subsequent re-evaluation with additional

information and data supplied by the performing laboratory were

adequate to upgrade this assay to fully acceptable in demonstrating no

potential for inducing chromosomal aberrations. (MRID# 423687-01)

Picloram isooctyl ester was evaluated in the mouse micronucleus

assay at single oral gavage doses of 0(2), 500, 1667 or 5000 mg/kg

(limit dose) using 24, 48 or 72 hour sacrifice times. The material was

found not to be clastogenic. No lethality was reported and there was no

evidence of target tissue cytotoxicity. The picloram compound was

tested at a sufficiently high level and found not to be clastogenic. 

(MRID# 421716-02)

Picloram triisopropanolamine salt was evaluated in the Ames test

using Salmonella typhimurium. Doses ranged up to 5000 ug/plate, with

and without metabolic activation. The test material did not produce a
21

mutagenic response either in the presence or absence of activation. 

(MRID# 414859-01)

Picloram triisopropanolamine salt was evaluated by oral

administration to mice in the mouse bone marrow micronucleus test, at

dosage levels of 0, 300, 1000 or 3000 mg/kg. The test agent was

determined to be non-clastogenic in mice, as determined by lack of

mutagenic effect at doses up to lethality (3000 mg/kg). (MRID#

415397-01)

Picloram triisopropanolamine salt (MRID# 415397-02) was

evaluated for genotoxic (DNA damage/repair) potential when

administered to primary rat hepatocyte cultures at concentrations up to

1500 ug/ml. The test material was negative for inducing unscheduled

DNA synthesis (UDS) at doses up to toxic levels (1500 ug/ml). 

(MRID# 415397-02)

h. Metabolism

The absorption, distribution, metabolism and excretion of

picloram acid was evaluated in female rats administered a single i.v. or

oral gavage dose of 10 mg/kg, an oral gavage dose of 1000 mg/kg C- 14

picloram, or 1 mg/kg/day unlabeled picloram by gavage for 14 days

followed by a single oral gavage dose of 10 mg/kg C-picloram on day 14

15. The study demonstrates that C-picloram is rapidly absorbed, 14

distributed and excreted following oral and i.v. administration. This

study alone is not adequate; however, this study is acceptable when

considered in conjunction with a male rat metabolism study (MRID#

00098321) which yielded similar results. (MRID# 412096-02)

The absorption, metabolism and excretion of picloram isooctyl

ester (also referred to as picloram ethylhexyl ester) was studied in male

F344 rats following single oral (gavage) dosing with 15 mg/kg of C- 14

picloram isooctyl ester. The ester was absorbed and excreted rapidly. 

By 48 hours post-exposure, mean recovery of radioactivity was 96.4%. 

The urine was the major elimination route (68 % of administered dose). 

The feces and expired CO represented 16.35% and 10.16%, 14

2

respectively, of the administered dose. Elimination of picloram

ethylhexyl ester was rapid, as indicated by 67% recovery at 24 hours

post-dosing. The major metabolite was 2-ethyl-1, 6-hexanoic acid. This

study supports the fact that picloram ethylhexyl ester is hydrolyzed

rapidly to picloram (free acid) and 2-ethyl hexanol, and that picloram

ethylhexyl ester does not influence the excretion of picloram in the rat. 

(MRID# 421716-03)
22

The absorption, metabolism and excretion of picloram

triisopropanolamine salt was studied in male F344 rats following

administration of single oral doses (gavage) of 9.5 mg/kg of C -

14

triisopropanolamine and 9.8 mg/kg of picloram. This level of dosing

delivered 20-30 uci per animal in the forms of C-triisopropanolamine. 14

The C-triisopropanolamine was absorbed readily, with peak plasma 14

radioactivity being observed at 0.25 hours post-dosing. The

administered dose of radioactivity as recovered primarily in urine, feces,

expired carbon dioxide, tissue/carcass and final cage rinse was 94%. 

Unchanged triisopropanolamine accounted for 80% of the total

radioactivity excreted in the urine. No other metabolites were identified

in the 0-6 hour pooled urine sample. The data suggest that the

conversion of picloram triisopropanolamine salt to picloram was not

affected by the presence of triisopropanolamine. (MRID# 423431-01)

i. Other Toxic Endpoints

Picloram isooctyl ester (also referred to as picloram ethylhexyl

ester) bears structural similarity to di(2-ethylhexyl)phthalate (DEHP) in

possessing a 2-ethylhexyl moiety. DEHP and certain other substances

containing the 2-ethylhexyl moiety have been found to be positive for

carcinogenicity in rodent bioassays. 2-Ethylhexanol was detected as a

metabolite in the metabolism studies summarized above. This metabolite

is also a primary hydrolytic cleavage product of DEHP, a positive

rodent liver carcinogen. This metabolite is thought to play a role in the

ability of DEHP to act as a peroxisome proliferator and it has been

suggested that peroxisome proliferation might be the underlying

mechanism in DEHP carcinogenicity. Available data indicate that

DEHP is most potent among the 2-ethylhexyl containing compounds

tested. For the purposes of carcinogenicity risk assessment for

occupational exposure with respect to picloram isooctyl ester, the

recommended toxicological endpoint is the Q1 value of 3.29 x 10 * -4

(mg/kg/day) obtained for DEHP in a carcinogenicity risk assessment on -1

this compound [D. Turnbull and J.V. Rodricks (1985)]. This Q is 1

*

based upon a 2-year carcinogenicity bioassay of DEHP in female mice

[National Toxicology Program (1982)] and although this Q was 1

*

generated by Turnbull et al., the value was generated using the same

model the Agency uses. 

Hexachlorobenzene (HCB), a recognized impurity in picloram

compounds, is considered to be an animal carcinogen and probable

human carcinogen as discussed in the 1988 Registration Standard for

picloram.
23

j. Reference Dose

In the meeting of September 30, 1993, the OPP RfD Peer

Review Committee recommended that the RfD for this chemical be

based on a NOEL of 20 mg/kg/day for a dose-related increase in size

and altered tinctorial properties of centrilobular hepatocytes in males and

females at 60 and 200 mg/kg/day in a chronic toxicity study in rats

(MRID# 00155940). An uncertainty factor (UF) of 100 was used to

account for the inter-species extrapolation and intra-species variability. 

On this basis, the RfD was calculated to be 0.20 mg/kg/day. It should

be noted that no regulatory value has been established for this chemical

by the World Health Organization (WHO) up to this date. The

committee classified picloram as a "Group E" chemical, no evidence of

carcinogenicity for humans.

There was no evidence, based on the available data, to suggest

that the chemical was associated with significant reproductive or

developmental toxicity under the testing conditions.

2. Exposure Assessment

a. Dietary

The qualitative nature of the residue in plants is adequately

understood based on a wheat metabolism study. The residue of concern

in wheat forage, straw, and grain is conjugated picloram, which is

hydrolyzable by acid, base, and ß-glucosidase. The minor metabolites

that were identified in grain and straw were 4-amino-6-hydroxy-3,5-

dichloropicolinic acid and 4-amino-2,3,5-trichloropyridine. The data

support the current uses. Additional plant metabolism studies may be

required if picloram uses are expanded to other crops. (MRID#s

00037880, 00041136, 00059411, 00111527, 00157171, and 42579004).

The qualitative nature of the residue in animals is adequately

understood. Picloram is the residue of concern in meat, milk, poultry

tissues, and eggs. The available ruminant metabolism study indicates

that picloram is the major residue in animal tissues of interest and that

picloram is not metabolized in ruminants to a significant degree; only

minor amounts (<10% of total radioactive residues) of 4-amino-2,3,5-

trichloropyridine were detected in goat fat and liver. In the submitted

poultry metabolism study, 99.9% of the recovered radioactivity was

found in the excreta and virtually all of the C-residues were identified 14

as picloram. (MRID#s 00023105, 00041125, 00161306, 00163216, and

42535301).
24

Adequate enforcement methods are available for the

determination of residues of picloram per se in/on plant and animal

commodities. All of these methods use GLC with electron capture

detection of the methyl ester of picloram. The Pesticide Analytical

Manual (PAM), Vol. II lists Methods A and III for plant commodities. 

DowElanco method ACR 73.3.S2 is a GC/ECD method based on

Method III with substantial modifications. Method ACR 73.3.S2 was

validated using samples from the wheat metabolism study and is

adequate for data collection of picloram residues. Method ACR

79.7.S.1 is adequate for collection of picloram data on grass forage and

hay. DowElanco Method ACR 91.4 is adequate for HCB data collection

from plant commodities.

PAM Vol. II Methods I and II are used to enforce tolerances for

picloram residues in animal commodities. DowElanco GC/ECD

methods ACR 67.2 and ACR 67.3 are equivalent to Methods II and I,

respectively, except that toluene is used in place of benzene. These

animal commodity methods have been validated using samples from the

goat metabolism study and are adequate for data collection and tolerance

enforcement for milk and animal tissues. (MRID#s 00026748,

00026749, 00026750, 00026751, 00026752, 00026753, 00027288,

00035959, 00045363, 00045366, 00045373, 00045374, 00045375,

00045376, 00045409, 00062818, 00069973, 00073972, 00073974,

00078483, 00085060, 00111404, 00111407, 00131364. 00132986,

00156366, and 42380201).

FDA has tested picloram using the PAM, Vol. I Multiresidue

Method for acids and phenols (Sec 221.1). Table 201-D of the volume

reports that picloram in nonfat foods is recovered completely through

PAM I 221.1 if a 100 mL ethyl ether Florisil elution is included whereas

only 6-10% is recovered from fatty foods.

Adequate storage stability data on picloram are available to

support the collected samples from metabolism and magnitude of the

residue studies in plants and animals. Residues of picloram per se are

stable under frozen storage conditions in/on: (i) wheat and barley grain,

forage, and straw; and grasses for up to 2 years; (ii) egg whites for up

to 18 months; (iii) milk for up to 15 months; and (iv) liver and muscle

for up to 6 months. Adequate storage stability data for HCB residues

are available for grass and small grain commodities; residues of HCB

are stable in frozen storage for up to 17 months. (MRID#s 00164725,

40082701, 40435601, 40731901, 41442301, 41976701 and 42494001).

All data requirements for magnitude of picloram residues in

plants have been evaluated and deemed adequate. The registered uses of
25

picloram on barley, oats, and wheat along with the established tolerances

on these commodities are supported by acceptable field residue data

from trials reflecting the maximum registered use patterns. Field trial

data representing maximum registered use patterns are available for

grasses and support the proposed tolerance of 225 ppm for grass hay;

however, residues on grass forage exceed the proposed tolerance of 225

ppm. The data indicate that a value of 300 ppm would be appropriate

for grass forage. 

The Agency has acceptable field residue data at the 0.5 lb. ae/A

and 2 lb. ae/A. However, through negotiations with the registrant the

new maximum use rate will be lowered to 1 lb. ae/A. Ordinarily, field

residue data would be required for this new maximum use rate,

however, since there are minimal dietary concerns involved with

picloram, no field residue data will be required for the 1 lb. ae/A

maximum use rate. Picloram tolerances are based on the 2 lb. ae/A data

and will remain in effect unless the Agency revisits the tolerance setting

database and lowers the tolerance based on the 0.5 and 2 lb. ae/A

residue field data or the registrant proposes a lower tolerance based upon

the 0.5 and 2 lb. ae/A. 

Acceptable grain dust data have been submitted for wheat, which

show that residues of picloram concentrate 7x in aspirated grain dust. 

The registrant must propose a suitable tolerance for grain dust.

The available field residue data on HCB residues in/on plants are

adequate. HCB residues were nondetectable in/on wheat grain(<0.001

ppm), grain dust(<0.001 ppm) and wheat straw (<0.002 ppm)

following applications of registered formulations of picloram according

to the maximum registered use patterns. Residues of HCB were

<0.001 ppm in/on grass forage and hay treated using the 2 lb/gal SC/L

potassium salt formulation at a rate of 2 lb ae/A, and containing residues

of picloram as high as 480 ppm. One hay sample, containing 270 ppm

picloram, bore 0.001 ppm HCB. Residues of HCB were shown to

dissipate from grass at a greater rate than picloram residues. (MRID#s

00026753, 00036168, 00036170, 00036171, 00045369, 00085060,

00108862, 00108864, 00111404, 00111470, 00111482, 00111557,

00128714, 41905401, 42037601, 42380201, 42535303, and 42784401).

The data requirements for magnitude of the residue in processed

food/feed have been evaluated and deemed adequate. Acceptable wheat

grain processing data have been submitted; the wheat processing data

will be translated to barley and oats. The wheat data indicate that

residues of picloram concentrate up to 5x in bran. HCB residues were
26

not detected in/on wheat grain or processed fractions. The existing feed

additive tolerance of 3 ppm for picloram residues in milled products of

wheat (exc. flour) is adequate. (MRID# 42535303).

The ruminant and poultry feeding studies that were reviewed in

the Residue Chemistry Chapter of the Picloram Reregistration Standard,

dated 10/29/84, are adequate to satisfy animal feeding study data

requirements. These feeding studies indicate that the existing tolerances

on animal commodities are supported by residue data from dietary

intakes exceeding the maximum dietary burden. (MRID#s 00045372,

00045374, 00045376, 00073921, and 00073973).

An acceptable confined rotational crop study has been submitted. 

Field rotational crop studies are not required; in addition, tolerances for

rotational crop commodities need not be established. (MRID#

42641801).

b. Occupational and Residential

Picloram is applied by ground, aerial, wiper applicator,

backpack, handheld sprayer/spraywands, tree injection, and

paintbrushes. Application types include: aerial and ground broadcast

spray treatments; band applications with helicopters; frill, girdle, and

stump treatments; spray or paint-on treatment to the base of a target

plant; direct injection into a target plant; high-volume spray treatments

using ground, handheld, or wiper-applicator equipment; spot treatments

(soil or plant) using ground, handheld, low-pressure, or wiper-applicator

equipment; basal bark and soil treatments using backpack, power, or

knapsack sprayers and low-volume ground equipment.

Minimum application volumes range from using small amounts

of undiluted end-use-products in some spot and basal bark treatments to

using various formulations diluted in up to approximately 100 gallons

per acre in some ground applications. Diluents include water and

various petroleum based derivatives. The maximum application rate,

regardless of the crop/target for all equipment categories, application

targets and formulation types is 2.16 lb active ingredient/acre. All

application rates are based on the acid moiety of picloram, the active

agent, and not each specific salt or ester of picloram contained in each

formulation. For a significant number of other application techniques,

picloram essentially is applied at the discretion of the applicator to a

particular target of choice (e.g., ad libitum or to run-off to a tree trunk

in a spot or frill/girdle treatment). For these types of application

scenarios, an application rate on a per acre basis was not calculated
27

because it is not expected to be worse than the backpack/knapsack

sprayer scenario which is considered the worst-case.

The maximum duration of any exposure for workers on a yearly

basis is likely to range from 10 to 40 days for commercial applicators,

i.e., rights-of-way spraying operations are likely to require 40 days.

Occupational-use products and homeowner-use products

At this time no products containing picloram are registered for

homeowner use. All products containing picloram are for occupational

use (all products are restricted-use pesticides). None of the registered

uses are likely to involve applications at residential sites.

Uses within the scope of the Worker Protection Standard

The 1992 Worker Protection Standard for Agricultural Pesticides

(WPS) established certain worker-protection requirements (personal

protective equipment, restricted entry intervals, etc.) to be specified on

the label of all products within the scope of the WPS. Uses within the

scope of the WPS include all commercial (non-homeowner) and research

uses on farms, forests, nurseries, and greenhouses to produce

agricultural plants (including food, feed, and fiber plants, trees, turf

grass, flowers, shrubs, ornamentals, and seedlings). Uses within scope

include not only uses on plants, but also uses on the soil or planting

medium the plants are (or will be) grown in.

At this time some of the registered uses of picloram are within

the scope of the Worker Protection Standard for Agricultural Pesticides

(WPS) and some uses are outside the scope of the WPS. Those that are

outside the scope of the WPS include use:

- on pastures or rangelands,

- in a manner not directly related to the production of

agricultural plants, including, for example, control of

vegetation along rights-of-way and in other noncrop

areas.

The WPS does not cover workers who are working in an area

where a pesticide has been injected directly into plants, i.e., there are no

entry restrictions or notification requirements. However, people who

handle pesticides that are to be applied by direct injection are covered by

the WPS and must receive WPS handler protection. Direct injection

does not include chemigation, soil incorporation, soil injection, hack and

squirt, or frill and spray application techniques.
28

Previous Data Requirements

Requirements for mixer/loader/applicator (i.e. handler) exposure

studies are addressed in Subdivision U of the Pesticide Assessment

Guidelines. Mixer/loader/applicator (M/L/A) exposure data for

picloram have not been required in the past, since no toxicological

criteria had been identified at that time. The complete review of the

toxicological data submitted to support reregistration indicates that these

data are now warranted.

Requirements for post-application exposure studies are addressed

by Subdivision K of the Pesticide Assessment Guidelines. Postapplication exposure data have not been required in the past, since no

toxicological criteria had been triggered for picloram. The complete

review of the data submitted to support reregistration now indicates that

picloram does trigger the toxicological criteria, but not for the

requirement of post-application exposure data. 

Occupational and Residential Exposure Assessment

An occupational and/or residential exposure assessment is

required for an active ingredient if (1) certain toxicological criteria are

triggered and (2) there is an exposure risk for handlers (mixers, loaders,

applicators) during use or for persons entering treated sites after

application is complete.

The toxicological data base for picloram is adequate and will

support reregistration. Studies for acute toxicity indicate that picloram

is classified as category III for acute oral toxicity, category III for acute

dermal toxicity, category I/II (depending on whether acid, ester or salts)

for acute inhalation toxicity, category III/IV (depending on whether

acid, ester or salts) for skin irritation potential, and category III for eye

irritation potential. The potassium salt, triisopropanolamine salt, and

isooctyl ester are classified as skin sensitizers. In addition, picloram has

a low vapor pressure. 

The toxicology criteria that trigger the requirements for an

exposure assessment include: (1) systemic toxicity at 500 mg/kg/day

(LOEL) based on the 21-day dermal study conducted, (2) classification

of the impurity, hexachlorobenzene as a Group B2, (probable human

carcinogen) having a Q X 1.7 (mg/kg/day) , and (3) classification of 1

* -1

DEHP as having a Q 3.29 X 10 (mg/kg/day) . (Picloram isooctyl 1

* -4 -1

ester bears structural similarity to DEHP since both possess a 2-

ethylhexyl moiety.)
29

There is an exposure risk for mixers, loaders, applicators, and

handlers for both dermal and inhalation routes during usual use-patterns

associated with picloram. Therefore, an occupational and/or residential

exposure assessment for handlers is required for picloram. A limited

exposure assessment was conducted for picloram using data from the

Pesticide Handlers Exposure Database (PHED) and surrogate data from

the open literature. No chemical-specific data are available for

picloram. It should be noted that all methods of application cited above

and in Table V are applicable to the ester but there are no terrestrial

food uses for this compound. 

Based on the use patterns and potential exposures described

above, major exposure scenarios were identified for picloram. Each

scenario is defined by the types of equipment that could be used on the

four major use-sites on which picloram is applied: terrestrial food crops,

terrestrial non-food crops, forestry sites, and terrestrial feed crops. The

scenarios include; (1) mixing/loading to support aerial applications, (2)

applying with a groundboom sprayer, (3) applying with a fixed-wing

aircraft, (4) applying with a rotor-wing, (5) applying with a paintbrush,

(6) applying through direct injection into a woody plant, (7) applying

with a high-pressure handwand, (8) applying with a hand-cannon along

right-of-ways, (9) applying with a wiper applicator, (10) applying with

backpack/knapsack equipment, (11) applying with a powered personal

sprayer, and (12) applying with a low-pressure handwand. These

exposure scenarios are presented in Table V along with the

corresponding exposure/risk assessment. The data for five scenarios

(5), (7), (9), (10) and (12), were insufficient to complete an

exposure/risk assessment. However, for the scenarios for which there

are insufficient data, exposures are expected to be no greater than

maximum exposure scenario, which is applying with a

backpack/knapsack sprayer. 

There is a risk associated with post-application exposure for

persons entering treated sites after application is complete particularly

following aerial and ground broadcast spray treatments. However, the 

crops and sites where picloram is applied are not those where postapplication activities (harvesting, scouting, irrigation, etc.) would be

expected soon after application is complete. Therefore, an occupational

and/or residential exposure assessment for post-application workers is

not required for picloram.

Additionally, to clarify the Table V, the Exposure Scenario

Description (Table VI) was developed. Table VI summarizes the

caveats and parameters specific to each exposure scenario. This table
30

also includes a description of the sources for each data point as well as

general information pertaining to the techniques used to calculate the

corresponding exposure values. The "Data Source" is self-explanatory. 

The "Clothing Scenario" represents the clothing worn by the test

subjects during the generation of the referenced exposure values. 

"Equipment" describes the application techniques used to generate the

referenced data. "Formulation" is self-explanatory. "Standard

Assumptions" represent the use scenarios employed by EPA to estimate

daily exposure levels. The "Comments" section includes any other

critical descriptions of the data including information pertaining to the

quality of the exposure data. 
31

TABLE V: Summary Exposure Values for Picloram

Exposure Scenario Exposure (mg/lb Exposure Rate Maximum (mg/kg/day) Exposure (mg/kg/day) (mg/kg/day)

(Scen. #) ai) ( g/lb ai) (lb ai/cycle) Treated (mg/kg/day)

Dermal Inhalation Application Daily Exposure Daily Dermal Exposure Exposure

a b

Maximum HCB

Label Daily Dermal HCB Daily Inhalation Daily Inhalation

c

d

e

d

d

e

d

Mixer/Loader Exposure

Open Mixing Liquids (I) 0.3 0.4 1.08 lb ai/A 500 acres 1.2 1.2 x 10 3.1 x 10 3.1 x 10

(aerial)

f -4 -3 -7

Applicator Exposure

Groundboom Application (II) 0.02 1.3 1.08 lb ai/ A 80 acres 1 x 10 1 x 10 1.6 x 10 1.6 x 10 g -2 f -6 -3 -7

Fixed-Wing Aerial (III) 0.005 0.2 1.08 lb ai/A 500 acres 4 x 10 4 x 10 1.5 x 10 1.5 x 10 g -2 -6 -3 -7

Helicopter (IV) No Data No Data 1.62 lb ai/A No Data No Data No data No data No Data h

Paintbrush (V) 290 570 (median) 0.54 lb ai/gal 1 gallon 1.1 1.1 x 10 4.4 x 10 4.4 x 10 h f -4 -3 -7

Tree Injection/ No Data No Data 0.54 lb ai/gal No Data No Data No data No data No Data

Hypo-hatchet (VI)

h

High Pressure Handwand (VII) 0.70 0.09 0.036 lb ai/gal 1000 gallon 1.8 x 10 1.8 x 10 5 x 10 5 x 10

spray solutionh

-1 f -4 -5 -9

Right-of-Way Hand Cannon (VIII) No Data No Data 2.16 lb ai/A No Data No Data No data No data No Data i h

Wiper Applicator (IX) No Data No Data --- No Data No Data No data No data No Data

Backpack/Knapsack (X) 159.1 mg/hr 36 g/hr 2.16 lb ai/A 8 hours 4.5 4.5 x 10 4.1 x 10 4.1 x 10 j

(average) (average)

h j,k -4 -3 -7

Powered Personal Sprayer (XI) No Data No Data --- No Data No Data No data No data No Data

Mixer/Loader/Applicator Exposure

Low Pressure Handwand (XII) 103 39 2.16 lb ai/A 2 acres 3.2 3.2 x 10 2.4 x 10 2.4 x 10 h f -4 -3 -7

a Exposure units may differ from those defined in headers. Alternate units are noted where appropriate. Dermal unit exposures are reported as the best fit mean, unless noted. The best fit mean is the composite total dermal exposure based on using the geometric mean for log normal distributed data,

arithmetic mean for normal distributed data, and the median for all other distribution types.

b Inhalation exposure values are reported as geometric means (log normal distributions), unless otherwise noted.

c Values represent the maximum area or the maximum volume of spray solution which can be used in a single day to complete treatments for each exposure scenario of concern.

d Daily Exposure (mg/kg/day) = Exposure (mg/lb ai) * Max. Appl. Rate (lb ai/cycle) * Max. Treated

 70 kg

e HCB is present as a 0.01% contaminant.

f These estimates for picloram and HCB are reduced by 50% for glove use. The unit exposure reflects PPE in the Exposure Scenario Descriptions Table (VI) for Picloram.

g Luis Report dated 1/4/93, Picloram, triisopropanolamine salt.

h Tordon 101 (EPA Reg. No. 62719-5).

i High Pressure Handwand (Scenario VII) data can be used for Hand Cannon (Scenario VII).

j This scenario represents the worst-case scenario and the exposure is based on only the applicator exposure. The combined mixer, loader and applicator exposure, i.e. if the same individual performed all three tasks, is less than the applicator only exposure.

k The estimate for total deposition is reduced by 75% to reflect use of long pants, long sleeved shirt, and gloves. The unit exposure reflects PPE in the Exposure Scenario Descriptions Table (VI) for Picloram. 

TABLE VI: Exposure Scenario Descriptions for Piclorama

Exposure Scenario Data Clothing Equipment Standard Assumptions Comments

(Scen. #) Source Scenario (8 hr work day)

b c

Mixer/Loader Exposure
TABLE VI: Exposure Scenario Descriptions for Piclorama

Exposure Scenario Data Clothing Equipment Standard Assumptions Comments

(Scen. #) Source Scenario (8 hr work day)

b c

32

Open Mixing (I) PHED Long Pants, Long-Sleeved Shirt, Open Mixing 500 acres (aerial) Acceptable grades; Dermal = 14 + replicates; Inhalation

No gloves = 40 replicates

Applicator Exposure

Groundboom Application (II) PHED Long Pants, Long-Sleeved Shirt, Open Cab Tractor 80 acres/day Grades A, B, C; Dermal = 6 + replicates;

No gloves Inhalation = 56 replicates.

Aerial (III) PHED Long pants, long-sleeved shirt, no All Cab types 500 acres/day Inhalation grades A, B, C; Dermal all grades; Dermal = 4

gloves - 41 replicates; Inhalation = 25 replicates.

Helicopter (IV) No Data No Data No Data No Data No Data

Paintbrush (V) PHED Long pants, Long sleeve shirt, no Paint brush 1 gallon undiluted Inhalation grade C; Dermal grades B, C; Dermal and

gloves Inhalation = 15 replicates.

Tree Injection/Hypo-Hatchet (VI) No Data No Data No Data No Data No Data

High Pressure Handwand (VII) PHED Long pants, Long-sleeved shirt, High pressure portable 1000 gallons/day Inhalation grades B and C; Dermal grade B and C; Dermal

no gloves hand wand on wheels and Inhalation = 9 replicates

Right-of Way Cannon (VIII) No Data No Data No Data No Data No Data

Wiper Applicator (IX) No Data No Data No Data No Data No Data

Backpack/ Abbott et Total Deposition Knapsack with 1 meter 8 hour work day Laboratory and field recovery available; Dermal = 6

Knapsack (X) al. 1987 boom replicates; Inhalation = 12 replicates.

Powered Personal Sprayer (XI) No Data No Data No Data No Data No Data

Mixer/Loader/Applicator Exposure

Low Pressure Handwand (XII) PHED Long pants, long-sleeved shirt, no Portable handwand 2 acres/day Inhalation grades B and C; Dermal all grades; Dermal =

gloves 25 to 95 replicates; Inhalation = 95 replicates.

a "No Data" indicates that no data were available to complete an exposure assessment.

b Standard Assumptions based on an 8 hour work day as estimated by OREB. BEAD data were not available.

c If dermal and inhalation grades are not listed separately, then the listed grades pertain to both dermal and inhalation. "Acceptable grades," as defined by OREB SOP for meeting

 Subdivision U Guidelines, are grades A and B for dermal and inhalation, and grade C for hand rinse method. All grades that do not meet OREB's SOP are listed individually.
33

Data Requirements

Although data are available to estimate the worker exposure for

the maximum exposure scenarios for the purposes of risk assessment,

the data sets available are limited in both quantity and quality as shown

in Table VI. In order to reduce the uncertainty associated with the

exposure assessments and thus the risk assessment and because the

following scenarios lack exposure data and have a potential for as high a

worker exposure as the backpack/knapsack scenario, these data must be

submitted for confirmation purposes:

1) Guideline 231: Estimation of Dermal Exposure at Outdoor Sites for

mixer/loaders and applicators using the hand cannon equipment.

2) Guideline 232: Estimation of Inhalation Exposure at Outdoor Sites

for mixer/loaders and applicators using the hand cannon equipment.

3) Guideline 231: Estimation of Dermal Exposure at Outdoor Sites for

mixer/loaders and applicators using the backpack/knapsack equipment.

4) Guideline 232: Estimation of Inhalation Exposure at Outdoor Sites

for mixer/loaders and applicators using the backpack/knapsack

equipment.

3. Risk Assessment

a. Dietary

There are two primary dietary exposure/risk analysis

considerations for picloram: (1) the chronic dietary exposure/risk to

picloram per se, and (2) dietary carcinogenicity exposure/risk to HCB,

an impurity. An acute oral toxicity endpoint has not been identified for

picloram; therefore, an acute dietary exposure/risk analysis was not

conducted for picloram per se. Picloram isooctyl ester has no food uses,

therefore no dietary exposure is expected. Thus, a dietary carcinogenic

exposure/risk analysis was not conducted for picloram IOE. 

The chronic analysis for picloram used a Reference Dose (RfD)

of 0.2 mg/kg bodyweight per day, based on a NOEL of 20.0 mg/kg

body-weight per day from a two-year rat feeding study and an

uncertainty factor of 100 to account for interspecies extrapolation and

intraspecies variability. The endpoint effects noted were altered size and

tinctorial properties of centrilobular hepatocytes in both male and female
34

rats. HCB is considered a Group B2 carcinogen. The carcinogenicity

analysis that was performed for HCB used a Q1* of 1.7 (mg/kg

bodyweight per day) . The residue values used are summarized in -1

Table VII. Residue values are based on the assumption of tolerance

level residues of picloram on crops. Residues of HCB were estimated

by assuming presence on all crops in direct proportion to the maximum

level of HCB in picloram TGAI as certified by the producer, i.e., at

0.01% of the picloram tolerance. All percent crop treated values were

available.

Table VII. Picloram and HCB Residue Values on Foods Used to Determine Dietary Risk. a

Commodity Picloram Residues (ppm) HCB Residues (ppm) % crop treated

Barley, grain 0.5 0.00005 2

Barley, milled fractions (exc. flour) 3 0.0003 2

Oats, grain 0.5 0.00005 1

Oat, milled fractions (exc. flour) 3 0.0003 1

Wheat, grain 0.5 0.00005 2

Wheat, milled fractions (exc. flour) 3 0.0003 2

 Secondary Residues

Milk 0.05 0.000011 (whole milk)

0.000265 (milk fat only

 assuming 4% fat)

Cattle, fat 0.2 0.00045

Cattle, kidney 5 0.000023b

Cattle, liver 0.5 0.000023b

Cattle, mbyp (exc kidney and liver) 0.2 0.000023b

Cattle, meat 0.2 0.000023b

Poultry, fat 0.05 0.000007

Poultry, mbyp 0.05 0.0000001c

Poultry, meat 0.05 0.0000001c

Eggs 0.05 0.000002 (yolk) 

0.000000007 (white) c

Hogs, fat 0.2 0.000008

Hogs, kidney 5 0.0000004c

Hogs, liver 0.5 0.0000004c

Hogs, mbyp (exc kidney and liver) 0.2 0.0000004c

Hogs, meat 0.2 0.0000004c

Horses, fat 0.2 0.00045

Horses, kidney 5 0.000023b

Horses, liver 0.5 0.000023b

Horses, mbyp (exc kidney and liver) 0.2 0.000023b

Horses, meat 0.2 0.000023b

Sheep, fat 0.2 0.00045

Sheep, kidney 5 0.000023b

Sheep, liver 0.5 0.000023b

Sheep, mbyp (exc kidney and liver) 0.2 0.000023b
Commodity Picloram Residues (ppm) HCB Residues (ppm) % crop treated

35

Sheep, meat 0.2 0.000023b

Goats, fat 0.2 0.00045

Goats, kidney 5 0.000023b

Goats, liver 0.5 0.000023b

Goats, mbyp (exc kidney and liver) 0.2 0.000023b

Goats, meat 0.2 0.000023b

a Tolerances are established for residues of picloram per se.

b These residue values were rounded up to the usable six decimal limit for the analysis resulting in a very slight overestimation of the risk.

c These residue values were so small, they rounded to less than 0.000000, the decimal places allowed in the analysis which lowered the risk just slightly.

The chronic dietary exposure/risk estimates for picloram are

extremely low. For the United States population as a whole, the

Theoretical Maximum Residue Contribution (TMRC) is 0.001845 mg/kg

bodyweight per day, only 0.9% of the RfD. For this same group, the

Anticipated Residue Contribution (ARC) is 0.001053 mg/kg bodyweight

per day, only 0.5% of the RfD. The subgroup with the greatest routine

chronic exposure/risk is Non-nursing Infants (Less Than One Year Old),

which has a TMRC of 0.004753 mg/kg bodyweight per day (2.4% of

the RfD) and an ARC of 0.003805 mg/kg bodyweight per day (1.9% of

the RfD). All of the exposure/risk for the U.S. population as a whole

and each of the 22 subgroups are contributed by published tolerances.

The HCB upper-bound carcinogenicity exposure/risk estimate,

which is performed only for the U.S. population as a whole, was an

ARC of 3.94 x 10 mg/kg bodyweight per day and produced a -7

calculated ARC upper-bound carcinogenicity risk estimate of 6.7 x 10 . 

-7

As a note, the estimated chronic toxicity ARC exposures and risks for

HCB, using an RfD of 8 x 10 mg/kg bodyweight per day and the same -4

residue figures that were used in the carcinogenicity analysis, were very

low. For all groups and subgroups, the exposure was 1 x 10 mg/kg -6

bodyweight per day or less and the calculated risk was less than 0.14%

of the RfD. The following commodities contributed the large majority

of the HCB carcinogenicity and chronic toxicity exposure/risk estimate:

Carcinogenic Carcinogenic

Commodity ARC Exposure ARC Risk 

* **

Cattle (beef) 0.000000195 0.33 (49.5%)

Milk 0.000000193 0.33 (49.0%)

Totals for both 0.000000388 0.66 (98.50%)

* In units of mg/kg bodyweight per day 

* *In units of E-6 (percent of the total risk--and exposure)

The Picloram chronic dietary TMRC and ARC exposure/risk

estimates are exceedingly low, about 1/200th of the RfD for each of the
36

groups and subgroups. There appears to be no reason for concern with

regards to chronic dietary exposure to Picloram at this time. 

The refined, ARC upper-bound dietary carcinogenicity risk

estimate for the U.S. population as a whole for Picloram's impurity

Hexachlorobenzene is 0.7 E-6; a risk below 1.0 E-6 is generally

considered to be negligible. It is also likely that this upper-bound risk

estimate is a substantial overestimate because the worst-case scenarios

and assumptions were used for determining HCB residues. The

rounding of the residue level numbers also may have contributed to

overestimation of the HCB exposure/risk because more happened to

require upward rounding. The estimated dietary carcinogenicity risk

from HCB, when dietary exposure to HCB is considered only for its

occurrence as an impurity of picloram, is within Agency acceptability

guidelines. It should be noted that HCB also occurs as an impurity in

several other pesticide technical products, so overall dietary exposure to

HCB is likely to be appreciably higher than HCB considered simply as a

picloram impurity as considered in this analysis.

b. Occupational and Residential

Picloram acid, potassium salt, triisopropanolamine and

isooctyl ester

In order to adequately determine the risk associated with a

chemical the toxicological end-points of concern must be identified in

relation to the duration of the exposures. The toxicological endpoints of

significance for occupational exposure are as follows:

1) There are no short term (one to seven day exposures) toxicological

concerns indicated for occupational exposure.

2) The intermediate term exposure (1 week to several months)

toxicological endpoints are indicated by the 21-day dermal rabbit studies

based upon increased bilirubin (males) and BUN (blood urea nitrogen

males/females). The NOELs range from 250 to 1320 mg/kg/day for the

picloram compounds. For the purposes of risk assessment, the lowest

LOEL of 500 mg/kg/day should be used as the toxicological end-point

(rather than 250 mg/kg/day). The effects observed at the LOEL of 500

mg/kg/day from the 21-day dermal rabbit study using picloram isooctyl

ester were minimal and of questionable biological significance. In

addition, studies conducted over a longer period of time by the oral

route do not show effects until a dose level of 500 mg/kg/day. 
37

3) Long-term non-cancer toxicological endpoints for worker exposure

are not required based on the use patterns of this chemical (<90

days/year worker exposure).

The Margins of Exposure (MOE) for workers involved with

mixing/loading and applying these chemicals for 7 to 40 days/year may

be estimated by the following equation:

MOE = NOEL (mg/kg/day)

Exposure (mg/kg/day)

For regulatory purposes the toxicological endpoint of concern is

500 mg/kg/day (LOEL) based on the 21-day dermal rabbit study

conducted with the picloram isooctyl ester (MRID#s 421716-01,

428707-01). The highest potential worker exposure by the dermal and

inhalation routes is represented by applicators in the backpack/knapsack

sprayer scenario at 4.5 mg/kg/day exposure; and the lowest by

applicators in the groundboom scenario at 0.012 mg/kg/day exposure. 

Therefore, the range of MOEs for workers involved in mixer/loader

and/or application activities is between 111 and 42,000. The risk to

mixers/loaders/applicators is considered to be minimal. The MOEs for

picloram are summarized in the Table VIII below:
38

TABLE VIII: The Margins of Exposure (MOE) for Picloram per se

Scenario / Mixer(M), Loader (L), Applicator (A) Exposure (mg/kg/day) (MOE)

Daily Dermal and Inhalation Margin of Exposure

Picloram Picloram

Open Mixing Liquids (aerial) (I) / M,L 1.2 417

Groundboom Application (II) / A 0.012 42,000

Fixed-Wing Aerial (III) / A 0.042 12,000

Helicopter (IV) / A - -

b

Paintbrush (V) / A 1.10 455

Tree Injection/Hypo-hatchet (VI) / A - -

High Pressure Handwand (VII) / A 0.18 2778

Right-of-Way Hand Cannon (VIII) / A - -

Wiper Applicator (IX) / A - -

Backpack/Knapsack (X) / A 4.50 111

Powered Personal Sprayer (XI) / A - -

Low Pressure Handwand (XII) / M,L,A 3.20 156

It should be noted that the MOE was calculated using a dermal LOEL and the combined dermal and inhalation exposure a

which would not be considered appropriate except that the inhalation exposure is so low it represents less that 0.1% of the

dermal exposure for the scenarios.

No Data. Exposures for the scenarios for which there are no data are expected to be no greater than the maximum b

exposure scenario, backpack/knapsack.

M/L, and A wear gloves c

Hexachlorobenzene (HCB) and Picloram Isooctyl Ester

The Agency has classified HCB as a probable human carcinogen

(Group B2) based on an increased incidence of malignant tumors in two

species, hemangioendothelioma in hamsters and hepatocellular

carcinoma in rats, as well as confirmed reports of hepatoma in both of

these species. A Q1 of 1.7 (mg/kg/day) was derived using data * -1

regarding the incidence of hepatocellular carcinoma in female rats. For

these reasons, an occupational carcinogenic risk assessment associated

with picloram is required since HCB could be present up to 100 ppm.

Picloram isooctyl ester (also referred to as picloram ethylhexyl

ester) bears structural similarity to di(2-ethylhexyl)phthalate (DEHP) in

possessing a 2-ethylhexyl moiety. DEHP and certain other substances

containing the 2-ethylhexyl moiety have been found positive for

carcinogenicity in rodent bioassays. 2-Ethylhexanol was detected as a

metabolite in the metabolism studies summarized above. This metabolite
39

is also a primary hydrolytic cleavage product of DEHP, a known rodent

liver carcinogen. This metabolite is thought to play a role in the ability

of DEHP to act as a peroxisome proliferator and it has been suggested

that peroxisome proliferation might be the underlying mechanism in

DEHP carcinogenicity. Available data indicate that DEHP is most

potent among the 2-ethylhexyl containing compounds tested. For the

purposes of carcinogenicity risk assessment for occupational exposure

with respect to picloram isooctyl ester the recommended toxicological

endpoint is the Q value of 3.29 x 10 (mg/kg/day) obtained for 1

* -4 -1

DEHP in a carcinogenicity risk assessment on this compound. [D.

