United States Prevention, Pesticides EPA 738-R-98-005

Environmental Protection And Toxic Substances November 1998

Agency (7508C)

Reregistration

Eligibility Decision (RED)

DCPA
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 DCPA which includes

the active ingredient Dimethyl tetrachloroterephthalate. The enclosed Reregistration Eligibility

Decision (RED), which was approved on September 30, 1995 contains the Agency's evaluation of

the data base of these chemicals, 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 ingredients 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 is due 90 days from the date of receipt

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

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

action of suspension against your products.

Please note that this RED was finalized and signed prior to August 3, 1996. On that date,

the Food Quality Protection Act of 1996 (“FQPA”) became effective, amending portions of both

the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not address any

issues raised by FQPA, and any tolerance-related statements in the RED did not take into account

any changes in tolerance assessment procedures required under FQPA. To the extent that this

RED indicates that a change in any tolerance is necessary, that determination will be reassessed by

the Agency under the standards set forth in FQPA before a proposed tolerance is issued. To the

extent that the RED does not indicate that a change in a tolerance is necessary, that tolerance too

will be reassessed in the future pursuant to the requirements of FQPA.
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 

Venus Eagle at (703) 308-8045. Address any questions on required generic data to the Special

Review and Reregistration Division representative Jill Bloom at (703)308-8019.

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, another DCI letter will be enclosed listing such requirements. If both generic and

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

enclosed describing such data. Complete the two response forms provided with each DCI letter

(or four forms for the combined) by following the instructions provided. You must submit the

response forms for each product and for each DCI within 90 days of the date of this letter

(RED issuance date); 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 data waivers must be submitted as part of the

90-day response. Requests for time extensions should be submitted in the 90-day response, but

certainly no later than the 8-month response date. 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 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

DCPA

LIST A

CASE 0270

TABLE OF CONTENTS

DCPA REREGISTRATION ELIGIBILITY DECISION TEAM ........................ i

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

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

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

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

B. Use Profile ..................................................... 2

C. Estimated Usage of Pesticide ...................................... 5

D. Data Requirements .............................................. 6

E. Regulatory History .............................................. 7

III. SCIENCE ASSESSMENT .............................................. 8

A. Physical Chemistry Assessment .................................... 8

1. Description of Chemical .................................... 8

2. Identification of Active Ingredient ............................ 8

3. Manufacturing-Use Products ................................ 9

B. Human Health Assessment ....................................... 9

1. Toxicology Assessment ..................................... 9

a. Acute Toxicity ...................................... 9

b. Subchronic Toxicity ................................. 9

c. Chronic Toxicity and Carcinogenicity .................. 10

d. Developmental Toxicity .............................. 11

e. Reproductive Toxicity ............................... 11

f. Mutagenicity ...................................... 12

g. Metabolism ....................................... 12

h. Dermal Absorption ................................. 13

i. DCPA Reference Dose (RfD) and Cancer Potency Factor . . 14

j. Hexachlorobenzene (HCB) as a DCPA Impurity .......... 15

k. Polyhalogenated dibenzo-p-dioxins/dibenzofurans as DCPA

Impurities ........................................ 15

l. Tetrachloroterephthalic Acid (TPA) as a DCPA Metabolite . 16

2. Exposure Assessment ..................................... 17

a. Dietary Exposure .................................. 17

b. Drinking Water Exposure ............................ 26

c. Occupational and Residential Exposure ................ 29

3. Risk Assessment ......................................... 39

a. Dietary Assessment ................................. 39

(1) Acute Dietary Risk ............................ 39
(2) Chronic Dietary Risk .......................... 40

(3) Carcinogenic Dietary Risk ..................... 42

b. Drinking Water Assessment .......................... 43

(1) Chronic Drinking Water Risk ................... 43

(2) Carcinogenic Drinking Water Risk ............... 45

c. Occupational and Residential Assessment .............. 46

(1) Short Term and Intermediate Term Risk .......... 46

(2) Carcinogenic Risk ............................ 46

C. Environmental Assessment ...................................... 53

1. Ecological Toxicity Data ................................... 53

a. Toxicity to Terrestrial Animals ........................ 53

(1) Birds, Acute and Subacute ..................... 53

(2) Birds, Chronic ............................... 53

(3) Mammals ................................... 54

(4) Insects ...................................... 54

b. Toxicity to Aquatic Animals .......................... 54

(1) Freshwater Fish .............................. 54

(2) Freshwater Invertebrates ...................... 55

(3) Estuarine and Marine Animals .................. 56

c. Toxicity to Plants ................................... 56

(1) Terrestrial .................................. 56

(2) Aquatic ..................................... 57

2. Environmental Fate ...................................... 57

a. Environmental Fate Assessment ....................... 57

b. Environmental Fate and Transport .................... 58

(1) Degradation ................................. 58

(2) Mobility .................................... 59

(3) Accumulation ................................ 60

(4) Terrestrial Field Dissipation .................... 60

(5) Spray Drift .................................. 61

(6) Water Resources ............................. 61

3. Ecological Exposure and Risk Characterization ................ 65

a. Nontarget Terrestrial Animals ........................ 67

(1) Birds ....................................... 67

(2) Mammals ................................... 68

(3) Insects ...................................... 70

b. Nontarget Aquatic Animals .......................... 71

(1) Freshwater Fish and Invertebrates ............... 71

(2) Estuarine Species ............................. 72

c. Nontarget Plants ................................... 72

(1) Terrestrial and Semi-aquatic ................... 72

(2) Aquatic ..................................... 72

IV. RISK MANAGEMENT AND REREGISTRATION DECISION .............. 74

A. Determination of Eligibility ...................................... 74
B. Determination of Eligibility Decision .............................. 74

1. Eligibility Decision ....................................... 74

2. Eligible and Ineligible Uses ................................ 75

C. Regulatory Position ............................................ 75

1. Tolerance Discussion ..................................... 75

a. HCB and dioxin/furans .............................. 75

b. DCPA Tolerance Reassessment ....................... 75

2. Tolerance Revocations and Import Tolerances ................. 78

3. Regulation of DCPA Impurities ............................. 79

4. Dietary Risk ............................................ 79

5. Drinking Water Risk ..................................... 80

6. Contamination of Water Resources and Mitigation Measures ..... 81

7. Occupational Risk ........................................ 81

8. Residential Risk ......................................... 82

9. Ecological Effects (Non-Endangered Species) .................. 83

10. Endangered Species ...................................... 83

11. Spray Drift ............................................. 84

12. Labeling Rationale ....................................... 84

V. ACTIONS REQUIRED OF REGISTRANTS ............................. 90

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

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

2. Labeling Requirements for Manufacturing-Use Products ........ 90

B. End-Use Products .............................................. 91

1. Additional Product-Specific Data Requirements ............... 91

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

3. Groundwater Advisory .................................... 97

a. Surface Water Advisory ............................. 97

b. Spray Drift Labeling ................................ 97

C. Tolerance Revocation and Import Tolerances ...................... 100

D. Existing Stocks ............................................... 100

VI. APPENDICES ..................................................... 103

APPENDIX A. Table of Use Patterns Subject to Reregistration ......... 105

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

Make the Reregistration Decision .................... 107

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

Reregistration of DCPA ............................ 121

APPENDIX D. Combined Generic and Product Specific Data Call-In .... 141

Attachment 1. Chemical Status Sheets ....................... 161

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

Response Forms (Form A inserts) Plus Instructions 163

Attachment 3. Generic and Product Specific Requirement Status and

Registrant's Response Forms (Form B inserts) and

Instructions ................................ 167
Attachment 4. EPA Batching of End-Use Products for Meeting Data

Requirements for Reregistration ................ 174

Attachment 5. List of All Registrants Sent This Data Call-In (insert)

Notice ..................................... 181

Attachment 6. Cost Share, Data Citation Forms, Confidential Statement

of Formula Form and Instructions .............. 182

APPENDIX E. List of Available Related Documents .................. 191
i

DCPA REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Assessment

Ghulam Ali Economic Analysis Branch

Dennis Szuhay Biological Analysis Branch

Environmental Fate and Effects Assessment

Akiva Abramovitch Environmental Fate and Groundwater Branch

Michael Davy Environmental Risk Characterization Branch

Janice Jensen Policy and Special Projects Staff

Sharlene Matten Science Analysis and Coordination Staff

Daniel Rieder Environmental Risk Characterization Branch

Stephanie Syslo Environmental Risk Characterization Branch

Health Effects Assessment

Kathryn Boyle Risk Characterization and Analysis Branch

Jeff Evans Occupational and Residential Exposure Branch

Peg Perreault Occupational and Residential Exposure Branch

William Smith Reregistration Support Chemistry Branch

Brian Steinwand Science Analysis Branch

Linda Taylor Toxicology Branch II

Jennifer Wintersteen Science Analysis Branch

Registration Support Risk Assessment

Tom Ellwanger Registration Support Branch

Joanne Miller Fungicide-Herbicide Branch

Eugene Wilson Fungicide-Herbicide Branch

Risk Management

Judith Coombs Reregistration Branch

Margery Exton Reregistration Branch

Eric Feris Reregistration Branch

Sherell Sterling Reregistration Branch

Walt Waldrop Reregistration Branch
ii
GLOSSARY OF TERMS AND ABBREVIATIONS

iii

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

AE Acid Equivalent

a.i. Active Ingredient

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

FAO/WHO Food and Agriculture Organization/World Health Organization

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA Federal Food, Drug, and Cosmetic Act

FQPA Food Quality Protection Act

FOB Functional Observation Battery

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.

LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%

of the 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.

LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.

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

Fg/L Micrograms per liter

mg/L Milligrams Per Liter

MOE Margin of Exposure 

MP Manufacturing-Use Product

MPI Maximum Permissible Intake
GLOSSARY OF TERMS AND ABBREVIATIONS

iv

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

N/A Not Applicable

NOEC No Observable Effect Concentration

NPDES National Pollutant Discharge Elimination System

NOEL No Observed Effect Level

NOAEL No Observed Adverse Effect Level

OP Organophosphate

OPP Office of Pesticide Programs

Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.

PADI Provisional Acceptable Daily Intake

PAG Pesticide Assessment Guideline

PAM Pesticide Analytical Method

PHED Pesticide Handler's Exposure Data 

PHI Preharvest Interval

ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million

PRN Pesticide Registration Notice

Q

*

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

RBC Red Blood Cell

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose

RS Registration Standard

RUP Restricted Use Pesticide

SLN Special Local Need (Registrations Under Section 24 © 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

TLC Thin Layer Chromatography

TMRC Theoretical Maximum Residue Contribution

torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.

WP Wettable Powder

WPS Worker Protection Standard
v

EXECUTIVE SUMMARY

This Reregistration Eligibility Document (RED) addresses the eligibility for reregistration

of pesticide products containing the active ingredient DCPA (dimethyl tetrachloroterephthalate)

which is commonly known by the trade name "Dacthal."

BACKGROUND

DCPA, an herbicide, was originally registered under FIFRA in 1958 for use on turf

grasses for the selective preemergence control of crabgrass and other assorted weeds. Today,

there are 72 FIFRA Section 3 registrations and 11 FIFRA Section 24(c) registrations - totaling 83

product registrations. DCPA is used for selective preemergence weed control on ornamental turf

and plants, strawberries, seeded and transplanted vegetables, cotton, and field beans. 

A Registration Standard was issued for DCPA in June of 1988. At that time, the Agency

required additional data in the areas of product chemistry, residue chemistry, environmental fate,

toxicology, and ecological effects to continue the registration of pesticide products containing

DCPA as an active ingredient. The DCPA technical grade active ingredient was subject to a 1987

Data Call-In requiring analysis for possible dioxin/furan contamination. A DCI was also issued on

September 28, 1992 requiring DCPA occupational exposure monitoring data. This RED

document represents a complete review of the data which has been submitted in response to the

Registration Standard and both the 1987 dioxin/furan and 1992 DCPA DCIs. 

REREGISTRATION ELIGIBILITY

The Agency is unable to make an eligibility decision for the use of DCPA on turf at this

time. The Agency has identified several risks of regulatory concern, and will be undertaking a full

benefits assessment before determining whether this use is eligible for reregistration. The risks of

concern include carcinogenic risk to children playing on lawns post-treatment, carcinogenic risk

through contaminated drinking water, chronic risks to wild mammalian species, including

endangered species, and acute risks to freshwater and estuarine mollusks, including endangered

species. The Agency will refine the risk estimates associated with the turf use, since a final report

regarding groundwater contamination associated with the use of DCPA on turf is expected during

the summer of 1996. 

The Agency has determined that all remaining currently registered uses of DCPA, with the

labeling changes required in Section V of this document, do not pose an unreasonable risk to

humans or the environment and are eligible for reregistration. 

HEALTH EFFECTS

The Agency's Carcinogenicity Peer Review Committee within the Office of Pesticide

Programs has classified DCPA as a Group C (possible human) carcinogen. The estimated Q1

*

 (a
vi

measure of carcinogenic potential) of DCPA is 0.00149 (mg/kg/day)-1. Dietary risk from

exposure to DCPA and its two metabolites, tetrachloroterephthalic acid (TPA) and monomethyl

tetrachloroterephthalic acid (MTP) was assessed using anticipated residues and percent crop

treated data for multiple crops. 

In the absence of a complete database on the metabolites, the Agency is assuming that the

carcinogenic potential of the metabolites is the same as the parent compound. Therefore, the Q1

*

for DCPA is also used for its metabolites. 

The resulting upper bound carcinogenic risk estimate for dietary exposure was 

3.5 x 10-7. The Agency generally considers dietary risks of 1 x 10-6 and less to be negligible, and

thus does not pursue risk reduction measures for such risks. Based on this risk assessment, the

Agency concludes that DCPA does not pose a significant cancer risk to the overall U.S.

population from dietary exposure as currently registered. 

The manufacturing process of DCPA produces several known contaminants. Of those of

toxicological concern are hexachlorobenzene (HCB) and congeners (structurally related

chemicals) of polyhalogenated dibenzo-p-dioxins/dibenzofurans (dioxins/furans). Carcinogenic

risk was assessed for dietary exposure to HCB and dioxin/furans using Q1

*

s of 1.02 (mg/kg/day)-1

and 1 x 105, respectively. Resulting dietary risk estimates are 7.1 x 10-7 for HCB and 7 x 10-8 for

dioxin/furans. The Agency concludes that neither HCB nor dioxin/furans pose a significant

cancer risk to the overall U.S. population through dietary exposure resulting from DCPA product

use. 

A chronic dietary risk assessment was performed to examine the most sensitive non-cancer

endpoint observed for DCPA, which includes effects in the lungs, liver, thyroid, and thyroid

hormones in rats of both sexes as well as the eyes of females rats. A Reference Dose (RfD) of

0.01 mg/kg/day was calculated using a 1.0 mg/kg/day No Observed Effect Level (NOEL) from a

chronic rat study and an uncertainty factor of 100 to account for inter-species extrapolation and

intra-species variability. When anticipated residues were used as well as percent of crop treated

data, risk estimates did not exceed a level of concern for the general population or any population

subgroup.

 Chronic dietary (non-cancer) risk was also assessed for exposure to 2,3,7,8-TCDD and

HCB resulting from DCPA product use. An RfD of 0.000001 ug/kg/day was calculated for

2,3,7,8-TCDD based on a LOEL of 0.001 ug/kg/day from a three generation feeding study in rats. 

An RfD of 0.0008 mg/kg/day was calculated for HCB based on a NOEL of 0.08 mg/kg/day from

a 130-week feeding study in rats. Neither of the resulting risk estimates exceeded a level of

concern for the general population or any subgroup.

Because one of DCPA's metabolites, TPA, is a frequently detected pesticide residue in

groundwater, both chronic and carcinogenic risk estimates were calculated to assess exposure to

DCPA and its metabolites through drinking water. The data from five geographic regions were
vii

used to generate exposure scenarios. The greatest contamination was found at a turf site in New

York, where the annual average contamination of DCPA and its metabolites was approximately

50 ppb. Exposure to this contamination level resulted in the highest risk estimates for both cancer

and non-cancer risk. 

The individual excess lifetime cancer risk estimate associated with the turf site is 1.7 x 10-

6

. The Agency is undertaking a risk-benefit assessment to determine whether the turf use is

eligible for reregistration. The groundwater contamination and cancer risk estimates associated

with this use will be evaluated in context of the benefits of DCPA use on turf. 

Once the benefits assessment has been completed, the Agency will make a final decision regarding

the eligibility for reregistration of DCPA use on turf. The Agency will announce the eligibility

decision through a Federal Register Notice, as an amendment to this document. 

The second highest carcinogenic risk estimate is based on data from Suffolk County, New

York. The risk estimate from that site is 9.7 x 10-7. DCPA's registrant has voluntarily withdrawn

from selling the product in Suffolk, New York. Exposure values from all other sites resulted in

risks below the Agency's cancer benchmark of 1 x 10-6. 

Chronic drinking water risk is expressed as a percent of the RfD. The chronic drinking

water risk estimate was 11 percent of the RfD at this site. Based on these estimates, the Agency

concludes that DCPA and its metabolites do not currently pose a significant cancer or chronic

non-cancer risk from non-turf uses to the overall U.S. population from exposure through

contaminated drinking water. 

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

DCPA is currently registered for commercial and residential use. Risk assessments were

performed to assess the individual excess lifetime cancer risk from DCPA and HCB resulting from

occupational and residential exposure to DCPA. The Agency will not generally allow non-dietary

risks to exceed 10-4, except in cases where EPA has determined that benefits exceed the risks. 

Risk was estimated for occupational exposures to both DCPA and HCB. The highest risk

for both commercial applicators and private applicators is associated with the use of the wettable

powder formulation. For the commercial applicator, the highest risk for DCPA was estimated to

be 7.5 x 10-5 and for HCB (in DCPA) to be 1.9 x 10-4. The Agency is requiring

mixer/loader/applicators using DCPA wettable powders to wear a dust-mist respirator fitted with

a TC-21 filter to mitigate this risk. Wearing a dust-mist respirator reduces the risks to 4.0 x 10-5

and 1.3 x 10-4 for DCPA and HCB respectively.

For the private applicator, the highest risk for DCPA was estimated to be 1.6 X 10-6 and

for HCB (in DCPA) to be 4.6 X 10-6. 

Risks to children playing on a treated lawn were assessed for exposure to DCPA and

HCB. The risks from DCPA and HCB to children playing on an irrigated lawn are 5.6 x 
viii

10-7 and 3.9 x 10-7, respectively. The risks from DCPA and HCB to children playing on nonirrigated lawns are 2.0 x 10-6 and 2.7 x 10-6, respectively. The Agency is conducting a risk/benefit

assessment to determine whether the turf use is eligible for reregistration. However, in the

interim, the Agency is requiring that residential lawns be watered after DCPA product use and

that reentry not occur until sprays have dried, in an effort to mitigate risks to children. 

Risk from exposure to DCPA and HCB through worker reentry into a cucumber field was

assessed. Harvesting cucumbers immediately after application resulted in risk estimates of 1.8 x

10-4 for DCPA and 3.2 x 10-4 for HCB. Delayed reentry periods only minimally reduced risk

estimates. However, the Agency believes that the worker exposures are overestimates. These

scenarios were based solely on a foliar dissipation study, not on dermal exposure studies. DCPA's

registrant is a member of a task force which will address dermal exposure for hand labor tasks

required by various crops, such as cucumber harvesting. The risk assessment will be refined when

the task force submits it dermal exposure data. 

ENVIRONMENTAL FATE AND ECOLOGICAL EFFECTS

Ecological effects risk assessments indicate that there may be a concern for endangered

mammals and mollusks exposed to DCPA. Since the Agency is developing an Endangered

Species Protection Program designed to minimize harm to endangered species from pesticide use,

the Agency is not requiring specific mitigation measures in this document. 

The Agency concludes that non-turf uses of DCPA, labeled and used as specified in this

document, will not pose unreasonable risks to birds, insects, fish and estuarine species, or

nontarget plants. However, the Agency is requiring additional data in the areas of avian toxicity

and reproduction, vegetative vigor, and seedling emergence to confirm these conclusions. The

Agency has concerns regarding chronic risks to mammalian species and acute risk to mollusk

species as a result of DCPA use on turf. Once the benefits assessment on turf has been

completed, the Agency will determine whether this use is eligible for reregistration. 

The Agency has concerns about contamination of groundwater by DCPA soil metabolites. 

The registrant has voluntarily agreed to limit the manufacture of DCPA technical grade active

ingredient for use within the United States to current production levels. This will help to ensure

that groundwater contamination rates do not significantly increase in the future. Since DCPA is

produced intermittently, the production limit will be set at the average of the last three production

campaigns, allowing for a 5% variance. The Agency will enforce this production cap through

review of manufacture data which the registrant is required to submit under FIFRA, Section 7. 

The registrant will produce no more than the agreed upon limit every 3 calendar years, beginning

in January, 1997. 

A final report regarding leaching of DCPA and its metabolites to groundwater is due to

the Agency during the summer of 1996. Once that data has been reviewed, the Agency will

reassess potential drinking water risk and evaluate the need for additional groundwater protection
ix

measures. 

The Agency is continuing to require all DCPA products to bear a groundwater advisory

statement. Through the reregistration process, the Agency has also identified concerns for the

contamination of surface water by DCPA. Consequently, the Agency is requiring all DCPA

products to bear a surface water advisory statement as well.

TOLERANCE REASSESSMENT

Sufficient data were available to ascertain the adequacy of the established tolerances listed

in 40 CFR §180.185(a) and §180.185(b) for those crops for which the use of DCPA is being

supported. New tolerances will be needed for parsley, cowpea (forage and hay), and cotton gin,

byproducts under §180.185 and §180.185(b). The registrant is being required to submit residue

data on parsley, cowpea (forage and hay), and cotton gin, byproducts. However, in lieu of

tolerances on cowpea commodities, the registrant may restrict the use of DCPA on beans to those

varieties that are used for human consumption only. 

Tolerances for animal commodities have not been established. The available ruminant

metabolism and poultry feeding studies indicated that tolerances may be needed. The need for

tolerances for animal commodities will be determined following review of the required data on

poultry metabolism and ruminant feeding studies. 

During the Agency's reregistration process, the registrant decided not to support the use

of DCPA on lettuce, soybeans, corn, and rutabagas. The use of DCPA on these four crops has

been voluntarily cancelled. Normally, once a pesticide use is no longer registered in the U.S., the

related pesticide residue tolerance is no longer needed. It is the Agency's policy to propose

revocation of a tolerance following the deletion of a related food use from a registration, or

following the cancellation of a related food-use registration. The Agency has the responsibility

under FFDCA to revoke a tolerance on the grounds that the Agency cannot conclude that the

tolerance is protective of public health.

However, in the case of DCPA, the Agency is not seeking revocation of these tolerances,

as it normally would under the above policy. The registrant is supporting rotational crop

tolerances for these four commodities, thereby allowing DCPA residues which result from use on

registered crops previously grown in the same field. The reassessed tolerances will be determined

once field rotational crop residue data has been submitted to the Agency and reviewed. 

Subsequently, the tolerances of DCPA on these four commodities may be significantly reduced. 

The Agency recognizes, however, that interested parties may want to retain a tolerance

which is higher than the rotational crop tolerance (yet to be determined) in the absence of a U.S.

registration, to allow legal importation of treated food into the U.S. To assure that all food

marketed in the U.S. is safe, under FFDCA, the Agency requires the same product chemistry and

toxicology data for such import tolerances (tolerances without related U.S. registrations) as are
x

required to support U.S. food use registrations and any resulting tolerances. In addition, the

Agency requires residue chemistry data (crop field trials) that are representative of growing

conditions in exporting countries in the same manner that the Agency requires representative

residue chemistry data from different U.S. regions to support domestic use of the pesticide and

the tolerance.

Parties interested in supporting an existing DCPA tolerance as an import tolerance should

ensure that all of the data noted above are available to the Agency, so that the Agency may

determine whether maintenance of the tolerance would be protective of the public health.

PRODUCT REREGISTRATION

Before reregistering the products containing DCPA, 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 for

each registration and acute toxicity testing. 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 ingredients are eligible for reregistration" 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 DCPA. The document consists of six sections. Section I is the introduction.

Section II describes DCPA, its 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 DCPA. Section V discusses the

reregistration requirements for DCPA. 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

Decision:

! Common Name: DCPA, or chlorthal dimethyl

! Chemical Name: Dimethyl tetrachloroterephthalate

! Chemical Abstracts

Index Name: 1,4-Benzenedicarboxylic acid, 2,3,5,6-tetrachloro-

,dimethyl ester

! Chemical Family: Chlorinated Benzoic Acids 

! CAS Registry Number: 1861-32-1

! OPP Chemical Code: 078701

! Empirical Formula: C10H6Cl4O4

! Trade and Other Names: Dacthal®

! Basic Manufacturer: ISK Biosciences

5966 Heisley Road, #8000

Mentor, Ohio USA

44061-8000

B. Use Profile

The following is information on the currently registered uses of DCPA with an overview

of use sites and application methods. A detailed table of these uses of DCPA is in Appendix A.

Type of Pesticide: A pre-emergent herbicide used to control annual grasses and

broadleaf weeds.

Use Sites: Terrestrial Food Crops: beans, beans (succulent, snap), beets, broccoli,

Brussels sprouts, cabbage, cauliflower, cole crops, collards, cress (garden)

cucumber, eggplant, garlic, kale, melons (cantaloupe, honeydew, and

water), mustards, onion, peas (southern), pepper, radish, squash (all or

unspecified), strawberry, sweet potato, tomato, turnip, and yam.
3

Terrestrial Food and Feed Crops: beans, beans (dried-type), bean (mung),

beans (succulent, lima) beans (succulent, snap), beets, eggplant, mustard,

peas (southern), pepper, potato (white/irish), tomato, turnip, and yam.

Terrestrial Feed Crops: alfalfa

Terrestrial Non-Food and Outdoor Residential Sites: ornamental and/or

shade trees, ornamental herbaceous plants, ornamental lawns and turf,

ornamental nonflowering plants, ornamental woody shrubs and vines.

Weeds Controlled: Broadleaves: black nightshade, burning nettle, carpetweed,

cheeseweed, common chickweed, common lambsquarters, dodder,

field pansy, Florida pusley, groundcherry, nodding spurge, prostrate

knotweed, prostrate spurge, purple deadnettle, purslane, redroot

pigweed, whombic copperleaf, spotted deadnettle, spotted spurge,

and Virginia copperleaf.

Grasses: annual bluegrass, barnyardgrass, browntop panicum,

goosegrass, green foxtail, Johnsongrass (free seed), large crabgrass,

lovegrass, sandbur, smooth crabgrass, witchgrass, and yellow

foxtail.

Weeds Suppressed: Broadleaves: annual sowthistle, curley dock (from seed), henbit,

ladysthumb, London rocket, nettleleaf goosefoot, polypogon,

shepherdspurse, silversheath knotweed, wild buckwheat, and

witchweed.

Grasses: giant foxtail, littleseed canarygrass, rabbitfoot fall

panicum, Texas panicum, and vaseygrass.

Formulation Types Registered: All currently registered DCPA products are single

active ingredient (AI) Formulations: 

20.7% AI emulsifiable concentrate

54.9% AI flowable concentrate

1.15% to 10% AI granular

6% AI soluble concentrate/liquid

25% and 75% AI wettable powder

20.7%, 75%, and 90% AI formulation intermediates

Method and Rates of Application:

Emulsifiable Concentrate Formulations: Apply to agricultural crops at planting,

transplant, post-emergence, or post-transplant as soil treatment using sprayer or
4

sprinkler can at .125 gal product/1000 square feet; or apply to strawberries in early

fall or early spring as soil treatment using sprayer or sprinkler can at .1016 gal

product/1000 square feet; apply to ornamental plants in early spring, late spring,

late fall, late winter, post-emergence, or post-transplant as soil treatment using

sprayer or sprinkler can at .125 gal product/1000 square feet; or apply to

ornamental lawns and turf in early fall or late summer as soil treatment using

sprayer or sprinkler can at .1693 gal product/1000 square feet. 

Flowable Concentrate Formulations: Apply to ornamental plants in early spring,

early fall, or late summer via irrigation at up to 12 lb AI/A; or apply (e.g. to

ornamental lawns and turf) in early spring, early summer, or early fall as soil

treatment using sprayer at up to 15 lb AI/A.

Granular Formulations: Apply to agricultural crops at planting or post-plant as

broadcast or soil treatment using spreader or sprinkler can at up to 10 lb AI/A; or

apply at planting, post-emergence, foliar, at layby, or at transplant using spreader

or shaker can at .2 lb AI/1000 square feet; or apply at planting, at transplant, postplant, post-transplant, or seed bed using spreader or shaker can at up to 10.5 lb

AI/A; or apply at planting as broadcast using spreader, sprayer, or shaker can at 10

lb AI/A; apply at planting, transplant, or post-transplant as soil treatment using

spreader at 11 lb AI/A; or apply as foliar broadcast at .2 lb AI/A; or apply to

ornamental plants at planting, early spring, late summer, fall, early fall, or

nurserystock as broadcast using spreader or shaker can at .2 to .347 lb AI/1000

square feet; or apply as broadcast at up to 10 lb AI/A; or apply to ornamental

lawns and turf in late summer, early fall, or late fall as soil treatment using spreader

or shaker can at up to 15 lb AI/A.

Wettable Powder Formulations: Apply to agricultural crops at planting, early

spring, layby, foliar, or transplant as soil treatment (includes soil incorporation)

using aircraft, spreader, shaker can, or irrigation at up to 10.5 lb AI/A; or apply to

strawberries early spring, summer, early fall, or transplant using soil incorporate

via spreader or aircraft or use irrigation at up to 9 lb AI/A; or apply to ornamental

plants in spring, late summer, or late fall as broadcast using sprayer, or apply in

April, early spring, late summer, nurserystock, or transplant as soil treatment via

aircraft, or sprayer, or use irrigation at up to 12 lb AI/A; or apply to ornamental

lawns and turf in late summer or early fall as broadcast using sprayer, or as soil

treatment via aircraft, or sprayer, or use irrigation at up to 15 lb AI/A.

 

Use Practice Limitations: (these do not apply to all uses on all products)

* Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes).

* Do not apply directly to water or wetlands.

* Do not apply directly to water.
5

* Do not apply through any type of irrigation system.

* Do not discharge effluent containing this pesticide into sewage systems without

notifying the sewage treatment plant authority (POTW).

* Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,

oceans, or public water. (NPDES license restriction)

* Do not feed clippings to livestock.

* Do not feed treated foliage to livestock or graze treated areas.

* Do not feed treated screenings or hay to livestock.

* Do not graze livestock in treated areas.

* Do not graze or feed forage, silage or fodder (stubble) from treated fields to dairy

animals. 

* Do not graze treated areas or feed crop refuse to livestock. 

* Do not graze treated areas or use clippings from treated areas for feed or forage.

* Do not graze treated areas.

* For terrestrial uses, do not apply directly to water or to areas where surface water is

present or to intertidal areas below the mean high water mark.

* Groundwater restriction.

* Keep out of lakes, streams, and ponds.

C. Estimated Usage of Pesticide

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

These estimates are derived from a variety of published and proprietary sources available to the

Agency for 1988-1994. 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.

DCPA is registered and labeled for use on the following crops for which there is no

reported usage: alfalfa, beans (succulent, snap) beets, cress (garden) kale, mustards, turnip, and

yam. Although not registered uses, DCPA tolerances are being maintained for four additional

crops which are sometimes grown in fields previously treated with DCPA. Those crops are: 

lettuce, soybeans, corn, and rutabagas. Table 1 below summarizes the use of DCPA by crop for

the remaining registered uses.

Table 1: Typical Annual Usage and Percentage of Various U.S. Crops Treated with DCPA

Crop Name

Acres Grown

/Harvesteda

(000)

Acres Treatedb

(000)

(Range)

Percentage of

Acres Treatedc

(Range)

Active Ingredientc

(000 Lbs A.I.)

(Range)

Percentage of

 Total A.I.

(Range)

BROCCOLI 110 55 83 50 61 230 300 14.29 20.91

BRUSSELS

SPROUT 5 0 1 --- 1 1 2

0.10 0.09

CABBAGE 91 18 23 18 24 30 50 2.38 2.73
Crop Name

Acres Grown

/Harvesteda

(000)

Acres Treatedb

(000)

(Range)

Percentage of

Acres Treatedc

(Range)

Active Ingredientc

(000 Lbs A.I.)

(Range)

Percentage of

 Total A.I.

(Range)

6

CANTALOUPE 111 1 2 1 3 1 2 0.10 0.09

CAULIFLOWER 55 14 36 26 36 50 100 4.76 4.55

COLLARDS 16 6 8 41 50 30 40 1.90 2.73

CUCUMBER 172 2 3 --- 1 2 3 0.14 0.18

EGGPLANT 3.4 0 0 1 3 1 2 0.10 0.09

GREEN

BEANS 306 3 6 --- 1 1 2 0.10 0.09

GARLIC 26 1 1 1 2 3 4 0.19 0.27

HOT PEPPERS 51 8 10 16 24 25 30 1.43 2.27

HONEYDEW 26 0 1 1 2 1 2 0.10 0.09

ONIONS 157 55 79 38 63 300 750 35.71 27.27

PEPPERS

(BELL) 68 1 1 1 2 1 3 0.14 0.09

POTATOES 1,379 14 28 --- 1 2 3 0.14 0.18

RADISHES 30 0 2 1 2 2 3 0.14 0.18

SQUASH 69 3 7 5 10 25 30 1.43 2.27

STRAWBERRIES 51 1 5 8 12 5 50 2.38 0.45

SWEET

POTATOES 83.1 --- 6 --- 7

TOMATOES 450 5 9 --- 1 10 20 0.95 0.91

WATERMELON 246 2 5 --- 1 1 2 0.10 0.09

SEED CROPS 1,516 15 30 1 2 150 250 11.90 13.64

GOLF

COURSES 1,445 29 43 2 3 150 300 14.29 13.64

SOD FARMS 152 8 15 5 10 75 150 7.14 6.82

TOTAL 0 0 1,100 2,100

a

 Three years 1992-1994 or 1991-1993 average (with some 1992 data when available) is reported. Sources:

USDA. Crop Production, 1994 Summary, January 1995; USDA. Vegetables 1994 Summary, January 1995; 

Department of Commerce. 1992 Census of Agriculture, Part 1, Volume 1, October 1994; EPA Proprietary

Sources; Gianessi L. P. and Anderson J. E. (National Center for Food and Agricultural Policy) Pesticide Use in

U.S. Crop Production, February 1995.

b

 Acres Treated is calculated by multiplying the Acres Grown by the Percentage of Acres Treated.

c

 Sources: EPA Proprietary Sources; Gianessi L. P. and Anderson J. E. (National Center for Food and

Agricultural Policy) Pesticide Use in U.S. Crop Production, February 1995; State of California. Pesticide Use

Report, Annual 1990; USDA. Agricultural Chemical Usage, 1993 Field Crop Summary, March 1994; USDA. 

Agricultural Chemical Usage, 1992 Field Crop Summary, March 1993; USDA. Agricultural Chemical Usage,

Vegetables 1992 Summary, June 1993. 

D. Data Requirements
7

Data requested in the June 1988 Registration Standard for DCPA include studies on

product chemistry, ecological effects, environmental fate, and residue chemistry, toxicology, and

occupational and residential exposure. These data were required to support the uses that were

listed in the Registration Standard. Appendix B of this document includes all data requirements

reviewed to support decisions in this reregistration document. 

E. Regulatory History

DCPA was first registered under FIFRA in 1958 for use on turf grasses as an herbicide for

the selective preemergence control of crabgrass and other assorted weeds. The DCPA

Registration Standard ("EPA Guidance for Reregistration of Pesticide Products Containing

DCPA as the Active Ingredient"), was issued in June, 1988. In the 1988 Registration Standard,

the Agency listed the data required for continued registration of pesticide products that were

manufactured with DCPA. Timeframes for submitting the required data to continue the

registration of these products were set forth in that document. In addition, labeling amendments

were required to bring all registered DCPA pesticide products into compliance with existing

labeling policy of the Agency. 

Today, there are 60 FIFRA Section 3 registrations and 6 FIFRA Section 24(c)

registrations totalling 66 product registrations. There are presently two manufacturing use

products from which all other products are formulated. ISK Biotech Corporation is the registrant

of these manufacturing-use products - Dacthal 1.92F and 90% Dimethyl-T. 

The DCPA technical products were subject to a June, 1987 Data Call-In Notice (DCI)

requiring analysis for polyhalogenated dibenzo-p-dioxins/dibenzofurans (referred to as

dioxin/furans). Data submitted by the registrant in response to the DCI reflected analysis of seven

batches of technical DCPA for 15 dioxin/furans. To completely comply with the requirements of

the 1987 DCI, ISK Biosciences must supply data reflecting analysis of duplicate samples spiked

with each of the 13C-labeled dioxin/furan standards at or below the EPA-required Level of

Quantitation (LOQ) for the corresponding dioxin/furan analyte. The percent recoveries shall be

50-150% and relative percent differences (RPDs) shall be <20%. The registrant has indicated that

two samples were sent for duplicate precision analysis in April of 1991. These data are

considered confirmatory; no further dioxin analysis will be required to fulfill reregistration data

requirements. 

Additionally, the Agency's Environmental Chemistry Laboratory analyzed DCPA technical

and end-use products for the presence of polyhalogenated dioxin/furans. One sample out of the

15 analyzed contained 2,3,7,8-TCDD at a level exceeding the Agency's specified Level of

Quantitation (LOQ), 0.1 ppb. The registrant, ISK Biosciences, informed the Agency that the

75% FI sample which contained 2,3,7,8-TCDD had not been produced commercially in the plant,

but had been formulated under laboratory conditions to fulfill the Agency's requirement for

product samples. The registrant stated that the sample was not representative of the DCPA
8

O

O

Cl

Cl

Cl

Cl

H3CO

OCH3

products currently produced by ISK Biosciences. 

DCPA formulations contain hexachlorobenzene (HCB) as an impurity. The Registration

Standard required analytical data to determine residues of HCB in/on representative test crops. 

HCB data, submitted from field trials with representative commodities, indicated that no residues

of HCB were present at greater than 1 ppb as the result of a 1x application of DCPA.

Because of TPA's potential to leach to groundwater, the Agency issued a Groundwater

Advisory notice in 1992 which required all DCPA end-use products to bear the following

statement: 

Tetrachloroterephthalic acid, a breakdown product of Dacthal, is known to leach

through soil as a result of agricultural and turf uses and has been found in

groundwater which may be used for drinking water. Users are advised not to apply

Dacthal to sand or loamy sand soils where the water table (groundwater) is close

to the surface and where those soils are very permeable, i.e. well drained. Your

local agricultural agencies can provide further information on the type of soil in

your area and the location of groundwater used for drinking water. 

III. SCIENCE ASSESSMENT

A. Physical Chemistry Assessment

1. Description of Chemical

DCPA (dimethyl tetrachloroterephthalate) is a pre-emergent herbicide used to control

annual grasses and broadleaf weeds. The molecular structure of DCPA is illustrated below in

figure A.

Other identifying characteristics and codes for the chemical are:

Empirical Formula: C10H6Cl4O4

Molecular Weight: 332

2. Identification of Active Ingredient
9

Technical DCPA is a colorless or white crystal with a melting point of 155o C and a bulk

density of 0.75 g/cm3. It is soluble in water at only 0.5 ppm at 25o C. Relative solubility of

organic solvents is as follows: benzene>toluene>xylene>dioxane>acetone>carbon tetrachloride

(25o C).

3. Manufacturing-Use Products

There are three DCPA manufacturing-use products (MPs) registered to ISK Biosciences

Corporation (formerly Fermenta ASC Corporation): a 20.7% formulation intermediate (FI; EPA

Reg. No. 50534-187), a 75% FI (EPA No. 50534-20), and a 90% FI (EPA Reg No. 50534-113). 

There is also a 98% minimum technical (T; EPA File Symbol No. 50534-ROA) which is currently

in the initial registration process. 

B. Human Health Assessment

1. Toxicology Assessment

The toxicological data base on DCPA is adequate for making reregistration eligibility

decisions. 

a. Acute Toxicity

Acute toxicity values and categories for DCPA are summarized in Table 2.

Table 2: Acute Toxicity Dataa

TEST RESULTS CATEGORY

Oral LD50--rat >5000 mg/kg IV

Dermal LD50--rabbit >2000 mg/kg III

Inhalation LC50--rat >4.48 mg/L III

Eye irritation--rabbita mild irritation III

Dermal irritation--rabbita mild irritation IV

Dermal sensitization--guinea

piga

not sensitizing --

a

 The dermal sensitization test was performed with a 90% technical material. All other acute

toxicity tests were performed using a 98% and a 90% technical material. The reported values are

the results from testing the 98% technical. 

b. Subchronic Toxicity

In a 21-day dermal toxicity study, Charles River CD rats were dermally exposed to DCPA

doses of 0, 100, 300, or 1000 mg/kg/day. No dermal irritation at the site of application was

observed. No adverse effects were found; therefore, the NOEL was equal to or greater than 1000
10

mg/kg/day, the highest dose tested (GLN 82-2; MRID 41231803). 

CD VAF/Plus Sprague Dawley rats were given 0, 10, 50, 100, 150, or 1000 mg/kg/day of

DCPA in the diet for 90 days. The NOEL was 10 mg/kg/day. The LOEL was 50 mg/kg/day,

based on increased liver weight and microscopic effects. The treatment-related effects were: 

increased weight and centrilobular hypertrophy in the liver; increased accumulation of foamy

macrophages in the lung; increased weight, epithelial hyperplasia, and tubular hypertrophy of the

kidney; and follicular hypertrophy of the thyroid. There were slight decreases in body weight and

food consumption in high dose females only (GLN 82-1; MRID 41767901). 

Male CD-1 mice were given doses of 0, 100, 199, 406, or 1235 mg/kg/day DCPA and

females were given 0, 223, 517, 1049, or 2198 mg/kg/day DCPA in the diet for 90 days. There

were no effects other than minimal histopathological effects on the liver. The NOEL was 406

mg/kg/day for males and 517 mg/kg/day for females. The LOEL for males was 1235 mg/kg/day

and for females was 1049 mg/kg/day, based on the liver effects (GLN 82-1; MRID 41064801). 

c. Chronic Toxicity and Carcinogenicity

Beagle dogs were given 0, 2.5, 25, or 250 mg/kg/day DCPA in the feed for two years. 

Adverse effects were not found. Therefore, the NOEL was equal to or greater than 250

mg/kg/day (GLN 83-1; MRID 00083584). 

A chronic toxicity and carcinogenicity study was conducted with Sprague Dawley CD

rats. The doses of DCPA given in the diet for two years were 0, 1,10, 50, 500 or 1000

mg/kg/day. The NOEL was 1 mg/kg/day. The LOEL was 10 mg/kg/day, with effects observed

in the lungs, liver, and thyroid; decreases in thyroid hormone levels in both sexes; and effects in

eyes in females. The specific effects were: (1) increased mortality in males at 1000 mg/kg/day

(HDT) during the second year; (2) either decreased body weights or decreased body weight gains

in both sexes at 1000 mg/kg/day, and in females at 500 mg/kg/day; (3) changes in hematology and

clinical chemistry parameters indicative of liver and kidney toxicity at both 500 and 1000

mg/kg/day in both sexes; (4) treatment-related increases in thyroid, liver, and kidney weights in

both sexes; (5) a dose-related increase in white foci in the lungs, which correlated with an

increased incidence of foaming macrophages in both sexes at doses of 10 mg/kg/day and higher;

(6) treatment-related exacerbation of chronic nephropathy in both sexes at 50 mg/kg/day and

higher; (7) a dose-related increase in centrilobular hepatocytic swelling in both sexes at doses of

10 mg/kg/day and higher; (8) a dose-related increase in liver neoplasms in females; (9) an increase

in follicular cell hyperplasia/hypertrophy at 10 mg/kg/day in males and at doses of 50 mg/kg/day

and higher in both sexes; (10) decreased T4 (thyroid hormone/thyroxine) values at 10 mg/kg/day

in males, and at 50 mg/kg/day and higher in both sexes; and (11) a treatment-related increase in

thyroid follicular cell neoplasms in both sexes (GLN 83-5; MRID 42731001). 

In another combined chronic toxicity and carcinogenicity study, CD-1 mice were given

DCPA in the diet for two years. The doses were 0, 12, 123, 435, or 930 mg/kg/day DCPA in the
11

diet for males and 0, 15, 150, 510, or 1141 mg/kg/day for females. The NOEL for systemic

effects was 435 mg/kg/day in males; 510 mg/kg/day in females. The systemic LOEL was 930

mg/kg/day in males; 1141 mg/kg/day in females, based on liver effects. There were increased

liver weights, increased SDH (sorbital dehydrogenase) and GPT (glutamic-pyruvic transaminase)

activities, and increased incidence of hepatocyte enlargement or vacuolation in both sexes at the

high dose levels; 930 and 1141 mg/kg/day for males and females, respectively. There was a

significant increase in hepatocellular neoplasms in females at the high dose level of 1141

mg/kg/day. Corneal opacity was observed in this study (GLN 83-5; MRID 40958701). 

Additionally, a supplementary rat chronic ophthalmology study was conducted to

investigate the corneal opacity observed in the mouse study. There was no evidence of ocular

toxicity observed in rats fed DCPA in the diet at levels up to 1000 mg/kg/day for two years

(MRID 41750102).

d. Developmental Toxicity

A developmental toxicity study with Sprague Dawley rats used doses of 0, 500, 1000, or

2000 mg/kg/day given by gavage on gestation days 6-15. No adverse effects on the maternal rats

or their offspring were observed. Therefore, the maternal and developmental toxicity NOELs

were set at 2000 mg/kg/day, HDT (GLN 83-3; MRID 00160685).

Two studies were conducted with New Zealand white rabbits. In the first study, DCPA

doses of 0, 500, 1000, or 1500 mg/kg/day were given by gavage on gestation days 6-19. There

were maternal deaths and adverse clinical signs at all dose levels. In the second study, DCPA

doses of 0, 125, 250, or 500 mg/kg/day were given by gavage on gestation days 7-19. None of

these levels produced any maternal or developmental toxicity. The second study tested dose

levels that overlapped those in the first study. Therefore, when considered together, the NOEL

for maternal toxicity can be set at 250 mg/kg and the LOEL can be set at 500 mg/kg based on

maternal deaths. The developmental toxicity NOEL can be set at 500 mg/kg. Although no

developmental effects were observed at any of the higher dose levels, a higher NOEL cannot be

set based on the limited number of litters at the higher dose levels. (The two studies together

fulfill GLN 83-3; MRID 41054820, 41838301).

e. Reproductive Toxicity

In a two generation reproduction study, female Sprague Dawley rats were fed DCPA at

doses of 0, 63, 319, or 1273 mg/kg/day while males received doses of 45, 233, or 952 mg/kg/day

DCPA. (These doses were equivalent to 0, 1000, 5000, and 20,000 ppm food residue values,

which are used for mammalian risk assessment in the Section III under Environmental

Assessment.) No effects on reproductive performance in 2 generations with 2 litters per

generation were seen. The maternal NOEL was 63 mg/kg/day. The maternal LOEL was 319

mg/kg/day, based on decreased body weight/body weight gain. The reproductive NOEL was 63

mg/kg/day. The LOEL was 319 mg/kg/day, based on decreased pup body weight. The paternal
12

NOEL was set at 233 mg/kg/day, and the LOEL was set at 952 mg/kg/day due to decreased

body-weight gain. On day 0 of the F2b litters, the diets for the low and mid-dose groups were

changed to 18 and 47 mg/kg/day respectively to be able to set a NOEL for pup body weight. The

offspring NOEL was set at 18 mg/kg/day (200 ppm), and the LOEL was 47 mg/kg/day (500 ppm)

based on decreased body weight. (GLN 83-4; MRID 41750103, 41905201). 

f. Mutagenicity

DCPA did not induce a mutagenic response in two independently performed mouse

lymphoma forward mutation assays. The nonactivated concentration range was 7.5 to 100 Fg/mL

and the S9-activated range was 15 to 200 Fg/mL (GLN 84-2(a) Category I; MRID 41054822). 

In an in vitro cytogenetic assay, Chinese hamster ovary cells were exposed to DCPA at

dose levels of 0, 30, 100, 300, or 1000 Fg/mL for 4 hours both with and without S-9 activation. 

Cells were harvested at 12 and 18 hours. There were no indications of a clastogenic response as a

result of exposure to test material at any dose level. (GLN 84-2(b) Category II; MRID

41054823). 

DCPA was not genotoxic in two independently performed unscheduled DNA synthesis

(UDS) assays in which the concentration ranged from 3 to 1000 Fg/mL (GLN 84-2(b) Category

III; MRID 41054824). 

An in vitro assay for sister chromatid exchange (SCE) in Chinese hamster ovary cells was

performed at dose levels of 0, 38, 75, 150, or 300 Fg/mL both with and without S9-activation.

There was no indication of a positive response; therefore, under the conditions of this assay the

test material is negative (GLN 84-2(b) Category III; MRID 41054825). 

g. Metabolism

In one study, a single oral dose of 14C-DCPA at either 1 or 1000 mg/kg was given to

Sprague-Dawley rats (5 rats/sex/dose level). The major metabolite of DCPA in the urine of both

sexes at both dose levels was 4-carbomethoxy-2,3,5,6-tetrachlorobenzoic acid. No radiolabel was

excreted in the urine as the parent compound, DCPA. (MRID 42155501)

There was a second study in which a single oral dose of 14C-DCPA at either 1 or 1000

mg/kg was given to Sprague-Dawley rats. Bile was found to be a negligible excretory route for

radiolabeled DCPA. At the low dose, 61% of the administered radiolabeled DCPA was excreted

in the urine. The percent absorption (urine, blood, bile, cage rinse, and carcass) was 79% of the

administered dose. At the high dose, 55 % of the administered radiolabel was excreted in the

feces or was found in the GIT (gastro-intestinal tract). The percent absorption was 8% of the

administered dose. (MRID 42155503) 

There was a third study in which a single oral dose of 14C-DCPA at either 1 or 1000
13

mg/kg was given to Sprague-Dawley rats (3 rats/sex/dose level) to determine the major route of

excretion. Urine was the major route at the low dose, and feces was the major route at the high

dose. Negligible amounts of radiolabel were found in the tissues examined at 48 hours following

dosing. There were no significant differences observed between the sexes at either dose level.

(MRID 42155502)

In a different study, nonradiolabeled DCPA was administered in single, daily oral doses to

Crl:CD BR VAF/Plus rats (15 rats/sex/dose level) for 14 consecutive days at either the 1 or 1000

mg/kg/day dose level. Twenty four hours after the 14th dose, a single oral dose of 14C-DCPA (1

or 1000 mg/kg) was administered to each rat. At the high dose level (both sexes), the majority of

the administered 14C-DCPA was unabsorbed and was eliminated in the feces, while at the lowdose level (both sexes) the majority of the administered 14C-DCPA was absorbed and excreted in

the urine. Radiolabel was found in all tissues examined, and the radiolabel concentration was

higher in the high-dose rat tissue than in the same tissue at the low dose level. At 168 hours,

radiolabel was still detectable in nearly all tissues at both dose levels and in both sexes. The

elimination half-life of radiolabel was calculated to be 22-23 hours at the high dose and

approximately 18 hours at the low dose. (MRID 42723201, 42723202)

In another study, Sprague-Dawley rats (5 rats/sex/dose level) were given single or

multiple (14 days) oral doses of 14C-DCPA (1 or 1000 mg/kg). The major metabolite of DCPA in

the urine of both sexes at both dose levels following both single and multiple dosing was 4-

carbomethoxy-2,3,5,6-tetrachlorobenzoic acid. A minor metabolite was tetrachloroterephthalic

acid. No radiolabel was excreted in the urine as the parent compound, DCPA. (MRID 42723203) 

Together these studies fulfill GLN 85-1. (MRID 43052201)

h. Dermal Absorption

A study was conducted with male Sprague-Dawley rats using doses of 4.75, 47.5, 475.0

and 1000.0 ug/cm2 of radiolabeled DCPA with a number of each dose group sacrificed at 0.5, 1.0,

2.0, 4.0, 10.0, and 24 hours. The area of the dermal application was washed to recover

unabsorbed DCPA. The skin, blood, urine, feces, and carcass were analyzed for percent of total

DCPA applied. At the 4.75 ug/cm2 dosing level, for the group sacrificed at 10 hours, 14.9 % of

the applied DCPA was absorbed. The percent absorption increased with duration of exposure

and generally decreased with increasing dose. (MRID 42651502)

A complimentary study of radiolabeled HCB in DCPA with male Sprague-Dawley rats

using dosing levels of 0.1%, 0.2%, and 0.3% (0.475, 0.950, and 1.425 ug/cm2) was conducted. 