Turnbull and J.V. Roderick (1985)] This Q is based upon a 2-year 1

*

carcinogenicity bioassay of DEHP in female mice [National Toxicology

Program (1982)] and although this Q1 was generated by Turnbull and *

Rodricks, the value was generated using the same model the Agency

uses. 

The estimated excess carcinogenic risk to agricultural workers

from HCB and picloram isooctyl ester based on the use patterns (Tables

V and VI) for picloram are calculated as follows:

Excess Carcinogenic Risk = Q1 x LADD *

where LADD represents the lifetime (35 work years/ 70 average

Lifetime years) times the Average number of work days over a year (40

work days/365 days) times the Daily Dose for each exposure scenario

(mg/kg/day) from Table V for HCB and Table VIII for picloram

isooctyl ester. The daily dose includes the dermal and inhalation

exposures combined. A dermal absorption factor of 100% was assumed

for both chemicals since an adequate dermal absorption study is not

available.

All exposure scenarios are appropriate for risk assessment for

HCB. The highest potential worker exposure by the dermal and

inhalation routes is represented by applicators in the backpack/knapsack

sprayer scenario at 4.50 x 10 mg/kg/day exposure; and the lowest by -4

applicators in the groundboom scenario at 1.16 x 10 mg/kg/day -6

exposure. The excess carcinogenic risk estimates for workers from

exposure to HCB are between 4.19 x 10 and 1.07 x 10 .

-5 -7

Picloram isooctyl ester is generally applied by spot treatment and

the exposure and risk are expected to be no greater than that determined

for the backpack sprayer. Since backpack sprayers represent the highest

exposure scenario, it is also representative of the worst-case scenario. 

The potential worker exposure for this scenario by the dermal and
40

inhalation routes is 4.50 mg/kg/day exposure. The excess carcinogenic

risk estimate for workers from exposure to picloram isooctyl ester is 8.6

x 10 . The groundboom scenario is not represented since picloram -5

isooctyl is currently not applied by this method. 

These risk assessments are considered worst-case since (1) a

100% dermal absorption factor was used (although the dermal

absorption is expected to be < 23% for HCB in picloram and < 10%

for picloram isooctyl ester), (2) a Q1 from DEHP was used for the *

picloram isooctyl ester which assumes the peroxisome proliferator

mechanism of carcinogenicity to be valid, and (3) the picloram isooctyl

toxicity endpoint was used as most representative, but it also happens to

be more toxic by comparison to the other forms of picloram. There is a

degree of uncertainty associated with this risk assessment which is highly

dependent on the quality and quantity of the exposure values summarized

in Table VI and the choice of the toxicity endpoint. Additional exposure

data for the most highly exposed scenario would reduce the uncertainty.

This is a restricted use chemical that has no residential uses at

this time; therefore, there are no human risks associated with residential

uses. 

Entry into a treated area soon after the application of picloram is

expected to be rare given the cultural practices typically associated with

the use-sites (rights-of-way, forestry, pastures, rangelands, and small

grains) defined by the picloram labels at this time. Furthermore, if

entry should occur, the potential exposures are expected to be minimal

due to the characteristics of those use-sites. However, due to the

toxicity concerns associated with picloram, EPA has determined that

entry should not be permitted immediately following application. 

Therefore, the Agency is establishing restrictions on entry to treated

areas.

WPS Entry Restriction: For occupational end-use products

containing picloram as an active ingredient, the Agency is requiring a

12-hour restricted-entry interval for each use of the product that is

within the scope of the Worker Protection Standard for Agricultural

Pesticides (WPS) (except when it is applied by direct injection into the

treated plants).

NonWPS Entry Restriction: For occupational end-use products

containing picloram as an active ingredient, the Agency is requiring a

prohibition on entry until sprays have dried for each use of the product
41

that is outside the scope of the Worker Protection Standard for

Agricultural Pesticides (WPS).

C. Environmental Assessment

1. Environmental Fate

The principal environmental risks of picloram relate to contamination of

surface and groundwater, and damage to nontarget terrestrial plants including

crops, in areas adjacent to areas of application, via runoff or drift, and possibly

from more distant areas where groundwater is used for irrigation or discharged

into surface water. Nontarget plants, in areas adjacent to areas of application,

may be exposed to chemical concentrations many times the levels that have been

associated with toxic effects. Some incidents of purported damage to crops

have in fact been reported. Additional concerns are identified relating to

endangered terrestrial mammals and endangered aquatic animals. 

Picloram (in all of the forms considered) is among the most mobile of

currently registered pesticides, and in some soils it is nearly recalcitrant to all

degradation processes. As of 1992, detections of picloram in ground water

have been reported to the Agency for 10 states. 

Limitations of the quantitative ecological risk assessment include: a.

Risk assessments are based on a single assumed application, because labels for

the most part do not specify maximum annual rates. b. Risks are not assessed

quantitatively for nontarget organisms exposed via irrigation with contaminated

surface or ground water at sites distant from areas of application. Effects at

distant locations are plausible in view of the high persistence, mobility, and

phytotoxicity of these chemicals. 

These chemicals are expected to be similar in their biological and

chemical characteristics in the environment. As a consequence of this

similarity, the different active ingredients are not usually distinguished in the

ecological chemistry and fate review (Section 1), which refers to "picloram" or

"the chemical" generically. The ecological effects review (Section 2)

distinguishes among active ingredients on the basis of use profiles of registered

products containing a given active ingredient. In particular, picloram acid is

not used as an end product, and so the ecological risk assessment is limited to

the salts (TIPA and potassium) and IOE.

a. Environmental Chemistry, Fate and Transport

The four active ingredients are expected to have very similar fate

and transport characteristics in the environment. For the three excluding
42

IOE, the part of the molecule that is principally responsible for

biological activity is the anion, which is chemically identical for all three

active ingredients. For all three, the molecule will dissociate in the

environment to yield the free anion, and the dissociation process is

governed by a rate constant (pKa) that is practically the same in value

for all three: literature submitted by the registrant indicates measured

pKa approximately 2 for the acid and salts (Osteryoung and Wittaker,

1980; Reim, 1989; Woodburn et al. 1989; Skurlatov et al., 1983). IOE

is expected to degrade rapidly (measured aerobic half-life 2 days), to

forms with the same anion as the acid and the salts. Consequently, IOE

is expected to have environmental fate characteristics very similar to

those of the other active ingredients.

The acid and salts are highly soluble in water (>100 ppm). The

Picloram acid water solubility is 560 ppm, while that of the Potassium

salt is 740,000 ppm at 20 C. From these values, it follows that at 0

typical soil pH (5-9) the anionic form comprises greater than 99% of the

dissolved chemical, regardless of the original molecular species. 

Therefore, regardless of the original molecular form, the

physical/chemical properties of the anion may be used to predict the

environmental fate of the applied molecule or formulation. IOE water

solubility is considerably lower at 0.23 ppm at 20 C. However, again, 0

IOE degrades quickly to the highly soluble anion.

Based on the high solubility of picloram in water, and on

resistance to biotic and abiotic degradation processes, as well as the

proven mobility of the chemical under both laboratory and field

conditions, it appears that the major route of dissipation for the chemical

is leaching. Based on low vapor pressure of picloram, volatilization

from soils will not be an important dissipation mechanism. 

Picloram acid has a significant number of physical/chemical

characteristics in common with various pesticides known to leach to

ground water. Picloram acid has a water solubility of 560 ppm, and is

anionic at the environmentally significant pH ranges. Picloram is stable

to hydrolysis in acidic, neutral and basic media. Data on aerobic soil

metabolism show that picloram acid degrades with half-lives ranging

from 167 to 513 days in seven soils, with carbon dioxide the major

degradate. (Two minor degradates are 4-amino-3,5-dichloro-2-pyridinol

and 4-amino-2,3,5-trichloro pyridine.) Data on anaerobic soil and

anaerobic aquatic metabolism indicate that picloram acid is stable to

anaerobic degradation, with over 90% of the chemical not degraded

after 300 days of incubation. Soil photolysis data indicate that picloram

acid is stable when irradiated on soil. Batch equilibrium studies of soils
43

with varying cation exchange capacity indicate that the chemical will be

very mobile (Freundlich Kd values <1), for soils with organic matter (ads)

(OM) content as high as 4.2%.

No acceptable ground water monitoring studies have been

submitted to the Agency; however, available soil residue studies clearly

indicate that picloram has very high potential to leach into ground water

in most soils and the chemical has been detected in 10 states to date

(USEPA 1992; 734/12-92-001) . For picloram that reaches surface

waters through runoff there would be some degradation, as indicated by

the aqueous photolysis study which showed a first-order half-life of 2.6

days for the acid, at 25 C. o

Forestry and terrestrial field data available to the Agency indicate

that picloram is extremely mobile under field conditions. In a forestry

dissipation study conducted in South Carolina, picloram applied at the

maximum application rate of 2.0 lb ai/A (see Use Profile Section) was

detectable 840 days after application, in the deepest samples (1.8 m). In

a study conducted in North Carolina, picloram applied at 2 lbs ai/A to a

bare soil plot and short grass plot (both with 4.01% OM) was detected in

all sampling intervals beyond 8 weeks, in the deepest soil samples (75 to

90 cm). In a field dissipation study conducted in Montana (MRID

#42535302, 42558302), picloram applied at half the maximum label rate

(i.e. at 1 lb ai/A) was detectable 790 days after application in the 48 to

60 inch soil layer (maximum sampling depth 72 inches; soil with 2.2%

OM). In a forestry dissipation study conducted near Ostrander

Washington, picloram applied at half the maximum label rate to exposed

soil was detectable nine months after treatment in the deepest samples

(36 inches). (Soil with 3.7% OM.) 

Data recently submitted to the Agency by T.L. Lavy and

colleagues (University of Arkansas) indicate that picloram leached but

did not degrade over a three-year period in a Crevasse loamy fine sand

treated at depths of 0 to 1.5 meters (data resulted from cooperative

special project CR-815154-03-0). In fact, nearly 100% of the applied

chemical leached from the treated soil over the first three years of the

study, but none of the picloram degraded. In a Captina silt loam,

picloram was mostly degraded within six months to one year, depending

on soil depth. Given the high persistence of picloram in coarse-textured

soils, it appears unlikely that picloram will degrade once it reaches

ground water, even over a period of several years.

Supplemental laboratory studies by Watson et al. (1989) found

that picloram was more persistent and mobile in a coarse-textured soil
44

(sandy loam with 61% sand and about 1.4% organic matter) than in a

finer textured soil (loam with 33% sand and about 3% organic matter). 

Given the low octanol-water partition coefficient, significant

bioaccumulation in aquatic organisms is not anticipated. 

b. Environmental Fate Assessment

The MCL for picloram has been established at 500 ppb. 

Picloram has been classified as a Group E chemical. Picloram generally

does not pose a threat to human health at the levels that have been

detected in ground water to this date. 

As described in greater detail in Section 2, concerns are related

principally to effects on nontarget plants. Exposure to nontarget plants

may occur via the following transport mechanisms.

Exposure of terrestrial plants in areas adjacent to areas of

application, by drift and/or runoff from areas of application. 

Exposure of crops by irrigation with contaminated surface or

ground water. 

Exposure of aquatic plants, via runoff or drift from application

areas, and via discharge of contaminated ground water into

surface water.

Ground Water. Data currently available to EPA indicate that picloram

has been detected in ground water in 10 states at concentrations ranging

up to 30 ppb. The following concerns have been identified: 

high mobility and persistence. Environmental fate data indicate

that picloram is mobile and persistent in laboratory and field

studies. Picloram (in all of the forms considered) is among the

most mobile of the currently registered pesticides. In some soils

it is nearly recalcitrant to all degradation processes.

ground water quality. The Pesticides in Ground Water

Database (USEPA 1992; 734/12-92-001) indicates that as of

1992, detections of picloram in ground water have been reported

in Iowa, Kansas, Maine, Minnesota, Montana, North Dakota,

South Dakota, Texas, Virginia, and Wyoming. Concentrations

in ground water range up to 30 ppb. Picloram has been detected
45

in a variety of environments in these states, although below the

toxicity threshold for human health. 

Considering the widespread use of picloram and the detections in

many states, the Agency is concerned about degradation of water

quality in picloram use areas. Despite a specialized use pattern,

eventual contamination of ground water is virtually certain in

areas where residues persist in the overlying soil. Once in

ground water, the chemical is unlikely to degrade even over a

period of several years. 

Surface Water. Picloram has high potential to contaminate

surface water by runoff from use areas. Regardless of the

original chemical form, substantial quantities of the anion will be

available for runoff for several months following application,

considering its persistence in the environment. As indicated

leaching will be the major route of dissipation from soil. 

Picloram that leaches into ground water may contaminate surface

water in places where ground water discharges into surface

water. 

Except in clear shallow water with substantial mixing, or waters

with short hydraulic residence times, picloram is expected to be

persistent in surface water. Picloram is susceptible to direct

photolysis in water, but not to abiotic hydrolysis or volatilization. 

Biological degradation will be slow under aerobic or anaerobic

conditions. 

Based on the Kd values observed, picloram in runoff and in

surface water will be mostly dissolved in the water rather than

absorbed to the surface of suspended particles. 

The STORET database maintained by the USEPA Office of

Drinking Water indicates that picloram in an unspecified form

has been reported for 420 of 744 surface water samples, collected

at 135 sampling locations, before 1988. Of these detections 85%

were at concentrations 0.13 ug/L or lower and the maximum was

4.6 ug/L. The maximum concentration reported was 4.6 μg/l.

At present, the Agency does not have data from monitoring of

picloram in surface water. However, picloram is regulated under

the Safe Drinking Water Act (SDWA), so water supply systems

are now required to sample for it. An MCL of 500 μg/l and a 1-

10 day health advisory of 20,000 μg/l have been established. 
46

These values are not likely to be exceeded by annual or short

term average concentrations; however considering the application

rates, mobility, and persistence of picloram, occasional

exceedances cannot be ruled out. Therefore the Agency will

carefully review picloram data collected under SDWA and in the

U.S. Geological Survey NAWQA Program when it becomes

available.

2. Ecological Effects

a. Ecological Effects Data

The following acute and chronic studies have been reviewed and

can be used in risk assessment for birds for the four active derivatives of

Picloram.

(1) Non-target Terrestrial Animals

(a) Birds

Picloram Acid P.C. Code: 005101

GLN# TEST TYPE MRID# EVALUATION CLASSIF. % TEST RESULT

DATE A.I. DATE

71-1(a) Mallard, Acute Accession #'s 7/1/87 core 93.8 1983 LD

50 >2150

265983 mg/kg 

40054501

MRID # 157173

50

Oral LD 261883

This avian study conducted with technical grade acid indicates that it is practically nontoxic to

birds on an acute oral basis (LD50 > 2150 mg/kg). This was the only avian study conducted

with the acid.
47

Picloram TIPA Salt P.C. Code: 005102

GLN# TEST TYPE MRID# EVALUATI CLASSIF. % TEST RESULT

ON DATE A.I. DATE

 71-2(a) Quail, Dietary not listed 10/14/82 supplemental (not 10.2 1975 LC

 LC completed with TGAI) >10,000 50

50

ppm

 71-2(b) Mallard, not listed 10/14/82 supplemental (not 10.2 1975 LC

 Dietary LC completed with TGAI) >10,000 50

50

ppm

 71-4(a) Ring-neck not listed 10/14/82 supplemental (not 10.2 1974 NOEC =

(Not required) pheasant,Avian completed with TGAI 2.8 kg/ha

 Reproduction or correct test species)

 71-4(a) Chicken, Avian not listed 10/14/82 supplemental (not 10.2 1974 NOEC =

 (Not required) Reproduction completed with TGAI 2.8 kg/ha

or correct test species)

The avian dietary studies conducted with a product with 10.2 % of technical grade active

ingredient indicate that the test material is practically nontoxic to birds on an acute dietary

basis (LC > 5620). Additionally, two reproduction studies put NOECs at 2.8 kg/ha. 50

Picloram IOE P.C. Code: 005103

GLN# TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

71-2(a) Quail, Dietary LC50 Accession 6/29/87 core 100 1986 LC >5620 ppm

#'s 265982

50 

71-2(a) Quail, Dietary LC50 164726 5/5/88 core Tech. (% not given) 1986 LC50 >5620 ppm

The avian dietary studies conducted with technical grade active ingredient indicate that IOE is

practically nontoxic to birds on an acute dietary basis (LC > 5620). 50

Picloram Potassium Salt P.C. Code: 005104

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DAT

E

71-1(a) Mallard, Acute Oral 164726 5/20/88 core tech. 1985 LD

LD50 (% not > 2250 mg/kg

given)

50

71-1(a) Quail, Acute Oral 164727 5/20/88 core tech. 1985 LD

LD (% not given) > 2250 mg/kg 50

50

71-2(a) Quail, Dietary LC50 REOPIC 08 10/14/82 supplemental because 11.6 1975 LC

study was not > 10,000 ppm

conducted with TGAI

50

71-2(a) Mallard, Dietary REOPIC 07 10/14/82 supplemental because 11.6 1975 LC

LC50 study was not > 10,000 ppm

conducted with TGAI

50

71-2(a) Mallard, Dietary 129070 10/14/82 supplemental because 24.4 1975 LC

LC50 study was not > 10,000 ppm

conducted with TGAI

50
GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DAT

E

48

71-2(a) Quail, Dietary LC50 129068 10/14/82 supplemental because 24.4 1975 LC

study was not > 10,000 ppm

conducted with TGAI

50

71-2(a) Quail, Dietary LC50 Accession 7/1/87 core 38.6 1982 LC

#'s 261883 >5620 ppm

265983

40054501

50

71-4(a) Chicken, Avian not given 10/14/82 supplemental was not 24.4 1978 NOEL

(not Reproduction conducted with TGAI = 11.2 kg/ha

required and required species

) was not used

The two avian acute oral studies conducted with technical grade active ingredient imply that

Picloram Potassium Salt is practically nontoxic on an acute oral basis (LD > 2250 mg/kg). 50

Testing on products containing 11.6, 24.4, and 38.6% of technical grade active ingredient

indicate that this salt is practically nontoxic on an acute dietary basis (LC50 > 5620). A

poultry study revealed a NOEC of 11.2 kg/ha for reproductive effects.

(b) Mammals

Essential results, by active ingredient are:

Picloram acid, the parent compound, is practically

nontoxic to mammals based on an acute oral rat

LD50 > 5000 mg/kg for males and a LD50 = 4012

mg/kg for females. Acute inhalation LC50 >

0.035 mg/l for both sexes.

The TIPA salt tested with 33.9% a.i. is practically

nontoxic to mammals based on an acute oral rate

LD50 > 5000 mg/kg for males and females. The

LC for an acute inhalation is > 0.07 mg/l. 50

IOE is practically nontoxic to mammals based on

an acute oral rate LD = 2830 mg/kg for males 50

and LD = 3250 mg/kg for females. 50

The Picloram Potassium Salt TIPA salt tested with

38.8% a.i. is practically nontoxic to mammals

based on an acute oral rate LD50 > 5000 mg/kg

for males and a LD = 3536 mg/kg for females. 50

The LC for an acute inhalation is > 1.63 mg/l. 50
49

(2) Non-target Aquatic Animals

(a) Freshwater Animals

The following table summarizes the acute and chronic

data which can be used in risk assessment for freshwater

organisms for the four active ingredients of Picloram.

Picloram Acid P.C. Code: 005101

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

72-1(a) Bluegill, Acute LC 00129078 10/15/82 core 92.74 1978 LC = 19.4 50 50

mg/l

72-1(a) Bluegill, Acute LC 112016 10/14/82 core 92.9 1974 LC = 14.5 50 50

mg/l

72-1(c) Rainbow, Acute LC50 112016 10/14/82 core 92.9 1974 LC50=

5.50

mg/l

72-2(a) Daphnia, Acute LC50 0096-008 12/21/88 core 90 1977 LC50=

34.4

mg/l

72-6 Aquatic Org. Accum. 1218947 (acces. 7/29/82 core, but was 99.6 1980 < 1 (Won't

(Bluegill) no.) classified as accum.in

supplemental aquatic

because it was organisms)

never required

for registration

72-6 Aquatic Org. Accum. none listed 10/14/82 core, but was 99.6 1980 < 1 (Won't

(Channel Catfish) classified as accum.in

supplemental aquatic

because it was organisms)

never required

for registration

N.A. Field runoff conditions 129085 12/6/82 Supplemental 90 1979 Study

for cutthroat trout because it was concludes that

never required conc. as low as

for registration 610 μg/l will

affect survival

& growth.

N.A. Field runoff conditions REOPICO2 10/14/82 supplemental 90 1979 Study

for cutthroat trout because it was concludes that

never required conc. as low as

for registration 290 μg/l will

affect survival

& growth.

The above table characterizes the Picloram acid as moderately toxic to freshwater fish with a

LC of 5.5 mg/l (ppm) and slightly toxic to freshwater invertebrates (LC of 34.4 mg/l). 50 50

Field runoff studies conducted with cutthroat trout conclude that concentrations as low as 290
50

μg/l and 610 μg/l will affect survival & growth of cutthroat trout. However, since these

studies were only conducted on the acid and not one of the salts or ester which are the actual

end-use products, these data were not used in the risk assessment.

There are no records indicating that tests for freshwater invertebrates (Daphnia magna) have

been conducted. The acid is not used as an end product, so this test is not required. 

Picloram TIPA Salt P.C. Code: 005102

GLN# TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

72-1(c) Rainbow, Acute LC not listed 10/14/82 supplemental 98-99 1968 LC =375 mg/l 50 50

72-1(d) Rainbow, Acute LC - TEP not listed 10/29/82 supplemental 8.1 1968 LC =25 mg/l 50 50

72-1(d) Rainbow, Acute LC - TEP not listed 10/29/82 supplemental 2.5 1968 LC = 1250 mg/l 50 50

No guideline Coho salmon, Acute LC not listed 10/29/82 supplemental 10.2 1979 LC = 20 mg/l

requirement

50 50

The above table characterizes this Picloram salt as slightly toxic to freshwater fish with a LC50

of 25 mg/l (ppm). However, a test with coho salmon yielded a LC of 20 ppm. 50

Picloram IOE P.C. Code: 005103

There are no data for freshwater organisms for IOE. An acute LC50s for a coldwater fish

(rainbow trout), a warmwater fish (Bluegill), and a freshwater invertebrate (Daphnia magna)

are required.

Picloram Potassium Salt P.C. Code: 005104

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

72-1(a) Bluegill, Acute LC GS0096-007 10/29/82 supplemental due to 91 1966 LC = 24 mg/l 50

lack of raw data

50

72-1(c) Rainbow, Acute LC GS0096-007 10/29/82 supplemental due to 91 1966 LC = 13 mg/l 50

lack of raw data

50

72-1(d) Rainbow, Acute LC50 Not given 10/14/82 core for formulated 24.4 1977 LC =

product only 26 mg/l

50

72-2(a) Daphnia, Acute LC 151783 5/20/85 core 93.8 1984 LC = 68.3 mg/l 50 50

72-2(b) Daphnia, Acute LC Not given 10/14/82 supplemental (not 88.6 1977 LC = 226 mg/l 50

(TEP) conducted with

TGAI)

50

72-4(a) Rainbow Trout, Early 151784 2/12/85 core 93.8 1984 LOEC= 0.88

life Stage mg/l

NOEC= 0.55 mg/l

MATC= 0.70 mg/l

72-4(b) Life-Cycle Aquatic 151783 5/20/85 core 93.8 1984 MATC= 14.6 mg/l

Invertebrate NOEC= 11.8 mg/l

LOEC= 18.1 mg/l
51

The above table characterizes this Picloram Potassium salt as moderately toxic to freshwater

fish with a LC50 of 13 mg/l (ppm) and slightly toxic to freshwater invertebrates (LC50 of 68.3

mg/l). The fish early life stage and the Life-Cycle Aquatic Invertebrate Studies gave LOECs

of 0.88 mg/l and 18.1 mg/l respectively as indicated. 

(b) Marine and Estuarine Organisms

As the use of products containing picloram may be

expected to enter a marine/estuarine environment a

limited amount of data which can be used in risk

assessment for marine/estuarine organisms is required.

The data presently reviewed for the marine/estuarine

studies are presented below.

Picloram Acid P.C. Code: 005101

There are no marine/estuarine data for the parent compound Picloram acid. As no products

containing the acid are used for anything other than manufacturing use products, no data

requirements are required at this time.

Picloram TIPA Salt P.C. Code: 005102

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

72-3(e) Oyster, Shell deposition EC50 not listed 10/14/82 supplemental (not 10.3 1975 10 < EC < 18 ppm

tested with TGAI)

50

72-3(f) Shrimp, Acute EC50 not listed 10/14/82 supplemental (not 10.3 1975 EC = 306 ppm

tested with TGAI)

50

The above table characterizes this Picloram salt as slightly toxic to marine/estuarine mollusc

with an EC between 10 and 18 mg/l (ppm) and practically nontoxic to marine crustaceans 50

(EC50 =306 ppm). As this salt is lacking data on marine/estuarine fish, an acute

marine/estuarine fish study is required.

Picloram IOE P.C. Code: 005103

There is no data for marine/estuarine or freshwater organisms for IOE. As the use of

products containing picloram may be expected to enter a marine/estuarine environment a

limited amount of data which can be used in risk assessment for marine/estuarine organisms is

required. An acute LC/EC study for marine/ fish, mollusc, shrimp is required. 50
52

Picloram Potassium Salt P.C. Code: 005104

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

72-3(e) Oyster, 48-h Embryo 111560 10/14/82 core for formulated 11.6 1975 EC > 1000

Larvae EC50 product only ppm

50

72-3(e) Oyster, 48-h Embryo 129073 10/14/82 core for formulated 24.9 1975 18 ppm <

Larvae EC product only EC < 32 50 50

ppm

The above table also characterizes this Picloram salt as slightly toxic to marine/estuarine

mollusks and invertebrates with an EC50 between 18 and 32 mg/l (ppm). As with the TIPA

salt this salt is lacking data on marine/estuarine fish; an acute marine fish study will be

required.

(3) Non-Target Insects Data

Available data for honeybees suggest that picloram is

practically nontoxic on an acute basis. In each study available

there was no significant mortality at the highest dose level

evaluated. In the table that follows, the toxicity (LD or LC ) is 50 50

reported as larger than the highest dose evaluated, for example

"LD50>25 μg/bee” indicates that doses up to 25 μg/bee were

evaluated, with no significant mortality observed at that level. 

The table indicates the highest dose evaluated in each study.

Picloram Acid P.C. Code: 005101

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

141-1 Honey Bee LC50 None 10/29/82 supplemental; test 8.7 as mixture 1965 LC

Study conducted with a mixture > 1000 ppm

50

No required Honeybee LC Not given 12/14/82 supplemental (not required Aqueous 1965 LC

guideline guideline requirement) emulsion > 4,000 ppm

50

(% not given

50

No required Honeybee LC 129066 10/29/82 supplemental (not required Aqueous 1965 LC

guideline guideline requirement) emulsion > 500 ppm

50

(% not given)

50

Picloram TIPA Salt P.C. Code: 005102

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

141-1 Honey Bee Acute 413669-01 4/90/92 core 5.68 1989 LD > 100

Contact Study μg/bee

50

No required Honeybee LC No given 10/29/82 supplemental 8.7 1965 LC

quideline >1000 ppm

50 50
53

Picloram IOE P.C. Code: 005103

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. YEAR RESULT

DATE

 141-1 Honey Bee Acute 421211-07 1/4/93 core 89.7 1991 LD > 25

Contact Study μg/bee

50

 141-1 Honey Bee Acute 426259-01 6/3/93 core 4.7 as 1992 LD > 25

Contact Study mixture μg/bee

50

Picloram Potassium Salt P.C. Code: 005104

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. YEAR RESULT

DATE

 141-1 Honey Bee Acute 413669-02 4/92 core 35.2 1989 LD > 100

Contact Study μg/bee

50

 No required Honeybee LC Not given 12/14/82 supplemental 23.6 1965 LC > 5,000

guideline because test not ppm

50

conducted with

TGAI

50

 No required Honeybee LC Not given 10/29/82 supplemental 8.7 1965 LC > 500 

guideline because test not ppm

50

conducted with

TGAI

50

(4) Non-Target Plants Data (Terrestrial, Aquatic)

Generally, nontarget plant data are required only for

herbicides and fungicides, but may be required for any pesticide

if phytotoxicity concerns cannot be resolved from the open

literature or existing Agency data bases. Testing can be

accomplished at the Tier 1 and/or Tier 2 level. Before the

implementation of the current policy paper ("the White Paper"or

"New Paradigm") resulting from the Ecological Fate and Effects

Task Force, the Agency requested Tier 3 field studies when the

Estimated Environmental Concentration (EEC) exceeded the

EC for terrestrial plants or the EC for aquatic plants. After 25 50

reevaluating the appropriateness of Tier 3 field studies, the

Agency no longer routinely requires these studies. The Tier 1

level tests are carried out at the maximum label rate, and if more

than 50% adverse effects are noted for aquatic plants and 25%

adverse effects for terrestrial plants, Tier 2 testing will be

required. Tier 2 tests use multiple dosages to determine an EC50

or EC and a NOEC for the plant species tested in Tier 1. 25

Nontarget phytotoxicity data are required automatically at the

Tier 2 level for all herbicides applied aerially, via mist blowers,

and with most irrigation equipment. In many cases Tier 1 tests

are bi-passed and the registrant begins with Tier 2 tests. The

current data base is presented in the tables below. 
54

Picloram Acid P.C. Code: 005101

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DATE

122-1(b) Vegetative Vigor 261128 (accession 4/29/86 supplemental not given 1985 No valid

Tier 1 no.) (needs to be results

repeated or go

to Tier 2)

122-2 Aquatic plant Tier 1 261128 (accession 4/29/86 core for 93.4 1986

no) Selenastrum. EC =

capricornutum 36.9mg/l

50

122-2 Aquatic plant - none listed 10/29/82 supplemental 91 1970 NOEC < 24

freshwater & mg/l

saltwater species

(Euglena gracilis &

Pedisastrum sp.)

Picloram TIPA Salt P.C. Code: 005102

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST RESULT

DATE DAT

E

122-2 Aquatic plant - freshwater none 10/29/82 supplemental 91 1970 NOEC < 24 mg/l

& saltwater species listed

(Euglena gracilis &

Pedisastrum sp.)

123-1(a) Seed Germination 412965- 5/25/93 supplemental 6.094 1989 Seed Germ.

/Seedling Emerg. - Tier 2 01 (NOECs lacking Soybean EC = 2.3 &

for soybean and NOEC < 0.25 g ae/ha

EC25 missing for Barley EC

barley) > 70 & 

25

25

NOEC = 35 g ae/ha

Seed Emerg.

Soybean EC = 0.027 25

& NOEC < 0.031 g

ae/ha

Wheat EC25

= 38.8 &

NOEC = 17.5 g ae/ha 

123-1(b) Vegetative Vigor - Tier 2 412965- 5/25/93 supplemental 6.094 1989 Tomato EC = 0.22 &

01 (NOECs lacking NOEC < 0.125 g ae/ha

for soybean & Wheat EC

tomato) = 227.7 & NOEC = 70

25

25

g ae/ha

123-2 Growth & Reproduction 414077- 5/26/93 core for S. 5.7 1990 EC = 234 mg/l

of Aquatic Plants - Tier 2 01 capricornutum NOEC = 18.5 mg/l

only

50
55

Picloram IOE P.C. Code: 005103

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST DATE RESULT

DATE

123-1(a) Seed Germination/ Seedling 412965-01 5/25/93 supplemental 11.7 1989 Seed Germ.

Emerg. - Tier 2 (NOEC Drybean EC = 1.5 & NOEC

lacking for < 0.25 g ae/ha

drybean) Barley EC

25

25

= 3.6 &

NOEC = 1.1

Seed Emerg.

Drybean EC25 = 0.004 &

NOEC < 0.031 g ae/ha

Wheat EC25

= 28.4 &

NOEC = 8.8 g ae/ha

123-1(b) Vegetative Vigor - Tier 2 412965-01 5/25/93 supplemental 11.7 1989 Soybean EC = 0.24 &

(NOECs NOEC < 0.125 g ae/ha

lacking for Wheat EC

soybean) = 235.3 &

25

25

NOEC = 70 g ae/ha

123-2 Growth and Reproduction 426459-01 6/15/93 core for S. 4.7 as 1993 EC = 4.9 mg/l

of Aquatic Plants - Tier 2 capricornutu mixture NOEC = 3.2 mg/l

m only LOEC = 5.5 mg/l

50

Picloram Potassium Salt P.C. Code: 005104

GLN # TEST TYPE MRID # EVALUATION CLASSIF. % A.I. TEST DATE RESULT

DATE

122-1(b) Vegetative Vigor Tier 1 261128 (accession 4/29/86 supplemental (needs not 1986 Info. in summary

no.) (Hemphill, D.D.) raw data or go to Tier given form. Need raw

2) for data.

Tordon

22K

123-2 Growth and Reproduction 414077-02 5/26/93 core for S. 35.2 1990 EC = 52.6 mg/l

of Aquatic Plants - Tier 2 capricornutum only

25

NOEC= 13.1 mg/l

123-1(a) Seed Germination/ 412965-01 5/25/93 supplemental (lacks 0.2885 1989 Seed Germ. Soybean

Seedling Emerg. - Tier 2 NOECs for soybean & EC = 3.5 &

drybean and lacks NOEC = 0.25 g

EC25 for barley) ae/ha

25

Barley EC25 > 70 &

NOEC = 4.4 g

ae/ha

Seed Emerg.

Soybean EC25 =

0.014 & NOEC <

0.031 g ae/ha

Wheat EC25

= 23.5 &

NOEC = 8.8 g

ae/ha

123-1(b) Vegetative Vigor - Tier 2 412965-01 5/25/93 core for veg. vigor test 0.2885 1989 Soybean EC = 0.4

of potassium alt only & NOEC = 0.125 g

25

ae/ha

Wheat EC25

= 310 &

NOEC = 70 g ae/ha

 Note: Only studies on which the Agency can make a judgement are included in the table above.
56
57

(5) Adequacy of Toxicity Data

Based on Picloram's extreme phytotoxicity, its persistence

under typical environmental conditions, and its extreme

propensity to leach into ground water in all soil types the

following additional data are needed as confirmatory data to

support this risk assessment.

Picloram TIPA Salt P.C. Code: 005102

Guideline # Study Reason Requesting

123-1(a) Seed Germination/Seedling Emergence - Tier 2 Need missing EC s and NOECs for most sensitive plants 25

123-1(b) Vegetative Vigor - Tier 2 Need missing EC s and NOECs for most sensitive plants 25

123-1(a) Seed Germination/Seedling Emergence - Tier 2 Need EC s and NOECs for sensitive crops which were 25

reported in damages from incident reports. These crops

include potatoes, tobacco, pasture, watermelons, tomatoes,

bell peppers, and hay

123-1(b) Vegetative Vigor - Tier 2 Need EC s and NOECs for sensitive crops which were

reported in damages from incident reports. These crops

25

include potatoes, tobacco, pasture, watermelons, tomatoes,

bell peppers, and hay

123-2 Growth & Reproduction of Aquatic Plants - Tier Due to extreme phytotoxicity, Rights of Way’s (ROWs),

2 aerial treatments, etc. all aquatic plant species must to

tested. These include Lemna gibba, Skeletonema costatum,

Anabaena flos-aquae, & a freshwater diatom.

72-3(d) Toxicity to Marine/Estuarine Fish LC (TEP) This study is a minimum core requirement for all active 50

ingredients.

72-4(a) Early Life Stage - Fish This pesticide is highly persistent and likely to be present

in water on a recurrent basis.

Picloram IOE P.C. Code: 005103

Guideline # Study Reason Requesting

123-1(a) Seed Germination/Seedling Emergence - Need missing NOEC for most sensitive plants 

Tier 2

123-1(b) Vegetative Vigor - Tier 2 Need missing NOEC for most sensitive plants

123-1(a) Seed Germination/Seedling Emergence - Need EC s and NOECs for sensitive crops which were reported in

Tier 2 damages from incident reports. These crops include potatoes,

25

tobacco, pasture, watermelons, tomatoes, bell peppers, and hay

123-1(b) Vegetative Vigor - Tier 2 Need EC s and NOECs for sensitive crops which were reported in

damages from incident reports. These crops include potatoes,

25

tobacco, pasture, watermelons, tomatoes, bell peppers, and hay

123-2 Growth & Reproduction of Aquatic Plants Due to extreme phytotoxicity, Right of Ways (ROWs), aerial

- Tier 2 treatments, etc. all aquatic plant species must to tested. These include

Lemna gibba, Skeletonema costatum, Anabaena flos-aquae, & a

freshwater diatom.

72-1(b) Bluegill, Acute LC (TEP) This study is a minimum core requirement for all active ingredients 50

72-1(d) Rainbow, Acute LC (TEP) This study is a minimum core requirement for all active ingredients 50

72-2(b) Toxicity to Freshwater Invertebrates This study is a minimum core requirement for all active ingredients

(Daphnia magna) (TEP)
Guideline # Study Reason Requesting

58

72-3(d) Toxicity to Marine/Estuarine Fish LC This study is a minimum core requirement for all active ingredients 50

(TEP)

72-3(e) Toxicity to Marine/Estuarine Mollusc This study is a minimum core requirement for all active ingredients

EC (TEP) 50

72-3(f) Toxicity to Marine/Estuarine Shrimp EC This study is a minimum core requirement for all active ingredients 50

(TEP)

72-4(a) Early Life Stage - Fish This pesticide is highly persistent and likely to be present in water on

a recurrent basis.

Picloram Potassium Salt P.C. Code: 005104

Guideline # Study Reason Requesting

123-1(a) Seed Germination/Seedling Emergence - Tier Need missing EC s and NOEC for most sensitive plants 

2

25

123-1(a) Seed Germination/Seedling Emergence - Tier Need EC s and NOECs for sensitive crops which were reported

2 in damages from incident reports. These crops include potatoes,

25

tobacco, pasture, watermelons, tomatoes, bell peppers, and hay

123-1(b) Vegetative Vigor - Tier 2 Need EC s and NOECs for sensitive crops which were reported

in damages from incident reports. These crops include potatoes,

25

tobacco, pasture, watermelons, tomatoes, bell peppers, and hay

123-2 Growth & Reproduction of Aquatic Plants - Due to extreme phytotoxicity, Right of Ways (ROWs), aerial

Tier 2 treatments, etc. all aquatic plant species must to tested. These

include Lemna gibba, Skeletonema costatum, Anabaena flosaquae, & a freshwater diatom.

72-3(d) Toxicity to Marine/Estuarine Fish LC (TEP) This study is a minimum core requirement for all active

ingredients

50

b. Ecological Effects Risk Assessment

The Agency's principal index of ecological risk is a risk

quotient or RQ, calculated by dividing a value of exposure by a value of

toxicity. The assessment in this document was developed just before a

recent standardization of terminology and does not use the new standard

definitions. These differences relate to presentation and do not concern

actual findings. The differences between usage in this document and the

new standard definitions are clarified below.
59

Usage in this document

LOC = Estimated environmental concentration (EEC) value that results in a concern

= k × [toxicity index, e.g., LC50 or MATC].

k depends on endpoint.

RQ = EEC / LOC

= EEC / ( k × toxicity index ).

RQ is how many times the EEC exceeds the LOC, so there is a concern when RQ

exceeds 1.

Example. For endangered small mammal exposed to TIPA salt,

EEC = 528 ppm, LC50 = 4545 ppm. There is a concern if the EEC exceeds a tenth

of the LC50 (k=1/10). It does:

LOC = 0.1 × 4545 = 454.5.

RQ = 528/454.5 = 1.16.

RQ > 1 so there is a concern.

New standard definition

RQ = EEC/[toxicity index] by definition.

LOC is the RQ value that results in a concern, and depends on endpoint. 

LOC in new standard terminology equals k for this document.

Example (same endpoint).

LOC = 0.1 for endangered small mammal.

RQ = 528/4545 = 0.116.

RQ > LOC so there is a concern.

Details of the computation of levels of concern are presented in

the sequel in sections devoted to specific categories of nontarget

organisms. The toxicity measure is most often an ECp or some variant

(effective concentration for p% response, e.g. EC50 for 50% response). 

Depending on the type of biological response measured, an ECp may be

the concentration corresponding to a p% change in mean response (e.g.

p% reduction in mean weight), or the concentration corresponding to

p% of organisms responding (usually p% mortality). In some cases, the

toxicity measurement is a low-effect level (LEL), i.e. the lowest dose

that resulted in a recognizable effect in a laboratory experiment. 