A number of each dose group was sacrificed at 0.5, 1.0, 2.0, 4.0, 10.0, and 24 hours. The area of

the dermal application was washed to recover unabsorbed HCB. The skin, blood, urine, feces,

and carcass were analyzed for percent of total HCB applied. At the 0.1% dosing level, for the

group sacrificed at 10 hours, 26.46 % of the applied HCB was absorbed. The percentage of HCB

that was removed during the washing procedure, as well as the percentage remaining in the skin at

the application site decreased with duration of exposure. The percentage of HCB in the carcass
14

increased as the exposure duration increased. (MRID 42651501) These studies together fulfill

GLN 85-2.

The Agency does not have dermal absorption data on dioxin/furans. 

i. DCPA Reference Dose (RfD) and Cancer Potency Factor

Previously, the RfD for DCPA was determined to be 0.5 mg/kg/day based on a No

Observed Effect Level (NOEL) of 50 mg/kg/day in a 1963 2-year rat study. DCPA's first RfD for

DCPA was verified on February 18, 1987. However, as part of the re-registration process, newer

information was submitted to the Agency, and it was decided to re-evaluate the RfD.

On 12/9/93 the Agency's Health Effects Division RfD Committee met and selected an RfD

of 0.01 mg/kg body wt/day, based on a NOEL of 1.0 mg/kg/day in the chronic rat toxicity study

(MRID 42731001, discussed in detail earlier). Effects were observed in lungs, liver, thyroid, and

thyroid hormones in both sexes and the eyes in females at 10 mg/kg/day. An uncertainty factor of

100 was used to account for the inter-species extrapolation and intra-species variability. The

current RfD was verified on February 17, 1994 by the Agency's Office of Research and

Development, and entered into the Agency's Integrated Risk Information System (IRIS) in August

1994. The IRIS entry indicates that the principal study was well conducted receiving a high

confidence level. The additional studies were considered to be of good quality and generally

supportive of the principal study. Therefore, the DCPA database was given a high confidence

rating which yields a logical conclusion of high confidence in the DCPA RfD.

The Carcinogenicity Peer Review Committee (CPRC) of the Office of Pesticide Programs

discussed DCPA on 6/29/94 and 11/16/94. The CPRC classified DCPA as Group C, possible

human carcinogen, based on evidence of increased incidence of thyroid tumors in both sexes of

the rat (although only at an excessive dose in the female), and liver tumors in female rats and

mice, at doses which were not excessive. It was recommended that a low dose extrapolation

model be applied to the animal data for the quantification of human risk based on the combined

liver tumors in the female rat liver. 

DCPA's cancer potency factor was calculated using a multi-stage model (Tox_Risk

Program, version 3.5). A 3/4's scaling factor is used to account for the body weight differences

when extrapolating from rodent carcinogen bioassays to humans. There are several

methodologies than can be used to produce good estimates of cancer potency in humans from

rodent bioassays. EPA, the Food and Drug Administration, and the Consumer Product Safety

Commission have all determined that the 3/4's scaling factor would be an appropriate default

methodology. (Specific reasons for the selection and the use of the 3/4's scaling factor are

specified in the June 5, 1992 Federal Register Notice.) The estimated Q1

*

 (mg/kg/day)-1 of DCPA

is 1.49 x 10-3. 

The CPRC agreed that the manufacturing process impurities contained in DCPA may have
15

contributed to DCPA's tumor response. However, the CPRC also concluded that the tumors seen

in these studies could not be attributed solely to the presence of either impurity HCB or 2,3,7,8-

TCDD.

j. Hexachlorobenzene (HCB) as a DCPA Impurity

HCB is a recognized impurity in DCPA. The maximum level of HCB that is allowed in

formulations of DCPA is 0.3 percent. Therefore, the risk assessments supporting this document

assume that HCB is present at a level of 0.3 percent of DCPA in the food supply and in DCPA

applied to a field. 

The Agency has classified HCB as a B2 (probable human) carcinogen, based on data sets

which showed significant increases of tumor incidence in two species: hamsters and rats. In the

IRIS database, the Q1

*

 was 1.7 (mg/kg/day)-1 calculated based on hepatocellular carcinomas in

female Sprague-Dawley rats. However, since DCPA was calculated using the 3/4's scaling factor,

the Q1

*

 for HCB was modified by multiplying by 0.6 to account for the newer factor. The

modified Q1

*

 used in this risk assessment was 1.02 (mg/kg/day)-1. 

The RfD for HCB is 0.0008 mg/kg body wt/day based on a NOEL of 0.08 mg/kg/day in a

130 week feeding study in rats. (Effects observed were hepatic centrilobular basophilic

chromogenesis.) An uncertainty factor of 100 was used to account for the inter-species

extrapolation and intra-species variability.

The dermal absorption factor of HCB is 26.46% (see MRID 42651501 under Dermal

Absorption). At this time no other toxicological endpoints of concern have been identified for

HCB.

k. Polyhalogenated dibenzo-p-dioxins/dibenzofurans as DCPA

Impurities

Polyhalogenated dibenzo-p-dioxins/dibenzofurans (dioxin/furans) are recognized

impurities of DCPA. Of the dioxin/furans, only the 2,3,7,8-tetrachloro-dibenzo-para-dioxin

(2,3,7,8-TCDD) congener has been assigned a quantified estimate of its carcinogenic potential. 

The Agency has classified 2,3,7,8-TCDD as a B2 (probable human) carcinogen based on data sets

which showed significant increases of tumor incidence in two species: Sprague-Dawley rats and

B6C3F1 mice. The cancer potency factor Q1* was calculated based on multiple tumor sites in the

female Sprague-Dawley rats and is therefore estimated to be 1.56 x 105 (mg/kg/day)-1. However,

since DCPA was calculated using the 3/4's scaling factor, the Q1

*

 for 2,3,7,8-TCDD was modified

by multiplying by 0.6 to account for the newer factor. The modified Q1

*

 used in this risk

assessment was 1 x 105 (mg/kg/day)-1.

Enough data exists, however, regarding the potency of the other congeners to estimate

their relative potency in comparison to the 2,3,7,8-TCDD. Therefore, in evaluating the
16

toxicological significance of the dioxin/furan contamination, the Agency converts all of the

congener detection values into one value which represents the equivalent 2,3,7,8-TCDD potency. 

For example, if a product contained 10 ppb of a dioxin congener other than the 2,3,7,8-

TCDD. If that congener is considered to be only 1/10 as potent as 2,3,7,8-TCDD, the Agency

would use the equivalent of 1 ppb of 2,3,7,8-TCDD in its risk assessment. 

DCPA's registrant submitted dioxin/furan detection values to the Agency from seven batch

samples, as required in the 1987 DCI. During the first sampling, one of the dioxin/furan

congeners was detected above the Agency specified Level of Quantitation (LOQ). The registrant

subsequently altered their manufacturing process in an effort to reduce this contamination. 

(MRID 41241801) 

Subsequent to this change, none of the dioxin/furan congeners were detected above

Agency specified LOQs in the remaining six batch samples. The 2,3,7,8-TCDD equivalency of

the dioxin/furans reported to the Agency is approximately 0.1 ppb, which would equal

0.00000001% of the DCPA formulations. The Agency used this contamination value

(0.00000001%) to determine exposure values used in the risk assessments for DCPA's

reregistration eligibility evaluation. The registrant must propose certified upper limits for all

dioxin/furan congeners for which detection values were reported to the Agency. 

The RfD for 2,3,7,8-TCDD is 0.000001 ug/kg/day based on a LOEL of 0.001 ug/kg/day

from a three-generation feeding study in rats. (Effects at the lowest dose tested included dilated

renal pelvises, decreased fetal weight, and changes in the gestational index). An uncertainty factor

of 100 was used to account for the inter-species extrapolation and intra-species variability. An

additional uncertainty factor of 10 was used to account for the lack of a NOEL. At this time, no

other toxicological endpoints of concern have been identified for 2,3,7,8-TCDD.

l. Tetrachloroterephthalic Acid (TPA) as a DCPA Metabolite

Tetrachloroterephthalic Acid (TPA) is one of two DCPA animal metabolites. DCPA fed

to lactating goats was metabolized into both TPA and monomethyl tetrachloroterephthalic acid

(MTP). It is the TPA metabolite, however, that is found most frequently in the environment after

DCPA use. Soil metabolism converts DCPA into TPA, which is known to leach through soil and

pollute ground water. Therefore, the registrant submitted the following additional studies to

specifically assess the toxicity of TPA. 

Subchronic Toxicity

Disodium 2,3,5,6-tetrachloroterephthalic acid was given to Charles River CD rats in the

diet for 13 weeks. There were 15 rats/sex/dose group using dose levels of 0, 2.5, 25, 50, or 500

mg/kg/day. There were no adverse effects in either sex at any dose level. The NOEL is greater
17

than or equal to 500 mg/kg/day, the highest dose tested. The LOEL cannot be determined. 

(GLN 82-1; MRID 00100773)

CD Sprague-Dawley rats (10/sex/dose group) were given 2,3,5,6-tetrachloroterephthalic

acid via gavage for 30 days at dose levels of 0, 100, 500, or 2000 mg/kg/day. There were no

apparent adverse effects observed at any dose level. The NOEL is greater than or equal to 2000

mg/kg/day, the highest dose tested. The LOEL cannot be determined. (MRID 00158011)

Developmental Toxicity

In a developmental toxicity study, 25 pregnant Charles River rats/dose group were dosed

via gavage on gestation days 6 - 15 with TPA at dose levels of 0, 625, 1250, or 2500 mg/kg/day. 

The maternal toxicity NOEL was 1250 mg/kg/day. The maternal LOEL was set at 2500

mg/kg/day based on decreased body-weight gain and food consumption. There were no signs of

developmental toxicity, therefore the developmental NOEL was set at 2500 mg/kg/day, the

highest dose tested. A LOEL was not determined. (GLN 83-3(a); MRID 262303)

Mutagenicity

TPA did not induce a mutagenic response in the Ames assay or the HGPRT assay with or

without metabolic activation. (GLN 84-2(a); MRID 262302) In the Sister Chromatid Exchange

(SCE) assay, TPA did not induce a significant increase in the SCE frequency of Chinese Hamster

Ovary cells, both with and without metabolic activation. 

TPA did not induce an increase in unscheduled DNA synthesis. In an in vivo mouse

micronucleus assay, TPA was negative for clastogenicity in females and at best equivocal in

males. Based on the overall weight of evidence of no mutagenic response of this compound in

other studies, as well as the lack of mutagenicity of the parent DCPA, further testing for

mutagenicity is not warranted at this time.

2. Exposure Assessment

a. Dietary Exposure 

Tolerances for residues of DCPA in or on raw agricultural commodities are currently

expressed as the combined residues of DCPA and its metabolites monomethyl

tetrachloroterephthalate (MTP) and tetrachloroterephthalic acid (TPA) calculated as DCPA. At

present, no tolerances exist for residues of DCPA in animal commodities.

Although all the data requirements of the Reregistration Guidance have not been met at

this time, the outstanding data are considered to be confirmatory to the reregistration eligibility

decision. Sufficient data are available to conduct reasonable anticipated residue assessments. 
18

O

O

Cl

Cl

Cl

Cl

H3CO

OCH3

O

O

Cl

Cl

Cl

Cl

OCH3

HO

Plant Metabolism

The qualitative nature of the residue in plants is adequately understood based on

acceptable studies on onions, turnips, and tobacco. The residues of concern in plants are DCPA,

and its metabolites MTP and TPA which are the parent and metabolites that are currently

regulated. (See Figure B below.) The proposed metabolism of DCPA in plants is via ester

hydrolysis. Studies conducted with onion and turnip indicate that the impurity HCB is not

metabolized appreciably in these plants.

Total radioactive residues (TRR) were 0.548 ppm in mature onion bulbs and 6.458 ppm in

onion tops treated with 14C-DCPA at 1x. DCPA and its metabolites, MTP and TPA, accounted

for 66% and 79% of the TRR in onion tops and mature bulbs, respectively. TRR in mature turnip

roots and tops were 4.732 and 2.015 ppm from 1x treatment with [14C]DCPA. Combined

residues of DCPA, MTP, and TPA accounted for 78-89% of the TRR in turnip roots and tops. In

tobacco treated with 14C-DCPA, TRR in whole plants were 21-23 ppm. DCPA, MTP, and TPA

accounted for 91-98% of the radioactivity in tobacco. 

Figure B: The Chemical Structure of DCPA and its Metabolites of Concern

Chemical name Chemical structure

DCPA

Dimethyl tetrachloroterephthalate

MTP

Monomethyl tetrachloroterephthalic acid
Chemical name Chemical structure

19

O

O

Cl

Cl

Cl

Cl

HO

OH

TPA

Tetrachloroterephthalic acid

Animal Metabolism

The nature of the residue in ruminants is adequately understood. DCPA, MTP, and TPA

are the residues of concern. A lactating goat was dosed with 14C-DCPA for 4 days. The daily

dose was equivalent to 10 ppm in the diet, -1x the theoretical maximum DCPA intake for dairy

cattle and 2x the maximum beef cattle intake. Total radioactive residues (TRR) were less than or

equal to 0.01 ppm in milk with 38.5% organosoluble (0.004 ppm). Milk residues were not further

characterized. Residues in tissues were 0.0057 ppm in loin muscle, 0.0109 ppm in leg muscle,

0.0168 to 0.0179 ppm in fat, 0.0333 ppm in liver, and 0.1007 ppm in kidney. MTP was the

predominant residue in kidney, liver, leg muscle, and fat, accounting for 80-98% of the TRR. The

parent compound DCPA was detected only in fat at 10-15% of TRR. TPA was found only in

omental fat at 5% of TRR. Until adequate cattle feeding studies are available, the data from this

metabolism study will be used for estimating residues in meat and milk commodities.

The requirement for a poultry metabolism study has not been met, and remains in effect. 

Until these data are generated, the Agency will use the existing poultry feeding studies for

exposure/risk assessment based on the assumption that the residues of concern in poultry tissues

and eggs are the same as those delineated in meat and milk from the acceptable ruminant

metabolism study. 

Residue Analytical Methods - Plants and Animals 

Three tolerance enforcement methods for plant commodities are published in the Pesticide

Analytical Manual (PAM), Vol. II (Section 180.185), as Methods A, B, and C. Residue data

submitted in response to the 6/88 Guidance Document were collected using GC/EC methods

similar to the PAM, Vol. II methods. These methods are adequate for collection of DCPA, HCB,

MTP, and TPA residue data from potatoes (including processed commodities), sweet potatoes,

broccoli, celery, cucumbers, green and bulb onions, strawberries, sweet and bell peppers,

cantaloupes, tomatoes (including processed commodities), summer squash, and processed

commodities of beans and cottonseed. The limits of detection (LOD) are 0.01 ppm each for
20

DCPA, MTP, and TPA, and 0.0005 ppm for HCB. These methods are suitable candidates for

validation procedures as enforcement methods for plant commodities.

Another GC/EC method, similar to those submitted for plants, is available for determining

DCPA, MTP, and TPA in milk and beef fat. Recoveries of each compound using 12 samples each

of milk and beef fat fortified at 0.01-5 ppm were acceptable. The LOD is 0.01 ppm. This method

is suitable for Agency validation and inclusion in PAM, Vol. II pending successful independent

laboratory validation. The registrant has indicated that independent laboratory validation of the

method is underway. The registrant must submit independent laboratory validation data for

enforcement method(s) for animal commodities and submit the method(s) for Agency validation

and inclusion in PAM, Vol. II. Representative samples from adequate animal metabolism studies

must be analyzed by preferred enforcement method(s) to ascertain their ability to adequately

recover and quantify DCPA, MTP, and TPA.

DCPA per se is completely recovered using PAM, Vol. I Multiresidue Protocols D and E

(PESTDATA, PAM, Vol. I, Appendix, 8/93). Data submitted by the registrant indicate that the

TPA is not recovered by Protocols B and C. Multiresidue testing data on MTP are still required.

Storage Stability 

The results of a storage stability study on tomato processed products demonstrated that

residues of DCPA, MTP, and TPA are stable in these commodities during frozen storage for up

to 3.5 years.

Adequate storage stability data on DCPA, MTP, TPA, and HCB residues are available for

broccoli, peppers (sweet and bell), onions (green and bulb), radish (tops and roots), celery,

succulent beans, and sweet potatoes. The available data from an ongoing 4-year storage stability

study indicate that these compounds are generally stable for intervals of 12 to 24 months in frozen

(-12 to -18 C) storage. The storage stability study on the above commodities encompassing

storage intervals of up to 4 years (i.e., study completion) must be submitted. 

Storage stability data supporting actual sample conditions and intervals of storage are

required for all samples from residue studies used to support tolerances. Sample storage

information is required to validate the residue studies.

These data are considered confirmatory to the existing evidence that residues of DCPA,

MTP and TPA are stable in plant matrices during frozen storage.

Magnitude of the Residue in Plants

Provided that the required confirmatory storage stability data support studies reviewed for

reregistration, all data requirements for the magnitude of DCPA and HCB residues in plants are

adequate. Field trials have been performed representing the various conditions under which the
21

pesticide can be applied. Geographical representation is adequate and a sufficient number of trials

reflecting representative formulation classes have been conducted. Field trial data are required

depicting residues of DCPA and its metabolites in/on cowpea forage hay. Alternatively, the

registrants may restrict the use of DCPA on beans to varieties that are used for human

consumption only. Because the Agency now considers cotton gin byproducts to be a feed

commodity, data are required depicting residues of DCPA and its metabolites in/on cotton gin byproducts. Once adequate data for the cowpea and cotton commodities have been submitted and

evaluated, then suitable tolerances must be proposed. 

Adequate HCB data were submitted from field trials with representative commodities

from the following crop groups: leafy vegetables (celery), brassica leafy vegetables (broccoli),

legume vegetables (beans), fruiting vegetables (tomatoes), small fruits and berries (strawberries),

bulb vegetables (green onions), cucurbit vegetables (cucumbers, melons, and squash), and

cottonseed. No residues of HCB were detected at $1 ppb (the required LOQ) as the result of a

1x application of DCPA; therefore, no additional HCB residue data are required.

Magnitude of the Residue in Processed Food/Feed

Processing studies have been conducted on beans, cottonseed, tomatoes, and potatoes. 

All data concerning the magnitude of the residue in processed food/feed commodities have been

deemed adequate to determine the extent to which residues of DCPA concentrate in food/feed

items upon processing of the raw agricultural commodity.

DCPA residues concentrate in wet (19x) and dry (35x) tomato pomace. The Agency no

longer considers tomato pomace to be a significant animal feed. Therefore, no feed additive

regulations are required. 

DCPA residues also concentrate in succulent bean cannery waste (2x) and in dry potato

peel (1.9x). The Agency no longer considers bean cannery waste a processed commodity; and

presently uses only wet potato peel residue levels to set tolerances on potato waste. Therefore,

no feed additive tolerances are necessary for beans and potatoes.

Magnitude of the Residue in Meat, Milk, Poultry, and Eggs

There are no established tolerances for DCPA residues in eggs, milk, animal fat, meat, and

meat by-products. The maximum theoretical daily dietary intake of DCPA for cattle is

approximately 10 ppm based on a dairy cattle diet consisting of 50% potato waste, 25%

cottonseed, 15% bean seed, and 10% bean forage. In a 1963 cattle feeding study DCPA feeding

levels of 200 and 20 ppm were used. At the 20 ppm feeding level, combined residues of DCPA,

MTP, and TPA were nondetectable in milk and fat. Muscle, liver, and kidney were not analyzed. 

These existing cattle feeding studies are of limited usefulness because edible tissues were not

analyzed. Furthermore, the data for milk and fat are inconsistent with the results of a recent goat

metabolism study, indicating detectable DCPA residues in milk, fat, muscle, liver, and kidney from
22

a 10 ppm (1x) dosing level. The goat metabolism study indicates that tolerances are needed for

DCPA and its metabolites in meat and milk. Therefore, a new cattle feeding study is needed to

determine the appropriate tolerance levels. Until the new feeding studies are received, the data

from the 1994 goat metabolism study will be used to estimate residues in meat and milk for

purposes of a human dietary risk assessment.

Poultry feeding studies were conducted in 1973. Residues of DCPA, MTP and TPA were

non-detectable in edible tissues from hens fed 4 ppm DCPA for 30 days. At the 10x feeding level

(40 ppm) detectable combined residues were observed only in fat at 0.14 ppm. Combined

residues in egg yolk from the 4 ppm feeding level were 0.07 ppm on day 21 of the study. At the

10x feeding level, 21-day egg yolk residues were 0.26 ppm. The existing data indicate that a

tolerance for combined residues of DCPA, MTP, and TPA in eggs may be needed. Final

judgment as to the adequacy of the existing hen feeding studies and the need for poultry

tolerances will be determined after the requested poultry metabolism studies have been evaluated. 

In the interim, data from the existing poultry feeding studies will be used to estimate residues in

poultry tissues and eggs for purposes of a human dietary risk assessment.

Confined/Field Rotational Crops

The confined rotational crop study is adequate. Carrots, lettuce, and green beans were

grown in a greenhouse in soil treated 11 weeks previously with 14C-DCPA. The identified 14Cresidues were DCPA, TPA, and MTP, with TPA being the predominant residue. 

The limited field rotational crops studies used plant-back intervals (PBIs) of 29 to 365

days in soil that had been treated at 10.5 lbs a.i./acre (0.5x the maximum seasonal rate). Residues

of DCPA, MTP, and TPA were detected in carrot roots and tops, corn fodder and silage, oat

forage, and turnip tops planted at a 1 year PBI. These data indicated that inadvertent residue

tolerance and label amendments imposing crop rotational restrictions for DCPA treated fields will

be necessary. Any crop(s) without a registered use for which an inadvertent tolerance is desired

will require field trial data to determine the appropriate tolerance level(s) for rotated crop

commodities. The registrant must clarify their intentions as to the specific crop(s) to be allowed

in rotation with the crops on the label(s) and the desired plant-back intervals. 

Anticipated Residues

Table 3 lists the anticipated residues (ARs) for calculating carcinogenic and chronic, noncarcinogenic risk of DCPA and HCB for all raw agricultural commodities (RACs) in which DCPA

tolerances have been established. The Dietary Risk Evaluation System (DRES) will incorporate

these residue values, taking into account the percentage of the entire crop which is likely to be

treated with DCPA. ARs were also calculated for animal commodities from uses of DCPA on

RACs which are eventually fed to animals used for human consumption. The residues of concern

in both plant and animal commodities are DCPA, its metabolites (MTP and TPA), and its

contaminant, HCB. Residue data used to calculate anticipated residues for the RACs were
23

obtained from registrant field trials and processing studies, from monitoring data supplied by the

U.S. Food and Drug Administration, and from survey data supplied by the U.S. Department of

Agriculture. 

Tolerances are presently established for corn, soybeans, rutabagas, and lettuce although

there are no federally registered uses of DCPA on these crops. These tolerances are being

retained to cover any inadvertent residues from rotation of crops to previously DCPA-treated

fields. As previously stated, rotational crop studies indicate the need for inadvertent residue

tolerances and label amendments imposing crop rotation restrictions for DCPA-treated fields. 

The established tolerances on corn, soybeans, rutabagas and lettuce will need to be reassessed.

Since the Agency lacks the needed data (from additional field rotational crop studies),

ARs for corn, soybeans, and rutabagas were based on the established tolerances. Any inadvertent

residues occurring on these crops should be considerably lower. For lettuce it was possible to

refine the estimate of anticipated inadvertent residues by combining data from field trials and

monitoring studies. 

For calculating meat, milk, poultry and eggs, the livestock diet was assumed to contain the

maximum levels of ARs of DCPA and HCB. Cottonseed commodities were chosen since it is the

most likely of the livestock feeds to be used in a typical national livestock diet over an extended

period of time. The transfer of DCPA to milk and livestock commodities was calculated using the

total radioactive residues (TRRs) detected in a goat metabolism study. HCB transfer to meat,

milk, poultry, and eggs was calculated using a transfer factor obtained from feeding studies of

PCNB (pentachloronitrobenzene) contaminated with HCB. It was assumed that the transfer of

HCB to animal tissues from feed would be independent of any other chemical(s) present in the

feed. 

Table 3: Anticipated Residues of DCPA, its Metabolites, and HCB from Use of DCPA on

Food/Feed Cropsa

Food Name

Residue Data Source Anticipated Residues (ppm)

DCPA HCB DCPA, MTP

& TPA

HCB

Strawberries Field Trials 0.3% a.i. 0.22 0.00066

Horseradish Field Trials 0.3% a.i. 0.81 0.00243

Paprika Field Trials 0.3% a.i. 0.17 0.00051

Cantaloupes-unspecified Field Trials 0.3% a.i. 0.25 0.00075

Cantaloupes-pulp

Honeydew melons Field Trials 0.3% a.i. 0.08 0.00024

Watermelon Field Trials 0.3% a.i. 0.20 0.0006

Cucumbers Field Trials 0.3% a.i. 0.08 0.00024

Squash-summer Field Trials 0.3% a.i. 0.16 0.00048

Squash-winter Field Trials 0.3% a.i. 0.16 0.00025

Eggplant Field Trials 0.3% a.i. 0.11 0.00033

Peppers-sweet, garden Field Trials 0.3% a.i. 0.17 0.00051
Food Name

Residue Data Source Anticipated Residues (ppm)

DCPA HCB DCPA, MTP

& TPA

HCB

24

Peppers-other Field Trials 0.3% a.i. 0.17 0.00051

Chili peppers Field Trials 0.3% a.i. 0.17 0.00051

Pimentos Field Trials 0.3% a.i. 0.17 0.00051

Tomatoes-whole Field Trials 0.3% a.i. 0.11 0.00033

Tomatoes-juice

Processing

Study 0.11 0.00033

Tomatoes-puree

Processing

Study 0.15 0.00045

Tomatoes-paste

Processing

Study

0.396 0.00119

Tomatoes-catsup Processing

Study

0.12 0.00036

Broccoli Field Trial 0.3% a.i. 0.10 0.0003

Brussels Sprouts Field Trials 0.3% a.i. 0.04 0.00012

Cauliflower Brussels

Sprouts Data

Brussels

Sprouts Data

0.04 0.00012

Cabbage-green/red Field Trials 0.3% a.i. 0.35 0.00105

Cabbage-Chinese/celery, inc.