Standard exposure scenarios for ecological risk involve transport by

runoff or drift of chemical applied to a target plot, to adjacent land or

water. Specific details of exposure scenarios are presented in (2) below. 
60

The following important limitations of the standard exposure

scenarios are noted here. a. For picloram active ingredients, risk

calculations are based on a single assumed application, because, as

indicated in the Use Profile Section, labels for the most part do not

specify maximum annual rates. b. The standard exposure scenarios do

not address the potential of picloram to contact nontarget plants as a

result of irrigation with contaminated surface or ground water. Further

consideration of these issues would be necessary in order to do a more

complete risk assessment for the chemical.

The principal findings and data gaps of the Agency's quantitative

risk assessment are summarized as follows, by category of nontarget

organism. 

Terrestrial Plants. Risks to nontarget terrestrial plants are very

significant (endangered species and otherwise) for all active ingredients

and all application methods considered. The following table of risk

quotients represents the most significant results of the Agency's

quantitative risk assessment. For these quotient values, the toxicity

measure is the LC25 for soybean seedling emergence, which is the

concentration that causes a quarter of seedlings to fail to emerge. The

EEC values used in these computations represents exposure to nontarget

plants in areas adjacent to the areas of application, with standard

assumptions regarding drift or runoff (Section below on Calculation of

EECs).

Number of Times the Level of Concern (LOC) is Exceeded by the Estimated Environmental Concentration (EEC)a

(Based on Terrestrial Plants)

Active Ingredient

Application Method

Unincorporated Ground Aerial/ Aerial/ Foliar

Soil

TIPA 4600 × 7500 × 550 ×

Salt 

IOE 5700 × - -

b

Potassium Salt 8100 × 13000 × 280 ×

 For example (row 1 column 2) the EEC for TIPA salt administered to the ground without a

incorporation is 4600 times a concentration level of concern.

With current registered products, IOE is applied only using backpack sprayers. b

For example, a quotient of 4600 is obtained for TIPA administered by

ground application without incorporation. This means that estimated
61

concentrations in the environment are 4600 times a magnitude that, in the

laboratory context, causes 25% of soybean seedlings to fail to emerge. (The

"×" symbol is used in the table to emphasize this interpretation.) Soybean

seedling emergence was chosen for this calculation because, in keeping with

standard practice, it has the smallest of available EC25 measurements (greatest

apparent sensitivity) among the measurement endpoints available, representing

four different terrestrial plant response variables. The other response variables

considered also had quotients mostly greater than one, indicating substantial

risk. 

Based on reports of incidents involving damage to crops, a complete risk

assessment would require additional phytotoxicity data for various crops

including potatoes, tobacco, soybeans, corn, watermelons, tomatoes, bell

peppers, hay, and pasture. 

Aquatic Organisms (Plants and Animals). Data requirements are not

fulfilled for aquatic plants or for aquatic animals. There are currently

no registered aquatic uses of picloram; however, again, picloram is

exceptionally mobile and persistent, and therefore has exceptional

potential for exposure of aquatic organisms, relative to other pesticides

with terrestrial uses only. Also, picloram has been shown to be very

toxic to terrestrial plants, for which the database is more complete than

for aquatic plants. 

For aquatic animals, estimated exposures exceed levels of

concern in two cases: Levels of concern are exceeded for endangered

fish species for the potassium salt administered by ground application

without incorporation, and for endangered mollusks based on the TIPA

salt applied aerially. A complete risk assessment for aquatic animals

would require the following acute toxicity studies. For IOE, no aquatic

toxicity studies are available. The minimal set of additional studies

would comprise coldwater fish (rainbow trout), warmwater fish

(bluegill), freshwater invertebrate, and marine invertebrate. For

potassium and TIPA salts, a marine fish study would be required. In

addition a fish early life cycle study would be required for TIPA salt and

IOE. Availability of complete toxicity data could likely result in

identification of additional concerns for aquatic animals, because

exposures approach levels of concern for various combinations of

species, chemical and application method. 

For aquatic plants, only one species has been tested (Selenastrum

carpricornutum), of the five that are normally required. The

Selensastrum data did not indicate a concern. The additional studies

would have substantial informational value in view of the high mobility,

persistence, and phytotoxicity of the chemicals. The aquatic vascular
62

plant study (Lemna sp.) could be particularly important, because of the

demonstrated high toxicity to several terrestrial vascular species. 

Given the low octanol-water partition coefficient, significant

bioaccumulation in aquatic organisms is not anticipated. 

Terrestrial birds and mammals. For mammals, exposure to endangered

terrestrial species will likely exceed levels of concern for TIPA and

potassium salts, administered by all application methods considered. 

For non-endangered species, exposures were not found to exceed levels

of concern. 

For birds (endangered and non-endangered), exposures were not found

to exceed levels of concern based on acute or chronic toxicity.

Terrestrial plant. For terrestrial plants, use rates that would result in

estimated environmental concentrations below levels of concern vary by

application procedure and product, but are uniformly lower than 1% of

current label rates.

(1) Calculation of Estimated Environmental

Concentrations

EEC calculations are based on maximum use rates

identified in the previous section (2.2 lb ai/A for TIPA salt; 2 lb

ai/A for IOE and Potassium salt), along with additional

assumptions regarding transport, dilution, and concentration. As

indicated, results are based on a single application. This section

describes the procedures used by EFED for calculating EECs: 

the numerical results are presented in sections devoted to specific

categories of nontarget organisms.

Nontarget Terrestrial vertebrates, dietary exposure. EEC values

for assessment of risk to terrestrial vertebrates are based on the

procedure of Kenaga and Hoerger, as described in the ecological

risk Standard Evaluation Procedure (USEPA, 1986; 540/9-85-

001). Results are illustrated for TIPA salt: Corresponding to a

single application of TIPA salt at 2.2 lb ai/A, the dietary EECs

based on the method of Kenaga and Hoerger are given by

wildlife use site as follows.
63

Use Sites Residues (ppm)

(TIPA salt)

Range grasses (short) 528

Long grasses 242

Leaves and leafy crops 275

Forage crops (small insects) 128

Pods containing seeds 

(large insects) 26

Fruits 15

Soil (Top 1 inch) 49

Corresponding to an application of TIPA salt at 2.2 lb

ai/A, the EEC is the maximum value (528 ppm), based on short

range grasses. For an application of IOE or potassium salt

applied at 2 lb ai/A the EEC is 480 ppm (=528×2/2.2). 

Nontarget Terrestrial Plants. EEC values are based on the

assumption that chemical applied to a target plot is transported by

drift and/or runoff (depending on the application method), to an

adjacent "nontarget" plot, of area equal to that of the target plot,

where it is distributed evenly. Application methods, considered

separately for picloram active ingredients, are unincorporated

ground application, and aerial application (foliar and soil). 

For unincorporated ground applications exposure to

nontarget organisms is assumed to result from runoff. The

fraction of chemical applied that is transported to the nontarget

plot is based on water solubility as follows:

Water Solubility (ppm) % Runoff

< 0.001 0.1

0.001 to 10 1

10 to 100 2

> 100 5

Therefore, it is assumed that 5% of chemical applied is

transported by runoff for TIPA salt and potassium salt, 1% for

IOE. Total mass transported by runoff (per application) is

therefore as follows:
64

Active Ingredient EEC (%Runoff×Appl.Rate)

TIPA salt 0.11 lb ai/A (=2.2 × 0.05), 

IOE 0.02 lb ai/A (=2.0 × 0.01), 

Potassium salt 0.10 lb ai/A (=2.0 × 0.05). 

However, IOE is expected to degrade rapidly to forms with high

water solubility (over 100 ppm). For IOE, substitution of a 5%

runoff assumption would multiply by 5 various risk quotients

presented in the sequel. 

For aerial application to soil it is assumed that the

chemical is transported by both runoff and drift, and the EEC is

calculated as the sum of terms representing these two transport

mechanisms.

EEC (lb/A) = Runoff (lb/A) + Drift (lb/A)

It is assumed that the nontarget plot receives 5% of the chemical

administered to the nontarget plot, by drift. The quantity

transported by runoff is given by

Maximum × 60% Application × %Runoff. 

Appl. Rate Efficiency

(lb/A)

Percentage runoff is calculated based on water solubility in the

same way as just described for unincorporated ground

application. 

For aerial application to foliage, it is assumed that the

nontarget plot receives 5% of the quantity applied on the target

plot, by drift.

Nontarget Aquatic Organisms (Plants and Animals). It is

assumed that a fraction of chemical applied to a 10-acre plot is

transported by drift and/or runoff to a body with surface area one

acre and depth 6 feet ("deep" water body) or 6 inches ("shallow"

water body). Identification of risk levels of concern is based on

the shallow water body scenario (6 inch depth) for endangered

species, and on the deep water body scenario (6 feet depth) for

non-endangered species. 
65

For unincorporated ground applications, it is assumed that

transport is by runoff. The fraction of material transported from

a 10-acre catchment is estimated based on solubility, as for

terrestrial plant exposures (5% for TIPA salt and potassium salt,

1% for IOE). It is assumed that all of the runoff from the 10-

acre catchment is intercepted by the 1-acre water body. The

mass loading for the receiving water body (w.b.) is therefore

given by 

 Mass Maximum 

 Loading = Appl.Rate × % Runoff × 10 A catchment 

 (lb./A (lb./A / A surface

 w.b.) catchment) 

Conversion of the mass loading to an EEC (in ppb), is

based on the assumed depth of the water body. For the deeper

water body the EEC is obtained by multiplying the mass loading

by 61.2 ( 61) ppb/(lb./A). For the more shallow water body the

same mass will be concentrated in a volume one twelfth of the

volume of the deeper water body, so the conversion factor is 734

ppb/(lb.A) (=61.2×12). 

For example, the EEC for TIPA salt in the deeper water body is 

67 ppb = 2.2 x 0.05 x 10 x 61

For aerial applications (not assessed separately for soil

and foliage), transport is by both runoff and drift, and the

resulting EEC is the sum of terms representing these two

transport mechanisms. For runoff, it is assumed that 60% of the

material applied is susceptible to runoff (60% is the "application

efficiency"). Of that fraction, the assumed percentage runoff is

based on water solubility as described for nontarget terrestrial

plants (5% for TIPA salt and potassium salt, 1% for IOE). All

of the runoff from a 10-acre catchment is received by a 1-acre

water body. Accordingly the mass loading resulting from runoff

is given by 

Mass Maximum 60% Appl. 10 A

catchment 

Loading = Appl.Rate × Efficiency × %Runoff × / A

surface 

(lb./A (lb./A 

w.b.) catchment) 
66

For input by drift, it is assumed that the water body

receives 5% of the quantity applied to an adjacent equal-area

plot. Finally, the total mass loading (representing drift plus

runoff) is converted to an EEC (in ppb) by the procedure just

described for unincorporated ground applications. (Multiply by

61 for the deeper water body or by 734 for the more shallow

water body.) 

(2) Non-target Terrestrial Animals

(a) Avian Acute Risk

For avian acute risk, exposure levels of concern

are LC50/2 for non-endangered species and LC50/10 for

endangered species. Calculation of the EEC representing

dietary exposure is based on maximum application rates

identified in the Use Profile Section (repeated in tables

following), using procedures described in Section (1), for

nontarget terrestrial vertebrates. 

Additional calculations that are standard for

granular pesticide formulations, involving numbers of

LD s per square feet, are not applicable to products 50

containing picloram salts and IOE. 

Endangered Bird Species. As indicated in the following

table, the estimated exposure levels do not exceed levels

of concern.

Acute Avian Dietary Risk for Endangered Species1

Active Ingredient Dietary LC (ppm) Highest Calculated Risk Quotient (RQ) 50

EEC (ppm) EEC/(LC50/10)

TIPA Salt > 10000 528 < 0.528

IOE > 5620 480 < 0.854

Potassium Salt > 5620 480 < 0.854

Non-endangered species: RQ values are values given for endangered species, divided by 5. (All 1

RQ<1.)

Non-Endangered Bird Species. Estimated exposures do

not exceed levels of concern for non-endangered bird

species. Risk assessment for non-endangered species is
67

similar to that for endangered species (just described),

except that levels of concern are calculated as LC50/2

rather than LC50/10. It follows that for nonendangered

species, the RQ values are <0.11 for TIPA salt, <0.17

for IOE and Potassium salt.

(b) Avian Chronic Risk

For avian chronic risk, estimated exposures do not

exceed levels of concern. Levels of concern are lowest

effect levels (LEL). Supplemental studies conducted

more than 10 years ago give NOELs 2.8 kg ai/ha (15.2 lb

ai/A) for TIPA salt and 11.2 kg ai/ha (60.9 lb ai/A) for

Potassium salt. (NOEL="No Observed Effect

Level"<LEL). By the method of Kenaga and Hoerger,

the EEC corresponding to 15.2 lb ai/A NOEL is 3648

ppm (=15.2 lb ai × 240 ppm/lb ai). This is substantially

larger than the previously-computed EEC of 528

(corresponding to the maximum label use rate of 2.2 lb

ai/A). In short, the actual environmental concentration is

estimated to be much lower than a value that produced no

discernable effect.

(c) Mammalian Acute Risk

Quantitative risk assessment for mammals is

similar to that for birds, but requires, in addition,

conversion of LD50 values (mg ai per kg body weight) to

LC50 values in the same units as the EECs (ppm). 

Exposure levels of concern are calculated as LC50/2 for

non-endangered species and LC50/10 for endangered

species. Calculation of the EEC representing dietary

exposure is based on maximum application rates identified

in Section (1) (repeated in tables following), using

procedures described in Section (2) for nontarget

terrestrial vertebrates. 

Conversion of LD50s to LC50s is represented by

the following formula:

LC50 = LD50 (mg/kg) x Body Weight (gms)

Weight Consumed (gms)
68

Assumptions regarding body weight and food

consumption are here based on Davis and Golly (1963). 

The RQ calculations for an endangered mammal are illustrated in the following table,

for picloram TIPA salt. LC50s are for three species that are representative of small wild

mammals. The lowest relevant LD50 measurement was more than 5000 mg/kg:

Risk Quotient Calculation Illustrated for a Hypothetical Endangered Mammal with LC50 5000 mg/kg, Based on

picloram TIPA salt 

Species Weight (ppm) (RQ)

Body Daily Food Intake LC50 Risk Quotient

(gms)

1 2

% Body Weight grams

Meadow vole (herbivore) 46 61 28.1 8185 0.645

Old-field mouse (granivore) 13 16 2.1 30952 0.17 

Least shrew (Insectivore) 5 110 5.5 4545 1.16 

Based on LD50 = 5000 mg/kg. 1

RQ = EEC / (0.1 × LC50); 2

EEC = 528 ppm

Non-Endangered: use RQ = EEC / (0.5 × LC50 )

Acute Risk to Endangered Mammalian Species. Risk quotients computed as just described are

presented in the following table. These results indicate exceedance of exposure levels of

concern for acute risk, for endangered insectivores from exposure to picloram TIPA and

Potassium salts, and for mammalian herbivores exposed to IOE.

Acute Risk Quotients for Endangered Mammals

Active Ingredient Highest Calculated Risk Quotient (EEC/

(P.C Code) Mammal LC50 (ppm) EEC Value (ppm) (0.1×LC50)

TIPA Salt (5102) 8185 

LD50 > 5000 mg/kg

Meadow vole (herbivore) 528 0.645

3095

2 Old field mouse (granivore) 0.17

4545

Least shrew (insectivore) 1.16

IOE (5103) 4632

LD50 = 2830 mg/kg

Meadow vole (herbivore) 480 1.036

17519

Old field mouse (granivore) 0.274

2572.7

Least shrew (insectivore) 1.866
Acute Risk Quotients for Endangered Mammals

Active Ingredient Highest Calculated Risk Quotient (EEC/

(P.C Code) Mammal LC50 (ppm) EEC Value (ppm) (0.1×LC50)

69

Potassium Salt (5104) 5788.5 480 0.829

LD = 3536 mg/kg 50

Meadow vole (herbivore)

21889.5

Old field mouse (granivore) 0.219

3214.6

Least shrew (insectivore) 1.5

Acute Risk to Nonendangered Mammal Species. 

Estimated exposures do not exceed levels of concern for

nonendangered mammals. Levels of concern are

calculated as LC50/2, rather than LC50/10 as for

endangered mammals. Therefore RQ values for

nonendangered mammals are equal to the values displayed

above for endangered mammals, divided by 5. The

maximum RQ value for nonendangered mammals is

therefore 0.37 (=1.866/5), corresponding to IOE and

least shrew. 

(d) Mammalian Chronic Risk

Because risks are low for acute effects, as just

described, chronic toxicity studies are not required. For

both endangered and non-endangered mammal species,

levels of concern for chronic effects are lowest effect

levels (LEL). 

(3) Non-target Terrestrial Plants

For non-target terrestrial plants (endangered or

nonendangered), exposure levels of concern are equated to the

lowest relevant EC25 measurements. Risk is assessed by

application method: unincorporated ground, aerial to soil, or

aerial to foliar. Calculation of EECs is based on maximum

application rates identified Section (1), repeated in subsequent

tables.

Unincorporated Ground Application. The following table gives

risk quotients for each active ingredient, along with the

application rates that would yield RQ=1. As described

previously, EECs are based on the assumption that chemical

applied to a target plot is transported by runoff to an adjacent
70

nontarget plot, with the assumed percentage runoff based on

water solubility. The results displayed below indicate that

picloram salts and IOE are very likely to affect nontarget plants

(especially dicots) in areas adjacent to areas of application. The

requirement for Tier 3 plant field testing has been met; however

the Agency does not routinely require these studies.

Terrestrial Plants Exposed via Runoff, Unincorporated Ground Application 

(Endangered or Non-endangered)

Active Ingredient Seed Germination Maximum % Runoff Based on EEC Risk Quotient

(P.C Code) EC Application Rate Solubility (lb ai/A) (EEC/EC ) 25

Seedling Emergence (lb ai/A)

LC25

(lb ai/A)

25

TIPA Salt (5102) 0.002 2.2 5 0.11 55

(Dicots-Soybeans)

> 0.035 < 3.14

(Monocots-barley)

0.0000239 4603

(Dicots-Soybeans)

0.0346 3.18

(Monocots-wheat)

IOE (5103) 0.0013376 2.0 1 0.02 14.99

(Dicots-Drybeans)

0.0032103 6.23

(Monocots-barley)

3.5 × 10 5714 -6

(Dicots-Soybeans)

0.0253259 0.790

(Monocots-wheat)

Potassium Salt (5104) 0.0031 2.0 5 0.1 32.3

(Dicots-Soybeans)

0.062 1.61

(Monocots-Barley)

0.0000124 8065

(Dicots-Soybeans)

0.02 5

(Monocots-Wheat)

Aerial Application to Soil. As described previously, EECs are based on the assumption that

chemical applied to a target plot is transported by both drift and runoff to an adjacent

nontarget plot of equal area. Results of these calculations (displayed in the following table)

indicate that picloram salts pose significant risks to nontarget plants (especially dicots) in areas

adjacent to application plots, when the chemical is applied aerially to soil. The same result is

obtained for IOE; however IOE is currently applied only using backpack sprayers. 
71

Risks to Nontarget Terrestrial Plants (Endangered, Non-Endangered), Aerial/Soil Application

Active Ingredient Seed Germination Maximum %Runoff EEC Risk

(P.C Code) EC25 Application Rate Based on (lb Quotien

Seedling Emergence (lb ai/A) Solubility ai/A) t

LC25 (EEC/E

(lb ai/A) C ) 25

TIPA Salt (5102) 0.002 2.2 5 0.18 90

(Dicots-Soybeans)

0.035 5.1

Monocots-barley)

0.0000239 7531

(Dicots-Soybeans)

0.062 2.9

(Monocots-wheat)

IOE (5103) 0.0013376 2.0 1 0.032 23.9

(Dicots-Drybeans)

0.0032103 9.9679

(Monocots-barley)

3.5 × 10 9143 -6

(Dicots-Soybeans)

0.0253259 1.2635

(Monocots-wheat)

Potassium Salt (5104) 0.0031 2.0 5 0.16 51.6

(Dicots-Soybeans)

0.062 2.5

(Monocots-Barley)

0.0000124 12,903

(Dicots-Soybeans)

0.02 8

(Monocots-Wheat)

Aerial Application - Foliar. As described previously, EECs are calculated under the

assumption that 5% of the chemical applied to a nontarget plot is transported by runoff to an

adjacent nontarget plot of equal area. The resulting risk quotient values (displayed in the

following table) indicate that picloram salts pose significant risks to nontarget dicot plants and

root crops in areas adjacent to application areas when the chemical is applied by foliar aerial

applications. The same result is obtained for IOE; however IOE is currently applied only

using backpack sprayers. 
72

Risk to Nontarget Terrestrial Plants (Endangered, Non-endangered) from Aerial Foliar

Application.

Active Ingredient Vegetative Vigor Maximum Application Rate % Runoff Based on EEC Risk Quotient

(P.C Code) EC (lb ai/A) Drift (lb ai/A) (EEC/EC ) 25

(lb ai/A)

25

TIPA Salt (5102) 0.0002 2.2 5 0.11 550

(Dicots-Tomatoes)

0.20 0.55

(Monocots-Wheat)

0.012 9.2

(Root crops-Radish)

IOE (5103) 0.000214 2.0 1 0.02 93.

(Dicots-Soybeans)

0.2098307 0.095

(Monocots-Wheat)

0.0346893 0.58

(Root crops-Radish)

Potassium Salt (5104) 0.00036 2.0 5 0.1 277.7

(Dicots-Soybeans)

0.276 0.36

(Monocots-Wheat)

0.062 1.6

(Root crops-Radish

Additional Phytotoxicity Information. The use of products

containing picloram has on occasion resulted in unintentional

damage to crops outside of areas where applied. Based on the

data available, picloram appears to have caused adverse effects to

trees, grasses, shrubbery, strawberries, watermelons, potatoes,

grapes, peanuts, and soybeans. Three incidents are reported of

damage to potatoes. Therefore confirmatory toxicity data are

needed for various crops, and for potatoes in particular.

(4) Non-target Aquatic Plants

For nontarget aquatic plants, a complete risk assessment 

involves toxicity tests for five plant species. At present data are

available only for Selenastrum capricornutum (a freshwater green

alga). 

Standard quantitative risk calculations have been

performed based on the S. capricornutum toxicity measurements. 

This incomplete risk assessment, which is not presented here in

detail, indicates that exposure levels of concern are not exceeded

for picloram salts and IOE. This result does not indicate that

current picloram uses are benign for nontarget aquatic plants in

general: testing of the additional species are being required as

confirmatory data. 
73

(5) Non-target Aquatic Animals

(a) Acute Risks

Acute risk to non-target aquatic animals is presumed low

for risk quotient (RQ) values less than 1, calculating RQ as

EEC/(0.1×LC50) (nonendangered species) or

EEC/(0.05×LC50) (endangered species), based on the lowest

relevant LC50 measurement. The calculation of EECs depends

upon the maximum use rates identified in the Use Profile Section

and formula given in Section (1). EEC calculations assume that

a proportion of chemical applied in a 10 acre drainage basin is

transported by drift and/or runoff (depending on the application

method) to a 1 acre water body, depth 6 feet or 6 inches. Again,

concentration levels of concern are based on the 6 inch depth for

endangered species and on 6 foot depth for non-endangered

species.

A reasonably complete acute risk assessment would

require, at minimum, the following acute toxicity studies not

presently available: for TIPA salt and IOE, LC50s for a

coldwater fish (rainbow trout), a warmwater fish (bluegill), and a

freshwater invertebrate (Daphnia magna); for potassium salt the

LC50 for bluegill. For IOE, there are no available acute toxicity

data for freshwater marine/estuarine organisms. 

Standard calculations have been performed using the

available toxicity data. The results are presented in detail only

for endangered species, for which in some cases the risk

quotients approach or exceed one. For non-endangered species,

risk quotients can be obtained as 0.5 times the values presented

for endangered species. This incomplete risk assessment has

identified the following ecological risk concern: The potassium

salt is likely to affect endangered fish with unincorporated

ground application (risk quotient=1.13). With plausible levels

of variation in sensitivity among species, it is not improbable that

additional concerns would be identified if the minimal toxicity

data requirements identified were fulfilled. An additional risk

quotient greater than one is obtained with the endangered species

risk assessment for TIPA salt, based on the eastern oyster shell

deposition test (unincorporated ground application); however,

currently there are no federally listed marine or estuarine

organisms. 

Unincorporated Ground Applications, Endangered Species. As

described previously for aquatic organisms (plants and animals)

EEC calculations assume that chemical applied to a target plot is
74

transported by runoff to an adjacent plot of equal area, at a rate

that depends on water solubility of the chemical. Results are

presented separately for TIPA salt and potassium salt in the

following tables. (For IOE there are no available aquatic toxicity

data.) For TIPA and potassium salt, it is assumed that 5% of

chemical applied is transported to the nontarget plot, based on the

high water solubility of these chemicals. 

For nonendangered species, risk quotients will equal 0.5

times the values presented.

Risk Quotients (RQ) for Endangered Aquatic Animals,

based on Unincorporated Ground Applications

1. Picloram TIPA salt Applied at 2.2 lb. ai/A

Species LC (ppb) 6 Feet Deep (67.1/(0.05 x LC ) 6 Inch Deep (807.4/(0.05 x LC ) 50

RQ RQ

50 50

Coho Salmon 20,000 0.067 0.807

(FW fish - coldwater)

Marine Shrimp 306,000 0.0044 0.0528

Eastern Oyster 10,000 0.134 1.615

(Shell deposition)

2. Picloram IOE: no toxicity data.

3. Picloram Potassium Salt Applied at 2.0 lb. ai/A

Species LC50 RQ RQ

(ppb) 6 Feet Deep 6 Inch Shallows

(61/(0.05 x LC ) (734/(0.05 x LC ) 50 50

Rainbow Trout 13,000 0.0938 1.13

(FW fish - coldwater)

Daphnia 68,300 0.0179 0.215

(FW Invertebrate)

Eastern Oyster 18,000 0.0677 0.816

(Embryo Larvae)

Aerial or Mist Blower Applications (endangered species). EECs are calculated as

described in Section (1) for aquatic organisms (both animals and plants), under the

assumption that a water body with 1 acre surface receives input of chemical by both

drift and runoff from the 10-acre plot. 
75

Results are presented separately for TIPA salt and potassium salt in the following

tables. (For IOE there are no available aquatic toxicity data and no aerial or mist

blower applications, only backpack.) For nonendangered species, risk quotients will

equal 0.5 times the values presented. The results for the TIPA salt and the oyster shell

deposition study indicate a concern for endangered species of mollusks.

Risk Quotients (RQ) for Endangered Aquatic Animals

based on Aerial Application

1. Picloram TIPA Salt Applied at 2.2 lb. ai/A

LC RQ RQ

Species ppb 6 Feet Deep 6 Inch Shallows

50

(47/(0.05 x LC )) (566/(0.05 x LC )) 50 50

Coho Salmon 20,000 0.047 0.57

(FW fish - coldwater)

Marine Shrimp 306,000 0.0030 0.037

Eastern Oyster 10,000 0.094 1.13

(Shell deposition)

2. Picloram IOE: No toxicity data.

3. Picloram Potassium Salt Applied of 2.0 lb. ai/A

SPECIES LC50 RQ RQ

ppb 6 FEET DEEP 6 INCH SHALLOWS

(42.7/(0.05 x LC )) (514.5/(0.05 x LC )) 50 50

Rainbow Trout (FW fish - coldwater) 13,000 0.066 0.79

Daphnia (FW Invertebrate) 68,300 0.12 0.15

Eastern Oyster (Embryo Larvae) 18,000 0.047 0.57

(b) Chronic Risk

Subdivision E, Section 72-4 of FIFRA requires

submission of a fish early life-cycle test for pesticides that

are likely to be highly persistent in the aquatic

environment. The only picloram active ingredient for

which this requirement is satisfied is potassium salt. 

Chronic fish studies are needed for the remaining active

ingredients. 

For risks of chronic effects, levels of concern are

equated to Maximum Acceptable Concentrations

(MATC). For the picloram potassium salt, MATCs for

the fish early life stage and aquatic invertebrate life-cycle

tests are 700 ppb and 14600 ppb respectively. Neither of

these values exceeds relevant EECs based on the
76

application methods considered here (unincorporated

ground application and aerial application). 

(6) Non-target Insects 

As indicated in discussion of toxicity data, honey bee

acute toxicity studies indicate that all active ingredients of

picloram are practically nontoxic to that species, with contact

LD50 > 25 mg per bee.

IV. RISK MANAGEMENT AND REREGISTRATION DECISION

A. Determination of Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after

submission of relevant data concerning an active ingredient, whether products

containing the active ingredient are eligible for reregistration. The Agency has

previously identified and required the submission of the generic (i.e. active ingredient

specific) data required to support reregistration of products containing picloram acid

and its derivatives as active ingredients. The Agency has completed its review of these

generic data, and has determined that the data are sufficient to support reregistration of

all products containing picloram acid and its derivatives. Appendix B identifies the

generic data requirements that the Agency reviewed as part of its determination of

reregistration eligibility of picloram acid and its derivatives, and lists the submitted

studies that the Agency found acceptable.

The data identified in Appendix B were sufficient to allow the Agency to assess

the registered uses of picloram acid and its derivatives and to determine that picloram

and its derivatives can be used without resulting in unreasonable adverse effects to

humans and the environment. The Agency therefore finds that all products containing

picloram acid and its derivatives as the active ingredients are eligible for reregistration

conditional upon implementation of the mitigation measures specified in this document. 

The reregistration of particular products is addressed in Section V of this document. 

The Agency made its reregistration eligibility determination based upon the

target data base required for reregistration, the current guidelines for conducting

acceptable studies to generate such data and the data identified in Appendix B. 

Although the Agency has found that all uses of picloram acid and its derivatives are

eligible for reregistration, it should be understood that the Agency may take

appropriate regulatory action, and/or require the submission of additional data to

support the registration of products containing picloram acid and its derivatives, if new

information comes to the Agency's attention or if the data requirements for registration

(or the guidelines for generating such data) change.
77

1. Eligibility Decision

Based on the reviews of the generic data for the active ingredients picloram acid

and its derivatives, the Agency has sufficient information on the health effects of

picloram and on its potential for causing adverse effects in fish and wildlife and the

environment. The Agency concludes that products containing picloram for all uses are

eligible for reregistration provided the risk mitigation measures specified in this

document are implemented. 

The Agency has determined that picloram, labeled and used as specified in this

Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects

to humans or the environment.

2. Eligible and Ineligible Uses 

The Agency has determined that all uses of picloram and its derivatives

are eligible for reregistration. 

B. Regulatory Position

The following is a summary of the regulatory positions and rationales for

picloram acid and its derivatives. Where labeling revisions are imposed, specific

language is set forth in Section V of this document.

1. Tolerance Reassessment

Tolerances Listed Under 40 CFR §180.292:

The tolerances listed in 40 CFR §180.292 are for residues of picloram

per se. Sufficient data are available to ascertain the adequacy of the established

tolerances listed in 40 CFR §180.292 for the following commodities: barley

grain; barley forage; barley straw; oat grain; oat forage; oat straw; wheat grain;

wheat forage; wheat straw; fat, meat, kidney, liver, and meat by-products of

cattle; goats, hogs, horses, and sheep; and fat, meat, and meat by-products of

poultry, milk, and eggs. See Table IX for modifications in commodity

definitions.

Sufficient field residue data are available for grasses, although the data

indicate that the established tolerance of 80 ppm for picloram residues in/on

grass forage is not adequate. Tolerances of 225 ppm have been proposed for

picloram residues in/on grass forage and hay. The available data support the

proposed tolerance for grass hay but show that a higher tolerance must be

proposed for grass forage. The data indicate that a level of 300 ppm would be

appropriate. 

The Agency has acceptable field residue data at the 0.5 lb. ae/A and 2

lb. ae/A. However, through negotiations with the registrant the new maximum
78 (continued)

use rate will be lowered to 1 lb. ae/A. Ordinarily, field residue data would be

required for this new maximum use rate, however, since there are minimal

dietary concerns involved with picloram, no field residue data will be required

for the 1 lb. ae/A maximum use rate. Picloram tolerances are based on the 2

lb. ae/A data and will remain in effect unless the Agency revisits the tolerance

setting database and lowers the tolerance based on the 0.5 and 2 lb. ae/A

residue field data or the registrant proposes a lower tolerance based upon the

0.5 and 2 lb. ae/A. 

A wheat grain dust study has shown that a tolerance must be proposed. 

The available data indicate that a tolerance of 4 ppm would be appropriate for

grain dust.

The established tolerances for picloram residues in/on flax seed and flax

straw will be proposed for revocation, as there is no registered use of picloram

on flax.

Tolerances Listed Under 40 CFR §185.4850 and 40 CFR §186.4850:

The tolerances listed in 40 CFR §185.4850 and 40 CFR §186.4850 are

for residues of picloram per se. Sufficient data are available to ascertain the

adequacy of the established food/feed additive tolerances listed in 40 CFR

§185.4850 and 40 CFR §186.4850 for barley, oat, and wheat milled fractions

(excluding flour).

CODEX HARMONIZATION

There are no Codex MRLs established or proposed for residues of

picloram. Therefore, there are no questions with respect to compatibility of

U.S. tolerances with Codex MRLs.

Table IX. Tolerance Reassessment Summary for Picloram

Commodity (ppm) (ppm) Commodity Definition

Current Tolerance

Tolerance Reassessment Comment/Correct

Tolerances listed under 40 CFR §180.292:

Barley, grain 0.5 0.5

Barley, green forage 1 1 Barley, forage

Barley, straw 1 1

Cattle, fat 0.2 0.2

Cattle, kidney 5 5

Cattle, liver 0.5 0.5
Table C (continued).

Commodity (ppm) (ppm) Commodity Definition

Current Tolerance

Tolerance Reassessment Comment/Correct

79 (continued)

Cattle, mbyp (exc kidney 0.2 0.2 Cattle, mbyp (exc. liver

and liver) and kidney)

Cattle, meat 0.2 0.2

Eggs 0.05 0.05

Flax, seed 0.5 Revoke No registered use

Flax, straw 0.5 Revoke No registered use

Goats, fat 0.2 0.2

Goats, kidney 5 5

Goats, liver 0.5 0.5

Goats, mbyp (exc kidney 0.2 0.2 Goats, mbyp (exc. liver

and liver) and kidney)

Goats, meat 0.2 0.2

[Grain dust] none 4 Registrant must propose

tolerance

Grasses, forage 80 300 Revised tolerance

proposal of 225 ppm

pending (PP#6F3367);

registrant must propose

higher tolerance/Grass,

forage

[Grass, hay] none 225 Tolerance pending

(PP#6F3367)/Grass, hay

Hogs, fat 0.2 0.2

Hogs, kidney 5 5

Hogs, liver 0.5 0.5

Hogs, mbyp (exc kidney 0.2 0.2 Hogs, mbyp (exc. liver

and liver) and kidney)

Hogs, meat 0.2 0.2

Horses, fat 0.2 0.2

Horses, kidney 5 5

Horses, liver 0.5 0.5

Horses, mbyp (exc 0.2 0.2 Horses, mbyp (exc. liver

kidney and liver) and kidney)

Horses, meat 0.2 0.2

Milk 0.05 0.05
Table C (continued).

Commodity (ppm) (ppm) Commodity Definition

Current Tolerance

Tolerance Reassessment Comment/Correct

80

Oats, grain 0.5 0.5

Oats, green forage 1 1 Oats, forage

Oats, straw 1 1

Poultry, fat 0.05 0.05

Poultry, mbyp 0.05 0.05

Poultry, meat 0.05 0.05

Sheep, fat 0.2 0.2

Sheep, kidney 5 5

Sheep, liver 0.5 0.5

Sheep, mbyp (exc kidney 0.2 0.2 Sheep, mbyp (exc. liver

and liver) and kidney)

Sheep, meat 0.2 0.2

Wheat, grain 0.5 0.5

Wheat, green forage 1 1 Wheat, forage

Wheat, straw 1 1

Tolerances listed under 40 CFR §185.4850

Barley, milled fractions 3 3

(exc. flour)

Oat, milled fractions 3 3

(exc. flour)

Wheat, milled fractions 3 3

(exc. flour)

Tolerances listed under 40 CFR §186.4850

Barley, milled fractions 3 3

(exc. flour)

Oat, milled fractions 3 3

(exc. flour)

Wheat, milled fractions 3 3

(exc. flour)

2. Restricted Use Classification

All the picloram derivatives (potassium picloram, triisopropanolamine

picloram and isooctyl picloram) are currently classified as restricted use

pesticides by regulation (40 CFR section 152.175) on the basis of being a
81

hazard to non-target organisms both crop and non-crop. Picloram will remain a

restricted use pesticide. Picloram may also be considered for restricted use for

ground water concerns once the Ground Water Restricted Use Rule is finalized. 

The eligibility determination made at this time is based upon a presumption that

registrations will conform to all applicable regulatory conditions included in the

final restricted use rule for groundwater. 

3. State Management Plan 

EPA is proposing regulations that will: 1) designate certain pesticides to

be subject to EPA-approved State Management Plans (SMPs) as a condition of

their legal sale and use; and 2) establish these SMPs as an "other regulatory

restriction" by specifying procedures and criteria for SMP development, review

and approval, as provided under the Federal Insecticide, Rodenticide and

Fungicide Act (FIFRA) Section 3(d). In proposing these individual pesticides

to be subject to SMPs, EPA has determined that these pesticides may pose an

unreasonable adverse effect to the environment by their ground-water

contamination potential, in the absence of effective local management measures

provided in a State plan. Any uses of picloram allowed pursuant to the final

rule will be predicated on a finding that such uses will not pose unreasonable

adverse effects on the environment when used pursuant to the conditions

contained in the rule. Upon promulgation of this rule, the labels for these

pesticides will be changed to require use in accordance with an EPA-approved

SMP, and to prohibit sale and use in those States without such an EPAapproved SMP, after a period (to be established in the rule) allowed for

development and approval of these State plans. The eligibility determination

made at this time is based upon a presumption that registrations will conform to

all applicable requirements of the final regulation addressing this issue. 

Picloram is not now one of the pesticides that EPA will be proposing to

be subject of a SMP. However, the Agency may consider picloram as a

candidate for a SMP at some later date.

4. Reference Dose 

A reference dose (RfD) for the picloram acid and its derivatives was

calculated to be 0.20 mg/kg/day based on a NOEL of 20 mg/kg/day bodyweight per day from a two-year chronic rat feeding study. An uncertainty

factor of 100 was used to account for the inter-species extrapolation and intraspecies variability. The picloram chronic dietary exposure/risk estimates are

extremely low. For the United States population as a whole, the Theoretical

Maximum Residue Contribution (TMRC) is 0.9% of the RfD. For this same

group, the Anticipated Residue Contribution (ARC) is 0.5% of the RfD. 

Because the dietary exposure/risk is so low, about 1/200th of the RfD, there are

no concerns regarding chronic dietary exposure to picloram at this time.
82

5. Cancer Risk Assessment 

The Agency has classified picloram as a Group E (evidence of noncarcinogenicity for humans). Even though picloram was shown to be noncarcinogenic, a cancer risk assessment was performed on the maximum

concentration of the impurity HCB, since HCB has been classified by the

Agency as a Group B2 (probable human carcinogen). The refined, ARC dietary

carcinogenicity risk estimates for the United States population as a whole for the

impurity, HCB, is 7 x 10 . A risk less than 1.0 x 10 is generally considered -7 -6

to be negligible.

Picloram IOE bears structural similarity to di(2-ethylhexyl)phthalate

(DEPH) in that both possess a 2-ethylhexyl moiety. DEPH and certain other

substances containing the 2-ethylhexyl moiety have been found to be

carcinogenic. The Agency performed a cancer risk assessment for workers and

found that the risk associated with post-application exposure is not a major

concern since exposure to workers is minimal due to the use patterns defined by

the picloram IOE labels and the cultural practices typically associated with a

broad spectrum herbicide of this type. This ester formulation is not used on

food.

6. Endangered Species Statement

Currently, the Agency is developing a program ("The Endangered

Species Protection Program") to identify all pesticides whose use may cause

adverse impacts on endangered and threatened species and to implement

mitigation measures that will eliminate the adverse impacts. The program

would require use restrictions to protect endangered and threatened species at

the county level. Consultations with the Fish and Wildlife Service may be

necessary to assess risks to newly listed species or from proposed new uses. In

the future, the Agency plans to publish in the Federal Register a description of

the program and have available enforceable county-specific bulletins. Because

the Agency is taking this approach for protecting endangered and threatened

species, it is not imposing label modifications at this time through the RED. 

Rather, any requirements for product use modifications will occur in the future

under the Endangered Species Protection Program.