Bok Choy

Collards Kale Data 0.3% a.i. 0.5 0.0015

Kale Field Trials 0.3% a.i. 0.5 0.0015

Kohlrabi Brussels

Sprouts Data

Brussels

Sprouts Data

0.04 0.00012

Lettuce-leafy varietiesa,b FDA

Monitoring

PDP Survey 0.65 0.002

Lettuce-unspecifieda,b FDA

Monitoring

PDP Survey 0.65 0.002

Mustard Greensa Field Trials FDA

Monitoring

1 0.000625

Turnip-tops Field Trials 0.3% a.i. 0.775 0.002325

Cress, Upland Field Trials 0.3% a.i. 0.36 0.0011

Lettuce-head varietiesa,b FDA

Monitoring

PDP Survey 0.65 0.002

Garlic Onion Data Onion Data 0.02 0.000063

Leeks Field Trials 0.3% a.i. 0.57 0.00103

Onions-dry bulb (cipollini) Field Trials 0.3% a.i. 0.02 0.000063

Onions-dehydrated or dried

Potatoes-whole Field Trials 0.3% a.i. 0.25 0.00075

Potatoes-unspecified

Potatoes-peeled Field Trials 0.3 % a.i. 0.25 0.00075

Potatoes-dry

Potatoes-peel

Radishes-roots Field Trials 0.3% a.i. 0.07 0.00021

Radishes-tops Field Trials 0.3% a.i. 9.12 0.027
Food Name

Residue Data Source Anticipated Residues (ppm)

DCPA HCB DCPA, MTP

& TPA

HCB

25

Rutabagas-rootsb Tolerance 0.3%

Tolerance

2 0.006

Shallots Field Trials 0.3% a.i. 0.57 0.00103

Sweet potatoes (including

Yams)

Field Trials 0.3% a.i. 0.64 0.00192

Turnip-roots Field Trials 0.3% a.i. 0.275 0.000825

Corn, popb Tolerance 0.3%

Tolerance

0.05 0.00015

Corn, sweetb

Corn, grain-endospermb

Corn, grain-branb

Corn, sugarb

Corn, grain-oilb

Beans-succulent, lima Field Trials 0.3% a.i. 0.26 0.00078

Beans-succulent, green

Beans-succulent, other

Beans-succulent, yellow, wax

Beans-succulent, broadbeans

(immat. seed)

Beans-dry Field Trials 0.3% a.i. 0.09 0.00027

Mung Beans (sprouts)

Black-eyed Peas dry Field Trials 0.3% a.i. 0.36 0.00108

Onions-green Field Trials 0.3% a.i. 0.57 0.00103

Cottonseed-oil

Cottonseed-meal

Field Trial 0.3% a.i. 0.02 0.00006

Soybeans-mature, seeds dryb Tolerance 0.3%

Tolerance

2 0.006

Soybeans-oilb

Soybeans-unspecifiedb

Soybeans-flour, full fatb

Soybeans-flour, low fatb

Soybeans-flour, defattedb

Milk-non-fat solids Goat

Metabolism

Study

Cattle

Feeding

Study

0.0000006 0.0000001

Milk-fat solids

Milk sugar (lactose)

Beef, Goat, Sheep, Pork - meat

byproducts

Goat

Metabolism

Study

Cattle

Feeding

Study

0.0000011 c0.0000068 c

Beef, Goat, Sheep, Pork -

(organ meats) - other

0.0000017 0.0000003

Beef- dried 0.0000006 0.0000005

Beef,Goat,Sheep,Pork(boneless)

-fat 

0.0000011 0.0000068

Beef, Goat, Sheep, Pork (organ

meats) - kidney

0.0000057 0.0000003
Food Name

Residue Data Source Anticipated Residues (ppm)

DCPA HCB DCPA, MTP

& TPA

HCB

26

Beef, Goat, Sheep, Pork (organ

meats) - liver

0.0000017 0.0000003

Beef, Goat, Sheep, Pork

(boneless)- lean (w/o removable

fat)

0.0000006 0.0000005

Turkey, Other Poultry, Chicken

- byproducts

Poultry

Feeding

Study

Poultry

Feeding

Study

0.0000230 c0.0000084 c

Turkey, Other Poultry, Chicken

- giblets (liver)

0.0000009 0.0000028

Turkey, Chicken - flesh (w/o

skin, w/o bones)

0.0000009 0.0000002

Turkey, Other Poultry, Chicken

-flesh (+skin,w/o bones)

0.0000230 c0.0000084 c

Turkey-unspecified 0.0000230 c0.0000084 c

Eggs-whole (36.55 yolk) 0.0000011 0.0000001

Eggs-white only 0.0000009 0.0000000

Eggs-yolk only 0.0000138 0.0000028

a

 The residue values for these crops are based on FDA monitoring or USDA survey data, and were not adjusted for

% crop treated in the DRES analysis. 

b

 There are no established uses on this crop; however, the registrant has expressed an interest in retaining a

tolerance to cover potential residues from rotation of this crop into fields that have been previously treated with

DCPA. The tolerance on this crop, and anticipated residues, will be reassessed in conjunction with review of

rotational crop studies and registrant proposals for inadvertent residue tolerance and rotational crop restrictions on

DCPA labels.

c

 The anticipated residue on this food is assumed to be the same as for fat.

b. Drinking Water Exposure

 The available information is inadequate to assess exposure to DCPA and its metabolites

on a national level. However, sufficient information is available on local detections of DCPA and

its metabolites which can be used to extrapolate the following conclusions/generalizations. Note

that HCB and 2,3,7,8-TCDD were not considered in the drinking water assessment. Sufficient

information on their detections was not available. 

Ground Water

National Survey of Pesticides in Drinking Water Wells

The Agency's National Survey of Pesticides in Drinking Water Wells (NPS) detected a

DCPA metabolite, TPA, in the ground water in 25 states. TPA was the most frequently detected

pesticide residue (49 detections in 1347 wells). The limit of detection (LOD) for TPA in the NPS
27

was 0.10 ug/L. The highest concentration of detected TPA was 7.20 ug/L. DCPA was not

detected in the NPS; the LOD for DCPA was 0.06 ug/L.

State Studies

Ground water monitoring studies for pesticides have been conducted in a number of states

and regions. Several of these monitoring studies have also detected DCPA and/or its metabolites

in ground water.

The occurrence of DCPA residues have been confirmed in groundwater in Suffolk

County, New York, by pesticide sampling programs conducted by the Suffolk County

Department of Health Services. Water samples were analyzed for DCPA, its metabolites TPA

and MTP, and the manufacturing impurity HCB. DCPA degradates were detected in 56 of 213

samples (26%) analyzed from shallow private and public water supply wells. HCB was not

detected in any samples. It should be noted that only the number of samples, including

resampling, were given and not the actual number of wells. Therefore, the number of wells for

this report was assumed to be equal to the number of samples. The average concentration of the

positive samples was 109 ug/L with the highest concentration detected being 1039 ug/L. The

limit of detection (LOD) for the Suffolk County sampling program is 0.3 ug/L.

This information was used to perform an exposure assessment of groundwater in Suffolk

County. Using the average concentration of the detected samples (109 ug/L) and one-half of the

LOD (0.15 ug/L) for the non-detected samples, an average of all 213 samples can be calculated,

which is 28.768 ug/L.

Registrant Studies

As required by the Agency, the registrant is currently performing two small-scale

groundwater monitoring studies to determine the potential for DCPA residues to leach to

groundwater from current uses. Both studies (onions in California and turf in New York) began

in 1992. The Agency received preliminary data in support of the registrant's request to terminate

the studies. To date, the studies have been performed over a time-period of 17 months in New

York, and 22 months in California. Since these time periods are greater than a year, the Agency

used these data in assessing drinking water risk in this RED. However, the delivery date for the

final report is July 1996. At that time the Agency will revise its drinking water risk assessment. 

The ground water was analyzed for DCPA, TPA, and MTP. More data points were

collected in the New York study. The LOD was 0.1 ug/L; therefore, one-half of the LOD (0.05

ug/L) was used for non-detects. When analyses were performed in duplicate, the two results

were averaged to obtain a single result. The data did not indicate which wells were in a cluster or

the screening depth. Therefore, the average concentrations for DCPA, for MTP, and for TPA

were calculated for each well. These averages were summed to obtain the total residues in each

well without regard for depth.
28

At the New York site, a total of 29.4 lbs a.i./acre was applied in three applications. The

data are from nine wells (three clusters with three wells each). This information can be used to

perform an exposure assessment of groundwater at the turf site in New York. The average of the

sums of DCPA, TPA, and MTP over the 17 months was 50.36 ug/L.

At the California site, a total of 18.2 lbs a.i./acre was applied in two applications. 

However, the results of analyses from only eight wells were reported, although it was stated that

cluster wells were also used. This information can be used to perform an exposure assessment of

groundwater at the onion site in California. The average of the sums of DCPA, TPA, and MTP

over the 22 months was 12.75 ug/L.

Surface Water

The available data on concentrations of DCPA in surface waters is limited. The U.S.

Geological Survey collected samples from two creeks in Colorado from April, 1993 to April,

1994. Samples were collected once a month from October through March, and two or more

times per month during other months. The reported LODs for DCPA varied from 0.002 to 0.005

ug/L. One-half of the LOD was used for non-detects (varying 0.001 to 0.0025 ug/L.)

One of the creeks, Lonetree Creek, drained an agricultural watershed. The time-weighted

mean for DCPA concentration was 5.95 ug/L. The second creek, Cherry Creek, drained an urban

watershed. The time-weighted mean for DCPA concentration was 0.0078 ug/L.

Exposure Estimates

For drinking water, exposure is calculated using the following formula:

# exposure = (ppb DCPA and/or metabolites in the water consumed) (10-6)(22.6)

Water consumption is defined as all water obtained from the household tap that is

consumed either directly as a beverage or is used to prepare foods (mixing water with a can of

soup) and beverages (diluting frozen juice concentrate). Two generally accepted default values

for water consumption are 2 liters (28.57 g/kg/day based on a 70 kg adult male) or 1.5 liters

(21.42 g/kg day based on a 70 kg adult male). The 22.6 g/kg/day used in this calculation was

derived using water consumption values obtained from USDA's 1977-1978 Nationwide Food

Consumption Survey. It should be noted that the individuals participating in the survey selfreported their body weights which were then used in calculating the 22.6 value.

The other assumption used is that water from the same source containing the same

contaminant level is consumed throughout a 70-year lifetime. The second of these assumptions is

extremely conservative, since most of the U.S. population moves at some time during their life

and does not live in the same area, drinking from the same water source for a 70-year lifetime. It
29

could be considered as either an over-estimation or an under-estimation of risk depending on the

contaminant levels in the other sources of drinking water.

Groundwater

State Studies (Suffolk County, NY)

Exposure = (28.768) (10-6) (22.6)

Registrant Studies

New York turf

Exposure = (50.36) (10-6) (22.6)

California onions

Exposure = (12.75) (10-6) (22.6)

Surface Water

Lonetree Creek

Exposure = (5.95) (10-6) (22.6)

Cherry Creek

Exposure = (0.0078) (10-6) (22.6)

c. Occupational and Residential Exposure 

Use Patterns 

DCPA is applied with tractor mounted boom sprayers, tractor drawn granular spreaders,

shaker cans, residential push-type and whirly-bird spreaders, and by aerial application. 

An occupational and/or residential exposure assessment is required for an active ingredient

if (1) certain toxicological criteria are met, AND (2) there is potential exposure to handlers

(mixers, loaders, applicators) during use or to persons entering treated sites after application is

complete.

DCPA contains small amounts of several contaminants, HCB and dioxin/furans

(represented as 2,3,7,8-TCDD). The Registration Standard required foliar dissipation data
30

(turfgrass) for both HCB and 2,3,7,8-TCDD. A foliar dissipation study was submitted for HCB,

but not for 2,3,7,8-TCDD, with the registrant stating that 2,3,7,8-TCDD data could not be

provided due to the unavailability of analytical methodology to detect the theoretical levels of

2,3,7,8-TCDD. The residues of 2,3,7,8-TCDD which would theoretically be present as a result of

an application of DCPA at the label rate of 10.5 lbs a.i./acre was estimated as 5.3 x 10-13 g/ft2 or

5.74 x 10-10 ug/cm2. The Agency agreed that this residue level was much lower than 1991

analytical methods could detect; therefore, assays for 2,3,7,8-TCDD were not subsequently

required. 

Both occupational and residential exposures to DCPA and its contaminant HCB are

estimated in the following assessment. However, exposure to 2,3,7,8-TCDD is not included. 

"Worst case" exposure values for 2,3,7,8-TCDD were calculated using application rates and the

percentage of contamination only, since there are no foliar dissipation or dermal absorption data

on 2,3,7,8-TCDD. These exposure values (shown in the risk assessment section) were used to

produce rough estimates of risk. 

Mixer/Loader/Applicator (M/L/A) exposure monitoring studies were not required in the

June, 1988 Registration Standard. However, a subsequent Data-Call-In (dated 9/25/92), did

include requirements for M/L/A exposure monitoring studies to support the application of DCPA

granulars to turf and DCPA wettable powders to various crops and turf. Protocols were

submitted and reviewed for the M/L/A studies. At that time, the Agency determined that these

studies were no longer required based on the availability of surrogate data in the Pesticide

Handlers Exposure Database (PHED) Version 1.1 which was used in this assessment to estimate

M/L/A exposures resulting from registered uses of DCPA. However, based on this exposure

assessment which used PHED surrogate data, confirmatory data are now required to address the

Agency's concerns for two of the exposure scenarios. 

Mixer/Loader/Applicator Exposure Scenarios

Based on the use-patterns and potential exposures previously described, ten major

exposure scenarios were identified for DCPA: (1) mixing/loading the liquid flowable formulation,

(1a) mixing/loading the wettable powder formulations, (2) mixing and loading granulars for

ground applications, (3a) aerial application of liquid formulation, (3b) aerial application of

granulars, (4) applying the liquid and wettable powders with groundboom equipment, (5) applying

with a granular spreader cultivator mounted, (6a) flagger exposure to liquids, (6b) flagger

exposure to granulars, (7) applying with a shaker can, (8) applying with a backpack, (9)

mixing/loading and applying with a residential push-type spreader, and (10) mixing/loading and

applying with a whirly-bird spreader. Table 4 summarizes the parameters specific to each

exposure scenario, including a description of the actual clothing and equipment worn by all

persons being monitored in the exposure studies. Each exposure assessment in Table 5, DCPA

Exposure Values, or Table 6, HCB Exposure Values, is based on workers wearing long pants,

long-sleeve shirts, and no gloves, with the exception of the exposure assessment for
31

mixing/loading liquids, wettable powder formulations, shaker cans, and backbacks (scenarios I, Ia,

VII, and VIII), which includes wearing gloves in addition to long pants and long-sleeve shirts.
32

Table 4: Exposure Scenarios

Exposure Scenario

(Scen. #)

Data

Source

Clothing Scenarioa

Equipment

Daily Max

Treatedb (acres) Commentsc

Mixer/Loader Exposure

Liquids (I) PHED

V1.1

Long pants, long

sleeves, chemical

resistant gloves

Open mixing for

groundboom and

aerial applications

80 acres

groundboom,

and 350 acres

aerial

Acceptable grades;

Dermal = 59 to 122 replicates;

Inhalation = 85 replicates;

High confidence in dermal and inhalation data.

Wettable Powder (Ia) PHED

V1.1

Long pants, long

sleeves, chemical

resistant gloves

Wettable powder

packaged in open

bags for groundboom

and aerial

applications

80 acres

groundboom,

and 350 acres

aerial

Dermal and inhalation grades A,B,C;

Dermal = 22 to 45 replicates;

Inhalation = 44 replicates;

Medium confidence in dermal and inhalation

data

Granular (II) PHED

V1.1

Long pants, long

sleeves, no gloves

Open mixing for

cultivated spreader

and aerial

applications

80 acres

spreader, and

350 acres aerial

All grades for dermal;

Acceptable grades for inhalation;

Dermal = 10 to 78 replicates

Inhalation = 58 replicates;

Low confidence in dermal data and high

confidence for inhalation data

Applicator Exposure

Aerial (liquids) (IIIa) PHED

V1.1

Long pants, long

sleeves, no gloves

Open cockpit 350 acres Dermal grades A, B, C; inhalation all grades;

Dermal = 1 to 17 replicates; Inhalation = 17

replicates; Low confidence in dermal and

inhalation data

Aerial (granulars)

(IIIb)

PHED

V1.1

Long pants, long

sleeves, no gloves

Open cockpit 350 acres Dermal and inhalation all grades; Dermal = 4

to 13 replicates; inhalation = 13 replicates; 

Low confidence in dermal and inhalation data

Groundboom (IV) PHED

V1.1

Long pants, long

sleeves, no gloves

Open Cab 80 acres Acceptable grades;

Dermal = 23 to 33 replicates;

Inhalation = 22 replicates;

High confidence in dermal and inhalation data

Granular Spreader

Cultivator Mounted

(V)

PHED

V1.1

Long pants, long

sleeves, no gloves

Cultivator mounted

or pull-behind; Ag or

Turf; closed cab

80 acres Acceptable grades; Dermal = 24 to 25

replicates; Inhalation = 25 replicates; High

confidence in dermal and inhalation data

Flagger Exposure

Liquids (VIa) PHED

V1.1

Long pants, long

sleeves, no gloves

Unknown 350 acres Acceptable grades; Dermal = 16 to 18

replicates; Inhalation = 18 replicates; High

confidence in dermal and inhalation data

Granulars (VIb) PHED

V1.1

Long pants, long

sleeves, no gloves

Unknown 350 acres Dermal and inhalation all grades; Dermal = 4

to 20 replicates; inhalation = 4 replicates; Low

confidence in dermal and inhalation data

Mixer/Loader/Applicator Exposure

Shaker Can (VII) PHED

V1.1

Long pants, long

sleeves, chemical

resistant gloves

Granulars dispersed

by hand (worst case

surrogate)

1,000ft2

residential,

5,000ft2

commercial

Dermal and inhalation grades A, B, C; Dermal

= 15 to 16 replicates; inhalation = 16

replicates; Medium confidence in dermal and

inhalation data

Backpack (VIII) PHED

V1.1

Long pants, long

sleeves, chemical

resistant gloves

Backpack sprayer 1 acre

residential, 5

acres commercial

Dermal grades A, B, C; acceptable inhalation

grades; Dermal = 9 to 11 reps.; inhalation = 11

replicates; Low confidence in dermal and

inhalation data
Exposure Scenario

(Scen. #)

Data

Source

Clothing Scenarioa

Equipment

Daily Max

Treatedb (acres) Commentsc

33

Residential Push-type

Spreader (IX)

PHED

V1.1

Long pants, long

sleeves, no gloves

Rotary spreader 1 acre

residential, 5

acres commercial

Dermal grade C; inhalation grade B;

Dermal = 15 (no head data) replicates;

Inhalation = 15 replicates;

Medium confidence in dermal data and high

confidence for inhalation data

Whirly-bird spreader

(X)

PHED

V1.1

Long pants, long

sleeves, no gloves

Belly grinder 1 acre Dermal grades = 9A and 36C;

Inhalation grades = acceptable;

Dermal = 23 to 45 replicates;

Inhalation = 40 replicates;

Medium confidence in data

a

 Clothing scenario represents actual, not simulated, exposure data. 

b

 The value represents the maximum area or the maximum volume of spray solution which can be used in an 8 hour work

day to complete treatments for each exposure scenario of concern. 

c

 These grades are based on Quality Assurance/Quality Control data provided as part of the exposure studies. "Acceptable

grades" for dermal and inhalation studies are A and B as defined in Subdivision U Guidelines. All grades that do not meet

the guidelines are listed separately. A replicate refers to data acquired during one complete work cycle. High confidence in

data indicates that there were at least 15 replicates of Grades A and B data. Medium confidence in data indicates that there

were at least 15 replicates, but that some of the data did not meet the criteria for Grades A and B data. Low confidence in

data indicates that there were less than 15 replicates of data. 
34

Table 5: DCPA Occupational and Residential Exposure Values

Exposure

Scenario

(Scen. #)

Dermal

Exposurea1

(mg/lb ai)

Absorbed

Dermal

Exposurea2

(mg/lb ai)

Inhalation

Exposureb

(mg/lb ai) 

Total

Absorbed

Exposure

(mg/lb ai)

Label

Application

Ratec (lb

ai/acre)

Daily Max.

Treatedd

(acres)

Daily Dosee

(mg/kg/day)

LADDf (mg/kg/day)

Private

Appl.g

Commercial

Appl.h

Mixer/Loader Exposure

Liquids (I) 0.04 0.0060 0.0012 0.0072 10

80 0.082 0.00011 0.0011

350 0.36 NA 0.0049

Wettable Powder

(Ia) 0.2 0.030 0.0434 0.073 10

80 0.83 0.0011 0.011

350 3.65 NA 0.05

Granulars (II) 0.01 0.0015 0.0017 0.0032 10

80 0.037 0.000051 0.00051

350 0.16 NA 0.0022

Applicator Exposure

Aerial (liquids)

(IIIa) 0.05 0.00745 0.0003 0.0078 10 350 0.39 NA 0.0053

Aerial (granulars)

(IIIb) 0.002 0.00030 0.0013 0.0016 10 350 0.08 NA 0.0011

Groundboom (IV) 0.01 0.0015 0.0007 0.0022 10 80 0.025 0.00003 0.0003

Granular

Spreader

Cultivator

Mounted (V)

0.002 0.00030 0.0001 0.00040 10 80 0.0046 6.3 x 10-6 6.3 x 10-5

Flagger Exposure

Liquids (VIa) 0.01 0.0015 0.0003 0.0018 10 350 0.09 NA 0.0012

Granulars (VIb) 0.003 0.00045 0.0001 0.00055 10 350 0.028 NA 0.00038

Mixer/Loader/Applicator Exposure

Shaker Can (VII) 71.3 10.6 0.468 11.1 10

1,000ft20.036 0.00005 5 x 10-4

5,000ft20.18 0.00025 0.0025

Backpack (VIII) 2.5 0.37 0.03 0.40 10 1, 5i0.057, 0.29i0.00008 0.004
Exposure

Scenario

(Scen. #)

Dermal

Exposurea1

(mg/lb ai)

Absorbed

Dermal

Exposurea2

(mg/lb ai)

Inhalation

Exposureb

(mg/lb ai) 

Total

Absorbed

Exposure

(mg/lb ai)

Label

Application

Ratec (lb

ai/acre)

Daily Max.

Treatedd

(acres)

Daily Dosee

(mg/kg/day)

LADDf (mg/kg/day)

Private

Appl.g

Commercial

Appl.h

35

Residential Pushtype Spreader

(IX)

2.9 0.43 0.0063 0.44 10 1, 5i0.063, 0.31i0.00009 0.0042

Whirly-bird

Spreader (X) 10.4 1.55 0.0618 1.61 10 1 0.23 0.00032 NA

a1 Dermal unit exposures are reported as the best fit mean to simulate workers wearing long pants, long-sleeve shirts, and no gloves except for

mixer/loaders/liquid/wettable powder and shaker can and backpack applicators. The liquid and wettable powder mixer/loaders and shaker can and backpack applicators

simulate workers wearing long pants, long sleeve shirts, and chemical resistant gloves. The best fit mean is the composite total dermal exposure based on using the

geometric mean for lognormal distributed data, arithmetic mean for normal distributed data, and the median for all other distribution types. Protection factors were not

used to calculate dermal unit exposure values because sufficient data are available for PPE in these scenarios. 

a2 Dermal exposure was multiplied by the dermal absorption factor (which for DCPA is 14.9%) to obtain an exposure consistent with the amount of DCPA absorbed,

not the amount of DCPA in contact with the skin.

b

 Inhalation Exposure Values are reported as geometric means (lognormal distributions). No adjustment has been made to simulate workers wearing dust/mist

respirators.

c

 Dacthal W75 Label, EPA Reg # 50534-1; Dacthal Flowable Herbicide Label, EPA Reg # 50534-10; Dacthal G-2.5 Label, EPA Reg # 50534-17; Dacthal G-5 Label,

EPA Reg # 50534-3. The 10 lb ai/acre application rate represents the high rate that is used on clay loams having 3-5% organic matter. The rate of 15 lb ai/acre was not

used in the assessment since this rate is for turfgrass. The 15 lb rate requires 40 to 100 gallons of water per acre for grass which is unlikely for aerial applications. 

d

 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.

e

 Daily Dose (mg/kg/day) = Total Absorbed Exposure (mg/lb ai) * Max. Appl. Rate (lb ai/cycle) * Max. Treated

70 kg

f

 Lifetime Average Daily Dose (LADD) (mg/kg/day) = Daily Dose (mg/kg/day) * (Work Days Per Yr/365 Days Per Year) * (35 Yrs/70 Yrs).

g

 Private applicator is defined as a short term exposed individual (i.e., one day).

h

 Commercial applicator is defined as an intermediately exposed individual (i.e. 10 days).

i

 Homeowner treats 1 acre; commercial home-lawn applicator can treat 5 acres/day.
36

Table 6: HCB Occupational and Residential Exposure Values

Exposure Scenario

(Scen. #)

Dermal

Exposurea1

(mg/lb ai)

Absorbed Dermal

Exposurea2

(mg/lb ai)

Inhalation

Exposureb

(mg/lb ai) 

Total Absorbed

Exposure

(mg/lb ai)

Label

Application

Ratec (lb ai/acre)

Daily Max.