7. Worker Protection

a. Compliance with Worker Protection Standard

Any product whose labeling reasonably permits use in the

production of an agricultural plant on any farm, forest, nursery, or

greenhouse must comply with the labeling requirements of PR Notice

93-7, "Labeling Revisions Required by the Worker Protection Standard
83

(WPS), and PR Notice 93-11, "Supplemental Guidance for PR Notice

93-7, which reflect the requirements of EPA's labeling regulations for

worker protection statements (40 CFR part 156, subpart K). These

labeling revisions are necessary to implement the Worker Protection

Standard for Agricultural Pesticides (40 CFR part 170) and must be

completed in accordance with, and within the deadlines specified in, PR

Notices 93-7 and 93-11. Unless otherwise specifically directed in this

RED, all statements required by PR Notices 93-7 and 93-11 are to be on

the product label exactly as instructed in those notices.

After April 21, 1994, except as otherwise provided in PR

Notices 93-7 and 93-11, all products within the scope of those notices

must bear WPS PR Notice complying labeling when they are distributed

or sold by the primary registrant or any supplementally registered

distributor.

After October 23, 1995, except as otherwise provided in PR

Notices 93-7 and 93-11, all products within the scope of those notices

must bear WPS PR Notice complying labeling when they are distributed

or sold by any person.

Post-application Reentry

Under the Worker Protection Standard (WPS), interim restricted

entry intervals (REI) for all uses within the scope of the WPS are

established on the basis of the acute toxicity of the active ingredient. The

toxicity categories of the active ingredient for acute dermal toxicity, eye

irritation potential, and skin irritation potential are used to determine the

interim WPS REI. If one or more of the three acute toxicity effects are

in toxicity category I, the interim WPS REI is established at 48 hours. 

If none of the acute toxicity effects are in category I, but one or more of

the three is classified as category II, the interim WPS REI is established

at 24 hours. If none of the three acute toxicity effects are in category I

or II, the interim WPS REI is established at 12 hours. A 48-hour REI is

increased to 72 hours when an organophosphate pesticide is applied

outdoors in arid areas. In addition, the WPS specifically retains two

types of REI's established by the Agency prior to the promulgation of

the WPS: product-specific REI's established on the basis of adequate

data and interim REI's that are longer than those that would be

established under the WPS.

At this time some registered uses of picloram are within the

scope of the Worker Protection Standard for agricultural pesticides

(WPS) and some are outside the scope of the WPS. EPA has

determined that entry should not be permitted immediately following
84

application. Therefore, the Agency is establishing restrictions on entry

to treated areas. For each use of the product that is within the scope of

the Worker Protection Standard for Agricultural Pesticides (WPS)

(except when it is applied by direct injection into the treated plants), the

Agency is requiring a 12-hour restricted-entry interval on all

occupational end-use products containing picloram as an active

ingredient. For each use of the product that is outside the scope of the

Worker Protection Standard for Agricultural Pesticides (WPS), the

Agency is requiring a prohibition on entry until sprays have dried on

occupational end-use products containing picloram as an active

ingredient.

The WPS places very specific restrictions on entry during

restricted-entry intervals when that entry involves contact with treated

surfaces. The Agency believes that these existing WPS protection are

sufficient to mitigate post-application exposures of workers who contact

surfaces treated with picloram. The WPS REI in effect until now was a

12-hour REI placed on picloram products by PR Notice 93-7.

When picloram is applied by direct injection into treated plants,

there are no entry restrictions. The WPS does not cover workers who

are working in an area where a pesticide has been injected directly into

plants, therefore, there are no entry restrictions or notification

requirements.

Personal Protective Equipment (PPE) Requirements

Mixer/loader/applicator PPE For each end-use product, PPE

requirements for pesticide handlers will be set during

reregistration in one of two ways:

1. If the Agency has no special concerns regarding other adverse

effects of an active ingredient, the PPE for pesticide handlers will be

established based on the acute toxicity of the end-use product. For

occupational-use products, PPE will be established using the process

described in PR Notice 93-7 or more recent EPA guidelines.

2. If the Agency has special concerns about an active ingredient due

to very high acute toxicity or certain adverse effects, such as allergic

effects or other effects (cancer, developmental toxicity, reproductive

effects, etc):

In the RED document for that active ingredient, the Agency may

establish minimum or "baseline" handler PPE requirements that
85

pertain to all or most occupational end-use products containing

that active ingredient.

These minimum PPE requirements must be compared with the

PPE that would be designated on the basis of the acute toxicity of

each end-use product.

The more stringent choice for each type of PPE (i.e., bodywear,

hand protection, footwear, eyewear, etc.) must be placed on the

label of the end-use product.

There are special toxicological concerns about picloram that

warrant the establishment of active-ingredient based PPE requirements. 

The MOE's for some of the use-scenarios for handlers (mixers, loaders,

applicators, etc.) are acceptable only with the addition of chemicalresistant gloves.

To the Agency's knowledge, at this time some of the registered

uses of picloram are within the scope of the Worker Protection Standard

for Agricultural Pesticides (WPS) and some are outside the scope of the

WPS. However, the minimum (baseline) PPE requirements for both the

WPS and nonWPS uses are the same, since the potential exposure to

handlers is similar for WPS and nonWPS uses.

The minimum (baseline)PPE for all WPS and nonWPS uses of

picloram end-use products is: chemical-resistant gloves.

 

Personal Protective Equipment (PPE) Requirements

Early Entry PPE The WPS establishes very specific restrictions on

entry by workers to areas that remain under a restricted-entry by

workers if the entry involves contact with treated surfaces. Among

those restrictions are a prohibition of routine entry to perform hand

labor tasks and requirement that personal protective equipment be worn. 

Personal protective equipment requirements for persons who must enter

areas that remain under a restricted-entry interval are based on the

toxicity concerns about the active ingredient. The requirements are set

in one of two ways.

1. If the Agency has no special concerns about the acute or other

adverse effects of an active ingredient, it establishes the early-entry PPE

requirements based on the acute dermal toxicity, skin irritation potential,

and eye irritation potential of the active ingredient.

2. If the Agency has special concerns about an active ingredient due

to very high acute toxicity or to certain other adverse effects, such as
86

allergic effects, cancer, developmental toxicity, or reproductive effects,

it may establish early-entry PPE requirements that are more stringent

than would be established otherwise.

Since there are special toxicological concerns about picloram and

picloram is classified as toxicity category III or IV for acute dermal

toxicity and skin irritation potential, the PPE required for early entry is

coveralls, chemical-resistant gloves, shoes, and socks. Since picloram is

classified as toxicity category III for eye irritation potential, no

protective eyewear is required. The Agency will not require a respirator

for early-entry workers, since the WPS places very specific restrictions

on early entry and the Agency believes that these existing WPS

protections are sufficient to mitigate post-application inhalation

exposures of workers.

There are no special toxicological concerns about picloram that

warrant the establishment of active-ingredient-based early entry PPE

requirements.

Entry Restrictions for Occupational-Use Products (nonWPS

uses)

At this time some registered uses of picloram are outside the

scope of the WPS. The Agency is requiring the following entry

restrictions for all nonWPS occupational uses of picloram end-use

products:

"Do not enter or allow others to enter the treated area until

sprays have dried."

Entry Restrictions for Residential-Use Products

At this time no products containing picloram are registered for

residential use. 

8. Spray Drift Advisory

The Agency has been working with the Spray Drift Task Force, EPA

Regional Offices and State Lead Agencies for pesticide regulation to develop the

best spray drift management practices. The Agency is now requiring interim

measures that must be placed on product labels/labeling as specified in Section

V. Once the Spray Drift Task Force completes their studies, submits data, and

the Agency evaluation is completed, there may be further refinements in spray

drift management practices.
87

9. Ground Water and Surface Water Advisories

Because picloram has been shown to be exceptionally mobile and

persistent the Agency is requiring ground and surface water advisories.

To better refine the extent and nature of the ground water

contamination, the Agency has required a surveillance/monitoring program. 

Based on the data, the Agency may require further registrant action, including

prohibition in vunerable areas or possible cancellation.

See section V for labeling statements.

10. Phytotoxic Concerns

The Agency is very concerned about the phytotoxicity effects of

picloram. As an indication of potential for mitigation of phytotoxic effects by

use reduction, one can estimate the maximum use rate that would correspond to

an environmental concentration not exceeding the level of concern. The

reciprocal of the risk quotients (i.e. 1/RQ) gives the fraction of the current use

rate that would result in an EEC equal to the LOC. For example, if the risk

quotient is 2, then a halving of the application rate would result in an EEC

equal to the LOC. Results of such calculations, based on RQ values in tables

found in section 3, vary according to product and application procedure, but

uniformly indicate that application rates less than 1% of current rates would be

required, for the EECs to not exceed the LOCs. 

Currently, most of the picloram products can be applied at any season

and there are no limitations or restrictions on the maximum number of

treatments per season. The maximum rates per application are also unclear for

some products. 

Products containing picloram are on occasion transported from where

they are applied so that crops and other nontarget plants are damaged

unintentionally. Not withstanding these serious phytotoxic concerns, the

Agency believes that sufficient measures are in place such that all the uses for

picloram are eligible for reregistration. These measures include a)

implementation of risk reduction measures; b) monitoring programs and current

state regulation of picloram c) a cursory benefits analysis and; d) the tightly

controlled product distribution system that has been put in place by the sole

producer, DowElanco. 

a. Risk Reduction Measures

 The Agency is requiring lower application rates and limits on the

number and frequency of applications for all use patterns:
88

 the broadcast rate for range and pasture use will be lowered from the

current maximum of 2.0 lb. ae/A to 0.5 ae/A for control of broadleaf

weeds and woody plants. For the control of noxious weeds, a broadcast

application of up to 1.0 lb. ae/A may be used annually. Spot treatment

will be lowered to a maximum of 1.0 lb. ae/A with no more than 50%

of an acre being treated. Spot treatments and broadcast treatments can

be applied during the same growing season only if the total amount

applied does not exceed 1.0 lb. ae/A per annual growing season. The

range and pasture use accounts for over 85% of picloram's use.

 the forestry use rate will be lowered from a maximum of 2.2 lbs.

ae/A to 1.0 lb. ae/A for spot and broadcast treatment. Use will be

allowed only once every 2 years. There is no interval currently listed on

the label.

 the rights-of-Ways use rate will be lowered from a maximum of 2.2

lb ae/A to 1 lb ae/A annually. There is no interval currently listed on

the label.

 Finally picloram will remain classified for restricted use and may be

identified as a candidate for the State Management Plan.

b. Monitoring and Other Programs

 Through negotiations with the Agency the registrant has committed to

a state ground water monitoring/surveillance plan. The plan will be

based on modeling which will be completed by 6-30-95. Parameters of

the monitoring/surveillance program (e.g. location, duration, etc.) will

be defined based on the results of the modeling effort. The results of the

monitoring/surveillance program, will determine if additional data (e.g.

prospective study) may be required or if other appropriate regulatory

action is necessary.

 Additionally, through negotiations with the Agency, the registrant has

committed to provide financial support to the Heritage programs for the

six states with the highest usage of picloram. These six states cover

75% of all picloram usage in pounds and most geographic/climatic

conditions. State Heritage programs are responsible for mapping and

monitoring sensitive habitat in 48 states. A geographical information

system (GIS) will be developed that will relate sensitive habitat to land

use and land characteristics. The registrants financial support of the

State Heritage programs will greatly facilitate and speed the mapping

and implementation of the Endangered Species Task force efforts. This

program will enhance the capability of the states to identify sensitive

habitat, based on the presence of endangered species and other

considerations. Ultimately, this approach will help secure protection for

sensitve habitats/endangered species while providing state and federal
89

agencies with the critical information needed to identify any further

mitigation measures should picloram use be found to effect any sensitive

habitat/endangered species.

 Although these measures will reduce risks, the remaining potential

risk to nontarget plants and the potential for ground water contamination

are still expected to be high.

 

 The Agency has also consulted with State Lead Agencies in States

with high picloram use (TX, OK, KS, MT, ND, NE, WY, SD and

WA). Most of the states responded and identified picloram as an

important weed control chemical. States believe they have programs in

place to adequately deal with phytotoxicity. The States responses were

also useful in establishing acceptable modifications of reduced

application rates and treatment frequencies. 

c. Benefits

The Agency has done a cursory benefits analysis for picloram

and found that it is an extremely effective herbicide at relatively low

rates. It also controls a wide spectrum of unwanted broadleaf and brush

species without causing injury to grass. 

Some alternatives for picloram are 2,4-D, triclopyr, dicamba,

clopyralid and tebuthiuron. However, it should be noted that in order to

achieve the same spectrum of control as picloram, especially for weed

control in rangeland and pasture, a combination of 2,4-D and some other

herbicide (e.g. triclopyr or dicamba) would probably have to be used. 

The Agency has not completed its evaluation of the carcinogenic

potential of 2,4-D. New chronic studies for 2,4-D are due to the

Agency in the spring of 1995. Therefore, the Agency would be

concerned about restricting picloram use in favor of 2,4-D at this time. 

Picloram alternatives will generally have to be used at higher rates to

achieve control. Additionally, picloram is the only effective herbicide

that can control pricklypear cactus, a significant economic pest in range

and pastureland. 

d. DowElanco's Stewardship

DowElanco has instituted a strict product distribution system. 

There are only 53 companies that DowElanco allows to distribute

picloram. Of the 53 companies, 19 companies account for 90% of the

total sales in the U.S.. All 53 companies and their employees must

attend DowElanco training program(s) annually in order to continue to
90

sell picloram. Additionally, every company has a contractual obligation

to represent strict DowElanco product stewardship or otherwise lose

their privilege to sell picloram. This limited distribution approach

allows consistent product stewardship and enables Dow to effect use

recommendations/changes immediately throughout the U.S.

V. ACTIONS REQUIRED BY REGISTRANTS

This section specifies the data requirements and responses necessary for the

reregistration of both manufacturing-use and end-use products.

A. Manufacturing-Use Products

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of picloram acid and

its derivatives for the above eligible uses has been reviewed and determined to

be substantially complete. The following generic data will be required on a

confirmatory basis: 

 For Triisopropanolamine Picloram 

Guideline 72-3(d), Toxicity to marine/estuarine fish (TEP)

Guideline 72-4(a), Early life stage - fish

Guideline 123-1(a), Seed germination/emergence

Guideline 123-1(b), Vegetative vigor

Guideline 123-2, Aquatic plant growth (marine diatom) 

 For Isooctyl Picloram

Guideline 72-1(b), Bluegill, Acute LC (TEP) 50

Guideline 72-1(d), Rainbow, Acute LC (TEP) 50

Guideline 72-2(b), Invertebrate toxicity (Daphina magna) 

Guideline 72-3(d), Toxicity to marine/estuarine fish (TEP)

Guideline 72-3(e), Toxicity to marine/estuarine mollusk (TEP)

Guideline 72-3(f), Toxicity to marine/estuarine shrimp (TEP)

Guideline 72-4(a), Early life stage - fish

Guideline 123-1(a), Seed germination/emergence

Guideline 123-1(b), Vegetative vigor

Guideline 123-2, Aquatic plant growth (diatoms, algae)

 For Potassium Picloram

Guideline 72-3(d), Toxicity to marine/estuarine fish (TEP)

Guideline 123-1(a), Seed germination/emergence

Guideline 123-1(b), Vegetative Vigor

Guideline 123-2, Aquatic plant growth (marine diatom)
91

 Mixer/Loader/Applicator Exposure Monitoring

Guideline 231, Estimation of Dermal Exposure at Outdoor Sites for

mixer/loaders and applicators using the hand cannon equipment.

Guideline 232, Estimation of Inhalation Exposure at Outdoor Sites

for mixer/loaders and applicators using the hand cannon equipment.

Guideline 231, Estimation of Dermal Exposure at Outdoor Sites for 

mixer/loaders and applicators using the backpack/knapsack

equipment.

Guideline 232, Estimation of Inhalation Exposure at Outdoor Sites 

for mixer/loaders and applicators using the backpack/knapsack

equipment.

Ground Water/Surveillance Monitoring

Through negotiations with the Agency the registrant has committed to a

state ground water monitoring/surveillance plan. The plan will be based on

modeling which will be completed by 6-30-95. Parameters of the

monitoring/surveillance program (e.g. location, duration, etc.) will be defined

based on the results of the modeling effort and in cooperation with the States. 

The results of the monitoring/surveillance program, will determine if additional

data (e.g. prospective study) may be required or if other appropriate regulatory

action is necessary.

 State Heritage Programs for Endangered Species

Through negotiations with the Agency, the registrant has committed to

provide financial support to the Heritage programs for the six states with the

highest usage of picloram. These six states cover 75% of all picloram usage in

pounds and most geography/climatic conditions. State Heritage programs are

responsible for mapping and monitoring sensitive habitat/endangered species in

48 states. A geographical information system (GIS) will be developed that will

relate sensitive habitat to land use and land characteristics. The registrants

financial support of the State Heritage programs will greatly facilitate and help

speed up the mapping and implementation of the Endangered Species Task

Force efforts. Ultimately, this approach will help secure protection for sensitve

habitats/endangered species while providing state and federal agencies with the

critical information needed to identify any further mitigation measures should

picloram use be found to affect any sensitive habitat/endangered species.

2. Labeling Requirements for Manufacturing-Use Products

To remain in compliance with FIFRA, manufacturing use

product (MP) labeling must be revised to comply with all current EPA
92

regulations, PR Notices and applicable policies. The MP labeling must bear the

following statement under Directions For Use:

"Only for formulation into an [fill blank with Insecticide,

Herbicide or the applicable term which describes the type of pesticide uses(s)]

for the following uses(s): (fill blank only with those uses that are

being supported by MP registrant)." 

An MP registrant may, at his/her discretion, add one of the following

statements to an MP label under "Directions for Use" to permit the

reformulation of the product for a specific use or all additional uses supported

by a formulator or user group:

(a) "This product may be used to formulate products for specific

use(s) not listed on the MP label if the formulator, user group, or

grower has complied with U.S. EPA submission requirements

regarding the support of such uses(s)."

(b) "This product may be used to formulate products for any

additional use(s) not listed on the MP label if the formulator,

user group, or grower has complied with U.S. EPA submission

requirements regarding the support of such uses(s)."

B. End-Use Products

1. Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed

product-specific data regarding the pesticide after a determination of eligibility

has been made. The product specific data requirements are listed in Appendix

G, the Product Specific Data Call-In Notice.

Registrants must review previous data submissions to ensure that they

meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,

commit to conduct new studies. If a registrant believes that previously

submitted data meet current testing standards, then study MRID numbers should

be cited according to the instructions in the Requirement Status and Registrants

Response Form provided for each product.
93

2. Labeling Requirements for End-Use Products

a. Reduced Use Rates and Increased Intervals

 Labels must be amended to reflect the following changes in maximum

application rates and treatment intervals:

 the broadcast rate for range and pasture use is lowered from

the current maximum of 2.0 lb. to 0.5 ae/A for control of

broadleaf weeds and woody plants. For the control of noxious

weeds, a broadcast application of up to 1.0 lb. ae/A may be used

annually. Spot treatment will be lowered to a maximum of 1.0

lb. ae/A with no more than 50% of an acre being treated. Spot

treatments and broadcast treatments can be applied during the

same growing season only if the total amount applied does not

exceed 1.0 ae/A per annual growing season. 

 the forestry use rate is lowered from a maximum of 2.2 lb.'s

ae/A to 1.0 lb. ae/A for spot and broadcast treatment. Use is

allowed only once every 2 years. 

 the rights-of-ways use rate is lowered from a maximum of 2.2

lb. ae/A to 1 lb. ae/A annually. 

b. Other Labeling Requirements

The Agency is requiring the following labeling statements to be

located on all end-use products containing picloram:

 Personal Protective Equipment for Handlers (mixers, loaders,

applicators, etc.) : 

The minimum (baseline) handler personal protective equipment (PPE)

for all WPS and nonWPS uses of picloram end-use products is chemicalresistant gloves. The remaining PPE for handlers is to be based on the

toxicity of the end-use product. See PR Notice 93-7 or more recent

Agency guidance for instructions on establishing PPE for occupational

handlers.

 Entry Restrictions for Occupational-Use Products (WPS uses):

The Agency is establishing a 12-hour restricted-entry interval (REI). 

Personal protective equipment required for WPS-permitted early entry

into treated areas that involves contact with anything that has been

treated, such as plants, soil, or water is: coveralls, chemical-resistant

gloves, socks, and shoes.
94

 Entry Restrictions for Occupational-Use Products (NonWPS

Uses):

For nonWPS uses of picloram the Agency is requiring the following: 

"Do not enter or allow others to enter the treated area until sprays have

dried."

The following statements are required on all picloram end-use

product labeling:

Application Restrictions:

"Do not apply this product in a way that will contact workers or other

persons, either directly or through drift. Only protected handlers may

be in the area during application."

Engineering Controls:

"When handlers use closed systems, enclosed cabs, or aircraft in a

manner that meets the requirements listed in the WPS (40 CFR

170.240(d)(4-6)), the handler PPE requirements may be reduced or

modified as specified in the WPS."

User Safety Requirements:

"Follow manufacturer's instructions for cleaning/maintaining PPE. If

no such instructions exist for washables, use detergent and hot water. 

Keep and wash PPE separately from other laundry."

User Safety Recommendations:

"Users should wash hands before eating, drinking, chewing gum, using

tobacco, or using the toilet."

"Users should remove clothing immediately if pesticide gets inside. 

Then wash thoroughly and put on clean clothing."

"Users should remove PPE immediately after handling this product. 

Wash the outside of gloves before removing. As soon as possible, wash

thoroughly and change into clean clothing."

In addition, because picloram potassium salt, picloram isooctyl

ester, and picloram triisopropanolamine salt are classified as skin

sensitizers, the following statement is required in the "Hazards to

Humans (and Domestic Animals)" section of the Precautionary

Statements on the labeling of all end-use products containing picloram in

those forms:
95

"Prolonged or frequent repeated skin contact may cause allergic

reactions in some individuals."

Type of Respirator: If the acute inhalation toxicity of the end-use

product is in category I or II, a respirator is required for pesticide

handlers. The following type of respirator is appropriate to mitigate

picloram inhalation concerns:

"A dust/mist filtering respirator (MSHA/NIOSH approval number prefix

TC-21C)."

c. Spray Drift Labelling

The following language must be placed on each product label that

can be applied aerially:

Avoiding spray drift at the application site is the responsibility of the

applicator. The interaction of many equipment-and-weather-related

factors determine the potential for spray drift. The applicator and the

grower are responsible for considering all these factors when making

decisions.

The following drift management requirements must be followed to avoid

off-target drift movement from aerial applications to agricultural field

crops. These requirements do not apply to forestry applications, public

health uses or to applications using dry formulations.

1. The distance of the outer most nozzles on the boom must not

exceed 3/4 the length of the wingspan or rotor.

2. Nozzles must always point backward parallel with the air stream

and never be pointed downwards more than 45 degrees.

Where states have more stringent regulations, they should be observed.

The applicator should be familiar with and take into account the

information covered in the Aerial Drift Reduction Advisory.

The following aerial drift reduction advisory information must be

contained in the product labeling:

[This section is advisory in nature and does not supersede the mandatory

label requirements.]
96

INFORMATION ON DROPLET SIZE

The most effective way to reduce drift potential is to apply large

droplets. The best drift management strategy is to apply the largest

droplets that provide sufficient coverage and control. Applying larger

droplets reduces drift potential, but will not prevent drift if applications

are made improperly, or under unfavorable environmental conditions

(see Wind, Temperature and Humidity, and Temperature Inversions).

CONTROLLING DROPLET SIZE

Volume - Use high flow rate nozzles to apply the highest

practical spray volume. Nozzles with higher rated flows produce larger

droplets.

Pressure - Do not exceed the nozzle manufacturer's

recommended pressures. For many nozzle types lower pressure

produces larger droplets. When higher flow rates are needed, use

higher flow rate nozzles instead of increasing pressure.

Number of nozzles - Use the minimum number of nozzles that

provide uniform coverage.

Nozzle Orientation - Orienting nozzles so that the spray is

released parallel to the airstream produced larger droplets than other

orientations and is the recommended practice. Significant deflection

from horizontal will reduce droplet size and increase drift potential.

Nozzle Type - Use a nozzle type that is designed for the intended

application. With most nozzle types, narrower spray angles produce

larger droplets. Consider using low-drift nozzles. Solid stream nozzles

oriented straight back produce the largest droplets and the lowest drift.

BOOM LENGTH

For some use patterns, reducing the effective boom length to less than

3/4 of the wingspan or rotor length may further reduce drift without

reducing swath width.

APPLICATION HEIGHT

Applications should not be made at a height greater than 10 feet above

the top of the largest plants unless a greater height is required for
97

aircraft safety. Making applications at the lowest height that is safe

reduces exposure of droplets to evaporation and wind.

SWATH ADJUSTMENT

When applications are made with a crosswind, the swath will be

displaced downward. Therefore, on the up and downwind edges of the

field, the applicator must compensate for this displacement by adjusting

the path of the aircraft upwind. Swath adjustment distance should

increase, with increasing drift potential (higher wind, smaller drops,

etc.)

WIND

Drift potential is lowest between wind speeds of 2-10 mph. However,

many factors, including droplet size and equipment type determine drift

potential at any given speed. Application should be avoided below 2

mph due to variable wind direction and high inversion potential. 

NOTE: Local terrain can influence wind patterns. Every applicator

should be familiar with local wind patterns and how they affect spray

drift.

TEMPERATURE AND HUMIDITY

When making applications in low relative humidity, set up equipment to

produce larger droplets to compensate for evaporation. Droplet

evaporation is most severe when conditions are both hot and dry.

TEMPERATURE INVERSIONS

Applications should not occur during a temperature inversion because

drift potential is high. Temperature inversions restrict vertical air

mixing, which causes small suspended droplets to remain in a

concentrated cloud. This cloud can move in unpredictable directions due

to the light variable winds common during inversions. Temperature

inversions are characterized by increasing temperatures with altitude and

are common on nights with limited cloud cover and light to no wind. 

They begin to form as the sun sets and often continue into the morning. 

Their presence can be indicated by ground fog; however, if fog is not

present, inversions can also be identified by the movement of the smoke

from a ground source or an aircraft smoke generator. Smoke that layers

and moves laterally in a concentrated cloud (under low wind conditions)
98

indicates an inversion, while smoke that moves upward and rapidly

dissipates indicates good vertical air mixing.

SENSITIVE AREAS

The pesticide should only be applied when the potential for drift to

adjacent sensitive areas (e.g. residential areas, bodies of water, known

habitat for threatened or endangered species, non-target crops) is

minimal (e.g. when wind is blowing away form the sensitive areas).

d. Ground Water Statements

The following ground water advisory language must be placed on all

picloram labels: 

"This chemical is known to leach through soil into ground water

under certain conditions as a result of agricultural use. Use of

this chemical in areas where soils are permeable, particularly

where the water table is shallow, may result in ground-water

contamination."

e. Surface Water Statements

The following surface water advisory language must be placed on all

picloram labels:

"This chemical can contaminate surface water through spray

drift. Under some conditions, picloram may also have a high

potential for runoff into surface water (primarily via dissolution

in runoff water), for several months post-application. These

include poorly draining or wet soils with readily visible slopes

toward adjacent surface waters, frequently flooded areas, areas

over-laying extremely shallow ground water, areas with in-field

canals or ditches that drain to surface water, areas not separated

from adjacent surface waters with vegetated filter strips, and

areas over-laying tile drainage systems that drain to surface

water."

f. Phytotoxicity Statements

The following phytotoxicity advisory language must be placed on

all picloram labels: 
99

"This pesticide is toxic to some plants at very low

concentrations. Non-target plants may be adversely

affected if pesticide is allowed to drift from areas of

application."

Precautionary hazard labelling should include the following based

on PR Notice 93-3.

"Do not apply this product to water, or to areas where

surface water is present, or to intertidal areas below the

mean high water mark."

C. Existing Stocks

Registrants may generally distribute and sell products bearing old

labels/labeling for 26 months from the date of the issuance of this Reregistration

Eligibility Decision (RED). Persons other than the registrant may generally distribute

or sell such products for 50 months from the date of the issuance of this RED.

However, existing stocks time frames will be established case-by-case, depending on

the number of products involved, the number of label changes, and other factors. Refer

to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register,

Volume 56, No. 123, June 26, 1991.

The Agency has determined that registrants may distribute and sell picloram

products bearing old labels/labeling for 26 months from the date of issuance of this

RED. Persons other than the registrant may distribute or sell such products for 50

months from the date of the issuance of this RED. Registrants and persons other than

registrants remain obligated to meet pre-existing Agency imposed label changes and

existing stocks requirements applicable to products they sell or distribute.
100
101

VI. APPENDICES
102
103

APPENDIX A. Table of Use Patterns Subject to Reregistration
104
 APPENDIX A ) CASE 0096, [Picloram] Chemical 005102 [Picloram, triisopropanolamine salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT

 LUIS 1.5 ) Page 1

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES:

FOOD/FEED USES

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PASTURES Use Group: TERRESTRIAL FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .54 lb (AE) A * NS NS NS NS NS NS AL, AR, GA, LA, C46, CAE, G01(7),

 MS, NM, OK, TX H12(30), S09(3)

Broadcast., Foliar., Ground. SC/L NA .54 lb (AE) A * NS NS NS NS NS NS AL, AR, GA, LA, C46, CAE, G01(7),

 MS, NM, OK, TX H12(30), S09(3)

High volume spray (dilute)., Foliar., High SC/L NA .54 lb (AE) A * NS NS NS NS NS NS AL, AR, GA, LA, C46, CAE, G01(7),

volume ground. MS, NM, OK, TX H12(30), S09(3)

RANGELAND Use Group: TERRESTRIAL FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .54 lb (AE) A * NS NS NS NS NS NS AL, AR, GA, LA, C46, CAE, G01(7),

 MS, NM, OK, TX H12(30), S09(3)

Broadcast., Foliar., Ground. SC/L NA .54 lb (AE) A * NS NS NS NS NS NS AL, AR, GA, LA, C46, CAE, G01(7),

 MS, NM, OK, TX H12(30), S09(3)

High volume spray (dilute)., Foliar., High SC/L NA .54 lb (AE) A * NS NS NS NS NS NS AL, AR, GA, LA, C46, CAE, G01(7),

volume ground. MS, NM, OK, TX H12(30), S09(3)

NON-FOOD/NON-FEED

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FOREST PLANTINGS (REFORESTATION PROGRAMS) Use Group: FORESTRY

Broadcast., Foliar., Aircraft. SC/L NA 1.62 lb (AE) A * NS NS NS NS NS NS C46, CAE

Broadcast., Foliar., Ground. SC/L NA 1.62 lb (AE) A * NS NS NS NS NS NS C46, CAE

FOREST TREES (ALL OR UNSPECIFIED) Use Group: FORESTRY

Frill treatment., When needed., Oil can (or RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

other stream type applicator). GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

 SC/L NA UC * NS NS NS NS NS NS C46, CAE

Frill treatment., When needed., Paintbrush. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Frill treatment., When needed., Squirt RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

bottle. GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA
 APPENDIX A ) CASE 0096, [Picloram] Chemical 005102 [Picloram, triisopropanolamine salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT

 APPENDIX A ) CASE 0096, [Picloram] Chemical 005102 [Picloram, triisopropanolamine salt] LUIS 1.5 ) Page 2

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

NON-FOOD/NON-FEED (con't)

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FOREST TREES (ALL OR UNSPECIFIED) (con't) Use Group: FORESTRY (con't)

 SC/L NA UC * NS NS NS NS NS NS C46, CAE

Girdle treatment., When needed., Oil can (or RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

other stream type applicator). GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

 SC/L NA UC * NS NS NS NS NS NS C46, CAE

Girdle treatment., When needed., Paintbrush. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Girdle treatment., When needed., Squirt RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

bottle. GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

 SC/L NA UC * NS NS NS NS NS NS C46, CAE

Stump treatment., When needed., Paintbrush. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

 SC/L NA UC * NS NS NS NS NS NS C46, C58, CAE

Stump treatment., When needed., Sprayer. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

 SC/L NA UC * NS NS NS NS NS NS C46, C58, CAE

Tree injection treatment., When needed., RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

Tree injection equipment. GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

 SC/L NA UC * NS NS NS NS NS NS C46, C58, CAE

NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS Use Group: TERRESTRIAL NON-FOOD CROP

Broadcast., Foliar., Ground. SC/L NA 1.08 lb (AE) A * NS NS NS NS NS NS C46, CAE
 APPENDIX A ) CASE 0096, [Picloram] Chemical 005102 [Picloram, triisopropanolamine salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT

LUIS 1.5 ) Page 3

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

NON-FOOD/NON-FEED (con't)

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS (con't) Use Group: TERRESTRIAL NON-FOOD CROP (con't)

Frill treatment., When needed., Oil can (or RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

other stream type applicator). GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Frill treatment., When needed., Paintbrush. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Frill treatment., When needed., Squirt RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

bottle. GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Girdle treatment., When needed., Oil can (or RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

other stream type applicator). GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Girdle treatment., When needed., Paintbrush. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Girdle treatment., When needed., Squirt RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

bottle. GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

High volume spray (dilute)., Foliar., High SC/L NA 1.08 lb (AE) A * NS NS NS NS NS NS C46, CAE

volume ground.

Stump treatment., When needed., Paintbrush. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Stump treatment., When needed., Sprayer. RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

 GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA

Tree injection treatment., When needed., RTU NA UC * NS NS NS NS NS NS AL, AR, DE, FL, CAE

Tree injection equipment. GA, LA, MD, MS,

 NC, OK, SC, TN,

 TX, VA
LUIS 1.5 ) Page 4

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LEGEND

444444

 HEADER ABBREVIATIONS

 Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.

 noted otherwise)

 Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.

 noted otherwise)

 Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).

 Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3 

 years" is expressed as "4/3 yr" 

 Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.

 noted otherwise)/A]

 Min. Interv (days) : Minimum Interval between Applications (days)

 Restr. Entry Interv (days) : Restricted Entry Interval (days)

 SOIL TEXTURE FOR MAX APP. RATE

 * : Non-specific

 C : Coarse

 M : Medium

 F : Fine

 O : Others

 FORMULATION CODES

 RTU : LIQUID-READY TO USE

 SC/L : SOLUBLE CONCENTRATE/LIQUID

 ABBREVIATIONS 

 AN : As Needed

 NA : Not Applicable

 NS : Not Specified (on label)

 UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet, 

 briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part, 

 parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, -- 

 

 APPLICATION RATE

 DCNC : Dosage Can Not be Calculated

 No Calc : No Calculation can be made

 W : PPM calculated by weight

 V : PPM Calculated by volume

 cwt : Hundred Weight

 nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"

 USE LIMITATIONS CODES

 C46 : Do not apply through any type of irrigation system.

 C58 : May be applied undiluted.

 CAE : Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes).

 G01 : __ day(s) pregrazing interval.

 * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.

 GEOGRAPHIC CODES

 AL : Alabama

 AR : Arkansas

 DE : Delaware

 FL : Florida

 GA : Georgia

 LA : Louisiana

 MD : Maryland

 MS : Mississippi

 NC : North Carolina

 NM : New Mexico

 OK : Oklahoma

 SC : South Carolina

 TN : Tennessee

 TX : Texas

 VA : Virginia
APPENDIX A ) CASE 0096, [Picloram] Chemical 005103 [Picloram, isooctyl ester] 

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:51 LUIS 1.5 ) Page 1

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

NON-FOOD/NON-FEED

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

FOREST TREES (ALL OR UNSPECIFIED) Use Group: FORESTRY

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Backpack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Knapsack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Power sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., Low SC/L NA UC * NS NS NS NS NS NS C13

volume sprayer.

Basal bark treatment., When needed., Power SC/L NA UC * NS NS NS NS NS NS C13

sprayer.

INDUSTRIAL AREAS (OUTDOOR) Use Group: TERRESTRIAL NON-FOOD CROP

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Backpack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Knapsack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Power sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.
APPENDIX A ) CASE 0096, [Picloram] Chemical 005103 [Picloram, isooctyl ester] 

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:51 LUIS 1.5 ) Page 2

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

NON-FOOD/NON-FEED (con't)

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

INDUSTRIAL AREAS (OUTDOOR) (con't) Use Group: TERRESTRIAL NON-FOOD CROP (con't)

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., Low SC/L NA UC * NS NS NS NS NS NS C13

volume sprayer.

Basal bark treatment., When needed., Power SC/L NA UC * NS NS NS NS NS NS C13

sprayer.

NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS Use Group: TERRESTRIAL NON-FOOD CROP

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Backpack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Knapsack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Power sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., Low SC/L NA UC * NS NS NS NS NS NS C13

volume sprayer.

Basal bark treatment., When needed., Power SC/L NA UC * NS NS NS NS NS NS C13

sprayer.

NONAGRICULTURAL UNCULTIVATED AREAS/SOILS Use Group: TERRESTRIAL NON-FOOD CROP

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Backpack sprayer.

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Knapsack sprayer.
APPENDIX A ) CASE 0096, [Picloram] Chemical 005103 [Picloram, isooctyl ester] 

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:51 LUIS 1.5 ) Page 3

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

NON-FOOD/NON-FEED (con't)

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't) Use Group: TERRESTRIAL NON-FOOD CROP (con't)

Basal bark and soil treatment., When SC/L NA UC * NS NS NS NS NS NS C13

needed., Power sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., Not on label., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Backpack sprayer.

Basal bark treatment., When needed., SC/L NA UC * NS NS NS NS NS NS C13

Knapsack sprayer.

Basal bark treatment., When needed., Low SC/L NA UC * NS NS NS NS NS NS C13

volume sprayer.

Basal bark treatment., When needed., Power SC/L NA UC * NS NS NS NS NS NS C13

sprayer.
Date 08/04/94 ) Time 09:51 LUIS 1.5 ) Page 4

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LEGEND

444444

 HEADER ABBREVIATIONS

 Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.

 noted otherwise)

 Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.

 noted otherwise)

 Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).

 Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3 

 years" is expressed as "4/3 yr" 

 Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.

 noted otherwise)/A]

 Min. Interv (days) : Minimum Interval between Applications (days)

 Restr. Entry Interv (days) : Restricted Entry Interval (days)

 SOIL TEXTURE FOR MAX APP. RATE

 * : Non-specific

 C : Coarse

 M : Medium

 F : Fine

 O : Others

 FORMULATION CODES

 SC/L : SOLUBLE CONCENTRATE/LIQUID

 ABBREVIATIONS 

 AN : As Needed

 NA : Not Applicable

 NS : Not Specified (on label)

 UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet, 

 briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part, 

 parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, -- 

 

 APPLICATION RATE

 DCNC : Dosage Can Not be Calculated

 No Calc : No Calculation can be made

 W : PPM calculated by weight

 V : PPM Calculated by volume

 cwt : Hundred Weight

 nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"

 USE LIMITATIONS CODES

 C13 : Groundwater restriction.

 * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
APPENDIX A ) CASE 0096, [Picloram] Chemical 005104 [Picloram, potassium salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:53 LUIS 1.5 ) Page 1

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

FOOD/FEED USES

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

AGRICULTURAL FALLOW/IDLELAND Use Group: TERRESTRIAL FOOD+FEED CROP

Broadcast., Fallow., Aircraft. SC/L NA .25 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., Fallow., Low pressure ground. SC/L NA .25 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., Foliar., Aircraft. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., Foliar., Low pressure ground. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., Postharvest., Aircraft. SC/L NA .25 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., Postharvest., Low pressure SC/L NA .25 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

ground.

Spot treatment., Fallow., Sprayer. SC/L NA 1 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Spot treatment., Foliar., Sprayer. SC/L NA 2 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Spot treatment., Postharvest., Sprayer. SC/L NA 1 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Wipe-on/wiper treatment., Foliar., Wick SC/L NA UC * NS NS NS NS NS NS 011 C46, CAE

applicator.

BARLEY Use Group: TERRESTRIAL FOOD+FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .023 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), H01(50)

Broadcast., Foliar., Low pressure ground. SC/L NA .023 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), H01(50)

OATS Use Group: TERRESTRIAL FOOD+FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .375 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), H01(50)

Broadcast., Foliar., Low pressure ground. SC/L NA .375 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), H01(50)

PASTURES Use Group: TERRESTRIAL FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14)

 SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

Broadcast., Foliar., Low pressure ground. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14)

 SC/L NA .5 lb (AE) A * NS NS NS NS NS NS OK, NM, TX C13, C46
APPENDIX A ) CASE 0096, [Picloram] Chemical 005104 [Picloram, potassium salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:53 LUIS 1.5 ) Page 2

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

FOOD/FEED USES (con't)

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

PASTURES (con't) Use Group: TERRESTRIAL FEED CROP (con't)

Frill treatment., Foliar., Not on label. SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

 S09(14)

Girdle treatment., Foliar., Not on label. SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

 S09(14)

High volume spray (dilute)., Foliar., High SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

volume ground.

Spot soil treatment., Foliar., Not on label. SC/L NA UC * NS NS NS NS NS NS OK, TX NM C13, C46

Spot treatment., Foliar., Low pressure SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

ground. G83(14), S09(14)

Spot treatment., Foliar., Sprayer. SC/L NA 2 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), S09(3)

Tree injection treatment., Foliar., Tree SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

injection equipment. S09(14)

Wipe-on/wiper treatment., Foliar., Roller. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

Wipe-on/wiper treatment., Foliar., Wick SC/L NA UC * NS NS NS NS NS NS 011 C46, CAE, G01(14),

applicator. G83(14), S09(3)

RANGELAND Use Group: TERRESTRIAL FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), S09(3)

 SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

Broadcast., Foliar., Low pressure ground. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), S09(3)

 SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

Frill treatment., Foliar., Not on label. SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

 S09(14)

Girdle treatment., Foliar., Not on label. SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

 S09(14)

High volume spray (dilute)., Foliar., High SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

volume ground.

Spot soil treatment., Foliar., Not on label. SC/L NA UC * NS NS NS NS NS NS OK, TX NM C13, C46
APPENDIX A ) CASE 0096, [Picloram] Chemical 005104 [Picloram, potassium salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:53 LUIS 1.5 ) Page 3

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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

FOOD/FEED USES (con't)

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

RANGELAND (con't) Use Group: TERRESTRIAL FEED CROP (con't)

Spot treatment., Foliar., Low pressure SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

ground. S09(14)

Spot treatment., Foliar., Sprayer. SC/L NA 2 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), S09(3)

Tree injection treatment., Foliar., Tree SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

injection equipment. S09(14)

Wipe-on/wiper treatment., Foliar., Roller. SC/L NA .5 lb (AE) A * NS NS NS NS NS NS NM, OK, TX C13, C46

Wipe-on/wiper treatment., Foliar., Wick SC/L NA UC * NS NS NS NS NS NS 011 C46, CAE, G01(14),

applicator. G83(14), S09(3)

WHEAT Use Group: TERRESTRIAL FOOD+FEED CROP

Broadcast., Foliar., Aircraft. SC/L NA .375 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), H01(50)

Broadcast., Foliar., Low pressure ground. SC/L NA .375 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE, G01(14),

 G83(14), H01(50)

NON-FOOD/NON-FEED

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

FOREST PLANTINGS (REFORESTATION PROGRAMS) Use Group: FORESTRY

Broadcast., Foliar., Aircraft. SC/L NA 1.5 lb (AE) A * NS NS NS NS NS NS CAE

Broadcast., Foliar., Ground. SC/L NA 1.5 lb (AE) A * NS NS NS NS NS NS CAE

NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS Use Group: TERRESTRIAL NON-FOOD CROP

Broadcast., When needed., Aircraft. SC/L NA 1 lb (AE) A * NS NS NS NS NS NS CAE

 SC/L NA 1 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., When needed., Ground. SC/L NA 1 lb (AE) A * NS NS NS NS NS NS CAE

Broadcast., When needed., Low pressure SC/L NA 1 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

ground.

High volume spray (dilute)., When needed., SC/L NA 1 lb (AE) A * NS NS NS NS NS NS CAE

High volume ground.

Spot treatment., When needed., Sprayer. SC/L NA 1 lb (AE) A * NS NS NS NS NS NS CAE
APPENDIX A ) CASE 0096, [Picloram] Chemical 005104 [Picloram, potassium salt]

ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.

Date 08/04/94 ) Time 09:53 LUIS 1.5 ) Page 4

4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444

SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

THESE ARE CURRENT USES

NON-FOOD/NON-FEED (con't)

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS (con't) Use Group: TERRESTRIAL NON-FOOD CROP (con't)

 SC/L NA 2 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Wipe-on/wiper treatment., When needed., Wick SC/L NA UC * NS NS NS NS NS NS 011 C46, CAE

applicator.

NONAGRICULTURAL UNCULTIVATED AREAS/SOILS Use Group: TERRESTRIAL NON-FOOD CROP

Broadcast., When needed., Aircraft. SC/L NA 1 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Broadcast., When needed., Low pressure SC/L NA 1 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

ground.

Directed spray., When needed., Low pressure SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

ground. S09(14)

Frill treatment., When needed., Not on SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

label. S09(14)

Girdle treatment., When needed., Not on SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

label. S09(14)

Spot treatment., When needed., Sprayer. SC/L NA 2 lb (AE) A * NS NS NS NS NS NS 011 C46, CAE

Tree injection treatment., When needed., SC/L NA UC * NS NS NS NS NS NS HI C46, CAE, G01(14),

Tree injection equipment. S09(14)

Wipe-on/wiper treatment., When needed., Wick SC/L NA UC * NS NS NS NS NS NS 011 C46, CAE

applicator.
Date 08/04/94 ) Time 09:53 APPENDIX A ) CASE 0096, [Picloram] Chemical 005104 [Picloram, potassium salt] LUIS 1.5 ) Page 5

4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444

LEGEND

444444

 HEADER ABBREVIATIONS

 Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.

 noted otherwise)

 Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.

 noted otherwise)

 Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).

 Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3 

 years" is expressed as "4/3 yr" 

 Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.

 noted otherwise)/A]

 Min. Interv (days) : Minimum Interval between Applications (days)

 Restr. Entry Interv (days) : Restricted Entry Interval (days)

 SOIL TEXTURE FOR MAX APP. RATE

 * : Non-specific

 C : Coarse

 M : Medium

 F : Fine

 O : Others

 FORMULATION CODES

 SC/L : SOLUBLE CONCENTRATE/LIQUID

 ABBREVIATIONS 

 AN : As Needed

 NA : Not Applicable

 NS : Not Specified (on label)

 UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet, 

 briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part, 

 parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, -- 

 

 APPLICATION RATE

 DCNC : Dosage Can Not be Calculated

 No Calc : No Calculation can be made

 W : PPM calculated by weight

 V : PPM Calculated by volume

 cwt : Hundred Weight

 nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"

 USE LIMITATIONS CODES

 C13 : Groundwater restriction.

 C46 : Do not apply through any type of irrigation system.

 CAE : Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes).

 G01 : __ day(s) pregrazing interval.

 * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.

 GEOGRAPHIC CODES

 011 : West of the Mississippi River

 HI : Hawaii

 NM : New Mexico

 OK : Oklahoma

 TX : Texas
118
119

APPENDIX B. Table of the Generic Data Requirements

and Studies Used to Make the Reregistration Decision
120
121

GUIDE TO APPENDIX B

Appendix B contains listings of data requirements which support the reregistration for active

ingredients within the case 0096 covered by this Reregistration Eligibility Decision Document.

It contains generic data requirements that apply to 0096 in all products, including data

requirements for which a "typical formulation" is the test substance.

The data table is organized in the following format:

1. Data Requirement (Column 1). The data requirements are listed in the order in

which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer

to the test protocols set in the Pesticide Assessment Guidelines, which are available from the

National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)

487-4650.

2. Use Pattern (Column 2). This column indicates the use patterns for which the data

requirements apply. The following letter designations are used for the given use patterns:

A Terrestrial food

B Terrestrial feed

C Terrestrial non-food

D Aquatic food

E Aquatic non-food outdoor

F Aquatic non-food industrial

G Aquatic non-food residential

H Greenhouse food

I Greenhouse non-food

J Forestry

K Residential

L Indoor food

M Indoor non-food

N Indoor medical

O Indoor residential

3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,

this column lists the identifying number of each study. This normally is the Master Record

Identification (MRID) number, but may be a "GS" number if no MRID number has been

assigned. Refer to the Bibliography appendix for a complete citation of the study.
122
123

APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

PRODUCT CHEMISTRY

61-1 Chemical Identity All CSF, dated 11/02/93

61-2A Start. Mat. & Mnfg. Process All 41094901

61-2B Formation of Impurities All 41094901

62-1 Preliminary Analysis All 41094902

62-2 Certification of limits All CSF, dated 11/02/93

62-3 Analytical Method All 41094902

63-2 Color All 41094903

63-3 Physical State All 41094903

63-4 Odor All 41094903

63-5 Melting Point All 41094903

63-6 Boiling Point All N/A

63-7 Density All 41094903

63-8 Solubility All 41094903

63-9 Vapor Pressure All 41094903

63-10 Dissociation Constant All 41094903

63-11 Octanol/Water Partition All 41094903

63-12 pH All 41094903

63-13 Stability All 41094903
Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

124

ECOLOGICAL EFFECTS

71-1A/B Acute Avian Oral - Quail/Duck A,B,C,J 00261883, 00265983, 40054501, 00157173

71-2A Avian Dietary - Quail A,B,C,J 22923

71-2B Avian Dietary - Duck A,B,C,J 22923

72-1A Fish Toxicity Bluegill A,B,C,J 00129076, 00129078, 00112016

72-1C Fish Toxicity Rainbow Trout A,B,C,J 112016

72-2A Invertebrate Toxicity A,B,C,J 00129076, 00141979, 00151783, 40094602

72-3A Estuarine/Marine Toxicity - Fish A,B,C,J 00111560, 00129073

72-4A Early Life Stage Fish A,B,C,J 129085

72-4B Life Cycle Invertebrate A,B,C,J 151784

72-6 Aquatic Organism Accumulation A,B,C,J 128947

123-1A Seed Germination/Seedling

Emergence

A,B,C,J See Potassium Salt 

123-1B Vegetative Vigor A,B,C,J See Potassium Salt 

123-2 Aquatic Plant Growth A,B,C,J See Potassium Salt

141-1 Honey Bee Acute Contact A,B,C,J 36935

TOXICOLOGY

81-1 Acute Oral Toxicity - Rat A,B,C,J 40479413

81-2 Acute Dermal Toxicity - Rabbit/Rat A,B,C,J 40479414

81-3 Acute Inhalation Toxicity - Rat A,B,C,J 40479415

81-4 Primary Eye Irritation - Rabbit A,B,C,J 40479416
Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

125

81-5 Primary Dermal Irritation - Rabbit A,B,C,J 40479417

81-6 Dermal Sensitization - Guinea Pig A,B,C,J 40479418

82-1A 90-Day Feeding - Rodent A,B,C,J 110537

82-1B 90-Day Feeding - Non-rodent A,B,C,J 110534

82-2 21-Day Dermal - Rabbit/Rat A,B,C,J 41384901

83-1A Chronic Feeding Toxicity - Rodent A,B,C,J 00155940, 42619302

83-1B Chronic Feeding Toxicity - NonRodent

A,B,C,J 40834301

83-2A Oncogenicity - Rat A,B,C,J 00155940, 42619302

83-2B Oncogenicity - Mouse A,B,C,J 42619301

83-3A Developmental Toxicity - Rat A,B,C,J 41382502

83-3B Developmental Toxicity - Rabbit A,B,C,J 41069501

83-4 2-Generation Reproduction - Rat A,B,C,J 42078701

84-2A Gene Mutation (Ames Test) A,B,C,J 41485902

84-2B Structural Chromosomal Aberration A,B,C,J 40072601, 00098322

84-4 Other Genotoxic Effects A,B,C,J 41549701

85-1 General Metabolism A,B,C,J 41209602, 00098321
Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

126

ENVIRONMENTAL FATE

161-1 Hydrolysis A,B,C,J 164749

161-2 Photodegradation - Water A,B,C,J 00164943, 41092501

161-3 Photodegradation - Soil A,B,C,J 41260101

162-1 Aerobic Soil Metabolism A,B,C,J 128976

162-2 Anaerobic Soil Metabolism A,B,C 128976

162-3 Anaerobic Aquatic Metabolism A,B,C,J 128976

163-1 Leaching/Adsorption/Desorption A,B,C,J 00111473, 41209601

163-2 Volatility - Lab A,B Waived

163-3 Volatility - Field A,B Waived

164-1 Terrestrial Field Dissipation A,B,C 42579002, 42579001, 42535302, 42448302

164-3 Forest Field Dissipation J 42579003, 41395301

164-5 Long Term Soil Dissipation A,B,C,J Reserved

165-1 Confined Rotational Crop A,B,C 42641801

165-2 Field Rotational Crop A,B,C Reserved

165-4 Bioaccumulation in Fish A,B,C,J 128947

165-5 Bioaccumulation - Aquatic NonTarget A,B,C,J Reserved

166-1 Ground Water - Small Prospective A,B,C,J Reserved

166-2 Ground Water - Small Retrospective A,B,C,J Reserved

201-1 Droplet Size Spectrum A,B,C,J DATA GAP

202-1 Drift Field Evaluation A,B,C,J DATA GAP
Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

127

RESIDUE CHEMISTRY

171-4A Nature of Residue - Plants A,B 00037880, 00041136, 00059411, 00111527,

00157171, 42579004

171-4B Nature of Residue - Livestock A,B 00023105, 00041125, 00161306, 00163216,

42535301

171-4C/D Residue Analytical Method - Plants

and Animals

A,B 00026748, 00026749, 00026750, 00026751,

00026752, 00026753, 00027288, 00035959,

00045363, 00045366, 00045373, 00045374,

00045375, 00045376, 00045409, 00062818,

00069973, 00073972, 00073974, 00078483,

00085060, 00111404, 00111407, 00131364,

00132986, 00156366, 42380201

171-4E Storage Stability A,B 00164725, 40082701, 40435601, 40731901,

41442301, 41976701, 42494001

171-4J Magnitude of Residues -

Meat/Milk/Poultry/Egg

A,B 00045374, 00045376, 00073973, 00045372,

00073921, 00035959
Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

128

171-4K Crop Field Trials:

Barley grain

Oat grain

Wheat grain

Barley forage and straw

Oat forage and straw

Wheat forage and straw

Grass forage

Flax seed

Flax straw

A,B 00036168, 00036170, 00036171, 00045369,

A,B 00036168, 00036170, 00036171, 00045369,

A,B 00036168, 00036170, 00036171, 00045369,

B 00036168, 00036170, 00036171, 00128714,

B 00036168, 00036170, 00036171, 00128714,

B 00036168, 00036170, 00036171, 00128714,

B 00108862, 00108864, 00111404, 00111470,

B

B

00128714, 42380201

00128714, 42380201

00128714, 42380201

42380201

42380201

42380201

00111482, 00111557, 00128714, 00156366,

41905401, 42037601, 42784401

00026753, 00085060

00026753, 00085060
Data Supporting Guideline Requirements for the Reregistration of Picloram Acid (005101)

REQUIREMENT USE PATTERN CITATION(S)

129

171-4L Processed Food:

Wheat A 42535303
130
131

APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of Triisopropanolamine Picloram

(005102)

REQUIREMENT USE PATTERN CITATION(S)

PRODUCT CHEMISTRY

61-1 Chemical Identity All N/A

61-2A Start. Mat. & Mnfg. Process All 41594601

61-2B Formation of Impurities All 43065001, 41594601

62-1 Preliminary Analysis All 43065001, 41594602

62-2 Certification of limits All N/A

62-3 Analytical Method All N/A

63-2 Color All 42840803

63-3 Physical State All 42840803

63-4 Odor All 42840803

63-5 Melting Point All 42840803

63-6 Boiling Point All N/A

63-7 Density All 42840803

63-8 Solubility All 43307401, 43027801

63-9 Vapor Pressure All Letter (1993) from G. Murphy, DowElano

63-10 Dissociation Constant All 42840809

63-11 Octanol/Water Partition All 43065001

63-12 pH All 42840803

63-13 Stability All 42840803
Data Supporting Guideline Requirements for the Reregistration of Triisopropanolamine Picloram

(005102)

REQUIREMENT USE PATTERN CITATION(S)

132

ECOLOGICAL EFFECTS

72-3D Estuarine/Marine Toxicity Fish- DATA GAP

TEP

A,B,C,J

72-4A Early Life Stage Fish A,B,C,J DATA GAP 

123-1A Seed Germination/Seedling 41296501, 43276601, DATA GAP

Emergence

A,B,C,J

123-1B Vegetative Vigor A,B,C,J 41296501, 43276601, DATA GAP

123-2 Aquatic Plant Growth A,B,C,J 41407701, DATA GAP

141-1 Honey Bee Acute Contact A,B,C,J 41366901

TOXICOLOGY

81-1 Acute Oral Toxicity - Rat A,B,C,J 41381201

81-2 Acute Dermal Toxicity -

Rabbit/Rat

A,B,C,J 41381203

81-4 Primary Eye Irritation - Rabbit A,B,C,J 41381204

81-5 Primary Dermal Irritation - Rabbit A,B,C,J 41381205

81-6 Dermal Sensitization - Guinea Pig A,B,C,J 41381206

82-1A 90-Day Feeding - Rodent A,B,C,J 41442701

82-1B 90-Day Feeding - Non-rodent A,B,C,J Waived

82-2 21-Day Dermal - Rabbit/Rat A,B,C,J 41384902

83-1A Chronic Feeding Toxicity - Rodent A,B,C,J 41442701
Data Supporting Guideline Requirements for the Reregistration of Triisopropanolamine Picloram

(005102)

REQUIREMENT USE PATTERN CITATION(S)

133

83-1B Chronic Feeding Toxicity - NonRodent

A,B,C,J Reserved

83-2A Oncogenicity - Rat A,B,C,J Reserved

83-2B Oncogenicity - Mouse A,B,C,J Reserved

83-3A Developmental Toxicity - Rat A,B,C,J 41382504

83-3B Developmental Toxicity - Rabbit A,B,C,J 42460901

83-4 2-Generation Reproduction - Rat A,B,C,J Reserved

84-2A Gene Mutation (Ames Test) A,B,C,J 41485901

84-2B Structural Chromosomal

Aberration

A,B,C,J 41539701

84-4 Other Genotoxic Effects A,B,C,J 41539702

85-1 General Metabolism A,B,C,J 42343101

ENVIRONMENTAL FATE

161-1 Hydrolysis A,B,C,J See Picloram Acid

161-2 Photodegradation - Water A,B,C,J See Picloram Acid

161-3 Photodegradation - Soil A,B,C,J See Picloram Acid

162-1 Aerobic Soil Metabolism A,B,C,J See Picloram Acid

162-2 Anaerobic Soil Metabolism A,B,C See Picloram Acid

162-3 Anaerobic Aquatic Metabolism A,B,C,J See Picloram Acid

163-1 Leaching/Adsorption/Desorption A,B,C,J See Picloram Acid

163-2 Volatility - Lab A,B Waived
Data Supporting Guideline Requirements for the Reregistration of Triisopropanolamine Picloram

(005102)

REQUIREMENT USE PATTERN CITATION(S)

134

163-3 Volatility - Field A,B Waived

164-1 Terrestrial Field Dissipation A,B,C,J See Picloram Acid

164-3 Forest Field Dissipation J See Picloram Acid

164-5 Long Term Soil Dissipation A,B,C,J Reserved

165-1 Confined Rotational Crop A,B,C See Picloram Acid

165-2 Field Rotational Crop A,B,C Reserved

165-4 Bioaccumulation in Fish A,B,C,J See Picloram Acid

165-5 Bioaccumulation - Aquatic

NonTarget

A,B,C,J Reserved

166-1 Ground Water - Small Prospective A,B,C,J Reserved

166-2 Ground Water - Small

Retrospective

A,B,C,J Reserved

166-3 Ground Water - Irrigated

Retrospective

Not Applicable

201-1 Droplet Size Spectrum A,B,C,J DATA GAP

202-1 Drift Field Evaluation A,B,C,J DATA GAP

RESIDUE CHEMISTRY

171-4A Nature of Residue - Plants A,B See Picloram Acid

171-4B Nature of Residue - Livestock A,B See Picloram Acid

171-4C Residue Analytical Method - Plants A,B See Picloram Acid

171-4D Residue Analytical Method -

Animal

A,B See Picloram Acid
Data Supporting Guideline Requirements for the Reregistration of Triisopropanolamine Picloram

(005102)

REQUIREMENT USE PATTERN CITATION(S)

135

171-4E Storage Stability A,B See Picloram Acid

171-4J Magnitude of Residues -

Meat/Milk/Poultry/Egg

A,B See Picloram Acid

171-4K Crop Field Trials A,B See Picloram Acid

171-4L Processed Food A,B See Picloram Acid
136
137

APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of Isooctyl Picloram (005103)

REQUIREMENT USE PATTERN CITATION(S)

PRODUCT CHEMISTRY

61-1 Chemical Identity All N/A

61-2A Start. Mat. & Mnfg. Process All 41094904

61-2B Formation of Impurities All 41094904

62-1 Preliminary Analysis All 42840811

62-2 Certification of limits All N/A

62-3 Analytical Method All N/A

63-2 Color All 42840804

63-3 Physical State All 42840804

63-4 Odor All 42840804

63-5 Melting Point All 42840804

63-6 Boiling Point All N/A

63-7 Density All 42840804

63-8 Solubility All 42840808, 42840810

63-9 Vapor Pressure All 42840806

63-10 Dissociation Constant All N/A

63-11 Octanol/Water Partition All 42840807

63-12 pH All N/A

63-13 Stability All 42840804

ECOLOGICAL EFFECTS
Data Supporting Guideline Requirements for the Reregistration of Isooctyl Picloram (005103)

REQUIREMENT USE PATTERN CITATION(S)

138

71-2A Avian Dietary - Quail C,J 00265982, 00164726

72-1A Fish Toxicity Bluegill C,J 40094602

72-1B Fish Toxicity Bluegill - TEP C,J DATA GAP

72-1D Fish Toxicity Rainbow Trout- TEP C,J DATA GAP

72-2B Invertebrate Toxicity - TEP C,J DATA GAP

72-3D Estuarine/Marine Toxicity Fish- DATA GAP

TEP

C,J

72-3E Estuarine/Marine Toxicity Mollusk DATA GAP

- TEP

C,J

72-3F Estuarine/Marine Toxicity Shrimp DATA GAP

- TEP

C,J

72-4A Early Life Stage Fish C,J DATA GAP

123-1A Seed Germination/Seedling 41296501, 43276601, DATA GAP

Emergence

C,J

123-1B Vegetative Vigor C,J 41296501, 43276601, DATA GAP

123-2 Aquatic Plant Growth C,J 42645901, DATA GAP

141-1 Honey Bee Acute Contact C,J 42121107, 42625901

TOXICOLOGY

81-1 Acute Oral Toxicity - Rat C,J 40479407

81-2 Acute Dermal Toxicity -

Rabbit/Rat

C,J 40479408

81-3 Acute Inhalation Toxicity - Rat C,J 40479409

81-4 Primary Eye Irritation - Rabbit C,J 40479410
Data Supporting Guideline Requirements for the Reregistration of Isooctyl Picloram (005103)

REQUIREMENT USE PATTERN CITATION(S)

139

81-5 Primary Dermal Irritation - Rabbit C,J 40479411

81-6 Dermal Sensitization - Guinea Pig C,J 40479412

82-1A 90-Day Feeding - Rodent C,J 42297001

82-1B 90-Day Feeding - Non-rodent C,J Waived

82-2 21-Day Dermal - Rabbit/Rat C,J 42171601, 42870701

83-1A Chronic Feeding Toxicity - Rodent C,J Reserved

83-1B Chronic Feeding Toxicity - 

Non-Rodent

C,J Reserved

83-2A Oncogenicity - Rat C,J Reserved

83-2B Oncogenicity - Mouse C,J Reserved

83-3A Developmental Toxicity - Rat C,J 42121102, 42296901

83-3B Developmental Toxicity - Rabbit C,J 42121103, 42121104

83-4 2-Generation Reproduction - Rat C,J Reserved

84-2A Gene Mutation (Ames Test) C,J 42121106

84-2B Structural Chromosomal

Aberration

C,J 42171602

84-4 Other Genotoxic Effects C,J 42414001

85-1 General Metabolism C,J 42171603

OCCUPATIONAL/RESIDENTIAL EXPOSURE

231 Estimation of Dermal Exposure at DATA GAP

Outdoor Sites

C,J
Data Supporting Guideline Requirements for the Reregistration of Isooctyl Picloram (005103)

REQUIREMENT USE PATTERN CITATION(S)

140

232 Estimation of Inhalation Exposure DATA GAP

at Outdoor Sites

C,J

ENVIRONMENTAL FATE

161-1 Hydrolysis C,J 131365

161-2 Photodegradation - Water C,J 42811901

161-3 Photodegradation - Soil C,J See Picloram Acid

162-1 Aerobic Soil Metabolism C,J 40178601

162-2 Anaerobic Soil Metabolism C See Picloram Acid

162-3 Anaerobic Aquatic Metabolism C,J Waived

163-1 Leaching/Adsorption/Desorption C,J See Picloram Acid

163-2 Volatility - Lab C,J Waived

163-3 Volatility - Field C,J Waived

164-1 Terrestrial Field Dissipation C See Picloram Acid

164-2 Aquatic Field Dissipation C,J Not Applicable

164-3 Forest Field Dissipation J See Picloram Acid

164-5 Long Term Soil Dissipation C,J Reserved

165-3 Accumulation - Irrigated Crop C,J Not Applicable

165-4 Bioaccumulation in Fish C,J 42121108

165-5 Bioaccumulation - Aquatic

NonTarget

C,J Reserved

166-1 Ground Water - Small Prospective C,J Reserved
Data Supporting Guideline Requirements for the Reregistration of Isooctyl Picloram (005103)

REQUIREMENT USE PATTERN CITATION(S)

141

166-2 Ground Water - Small

Retrospective

C,J Reserved

201-1 Droplet Size Spectrum C,J DATA GAP

202-1 Drift Field Evaluation C,J DATA GAP
142
143

APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of Potassium Picloram (005104)

REQUIREMENT USE PATTERN CITATION(S)

PRODUCT CHEMISTRY

61-1 Chemical Identity All 41094907, CSF dated 12-2-94

61-2A Start. Mat. & Mnfg. Process All 41094907

61-2B Formation of Impurities All 41094907, CSF dated 12-2-94

62-1 Preliminary Analysis All 41094908, 43065001 

62-2 Certification of limits All 41094908

62-3 Analytical Method All 41094908

63-2 Color All 42840801

63-3 Physical State All 42840801

63-4 Odor All 42840801

63-5 Melting Point All 42840801

63-6 Boiling Point All N/A 

63-7 Density All 42840801

63-8 Solubility All 42978101

63-9 Vapor Pressure All Letter (1993) from G. Murphy, DowElanco

63-10 Dissociation Constant All 42840809

63-11 Octanol/Water Partition All 43065001

63-12 pH All 42840801

63-13 Stability All 42840801
Data Supporting Guideline Requirements for the Reregistration of Potassium Picloram (005104)

REQUIREMENT USE PATTERN CITATION(S)

144

ECOLOGICAL EFFECTS

71-1A/B Acute Avian Oral - Quail/Duck A,B,C,J 00157174, 00164726, 00164727

71-2A Avian Dietary - Quail A,B,C,J 164727

71-2B Avian Dietary - Duck A,B,C,J See Picloram Acid

72-1A Fish Toxicity Bluegill A,B,C,J 00129063, 00041475

72-1C Fish Toxicity Rainbow Trout A,B,C,J 00129063, 00041475

72-2A Invertebrate Toxicity A,B,C,J 151783

72-3D Estuarine/Marine Toxicity Fish- DATA GAP

TEP

A,B,C,J

72-4A Early Life Stage Fish A,B,C,J 151784

72-4B Life Cycle Invertebrate A,B,C,J 151783

123-1A Seed Germination/Seedling 43276601, DATA GAP

Emergence

A,B,C,J

123-1B Vegetative Vigor A,B,C,J 43276601, DATA GAP

123-2 Aquatic Plant Growth A,B,C,J 41407702, DATA GAP

141-1 Honey Bee Acute Contact A,B,C,J 41366902

TOXICOLOGY

81-1 Acute Oral Toxicity - Rat A,B,C,J 40479401

81-2 Acute Dermal Toxicity -

Rabbit/Rat

A,B,C,J 40479402

81-3 Acute Inhalation Toxicity - Rat A,B,C,J 40479403
Data Supporting Guideline Requirements for the Reregistration of Potassium Picloram (005104)

REQUIREMENT USE PATTERN CITATION(S)

145

81-4 Primary Eye Irritation - Rabbit A,B,C,J 40479404

81-5 Primary Dermal Irritation - Rabbit A,B,C,J 40479405

81-6 Dermal Sensitization - Guinea Pig A,B,C,J 40479406

81-7 Acute Delayed Neurotoxicity - Hen A,B,C,J Not Required

82-1A 90-Day Feeding - Rodent A,B,C,J 110537

82-1B 90-Day Feeding - Non-rodent A,B,C,J 110534

82-2 21-Day Dermal - Rabbit/Rat A,B,C,J 41384901

82-3 90-Day Dermal - Rodent A,B,C,J Not Required

82-4 90-Day Inhalation - Rat A,B,C,J Not Required

82-5A 90-Day Neurotoxicity - Hen A,B,C,J Not Required

82-5B 90-Day Neurotoxicity - Mammal A,B,C,J Not Required

83-1A Chronic Feeding Toxicity - Rodent A,B,C,J 155940

83-1B Chronic Feeding Toxicity - 

Non-Rodent

A,B,C,J 40834301

83-2A Oncogenicity - Rat A,B,C,J 42619302

83-2B Oncogenicity - Mouse A,B,C,J 42619301

83-3A Developmental Toxicity - Rat A,B,C,J 41382501, 41382502

83-3B Developmental Toxicity - Rabbit A,B,C,J 41069501

83-4 2-Generation Reproduction - Rat A,B,C,J 42078701

84-2A Gene Mutation (Ames Test) A,B,C,J 41485902

84-2B Structural Chromosomal

Aberration

A,B,C,J 98322
Data Supporting Guideline Requirements for the Reregistration of Potassium Picloram (005104)

REQUIREMENT USE PATTERN CITATION(S)

146

84-4 Other Genotoxic Effects A,B,C,J 41549701

85-1 General Metabolism A,B,C,J 00098321, 41209602

OCCUPATIONAL/RESIDENTIAL EXPOSURE

231 Estimation of Dermal Exposure at DATA GAP

Outdoor Sites

A,B,C,J

232 Estimation of Inhalation Exposure DATA GAP

at Outdoor Sites

A,B,C,J

ENVIRONMENTAL FATE

161-1 Hydrolysis A,B,C,J See Picloram Acid

161-2 Photodegradation - Water A,B,C,J Waived, see Picloram Acid

161-3 Photodegradation - Soil A,B,C,J Waived, see Picloram Acid

162-1 Aerobic Soil Metabolism A,B,C,J See Picloram Acid

162-2 Anaerobic Soil Metabolism A,B,C See Picloram Acid

162-3 Anaerobic Aquatic Metabolism A,B,C,J See Picloram Acid

163-1 Leaching/Adsorption/Desorption A,B,C,J See Picloram Acid

163-2 Volatility - Lab A,B Waived

163-3 Volatility - Field A,B Waived

164-1 Terrestrial Field Dissipation A,B,C,J See Picloram Acid

164-3 Forest Field Dissipation J See Picloram Acid

164-5 Long Term Soil Dissipation A,B,C,J Reserved

165-1 Confined Rotational Crop A,B,C See Picloram Acid

165-4 Bioaccumulation in Fish A,B,C,J See Picloram Acid
Data Supporting Guideline Requirements for the Reregistration of Potassium Picloram (005104)

REQUIREMENT USE PATTERN CITATION(S)

147

165-5 Bioaccumulation - Aquatic

NonTarget

A,B,C,J Reserved

166-1 Ground Water - Small Prospective A,B,C,J Reserved

166-2 Ground Water - Small

Retrospective

A,B,C,J Reserved

201-1 Droplet Size Spectrum A,B,C,J Data Gap

202-1 Drift Field Evaluation A,B,C,J Data Gap

RESIDUE CHEMISTRY

171-4A Nature of Residue - Plants A,B See Picloram Acid

171-4B Nature of Residue - Livestock A,B See Picloram Acid

171-4C Residue Analytical Method - Plants A,B See Picloram Acid

171-4D Residue Analytical Method -

Animal

A,B See Picloram Acid

171-4E Storage Stability A,B See Picloram Acid

171-4J Magnitude of Residues -

Meat/Milk/Poultry/Egg

A,B See Picloram Acid

171-4K Crop Field Trials A,B See Picloram Acid

171-4L Processed Food A,B See Picloram Acid
148
149

APPENDIX C. Citations Considered to be Part of the Data

Base Supporting the Reregistration of Picloram
150
151

GUIDE TO APPENDIX C

1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies

considered relevant by EPA in arriving at the positions and conclusions stated

elsewhere in the Reregistration Eligibility Document. Primary sources for studies in

this bibliography have been the body of data submitted to EPA and its predecessor

agencies in support of past regulatory decisions. Selections from other sources

including the published literature, in those instances where they have been considered,

are included.

2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the

case of published materials, this corresponds closely to an article. In the case of

unpublished materials submitted to the Agency, the Agency has sought to identify

documents at a level parallel to the published article from within the typically larger

volumes in which they were submitted. The resulting "studies" generally have a

distinct title (or at least a single subject), can stand alone for purposes of review and

can be described with a conventional bibliographic citation. The Agency has also

attempted to unite basic documents and commentaries upon them, treating them as a

single study.

3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted

numerically by Master Record Identifier, or "MRID number". This number is unique

to the citation, and should be used whenever a specific reference is required. It is not

related to the six-digit "Accession Number" which has been used to identify volumes of

submitted studies (see paragraph 4(d)(4) below for further explanation). In a few

cases, entries added to the bibliography late in the review may be preceded by a nine

character temporary identifier. These entries are listed after all MRID entries. This

temporary identifying number is also to be used whenever specific reference is needed.

4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry

consists of a citation containing standard elements followed, in the case of material

submitted to EPA, by a description of the earliest known submission. Bibliographic

conventions used reflect the standard of the American National Standards Institute

(ANSI), expanded to provide for certain special needs.

a Author. Whenever the author could confidently be identified, the Agency has

chosen to show a personal author. When no individual was identified, the

Agency has shown an identifiable laboratory or testing facility as the author. 

When no author or laboratory could be identified, the Agency has shown the

first submitter as the author.

b. Document date. The date of the study is taken directly from the document. 

When the date is followed by a question mark, the bibliographer has deduced

the date from the evidence contained in the document. When the date appears
152

as (19??), the Agency was unable to determine or estimate the date of the

document.

c. Title. In some cases, it has been necessary for the Agency bibliographers to

create or enhance a document title. Any such editorial insertions are contained

between square brackets.

d. Trailing parentheses. For studies submitted to the Agency in the past, the

trailing parentheses include (in addition to any self-explanatory text) the

following elements describing the earliest known submission:

(1) Submission date. The date of the earliest known submission appears

immediately following the word "received."

(2) Administrative number. The next element immediately following the

word "under" is the registration number, experimental use permit

number, petition number, or other administrative number associated

with the earliest known submission.

(3) Submitter. The third element is the submitter. When authorship is

defaulted to the submitter, this element is omitted.

(4) Volume Identification (Accession Numbers). The final element in the

trailing parentheses identifies the EPA accession number of the volume

in which the original submission of the study appears. The six-digit

accession number follows the symbol "CDL," which stands for

"Company Data Library." This accession number is in turn followed by

an alphabetic suffix which shows the relative position of the study within

the volume.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Picloram Acid - 005101

153

------------ D. Turnbull and J.V. Rodricks (1985): Assessment of Possible Carcinogenic

Risk to Humans Resulting from Exposure to Di(2-ethylhexyl)phthalate (DEHP).

J. Am. Coll. Toxicol., 4(2), pp.111-145.

------------- National Toxicology Program (1982): NTP Technical Report on the

carcinogenesis bioassay of di(2-ethylhexyl)phthalate (CAS No. 117-81-7) in

F344 rats and B6C3F1 mice (feed study) NIH Pub. No. 82-1773.

00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities

of Environmental Pollutants to Birds: Special Scientific Report--Wildlife No.

191. (U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife

Research Center; unpublished report) 00023105 Fisher, D.E.; St. John, L.E.,

Jr.; Guntenman, W.E.; et al. (1965) Fate of Banvel T, Ioxynil, Tordon and

Trifluorilin in the dairy cow. Journal of Dairy Science 48(12):1711-1715. 

(Also In unpublished submission received Apr 8, 1976 under 876-203;

submitted by Velsicol Chemical Corp., Chicago, Ill.; CDL:235226-Y)

00026748 Leahy, J.S.; Taylor, T. (1966) Residues of Tordon in Treated Grain. 

Undated method 1556/66/85. (Unpublished study received Nov 21, 1967 under

8F0660; prepared by Huntingdon Research Centre, submitted by Dow Chemical

U.S.A., Midland, Mich.; CDL:091151-I)00026749 Dow Chemical Company

(19??) Analytical Methods for Residues in Grain and Straw. Summary of

studies 091151-I and 091151-K through 091151-O. (Unpublished study

received Nov 21, 1967 un- der 8F0660; CDL:09151-J)

00026750 Dow Chemical Company (1966) Determination of Residues of Tordon Acid in

Wheat Grain by Gas Chromatography. Method ACR 65.3R dated Feb 4, 1966. 

(Unpublished study received Nov 21, 1967 under 8F0660; CDL:091151-K)

00026751 Dow Chemical Company (1965) Gas Chromatographic Method for the

Determination of Residues of Tordon Acid in Wheat Straw. Method ACR

65.4R dated Nov 15, 1965. (Unpublished study received Nov 21, 1967 under

8F0660; CDL:091151-L)

00026752 Dow Chemical Company (1966) Determination of Residues of Tordon 

Acid in Wheat Straw by Gas Chromatography. Method ACR 66.5 dated May

6, 1966. (Unpublished study received Nov 21, 1967 under 8F0660;

CDL:091151-M)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Picloram Acid - 005101

154

00026753 Leahy, J.S.; Taylor, T. (1967) A gas-chromatographic determination of

residues in Picloram. Analyst 92(?/Jun):371-374. (Also In unpublished

submission received Nov 21, 1967 under 8F0660; submitted by Dow Chemical

U.S.A., Midland, Mich.; CDL:091151-O)

00027288 Dow Chemical Company (1967) Determination of Residues of Tordon Acid in

Barley Straw by Gas Chromatography. Method ACR 67.4 dated Jul 7, 1967. 

(Unpublished study received Nov 21, 1967 under 8F0660; CDL:091151-N)

00035959 Riley, V.; Kutschinski, A.H. (1967) Residues of Tordon acid in Eggs and

Tissues from Chickens Fed the Herbicide. (Unpublished study received Jul 3,

1975 under 6F1653; submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:094501-E)

00036168 Bjerke, E.L.; Ervick, D.K.; Stymiest, C.; et al. (1973) A Residue Study of the

Disappearance of Picloram and 2,4-Dichlorophenoxyacetic acid in Small Grain

following Application of Tordon Her- bicide: GH-C 683. (Unpublished study

received Jul 3, 1975 under 6F1653; prepared in cooperation with South Dakota

State Univ and others, submitted by Dow Chemical Co., Indianapolis, Ind.; 

CDL:094498-C)

00036170 Southwick, L.; Behrens, R.; Hartman, G.P. (1975) A Residue Study of

Picloram and 2,4-Dichlorophenoxyacetic acid in Wheat following One, Two

and Three Years Use of Picloram and 2,4-D (Tordon(R) 202 Mixture):

GHP-913. (Unpublished study received Jul 3, 1975 under 6F1653; prepared in

cooperation with Univ. of Minnesota and Univ. of Montana, submitted by Dow

Chemical Co., Indianapolis, Ind.; CDL:094498-E)

00036171 Bjerke, E.L.; Dietrich, I.; Baker, L.O.; et al. (1975) A Residue Study of

Picloram and 2,4-D in Wheat and Barley following Postemergence Application

of Tordon 22K Weed Killer plus Formula 40 Herbicide: GH-C 821. 