Treatedd

(acres)

Daily Dosee

(mg/kg/day)

 LADDf (mg/kg/day)

Private

Appl.g

Commercial

Appl.h

Mixer/Loader Exposure

Liquids (I) 0.04 0.011 0.0012 0.012 0.03

80 0.00041 5.6 x 10-7 5.6 x 10-6

350 0.0018 NA 2.5 x 10-5

Wettable Powder (Ia) 0.2 0.053 0.0434 0.096 0.03

80 0.0033 4.5 x 10-6 4.5 x 10-5

350 0.014 NA 1.9 x 10-4

Granulars (II) 0.01 0.0026 0.0017 0.0043 0.03

80 0.00015 2.1 x 10-7 2.1 x 10-6

350 0.00065 NA 8.9 x 10-6

Applicator Exposure

Aerial (liquids) (IIIa) 0.05 0.013 0.0003 0.013 0.03 350 0.0020 NA 2.7 x 10-5

Aerial (granulars) (IIIb) 0.002 0.00053 0.0013 0.0018 0.03 350 0.00027 NA 3.7 x 10-6

Groundboom (IV) 0.01 0.0026 0.0007 0.0033 0.03 80 0.00011 1.5 x 10-7 1.5 x 10-6

Granular Spreader

Cultivator Mounted (V) 0.002 0.00053 0.0001 0.00063 0.03 80 2.2 x 10-5 3.0 x 10-8 3.0 x 10-7

Flagger Exposure

Liquids (VIa) 0.01 0.0026 0.0003 0.0029 0.03 350 0.00044 NA 6.0 x 10-6

Granulars (VIb) 0.003 0.00079 0.0001 0.00089 0.03 350 0.00013 NA 1.8 x 10-6

Mixer/Loader/Applicator Exposure

Shaker Can (VII) 71.3 18.9 0.468 19.4 0.03

1,000ft20.00019 2.6 x 10-7 2.6 x 10-5

5,000ft20.00096 1.4 x 10-6 1.4 x 10-5

Backpack (VIII) 2.5 0.66 0.03 0.69 0.03 1, 5i 0.00030,

0.0015i 4.1 x 10-7 2.1 x 10-5

Residential Push-type

Spreader (IX) 2.9 0.77 0.0063 0.78 0.03 1, 5i 0.00033,

0.0017i 4.5 x 10-7 2.3 x 10-5

Whirly-bird Spreader

(X) 10.4 2.75 0.0618 2.81 0.03 1 0.0012 1.6 x 10-6 NA
37

a1 Dermal unit exposures are reported as the best fit mean to simulate workers wearing long pants, long-sleeve shirts, and no gloves except for

mixer/loaders/liquids/wettable powder and shaker can and backpack applicators. The liquid and wettable powder mixer/loaders and shaker can and backpack

applicators simulate workers wearing long pants, long sleeve shirts, and chemical resistant gloves. The best fit mean is the composite total dermal exposure based on

using the geometric mean for lognormal distributed data, arithmetic mean for normal distributed data, and the median for all other distribution types. Protection factors

were not used to calculate dermal unit exposure values because sufficient data are available for PPE in these scenarios. 

a2 Dermal exposure was multiplied by the dermal absorption factor (which for HCB is 26.46%) to obtain an exposure consistent with the amount of HCB absorbed, not

the amount of HCB in contact with the skin.

b

 Inhalation Exposure Values are reported as geometric means (lognormal distributions). No adjustment has been made to simulate workers wearing dust/mist

respirators.

c

 The label application rate for HCB is 0.3 percent of the label application rate of DCPA which is taken from the Dacthal W75 Label, EPA Reg # 50534-1; Dacthal

Flowable Herbicide Label, EPA Reg # 50534-10; Dacthal G-2.5 Label, EPA Reg # 50534-17; Dacthal G-5 Label, EPA Reg # 50534-3. The 10 lb ai/acre application

rate represents the high rate that is used on clay loams having 3-5% organic matter. The rate of 15 lb ai/acre was not used in the assessment since this rate is for

turfgrass. The 15 lb rate requires 40 to 100 gallons of water per acre for grass which is unlikely for aerial applications. 

d

 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.

e

 Daily Dose (mg/kg/day) = Total Exposure (mg/lb ai) * Max. Appl. Rate (lb ai/cycle) * Max. Treated

70 kg

f

 Lifetime Average Daily Dose (LADD) (mg/kg/day) = Daily Dose (mg/kg/day) * (Work Days Per Yr/365 Days Per Year) * (35 Yrs/70 Yrs)

g

 Private applicator is defined as a short term exposed individual (i.e., one day)

h

 Commercial applicator is defined as an intermediate exposed individual (i.e. 10 days)

i

 Homeowner treats 1 acre; commercial home-lawn applicator can treat 5 acres/day.
38

Post-application Exposure

There is a potential for exposure to persons entering a DCPA treated area after application

is complete. One concern is potential post-application exposure arising from re-entering a treated

agricultural crop area. Based on label use information for application of DCPA to agricultural

crops (considering methods and timing of applications), the agricultural use site with the highest

potential for post-application worker exposure is cucumbers. Foliar dissipation data for DCPA

and HCB on cucumbers and the corresponding worker exposure levels during cucumber

harvesting are summarized in Table 7 below. These calculations incorporated the following

assumptions: an 8 hour work day; 30 days exposure each year for a total of 35 years over a 70

year lifetime; average body weight is 70 kg.

Table 7: Foliar Dislodgeable Residues (FDR) of DCPA and HCB on Cucumbers and

Corresponding Worker Reentry Exposure During Cucumber Harvesting 

DATa FDR (Fg/cm2)

b LADD (mg/kg/day)c

DCPA HCB DCPA HCB

0 17.4 0.025 0.82 0.0012

1 15.0 0.018 0.70 0.0009

2 12.9 0.013 0.61 0.0006

3 11.1 0.010 0.52 0.0005

4 9.5 0.007 0.45 0.0003

5 8.2 0.005 0.38 0.0002

6 7.0 0.004 0.33 0.0002

a

 DAT = Days After Treatment 

b

 FDR values were calculated using a regression analysis of dissipation data (MRID 41750105) 

c

 Lifetime Average Daily Dose (LADD) was calculated using the following equation:

[FDR (Fg/cm2) x (10000 cm2/hr) x (1 mg/1000 Fg) x (1/70 Kg) x (8 hrs/day) x (30 days harvesting/365

days per year) x (35 years harvesting/70 year lifetime)]

where 10,000 cm2/hour is a transfer coefficient for citrus harvesters excerpted from Zweig, Leffingwell, Popendorf,

1985. 

Another concern is potential post-application exposure arising from re-entering turf areas following

application of DCPA (e.g., residential lawns and recreational areas). 
39

Table 8 (Foliar Dislodgeable Residues of DCPA) and Table 9 (Foliar Dislodgeable Residues of HCB)

summarize the residue dissipation data on turf and the corresponding exposure levels for children (ages 2 - 12)

playing on treated lawns. The data necessary to assess a toddler's (age 1 -2) exposure are not available. 
40

Table 8: Foliar (turf) Dislodgeable Residues (FDR) of DCPA, Total (Dermal and Oral)

DCPA Exposure to Children Following Application of Dacthal W-75 to Turfgrass 

Sampling Interval

(hr/days post-treatment)

Irrigated* Nonirrigated

FDR

(ug/cm2)

Total DCPA Exposure to

Children (mg/kg/day)a,b,c

FDR

(ug/cm2)

Total DCPA Exposure to

Children (mg/kg/day)a,b,c

1 HAT 4.15 2.35 3.64 2.06

2 HAT 1.67 0.89 4.26 2.41

6 HAT 1.48 0.84 4.60 2.60

1 DAT 1.29 0.73 5.56 3.14

24 hour TWAd 1.46 0.82 5.27 2.98

2 DAT 1.33 0.75 4.83 2.73

3 DAT 1.20 0.68 2.16 1.22

7 DAT 0.79 0.45 3.35 1.89

14 DAT 0.67 0.38 2.22 1.26

14 Day TWAe 0.85 0.48 2.94 1.66

Average Annualf 0.018 0.064

HAT = Hours After Treatment DAT = Days After Treatment TWA = Time Weighted Average

* An irrigated lawn was watered 1 hour after the application of DCPA with 1/2 inch of water.

a

 Total exposures were calculated by adding the results of the equations listed in footnotes b and c below.

b

 Dermal + oral exposure for children (ages 2 - 6) was calculated using: [(FDR μg/cm2) x (0.0314 m2/kg/day) x (10,000 cm2/1

m2)/1,000 Fg/mg] + [(FDR μg/cm2 x 321.5 cm2)/17 kg/day/1,000 Fg/mg].

c

 Dermal + oral exposure for children (ages 7 - 12) was calculated using: [(FDR μg/cm2) x (0.0221 m2/kg/day) x (10,000 cm2/1

m2)/1,000 Fg/mg] + [(FDR μg/cm2 x 361.5 cm2)/31 kg/day/1,000 Fg/mg].

d

 The 24 hour TWA was calculated using:

sum (FDR μg/cm2 1 HAT x 1 hr, FDR μg/cm2 2 HAT x 1 hr, FDR μg/cm2 6 HAT x 4 hrs, FDR μg/cm2 1 DAT x 18 hrs)/24 hrs.

e

 The 14 day TWA was calculated using: 

sum (FDR μg/cm2 24 hr TWA x 1 day, FDR 2 DAT x 1 day, FDR 3 DAT x 1 day, FDR 7 DAT x 4 days, FDR 14 DAT x 7

days)/14 days.

f

 The Average Annual was calculated using: 

(14 Day TWA x 14 days)/365 days/year.
41

Table 9: Foliar (turf) Dislodgeable Residues (FDR) of HCB, Total (Dermal and Oral) HCB

Exposure to children Following Application of Dacthal W-75 to Turfgrass

Sampling Interval

(hr/days post-treatment)

Irrigated* Nonirrigated

FDR

(ug/cm2)

Total HCB Exposure to

Children (mg/kg/day)a,b,c FDR (ug/cm2)

Total HCB Exposure to

Children (mg/kg/day)a,b,c

1 HAT 0.0035 2.0 x 10-3 0.0091 5.2 x 10-3

2 HAT 0.0014 8 x 10-4 0.0024 1.4 x 10-3

6 HAT 0.0013 7.3 x 10-4 0.0033 1.9 x 10-3

1 DAT 0.0004 2.2 x 10-4 0.0028 1.6 x 10-3

24 hour TWAd 0.0007 4.1 x 10-4 0.0031 1.8 x 10-3

2 DAT 0.0042 2.4 x 10-3 0.0185 1.0 x 10-2

3 DAT 0.0009 5.1 x 10-4 0.0044 2.5 x 10-3

7 DAT 0.0004 2.2 x 10-4 0.0024 1.4 x 10-3

14 DAT 0.0000 0 0.0006 3.4 x 10-4

14 Day TWAe 0.0005 3.0 x 10-4 0.0028 1.6 x 10-3

Average Annualf 0.0000 1.0 x 10-5 0.0001 7.0 x 10-5

HAT = Hours After Treatment DAT = Days After Treatment TWA = Time Weighted Average

* An irrigated lawn was watered 1 hour after the application of DCPA with 1/2 inch of water.

a

 Total exposures were calculated by adding the results of the equations listed in footnotes b and c below.

b

 Dermal + oral exposure for children (ages 2 - 6) was calculated using:

[(FDR μg/cm2) x (0.0314 m2/kg/day) x (10,000 cm2/1 m2)/1,000 Fg/mg] + [(FDR μg/cm2 x 321.5 cm2)/17 kg/day/1,000 Fg/mg].

c

 Dermal + oral exposure for children (ages 7 - 12) was calculated using:

[(FDR μg/cm2) x (0.0221 m2/kg/day) x (10,000 cm2/1 m2)/1,000 Fg/mg] + [(FDR μg/cm2 x 361.5 cm2)/31 kg/day/1,000 Fg/mg].

d

 The 24 hour TWA was calculated using: sum (FDR μg/cm2 1 HAT x 1 hr, FDR μg/cm2 2 HAT x 1 hr, FDR μg/cm2 6 HAT x

4 hrs, 

FDR μg/cm2 1 DAT x 18 hrs)/24 hrs.

e

 The 14 day TWA was calculated using: sum (FDR μg/cm2 24 hr TWA x 1 day, FDR 2 DAT x 1 day, FDR 3 DAT x 1 day,

FDR 7 DAT x 4 days, FDR 14 DAT x 7 days)/14 days.

f

 The Average Annual was calculated using: (14 Day TWA x 14 days)/365 days/year.

3. Risk Assessment

a. Dietary Assessment

(1) Acute Dietary Risk

An acute (one day) dietary risk assessment was not required. The NOELs in the studies

appropriate for selecting this endpoint were too high to be of concern; therefore, an appropriate

toxicological endpoint of concern was not identified.
42

(2) Chronic Dietary Risk

To calculate chronic dietary risk, the RfDs (0.01 mg/kg/day for DCPA, 0.0008 mg/kg/day

for HCB, and 0.000001 ug/kg/day for 2,3,7,8-TCDD) are used. It was assumed that DCPA

(including the impurities HCB and TCDD) is uniformly distributed in the commodity supply,

however, it was not assumed that the entire commodity nationwide was treated with DCPA. 

Percent crop treated (%CT) information was obtained from a variety of published and proprietary

sources for 1988 - 1994. This information was presented previously in Table 1. 

Currently, there are no registrations for use on lettuce, soybeans, corn, and rutabagas; 

however, these four DCPA tolerances are being retained to cover any inadvertent residues from

rotation of crops in previously DCPA-treated fields. Percent crop treated for soybeans,

rutabagas, corn, sweet corn, and lettuce were estimated. This was done by estimating the

approximate number of acres that are treated with DCPA in a year (excluding seed crops, golf

courses, and sod farms) which is 440,000 acres. It was then assumed that each of these 440,000

acres was rotated to soybeans. Since over 61 million acres of soybeans are grown each year, the

resulting %CT is less than 1% (440,000/61,000,000). If all 440,000 DCPA treated acres are

rotated to sweet corn, then the %CT is 59% 440,000/798,000 total sweet corn acreage). For

corn grain, 1% was used since over 78 million acres of corn are grown each year. For rutabagas,

100% CT was used since the acres grown is less than 440,000. For lettuce, 100% CT as stated in

footnote A of Table 3 was used. 

The Agency was able to establish that there are no reported uses of DCPA for all dry

beans and peas. Therefore, a default value of 1% was used. One hundred percent CT was

assumed if data were not available. 

Two chronic dietary risk assessments (for DCPA and HCB) were performed. The first

analysis can be considered a worst case analysis. To calculate a Theoretical Maximum Residue

Contribution (TMRC), tolerance level residues (as specified in Table 30: Tolerance Reassessment

Summary) were used for DCPA. There are no tolerances for HCB; therefore, "tolerance level"

residues for HCB were calculated by multiplying the DCPA tolerance by 0.3%. 

A pending tolerance for parsley (4 ppm) was included since monitoring data indicate that

DCPA is being found on parsley. Currently, there are not any registered uses for lettuce,

soybeans, corn and rutabagas; however, these four DCPA tolerances are being retained to cover

any inadvertent residues from rotation of crops in previously DCPA-treated fields. There are no

tolerances for DCPA in meat, milk, poultry, or eggs; however, metabolism and feeding studies

indicate the probable need. Residue levels were estimated for meat, milk, poultry, or eggs using

total radioactive residues from a goat metabolism study and a poultry feeding study. These

estimated residues (see Table 3: Anticipated Residues) are the best information available at this

time. 
43

"Worst Case" Chronic Dietary Exposure from DCPA

The TMRC was calculated for the U.S. population and 22 subgroups. 

Subgroup Exposure(mg/kg/day) %Reference Dose

U.S. population 0.007446 74

Non-nursing Infants (< 1 yr) 0.010580 106

Children (1-6 yr) 0.012878 129

Children (7-12 yr) 0.010361 104

All other subgroups were less than 100% of the RfD.

"Worst Case" Chronic Dietary Exposure from HCB as an Impurity in DCPA

The TMRC was calculated for the U.S. population and 22 subgroups. 

Subgroup Exposure(mg/kg/day) %Reference Dose

U.S. population 0.000024 3

Non-Nursing Infants ( < 1 yr) 0.000037 5

Children (1-6) 0.000041 5

All other subgroups were less than 5% of the RfD.

In a second analysis, "More Realistic Case" Chronic Dietary Exposure, the anticipated

residues in Table 3 were used in the calculation. This is considered to be a more realistic scenario

since the residue data were obtained from field trials and surveys. As previously discussed, ARs

could not be calculated for corn, soybeans, and rutabagas and are therefore included at tolerance

level. Parsley also is included at the proposed tolerance level because monitoring data have

indicated the presence of DCPA residues on parsley in the food supply.

"More Realistic Case" Chronic Dietary Exposure from DCPA

The Anticipated Residue Contribution (ARC) was calculated for the U.S. population and

22 subgroups. 

Subgroup Exposure(mg/kg/day) %Reference Dose

U.S. population 0.000233 2

Non-Hispanic blacks 0.000305 3

All other subgroups were less than 3% of the RfD.
44

"More Realistic Case" Chronic Dietary Exposure from HCB as an Impurity of DCPA

The ARC was calculated for the U.S. population and 22 subgroups. 

Subgroup Exposure(mg/kg/day) %Reference Dose

U.S. population <0.0000007 0.09

Non-Hispanic Others <0.000001 0.1

All other subgroups were less than 1% of the RfD.

Thus, in the more realistic scenario in which anticipated residues and percent crop treated

refinements are used in estimating chronic dietary risk, the % Reference Dose for both DCPA and

its impurity HCB are less than 100 for the U.S. population and all subgroups.

Neither DCPA nor its impurity HCB pose a significant chronic dietary risk for uses that

are currently registered or for uses such as meat, milk, poultry, or eggs which may need to be

established.

"Worst Case" Chronic Dietary Exposure from 2,3,7,8-TCDD as an Impurity in DCPA

A chronic dietary risk for TCDD was calculated for the general population of the U.S.

only. To estimate exposure, the TMRC (Theoretical Maximum Residue Contribution) of

0.007446 mg/kg/day for exposure to DCPA in the diet was used. Exposure to 2,3,7,8-TCDD in

the diet can be estimated by multiplying DCPA exposure by the percent of 2,3,7,8-TCDD in the

formulation. 

(0.007446)(0.0000000001) = 7.446 x 10-13 mg/kg/day

Using an RfD of 0.000001 ug/kg/day (0.000000001 mg/kg/day), the percent RfD can be

estimated as 0.07%. 

(3) Carcinogenic Dietary Risk

Carcinogenic Risk from DCPA

The upper bound carcinogenic risk from food uses of DCPA for the general U.S.

population was estimated using anticipated residues and the following equation:

Upper Bound Cancer Risk = Dietary Exposure (ARC) x Q1

*

Based on a Q1

*

 of 0.00149 (mg/kg/day)-1, the upper bound carcinogenic risk was

estimated to be 3.5 x 10-7. 
45

For reasons previously stated, soybeans, corn, rutabagas, lettuce, parsley, meat, milk,

poultry, and eggs were included in this estimate of carcinogenic risk. The contributions to the risk

from these commodities are soybeans (1 x 10-8), corn (1.1 x 10-8), rutabagas (8 x 10-9), lettuce

(2.2 x 10-7), parsley (2.2 x 10-8), and meat, milk, poultry, and eggs (3 x 10-11). 

Carcinogenic Risk from HCB as an Impurity in DCPA

The upper bound carcinogenic risk from food uses of HCB for the general U.S. population

was estimated using the following equation:

HCB Upper Bound Cancer Risk = Dietary Exposure (ARC) x Q1

*

Based on a Q1

*

 of 1.02 (mg/kg/day)-1, the upper bound cancer risk was estimated to be

7x10-7. 

As with the DCPA risk assessment, soybeans, corn, rutabagas, lettuce, parsley, meat, milk,

poultry, and eggs were included in this estimate of carcinogenic risk. HCB does not pose a

significant risk of excess life time carcinogenic risk to the overall U.S. population with an upper

bound estimate of 7 x 10-7. In this risk assessment the estimate of upper bound carcinogenic risk

from HCB could be considered to be an over-estimate of actual risk. This is due to the

assumption that residues of HCB are present at the certified upper limit, 0.3%, in all DCPA

formulations.

Carcinogenic Risk for 2,3,7,8-TCDD as an Impurity in DCPA

To estimate exposure, the TMRC of 0.007446 mg/kg/day for exposure to DCPA in the

diet was used. Exposure to 2,3,7,8-TCDD in the diet can be estimated by multiplying DCPA

exposure by the percent of 2,3,7,8-TCDD in the formulation.

(0.007446)(0.0000000001) = 7.446 x 10-13 mg/kg/day

Carcinogenic risk can be estimated by multiplying the 2,3,7,8-TCDD exposure by its

cancer potency factor. 

(7.446 x 10-13)(1 x 105) = 7 x 10-8

b. Drinking Water Assessment

(1) Chronic Drinking Water Risk

Drinking water chronic risk was calculated using the following formula:

Risk = % RfD = [Exposure/RfD](100) where:
46

# the RfD for DCPA (0.01 mg/kg/day) is used for DCPA, TPA, and MTP. A complete

database exists only for DCPA. Without a complete database for each metabolite, Agency

policy is to use a default assumption that each metabolite is no more or less toxic than the

parent; and, as previously stated

# exposure = (ppb DCPA and/or metabolites in the water consumed) (10-6)(22.6)

Groundwater

State Studies (Suffolk County, NY)

%RfD = [(28.768) (10-6) (22.6)/(0.01)](100)

= 6.5%

Registrant Studies

New York turf

%RfD = [(50.36) (10-6) (22.6)/(0.01)](100)

= 11%

California onions

%RfD = [(12.75) (10-6) (22.6)/(0.01)](100)

= 3%

Surface Water

Lonetree Creek

%RfD = [(5.95) (10-6) (22.6)/(0.01)](100)

= 1%

Cherry Creek

Risk = [(0.0078) (10-6) (22.6)/(0.01)](100)

= 0.002%

The highest %RfD was 11% at the New York turf site. Even if this drinking water risk

were to be combined with the chronic dietary risk, the total %RfD would be much less than 100.
47

(2) Carcinogenic Drinking Water Risk

Carcinogenic risk for drinking water was calculated using the following formula.

Risk = Exposure x Q1

*

 where:

# the Q1

*

 for DCPA, 0.00149 (mg/kg/day)-1 is used for DCPA, TPA, and MTP. A

complete database exists only for DCPA. Without a complete database for each

metabolite, Agency policy is to use a default assumption that each metabolite is no more

or less carcinogenic than the parent; and as previously stated

# exposure = (ppb DCPA and/or metabolites in the water consumed) (10-6)(22.6)

Groundwater

State Studies (Suffolk County, NY)

Risk = (28.768)(10-6)(22.6)(0.00149)

= 9.7 x 10-7

Registrant Studies

New York turf

Risk = (50.36)(10-6)(22.6)(0.00149)

= 1.7 x 10-6

California onions

Risk = (12.75)(10-6)(22.6)(0.00149)

= 4.3 x 10-7

Surface Water

Lonetree Creek

Risk = (5.95)(10-6)(22.6)(0.00149)

= 2 x 10-7

Cherry Creek

Risk = (0.0078)(10-6)(22.6)(0.00149)

= 2.6 x 10-10
48

Generally, the information available to the Agency does not identify a population

consuming drinking water equal to or greater than 50 ug/L (DCPA and metabolites) for a period

of 70 years. It should be noted that the highest concentration of detected TPA in the NPS was

7.20 ug/L, and there were no detections of DCPA.

Consumption of drinking water obtained from groundwater at the New York turf site may

be a worst case scenario. If drinking water were to be obtained solely from this source

(containing DCPA and its metabolites at 50 ug/L) then the carcinogenic risk would be 1.7 x 10-6. 

The Agency will be refining this risk estimate, since it has been based on preliminary information

and could change based on final groundwater data due to the Agency in the summer of 1996.

The information available to the Agency indicates that the NOELs for TPA would be

higher than those of DCPA for similar studies. However, adequate information to estimate a

health advisory level for TPA is not available. As previously stated, a complete database exists

only for DCPA, and it was necessary for the Agency to default to the DCPA database for the

TPA (and MTP) metabolites.

c. Occupational and Residential Assessment

(1) Short Term and Intermediate Term Risk

A short term (1 - 7 days) occupational or residential risk assessment was not required

because the NOEL for the 21 day dermal study is greater than 1000 mg/kg/day. Additionally, no

appropriate toxicological endpoint of concern was identified.

An intermediate term (1 week to several months) occupational or residential risk

assessment was not required. The NOELs in the studies appropriate for selecting this endpoint

were too high to be of concern; therefore, an appropriate toxicological endpoint of concern was

not identified.

(2) Carcinogenic Risk

Using the exposures presented in Table 8, the carcinogenic risk after exposure to foliar

dislodgeable residues of DCPA following an application of Dacthal W-75 to turfgrass was

calculated using the following formula:

Risk = [[Average annual exposure (mg/kg/day)] [play exposure interval (10

yrs)/average lifetime (70 yrs)]] x [Q1

*

(0.00149 (mg/kg/day)-1)] x [dermal

absorption factor (0.149)].

For irrigated lawns the average annual risk estimate for children playing on a treated lawn

is 5.6 x 10-7. For non-irrigated lawns the average annual risk for children playing on a treated

lawn is 2.0 x 10-6. 
49

A similar formula was used to calculate the carcinogenic risk after exposure (Table 9) to

foliar dislodgeable residues of HCB following an application of Dacthal W-75 to turfgrass:

Risk = [[Average annual exposure (mg/kg/day)] [play exposure interval (10

yrs)/average lifetime (70 yrs)]] x [Q1

*

(1.02 mg/kg/day)-1)] x [dermal absorption

factor (0.2646)].

For irrigated lawns the average annual risk from HCB as an impurity of DCPA for

children playing on a treated lawn is 3.9 x 10-7. For non-irrigated lawns the average annual risk

for toddlers and children playing on a treated lawn is 2.7 x 10-6. 

As previously stated, the Agency does not have the foliar residue data to calculate

exposure to 2,3,7,8-TCDD following an application of Dacthal W-75 to turfgrass. However, a

rough estimation of the risk for children ages 2-12 playing on non-irrigated turf at 1 hour after

treatment was 3.9 x 10-7

.

The carcinogenic risk for the previously identified occupational and residential scenarios

are given in Table 10 for DCPA and in Table 11 for HCB. The highest estimated risk for a

commercial applicator is for the wettable powder scenario. For the commercial mixer/loader

(assuming 350 acres) the risk for DCPA was estimated to be 7.5 x 10-5 and for HCB (in DCPA)

to be 1.9 x 10-4.

These risks could be mitigated by the use of a dust mist respirator with a TC-21C filter. 

The application of an 80% protection factor for the inhalation exposure component of treating

350 acres yields an LADD (mg/kg/day) of 0.027 for DCPA and 1.3 x 10-4 for HCB. The

corresponding carcinogenic risk would be 4.0 x 10-5 for DCPA and 1.3 x 10-4 for HCB. 

The scenario with the highest risk for a private applicator for exposure to DCPA is also

the wettable powder scenario (assuming 80 acres are treated). For DCPA the risk is 1.6 x 10-6. 

The scenarios with the highest risk for a private applicator for exposure to HCB are the wettable

powder scenario (assuming 80 acres treated), the shaker can scenario (5000 ft2), and the whirlybird scenario with corresponding risk estimates of 4.6 x 10-6, 1.4 x 10-6, and 1.6 x 10-6. The

Agency is requiring additional handler studies for these scenarios.

Risk for several of the M/L/A scenarios for exposure to TCDD was estimated using an

application rate of 10-9, which is the DCPA label application rate of 10 multiplied by the TCDD

exposure values of 0.00000001%. The risk for the whirly-bird scenario was 2 x 10-8 and for the

wettable powder scenario, commercial applicator (300 acres) was 1.6 x 10-6. It should be

emphasized that these can be considered as overestimates due to the lack of a dermal absorption

factor and the use of 0.00000001% of the DCPA formulation.

Foliar dissipation data for DCPA and HCB on cucumbers and corresponding worker

exposure and risk during cucumber harvesting are summarized in Table 12. The highest risk for
50

exposure to DCPA is 1.8 x 10-4 and for exposure to HCB (in DCPA) is 3.2 x 10-4 both at zero

days after treatment. The risk values decrease as the days after treatment increase. The exposure

and risk levels in 12 were calculated based on very conservative assumptions regarding transfer

of foliar dislodgeable residues (FDRs) to fieldworkers during harvesting and the number of days

of exposure per year at each FDR level (i.e., 30 days of exposure per year at each FDR level).

The Agency also lacks the FDR data to calculate TCDD exposure during cucumber

harvesting. However, a rough estimation for zero days after treatment is 8 x 10-6, which should

be considered as an overestimation since a very conservative transfer factor was used and no

dermal absorption factor was available. 
51

Table 10: DCPA Occupational and Residential Carcinogenic Risk Values (based upon

exposure values from Table 5)

Exposure Scenario (Scen. #)

Riska 

 Private Appl.b Commercial Appl.c

Mixer/Loader Risk

Liquids (I) 80A: 1.6 x 10-7 80A: 1.6 x 10-6

350A: 7.3 x 10-6

Wettable Powder (Ia) 80A: 1.6 x 10-6 80A: 1.6 x 10-5

350A: 7.5 x 10-5

Granulars (II) 80A: 7.6 x 10-8 80A: 7.6 x 10-7

350A: 3.3 x 10-6

Applicator Risk

Aerial (liquids) (IIIa) NA 7.9 x 10-6

Aerial (granulars) (IIIb) NA 1.6 x 10-6

Groundboom (IV) 4.5 x 10-8 4.5 x 10-7

Granular Spreader Cultivator Mounted (V) 9.4 x 10-9 9.4 x 10-8

Flagger Risk

Liquids (VIa) NA 1.8 x 10-6

Granulars(VIb) NA 5.7 x 10-7

Mixer/Loader/Applicator Risk

Shaker Can (VII) 1000 ft2 7.3 x 10-8 7.3 x 10-7

Shaker Can (VII) 5000 ft2 3.7 x 10-7 3.7 x 10-6

Backpack (VIII) 1.2 x 10-7 6.0 x 10-6

Residential Push-type Spreader (IX) 1.3 x 10-7 6.3 x 10-6

Whirly-bird Spreader (X) 4.8 x 10-7 NA

a

 Risk = [LADD (mg/kg/day)] * [Q1

*

 of 0.00149 (mg/kg/day)-1] 

b

 Private applicator is defined as a short term exposed individual (i.e., one day).

c

 Commercial applicator is defined as an intermediate exposed individual (i.e. 10 days).
52

Table 11: HCB Occupational and Residential Carcinogenic Risk Values (based upon

exposure values from Table 6)

Exposure Scenario (Scen. #)

Riska

Private Appl.b

Commercial

Appl.c

Mixer/Loader Risk

Liquids (I) 80A: 5.7 x 10-7 80A: 5.7 x 10-6

350A: 2.6 x 10-5

Wettable Powder (Ia) 80A: 4.6 x 10-6 80A: 4.6 x 10-5

350A: 1.9 x 10-4

Granulars (II) 80A: 2.1 x 10-7 80A: 2.1 x 10-6

350A: 9.1 x 10-6

Applicator Risk

Aerial (liquids) (IIIa) NA 2.8 x 10-5

Aerial (granulars) (IIIb) NA 3.8 x 10-6

Groundboom (IV) 1.5 x 10-7 1.5 x 10-6

Granular Spreader Cultivator Mounted (V) 3.1 x 10-8 3.1 x 10-7

Flagger Risk

Liquids (VIa) NA 6.1 x 10-6

Granulars (VIb) NA 1.8 x 10-6

Mixer/Loader/Applicator Risk

Shaker Can (VII) 1000 ft2 2.6 x 10-7 2.6 x 10-5

Shaker Can (VII) 5000 ft2 1.4 x 10-6 1.4 x 10-5

Backpack (VIII) 4.2 x 10-7 2.1 x 10-5

Residential Push-type Spreader (IX) 4.6 x 10-7 2.3 x 10-5

Whirly-bird Spreader (X) 1.6 x 10-6 NA

a

 Risk = LADD (mg/kg/day)] * [Q1

*

 of 1.02 (mg/kg/day)-1]

b

 Private applicator is defined as a short term exposed individual (i.e., one day)

c

 Commercial applicator is defined as an intermediate exposed individual (i.e. 10 days)
53

Table 12: Foliar Dislodgeable Residues (FDR) of DCPA and HCB on Cucumbers and the

Worker Reentry Exposure and Risk During Cucumber Harvesting

Corresponding

DAT

FDR (Fg/cm2)

a LADD (mg/kg/day)b Risk Levelsc

DCPA HCB DCPA HCB DCPA HCB

0 17.4 0.025 0.82 0.0012 1.8 x 10-4 3.2 x 10-4

1 15.0 0.018 0.70 0.0009 1.6 x 10-4 2.3 x 10-4

2 12.9 0.013 0.61 0.0006 1.3 x 10-4 1.6 x 10-4

3 11.1 0.010 0.52 0.0005 1.2 x 10-4 1.3 x 10-4

4 9.5 0.007 0.45 0.0003 9.9 x 10-5 8.9 x 10-5

5 8.2 0.005 0.38 0.0002 8.5 x 10-5 6.3 x 10-5

6 7.0 0.004 0.33 0.0002 7.3 x 10-5 5.1 x 10-5

DAT = Days After Treatment 

The calculations use the following assumptions: 8 hour work day, 30 days exposure each year for a total of 35 years over a 70

year lifetime, average body weight of 70 kg

a

 FDR values were calculated using a regression analysis of dissipation data (MRID 417501-05) 

b

 Lifetime Average Daily Dose (LADD) was calculated using the following equation:

[FDR (Fg/cm2) x (10000 cm2/hr) x (1 mg/1000 Fg) x (1/70 Kg) x (8 hrs/day) x (30 days harvesting/365 days per year)

x 

(35 years harvesting/70 year lifetime)]

where 10,000 cm2/hour is a transfer coefficient for citrus harvesters excerpted from Zweig, Leffingwell, Popendorf, 1985. 

c

 Risks for DCPA and HCB were calculated using the following equation:

[LADD (mg/kg/day) x Q1* (mg/kg/day)-1 x (Dermal Absorption Factor)

The Q1

*

 value for DCPA is 0.00149 (mg/kg/day)-1 and for HCB is 1.02 (mg/kg/day)-1. 

The dermal absorption factor for DCPA is 0.149 and for HCB is 0.2646

Additional Occupational/Residential Exposure Studies

Handler Studies

The Agency does not have handler exposure studies for three of the occupational

scenarios for which DCPA is used. The Agency used surrogate data from the Pesticide Handler's

Exposure Database to estimate a handler's exposure to DCPA and HCB in these scenarios. 

Resulting risk estimates are in the 10-4 to 10-6 range, with a great amount of uncertainty associated

with those values. Therefore, the registrant is being required to submit handler exposure studies

for three scenarios to confirm that these uses are eligible for reregistration. The three scenarios

are listed below. 

C loading/applying granular formulations using whirly-bird spreader equipment, 

C mixing/loading wettable powder formulations to support aerial applications, and

C loading/applying granular formulations using a shaker can.

A dermal exposure study (Guideline 231) and an inhalation exposure study (Guideline

232) are being required for each of these scenarios. These studies should be conducted

concurrently; i.e., dermal and inhalation samples should be collected from the same handler and at

the same site during each trial for both DCPA and HCB exposure. Requirements for such studies

are addressed in subdivision U of the Pesticide Assessment Guidelines. 
54

Post-Application Studies

The registrant must submit post-application exposure studies as confirmatory data for

reregistration. Requirements for such post-application exposure studies are addressed by

Subdivision K of the Pesticide Assessment Guidelines. Post-application/reentry exposure studies

are required as confirmatory data to determine definitive REIs for crop/use sites on which DCPA

is registered for use. The REIs established in this document will be adjusted accordingly upon

submission of the additional data. Studies are required for: 

C Low crops (such as cucumber)

C Residential sites (turfgrass)

Requirements for post-application/reentry exposure studies are addressed by Subdivision

K of the Pesticide Assessment Guidelines. The required data include:

*133-3 Post-application Dermal Passive Dosimetry Exposure

*133-4 Post-application Inhalation Passive Dosimetry Exposure

*Guidelines 133-3 and 133-4 may be reserved at this time pending completion of

the databases on agricultural and residential postapplication/reentry exposure

currently being developed by the Agricultural Reentry Task Force and Outdoor

Residential Exposure Task Force, provided the registrant is a member of both

Task Forces.
55

C. Environmental Assessment

1. Ecological Toxicity Data

The Agency has adequate data to assess the hazard of DCPA to nontarget terrestrial

organisms, although the guideline requirements for avian reproduction are not fulfilled; and plant

seedling emergence, germination and vegetative vigor are only partially fulfilled (i.e., the risk

assessment was completed with supplemental data). 

a. Toxicity to Terrestrial Animals

(1) Birds, Acute and Subacute

In order to establish the toxicity of DCPA to birds, the following tests are required using

the technical grade material: one avian single-dose oral (LD50) study on one species (preferably

mallard or bobwhite quail); two subacute dietary studies (LC50) on one species of waterfowl

(preferably the mallard duck) and one species of upland game bird (preferably bobwhite quail).

Table 13: Avian Acute Oral Toxicity

Avian Acute Oral Toxicity Findings 

Species % A.I. LD50 mg/kg) MRID No

Toxicity

Category

Fulfills Guideline

Requirement

Northern Bobwhite 100 >2,250 41155705

practically

nontoxic yes 

Table 14: Avian Subacute Oral Dietary Toxicity

Avian Subacute Dietary Toxicity Findings

Species % A.I. LC50 (ppm) MRID No. Toxicity Category

Fulfills Guideline

Requirement

Northern Bobwhite 100 >5,620 41155706 practically nontoxic yes

Mallard 100 >5,000 41155707 practically nontoxic yes

 1 This study is classified as supplemental.

These results indicate that DCPA is practically nontoxic to avian species on an acute oral

and subacute dietary basis. The guideline requirements are fulfilled. (MRID 411557705,

41155706, and 41155707) 

(2) Birds, Chronic

Avian reproduction studies are required when birds may be exposed repeatedly or

continuously through persistence, bioaccumulation, or multiple applications, or if mammalian

reproduction tests indicate reproductive hazard. DCPA is persistent enough to result in chronic

exposure to birds. 
56

However, no data were available on the effect of DCPA on reproduction of the quail and

mallard duck. Therefore, the Agency requires that an avian reproduction study be conducted in

order to quantify the chronic risks of DCPA use to avian species. The guideline requirements for

avian reproduction testing are not satisfied. 

(3) Mammals

Wild mammal testing is required on a case-by-case basis, depending on the results of the

lower tier studies such as acute and subacute testing, intended use pattern, and pertinent

environmental fate characteristics. In most cases, however, a rat acute oral LD50 is used as a small

mammal surrogate to estimate toxicity to mammals. This LD50 is reported below.

Table 15: Mammalian Acute Oral Toxicity

Mammalian Acute Oral Toxicity Findings

Species % A.I. LD50 (mg/kg) 

MRID

No.

Toxicity

Category

Fulfills Guideline

Requirement

Rat (small mammal surrogate) 90 >5,000 41054808

practically

nontoxic Yes

The available mammalian data indicate that DCPA is practically nontoxic to small

mammals on an acute oral basis. (MRID 41054808)

(4) Insects

A honey bee acute contact LD50 study is required if the proposed use will result in honey

bee exposure.

Table 16: Nontarget Insect Acute Toxicity

Nontarget Insect Acute Contact Toxicity Findings

Species % A.I. LD50 Fg

a.i./bee

MRID No. Toxicity Category Fulfills Guideline Requirement

Honey Bee 99.6 >230 00009181 practically nontoxic Yes

There is sufficient information to characterize DCPA as practically nontoxic to bees. The

guideline requirement is fulfilled. (MRID 00009181)

b. Toxicity to Aquatic Animals

(1) Freshwater Fish

In order to establish the toxicity of a pesticide to freshwater fish, the minimum data

required on the technical grade of the active ingredient are two freshwater fish toxicity studies. 

One study must use a coldwater species (preferably the rainbow trout), and the other must use a

warmwater species (preferably the bluegill sunfish).
 This study is classified as supplemental.

57

Table 17: Freshwater Fish Acute Toxicity

Freshwater Fish Acute Toxicity Findings

Species % A.I. LC50

(ppm) 

MRID No. Toxicity Category Fulfills Guideline

Requirement

Rainbow trout 2.5

75 

75

>180

30

>6.6 

 00107142

 40227001

41054826

practically nontoxic

slightly toxic

No1

Yes

Yes

Bluegill sunfish 75

75

96.7 

>320

>120

>96.7

 00045822

 40227002

41054827

practically nontoxic

practically nontoxic

slightly toxic

No1

Yes

 Yes

1

 This study is classified as supplemental.

The results of the 96-hour acute toxicity studies indicate that DCPA is probably no more

than slightly toxic to fish. The guideline requirements are fulfilled. (MRID 41054827, 00107142,

40227001, 00045822, 40227002 and 41054826) 

(2) Freshwater Invertebrates

The minimum testing required to assess the hazard of a pesticide to freshwater

invertebrates is a freshwater aquatic invertebrate toxicity test, preferably using first instar

Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges.

Table 18: Freshwater Invertebrate Toxicity

Freshwater Invertebrate Toxicity Findings

Species % A.I.

LC50

(ppm) MRID No. Toxicity Category

Fulfills Guideline

Requirement

Daphnia magna tech.

75

75

75

75

>100

138

27

30

47

 40098001

 40226901

078701 40098001

 40098001

 40098001

practically nontoxic

practically nontoxic

slightly toxic

slightly toxic

slightly toxic

Yes

Yes

Yes

Yes

Yes

Chironomus plumous tech.

75

>100

138

 40098001

 40098001

practically nontoxic

practically nontoxic

Yes

Yes

Gammarus pseudolimnaeus tech.

75

138

138

 40098001

 40098001

practically nontoxic

practically nontoxic

No1

No1

1

 This study is classified as supplemental.

There is sufficient information to characterize DCPA as slightly toxic to practically

nontoxic to aquatic invertebrates. The guideline requirement is fulfilled. (MRID 40098001,

40226901)
58

(3) Estuarine and Marine Animals

Acute toxicity testing with estuarine and marine organisms is required when an end-use

product is intended for direct application to the marine/estuarine environment or is expected to

reach this environment in significant concentrations. The terrestrial uses of DCPA may result in

exposure to the estuarine environment.

The requirements under this category include a 96-hour LC50/EC50 for an estuarine fish, a

96-hour LC50 for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell deposition

study with oysters. 

Table 19: Estuarine/Marine Acute Toxicity

Estuarine/Marine Acute Toxicity Findings

Species % A.I.

EC/LC50

(ppm) MRID No. Toxicity Category

Fulfills Guideline

Requirement

Eastern oyster shell deposition tech. 0.62 40098001 highly toxic Yes

Brown Shrimp tech. >1.0 40098001 moderately toxic Partial1

Sheepshead minnow tech. >1.0 40098001 moderately toxic Partial1

1 These studies are classified as supplemental because no LC50 was obtained. However, they provide sufficient information to show that the LC50 for

these species is greater than 1 ppm, which approximates maximum solubility.

There is sufficient information to characterize DCPA as moderately to highly toxic to

nontarget estuarine and marine organisms. The guideline requirement is fulfilled. (MRID 078701) 

c. Toxicity to Plants

(1) Terrestrial

Currently, terrestrial plant testing (seedling emergence and vegetative vigor) is required

for herbicides which have terrestrial non-residential outdoor use patterns and appear to move offsite of application through volatilization (vapor pressure 2.5 x 10-

6 torr at 25 C) or drift (aerial

or irrigation); and/or which may have endangered or threatened plant species associated with the

site of application. The above conditions apply for DCPA (refer to Section IV.C.3, Endangered

Species).

Tier II toxicity data on the technical/TEP material for the most sensitive species is listed

below:

Table 20: Nontarget Terrestrial Plant Toxicity

Nontarget Terrestrial Plant Toxicity Findings 

Test and Species % A.I. EC25

Seedling emergence and germination (tomato) tech. >7.5 lbs ai/acre

Vegetative vigor (soybean) tech. >7.5 lbs ai/acre
59

The studies submitted for seedling emergence and germination and vegetative vigor have

been classified as supplemental. The Agency did not use these data for risk assessment purposes

since tolerant species were used. Further, the Agency is requiring that additional nontarget

testing not be conducted with these same species. See Data Requirements section of DCPA

RED for discussion.

The guideline requirements are not fulfilled. (MRID 41564901, 41440101)

(2) Aquatic

Currently, aquatic plant testing is required for any herbicide which has outdoor nonresidential terrestrial uses that may move off-site of application by runoff (solubility >10 ppm in

water), by drift (aerial or irrigation), or is applied directly to aquatic use sites (except residential)

as in the case of DCPA. The following species must be tested: Selenastrum capricornutum,

Lemna gibba, Skeletonema costatum, Anabaena flos-aquae, and a freshwater diatom. 

Tier II toxicity data on the technical/TEP material is listed below:

Table 21: Nontarget Aquatic Plant Toxicity

Nontarget Aquatic Plant Toxicity Findings 

 Species % A.I. EC50 (ppm)

Navicula pelliculosa (Freshwater diatom) 98.4 >11.0

Lemna gibba 98.4 >11.0

Selenastrum capricornutum 98.0 >12.38 

Skeletonema costatum 98.4 >11.0

Anabaena flos-aquae 98.4 >11.0 

The guideline requirements are fulfilled. (MRID 41155714, 42836102, 42882401,

42836103, 4236101, and 41054829) 

2. Environmental Fate

a. Environmental Fate Assessment

The Agency has sufficient data to define the environmental fate of DCPA. Biodegradation

is the primary dissipation process for DCPA. Under laboratory conditions, the half-life is

approximately 15-30 days, but longer half-lives have been reported in the field. Parent DCPA is

not especially persistent or mobile. Tetrachloroterephthalic acid (TPA or di-acid) is the only

significant DCPA metabolite, with monomethyl tetrachloroterephthalic acid (mono-acid) as a

minor metabolite. TPA is unusually mobile and persistent in the field. Data suggest that TPA will

leach to groundwater wherever DCPA is used, regardless of soil properties. 

Volatilization from soil is also a major dissipation route for parent DCPA. Volatilization

appears to be the source of DCPA residues on crops to which it has not been applied. The

maximum distance that DCPA may move following volatilization is not known, but drift has been

reported in the published literature. Under warm conditions in fields with high soil moisture

levels, volatilization may be the major dissipation route for DCPA. More typically, volatilization
60

probably accounts for 20-40 percent of DCPA loss. For TPA, leaching is the major dissipation

route.

TPA does not appear to be phytotoxic, as weed control occurs rapidly after application of

DCPA and control declines with the decline of parent DCPA concentration in the soil. 

Concentrations of DCPA reported in fish exposed to DCPA through volatility drift alone

(38 ppb) raise concerns about exposure of endangered freshwater mollusks to DCPA. Substantial

amounts of DCPA could be available for runoff for several weeks post-application. Most DCPA

runoff will generally occur in the form of adsorption to eroding soil as opposed to dissolution in

runoff water. DCPA could be somewhat persistent in many surface waters, particularly those

with low microbiological activities and long hydrological residence times. 

TPA appears to be substantially more persistent than parent DCPA and exhibits low

soil/water partitioning. Therefore, substantial quantities of TPA should be available for runoff for

a longer period than the parent DCPA. 

TPA is extremely mobile and can leach to ground water under many different conditions. 

Although contrary to the environmental chemistry and environmental fate data which indicate that

parent DCPA would not be very mobile, it appears that under certain conditions both the DCPA

parent and the mono-acid can also find their way into the ground water. The persistence of TPA

in ground water is not known. 

The lifetime Health Advisory for DCPA in drinking water is currently established at 4000

μg/L (ppb). DCPA and/or TPA have been reported in four percent of ground water (206 wells of

4917) in ground water monitoring studies conducted in 24 states. Concentrations of TPA ranged

from trace levels to 1477 ppb. The maximum parent DCPA concentration reported is 7.7 ppb. 

Concentrations of DCPA residues have all been below the current lifetime Health Advisory. 

b. Environmental Fate and Transport

(1) Degradation

Hydrolysis. DCPA was stable in water for 36 days at pH 5, 7, and 9. (MRID 00114648)

Photolysis in water. DCPA was stable to photolysis in unbuffered water. After the

equivalent of 191 12-hour exposure days, less than 10 percent of the parent DCPA had

photolyzed. (MRID 41508607)

Photolysis on soil. DCPA was stable to photolysis on soil. In an early study, DCPA was

stable under a sunlamp having "297 nm in wavelength." After 38.5 days equivalent of radiation on

a glass bead surface, 95.7 percent of the applied was present as parent DCPA. With the same

sunlamp and DCPA on silica gel in the presence of a photosensitizer (unnamed), 90.8 percent

remained as DCPA after the equivalent of 168 days of exposure. The primary photoproduct was

monomethyl tetrachloroterephthalic (MTP or mono-acid) at 5.2 percent. No photodegradation
61

occurred under black light and fluorescent light, shown to be similar to natural sunlight in the

range of wavelengths where DCPA absorbs light. (MRID 41508608, accession number 093786) 

Aerobic soil metabolism. DCPA will undergo microbial degradation and is enhanced by

warmer temperatures and increased soil water content. Parent half-life was estimated at 18-37

days. After 197 days, virtually all of the parent DCPA had been converted into TPA, although

small amounts of monomethyl tetrachloroterephthalic acid (MTP) were also identified. DCPA did

not degrade in steam-sterilized soil. Wettasinghe and Tinsley (1993) confirmed these results, with

a half-life of 16.6 days at 25 C and 12.6 percent water content. Decreasing the temperature to 5

C and the water constant to 9.6 percent decreased the rate of degradation, giving a half-life of

289 days (Walker 1978, cited by Wettasinghe and Tinsley). Choi et. al. (1988, cited by

Wettasinghe and Tinsley) confirmed these observations, reporting a half-life of parent DCPA at

11-16 days at medium soil moisture and 25 C. For the DCPA degradates, the mono-acid had a

half-life of 2.8 ± 0.1 days. However, TPA was very persistent. There was virtually no 

degradation of TPA during a 300 day study. (MRID 00114649, 41648801)

Anaerobic soil metabolism. Anaerobic soil conditions slowed DCPA degradation only

slightly, with estimated half-lives of 37-59 days. TPA was also the final degradate under anaerobic

conditions. (MRID 00114651, 41648802).

(2) Mobility

Leaching/adsorption/desorption. Although not fully acceptable, the study of parent

DCPA strongly suggests that DCPA is not mobile. In an unaged column leaching study, the sand

portion of the soil may have been removed by sieving through too fine a mesh, resulting in a finer

soil fraction and making the parent compound appear less mobile. For the degradates of DCPA,

both TPA and MTP are highly mobile in all soils. (MRID 41648803, 41648804, 41648805,

42262602)

Aged column leaching. DCPA residues were shown to leach through soil, with the

leachate containing primarily TPA. In this early study, soil columns were prepared with 2 g of

treated soil aged 30 days placed atop a 12 inch column. The columns were leached with 1/2 inch

of water a day for 45 days. In two sandy loams, one pH 5.9 and the other pH 8.0, DCPA residues

were shown to leach. The residue found in the leachate was overwhelmingly TPA. Leaching was

much more extensive in the high pH soil: 85.2 percent of the applied was found in the leachate.

(MRID 00114650) 

Lab and field volatility. Based on a relatively low Henry's constant 

(2.2 x 10-6 atm-m3/mol) and moderately to relatively high soil/water partitioning, DCPA does not

appear to have a high volatilization potential from soil. Nevertheless, several published studies

have shown that parent DCPA is volatile, especially from moist or wet soil. 

Nash and Gish (1989) suggested that DCPA volatilization may be adsorption and diffusion

controlled, which would explain the poor predictability of volatilization from vapor pressure. At a

temperature of 35 C, volatility accounts for the majority of the applied DCPA.
62

Majewski et.al. (1991) suggested that in the early phase after application, volatilization is

the primary dissipation route for DCPA. They measured a total DCPA loss of between 1.27 and

1.59 kg per hectare out of 7 kg per hectare applied. They also found that DCPA volatilization flux

was very dependent upon the soil surface moisture content. High fluxes occurred immediately

following irrigation. Approximately 36 to 52 percent of the total measured DCPA loss from soil

was accounted for by volatilization and 26 percent by breakdown in soil during the 21 days of air

sampling.

Ross et. al. (1990) estimated that 10 percent of the DCPA applied was lost to the

atmosphere within 21 days of application. This group investigated DCPA volatility because

DCPA residues have been found repeatedly on a variety of produce samples to which it had not

been applied in California. They concluded that these detections may have been due to DCPA

volatilization and drift. Volatilization accounted for 29 percent of the DCPA lost from soil in this

study. Although DCPA moved off target both as a gas and on particles, 62 to 93 percent of the

atmospheric residues were in the vapor phase when the field was wet. Field moisture in this case

may have reduced the number of airborne dust particles as well as promoted DCPA volatilization.