(Unpublished study received Jul 3, 1975 under 6F1653; prepared in

cooperation with Univ. of Montana and Montana State Univ., submitted by

Dow Chemical Co., Indianapolis, Ind.; CDL:094498-F)

00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of 

Pesticides and Other Agricultural Chemicals to Honey Bees: Laboratory

Studies. By University of California, Dept. of Entomology. ?: UC,

Cooperative Extension. (Leaflet 2287; published study.)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Picloram Acid - 005101

155

00037880 Meikle, R.W.; Williams, E.A.; Redemann, C.T. (1966) Metabolism of 

Tordon herbicide (4-Amino-3,5,6-trichloropicolinic acid) in cotton and

decomposition in soil. Journal of Agricultural and Food Chemistry

14(4):384-387. (Also In unpublished submission received Jun 6, 1973 under

2F1265; submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:092164-N)

00041125 Dow Chemical Company (1964) A Residue Study on Tissues from Beef Cattle

Fed Diets Containing Tordon Herbicide. (Unpublished study received Nov 6,

1967 under 0F0863; CDL:094525-AJ)

00041136 Bauriedel, W.R.; Neipert, N. (1965) The Fate of Labeled 14C-Triisopropanol

amine Applied to Spring Wheat, (Unpublished study re- ceived Nov 6, 1967

under 0F0863; submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:094525-AX)

00045363 Swann, R.L.; Pettyjohn, M.A.; Bjerke, E.L. (1972) Determination of Residues

of Picloram in Wheat, Barley and Oat Green Forage, Grain and Straw by Gas

Chromatography. Method ACR 72.7 dated May 12, 1972. (Unpublished

study received Jul 3, 1975 under 6F1653; prepared in cooperation with

International Research and Development Corp., submitted by Dow Chemical

U.S.A., Midland, Mich.; CDL:094500-A)

00045366 Bjerke, E.L. (1973) Determination of Residues of Picloram in Soil by Gas

Chromatography. Method ACR 73.3 dated May 21, 1973 (Unpublished study

received Jul 3, 1975 under 6F1653; submitted by Dow Chemical U.S.A.,

Midland, Mich.; CDL:094500-D)

00045369 Bjerke, E.L.; Ervick, D.K. (1975) A Residue Study of Picloram and 2,4-D in

Milled Wheat Fractions: GH-C 798. (Unpublished study received Jul 3, 1975

under 6F1653; submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:094501-B)

00045372 Kutschinski, A.H.; Stevenson, G.T. (1967) Residues of Tordon acid in Milk

from Cows Fed the Herbicide. (Unpublished study including experiment no.

3-1400-5, received Jul 3, 1975 under 6F1653; submitted by Dow Chemical

U.S.A., Midland, Mich.; CDL:094501-F)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Picloram Acid - 005101

156

00045373 Dow Chemical U.S.A. (1967) Determination of Residues of Tordon acid in

Milk by Gas Chromatography. Method ACR 67.3 dated Jun 22, 1967. 

(Unpublished study received Jul 3, 1975 under 6F1653; CDL:094501-G)

00045374 Kutschinski, A.H.; Riley, V. (1967) Residues of Tordon acid in Tissues from

Steers Fed the Herbicide. (Unpublished study received Jul 3, 1975 under

6F1653; submitted by Dow Chemical U.S.A., Mid- land, Mich.;

CDL:094501-H)

00045375 Dow Chemical U.S.A. (1967) Determination of Residues of Tordon acid 

in Bovine Tissues by Gas Chromatography. Method ACR 67.2 dated Jun 21,

1967. (Unpublished study received Jul 3, 1975 under 6F1653; CDL:094501-I)

00045376 Bjerke, E.L.; Riley, V.; Bucek, O.C.; et al. (1969) Residues of Picloram in

Sheep Tissues. (Unpublished study received Jul 3, 1975 under 6F1653;

submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:094501-J)

00045409 Dow Chemical Company (1966) Determination of Residues of Tordon acid in

Grass by Gas Chromatography. Analytical method ACR 66.7 dated Jul 11,

1966. (Unpublished study received Aug 4, 1969 under 0F0863;

CDL:093160-G)

00059411 Redemann, C.T.; Meikle, R.W.; Hamilton, P.; et al. (1968) The fate of

4-Amino-3,5,6-trichloropicolinic acid in spring wheat and soil. Bulletin of

Environmental Contamination & Toxicology 3 (2):80-96. (Also In

unpublished submission received Sep 26, 1974 under 464-323; submitted by

Dow Chemical U.S.A., Midland, Mich.; CDL:120353-B)

00062818 (1980) Determination of Residues of 3,6-Dichloropicolinic acid and Picloram in

Grass by Electron Capture Gas Chromatography. Method ACR 80.8 dated Jul

24, 1980. (Unpublished study received Nov 28, 1980 under 464-EX-67;

submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:099796-Q)

00069973 Dow Chemical Company (1964) Determination of Tordon Residues in Water

and Blood by Gas Chromatography. Tentative residue determination method

ACR 64.6 dated Nov 18, 1964. (Unpublished study received on unknown date

under unknown admin. no.; CDL: 130992-J)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Picloram Acid - 005101

157

00073921 Higham, J.W. (1973) Cycocel(R): Cycocel Residues in Affined Raw Sugar

(Ewa and Hilo, Hawaii): Report No. C-370. Includes methods M-369 and

M-440. (Unpublished study received Jan 28, 1974 under 4G1461; submitted

by American Cyanamid Co., Prince- ton, N.J.; CDL:093894-R)

00073972 Dow Chemical Company (1967) Residue Determination Method: Determination

of Residues of Tordon Acid in Milk by Gas Chromatography. Method ACR

67.3 dated Jun 22, 1967. (Unpublished study received Mar 3, 1970 under

8F0660; CDL:090780-I)

00073973 Kutschinski, A.H.; Riley, V. (1967) Residues of Tordon Acid in Tissues from

Steers Fed the Herbicide. (Unpublished study received Mar 3, 1970 under

8F0660; submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:090780-J)

00073974 Dow Chemical Company (1967) Residue Determination Method: Determination

of Residues of Tordon Acid in Bovine Tissues by Gas Chromatography. 

Method ACR 67.2 dated Jun 21, 1967. (Unpublished study received Mar 3,

1970 under 8F0660; CDL:090780-K)

00078483 Dow Chemical Company (1967) Residue Determination Method: Determination

of Residues of Tordon(R) Acid in Chicken Eggs and Tissues by Gas

Chromatography. Method ACR 67.5 dated Sep 14, 1967. (Unpublished study

received on unknown date under 4E1489; submitted by Montana, Dept. of

Agriculture, Helena, Mont.; CDL: 093949-B)

00085060 Interregional Research Project Number 4 (1981) Summary of Residue

Chemistry Data: [Picloram]. (Compilation; unpublished study received Oct 20,

1981 under 2E2585; CDL:070422-A)

00098321 Nolan, R.J.; Smith, F.A.; Muller, C.J.; et al. (1980) Kinetics of 

14C-labeled Picloram in Male Fischer 344 Rats. (Unpublished study received

Apr 6, 1982 under 464-320; submitted by Dow Chem- ical U.S.A., Midland,

Mich.; CDL:247156-H)

00098322 Mensik, D.C.; Johnston, R.V.; Pinkerton, M.N.; et al. (1976) The Cytogenetic

Effects of Picloram on the Bone Marrow Cells of Rats. (Unpublished study

received Apr 6, 1982 under 464-320; prepared in cooperation with Univ. of
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Picloram Acid - 005101

158

Texas, Medical Branch, submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:247156-I)

00108862 Dow Chemical Co. (1970) Residues of Picloram in Grass. (Compi lation;

unpublished study received Apr 5, 1970 under 0F0863; CDL:091493-A)

00108864 Dow Chemical Co. (1969) The Results of Tests on the Amount of Residue

Remaining Including a Description of the Analytical Methods Used: [Tordon]. 

(Compilation; unpublished study re ceived Apr 5, 1970 under 0F0863;

CDL:091494-B)

00110534 Barna-Lloyd, T.; Taylor, H.; Swaim, L.; et al. (1982) Results of a Six-month

Dietary Toxicity Study of Picloram ..., Administered in the Diet to Male and

Female Beagle Dogs: Study TXT:K-038323 (28). Final rept. (Unpublished

study received Aug 23, 1982 under 464-502; submitted by Dow Chemical

U.S.A., Midland, MI; CDL:248162-A)

00110537 Gorzinski, S.; Johnson, K.; Campbell, R.; et al. (1982) Technical Grade

Picloram: Results of a 13-week Dietary Toxicity Study in Fischer 344 Rats:

Laboratory Report Code HET K-038323-(32). Final rept. (Unpublished study

received Aug 23, 1982 under 464 502; submitted by Dow Chemical U.S.A.,

Midland, MI; CDL: 248162-D)

00111404 Dow Chemical U.S.A. (1974) Residues: [Tordon 22K]. (Compilation;

unpublished study received Sep 26, 1974 under 464-323; CDL: 009845-A)

00111407 Dow Chemical Co. (1967) The Results of Tests on the Amount of Res idue

Remaining, Including a Description of the Analytical Method used: [Tordon]. 

(Compilation; unpublished study received Nov 21, 1967 under 8F0660;

CDL:090777-A)

00111470 Getzendaner, M.; Herman, J.; Van Giessen, B. (1969) Residues of 4 

amino-3,5,6-trichloropicolinic acid in grass from applications of Tordon

herbicides. Agricultural and Food Chemistry 17 (6):1251-1256. (Also In

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Bobwhite: Final Report: WIL Project No. 103-249. Un published study

prepared by Wildlife International Ltd. 17 p.

40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to

Fish and Aquatic Invertebrates: Resource Publi cation 137. US Fish and

Wildlife Service, Washington, D.C. 106 p.

40178601 Laskowski, D. (1987) Aerobic Soil Degradation of Picloram Isooctyl Ester:

Laboratory Project ID: GH-C 1901. Unpublished study prepared by Dow

Chemical U.S.A. 49 p.

40479407 Jeffrey, M.; Schuetz, D.; Eisenbrandt, D. (1987) Picloram Isooctyl Ester:

Acute Oral Toxicity Study in Fischer 344 Rats: Study No. K-041284-005A. 

Unpublished study prepared by The Dow Chemical Co., Mammalian and

Environmental Toxicology Research Laboratory. 22 p.

40479408 Jeffrey, M.; Schuetz, D.; Yano, B. (1987) Picloram Isooctyl Ester: Acute

Dermal Toxicity Study in New Zealand White Rabbits: Study ID

K-041284-005D. Unpublished study prepared by The Dow Chemical Co.,

Mammalian and Environmental Toxicology Research Laboratory. 18 p.

40479409 Streeter, C.; Battjes, J.; Johnson, K. (1987) Picloram Isooctyl Ester: An Acute

Aerosol Inhalation Study in Fischer 344 Rats: K-041284-006. Unpublished

study prepared by The Dow Chemical Co., Mammalian and Environmental

Toxicology Research Laboratory. 21 p.

40479410 Jeffrey, M. (1987) Picloram Isoctyl Ester: Primary Eye Irritation Study in New

Zealand White Rabbits: K-041284-005C. Unpublished study prepared by The

Dow Chemical Co., Mammalian and Environmental Toxicology Research

Laboratory. 11 p.

40479411 Jeffrey, M. (1987) Picloram Isooctyl Ester: Primary Dermal Irritation Study in

New Zealand White Rabbits: Final Rept.: K-041284005B. Unpublished study
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Isooctyl/Ethylhexyl Picloram - 005103

172

prepared by The Dow Chemical Co., Mammalian and Environmental

Toxicology Research Laboratory. 12 p.

40479412 Jeffrey, M. (1987) Picloram Isooctyl Ester: Dermal Sensitization Potential in

the Hartley Albino Guinea Pig: Final Report: K041284-005E. Unpublished

study prepared by The Dow Chemical Co., Mammalian and Environmental

Toxicology Research Laboratory. 14 p.

41094904 Baker, R. (1989) Product Chemistry: Picloram Isooctyl Ester. Unpublished

study prepared by Dow Chemical U.S.A. 19 p.

41296501 Weseloh, J.; Stockdale, G. (1989) A Study To Determine the Effects of

Picloram on Seed Germination, Seedling Emergence and Vegetative Vigor: Lab

Project Number GH-P 1444; Protocol 89040. Unpublished study prepared by

Dow Chemical U.S.A. Midland Field Research Station. 170 p.

42121102 Vedula, U.; Jersey, G.; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:

Oral Gavage Teratology Probe Study in Sprague-Dawley Rats: Lab Project

Number: DR-0044-1725-006/P. Unpublished study prepared by Dow Chemical

Co. 86 p.

42121103 Zablotny, C,; Stebbins, K.; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:

Oral Gavage Teratology Probe Study in New Zealand White Rabbits: Lab

Project Number: DR-0044-1725-004. Unpublished study prepared by Dow

Chemical Co. 80 p.

42121104 Zablotny, C.; Stebbins, K,; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:

Oral Gavage Teratology Study in New Zealand White Rabbits: Lab Project

Number: DR-0044-1725-008. Unpublished study prepared by Dow Chemical

Co. 260 p.

42121106 Samson, Y.; Gollapudi, B. (1991) Evaluation of Picloram EHE in the Ames

Salmonella/Mammalian Bacterial Mutagenicity Assay.: Lab Project Number:

DR-0044-1725-001. Unpublished study prepared by Dow Chemical Co. 30 p.

42121107 Hoxter, K.; Lynn, S. (1991) Picloram 2-EHE: An Acute Contact Toxicity

Study with the Honey Bee: Lab Project Number: 103-367: ESDR-0044-1725-2. 

Unpublished study prepared by Wildlife International, Inc. 18 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Isooctyl/Ethylhexyl Picloram - 005103

173

42121108 Woodburn, K.; Hansen, S.; Ball, T. (1991) Picloram 2-EthylHexyl Ester:

Bioconcentration in Rainbow Trout, Oncorhynchus mykiss: Lab Project

Number: ES-DR-0044-1725-1. Unpublished study prepared by Dow Chemical

Co. 71 p.

42171601 Lockwood, D.; Szabo, J. (1991) Picloram 2-Ethylhexyl Ester (Picloram EHE):

Probe and 21-Day Dermal Toxicity Studies in New Zealand White Rabbits: Lab

Project Number: DR-0044-1725-005. Unpublished study prepared by Dow

Chemical Co. 123 p.

42171602 Samson, Y.; Gollapudi, B. (1991) Evaluation of Picloram EHE in the Mouse

Bone Marrow Micronucleus Test: Lab Project Number: DR-0044-1725-003. 

Unpublished study prepared by Dow Chemical Co. 32 p.

42171603 Domoradzki, J.; Brzak, K.; Bormett, G.; et al. (1991) Picloram 2Ethylhexyl

Ester: Hydrolysis in vitro and in vivo in Fixcher 344 Rats: Lab Project

Number: DR-0044-1725-009. Unpublished study prepared by The Dow

Chemical Co. 55 p.

42296901 Vedula, U.; Stebbins, K.; Breslin, W. (1991) 2-Ethylhexyl Ester of Picloram:

Oral Gavage Teratology Study in Sprague-Dawley Rats: Lab Project Number:

DR-0044-1752-007. Unpublished study prepared by Dow Chemical Co. 193 p.

42297001 Barna-Lloyd, T.; Szabo, J.; and Davis, N. (1991) Picloram 2-Ethylhexyl Ester

(Picloram EHE): Subchronic Dietary Toxicity Study in Fischer 344 Rats: Lab

Project Number: DR-0044-1725-002. Unpublished study prepared by The Dow

Chemical Co. 213p.

42414001 Cifone, M. (1992) Mutagenicity Test on Picloram-2-ethylhexyl Ester in the

CHO/HGPRT Forward Mutation Assay: Lab Project Number:

DR-0044-1725-010;14880-0-435DR. Unpublished study prepared by Hazleton

Washington, Inc. (Vienna and Kensington). 40 p.

42625901 Hoxter, K.; Bernard, W.; Smith, G. (1992) Access Herbicide: An Acute

Contact Toxicity Study with the Honey Bee: Lab Project Number: ES-2602:

103-389. Unpublished study prepared by Wildlife International Ltd. 20 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Isooctyl/Ethylhexyl Picloram - 005103

174

42645901 Hughes, J.; Williams, T. (1993) The Toxicity of Access Herbicide Formulation

to Selenastrum capricornutum: Lab Project Number: ES-2587: B460-152-1. 

Unpublished study prepared by Malcolm Pirnie, Inc. 35 p.

42811901 Batzer, F.; Lubinski, R. (1993) Aqueous Photolysis of Picloram-IOE: Lab

Project Number: ENV93003. Unpublished study prepared by DowElanco

North American Chemistry Lab. 56 p.

42840804 Murphy, G. (1993) Determination of Color, Physical State, Odor, Melting

point, Density, pH and Stability of Picloram 2-Ethylhexyl Ester (2-EHE)

Technical Grade od Active Ingredient (TGAI): Lab Project Number:

FOR91114. Unpublished study prepared by Dow Elanco, Formulations Science

and Technology Lab. 10 p.

42840806 Chakrabarti, A. (1989) Vapor Pressure of the 2-Ethylhexyl Ester of Picloram

Measured by the Knudsen-Effusion/Weight Loss Method: Lab Project Number:

89-020121R. Unpublished study prepared by The Dow Chemical Co. 11 p.

42840807 Nicholson, L. (1989) Determination of the Octanol/Water Partition Coefficient

for Picloram 2-Ethylhexyl Ester Using Generator Column Technology: Lab

Project Number: ML-AL 89-080239. Unpublished study prepared by The Dow

Chemical Co. 25 p.

42840808 White-Henson, K. (1989) Determination of Water Solubility for Picloram

2-Ethylhexyl Ester Using Generator Column Technology: Lab Project Number:

ML-AL 89-080193. Unpublished study prepared by The Dow Chemical Co. 

24 p.

42840810 Murphy, G. (1993) Determination of Solubility of Picloram 2-Ethylhexyl Ester

(2-EHE) Technical Grade of Active Ingredient (TGAI): Lab Project Number:

FOR91120. Unpublished study prepared by DowElanco, Formulation Science

and Technology Lab. 22 p.

42840811 Murphy, G. (1993) Response to Letter Written by Lois A. Rossi (1/22/93)

Subject: Picloram's Product Chemistry Review: Lab Project Number:

GM070993B. Unpublished study prepared by DowElanco, Analytical and

Product Chemistry. 11 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Isooctyl/Ethylhexyl Picloram - 005103

175

42870701 Bond, D. (1993) Picloram 2-Ethylhexyl Ester (Picloram EHE): Probe and

21-Day Dermal Toxicity Studies in New Zealand White Rabbits: Supplement to

MRID 42171601: Lab Project Number: DR-0044-1725-005. Unpublished

study prepared by DowElanco. 34p.

43276601 Schwab, D. (1994) Evaluating the Effects of Picloram on the Germination,

Emergence, and Vegetative Vigor of Non-Target Terrestrial Plants: Final

Report: Lab Project Number: 41404. Unpublished study prepared by ABC

Laboratories, Inc. 137 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Potassium Picloram - 005104

176

00041475 Alexander, H.C.; Batchelder, T.L. (1965) Results of a Study on the Acute

Toxicity of Tordon(R) Herbicide to Three Species of Fish. (Unpublished study

received Nov 6, 1967 under 0F0863; submitted by Dow Chemical U.S.A.,

Midland, Mich.; CDL:094524-H)

00098321 Nolan, R.J.; Smith, F.A.; Muller, C.J.; et al. (1980) Kinetics of 14C-labeled

Picloram in Male Fischer 344 Rats. (Unpublished study received Apr 6, 1982

under 464-320; submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:247156-H)

00098322 Mensik, D.C.; Johnston, R.V.; Pinkerton, M.N.; et al. (1976) The Cytogenetic

Effects of Picloram on the Bone Marrow Cells of Rats. (Unpublished study

received Apr 6, 1982 under 464-320; prepared in cooperation with Univ. of

Texas, Medical Branch, submitted by Dow Chemical U.S.A., Midland, Mich.;

CDL:247156-I)

00110534 Barna-Lloyd, T.; Taylor, H.; Swaim, L.; et al. (1982) Results of a Six-month

Dietary Toxicity Study of Picloram ..., Administered in the Diet to Male and

Female Beagle Dogs: Study TXT:K-038323(28). Final rept. (Unpublished

study received Aug 23, 1982 under 464-502; submitted by Dow Chemical

U.S.A., Midland, MI; CDL:248162-A)

00110537 Gorzinski, S.; Johnson, K.; Campbell, R.; et al. (1982) Technical Grade

Picloram: Results of a 13-week Dietary Toxicity Study in Fischer 344 Rats:

Laboratory Report Code HET K-038323-(32). Final rept. (Unpublished study

received Aug 23, 1982 under 464502; submitted by Dow Chemical U.S.A.,

Midland, MI; CDL: 248162-D)

00129063 Cope, O. (1966) Sport Fishery Research. Denver, CO: USDI. (Quarterly

progress reports, Sep 30; also In unpublished submission received Jun 24, 1983

under 464-502; submitted by Dow Chemical U.S.A., Midland, MI;

CDL:250605-B)

00151783 Gersich, F.; Hopkins, D.; Milazzo, D. (1984) The Acute and Chronic Toxicity

of Technical Picloram (4-Amino-3,5,6-trichloropicolinic acid) to Daphnia

magna Straus: ES-690. Unpublished study prepared by Dow Chemical USA. 

16 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Potassium Picloram - 005104

177

00151784 Mayes, M.; Dill. D.; Hopkins, D. (1984) The Toxicity of Technical Picloram

to the Embryo, Larval, and Juvenile Stages of the Rainbow Trout (Salmo

gairdneri Richardson): ES-703. Unpublished study prepared by Dow Chemical

USA. 17 p.

00155940 Landry, T.; Johnson, K.; Cieszlak, F.; et al. (1986) Picloram: A Two-year

Dietary Chronic Toxicity-oncogenicity Study in Fischer 344 Rats. Unpublished

study prepared by Dow Chemical U.S.A. 1243 p.

00157174 Beavers, J. (1985) Picloram Potassium Salt: An Acute Oral Toxicity Study with

the Mallard: Final Report: Project No. 103-245. Unpublished study prepared

by Wildlife International Ltd. 17 p.

00164726 Grimes, J. (1986) Picloram Isooctyl Ester: A Dietary LC50 Study with the

Bobwhite: Final Report: WIL Project No. 103-249. Unpublished study

prepared by Wildlife International Ltd. 17 p.

00164727 Beavers, J. (1986) Picloram Potassium Salt: A Dietary LC50 Study with the

Bobwhite: Final Report: WIL Project No. 103-244. Unpublished study

prepared by Wildlife International Ltd. 17 p.

40479401 Jeffrey, M.; Battjes, J.; Yano, B. (1987) Tordon K Salt Liquor: Acute Oral

Toxicity Study in Fischer 344 Rats: Final Report: K050731-004A. 

Unpublished study prepared by The Dow Chemical Co. Mammalian and

Environmental Toxicology Research Laboratory. 26p.

40479402 Jeffrey, M.; Phillips, J.; Lomax, L. (1987) Tordon K Salt Liquor: Acute

Dermal Toxicity Study in New Zealand White Rabbits: Final Rept.:

K-050731-004D. Unpublished study prepared by The Dow Chemical Co.,

Mammalian and Environmental Toxicology Research Laboratory. 18 p.

40479403 Streeter, C.; Battjes, J.; Yano, B. (1987) Tordon K Salt Liquor: An Acute

Aerosol Inhalation Study in Fischer 344 Rats: Final Rept.: K-050731-005. 

Unpublished study prepared by The Dow Chemical Co., Mammalian and

Environmental Toxicology Research Laboratory. 20 p.

40479404 Jeffrey, M. (1987) Tordon K Salt Liquor: Primary Eye Irritation Study in New

Zeland White Rabbits: Final Rept.: K-050731-004C. Unpublished study
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Potassium Picloram - 005104

178

prepared by The Dow Chemical Co., Mammalian and Environmental

Toxicology Research Laboratory. 12 p.

40479405 Jeffrey, M. (1987) Tordon K Salt Liquor: Primary Dermal Irritation Study in

New Zealand White Rabbits: K-050731-004B. Unpublished study prepared by

The Dow Chemical Co., Mammalian and Environmental Toxicology Research

Laboratory. 10 p.

40479406 Jeffrey, M. (1987) Tordon K Salt Liquor: Dermal Sensitization Potential in the

Hartley Albino Guinea Pig: K-050731-004E. Unpublished study prepared by

The Dow Chemical Co., Mammalian and Environmental Toxicology Research

Laboratory. 13 p.

40834301 Young, J. (1988) Picloram: 12-Month Dog Chronic Dietary Toxicity Study:

Project Study ID: TXT:K-038323-040. Unpublished study prepared by Dow

Chemical Co. 154 p.

41069501 Breslin, W. (1989) Historical Control Data in New Zealand White Rabbits:

Picloram: Project ID: K-050731-003. Unpublished study prepared by Dow

Chemical U.S.A. 75 p.

41094907 Baker, R. (1989) Product Chemistry: Tordon K Salt Liquor. Unpublished

study prepared by Dow Chemical U.S.A. 17 p.

41094908 Baker, R. (1989) Product Chemistry: Tordon K Salt Liquor. Unpublished

study prepared by Dow Chemical U.S.A. 21 p.

41094909 Baker, R. (1989) Product Chemistry: Tordon K Salt Liquor. Unpublished

study prepared by Dow Chemical U.S.A. 5 p.

41209602 Reitz, R.; Dryzga, M.; Helmer, D.; et al. (1989) Picloram: General

Metabolism Studies in Female Fischer 344 Rats: Project ID K-038323-044. 

Unpublished study prepared by Dow Chemical Co. 57 p.

41366902 Hoxter, K.; Thompson, M.; Jaber, M. (1989) Picloram (4-Amino-3,5,

6-trichloropicolinic Acid) K Salt (Technical): An Acute Contact Toxicity Study

with the Honey Bee: [Amended Report]: Lab Project No. 103-305. 

Unpublished study prepared by Wildlife International Ltd. 18 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Potassium Picloram - 005104

179

41382501 Schroeder, R. (1990) A Range-finding Study to Evaluate the Toxicity of

Picloram K Salt in the Pregnant Rat: Final Report: Lab Project Number:

89-3460. Unpublished study prepared by Bio/dynamics, Inc. 136 p.

41382502 Schroeder, R. (1990) A Teratogenicity Study in Rats with Picloram K Salt:

Final Report: Lab Project Number: 89-3459. Unpublished study prepared by

Bio/dynamics, Inc. 434 p.

41384901 Atkin, L.; Stott, W.; Stebbins, K. (1990) Picloram, Potassium Salt: 21-Day

Dermal Toxicity Study in New Zealand White Rabbits: Lab Project Study ID:

K-050731-008. Unpublished study prepared by Dow Chemical Co.,

Toxicology Research Laboratory, Health and Environmental Sciences. 160 p.

41407702 Hughes, J. (1990) The Toxicity of Picloram, Potassium Salt to Selenastrum

capricornutum: Lab Project Number: 0460-04-1100-2. Unpublished study

prepared by Malcolm Pirnie, Inc. 33 p.

41485902 Samson, Y.; Gollapudi, B. (1990) Evaluation of Picloram in the Ames

Salmonella/Mammalian-microsome Bacterial Mutagenicity Assay: Lab Project

Study I.D.: TXT:K-038323-046. Unpublished study prepared by The Dow

Chemical Co., Health and Environmental Sciences. 25 p.

41549701 McClintock, M.; Gollapudi, B. (1990) Evaluation of Picloram in the Rat

Hepatocyte: Unscheduled DNA Synthesis (UDS) Assay: Lab Project Number:

TXT:K-038323-047. Unpublished study prepared by Dow Chemical Co.,

Health and Environmental Sciences-Texas. 45 p.

42078701 Breslin, W.; Zielke, G.; Kociba, R. (1991) Picloram: Two-Generation on Diet

Reproduction Study in Sprague-Dawley Rats: Lab Project Number:

K-038323-057F0: K-038323-057F1W: K-038323-057F1. Unpublished study

prepared by The Toxicology Research Lab. & The Dow Chemical Co. 1225 p.

42619301 Stott, W.; Yano, B.; Haut, K.; et al. (1992) Picloram: Two-year Dietary

Oncogenicity Study in B6C3F1 Mice: Lab Project Number: K-038323-058. 

Unpublished study prepared by The Dow Chemical Co. 919 p.

42619302 Cosse, P.; Stebbins, K.; Sames, K.; et al. (1992) Picloram: Two-year Dietary

Chronic Toxicity/Oncogenicity Study in Fischer 344 Rats: Lab Project Number:

K-038323-056. Unpublished study prepared by The Dow Chemical Co. 983 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

Potassium Picloram - 005104

180

42840801 Murphy, G. (1993) Determination of Color, Physical State, Odor, Melting

Point, Density, pH and Stability of Picloram Potassium Salt (K) Technical

Grade of Active Ingredient (TGAI): Lab Project Number: FOR93047. 

Unpublished study prepared by DowElanco, Formulations Science and

Technology Lab. 10 p.

42840809 Reim, R. (1993) Determination of the Conditional Acid Dissociation Constant

of Picloram by Normal Pulse Polarography: Lab Project Number: ML-AL

89-040540R. Unpublished study prepared by The Dow Chemical Co. 10 p.

42978101 Murphy, G. (1993) Determination of Solubility of Picloram Potassium Salt (K)

Technical Grade of Active Ingredient (TGAI): Lab Project Number:

FOR93049. Unpublished study prepared by DowElanco, Formulations Science

Technology Lab. 17 p.

43065001 Murphy, G. (1993) Response to Letter Written by Walter I. Waldrop (Received

12/3/93): Subject: Picloram Registration Standard: Lab Project Number:

GM122293A. Unpublished study prepared by DowElanco, Analytical and

Product Chemistry. 8 p.

43276601 Schwab, D. (1994) Evaluating the Effects of Picloram on the Germination,

Emergence, and Vegetative Vigor of Non-Target Terrestrial Plants: Final

Report: Lab Project Number: 41404. Unpublished study prepared by ABC

Laboratories, Inc. 137 p.
181

APPENDIX D. List of Available Related Documents
182
183

The following is a list of available documents related to Picloram acid and its

derivatives (Case # 0096). It's purpose is to provide a path to more detailed information if it

is needed. These accompanying documents are part of the Administrative Record for

Picloram acid and its derivatives and are included in the EPA's Office of Pesticide Programs

Public Docket.

1. Health and Environmental Effects Science Chapters

2. Detailed Label Usage Information System (LUIS) Report

3. Picloram RED Fact Sheet

4. PR Notice 86-5 (included in this appendix)

5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient

Statement
184
185

APPENDIX E. PR Notices 86-5 and 91-2
186
187

PR Notice 86-5
188
189

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

July 29, 1986

OFFICE OF 

PR NOTICE 86-5 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS

AND REGISTRANTS

Attention: Persons responsible for Federal registration of pesticides.

Subject: Standard format for data submitted under the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the

Federal Food, Drug, and Cosmetic Act (FFDCA).

I. Purpose

To require data to be submitted to the Environmental Protection Agency (EPA) in a

standard format. This Notice also provides additional guidance about, and illustrations of, the

required formats.

II. Applicability

This PR Notice applies to all data that are submitted to EPA to satisfy data

requirements for granting or maintaining pesticide registrations, experimental use permits,

tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data

are defined in FIFRA §10(d)(1). This Notice does not apply to commercial, financial, or

production information, which are, and must continue to be, submitted differently under

separate cover.

III. Effective Date

This notice is effective on November 1, 1986. Data formatted according to this notice

may be submitted prior to the effective date. As of the effective date, submitted data packages

that do not conform to these requirements may be returned to the submitter for necessary

revision.

IV. Background

On September 26, 1984, EPA published proposed regulations in the Federal Register

(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and

Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations 

specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and

409 of FFDCA, and procedures which must be followed to make and substantiate claims of

confidentiality. No entitlements to data confidentiality are changed, either by the proposed

regulation or by this notice.

OPP is making these requirements mandatory through this Notice to gain resourcesaving benefits from their use before the entire proposed regulation becomes final. Adequate

lead time is being provided for submitters to comply with the new requirements.
190

V. Relationship of this Notice to Other OPP Policy and Guidance

While this Notice contains requirements for organizing and formatting submittals of

supporting data, it does not address the substance of test reports themselves. "Data reporting"

guidance is now under development in OPP, and will specify how the study objectives,

protocol, observations, findings, and conclusions are organized and presented within the study

report. The data reporting guidance will be compatible with submittal format requirements

described in this Notice.

OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that

provides for early screening of certain applications for registration under FIFRA §3. The

objective of the screen is to avoid the additional costs and prolonged delays associated with

handling significantly incomplete application packages. As of the effective date of this Notice,

the screen will include in its criteria for acceptance of application packages the data formatting

requirements described herein.

OPP has also established a public docket which imposes deadlines for inserting into the

docket documents submitted in connection with Special Reviews and Registration Standards

(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional

copy of any data submitted to the docket. Please refer to Page 10 for more information about

this requirement.

For several years, OPP has required that each application for registration or other

action include a list of all applicable data requirements and an indication of how each is

satisfied--the statement of the method of support for the application. Typically, many

requirements are satisfied by reference to data previously submitted--either by the applicant or

by another party. That requirement is not altered by this notice, which applies only to data

submitted with an application.

VI. Format Requirements

A more detailed discussion of these format requirements follows the index on the next

page, and samples of some of the requirements are attached. Except for the language of the

two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)

which cannot be altered, these samples are illustrative. As long as the required information is

included and clearly identifiable, the form of the samples may be altered to reflect the

submitter's preference.

- INDEXText Example

Page Page 

A. Organization of the Submittal Package ................................ 3 17

B. Transmittal Document .......................................... 4 11

C. Individual Studies ............................................. 4 

C. 1 Special Considerations for Identifying Studies ....................... 5 

D. Organization of each Study Volume ................................. 6 17

D. 1 Study Title Page .......................................... 7 12

D. 2 Statement of Data Confidentiality Claims

 (based on FIFRA §10(d)(1)) .................................. 8 13

D. 3 Confidential Attachment ..................................... 8 15

D. 4 Supplemental Statement of Data Confidentiality
191

 Claims (other than those based on FIFRA §10(d)(1)) .................. 8 14

D. 5 Good Laboratory Practice Compliance Statement ..................... 9 16

E. Reference to Previously Submitted Data ............................... 9 

F. Physical Format Requirements & Number of Copies ....................... 9 

G. Special Requirements for Submitting Data to the Docket .................... 10 

---------------------------

A. Organization of Submittal Package

A "submittal package" consists of all studies submitted at the same time for review in

support of a single regulatory action, along with a transmittal document and other related

administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,

8570-20, etc.) as appropriate.

Data submitters must organize each submittal package as described in this Notice. The

transmittal and any other administrative material must be grouped together in the first physical

volume. Each study included in the submittal package must then be bound separately.

Submitters sometimes provide additional materials that are intended to clarify,

emphasize, or otherwise comment to help Product Managers and reviewers better understand

the submittal.

- If such materials relate to one study, they should be included as an appendix to that

study.

- If such materials relate to more than one study (as for example a summary of all

studies in a discipline) or to the submittal in general, they must be included in the

submittal package as a separate study (with title page and statement of confidentiality

claims).

B. Transmittal Document

The first item in each submittal package must be a transmittal document. This

document identifies the submitter or all joint submitters; the regulatory action in support of

which the package is being submitted--i.e., a registration application, petition, experimental

use permit (EUP), §3(c)(2)(B) data call-in, §6(a)(2) submittal, or a special review; the

transmittal date; and a list of all individual studies included in the package in the order of their

appearance, showing (usually by Guideline reference number) the data requirement(s)

addressed by each one. The EPA-assigned number for the regulatory action (e.g. the

registration, EUP, or tolerance petition number) should be included in the transmittal

document as well, if it is known to the submitter. See Attachment 1 for an example of an

acceptable transmittal document.

The list of included studies in the transmittal of a data submittal package supporting a

registration application should be subdivided by discipline, reflecting the order in which data

requirements appear in 40 CFR 158.

The list of included studies in the transmittal of a data submittal package supporting a

petition for tolerance or an application for an EUP should be subdivided into sections A, B,

C,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or

Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
192

When a submittal package supports a tolerance petition and an application for a

registration or an EUP, list the petition studies first, then the balance of the studies. Within

these two groups of studies follow the instructions above.

C. Individual Studies

A study is the report of a single scientific investigation, including all supporting

analyses required for logical completeness. A study should be identifiable and distinguishable

by a conventional bibliographic citation including author, date, and title. Studies generally

correspond in scope to a single Guideline requirement for supporting data, with some

exceptions discussed in section C.1. Each study included in a submittal package must be

bound as a separate entity. (See comments on binding studies on page 9.)

Each study must be consecutively paginated, beginning from the title page as page 1. 

The total number of pages in the com-plete study must be shown on the study title page. In

addition (to ensure that inadvertently separated pages can be reassociated with the proper study

during handling or review) use either of the following:

- Include the total number of pages in the complete study on each page (i.e., 1 of 250,

2 of 250, ...250 of 250).

- Include a company name or mark and study number on each page of the study, e g ,

Company Name-1986-23. Never reuse a study number for marking the pages of

subsequent studies.

When a single study is extremely long, binding it in mul-tiple volumes is permissible

so long as the entire study is pag-inated in a single series, and each volume is plainly identified

by the study title and its position in the multi-volume sequence.

C.1 Special Considerations for Identifying Studies

Some studies raise special problems in study identification, because they address

Guidelines of broader than normal scope or for other reasons.

a. Safety Studies. Several Guidelines require testing for safety in more than one

species. In these cases each species tested should be reported as a separate study, and bound

separately.

Extensive supplemental reports of pathology reviews, feed analyses, historical control

data, and the like are often associated with safety studies. Whenever possible these should be

submitted with primary reports of the study, and bound with the primary study as appendices. 

When such supplemental reports are submitted independently of the primary report, take care

to fully identify the primary report to which they pertain.

Batteries of acute toxicity tests, performed on the same end use product and covered by

a single title page, may be bound together and reported as a single study.

b. Product Chemistry Studies. All product chemistry data within a submittal package

submitted in support of an end-use product produced from registered manufacturing-use

products should be bound as a single study under a single title page.

Product chemistry data submitted in support of a technical product, other

manufacturing-use product, an experimental use permit, an import tolerance petition, or an

end-use product produced from unregistered source ingredients, should be bound as a single

study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the

equivalent subject range for biorational pesticides. The first of the three studies in a complete
193

product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,

151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third

would cover Guideline 151-17. The first study for a microbial pesticide would cover

Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and

151-25; the third would cover Guideline 151-26.

Note particularly that product chemistry studies are likely to contain Confidential

Business Information as defined in FIFRA §10(d)(1)(A), (B), or (C), and if so must be

handled as described in section D.3. of this notice.

c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely

broad in scope; studies addressing residue chemistry requirements must thus be defined at a

level below that of the Guideline code. The general principle, however, of limiting a study to

the report of a single investigation still applies fully. Data should be treated as a single study

and bound separately for each analytical method, each report of the nature of the residue in a

single crop or animal species, and for each report of the magnitude of residues resulting from

treatment of a single crop or from processing a single crop. When more than one commodity

is derived from a single crop (such as beet tops and beet roots) residue data on all such

commodities should be reported as a single study. When multiple field trials are associated

with a single crop, all such trials should be reported as a single study.

D. Organization of Each Study Volume

Each complete study must include all applicable elements in the list below, in the order

indicated. (Also see Page 17.) Several of these elements are further explained in the following

paragraphs. Entries in the column headed "example" cite the page number of this notice

where the element is illustrated.

Element When Required Example

Study Title Page Always Page 12

Statement of Data One of the two alternative Page 13

Confidentiality forms of this statement

Claims is always required

Certification of Good If study reports laboratory Page 16

Laboratory Practice work subject to GLP requirements

Flagging statements For certain toxicology studies (When

flagging requirements are finalized.)

Body of Study Always - with an English language 

translation if required.

Study Appendices At submitter's option

Cover Sheet to Confi- If CBI is claimed under FIFRA 

dential Attachment §10(d)(1)(A), (B), or (C)

CBI Attachment If CBI is claimed under FIFRA 

§10(d)(1)(A), (B), or © Page 15

Supplemental Statement Only if confidentiality is Page 14
194

of Data Confidentiality claimed on a basis other than 

Claims FIFRA §10(d)(1)(A), (B), or (C)

D.1. Title Page

A title page is always required for each submitted study, published or unpublished. 

The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON

THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice. 

The following information must appear on the title page:

a. Study title. The study title should be as descriptive as possible It must clearly identify

the substance(s) tested and correspond to the name of the data requirement as it appears in the

Guidelines.

b. Data requirement addressed. Include on the title page the Guideline number(s) of the

specific requirement(s) addressed by the study.

c. Author(s). Cite only individuals with primary intellectual responsibility for the content

of the study. Identify them plainly as authors, to distinguish them from the performing

laboratory, study sponsor, or other names that may also appear on the title page.

d. Study Date. The title page must include a single date for the study. If parts of the

study were performed at different times, use only the date of the latest element in the study.

e. Performing Laboratory Identification. If the study reports work done by one or more

laboratories, include on the title page the name and address of the performing laboratory or

laboratories, and the laboratory's internal project number(s) for the work. Clearly distinguish

the laboratory's project identifier from any other reference numbers provided by the study

sponsor or submitter.

f. Supplemental Submissions. If the study is a commentary on or supplement to another

previously submitted study, or if it responds to EPA questions raised with respect to an earlier

study, include on the title page elements a. through d. for the previously submitted study,

along with the EPA Master Record Identifier (MRID) or Accession number of the earlier

study if you know these numbers. (Supplements submitted in the same submittal package as

the primary study should be appended to and bound with the primary study. Do not include

supplements to more than one study under a single title page).

g. Facts of Publication. If the study is a reprint of a published document, identity on the

title page all relevant facts of publication, such as the journal title, volume, issue, inclusive

page numbers, and publication date.