(3) Accumulation

Fish bioaccumulation. DCPA bioaccumulates significantly in bluegill sunfish with

bioconcentration factors (BCFs) of 1894, 777, and 2574 in whole fish, edible tissue, and viscera,

respectively. Depuration appears to be complete after 14 days. Little metabolism or degradation

of DCPA occurs in fish tissues, although there is a detectable amount of demethylation. (MRID

41155716, 41197602)

(4) Terrestrial Field Dissipation

Gilroy, CA: Bareground plots of loam soil were treated up to three times with DCPA

(75% WP), at 7.0-10.5 lbs. a.i. per application. DCPA was detected to 18-inches, the maximum

sampling depth, in all of the plots, while the mono-acid was not detected below 6 inches in any

plot. However, TPA was detected as deep as 60 inches 552 days after the single treatment and up

to 96 inches 552 days after the double treatment. TPA was found at 0.03 ppm at the 72 inch

depth 552 days after the triple treatment. (MRID 41508609) 

This study was rejected for the large variation of DCPA concentrations with time. DCPA

did not degrade steadily with time, but increased and decreased erratically until a significant

reduction in concentration was noted in all experiments after about 185 days. The study author

calculated a half-life of 35 days for all plots based on DCPA residues in the upper 18 inches of

soil, but the erratic decline curves meant that half-life determinations were not statistically

significant. The study author suggested that detections of parent DCPA below the surface layer

were most likely due to sample contamination with surface soil. The study was considered

supplemental. 

Greenfield, CA: Bareground plots of sandy loam soil were treated up to three times with

DCPA (75% WP), at 7.0-10.5 lbs. a.i. per application. DCPA was detected to 18-inches, the

maximum sampling depth, in all of the plots, while the mono-acid was not detected below 6
63

inches in any plot. TPA was detected at 48 inches. In the plot treated three times, parent DCPA

was again detected in the 15-18 inch layer. The mono-acid was not found below 6 inches, while

TPA was found at 18 inches (the lowest layer sampled). 

This study was rejected for the large variation of DCPA concentrations with time. DCPA

did not degrade steadily with time, but increased and decreased erratically until a significant

reduction in concentration was noted in all experiments between about 60 and about 120 days.

The study author calculated half-lives of 44 days for the single application plot, 86 days for the

double application plot, and 126 days for the triple application plot, but the erratic decline curves

meant that half-life determinations were not statistically significant. The study author suggested

that detections of parent DCPA below the surface layer were most likely due to sample

contamination with surface soil. The study was considered supplemental. The data requirement

is not satisfied. (MRID 41508609, 41508610) 

(5) Spray Drift

Droplet size spectrum (Guideline 201-1) and drift field evaluation (Guideline 202-1) data

are required for DCPA, as the 75 percent wettable powder formulation may be applied by aircraft. 

Since the registrant, ISK Biosciences, is a member of the Spray Drift Task Force, the Agency will

not require droplet size spectrum or drift field evaluation data at this time. The registrant may

satisfy these data requirements through the Spray Drift Task Force unless required by the Agency

in advance of the Task Force's final report.

(6) Water Resources

(a) Ground Water

Detections of parent DCPA have been reported. This is contrary to the environmental

chemistry and environmental fate data of parent DCPA which indicate that parent DCPA would

not be mobile. TPA (the di-acid metabolite of DCPA) is extremely mobile and can leach to

ground water under many different conditions. Although the persistence of TPA in ground water

is not known, indications are that TPA is quite persistent. The mono-acid can also find its way

into the ground water. However, TPA is the major degradate found in ground water. 

The lifetime Health Advisory for parent DCPA in drinking water is currently established at

4000 μg/L (ppb). DCPA or TPA and the mono-acid degradate have been detected in ground

water in 24 states. Concentrations of DCPA degradates ranged from trace levels to 1477 ppb. 

The maximum parent DCPA concentration reported is 7.7 ppb. Concentrations of DCPA residues

have all been below the current lifetime Health Advisory. 

National Survey of Pesticides in Drinking Water Wells (NPS): The Agency initiated

the National Survey of Pesticides in Drinking Water Wells (NPS) to determine the frequency of

community water systems (CWS) and rural drinking water wells (RDW) nationwide were

contaminated by pesticides and nitrate-nitrogen (USEPA, 1990). DCPA and TPA were included

in the suite of pesticides analyzed in the NPS. Parent DCPA was not detected in the NPS. 

However, TPA was the most commonly detected pesticide residue by the NPS. There were 31
64

CWS (5.5 percent of CWS 564 wells) and 18 RDW (2.3 percent of the 783 RDW wells) wells

with detections (49 or 3.7 percent of 1347 wells) of TPA in twenty-two states. States with

confirmed detections were AK, CA, CO, CT, IA, IL, IN, MA, MI, MN, MO, NH, NJ, NM, NY,

OH, PA, RI, SD, VA, and WI. Maximum values of TPA were 7.2 ppb in CWS wells and 2.4 ppb

in RDW wells. The median of the detectable values were 0.34 ppb and 0.38 ppb for the CWS and

RDW wells, respectively. 

State Studies. Approximately 157 wells (4.4 percent) of 3570 wells sampled in the

various state ground-water monitoring studies (excluding registrants prospective studies) have

detected parent DCPA residues. The 157 wells were located in seven (CA, IA, MA, NY, OR,

WA, and WI) states.

Of the 3570 wells mentioned above, only parent DCPA was analyzed for in 2229 of the

wells. For the remaining 1341 wells, analysis included both parent DCPA and TPA. For these

wells, TPA was detected in 11.3 percent of the wells. The highest TPA value reported was 1039

ppb, which occurred in Suffolk County, New York. Suffolk County is highly vulnerable to

ground water contamination as the frequency of detections for other pesticides is also quite high. 

Reported average and median DCPA residue concentrations for the New York data were 109 ppb

and 13.2 ppb, respectively. The highest reported TPA value in Oregon was 986 ppb (Cox, 1991). 

The average TPA concentration reported for three wells in Wisconsin was 256 ppb. Generally,

the maximum reported values were 15 ppb or less.

Both Suffolk County, New York, and Treasure Valley in Malheur County, Oregon, may

represent examples of "hotspots." More than half (116 wells out of 206) of the wells with

confirmed DCPA detections occurred in these two areas. The California Department of Food and

Agriculture conducted a seven county study which may also be considered a hot spot, as 18 wells

of 60 were confirmed to be contaminated with DCPA residues, with an additional 33 wells having

unconfirmed detections. 

Registrant studies. The registrant is currently conducting two small-scale ground water

monitoring studies: on onions in California and on turf in New York. Although only a portion of

data have been collected and analyzed to date, the ground water monitoring results are

informative. As expected, TPA was detected most frequently and in the highest concentrations;

however, both DCPA and the monoacid were detected in higher than expected frequency,

although much lower concentrations. DCPA parent was detected in 16 and 26 percent of the

wells in New York and California, respectively; the mono-acid was detected in 12 and 29 percent

of the wells in New York and California, respectively. Preferential flow and transport

mechanisms may have contributed to presence of these residues in ground water. 

Other Observations and Concerns. Environmental fate data indicate that DCPA

degradation is slower under cooler conditions compared to warmer conditions. This factor may

at least partially explain the greater frequency of detections in New York and Oregon (cool) in

comparison to California (warm) conditions. Seventeen states with DCPA residue detections

could be classified as states with cooler temperatures (AK, CT, IA, IL, IN, MA, MI, MN, NH,

NJ, NY, OH, OR, PA, RI, SD, and WI). States considered "warm" states with detections were

California, Colorado, and New Mexico. Irrigation also is potentially a factor affecting the degree
65

of leaching in California, Colorado, and New Mexico, and should not be ruled out in the other

states. Other environmental factors which can influence the transport of chemicals to ground

water are the amount, intensity, frequency, and temporal distribution of precipitation.

Summary. The state and NPS studies found DCPA or TPA in 4.2 percent (excluding

repeated samples) of the 4917 wells sampled and analyzed for either DCPA or TPA. TPA was

found in 7.6 percent of the 2688 wells sampled and analyzed for that metabolite, and parent

DCPA was detected in 0.12 percent. DCPA and its metabolites were detected in a total of

twenty-four states. Parent DCPA residues were detected in the New York, Iowa, and

Washington state studies, but no residues were found in those states where sampling was done for

the NPS. 

The maximum values of DCPA reported by all studies were less than the LHA of 4000

ppb. The maximum value found of TPA in the NPS was 7.2 ppb. DCPA was not found. 

Maximum TPA residue values reported (in ppb) by state are: California, 15 (326 for registrant

sponsored study); Iowa, 0.03; Massachusetts, 1.07; New York, 1039 (1477 for registrant

sponsored study); Oregon, 986; and Washington, 1.1. 

(b) Surface Water

Substantial amounts of DCPA could be available for runoff for several weeks postapplication (aerobic soil metabolism half-lives of 18-37 days). The intermediate soil/water

partitioning of DCPA (Freundlich Kads values of 5.5, 32.1, 9.4, and 70.3; SCS database Koc of

5000) indicates that DCPA runoff will occur via both dissolution in runoff water and adsorption

to eroding soil. The resistance of DCPA to abiotic hydrolysis and to direct photolysis in water

coupled with only a moderate susceptibility to aerobic biodegradation and a lower susceptibility to

anaerobic biodegradation (anaerobic metabolism half-life 37-59 days) indicates that DCPA will be

somewhat persistent in many surface waters, particularly those with low microbiological activities

and long hydrological residence times. Although the magnitude of its Henry's constant (2.2 X 10-6

atm-m3/mol) is sufficient to indicate some moderate susceptibility to volatilization from water, it

does not appear to be high enough for volatilization to rapidly remove DCPA from surface

waters. The intermediate soil/water partitioning of DCPA indicates that it will be both dissolved in

the water column and adsorbed to suspended and bottom sediment. However, concentrations

should be greater on suspended and bottom sediment than in the water column.

The primary degradate of DCPA is tetrachloroterephthlate acid (TPA). TPA appears to be

substantially more persistent than dacthal and exhibits low soil/water partitioning. Therefore,

substantial quantities of TPA should be available for runoff for a longer period than the parent

DCPA. Unlike DCPA, most TPA runoff should be in the form of dissolution in runoff water. TPA

should also persist longer in most surface waters than DCPA, and unlike DCPA, exist primarily

dissolved in the water column. 

According to the pre-1988 listings in STORET, DCPA was detected in 386 of 1995

surface water samples at a 85th percentile of detections of 0.39 ug/L, and a maximum

concentration of 8.5 ug/L. 
66

The available data on concentrations of DCPA in surface waters is limited. Although most

detections have been below 1 ug/L, concentrations of 30, 40, and 100 ug/L were reported in a

stream draining a small agricultural watershed in Colorado.

The USGS (Kimbrough and Litke 1995) collected samples from Cherry Creek at Denver,

CO and from Lonetree Creek at Greely, CO from April 1993 through April 1994. Samples were

collected once a month from October through March, and two or more times per month during

other months. Reported method detection limits for DCPA varied from 0.002 to 0.005 ug/L. In

Cherry Creek which drains a primarily urban watershed, DCPA was detected in 14 of 25 samples

at concentrations ranging from 0.004 to 0.029 ug/L. Five of the samples had DCPA

concentrations > 0.020 ug/L. In Lonetree Creek which drains a primarily agricultural watershed,

DCPA was detected in 21 of 25 samples at concentrations ranging from 0.002 to 100 ug/L. 

Eight of the samples had DCPA concentrations > 1ug/L (30, 1.9, 2.4, 40, 8.9, 6.0, 2.6, and 100

ug/L). The highest concentrations were in samples collected in May 1993 and in April 1994.

The USGS (MacCoy, Crepeau, and Kuivila 1995) collected samples daily from the San

Joaquin River at Vernalis, and three times per week from the Sacramento River at Sacramento

from October 1992 through September 1993. Samples collected two days in a row from the San

Joaquin River were combined for analysis unless they were collected during runoff events.

Samples were collected close to the center of the rivers with depth integrating samplers. The

samples were filtered through 0.7 u filters and analyzed by GC/mass spectrometry. The reported

method detection limits for DCPA were 0.063 ug/L and 0.044 ug/L for the San Joaquin and

Sacramento River samples, respectively. DCPA was not detected in any of the Sacramento River

water samples. DCPA was not analyzed for in samples collected from the San Joaquin River from

October 1992 through mid-January 1993. In 176 samples collected from mid-January 1993

through September 1993 that were analyzed for DCPA, the compound was detected in 42

samples, but only 2 of the detections were above the reported method detection limit of 0.063

ug/L (0.091 ug/L and 0.181 ug/L). 

The state of Kansas (Robbins 1987) reported DCPA detections in their surface waters.

Over a period of 13 years from 1973 to 1986, DCPA was detected in 21 samples at

concentrations ranging from 0.03 to 5.6 ug/L with a mean detected concentration of 0.49 ug/L.

The Kansas river and stream sampling network includes up to 110 sampling stations, but no

information was provided on the number of samples collected, where the samples were collected,

the sampling intervals or the detection limit.

Washington State (Davis 1993) reported DCPA concentrations ranging from 0.006 to

12.1 ug/L in samples collected from various surface waters in 1992 and 1993. The four

concentrations > 1 ug/L (1.24, 2.2, 3.9 and 12.1 ug/L) were all in samples collected from

agricultural watersheds east of the Cascades. No information was provided on the number of

samples collected, the sampling intervals or the detection limit. 

DCPA is not currently regulated under the Safe Drinking Water Act (SDWA). Therefore,

no MCL has been established for it, and water supply systems are not required to sample and

analyze for it. However, it has high 1-10 day drinking water HAs (80,000 ug/L), a high lifetime

drinking water HA (4000 ug/L), and an intermediate soil/water partitioning that should make the
67

primary treatment process employed by most water supply systems somewhat effective in

removing it. Consequently, DCPA does not appear to pose a direct substantial risk to surface

source drinking water. Although the low soil/water partitioning of the TPA degradate should

make its removal by primary methods ineffective, no drinking water HAs have been established

for TPA. 

3. Ecological Exposure and Risk Characterization

Explanation of the Risk Quotient (RQ) and the Level of Concern (LOC): The Levels

of Concern are criteria used to indicate potential risk to nontarget organisms. The criteria

indicate that a chemical, when used as directed, has the potential to cause undesirable effects on

nontarget organisms. 

There are two general categories of LOC (acute and chronic) for each of the four

nontarget faunal groups and one category (acute) for each of two nontarget floral groups. In

order to determine if an LOC has been exceeded, a risk quotient must be derived and compared to

the LOC. A risk quotient is calculated by dividing an appropriate exposure estimate, e.g. the

estimated environmental concentration (EEC), by an appropriate toxicity test effect level, e.g. the

LC50. 

The acute effect levels typically are:

! EC25 for terrestrial plants; 

! EC50 for aquatic plants and invertebrates; 

! LC50 for fish and birds; and 

! LD50 for birds and mammals.

The chronic test results are: 

! NOEL (No Observable Effect Level) for avian and mammal reproduction

studies; and 

! NOEL or MATC (Maximum Allowable Toxicant Concentration), which is

the geometric mean of the NOEL and the LOEL (Lowest Observable

Effect Level) for chronic aquatic studies.

When the risk quotient exceeds the LOC for a particular category, risk to that particular

category is presumed to exist. Risk presumptions are presented below along with the

corresponding LOCs.
68

Table 22: Levels of Concern (LOCs)

Levels of Concern (LOC) and Associated Risk Presumption1

SPECIES LOC PRESUMPTION

Mammals, Birds

If the 

acute RQ >0.5 High acute risk

acute RQ >0.2 Risk that may be mitigated through restricted use

acute RQ >0.1 Endangered species may be affected acutely

chronic RQ >1 Chronic risk, endangered species may be affected

chronically,

Fish, Aquatic Invertebrates

If the 

acute RQ >0.5 High acute risk

acute RQ >0.1 Risk that may be mitigated through restricted use

acute RQ >0.05 Endangered species may be affected acutely

chronic RQ >1 Chronic risk, endangered species may be affected

chronically

Plants

If the 

RQ >1 High risk

RQ >1 Endangered plants may be affected

1. Currently, no separate criteria for restricted use or chronic effects for plants exist.

Table 23: Established Levels of Concern (LOCs)

Established Levels of Concern (LOCs)

Risk

Endpoint/Scenario

Quotient Non-Endangered LOC Endangered LOC

Mammalian acute EEC/LC50 0.5 0.1

Mammalian chronic EEC/LEL* 1.0 1.0

Avian acute EEC/LC50 0.5 0.1

Avian chronic EEC/LEL* 1.0 1.0 

Aquatic acute EEC/LC50 0.5 0.05

Aquatic chronic EEC/LEL* 1.0 1.0

Non-target insects Not Quantified N/A N/A

Non-target plants EEC/EC25 or EC50 1.0 1.0

* LEL= Lowest Effect Level. The LEL is a theoretical level which is a value somewhere between the NOEL and the LOEL.
69
70

a. Nontarget Terrestrial Animals

(1) Birds

Acute Risks to Birds

Definitive LC50 values are not available for birds. The available data indicate the LC50 is

greater than 5,620 ppm. It is not considered useful to calculate risk quotients using a "greater

than" value, since the resulting quotient is not an indication of likely acute effects. The maximum

concentration on food items from the maximum application rate (15 lb a.i./acre for turf) would

probably not exceed 3,600 ppm. This is significantly less than the dietary concentration that did

not kill any birds. Therefore, it may be reasonable to conclude that DCPA represents minimal

acute risk to birds including endangered species.

However, there is uncertainty in this conclusion, since the standard risk assessment

procedure used by the Agency is to apply a safety factor to the avian LC50 values to determine

potential risk. These safety factors are applied to accommodate possible greater sensitivity of

birds other than those tested and to protect a greater portion of the bird population than 50

percent. 

As stated above, the estimated residues on short grass for turf use are approximately

3,600 ppm. These residues potentially exceed the LOC of 0.5 (3,600 ppm/>5,620 ppm = 0.6) for

avian acute risk if the LC50 is indeed close to 5,620 ppm. Normally, when such exposure exceeds

an LOC of 0.5, a conclusion of high risk to birds is made. When exposure exceeds an LOC of

0.2, a restricted use classification is warranted. If exposure exceeds 0.1, effects to endangered

birds are presumed. However, the LC50 is greater than 5,620 ppm. Therefore, it cannot be

presumed that the LOC has in fact been exceeded, as the Agency does not know what the true

LC50 value is. 

To address this question, the registrant must conduct a special dietary study with mallard

ducks at higher test levels. If that test shows the LC50 is substantially greater than 5,000 ppm,

(e.g., at least greater than 18,000 ppm), it would be possible to conclude with a very high degree

of certainty that use rates up to 15 lb a.i./acre do not represent an acute risk to birds, including

endangered species.

Chronic Risks to Birds

Long-term exposure to birds is possible since DCPA is persistent. Such exposure is

possible not only from turf treatment, but also on other use sites. Even though the application is

to bare ground, residual seeds, and other food items may be contaminated and provide a food

source for some birds. The Agency cannot provide a risk assessment for chronic affects to birds

because of lack of chronic data on birds. The Agency requires an avian reproduction study for

mallard duck and bobwhite quail so that chronic effects to birds can be assessed. 
71

(2) Mammals

Small mammal risk is addressed using acute oral LD50 values converted to estimate a LC50

value for dietary exposure. The estimated LC50 is derived using the following formula:

LC50 = LD50 x body weight (g)

food consumed per day (g)

Table 24: Small Mammal Food Consumption

Small Mammal Food Consumption in PPMs 

(Based on an LD50 = >5,000 mg/kg) 

Small Mammal Body Weight in

Grams

% of Weight

Eaten Per Day

Food Consumed Per

Day in Grams 

Estimated LC50

Per Day (ppm)

Meadow vole 46 gms 61 % 28.1 gms >8,185 

Adult field mouse 13 gms 16 % 2.1 gms >30,952

Least shrew 5 gms 110 % 5.5 gms >4545

The above table is based on information contained in Principles of Mammalogy by D. E. Davis and F. Golly,

published by Reinhold Corporation, 1963.

Acute Risks to Mammals

The estimated LC50 is then compared to the residues listed above to calculate a risk

quotient (EEC/LC50). The table below indicates the risk quotients for application of DCPA at the

highest application rate of 15 lb a.i./A on turf.

Table 25: Mammalian Dietary Risk Quotients on Turf

Mammalian Dietary Risk Quotients on Turf

(based on Dietary RQ = EEC/Lowest LC50)

Mammal Type Food Item Residues

(ppm)

Risk Quotient

Meadow vole consuming range grasses short grasses 3600

leafy crops 1875

<.43

<.23

Adult field mouse consuming seeds short grass 3600

seeds 180

<.12

<.006

Least shrew consuming forage and insects small insects 870 <0.19

The table below indicates the risk quotients for application of DCPA at the application

rate of 10.5 lb a.i./A on vegetables and cotton.
72

Table 26: Mammalian Dietary Risk Quotients on Vegetables and Cotton

Mammalian Dietary Risk Quotients on Vegetables and Cotton

(based on Dietary RQ = EEC/Lowest LC50)

Mammal Type Food Item Residues

(ppm)

Risk Quotient

Meadow vole consuming range grasses short grasses 2520

leafy crops 1313

<.31

<.16

Adult field mouse consuming seeds short grass 2520

seeds 126

<.08

<.004

Least shrew consuming forage and insects small insects 609 <0.13

The LOC for high acute risk (0.5) to mammals has not been exceeded. Residues on short

grass when divided by the meadow vole LC50 do result in a risk quotient which exceeds the LOC

(0.2) for restricted use. Also, endangered mammals exposed to areas treated with DCPA may be

affected (RQ for endangered species LOC of 0.1).

Chronic Risks to Mammals

The table below indicates the Chronic risk quotients for application of DCPA at various

application rates. For purposes of establishing chronic risk, the two-generation reproduction

study on rats was used, with a NOEL of 1,000 ppm/day. The LOEL for this study was 5,000

ppm/day, resulting in weight loss and an increase in stillborn births. (MRIDs 41905201,

41750103)

Table 27: Mammalian Chronic Risk Quotients

Mammalian Chronic Risk Quotients

(based on Dietary RQ = EEC/1,000 ppm NOEL)

Use Rate 

lb a.i./A(Crop)

Food Item Residues Risk

Quotient

LOC

15 (on turf) short grass 3600 3.6 1

10.5 (on vegs & cotton) leafy crops 1313 1.3 1

10.5 (on vegs & cotton) short grass 2520 2.5 1

9 (on strawberry) leafy crops 1125 1.1 1

For ground application to vegetables, cotton, and strawberries, the risk quotients in the

above table may be misleading, overstating the potential risks. This is because for these crops, the

treated area is usually free of vegetation before DCPA is applied. Alternatively, if the crop is

present during treatment, the spray is directed past the foliage to treat only the bare ground. 

Therefore, minimal chronic risk to mammals is concluded for these crops. 
73

Aerial application (cotton and vegetables) would result in treatment of crop foliage of

cotton and vegetables. However, the maximum level of residues (about 780 ppm) does not

exceed the NOEL for mammals.

For turf, on the other hand, both aerial and ground treatment is applied to newly emerged

grass or established turf. So, using maximum residues on typical food items for mammals, the risk

quotients exceed the chronic LOC. 

Other factors are considered when determining the extent of risk and the certainty that

chronic effects will occur. Uncertainty stems both from using laboratory toxicity test results, and

from limitations in estimating actual exposure.

1. The study, from which the chronic NOEL was derived was a 2-generation rat

reproduction study. It is not known at what duration of exposure at 5000 ppm would be

required to result in the observed effects. Relatively short exposure to some chemicals has

been known to cause delayed effects.

2. There is a large gap between the NOEL (1000 ppm) and the LOEL (5000 ppm). It is

not known at what concentration between those test levels adverse effects may actually

occur. The estimated residues exceed the NOEL, but do not exceed the LOEL. 

3. It is assumed that other mammals would have different sensitivities than the

representative test organism (laboratory rat). It is not known if wild mammals would be

more or less sensitive. If they are more sensitive, even the lower residue levels may result

in sublethal or reproductive risk.

4. It is not known how long the residues will last on mammalian food items. It is unlikely

they will last the full 2 or so months that the rat 2-generation study lasted, especially at

levels exceeding the NOEL.

5. Not all vegetation would contain residue levels exceeding the NOEL. In turf, where

the predominant vegetation type is short grass, risk from consumption of maximum or

typical residues exceed the LOC for chronic risk. Therefore, mammals grazing on treated

turf would have a high probability of ingesting food items with residues exceeding the

NOEL of 1000 ppm. However, in other crop areas, where application is to bare ground,

the potential for exposure is minimal.

There seems to be moderate probability that chronic effects to mammals will occur. It is

not clear how significant this risk is ecologically. It is possible that endangered mammals may be

affected from turf use.

(3) Insects
74

For beneficial insects, it appears that there will be minimum adverse effects (LD50 >230

ug/bee) since it is practically nontoxic to bees. 

b. Nontarget Aquatic Animals

Below are Estimated Environmental Concentrations from a 10 hectare watershed basin

runoff into an hectare pond 6 feet deep after one application. The exposures are in ppb and are

derived from a computer program (GENEEC) using Koc values, aerobic soil metabolism half-life,

and solubility and use rates. 

For calculating the risk quotient (RQ), the exposure (EEC) will be divided by the toxicity

values of the organisms (fish LC50=30 ppm, aquatic invertebrates LC50=27 ppm and estuarine

species LC50=0.62 ppm). Since the invertebrates and freshwater fish share a similar LC50 value,

the toxicity value in the RQ formula will be LC50 = 27 ppm. The RQ is derived from EEC/LC50. 

Below is a table of risk quotients and risk criteria for DCPA:

Table 28: Application Rate with EEC and Risk Quotient for Aquatic Organisms (including endangered

species)

Use Sites

Maximum Application

Rate 

(lb ai/A)

Method of

Application

EEC (ppb) RQ1 Freshwater Fish &

Invertebrates

RQ1 Estuarine

Species

Strawberries 9.0 ground 33 <0.05 0.052

aerial 45 <0.05 0.07

Broccoli, Cabbage, Cauliflower, Kale, Field

Beans, Mung Beans, Snap Beans, Cowpeas,

Garlic, Horseradish, Onions, Potatoes, Sweet

Potatoes, Yams, Radish, Tomato, Eggplant,

Pepper, Cotton, Watermelon, Cantaloupe,

Cucumber, Squash, Newly Seeded Turf

10.5 ground 38 <0.05 0.06

aerial 53 <0.05 0.08

Established Turf 15.0 ground 55 <0.05 0.09

aerial 76 <0.05 0.12

1

 High acute risk RQ $ 0.5, Restricted use RQ $ 0.1, Endangered Species RQ$ 0.05.