D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(1).

Each submitted study must be accompanied by one of the two alternative forms of the

statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)

and (c) (See Attachment 3). These statements apply only to claims of data confidentiality

based on FIFRA §10(d)(1)(A), (B), or (C). Use the appropriate alternative form of the

statement either to assert a claim of §10(d)(1) data confidentiality (§158.33(b)) or to waive

such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must

include the typed name and title of the official who signs it. Do not make CBI claims with

respect to analytical methods associated with pet-itions for tolerances or emergency

exemptions (see NOTE Pg 13).
195

D.3. Confidential Attachment

If the claim is made that a study includes confidential business information as defined

by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such

information must be excised from the body of the study and confined to a separate

study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by

a reference number cited within the body of the study at the point from which the passage was

excised (See Attachment 5).

The Confidential Attachment to a study must be identified by a cover sheet fully

identifying the parent study, and must be clearly marked "Confidential Attachment." An

appropriately annotated photocopy of the parent study title page may be used as this cover

sheet. Paginate the Confidential Attachment separately from the body of the study, beginning

with page 1 of X on the title page. Each passage confined to the Confidential Attachment

must be associated with a specific cross reference to the page(s) in the main body of the study

on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(1) on

which the confidentiality claim is based.

D.4. Supplemental Statement of Data Confidentiality Claims (See

Attachment 4)

If you wish to make a claim of confidentiality for any portion of a submitted study

other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:

- The specific information to which the claim applies must be clearly marked in the

body of the study as subject to a claim of confidentiality.

- A Supplemental Statement of Data Confidentiality Claims must be submitted,

identifying each passage claimed confidential and describing in detail the basis for the

claim. A list of the points to address in such a statement is included in Attachment 4

on Pg 14.

- The Supplemental Statement of Data Confidentiality Claims must be signed and dated

and must include the typed name and title of the official who signed it.

D.5. Good Laboratory Practice Compliance Statement

This statement is required if the study contains laboratory work subject to GLP

requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment

6.

E. Reference to Previously Submitted Data

DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED

FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page

plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately

for review. This prevents duplicate entries in the Agency files, and saves you

the cost of sending more copies of the study. References to previously submitted studies

should not be included in the transmittal document, but should be incorporated into the

statement of the method of support for the application.

F. Physical Format Requirements

All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white

paper, printed on one side only in black ink, with high contrast and good resolution. Bindings

for individual studies must be secure, but easily removable to permit disassembly for
196

microfilming. Check with EPA for special instructions before submitting data in any medium

other than paper, such as film or magnetic media.

Please be particularly attentive to the following points:

Do not include frayed or torn pages.

Do not include carbon copies, or copies in other than black ink.

Make sure that photocopies are clear, complete, and fully readable.

Do not include oversize computer printouts or fold-out pages.

Do not bind any documents with glue or binding tapes.

Make sure that all pages of each study, including any attachments or

appendices, are present and in correct sequence.

Number of Copies Required - All submittal packages except those associated with a

Registration Standard or Special Review (See Part G below) must be provided ln three

complete, identical copies. (The proposed regulations specified two copies; three are now

being required to expedite and reduce the cost of processing data into the OPP Pesticide

Document Management System and getting it into review.)

G. Special Requirements for Submitting Data to the Docket

Data submittal packages associated with a Registration Standard or Special Review

must be provided in four copies, from one of which all material claimed as CBI has been

excised. This fourth copy will become part of the public docket for the RS or SR case. If no

claims of confidentiality are made for the study, the fourth copy should be identical to the

other three. When portions of a study submitted in support of an RS or SR are claimed as

CBI, the first three copies will include the CBI material as provided in section D of this

notice. The following special preparation is required for the fourth copy.

Remove the "Supplemental Statement of Data Confidentiality Claims".

Remove the "Confidential Attachment".

Excise from the body of the study any information you claim as confidential,

even if it does not fall within the scope of FIFRA §10(d)(1)(A), (B), or (C). 

Do not close up or paraphrase text remaining after this excision.

Mark the fourth copy plainly on both its cover and its title page with the phrase

"Public Docket Material - contains no information claimed as confidential".
197

V. For Further Information

For further information contact John Carley, Chief, Information Services Branch,

Program Management and Support Division, (703) 305-5240.

/S/

James W. Akerman

Acting Director,

Registration Division

Attachment 1. Sample Transmittal Document

Attachment 2. Sample Title Page for a Newly Submitted Study

Attachment 3. Statements of Data Confidentiality Claims

Attachment 4. Supplemental Statement of Data Confidentiality Claims

Attachment 5. Samples of Confidential Attachments

Attachment 6. Sample Good Laboratory Practice Statements

Attachment 7. Format Diagrams for Submittal Packages and Studies
198

ATTACHMENT 1 

ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*

1. Name and address of submitter (or all joint submitters**)

Smith Chemical Corporation Jones Chemical Company +

 1234 West Smith Street -and- 5678 Wilson Blvd

 Cincinnati, OH 98765 Covington, KY 56789

Smith Chemical Corp will act as sole agent for all submitters. +

2. Regulatory action in support of which this package is submitted

Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the

type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).

3. Transmittal date

4. List of submitted studies

Vol 1. Administrative materials - forms, previous corres-pondence with Project

Managers, and so forth.

Vol 2. Title of first study in the submittal (Guideline No.)

Vol n Title of nth study in the submittal (Guideline No.)

* Applicants commonly provide this information in a tran-smittal letter. This

remains an acceptable practice so long as all four elements are included.

* Indicate which of the joint submitters is empowered to act on behalf of all joint

submitters in any matter concerning data compensation or subsequent use or

release of the data.

Company Official: 

Signature Name

Company Name 

Company Contact: 

 Name Phone
199

ATTACHMENT 2 

SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY

Study Title

(Chemical name) - Magnitude of Residue on Corn

Data Requirement

Guideline 171-4

Author

John C. Davis

Study Completed On

January 5, 1979

Performing Laboratory

ABC Agricultural Laboratories

940 West Bay Drive

Wilmington, CA 39897

Laboratory Project ID

ABC 47-79

Page 1 of X

(X is the total number of pages in the study)
200
201

No claim of confidentiality is made for any information contained in this

study on the basis of its falling within the scope of FIFRA

6§10(d)(1)(A), (B), or (C). 

Company 

 

Company Agent: Typed Name Date: 

 Title Signature 

Information claimed confidential on the basis of its falling within the

scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a

confidential appendix, and is cited by cross-reference number in the body

of the study. 

 Company: 

 Company Agent: Typed Name Date: 

 Title Signature 

 

ATTACHMENT 3

STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C).

STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS 

2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).

STATEMENT OF DATA CONFIDENTIALITY CLAIMS

NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy

that no permanent tolerance, temporary tolerance, or request for an emergency exemption

incorporating an analytical method, can be approved unless the applicant waives all claims of

confidentiality for the analytical method. These analytical methods are published in the FDA

Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP

implements this policy by returning submitted analytical methods, for which confidentiality

claims have been made, to the submitter, to obtain the confidentiality waiver before they can

be processed.
202

ATTACHMENT 4 

SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS

For any portion of a submitted study that is not described by FIFRA §10(d)(1)(A), (B),

or (C), but for which you claim confidential treatment on another basis, the following

information must be included within a Supplemental Statement of Data Confidentiality Claims:

Identify specifically by page and line number(s) each portion of the study for

which you claim confidentiality.

Cite the reasons why the cited passage qualifies for confidential treatment.

Indicate the length of time--until a specific date or event, or permanently--for

which the information should be treated as confidential.

Identify the measures taken to guard against undesired disclosure of this

information.

Describe the extent to which the information has been disclosed, and what

precautions have been taken in connection with those disclosures.

Enclose copies of any pertinent determinations of confidentiality made by EPA,

other Federal agencies, of courts concerning this information.

If you assert that disclosure of this information would be likely to result in

substantial harmful effects to you, describe those harmful effects and explain

why they should be viewed as substantial.

If you assert that the information in voluntarily submitted, indicate whether you

believe disclosure of this information might tend to lessen the availability to

EPA of similar information in the future, and if so, how.
203

CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the

following paragraph(s) at the indicated volume and page

references. 

DELETED WORDS OR PHRASE: Ethylene Glycol

PAGE LINES REASON FOR THE DELETION FIFRA

REFERENCE

 6 14 Identity of Inert Ingredient §10(d)(C)

 28 25 " "

100 19 " "

CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the

following paragraph(s) at the indicated volume and page

references. 

 DELETED PARAGRAPH(S): 

( )

( Reproduce the deleted paragraph(s) here )

( ) 

PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE

 20. 2-17 Description of the quality control process §10(d)(1)(C) 

CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the

following paragraph(s) at the indicated volume and page

references. 

 DELETED PAGES(S): are attached immediately behind this page

PAGES REASON FOR THE DELETION FIFRA REFERENCE

35-41. Description of product manufacturing process §10(d)(1)(A) 

ATTACHMENT 5

EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS

Example 1. (Confidential word or phrase that has been deleted from the study)

Example 2. (Confidential paragraph(s) that have been deleted from the study) 

Example 3. (Confidential pages that have been deleted from the study)
204
205

This study meets the requirements for 40 CFR Part 160

Submitter 

 

Sponsor 

This study does not meet the requirements of 40 CFR Part 160, and

differs in the following ways:

1.________________________________________________

2.________________________________________________

3.________________________________________________

Submitter____________________________________

Sponsor______________________________________

Study Director_______________________________

The submitter of this study was neither the sponsor of this study nor

conducted it, and does not know whether it has been conducted in

accordance with 40 CFR Part 160.

Submitter__________________________________________________

ATTACHMENT 6.

SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

Example 1.

Example 2.

Example 3.
206
207
208
209

PR Notice 91-2
210
211

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

PR NOTICE 91-2

NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,

AND REGISTRANTS OF PESTICIDES

ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients

Statement

I. PURPOSE:

The purpose of this notice is to clarify the Office of Pesticide Program's policy with

respect to the statement of percentages in a pesticide's label's ingredient statement.

Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient

statement on the label must be stated as the nominal concentration of such ingredient(s), as that

term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal

concentration as the only acceptable label claim for the amount of active ingredient in the

product.

II. BACKGROUND

For some time the Agency has accepted two different methods of identifying on the

label what percentage is claimed for the ingredient(s) contained in a pesticide. Some applicants

claimed a percentage which represented a level between the upper and the lower certified

limits. This was referred to as the nominal concentration. Other applicants claimed the lower

limit as the percentage of the ingredient(s) that would be expected to be present in their

product at the end of the product's shelf-life. Unfortunately, this led to a great deal of

confusion among the regulated industry, the regulators, and the consumers as to exactly how

much of a given ingredient was in a given product. The Agency has established the nominal

concentration as the only acceptable label claim for the amount of active ingredient in the

product.

Current regulations require that the percentage listed in the active ingredient statement

be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The

certified limits required for each active ingredient are intended to encompass any such "good

manufacturing practice" variations 40 CFR 158.175(c)(3). 

The upper and lower certified limits, which must be proposed in connection with a

product's registration, represent the amounts of an ingredient that may legally be present 40

CFR 158.175. The lower certified limit is used as the enforceable lower limit for the product

composition according to FIFRA section 12(a)(1)(C), while the nominal concentration

appearing on the label would be the routinely achieved concentration used for calculation of

dosages and dilutions.

The nominal concentration would in fact state the greatest degree of accuracy that is

warranted with respect to actual product composition because the nominal concentration would

be the amount of active ingredient typically found in the product.

It is important for registrants to note that certified limits for active ingredients are not

considered to be trade secret information under FIFRA section l0(b). In this respect the
212

certified limits will be routinely provided by EPA to States for enforcement purposes, since

the nominal concentration appearing on the label may not represent the enforceable

composition for purposes of section 12(a)(1)(C).

III. REQUIREMENTS

As described below under Unit V. " COMPLIANCE SCHEDULE," all currently

registered products as well as all applications for new registration must comply with this

Notice by specifying the nominal concentration expressed as a percentage by weight as the

label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,

elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing

sample analyses of five or more representative samples must be fulfilled. Copies of the raw

analytical data must be submitted with the nominal ingredient label claim. Further information

about the analysis requirement may be found in the 40 CFR 158.170. All products are

required to provide certified limits for each active, inert ingredient, impurities of toxicological

significance(i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These

limits are to be set based on representative sampling and chemical analysis(i.e., quality

control) of the product.

The format of the ingredient statement must conform to 40 CFR 156-Labeling

Requirements For Pesticides and Devices.

After July 1, 1997, all pesticide ingredient Statements must be changed to nominal

concentration.

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

All pesticides are required to be efficacious. Therefore, the certified lower limits may

not be lower then the minimum level to achieve efficacy. This is extremely important for

products which are intended to control pests which threaten the public health, e.g., certain

antimicrobial and rodenticide products. Refer to 40 CFR 153.640.

In those cases where efficacy limits have been established, the Agency will not accept

certified lower limits which are below that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

As described earlier, the purpose of this Notice is to make the registration process

more uniform and more manageable for both the agency and the regulated community. It is

the Agency's intention to implement the requirements of this notice as smoothly as possible so

as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new

chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are

expected to comply with the requirements of this Notice as follows:

(1) Beginning July 1, 1991, all new product registrations submitted to the Agency

are to comply with the requirements of this Notice.

(2) Registrants having products subject to reregistration under FIFRA section 4(a)

are to comply with the requirements of this Notice when specific products are

called in by the Agency under Phase V of the Reregistration Program.
213

(3) All other products/applications that are not subject to (1) and (2) above will

have until July 1, 1997, to comply with this Notice. Such applications should

note "Conversion to Nominal Concentrations on the application form. These

types Or amendments will not be handled as "Fast Track" applications but will

be handled as routine requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning

this notice on (703) 308-7031.

/s/

Anne E. Lindsay, Director

Registration Division (H-7505C)
214
215

APPENDIX F. Combined Generic and Product Specific

Data Call-In
216
217

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

GENERIC AND PRODUCT SPECIFIC

DATA CALL-IN NOTICE

CERTIFIED MAIL

Dear Sir or Madam:

This Notice requires you and other registrants of pesticide products containing the

active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status

Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency

(EPA, the Agency). These data are necessary to maintain the continued registration of your

product(s) containing this active ingredient. Within 90 days after you receive this Notice you

must respond as set forth in Section III below. Your response must state:

1. How you will comply with the requirements set forth in this Notice and its

Attachments 1 through 7; or

2. Why you believe you are exempt from the requirements listed in this Notice and

in Attachment 3 (for both generic and product specific data), the Requirements

Status and Reqistrant's Response Form, (see section III-B); or

3. Why you believe EPA should not require your submission of data in the manner

specified by this Notice (see section III-D).

If you do not respond to this Notice, or if you do not satisfy EPA that you will comply

with its requirements or should be exempt or excused from doing so, then the registration of

your product(s) subject to this Notice will be subject to suspension. We have provided a list of

all of your products subject to this Notice in Attachment 2. All products are listed on both the

generic and product specific Data Call-In Response Forms. Also included is a list of all

registrants who were sent this Notice (Attachment 6).

The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide

and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this

information is authorized under the Paperwork Reduction Act by OMB Approval No.

2070-0107 and 2070-0057 (expiration date 3-31-96).

This Notice is divided into six sections and seven Attachments. The Notice itself

contains information and instructions applicable to all Data Call-In Notices. The Attachments

contain specific chemical information and instructions. The six sections of the Notice are:

Section I - Why You are Receiving this Notice

Section II - Data Required by this Notice

Section III - Compliance with Requirements of this Notice

Section IV - Consequences of Failure to Comply with this Notice

Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects

Section VI - Inquiries and Responses to this Notice
218

The Attachments to this Notice are:

1 - Data Call-In Chemical Status Sheet

2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with

Instructions

3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status

and Registrant's Response Forms with Instructions

4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data

Requirements for Reregistration

5 - EPA Acceptance Criteria

6 - List of Registrants Receiving This Notice

7 - Cost Share and Data Compensation Forms

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

The Agency has reviewed existing data for this active ingredient(s) and reevaluated the

data needed to support continued registration of the subject active ingredient(s). This

reevaluation identified additional data necessary to assess the health and safety of the continued

use of products containing this active ingredient(s). You have been sent this Notice because

you have product(s) containing the subject active ingredients.

SECTION II. DATA REQUIRED BY THIS NOTICE

II-A. DATA REQUIRED

The data required by this Notice are specified in the Requirements Status and

Registrant's Response Forms: Attachment 3 (for both generic and product specific data

requirements). Depending on the results of the studies required in this Notice, additional

studies/testing may be required.

II-B. SCHEDULE FOR SUBMISSION OF DATA

You are required to submit the data or otherwise satisfy the data requirements specified

in the Requirements Status and Registrant's Response Forms (Attachment 3) within the

timeframes provided.

II-C. TESTING PROTOCOL

All studies required under this Notice must be conducted in accordance with test

standards outlined in the Pesticide Assessment Guidelines for those studies for which

guidelines have been established.

These EPA Guidelines are available from the National Technical Information Service

(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:

703-487-4650).

Protocols approved by the Organization for Economic Cooperation and Development

(OECD) are also acceptable if the OECD recommended test standards conform to those

specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the

OECD protocols, they should be modified as appropriate so that the data generated by the

study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend

deadlines for complying with data requirements when the studies were not conducted in

accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
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Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone

number 202-785-0350).

All new studies and proposed protocols submitted in response to this Data Call-In

Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].

II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED

BY THE AGENCY

Unless otherwise noted herein, this Data Call-In does not in any way supersede or

change the requirements of any previous Data Call-In(s), or any other agreements entered into

with the Agency pertaining to such prior Notice. Registrants must comply with the

requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected

products.

SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

You must use the correct forms and instructions when completing your response to this

Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is

specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).

III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

The appropriate responses initially required by this Notice for generic and product

specific data must be submitted to the Agency within 90 days after your receipt of this Notice.

Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for

issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for

issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and

IV-B.

III-B. OPTIONS FOR RESPONDING TO THE AGENCY

1. Generic Data Requirements

The options for responding to this Notice for generic data requirements are: (a)

voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy

the generic data requirements imposed by this Notice or (e) request a data waiver(s).

A discussion of how to respond if you choose the Voluntary Cancellation option, the

Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion

of the various options available for satisfying the generic data requirements of this Notice is

contained in Section III-C. A discussion of options relating to requests for data waivers is

contained in Section III-D.

Two forms apply to generic data requirements, one or both of which must be used in

responding to the Agency, depending upon your response. These two forms are the

Data-Call-In Response Form, and the Requirements Status and Registrant's Response Form,

(contained in Attachments 2 and 3, respectively). 

The Data Call-In Response Forms must be submitted as part of every response to this

Notice. The Requirements Status and Registrant's Response Forms also must be submitted if

you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation

of your registration(s). Please note that the company's authorized representative is required to

sign the first page of both Data Call-In Response Forms and the Requirements Status and

Registrant's Response Forms (if this form is required) and initial any subsequent pages. The

forms contain separate detailed instructions on the response options. Do not alter the printed
220

material. If you have questions or need assistance in preparing your response, call or write the

contact person(s) identified in Attachment 1.

a. Voluntary Cancellation - 

You may avoid the requirements of this Notice by requesting voluntary cancellation of

your product(s) containing the active ingredient that is the subject of this Notice. If you wish

to voluntarily cancel your product, you must submit completed Generic and Product Specific

Data Call-In Response Forms (Attachment 2), indicating your election of this option.

Voluntary cancellation is item number 5 on both Data Call-In Response Form(s). If you

choose this option, these are the only forms that you are required to complete.

If you chose to voluntarily cancel your product, further sale and distribution of your

product after the effective date of cancellation must be in accordance with the Existing Stocks

provisions of this Notice, which are contained in Section IV-C.

b. Use Deletion - 

You may avoid the requirements of this Notice by eliminating the uses of your product

to which the requirements apply. If you wish to amend your registration to delete uses, you

must submit the Requirements Status and Reqistrant's Response Form (Attachment 3), a

completed application for amendment, a copy of your proposed amended labeling, and all

other information required for processing the application. Use deletion is option number 7

under item 9 in the instructions for the Requirements Status and Reqistrant's Response Forms.

You must also complete a Data Call-In Response Form by signing the certification, item

number 8. Application forms for amending registrations may be obtained from the

Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by

calling (703) 308-8358.

If you choose to delete the use(s) subject to this Notice or uses subject to specific data

requirements, further sale, distribution, or use of your product after one year from the due

date of your 90 day response, is allowed only if the product bears an amended label.

c. Generic Data Exemption - 

Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is

exempt from the requirement to submit or cite generic data concerning an active ingredient if

the active ingredient in the product is derived exclusively from purchased, registered pesticide

products containing the active ingredient. EPA has concluded, as an exercise of its discretion,

that it normally will not suspend the registration of a product which would qualify and

continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,

all of the following requirements must be met:

(i). The active ingredient in your registered product must be present solely because of

incorporation of another registered product which contains the subject active ingredient

and is purchased from a source not connected with you;

(ii). Every registrant who is the ultimate source of the active ingredient in your

product subject to this DCI must be in compliance with the requirements of this Notice

and must remain in compliance; and

(iii). You must have provided to EPA an accurate and current "Confidential Statement

of Formula" for each of your products to which this Notice applies.
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To apply for the Generic Data Exemption you must submit a completed Data Call-In

Response Form, Attachment 2 and all supporting documentation. The Generic Data Exemption

is item number 6a on the Data Call-In Response Form. If you claim a generic data exemption

you are not required to complete the Requirements Status and Registrant's Response Form.

Generic Data Exemption cannot be selected as an option for responding to product specific

data requirements.

If you are granted a Generic Data Exemption, you rely on the efforts of other persons

to provide the Agency with the required data. If the registrant(s) who have committed to

generate and submit the required data fail to take appropriate steps to meet requirements or are

no longer in compliance with this Data Call-In Notice, the Agency will consider that both they

and you are not compliance and will normally initiate proceedings to suspend the registrations

of both your and their product(s), unless you commit to submit and do submit the required

data within the specified time. In such cases the Agency generally will not grant a time

extension for submitting the data.

d. Satisfying the Generic Data Requirements of this Notice

There are various options available to satisfy the generic data requirements of this

Notice. These options are discussed in Section III-C.1. of this Notice and comprise options 1

through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response

Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy

the generic data requirements), you must submit the Data Call-In Response Form and the

Requirements Status and Registrant's Response Form as well as any other information/data

pertaining to the option chosen to address the data requirement. Your response must be on the

forms marked "GENERIC" in item number 3.

e. Request for Generic Data Waivers.

Waivers for generic data are discussed in Section III-D.1. of this Notice and are

covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and

Registrant's Response Form. If you choose one of these options, you must submit both forms

as well as any other information/data pertaining to the option chosen to address the data

requirement.

2. Product Specific Data Requirements

The options for responding to this Notice for product specific data are: (a) voluntary

cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice

or (c) request a data waiver(s).

A discussion of how to respond if you choose the Voluntary Cancellation option is

presented below. A discussion of the various options available for satisfying the product

specific data requirements of this Notice is contained in Section III-C.2. A discussion of

options relating to requests for data waivers is contained in Section III-D.2.

Two forms apply to the product specific data requirements one or both of which must

be used in responding to the Agency, depending upon your response. These forms are the

Data-Call-In Response Form, and the Requirements Status and Registrant's Response Form,

for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-In

Response Form must be submitted as part of every response to this Notice. In addition, one

copy of the Requirements Status and Registrant's Response Form also must be submitted for

each product listed on the Data Call-In Response Form unless the voluntary cancellation option

is selected. Please note that the company's authorized representative is required to sign the

first page of the Data Call-In Response Form and Requirements Status and Reqistrant's

Response Form (if this form is required) and initial any subsequent pages. The forms contain
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separate detailed instructions on the response options. Do not alter the printed material. If you

have questions or need assistance in preparing your response, call or write the contact

person(s) identified in Attachment 1.

a. Voluntary Cancellation

You may avoid the requirements of this Notice by requesting voluntary cancellation of

your product(s) containing the active ingredient that is the subject of this Notice. If you wish

to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,

indicating your election of this option. Voluntary cancellation is item number 5 on both the

Generic and Product Specific Data Call-In Response Forms. If you choose this 

option, you must complete both Data Call-In response forms. These are the only forms that

you are required to complete. 

If you choose to voluntarily cancel your product, further sale and distribution of your

product after the effective date of cancellation must be in accordance with the Existing Stocks

provisions of this Notice which are contained in Section IV-C.

b. Satisfying the Product Specific Data Requirements of this Notice. 

There are various options available to satisfy the product specific data requirements of

this Notice. These options are discussed in Section III-C.2. of this Notice and comprise

options 1 through 6 of item 9 in the instructions for the product specific Requirements Status

and Reqistrant's Response Form and item numbers 7a and 7b (agree to satisfy the product

specific data requirements for an MUP or EUP as applicable) on the product specific Data

Call-In Response Form. Note that the options available for addressing product specific data

requirements differ slightly from those options for fulfilling generic data requirements.

Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling

product specific data requirements. It is important to ensure that you are using the correct

forms and instructions when completing your response to the Reregistration Eligibility

Decision document.

c. Request for Product Specific Data Waivers.

Waivers for product specific data are discussed in Section III-D.2. of this Notice and

are covered by option 7 of item 9 in the instructions for the Requirements Status and

Registrant's Response Form. If you choose this option, you must submit the Data Call-In

Response Form and the Requirements Status and Registrant's Response Form as well as any

other information/data pertaining to the option chosen to address the data requirement. Your

response must be on the forms marked "PRODUCT SPECIFIC" in item number 3. 

III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

1. Generic Data

If you acknowledge on the Generic Data Call-In Response Form that you agree to

satisfy the generic data requirements (i.e. you select item number 6b), then you must select

one of the six options on the Generic Requirements Status and Registrant's Response Form

related to data production for each data requirement. Your option selection should be entered

under item number 9, "Registrant Response." The six options related to data production are

the first six options discussed under item 9 in the instructions for completing the Requirements

Status and Registrant's Response Form. These six options are listed 

immediately below with information in parentheses to guide you to additional instructions

provided in this Section. The options are:
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(1) I will generate and submit data within the specified timeframe (Developing

Data)

(2) I have entered into an agreement with one or more registrants to develop data

jointly (Cost Sharing) 

(3) I have made offers to cost-share (Offers to Cost Share)

(4) I am submitting an existing study that has not been submitted previously to the

Agency by anyone (Submitting an Existing Study) 

(5) I am submitting or citing data to upgrade a study classified by EPA as partially

acceptable and upgradeable (Upgrading a Study)

(6) I am citing an existing study that EPA has classified as acceptable or an existing

study that has been submitted but not reviewed by the Agency (Citing an

Existing Study)

Option 1. Developing Data

If you choose to develop the required data it must be in conformance with Agency

deadlines and with other Agency requirements as referenced herein and in the attachments. All

data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40

CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be

in conformance with the requirements of PR Notice 86-5. In addition, certain studies require

Agency approval of test protocols in advance of study initiation. Those studies for which a

protocol must be submitted have been identified in the Requirements Status and Registrant's

Response Form and/or footnotes to the form. If you wish to use a protocol which differs from

the options discussed in Section II-C of this Notice, you must submit a detailed description of

the proposed protocol and your reason for wishing to use it. The Agency may choose to reject

a protocol not specified in Section II-C. If the Agency rejects your protocol you will be

notified in writing, however, you should be aware that rejection of a proposed protocol will

not be a basis for extending the deadline for submission of data.

A progress report must be submitted for each study within 90 days from the date you

are required to commit to generate or undertake some other means to address that study

requirement, such as making an offer to cost share or agreeing to share in the cost of

developing that study. This 90-day progress report must include the date the study was or will

be initiated and, for studies to be started within 12 months of commitment, the name and

address of the laboratory(ies) or individuals who are or will be conducting the study.

In addition, if the time frame for submission of a final report is more than 1 year,

interim reports must be submitted at 12 month intervals from the date you are required to

commit to generate or otherwise address the requirement for the study. In addition to the other

information specified in the preceding paragraph, at a minimum, a brief description of current

activity on and the status of the study must be included as well as a full

description of any problems encountered since the last progress report.

The time frames in the Requirements Status and Registrant's Response Form are the

time frames that the Agency is allowing for the submission of completed study reports or

protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.

If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of

Intent to Suspend the affected registration(s).

If you cannot submit the data/reports to the Agency in the time required by this Notice

and intend to seek additional time to meet the requirements(s), you must submit a request to

the Agency which includes: (1) a detailed description of the expected difficulty and (2) a

proposed schedule including alternative dates for meeting such requirements on a step-by-step

basis. You must explain any technical or laboratory difficulties and provide documentation

from the laboratory performing the testing. While EPA is considering your request, the
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original deadline remains. The Agency will respond to your request in writing. If EPA does

not grant your request, the original deadline remains. Normally, extensions can be requested

only in cases of extraordinary testing problems beyond the expectation or control of the

registrant. Extensions will not be given in submitting the 90-day responses. Extensions will

not be considered if the request for extension is not made in a timely fashion; in no event shall

an extension request be considered if it is submitted at or after the lapse of the subject

deadline.

Option 2. Agreement to Share in Cost to Develop Data

If you choose to enter into an agreement to share in the cost of producing the required

data but will not be submitting the data yourself, you must provide the name of the registrant

who will be submitting the data. You must also provide EPA with documentary evidence that

an agreement has been formed. Such evidence may be your letter offering to join in an

agreement and the other registrant's acceptance of your offer, or a written statement by the

parties that an agreement exists. The agreement to produce the data need not specify all of the

terms of the final arrangement between the parties or the mechanism to resolve the terms.

Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they

may resolve their differences through binding arbitration.

Option 3. Offer to Share in the Cost of Data Development

If you have made an offer to pay in an attempt to enter into an agreement or amend an

existing agreement to meet the requirements of this Notice and have been unsuccessful, you

may request EPA (by selecting this option) to exercise its discretion not to suspend your

registration(s), although you do not comply with the data submission requirements of this

Notice. EPA has determined that as a general policy, absent other relevant considerations, it

will not suspend the registration of a product of a registrant who has in good faith sought and

continues to seek to enter into a joint data development/cost sharing program, but the other

registrant(s) developing the data has refused to accept the offer. To qualify for this option, you

must submit documentation to the Agency proving that you have made an offer to another

registrant (who has an obligation to submit data) to share in the burden of developing that

data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of

Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must

demonstrate that the other registrant to whom the offer was made has not accepted your offer

to enter into a cost-sharing agreement by including a copy of your offer and proof of the other

registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition

to anything else, offer to share in the burden of producing the data upon terms to be agreed to

or, failing agreement, to be bound by binding arbitration as provided by FIFRA section

3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its

election of an option to develop and submit the data required by this Notice by submitting a

Data Call-In Response Form and a Requirements Status and Registrant's Response Form

committing to develop and submit the data required by this Notice.

In order for you to avoid suspension under this option, you may not withdraw your

offer to share in the burden of developing the data. In addition, the other registrant must fulfill

its commitment to develop and submit the data as required by this Notice. If the other

registrant fails to develop the data or for some other reason is subject to suspension, your

registration as well as that of the other registrant normally will be subject to initiation of

suspension proceedings, unless you commit to submit, and do submit, the required data in the

specified time frame. In such cases, the Agency generally will not grant a time extension for

submitting the data.
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Option 4. Submitting an Existing Study

If you choose to submit an existing study in response to this Notice, you must

determine that the study satisfies the requirements imposed by this Notice. You may only

submit a study that has not been previously submitted to the Agency or previously cited by

anyone. Existing studies are studies which predate issuance of this Notice. Do not use this

option if you are submitting data to upgrade a study. (See Option 5).

You should be aware that if the Agency determines that the study is not acceptable, the

Agency will require you to comply with this Notice, normally without an extension of the

required date of submission. The Agency may determine at any time that a study is not valid

and needs to be repeated.

To meet the requirements of the DCI Notice for submitting an existing study, all of the

following three criteria must be clearly Met:

a. You must certify at the time that the existing study is submitted that the raw

data and specimens from the study are available for audit and review and you

must identify where they are available. This must be done in accordance with

the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR

Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory

worksheets, records, memoranda, notes, or exact copies thereof, that are the

result of original observations and activities of a study and are necessary for the

reconstruction and evaluation of the report of that study. In the event that exact

transcripts of raw data have been prepared (e.g., tapes which have been

transcribed verbatim, dated, and verified accurate by signature), the exact copy

or exact transcript may be substituted for the original source as raw data. 'Raw

data' may include photographs, microfilm or microfiche copies, computer

printouts, magnetic media, including dictated observations, and recorded data

from automated instruments." The term "specimens", according to 40 CFR

160.3, means "any material derived from a test system for examination or

analysis."

b. Health and safety studies completed after May 1984 also must also contain all

GLP-required quality assurance and quality control information, pursuant to the

requirements of 40 CFR Part 160. Registrants also must certify at the time of

submitting the existing study that such GLP information is available for post

May 1984 studies by including an appropriate statement on or attached to the

study signed by an authorized official or representative of the registrant.

c. You must certify that each study fulfills the acceptance criteria for the Guideline

relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3

Technical Guidance and that the study has been conducted according to the

Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both

available from NTIS). A study not conducted according to the PAG may be

submitted to the Agency for consideration if the registrant believes that the

study clearly meets the purpose of the PAG. The registrant is referred to 40

CFR 158.70 which states the Agency's policy regarding acceptable protocols. If

you wish to submit the study, you must, in addition to certifying that the

purposes of the PAG are met by the study, clearly articulate the rationale why

you believe the study meets the purpose of the PAG, including copies of any

supporting information or data. It has been the Agency's experience that studies

completed prior to January 1970 rarely satisfied the purpose of the PAG and

that necessary raw data usually are not available for such studies.
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If you submit an existing study, you must certify that the study meets all requirements

of the criteria outlined above.

If EPA has previously reviewed a protocol for a study you are submitting, you must

identify any action taken by the Agency on the protocol and must indicate, as part of your

certification, the manner in which all Agency comments, concerns, or issues were addressed

in the final protocol and study.

If you know of a study pertaining to any requirement in this Notice which does not

meet the criteria outlined above but does contain factual information regarding unreasonable

adverse effects, you must notify the Agency of such a study. If such study is in the Agency's

files, you need only cite it along with the notification. If not in the Agency's files, you must

submit a summary and copies as required by PR Notice 86-5.

Option 5. Upgrading a Study

If a study has been classified as partially acceptable and upgradeable, you may submit

data to upgrade that study. The Agency will review the data submitted and determine if the

requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still

be required to submit new data normally without any time extension. Deficient, but

upgradeable studies will normally be classified as supplemental. However, it is important to

note that not all studies classified as supplemental are upgradeable. If you have questions

regarding the classification of a study or whether a study may be upgraded, call or write the

contact person listed in Attachment 1. If you submit data to upgrade an existing study you

must satisfy or supply information to correct all deficiencies in the study identified by EPA.

You must provide a clearly articulated rationale of how the deficiencies have been remedied or

corrected and why the study should be rated as acceptable to EPA. Your submission must also

specify the MRID number(s) of the study which you are attempting to upgrade and must be in

conformance with PR Notice 86-5.

Do not submit additional data for the purpose of upgrading a study classified as

unacceptable and determined by the Agency as not capable of being upgraded.

This option also should be used to cite data that has been previously submitted to

upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID

number of the data submission as well as the MRID number of the study being upgraded.

The criteria for submitting an existing study, as specified in Option 4 above, apply to

all data submissions intended to upgrade studies. Additionally, your submission of data

intended to upgrade studies must be accompanied by a certification that you comply with each

of those criteria, as well as a certification regarding protocol compliance with Agency 

requirements.

Option 6. Citing Existing Studies

If you choose to cite a study that has been previously submitted to EPA, that study

must have been previously classified by EPA as acceptable, or it must be a study which has

not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been

classified as "core-guideline" or "core-minimum." For ecological effects studies, the

classification generally would be a rating of "core." For all other disciplines the classification

would be "acceptable." With respect to any studies for which you wish to select this option,

you must provide the MRID number of the study you are citing and, if the study has been

reviewed by the Agency, you must provide the Agency's classification of the study.

If you are citing a study of which you are not the original data submitter, you must
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submit a completed copy of EPA Form 8570-31, Certification with Respect to Data

Compensation Requirements.

2. Product Specific Data

If you acknowledge on the product specific Data Call-In Response Form that you agree

to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you

must select one of the six options on the Requirements Status and Reqistrant's Response Form

related to data production for each data requirement. Your option selection should be entered

under item number 9, "Registrant Response." The six options related to data production are

the first six options discussed under item 9 in the instructions for completing the Requirements

Status and Registrant's Response Form. These six options are listed immediately below with

information in parentheses to guide registrants to additional instructions provided in this

Section. The options are:

(1) I will generate and submit data within the specified time-frame (Developing

Data)

(2) I have entered into an agreement with one or more registrants to develop data

jointly (Cost Sharing) 

(3) I have made offers to cost-share (Offers to Cost Share)

(4) I am submitting an existing study that has not been submitted previously to the

Agency by anyone (Submitting an Existing Study) 

(5) I am submitting or citing data to upgrade a study classified by EPA as partially

acceptable and upgradeable (Upgrading a Study)

(6) I am citing an existing study that EPA has classified as acceptable or an existing

study that has been

submitted but not reviewed by the Agency (Citing an Existing Study)

Option 1. Developing Data -- The requirements for developing product specific data are the

same as those described for generic data (see Section III.C.1, Option 1) except that normally

no protocols or progress reports are required.

Option 2. Agree to Share in Cost to Develop Data -- If you enter into an agreement to cost

share, the same requirements apply to product specific data as to generic data (see Section

III.C.1, Option 2). However, registrants may only choose this option for acute toxicity data

and certain efficacy data and only if EPA has indicated in the attached data tables that your

product and at least one other product are similar for purposes of depending on

the same data. If this is the case, data may be generated for just one of the products in the

group. The registration number of the product for which data will be submitted must be noted

in the agreement to cost share by the registrant selecting this option.

Option 3. Offer to Share in the Cost of Data Development --The same requirements for

generic data (Section III.C.I., Option 3) apply to this option. This option only applies to acute

toxicity and certain efficacy data as described in option 2 above.

Option 4. Submitting an Existing Study -- The same requirements described for generic data

(see Section III.C.1., Option 4) apply to this option for product specific data.

Option 5. Upgrading a Study -- The same requirements described for generic data (see Section

III.C.1., Option 5) apply to this option for product specific data.

Option 6. Citing Existing Studies -- The same requirements described for generic data (see

Section III.C.1., Option 6) apply to this option for product specific data.

Registrants who select one of the above 6 options must meet all of the requirements

described in the instructions for completing the Data Call-In Response Form and the
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Requirements Status and Registrant's Response Form, and in the generic data requirements

section (III.C.1.), as appropriate.

III-D REQUESTS FOR DATA WAIVERS

1. Generic Data

There are two types of data waiver responses to this Notice. The first is a request for a

low volume/minor use waiver and the second is a waiver request based on your belief that the

data requirement(s) are not appropriate for your product.

a. Low Volume/Minor Use Waiver

Option 8 under item 9 on the Requirements Status and Registrant's Response

Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of

requiring data for low volume, minor use pesticides. In implementing this provision,

EPA considers low volume pesticides to be only those active ingredients whose total

production volume for all pesticide registrants is small. In determining whether to grant

a low volume, minor use waiver, the Agency will consider the extent, pattern and

volume of use, the economic incentive to conduct the testing, the importance of the

pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is

used for both high volume and low volume uses, a low volume exemption will not be

approved. If all uses of an active ingredient are low volume and the combined volumes

for all uses are also low, then an exemption may be granted, depending on review of

other information outlined below. An exemption will not be granted if any registrant of

the active ingredient elects to conduct the testing. Any registrant receiving a low

volume minor use waiver must remain within the sales figures in their forecast

supporting the waiver request in order to remain qualified for such waiver. If granted a

waiver, a registrant will be required, as a condition of the waiver, to submit annual

sales reports. The Agency will respond to requests for waivers in writing.

To apply for a low volume, minor use waiver, you must submit the following

information, as applicable to your product(s), as part of your 90-day response to this

Notice:

(i). Total company sales (pounds and dollars) of all registered product(s)

containing the active ingredient. If applicable to the active ingredient, include foreign

sales for those products that are not registered in this country but are applied to sugar

(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above

information by year for each of the past five years.

(ii) Provide an estimate of the sales (pounds and dollars) of the active

ingredient for each major use site. Present the above information by year for each of

the past five years.

(iii) Total direct production cost of product(s) containing the active ingredient

by year for the past five years. Include information on raw material cost, direct labor

cost, advertising, sales and marketing, and any other significant costs listed separately.

(iv) Total indirect production cost (e.g. plant overhead, amortized plant and

equipment) charged to product(s) containing the active ingredient by year for the past

five years. Exclude all non-recurring costs that were directly related to the active

ingredient, such as costs of initial registration and any data development.
229

(v) A list of each data requirement for which you seek a waiver. Indicate the

type of waiver sought and the estimated cost to you (listed separately for each data

requirement and associated test) of conducting the testing needed to fulfill each of these

data requirements.

(vi) A list of each data requirement for which you are not seeking any waiver

and the estimated cost to you (listed separately for each data requirement and associated

test) of conducting the testing needed to fulfill each of these data requirements.

(vii) For each of the next ten years, a year-by-year forecast of company sales

(pounds and dollars) of the active ingredient, direct production costs of product(s)

containing the active ingredient (following the parameters in item 2 above), indirect

production costs of product(s) containing the active ingredient (following the

parameters in item 3 above), and costs of data development pertaining to the active

ingredient.

(viii) A description of the importance and unique benefits of the active

ingredient to users. Discuss the use patterns and the effectiveness of the active

ingredient relative to registered alternative chemicals and non-chemical control

strategies. Focus on benefits unique to the active ingredient, providing information that

is as quantitative as possible. If you do not have quantitative data upon which to base

your estimates, then present the reasoning used to derive your estimates. To assist the

Agency in determining the degree of importance of the active ingredient in terms of its

benefits, you should provide information on any of the following factors, as applicable

to your product(s): (a) documentation of the usefulness of the active ingredient in

Integrated Pest Management, (b) description of the beneficial impacts on the

environment of use of the active ingredient, as opposed to its registered alternatives,

(c) information on the breakdown of the active ingredient after use and on its

persistence in the environment, and (d) description of its usefulness against a pest(s) of

public health significance.

Failure to submit sufficient information for the Agency to make a determination

regarding a request for a low volume/minor use waiver will result in denial of the

request for a waiver.

b. Request for Waiver of Data

Option 9, under Item 9, on the Requirements Status and Registrant's Response

Form. This option may be used if you believe that a particular data requirement should

not apply because the requirement is inappropriate. You must submit a rationale

explaining why you believe the data requirements should not apply. You also must

submit the current label(s) of your product(s) and, if a current copy of your

Confidential Statement of Formula is not already on file you must submit a current

copy.

You will be informed of the Agency's decision in writing. If the Agency

determines that the data requirements of this Notice are not appropriate to your

product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If

EPA determines that the data are required for your product(s), you must choose a

method of meeting the requirements of this Notice within the time frame provided by

this Notice. Within 30 days of your receipt of the Agency's written decision, you must

submit a revised Requirements Status and Registrant's Response Form indicating the

option chosen.
230

2. Product Specific Data

If you request a waiver for product specific data because you believe it is

inappropriate, you must attach a complete justification for the request including

technical reasons, data and references to relevant EPA regulations, guidelines or

policies. (Note: any supplemental data must be submitted in the format required by PR

Notice 86-5). This will be the only opportunity to state the reasons or provide

information in support of your request. If the Agency approves your waiver request,

you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If

the Agency denies your waiver request, you must choose an option for meeting the data

requirements of this Notice within 30 days of the receipt of the Agency's decision. 

You must indicate and submit the option chosen on the product specific Requirements

Status and Registrant's Response Form. Product specific data requirements for product

chemistry, acute toxicity and efficacy (where appropriate) are required for all products

and the Agency would grant a waiver only under extraordinary circumstances. You

should also be aware that submitting a waiver request will not automatically extend the

due date for the study in question. Waiver requests submitted without adequate

supporting rationale will be denied and the original due date will remain in force.

SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS

NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

The Agency may issue a Notice of Intent to Suspend products subject to this Notice due

to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant

to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent

to Suspend include, but are not limited to, the following:

1. Failure to respond as required by this Notice within 90 days of your receipt of

this Notice.

2. Failure to submit on the required schedule an acceptable proposed or final

protocol when such is required to be submitted to the Agency for review.

3. Failure to submit on the required schedule an adequate progress report on a

study as required by this Notice.

4. Failure to submit on the required schedule acceptable data as required by this

Notice.

5. Failure to take a required action or submit adequate information pertaining to

any option chosen to address the data requirements (e.g., any required action or

information pertaining to submission or citation of existing studies or offers,

arrangements, or arbitration on the sharing of costs or the formation of Task

Forces, failure to comply with the terms of an agreement or arbitration

concerning joint data development or failure to comply with any terms of a data

waiver).

6. Failure to submit supportable certifications as to the conditions of submitted

studies, as required by Section III-C of this Notice.

7. Withdrawal of an offer to share in the cost of developing required data.
231

8. Failure of the registrant to whom you have tendered an offer to share in the cost

of developing data and provided proof of the registrant's receipt of such offer

or failure of a registrant on whom you rely for a generic data exemption either

to:

i. Inform EPA of intent to develop and submit the data required by this Notice

on a Data Call-In Response Form and a Requirements Status and Reqistrant's

Response Form.

ii. Fulfill the commitment to develop and submit the data as required by this

Notice; or

iii. Otherwise take appropriate steps to meet the requirements stated in this

Notice,

unless you commit to submit and do submit the required data in the specified

time frame.

9. Failure to take any required or appropriate steps, not mentioned above, at any

time following the issuance of this Notice.

IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS

UNACCEPTABLE

The Agency may determine that a study (even if submitted within the required time) is

unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds

for suspension include, but are not limited to, failure to meet any of the following:

1) EPA requirements specified in the Data Call-In Notice or other documents

incorporated by reference (including, as applicable, EPA Pesticide Assessment

Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)

regarding the design, conduct, and reporting of required studies. Such requirements

include, but are not limited to, those relating to test material, test procedures, selection

of species, number of animals, sex and distribution of animals, dose and effect levels to

be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.

2) EPA requirements regarding the submission of protocols, including the

incorporation of any changes required by the Agency following review.

3) EPA requirements regarding the reporting of data, including the manner of

reporting, the completeness of results, and the adequacy of any required supporting (or

raw) data, including, but not limited to, requirements referenced or included in this

Notice or contained in PR 86-5. All studies must be submitted in the form of a final

report; a preliminary report will not be considered to fulfill the submission

requirement.

IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

EPA has statutory authority to permit continued sale, distribution and use of existing

stocks of a pesticide product which has been suspended or cancelled if doing so would be

consistent with the purposes of the Act.

The Agency has determined that such disposition by registrants of existing stocks for a

suspended registration when a section 3(c)(2)(B) data request is outstanding generally would

not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting

registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
232

exceptional circumstances. If you believe such disposition of existing stocks of your product(s)

which may be suspended for failure to comply with this Notice should be permitted, you have

the burden of clearly demonstrating to EPA that granting such permission would be consistent

with the Act. You also must explain why an "existing stocks" provision is necessary, including

a statement of the quantity of existing stocks and your estimate of the time required for their

sale, distribution, and use. Unless you meet this burden, the Agency will not consider any

request pertaining to the continued sale, distribution, or use of your existing stocks after

suspension.

If you request a voluntary cancellation of your product(s) as a response to this Notice

and your product is in full compliance with all Agency requirements, you will have, under

most circumstances, one year from the date your 90 day response to this Notice is due, to sell,

distribute, or use existing stocks. Normally, the Agency will allow persons other than the

registrant such as independent distributors, retailers and end users to sell, distribute or use

such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of

voluntarily cancelled products containing an active ingredient for which the Agency has

particular risk concerns will be determined on a case-by-case basis.

Requests for voluntary cancellation received after the 90 day response period required

by this Notice will not result in the agency granting any additional time to sell, distribute, or

use existing stocks beyond a year from the date the 90 day response was due, unless you

demonstrate to the Agency that you are in full compliance with all Agency requirements,

including the requirements of this Notice. For example, if you decide to voluntarily cancel

your registration six months before a 3-year study is scheduled to be submitted, all progress

reports and other information necessary to establish that you have been conducting the study in

an acceptable and good faith manner must have been submitted to the Agency, before EPA

will consider granting an existing stocks provision.

SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE

UNREASONABLE ADVERSE EFFECTS

Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a

pesticide is registered a registrant has additional factual information regarding unreasonable

adverse effects on the environment by the pesticide, the registrant shall submit the information

to the Agency. Registrants must notify the Agency of any factual information they have, from

whatever source, including but not limited to interim or preliminary results of studies,

regarding unreasonable adverse effects on man or the environment. This requirement

continues as long as the products are registered by the Agency.

SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding the requirements and procedures established by

this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status

Sheet.
233

All responses to this Notice must include completed Data Call-In Response Forms

(Attachment 2)and completed Requirements Status and Registrant's Response Forms

(Attachment 3), for both (generic and product specific data) and any other documents required

by this Notice, and should be submitted to the contact person(s) identified in Attachment 1. If

the voluntary cancellation or generic data exemption option is chosen, only the Generic and

Product Specific Data Call-In Response Forms need be submitted.

The Office of Compliance (OC) of the Office of Enforcement and Compliance

Assurance (OECA), EPA, will be monitoring the data being generated in response to this

Notice.

Sincerely yours,

Lois Rossi, Division Director 

Special Review and

 Reregistration Division

Attachments

The Attachments to this Notice are:

1 - Data Call-In Chemical Status Sheet

2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with

Instructions

3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status

and Registrant's Response Forms with Instructions

4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data

Requirements for Reregistration

5 - EPA Acceptance Criteria

6 - List of Registrants Receiving This Notice

7 - Confidential Statement of Formula, Cost Share and Data Compensation Forms
234
235

Attachment 1. Chemical Status Sheets
236
237

PICLORAM GENERIC DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

You have been sent this Generic Data Call-In Notice because you have product(s)

containing Picloram and its derivatives.

This Generic Data Call-In Chemical Status Sheet, contains an overview of data

required by this notice, and point of contact for inquiries pertaining to the reregistration of

Picloram. This attachment is to be used in conjunction with (1) the Generic Data Call-In

Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements

Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI

(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and

Data Compensation Forms in replying to this Picloram Generic Data Call-In (Attachment F). 

Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

The additional data requirements needed to complete the generic database for Picloram

are contained in the Requirements Status and Registrant's Response, Attachment C. The

Agency has concluded that additional product chemistry data on Picloram are needed. These

data are needed to fully complete the reregistration of all eligible Picloram products.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding the generic data requirements and procedures

established by this Notice, please contact Venus Eagle at (703) 308-8045.

All responses to this Notice for the generic data requirements should be submitted to:

Venus Eagle, Chemical Review Manager 

Reregistration Branch

Special Review and Registration Division (H7508W)

Office of Pesticide Programs

U.S. Environmental Protection Agency

Washington, D.C. 20460

RE: Picloram
238

PICLORAM PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

You have been sent this Product Specific Data Call-In Notice because you have

product(s) containing Picloram and its derivatives.

This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data

required by this notice, and point of contact for inquiries pertaining to the reregistration of

Picloram. This attachment is to be used in conjunction with (1) the Product Specific Data

Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the

Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use

Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA

Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)

and (7) the Cost Share and Data Compensation Forms in replying to this Picloram Product

Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

The additional data requirements needed to complete the database for Picloram are

contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency

has concluded that additional data on Picloram are needed for specific products. These data are

required to be submitted to the Agency within the time frame listed. These data are needed to

fully complete the reregistration of all eligible Picloram products.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding the generic database of Picloram, please contact

Venus Eagle at (703) 308-8045.

If you have any questions regarding the product specific data requirements and

procedures established by this Notice, please contact Emily Mitchell at (703) 308-8583.

All responses to this Notice for the Product Specific data requirements should be

submitted to:

Emily Mitchell

Chemical Review Manager Team 81

Product Reregistration Branch

Special Review and Reregistration Branch 7508W

Office of Pesticide Programs

U.S. Environmental Protection Agency

Washington, D.C. 20460

RE: Picloram
239

Attachment 2. Combined Generic and Product Specific

Data Call-In Response Forms (Form A inserts) Plus

Instructions
240
241

Instructions For Completing The "Data Call-In Response Forms" For The Generic And

Product Specific Data Call-In

INTRODUCTION

These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"

and are to be used by registrants to respond to generic and product specific Data Call-Ins as

part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and

Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI

letter as part of a RED document you have been sent just the product specific "Data Call-In

Response Forms." Only registrants responsible for generic data have been sent the generic

data response form. The type of Data Call-In (generic or product specific) is indicated in

item number 3 ("Date and Type of DCI") on each form.

Although the form is the same for both generic and product specific data, instructions for

completing these forms are different. Please read these instructions carefully before filling out

the forms.

EPA has developed these forms individually for each registrant, and has preprinted these

forms with a number of items. DO NOT use these forms for any other active ingredient.

Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by

the registrant as appropriate. Items 8 through 11 must be completed by the registrant before

submitting a response to the Agency.

The public reporting burden for this collection of information is estimated to average 15

minutes per response, including time for reviewing instructions, searching existing data

sources, gathering and maintaining the data needed, and completing and reviewing the

collection of information. Send comments regarding the burden estimate or any other aspect of

this collection of information, including suggestions for reducing this burden, to Chief,

Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M

St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,

Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
242

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic and Product Specific Data Call-In

Item 1.ON BOTH FORMS: This item identifies your company name, number and address.

Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical

number and chemical name.

Item 3.ON BOTH FORMS: This item identifies the type of Data Call-In. The date of

issuance is date stamped.

Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to

the data call-in. Please note that you are also responsible for informing the Agency of your

response regarding any product that you believe may be covered by this Data Call-In but that

is not listed by the Agency in Item 4. You must bring any such apparent omission to the

Agency's attention within the period required for submission of this response form.

Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel

voluntarily. If a registration number is listed for a product for which you previously requested

voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-In

requires both generic and product specific data, you must complete item 5 on both Data CallIn response forms. You do not need to complete any item on the Requirements Status and

Registrant's Response Forms.

Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for

generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the

chemical listed in Item 2 and used in the subject product. By electing this exemption, you

agree to the terms and conditions of a Generic Data Exemption as explained in the Data

Call-In Notice.

If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number

of each registered source of that active ingredient that you use in your product.

Typically, if you purchase an EPA-registered product from one or more other producers

(who, with respect to the incorporated product, are in compliance with this and any other

outstanding Data Call-In Notice), and 

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic and Product Specific Data Call-In

incorporate that product into all your products, you may complete this item for all products

listed on this form. If, however, you produce the active ingredient yourself, or use any

unregistered product (regardless of the fact that some of your sources are registered), you may

not claim a Generic Data Exemption and you may not select this item.

Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for

generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data

requirements of this Data Call-In. Attach the Requirements Status and Registrant's Response

Form that indicates how you will satisfy those requirements.

NOTE: Item 6a and 6b are not applicable for Product Specific Data.
243

Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you

may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this

product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.

Item 7a.ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use

product (MUP) for which you wish to maintain registration, you must agree to satisfy the data

requirements by responding "yes."

Item 7b.For each end use product (EUP) for which you wish to maintain registration, you

must agree to satisfy the data requirements by responding "yes." 

FOR BOTH MUP and EUP products

You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product

is identical to another product and you qualify for a data exemption. You must provide the

EPA registration numbers of your source(s); do not complete the Requirements Status and

Registrant's Response form. Examples of such products include repackaged products and

Special Local Needs (Section 24c) products which are identical to federally registered

products.

If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements

Status and Registrant's Response" form under Item 9, you must respond with option 7 (Waiver

Request) for each study for which you are requesting a waiver. 

NOTE: Item 7a and 7b are not applicable for Generic Data.

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic and Product Specific Data Call-In

Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized

representative of your company and the person signing must include his/her title. Additional

pages used in your response must be initialled and dated in the space provided for the

certification.

Item 9.ON BOTH FORMS: Enter the date of signature.

Item 10.ON BOTH FORMS: Enter the name of the person EPA should contact with

questions regarding your response.

Item 11.ON BOTH FORMS: Enter the phone number of your company contact.
244
245

Attachment 3. Generic and Product Specific Requirement

Status and Registrant's Response Forms (Form B inserts)

and Instructions
246
247

Instructions For Completing

The

"Requirements Status and Registrant's Response Forms"

For The Generic and Product Specific Data Call-In

INTRODUCTION

These instructions apply to the Generic and Product Specific "Requirements Status and

Registrant's Response Forms" and are to be used by registrants to respond to generic and

product specific Data Call-In's as part of EPA's reregistration program under the Federal

Insecticide, Fungicide, and Rodenticide Act. If you are an end-use product registrant only

and have been sent this DCI letter as part of a RED document you have been sent just the

product specific "Requirements Status and Registrant's Response Forms." Only registrants

responsible for generic data have been sent the generic data response forms. The type of

Data Call-In (generic or product specific) is indicated in item number 3 ("Date and Type

of DCI") on each form.

Although the form is the same for both product specific and generic data, instructions

for completing the forms differ slightly. Specifically, options for satisfying product specific

data requirements do not include (1) deletion of uses or (2) request for a low volume/minor

use waiver. Please read these instructions carefully before filling out the forms. 

EPA has developed these forms individually for each registrant, and has preprinted

these forms to include certain information unique to this chemical. DO NOT use these forms

for any other active ingredient.

Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the

registrant as appropriate. Items 10 through 13 must be completed by the registrant before

submitting a response to the Agency. 

The public reporting burden for this collection of information is estimated to average

30 minutes per response, including time for reviewing instructions, searching existing data

sources, gathering and maintaining the data needed, and completing and reviewing the

collection of information. Send comments regarding the burden estimate or any other aspect of

this collection of information, including suggestions for reducing this burden, to Chief,

Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M

St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,

Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
248

INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND

REGISTRANT'S RESPONSE FORMS" 

Generic and Product Specific Data Call-In

Item 1. ON BOTH FORMS: This item identifies your company name, number and

address.

Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,

case name, EPA chemical number and chemical name.

ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the 

case number, case name, and the EPA Registration Number of the product for

which the Agency is requesting product specific data. 

Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data

Call-In. The date of issuance is date stamped. 

ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type

of Data Call-In. The date of issuance is also date stamped. Note the unique

identifier number (ID#) assigned by the Agency. This ID number must be used

in the transmittal document for any data submissions in response to this Data

Call-In Notice.

Item 4. ON BOTH FORMS: This item identifies the guideline reference number of

studies required. These guidelines, in addition to the requirements specified in

the Data Call-In Notice, govern the conduct of the required studies. Note that

series 61 and 62 in product chemistry are now listed under 40 CFR 158.155

through 158.180, Subpart c.

Item 5. ON BOTH FORMS: This item identifies the study title associated with the

guideline reference number and whether protocols and 1, 2, or 3-year progress

reports are required to be submitted in connection with the study. As noted in

Section III of the Data Call-In Notice, 90-day progress reports are required for

all studies.

If an asterisk appears in Item 5, EPA has attached information relevant to this

guideline reference number to the Requirements Status and Reqistrant's

Response Form.

INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND

REGISTRANT'S RESPONSE FORMS" 

Generic and Product Specific Data Call-In

Item 6. ON BOTH FORMS: This item identifies the code associated with the use

pattern of the pesticide. In the case of efficacy data (product specific 

requirement), the required study only pertains to products which have the use

sites and/or pests indicated. A brief description of each code follows:

A Terrestrial food

B Terrestrial feed

C Terrestrial non-food
249

D Aquatic food

E Aquatic non-food outdoor

F Aquatic non-food industrial

G Aquatic non-food residential

H Greenhouse food

I Greenhouse non-food crop

J Forestry

K Residential

L Indoor food

M Indoor non-food

N Indoor medical

O Indoor residential

Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance

that must be used for testing. A brief description of each code follows: 

EUP End-Use Product

MP Manufacturing-Use Product

MP/TGAI Manufacturing-Use Product and Technical Grade Active

Ingredient

PAI Pure Active Ingredient

PAI/M Pure Active Ingredient and Metabolites

PAI/PAIRA Pure Active Indredient or Pute Active 

Ingredient Radiolabelled

PAIRA Pure Active Ingredient Radiolabelled

PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites

PAIRA/PM Pure Active Ingredient Radiolabelled and Plant

Metabolites

TEP Typical End-Use Product

TEP ___% Typical End-Use Product, Percent Active Ingredient

Specified

TEP/MET Typical End-Use Product and Metabolites

TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and

Metabolites

TGAI Technical Grade Active Ingredient

TGAI/PAI Technical Grade Active Ingredient or Pure Active

Ingredient

TGAI/PAIRA Technical Grade Active Ingredient or Pure Active

Ingredient Radiolabelled

TGAI/TEP Technical Grade Active Ingredient or Typical End-Use

Product

MET Metabolites

IMP Impurities

DEGR Degradates

* See: guideline comment

Item 8. This item completed by the Agency identifies the time frame allowed for

submission of the study or protocol identified in item 5. 

ON THE GENERIC DATA FORM: The time frame runs from the date of

your receipt of the Data Call-In notice.

ON THE PRODUCT SPECIFIC DATA FORM: The due date for

submission of product specific studies begins from the date stamped on the letter

transmitting the Reregistration Eligibility Decision document, and not from the
250

date of receipt. However, your response to the Data Call-In itself is due 90

days from the date of receipt. 

Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show

how you intend to comply with each data requirement. Brief descriptions of

each code follow. The Data Call-In Notice contains a fuller description of each

of these options.

Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study and

submit it within the time frames specified in item 8 above. By indicating

that I have chosen this option, I certify that I will comply with all the

requirements pertaining to the conditions for submittal of this study as

outlined in the Data Call-In Notice and that I will provide the protocols

and progress reports required in item 5 above.

Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have entered into an

agreement with one or more registrants to develop data jointly. By

indicating that I have chosen this option, I certify that I will comply with

all the requirements pertaining to sharing in the cost of developing data

as outlined in the Data Call-In Notice.

However, for Product Specific Data, I understand that this

option is available for acute toxicity or certain efficacy data ONLY if

the Agency indicates in an attachment to this notice that my product is

similar enough to another product to qualify for this option. I certify that

another party in the agreement is committing to submit or provide the

required data; if the required study is not submitted on time, my product

may be subject to suspension.

Option 3. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to

enter into an agreement with one or more registrants to develop data

jointly. I am also submitting a completed "Certification of offer to Cost

Share in the Development of Data" form. I am submitting evidence that

I have made an offer to another registrant (who has an obligation to

submit data) to share in the cost of that data. I am including a copy of

my offer and proof of the other registrant's receipt of that offer. I am

identifying the party which is committing to submit or provide the

required data; if the required study is not submitted on time, my product

may be subject to suspension. I understand that other terms under Option

3 in the Data Call-In Notice apply as well.

However, for Product Specific Data, I understand that this

option is available only for acute toxicity or certain efficacy data and

only if the Agency indicates in an attachment to this Data Call-In Notice

that my product is similar enough to another product to qualify for this

option. 

Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an

existing study by the specified due date that has never before been

submitted to EPA. By indicating that I have chosen this option, I certify

that this study meets all the requirements pertaining to the conditions for

submittal of existing data outlined in the Data Call-In Notice and I have

attached the needed supporting information along with this response.
251

Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit by the

specified due date, or will cite data to upgrade a study that EPA has

classified as partially acceptable and potentially upgradeable. By

indicating that I have chosen this option, I certify that I have met all the

requirements pertaining to the conditions for submitting or citing

existing data to upgrade a study described in the Data Call-In Notice. I

am indicating on attached correspondence the Master Record

Identification Number (MRID) that EPA has assigned to the data that I

am citing as well as the MRID of the study I am attempting to upgrade.

Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study

that has been previously classified by EPA as acceptable, core, core

minimum, or a study that has not yet been reviewed by the Agency. If

reviewed, I am providing the Agency's classification of the study.

However, for Product Specific Data, I am citing another

registrant's study. I understand that this option is available ONLY for

acute toxicity or certain efficacy data and ONLY if the cited study was

conducted on my product, an identical product or a product which the

Agency has "grouped" with one or more other products for purposes of

depending on the same data. I may also choose this option if I am citing

my own data. In either case, I will provide the MRID or Accession

number (s). If I cite another registrant's data, I will submit a completed

"Certification With Respect To Data Compensation Requirements"

form.

FOR THE GENERIC DATA FORM ONLY: The following three options

(Numbers 7, 8, and 9) are responses that apply only to the "Requirements Status

and Registrant's Response Form" for generic data. 

Option 7. (Deleting Uses) I am attaching an application for amendment to my

registration deleting the uses for which the data are required.

Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements

concerning low volume-minor use data waivers in the Data Call-In

Notice and I request a low-volume minor use waiver of the data

requirement. I am attaching a detailed justification to support this waiver

request including, among other things, all information required to

support the request. I understand that, unless modified by the Agency in

writing, the data requirement as stated in the Notice governs.

Option 9. (Request for Waiver of Data) I have read the statements concerning data

waivers other than lowvolume minor-use data waivers in the Data

Call-In Notice and I request a waiver of the data requirement. I am

attaching a rationale explaining why I believe the data requirements do

not apply. I am also submitting a copy of my current labels. (You must

also submit a copy of your Confidential Statement of Formula if not

already on file with EPA). I understand that, unless modified by the

Agency in writing, the data requirement as stated in the Notice governs.

FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a

response that applies to the "Requirements Status and Registrant's Response

Form" for product specific data. 
252

NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example,

you may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled

Option 7. (Waiver Request) I request a waiver for this study because it is

inappropriate for my product. I am attaching a complete justification for

this request, including technical reasons, data and references to relevant

EPA regulations, guidelines or policies. [Note: any supplemental data

must be submitted in the format required by P.R. Notice 86-5]. I

understand that this is my only opportunity to state the reasons or

provide information in support of my request. If the Agency approves

my waiver request, I will not be required to supply the data pursuant to

Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,

I must choose a method of meeting the data requirements of this Notice

by the due date stated by this Notice. In this case, I must, within 30

days-of my receipt of the Agency's written decision, submit a revised

"Requirements Status" form specifying the option chosen. I also

understand that the deadline for submission of data as specified by the

original Data Call-In notice will not change.

Item 10. ON BOTH FORMS: This item must be signed by an authorized representative

of your company. The person signing must include his/her title, and must initial

and date all other pages of this form.

Item 11. ON BOTH FORMS: Enter the date of signature.

Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with

questions regarding your response.

Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
253

Attachment 4. EPA Batching of End-Use Products for

Meeting Data Requirements for Reregistration
254
255

EPA'S DECISION ON BATCHING PRODUCTS CONTAINING PICLORAM FOR

PURPOSES OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR

REREGISTRATION

In an effort to reduce the time, resources and number of animals needed to fulfill the

acute toxicity data requirements for reregistration of products containing the active ingredient

picloram the Agency considered batching products. This process involves grouping similar

products for purposes of acute toxicity. Factors considered in the sorting process include each

product's active and inert ingredients (identity, percent composition and biological activity),

type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.),

and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the

Agency is not describing batched products as "substantially similar" since some products

within a batch may not be considered chemically similar or have identical use patterns.

Using available information, batching has been accomplished by the process described

in the preceding paragraph. Acute toxicity data on individual products has frequently been

found to be incomplete. Notwithstanding the batching process, the Agency reserves the right

to require, at any time, acute toxicity data for an individual product should the need arise.

Registrants of products within a batch may choose to cooperatively generate, submit or

cite a single battery of six acute toxicological studies to represent all the products within that

batch. It is the registrants' option to participate in the process with all other registrants, only

some of the other registrants, or only their own products within a batch, or to generate all the

required acute toxicological studies for each of their own products. If a registrant chooses to

rely upon previously submitted acute toxicity data, he/she may do so provided that the data

base is complete and valid by today's standards (see acceptance criteria attached), the

formulation tested is considered by EPA to be similar for acute toxicity, and the formulation

has not been significantly altered since submission and acceptance of the acute toxicity data. 

Regardless of whether new data is generated or existing data is cited, the registrant must

clearly identify the material tested by its EPA registration number. If more than one

Confidential Statement of Formula (CSF) exists for a product, the registrant must indicate the

formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements, registrants must follow

the directions given in the Data Call-In Notice and its attachments appended to the RED. The

DCI Notice contains two response forms which are to be completed and submitted to the

Agency within 90 days of receipt. The first form, "Data Call-In Response", asks whether the

registrant will meet the data requirements for each product. The second form, "Requirements

Status and Registrant's Response", lists the product specific data required for each product,

including the standard six acute toxicity tests. A registrant who wishes to participate in a

batch must decide whether he/she will provide the data or depend on someone else to do so. 

If a registrant supplies the data to support a batch of products, he/she must select one of the

following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),

Upgrading an Existing Study (Option 5), or Citing an Existing Study (Option 6). If a

registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2),

Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does

not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant

should know that choosing not to participate in a batch does not preclude other registrants in

the batch from citing his/her studies and offering to cost share (Option 3) those studies. 
256

Table I lists the single batch for picloram.

Batch No.

No.

EPA Reg. % of Picloram Formulation Type 

1 62719-6 24.2 liquid

62719-17 24.4 liquid

62719-181 24.4 liquid

Table II lists the products which could not be batched. For the purposes of acute

toxicity batching, these products were not considered similar, or their similarity could not be

determined with the information available. The registrants of these products are responsible

for meeting the acute toxicity data requirements specified in the data matrix for end-use

products.

Table II.

EPA Reg. No. % of Picloram Formulation Type 

& other Active Ingredients

62719-5 10.2 liquid

 2,4-Dichlorophenoxyacetic

acid: 39.6

62719-30 34.7 liquid

62719-31 5.4 liquid

2,4-Dichlorophenoxyacetic

acid: 20.9

62719-57 17.1 liquid

Triclopyr: 32.5

62719-179 72.0 solid

62719-182 10.2 liquid
257

Attachment 5. EPA Acceptance Criteria
258
259

SUBDIVISION D

Guideline Study Title

Series 61 Product Identity and Composition

Series 62 Analysis and Certification of Product Ingredients

Series 63 Physical and Chemical Characteristics 
260

61 Product Identity and Composition

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

1.____ Name of technical material tested (include product name and trade name, if appropriate). 

2.____ Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each

intentionally-added inert ingredient.

3.____ Name and upper certified limit for each impurity or each group of impurities present at > 0.1% by weight

and for certain toxicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1%. 

4.____ Purpose of each active ingredient and each intentionally-added inert.

5.____ Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)

Registry Number for each active ingredient and, if available, for each intentionally-added inert. 

6.____ Molecular, structural, and empirical formulas, molecular weight or weight range, and any company

assigned experimental or internal code numbers for each active ingredient. 

7.____ Description of each beginning material in the manufacturing process. 

____ EPA Registration Number if registered; 

for other beginning materials, the following:

____ Name and address of manufacturer or supplier.

____ Brand name, trade name or commercial designation.

____ Technical specifications or data sheets by which manufacturer or supplier describes composition,

properties or toxicity. 

8.____Description of manufacturing process.

____ Statement of whether batch or continuous process.

____ Relative amounts of beginning materials and order in which they are added. 

____ Description of equipment.

____ Description of physical conditions (temperature, pressure, humidity) controlled in each step and the

parameters that are maintained. 

____ Statement of whether process involves intended chemical reactions.

____ Flow chart with chemical equations for each intended chemical reaction.

____ Duration of each step of process.

____ Description of purification procedures.

____ Description of measures taken to assure quality of final product.

9.____ Discussion of formation of impurities based on established chemical theory addressing (1) each impurity

which may be present at > 0.1% or was found at > 0.1% by product analyses and (2) certain

toxicologically significant impurities (see #3).
261

62 Analysis and Certification of Product Ingredients

ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present

the information in items 6, 7, and 8.

Does your study meet the following acceptance criteria?

 1.____ Five or more representative samples (batches in case of batch process) analyzed for each active ingredient

and all impurities present at > 0.1%.

 2.____ Degree of accountability or closure > ca 98%.

 3.____ Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the case

of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;

polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and

stored samples must be analyzed.].

 4.____ Complete and detailed description of each step in analytical method used to analyze above samples.

 5.____ Statement of precision and accuracy of analytical method used to analyze above samples.

 6.____ Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.

 7.____ Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with

explanation of how the limits were determined.

 8.____ Upper certified limit proposed for each impurity present at > 0.1% and for certain toxicologically significant

impurities at <0.1% along with explanation of how limit determined.

 9.____ Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if

exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described. 

10.____ Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
262

63 Physical and Chemical Characteristics

ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered.

Does your study meet the following acceptance criteria?

63-2 Color

____ Verbal description of coloration (or lack of it)

____ Any intentional coloration also reported in terms of Munsell color system 

63-3 Physical State

____ Verbal description of physical state provided using terms such as "solid, granular, volatile liquid" 

____ Based on visual inspection at about 20-25° C

63-4 Odor

____ Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic

compounds" 

____ Observed at room temperature

63-5 Melting Point

____ Reported in °C

____ Any observed decomposition reported

63-6 Boiling Point

____ Reported in °C

____ Pressure under which B.P. measured reported

____ Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity

____ Measured at about 20-25° C

____ Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with

reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft or

3

lbs/gallon.] 

63-8 Solubility

____ Determined in distilled water and representative polar and non-polar solvents, including those used in

formulations and analytical methods for the pesticide

____ Measured at about 20-25° C

____ Reported in g/100 ml (other units like ppm acceptable if sparingly soluble) 

63-9 Vapor Pressure

____ Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if

pressure too low to measure at 25° C)

____ Experimental procedure described

____ Reported in mm Hg (torr) or other conventional units

63-10 Dissociation Constant

____ Experimental method described

____ Temperature of measurement specified (preferably about 

20-25°C)

63-11 Octanol/water Partition Coefficient

____ Measured at about 20-25° C

____ Experimentally determined and description of procedure provided (preferred method-45 Fed. Register

77350)

____ Data supporting reported value provided

63-12 pH

____ Measured at about 20-25° C

____ Measured following dilution or dispersion in distilled water

63-13 Stability

____ Sensitivity to metal ions and metal determined

____ Stability at normal and elevated temperatures

____ Sensitivity to sunlight determined
263

SUBDIVISION F

Guideline Study Title

 81-1 Acute Oral Toxicity in the Rat

 81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig

 81-3 Acute Inhalation Toxicity in the Rat

 81-4 Primary Eye Irritation in the Rabbit

 81-5 Primary Dermal Irritation Study

 81-6 Dermal Sensitization in the Guinea Pig

 
Criteria marked with an * are supplemental and may not be required for every study.

264

81-1 Acute Oral Toxicity in the Rat

ACCEPTANCE CRITERIA 

Does your study meet the following acceptance criteria?

 1.____ Identify material tested (technical, end-use product, etc).

 2.____ At least 5 young adult rats/sex/group.

 3.____ Dosing, single oral may be administered over 24 hrs.

 4. ___ Vehicle control if other than water. *

 5.____ Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg). 

 6.____ Individual observations at least once a day.

 7.____ Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.

 8.____ Individual daily observations.

 9.____ Individual body weights.

10.____ Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.

265

81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

 1._____ Identify material tested (technical, end-use product, etc). 

 2._____ At least 5 animals/sex/group.

 3.*____ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm. 

 4._____ Dosing, single dermal.

 5._____ Dosing duration at least 24 hours.

 6.*____ Vehicle control, only if toxicity of vehicle is unknown.

 7._____ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).

 8._____ Application site clipped or shaved at least 24 hours before dosing.

 9._____ Application site at least 10% of body surface area.

10._____ Application site covered with a porous nonirritating cover to retain test material and to prevent ingestion.

11._____ Individual observations at least once a day.

12._____ Observation period to last at least 14 days.

13._____ Individual body weights.

14._____ Gross necropsy on all animals.
266

81-3 Acute Inhalation Toxicity in the Rat

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

 1.____ Identify material tested (technical, end-use product, etc).

 2.____ Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use

or contains particles of inhalable size for man (aerodynamic diameter 15 μm or less). 

 3.____ At least 5 young adult rats/sex/group.

 4.____ Dosing, at least 4 hours by inhalation.

 5.____ Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.

 6.____ Chamber temperature, 22° C (+2 ), relative humidity 40-60%. o

 7.____ Monitor rate of air flow.

 8.____ Monitor actual concentrations of test material in breathing zone.

 9.____ Monitor aerodynamic particle size for aerosols.

10.___ Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of

respirable substance). 

11.___ Individual observations at least once a day.

12.___ Observation period to last at least 14 days. 

13.___ Individual body weights.

14.___ Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.

267

81-4 Primary Eye Irritation in the Rabbit

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

 1.____ Identify material tested (technical, end-use product, etc).

 2.____ Study not required if material is corrosive, causes severe 

dermal irritation or has a pH of <2 or >11.5. 

 3.____ 6 adult rabbits.

 4.____ Dosing, instillation into the conjunctival sac of one eye 

per animal. 

 5.____ Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.

 6.____ Solid or granular test material ground to a fine dust.

 7.____ Eyes not washed for at least 24 hours.

 8.____ Eyes examined and graded for irritation before dosing and 

at 1, 24, 48 and 72 hr, then daily until eyes are normal

or 21 days (whichever is shorter).

 9.*___ Individual daily observations. 
Criteria marked with an * are supplemental and may not be required for every study.

268

81-5 Primary Dermal Irritation Study

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

 1.____ Identify material tested (technical, end-use product, etc).

 2.____ Study not required if material is corrosive or has a pH of <2 or >11.5.

 3.____ 6 adult animals.

 4.____ Dosing, single dermal.

 5.____ Dosing duration 4 hours.

 6.____ Application site shaved or clipped at least 24 hours prior to dosing.

 7.____ Application site approximately 6 cm .

2

 8.____ Application site covered with a gauze patch held in place with nonirritating tape.

 9.____ Material removed, washed with water, without trauma to application site.

10.___ Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days

(whichever is shorter). 

11.*__ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.

269

81-6 Dermal Sensitization in the Guinea Pig 

ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

1.___ Identify material tested (technical, end-use product, etc).

2.___ Study not required if material is corrosive or has a

 pH of <2 or >11.5.

3.___ One of the following methods is utilized:

_____ Freund's complete adjuvant test

_____ Guinea pig maximization test

_____ Split adjuvant technique

_____ Buehler test

_____ Open epicutaneous test

_____ Mauer optimization test 

_____ Footpad technique in guinea pig.

4.___ Complete description of test.

5.*__ Reference for test.

6.___ Test followed essentially as described in reference document.

7.___ Positive control included (may provide historical data conducted within the last 6 months).
270
271

Attachment 6. List of All Registrants Sent This Data Call-In Notice

(insert)
272
273

Attachment 7. Cost Share, Data Compensation Forms, Confidential

Statement of Formula Form and Instructions
274
275
276
277

Instructions for Completing the Confidential Statement of Formula 

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are

required. Following are basic instructions:

a. All the blocks on the form must be filled in and answered completely. 

b. If any block is not applicable, mark it N/A. 

c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.

d. All applicable information which is on the product specific data submission must also be reported on the

CSF. 

e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet

for solids.

f. Flashpoint must be in degrees Fahrenheit and flame extension in inches. 

g. For all active ingredients, the EPA Registration Numbers for the currently registered source products

must be reported under column 12. 

h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for

the trade names must be reported.

i. For the active ingredients, the percent purity of the source products must be reported under column 10

and must be exactly the same as on the source product's label. 

j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will

volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms). 

k. All the items under column 13.b. must total 100 percent. 

1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form. 

m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175

instructions. An explanation must be provided if the proposed limits are different than standard certified

limits. 

n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that

specific formulation. 
278
279
280
281

United States Environmental Protection Agency Form Approved

Washington, DC 20460 OMB No. 2070-

CERTIFICATION WITH RESPECT TO

DATA COMPENSATION REQUIREMENTS

0107,

2070-0057

Approval Expires

3-31-96

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for 

reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the 

collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, 

including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection 

Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project 

(2070-0106), Washington, DC 20503.

Please fill in blanks below.

Company Name Company Number

Product Name EPA Reg. No.

I Certify that:

1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act 

(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original 

data submitter to cite that study.

2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the 

original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the 

company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections 

3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation 

requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)

 [ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached

"Requirements Status and Registrants' Response Form,"

3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or

reregistration under FIFRA.

Signature Date

Name and Title (Please Type or Print)

GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the

registration or reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).

Signature Date

Name and Title (Please Type or Print)

EPA Form 8570-31 (4-96)
282
283

APPENDIX G. FACT SHEET
284