(1) Freshwater Fish and Invertebrates

Application of DCPA will not result in risk that exceeds any of the LOCs for freshwater fish or

invertebrates. There are no data available to assess the risks to freshwater mollusks. Therefore, in the absence

of data and because the mollusk was the most sensitive aquatic species, it may be appropriate to use the results

from testing with estuarine species to assess risk to freshwater mollusks. LOCs for restricted use were exceeded

for estuarine mollusks by the turf use when applied aerially. LOCs for endangered mollusk species were

exceeded for all use scenarios. 
75

(2) Estuarine Species

Application of DCPA will not result in risk that exceeds any of the LOCs for estuarine species. LOCs for

restricted use were exceeded for estuarine mollusks by the turf use when applied aerially. LOCs for endangered

mollusk species were exceeded for all use scenarios. 

c. Nontarget Plants

(1) Terrestrial and Semi-aquatic

Nontarget terrestrial plants inhabit non-aquatic areas. Nontarget "semi-aquatic" plants are plants

that usually inhabit low-lying wet areas that may or may not be dry in certain times of the year. These plants are

not obligatory aquatic plants in that they do not live in a continuously aquatic environment. The terrestrial and

"semi-aquatic" plants are exposed to pesticides from runoff, drift or volatilization. 

With the available data, given the fact that little or no effect was seen at the 9 lb ai/acre application rate,

LOCs would not be exceeded for terrestrial plants. Since there is little confidence that the test data reflect the

potential toxicity of DCPA to terrestrial plants, numerical estimates of risk will not be made. Calculating

exposure and calculating risk quotients based on what is considered misleading data would yield equally

misleading risk conclusions.

It is recommended that additional (Guideline 123-1 a & b) vegetative vigor and seedling emergence studies (tier

II) be done with sensitive species.

(2) Aquatic

Runoff exposure is from preliminary EEC (GENEEC). Spray drift is assumed to be 5 percent of

the application rate. 

The risk assessment made for aquatic vascular plants is from the surrogate duckweed Lemna gibba. 

Algae and diatom risk assessment are useful indicators to determine impact to food sources of aquatic organisms. 

The EC50 values are similar for algae, diatoms and Lemna gibba. Therefore, the RQ will reflect all aquatic

species from the toxicity value of EC50= 11 ppm.
76

Table 29: Application Rate & EECs & Risk Quotients for Nontarget Aquatic Plant Species (including

endangered species)

 Use Site

Maximum

Application Rate

(lb ai/A)

Method of

Application

Estimated Environmental

Concentration

(ppb)

Risk Quotient* for

Aquatic Plants

(EEC/EC50)

strawberries 9 ground 33 <1

aerial 45 <1

broccoli, cabbage, cauliflower, kale,

collards, field bean, cowpeas, snap

bean, mung bean, horseradish, onion,

potato, radish, sweet potato, yams,

cotton, tomato, eggplant, pepper,

cucumber, squash, watermelon,

cantaloupe, newly seeded turf

 10.5 ground 38 <1

aerial 53 <1

established turf 15 ground 55 <1

aerial 76 <1

* Endangered and non-endangered plants species have the same LOC which is 1.0.

From the available data, minimal adverse impact is expected for aquatic plants from the

labeled uses of DCPA.
77

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 DCPA. 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 DCPA

under the conditions specified in the RED. Appendix B identifies the generic data requirements

that the Agency reviewed as part of its determination of reregistration eligibility of DCPA, 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 DCPA and to determine that DCPA can be used without resulting in

unreasonable adverse effects to humans and the environment, if used according to the labels as

amended by this RED. The Agency therefore finds that all products containing DCPA as the

active ingredient are eligible for reregistration under the conditions specified in this RED. 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, published scientific literature, etc. and the data identified in Appendix B. 

Although the Agency has found that all uses of DCPA are eligible for reregistration under the

conditions specified in this RED, it should be understood that the Agency may take additional

appropriate regulatory action, and/or require the submission of additional data to support the

registration of products containing DCPA, if new information comes to the Agency's attention or

if the data requirements for registration (or the guidelines for generating such data) change.

B. Determination of Eligibility Decision

1. Eligibility Decision

Based on the reviews of the generic data for the active ingredient DCPA, the Agency has

sufficient information on the health effects of DCPA and on its potential for causing adverse

effects in fish and wildlife and the environment. 

The Agency concludes that products containing DCPA for all non-turf uses are eligible for

reregistration. The Agency has determined that such DCPA products, labeled and used as

specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or adverse

effects to humans or the environment.
78

2. Eligible and Ineligible Uses 

The Agency is unable to make an eligibility decision regarding the use of DCPA on turf at

this time. The Agency has identified several risks of regulatory concern associated with DCPA's

turf use. These risks include carcinogenic risk (from DCPA and its impurities) to children playing

on lawns post-treatment, carcinogenic risk posed through contaminated drinking water, chronic

risks to wild mammalian species (including endangered species), and acute risks to estuarine and

freshwater mollusks. The Agency will conduct a risk-benefits assessment before determining

whether DCPA's use on turf is eligible for reregistration. The Agency will also refine some of the

risk estimates, as a final report regarding leaching of DCPA and its metabolites to groundwater

will be submitted to the Agency during the summer of 1996. 

The Agency will announce the eligibility decision for the turf use through a Federal

Register Notice, as an amendment to this document. 

C. Regulatory Position

The following is a summary of the regulatory positions and rationales for DCPA. Where

labeling revisions are imposed, specific language is set forth in Section V of this document.

1. Tolerance Discussion

a. HCB and dioxin/furans

Although DCPA end-use formulations may contain minute amounts of HCB and

dioxin/furans as impurities, tolerances for contaminants are not established on food commodities. 

The Food and Drug Administration (FDA) and the U.S. Department of Agriculture routinely

monitors the food supply. Unacceptable levels of such contaminants would be identified by the

FDA and affected crops would be removed from the market. However, the FDA monitoring

program to date has not found any crops treated with DCPA to show residues of HCB. 

b. DCPA Tolerance Reassessment

Tolerances are currently established for DCPA in or on beans, peas, cantaloupes, corn,

cottonseed, cress, cucumbers, eggplant, garlic, honeydew melons, horseradish, lettuce, onions

(green and dry bulbs), peppers, pimentos, potatoes, rutabagas, soybeans, squash (summer and

winter), strawberries, sweet potato, tomatoes, turnips, Brassica (cole), watermelon, yams, and

radish. 

Tolerances Listed Under 40 CFR §180.185(a):

The tolerances listed in 40 CFR §180.185(a) are for combined residues of DCPA and its

metabolites monomethyl tetrachloroterephthalic acid (MTP) and tetrachloroterephthalic acid
79

(TPA). A summary of the DCPA tolerance reassessment and modifications in commodity

definitions are presented in Table 30.

Sufficient data are available to ascertain the adequacy of the established tolerances listed in

40 CFR §180.185(a) for the following commodities: beans which include black-eyed peas

(succulent and dried), cantaloupes, cottonseed, cress, cucumbers, eggplant, garlic, honeydew

melons, horseradish, onions, peppers, pimentos, potatoes, squash (summer and winter),

strawberries, sweet potatoes, yams, tomatoes, turnips, brassica leafy vegetables, and watermelons.

ISK Biosciences Corp. is not supporting uses of DCPA on lettuce, soybeans, corn and

rutabagas. EPA will reassess the existing tolerances for residues in/on these crops on completion

of the review of the confined/field rotational crop studies. However, preliminary examination of

these studies indicates the need for inadvertent residue tolerance on crops rotated to DCPAtreated fields.

Tolerances Listed Under 40 CFR §180.185(b)

The tolerances listed in 40 CFR §180.185(b) are for a regional registration as defined in

40 CFR §180.1(n) for the combined residues of DCPA and its metabolites MTP and TPA in/on

radish roots and tops. Sufficient data are available to ascertain the adequacy of these established

tolerances. 

The tolerance for cress (upland) listed under 40 CFR §180.185(a) was established for a

regional registration and should therefore be listed under 40 CFR §180.185(b).

New Tolerances Required Under 40 CFR §180.185:

The updated Livestock Feeds Table (9/95) indicates that data depicting residues of DCPA

and its metabolites in or on cotton gin byproducts (gin trash), cowpea forage, and hay are

required. The registrant must propose tolerances for these commodities once adequate data have

been submitted and evaluated. In lieu of tolerances on cowpea commodities, the registrant may

restrict the use of DCPA on beans to those varieties that are used for human consumption only.

Tolerances for animal commodities have not been established. The available ruminant

metabolism and poultry feeding studies indicate that tolerances may be needed. The need for

tolerances for animal commodities will be determined following review of the required data on

poultry metabolism and ruminant feeding studies.

New Tolerances Proposed Under 40 CFR §180.185(b):

A tolerance for parsley at four ppm, with a regional registration for California only, has

been proposed for the combined residues of DCPA and its metabolites MTP and TPA. The

petitioner has been required to submit residue data for DCPA residues in/on parsley flakes

processed from DCPA-treated parsley. 
80

Table 30: Tolerance Reassessment Summary

Commodity

Current Tolerance

(ppm)

Tolerance

Reassessment (ppm)

Comment/Correct Commodity

Definition

Tolerances listed under 40 CFR 180.185(a):

Beans, field dry

Beans, mung, dry

Beans, snap, succulent

Peas, southern, black-eyed

2 2 A single tolerance for residues

in/on beans (dried and

succulent) is

appropriate/Beans, dried and

succulent

Cantaloupes 1 1 ---

Corn, field (forage and

fodder)

Corn, sweet (forage and

fodder)

Corn, pop (forage and

fodder)

0.4 TBD No registered uses exist. 

Tolerances will be reassessed in

conjunction with review of field

rotational crop studies.

Corn, sweet (K+CWHR)

Corn, grain (including field

and pop)

0.05

Cottonseed 0.2 0.2 Cotton, undelinted seed

Cress, upland 1 1 Tolerance should be

appropriately listed under 40

CFR §180.185(b).

Cucumbers 1 1 ---

Eggplant 1 1 ---

Garlic 1 1 ---

Honeydew melons 1 1 ---

Horseradish 2 2 ---

Lettuce 2 TBD No registered uses exist. 

Tolerances will be reassessed in

conjunction with review of field

rotational crop studies.

Onions (green and dry bulbs) 1 1 ---

Peppers 2 2 ---

Pimentos 2 Revoke The peppers tolerance applies

to pimentos. A separate

pimentos tolerance is not

necessary.

Potatoes 2 2 ---

Rutabagas 2 TBD No registered uses exist. 

Tolerances will be reassessed in

conjunction with review of field

rotational crop studies.
Commodity

Current Tolerance

(ppm)

Tolerance

Reassessment (ppm)

Comment/Correct Commodity

Definition

81

Soybeans 2 TBD No registered uses exist. 

Tolerances will be reassessed in

conjunction with review of field

rotational crop studies.

Squash (summer and winter) 1 1 ---

Strawberries 2 2 ---

Sweet potato 2 2 ---

Tomatoes 1 1 ---

Turnips, greens 5 5 Turnip, tops

Turnip, root 2 2 ---

Vegetables, leafy, Brassica

(cole)

5 5 ---

Watermelon 1 1 ---

Yams 2 2 ---

Tolerances listed under 40 CFR 180.185(b):

Radish, root 2 2 ---

Radish, tops 15 15 ---

New Tolerances Required under 40 CFR 180.185:

Cowpea, forage None TBD Data are required.

Cowpea, hay None TBD Data are required.

Cotton gin, byproducts None TBD Data are required.

New Tolerances Proposed under 40 CFR 180.185(b)

Parsley None TBD A 4 ppm tolerance with

regional registration has been

proposed (PP#0E3883). 

Additional data are required.

 Codex Harmonization

No maximum residue limits (MRLs) for DCPA have been established by Codex for any

agricultural commodity. Therefore, no compatibility questions exist with respect to U.S.

tolerances.

2. Tolerance Revocations and Import Tolerances

During the Agency's reregistration process, the registrant decided not to support the use

of DCPA on lettuce, soybeans, corn, and rutabagas. The use of DCPA on these four crops has

been voluntarily cancelled. Normally, once a pesticide use is no longer registered in the U.S., the

related pesticide residue tolerance is no longer needed. It is the Agency's policy to propose

revocation of a tolerance following the deletion of a related food use from a registration, or
82

following the cancellation of a related food-use registration. The Agency has the responsibility

under FFDCA to revoke a tolerance on the grounds that the Agency cannot conclude that the

tolerance is protective of public health.

However, in the case of DCPA, the Agency is not seeking revocation of these tolerances,

as it normally would under the above policy. The registrant is supporting rotational crop

tolerances for these four commodities, thereby allowing DCPA residues which result from use on

registered crops previously grown in the same field. The reassessed tolerances will be determined

once field rotational crop residue data has been submitted to the Agency and reviewed. 

Subsequently, the tolerances of DCPA on these four commodities may be significantly reduced. 

The Agency recognizes, however, that interested parties may want to retain a tolerance

which is higher than the rotational crop tolerance (yet to be determined) in the absence of a U.S.

registration, to allow legal importation of treated food into the U.S. To assure that all food

marketed in the U.S. is safe, under FFDCA, the Agency requires the same product chemistry and

toxicology data for such import tolerances (tolerances without related U.S. registrations) as are

required to support U.S. food use registrations and any resulting tolerances. In addition, the

Agency requires residue chemistry data (crop field trials) that are representative of growing

conditions in exporting countries in the same manner that the Agency requires representative

residue chemistry data from different U.S. regions to support domestic use of the pesticide and

the tolerance.

Parties interested in supporting an existing DCPA tolerance as an import tolerance should

ensure that all of the data noted above are available to the Agency, so that the Agency may

determine whether maintenance of the tolerance would be protective of the public health.

3. Regulation of DCPA Impurities

The Agency requires pesticide registrants to establish a certified upper limit for each

"impurity of toxicological significance associated with the active ingredient and found to be

present in any sample of the product" (40 CFR part 158.175). These certified limits, once

accepted by the Agency, become legally binding levels representing the maximum allowable

contamination of associated DCPA formulations. The Agency has identified HCB and all of the

15 dioxin/furan congeners for which DCPA was analyzed as being of toxicological significance. 

There is an existing certified upper limit for HCB of 0.3% and a preliminary certified

upper limit for the 2,3,7,8-TCDD congener. However, the registrant must propose certified

upper limits for each of the remaining dioxin/furans for which a positive detection was reported to

the Agency. 

4. Dietary Risk

Acute dietary risk assessments were not necessary since there were no acute toxicological

endpoints of concern for DCPA or its impurities. Chronic and carcinogenic dietary risk was
83

assessed, however, due to exposure to DCPA, HCB, and dioxin/furans. Chronic risk estimates

for the U.S. population and all subgroups were well below 100% of the RfD for DCPA, HCB,

and dioxin/furans. Based on these estimates, the Agency concludes that DCPA use does not pose

a significant chronic dietary risk.

Carcinogenic risk estimates for exposure to DCPA, HCB, and dioxin/furans through food

were 3.5 x 10-7, 7 x 10-7, and 7 x 10-8, respectively. All of these risk estimates are within the

range (zero to 1 x 10-6) generally considered to be negligible by the Agency. Thus, the Agency

concludes that DCPA use does not pose a significant excess lifetime cancer risk. 

5. Drinking Water Risk

Risk due to exposure to DCPA and its metabolites which have been detected in ground

and surface water was assessed. The Agency is concerned that the public may be exposed to

DCPA and its metabolites through drinking water. Since there is no Maximum Contaminant

Level (MCL) established for DCPA or its metabolites, there is no enforceable federal regulatory

oversight of DCPA and its metabolites in public drinking water systems. Therefore, the Agency

assumed that the public may be exposed to the contamination levels found in ground and surface

water. 

The Agency's Office of Water has established a Health Advisory (HA) for DCPA at 4000

ppb. Although not enforceable, a HA benchmarks the concentration of DCPA in drinking water

that is not expected to cause any adverse non-carcinogenic effects over a lifetime with a margin of

safety. The current HA was calculated using an RfD of 0.5 mg/kg/day based on a 1963 two year

rat study. Newer studies reviewed in this document have led to the RfD being lowered to 0.01

mg/kg/day. 

If a new HA were to be calculated with the revised RfD of 0.01 mg/kg/day, the HA would

likely decrease to 70 ppb. The Agency calculated this lowered HA estimate based on the

following formula, which uses default assumptions for body weight, amount of water consumed,

and the relative source contribution for DCPA exposure.

RfD(70 kg)(0.2 RSC) = 70 ug/l (ppb)

(2 L/day)

The information regarding the reevaluation of DCPA's RfD will be forwarded to the Office

of Water for HA recalculation as resources permit. 

The Agency assessed both chronic (non-cancer) and carcinogenic risk due to exposure to

DCPA and its metabolites through contaminated ground and surface water. The Agency used

annual contamination averages from five geographic regions as potential drinking water exposure

values. The highest annual average was 50 ppb in New York from a turf study. Although this

represents approximately 71% of the HA, it only corresponds to 11% of RfD. Even if part of this
84

population were exposed to the maximum 3% of the RfD from other dietary sources, the chronic

dietary risk would still be considered minimal. 

Individual excess lifetime cancer risk from the New York turf site was 1.7 x 10-6. The

next highest risk estimate is based on data from Suffolk County, New York. The risk estimate

from that site is 9.7 x 10-7. DCPA's registrant has voluntarily withdrawn from selling the product

in Suffolk, New York. Exposure values from all other sites resulted in risks below the Agency's

cancer benchmark of 1 x 10-6. 

Based on these estimates, the Agency concludes that DCPA and its metabolites do not

currently pose a significant cancer or chronic non-cancer risk from non-turf uses to the overall

U.S. population from exposure through contaminated drinking water. 

6. Contamination of Water Resources and Mitigation Measures

One of DCPA's metabolites, TPA, is known to leach to groundwater. TPA has been a

frequently detected pesticide residue in groundwater studies. The Agency is continuing to require

all DCPA products to bear a groundwater advisory statement. 

In addition, the registrant has voluntarily agreed to limit the manufacture of DCPA

technical grade active ingredient for use within the U.S. to current production levels. This will

help to ensure that contamination rates do not significantly increase in the future. Since DCPA is

produced intermittently, the production limit will be set at the average of the last three production

campaigns, allowing for a 5% variance. The Agency will enforce this production cap through

review of manufacture data which the registrant is required to submit under FIFRA, Section 7. 

The registrant will produce no more than the agreed upon limit every 3 calendar years, beginning

in January, 1997. 

The registrant has also voluntarily agreed to drop the fall turf application from their labels

in order to reduce the usage of DPCA. This will lower the maximum application rate on turf from

15 lbs. active ingredient/Acre to 12 lbs. active ingredient/Acre. There are additional groundwater

data due to the Agency in the summer of 1996. Once those data are reviewed, the Agency will

reassess potential drinking water risk and evaluate the need for additional groundwater protection

measures. 

Through the reregistration process, the Agency has also identified concerns for the

contamination of surface water by DCPA. Consequently, the Agency is requiring all DCPA

products to bear a surface water advisory statement as well. Refer to Section V of this document

for the language of the groundwater and surface water advisories. 

7. Occupational Risk

Risk assessments were performed to assess the individual excess lifetime cancer risk from

DCPA and HCB resulting from occupational exposure to DCPA. The Agency will not generally
85

allow non-dietary risks to exceed 10-4, except in cases where EPA has determined that benefits

exceed the risks. 

The highest risk for both commercial applicators and private applicators (farm owners) is

associated with the use of the wettable powder formulation. For the commercial applicator, the

risk for DCPA was estimated to be 7.5 x 10-5 and for HCB (in DCPA) to be 1.9 x 10-4. The

Agency is requiring mixer/loader/applicators using DCPA wettable powders to wear a dust-mist

respirator fitted with a TC-21 filter to mitigate these risks. Wearing a dust-mist respirator reduces

the risks to 4.0 x 10-5 and 1.3 x 10-4 for DCPA and HCB, respectively.

For the private applicator, the risk for DCPA was estimated to be 1.6 X 10-6 and for HCB

(in DCPA) to be 4.6 X 10-6. The Agency concludes DCPA does not pose a significant individual

excess lifetime cancer risk for occupational (commercial and private) applicators. 

Risk from exposure to DCPA and HCB through worker reentry into a cucumber field was

assessed. Harvesting cucumbers one day after application resulted in risk estimates of 1.8 x 10-4

for DCPA and 3.2 x 10-4 for HCB. Longer reentry periods only minimally reduced risk estimates. 

However, the Agency believes that the worker exposures are overestimates. These scenarios

were based solely on a foliar dissipation study, not on dermal exposure studies. DCPA's

registrant is a member of a task force which will address dermal exposure for hand labor tasks

required by various crops, such as cucumber harvesting. The risk assessment will be refined when

the task force submits it dermal exposure data. 

Only rough estimates of risk for occupational exposure to dioxin/furans were calculated,

since there are no foliar dissipation or dermal absorption data for dioxin/furans. The Registration

Standard required foliar dissipation data for both HCB and dioxin/furans. However, the registrant

asserted that the dioxin/furan data could not be provided due to the unavailability of analytical

methodology to detect the expected levels of dioxin/furans. The Agency agreed that the

theoretical residue level was lower than 1991 analytical methods could detect. 

The wettable powder scenario produced the highest dioxin/furan risk for

mixer/loader/applicators with a 1.6 x 10-6 estimate. Workers entering the cucumber harvesting

field at zero days after treatment were estimated to be exposed to a 8 x 10-6 risk. Both of these

risk estimates should be considered as overestimates since conservative assumptions were made in

estimating these exposures. 

8. Residential Risk

Risks to children playing on a treated lawn were assessed for exposure to DCPA and

HCB. These risks were estimated by assuming a child would be exposed to a DCPA product

applied to their lawn once a year. The exposure is assumed to be present for 14 continuous days

following treatment. The scenario presumed a child might play outdoors several times a day and

not receive a bath until 10 hours after the first play period. It was further assumed that children
86

between the ages of 2 and 6 weigh 17 kilograms and weigh 31 kilograms between the ages of 6

and 12. 

The resulting risks from DCPA and HCB to children playing on an irrigated lawn are 5.6 x

10-7 and 3.9 x 10-7, respectively. The risks from DCPA and HCB to children playing on nonirrigated lawns are 2.0 x 10-6 and 2.7 x 10-6, respectively. Based in part on these estimates, the

Agency has decided to assess the benefits from turf use before making an eligibility decision. 

However, to reduce risks to children in the interim period, the Agency is requiring DCPA labels

to recommend residential lawns be watered after DCPA product use and that reentry not occur

until the grass has dried. 

The rough estimation of risk from dioxin/furans to children playing on non-irrigated lawn

one hour after treatment is 3.9 x 10-7. Again, dioxin/furan risk values could be overestimated

since neither foliar dissipation or dermal absorption data are available for dioxin/furans. 

9. Ecological Effects (Non-Endangered Species)

Current risk estimates indicate minimal acute risks to birds from DCPA use. However,

there is uncertainty regarding the actual LC50 values available for birds. To address this concern,

the Agency is requiring a dietary study using mallard ducks. In addition, long-term exposure to

birds is possible; yet there are no data on DCPA to assess chronic effects to birds. Consequently,

the Agency is requiring avian reproduction studies using the mallard duck and bobwhite quail so

that chronic effects to birds can be assessed. 

Levels of Concern (LOCs) regarding chronic effects to mammals are exceeded for all four

use scenarios. In the three crop scenarios, the risk is overstated because DCPA is applied as a

pre-emergent herbicide, when the land is free of vegetation. If the crop has emerged, DCPA

sprays would be directed past the foliage to treat the bare ground. Therefore, the Agency does

not expect to see substantial mammalian exposure to DCPA through grazing on or near cropland.

The remaining use for which the mammalian chronic LOC is exceeded is turf. 

The restricted use LOC for freshwater and estuarine mollusks is also exceeded by the turf use,

aerial application. In the interim period while the Agency assesses benefits from the turf use,

spray drift advisory language is being required which may mitigate the risk to mollusk species.

Numerical estimates of risk were not calculated for terrestrial and semi-aquatic nontarget

plant species. Since little or no effect was seen at 9 lbs a.i./acre application rate in the toxicity

study, LOCs are not likely to be exceeded. Since it is unlikely that a herbicide would not affect

plant species, the Agency is requiring additional testing of sensitive species in the areas of

vegetative vigor and seedling emergence. Minimal adverse impact is expected for aquatic plants

from DCPA use. 

10. Endangered Species
87

The Agency has concerns about the exposure of threatened and endangered mammal and

mollusk species to DCPA as discussed above in the Section III. 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

modifications or a generic product label statement, requiring users to consult county-specific

bulletins. These bulletins would provide information about specific use limitations to protect

endangered and threatened species in the county. Consultations with the Fish and Wildlife

Service may be necessary to assess risks to newly listed species or from existing or proposed new

uses.

The Agency plans to publish a description of the Endangered Species Program in the

Federal Register in the future. 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.

11. Spray Drift

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 DCPA product

labels/labeling as specified in Section V of this document. Once the Agency completes its

evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U.S.

pesticide registrants, the Agency may impose further refinements in spray drift management

practices to further reduce off-target drift and risks associated with this drift. Actions taken to

reduce spray drift will help to mitigate contamination of surface water, reduce risk to estuarine

species, and reduce harm to nontarget crops and plants. 

12. Labeling Rationale

THE WORKER PROTECTION STANDARD (WPS)

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 that contain uses 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,

fiber plants, trees, turf grass, flowers, shrubs, ornamentals, and seedlings). Uses within the scope

include not only uses on plants, but also uses on the soil or planting medium the plants are (or will

be) grown in.
88

Current registered uses of DCPA include uses within the scope as well as some uses

outside the scope of the Worker Protection Standard for Agricultural Pesticides (WPS). Those

that are outside the scope of the WPS include:

• on plants grown for other than commercial or research purposes, which may

include homeowner uses; and

• on plants that are in ornamental gardens, parks, golf courses, and public or private

lawns and grounds and that are intended only for decorative or environmental

benefit. (However, pesticides used on sod farms are covered by the WPS).

Compliance with the WPS

Any product whose labeling can be reasonably interpreted to permit 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 (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,

the labeling of all products within the scope of those notices must meet the

requirements of the notices when the products 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, the labeling of all products within the scope of those notices must meet the

requirements of the notices when the products are distributed or sold by any

person.

Personal Protective Equipment (PPE) for Handlers (Mixer/Loader/ Applicators) 

Current labels for end-use products containing DCPA do not include engineering control

requirements for mixers, loaders, or applicators, such as closed mixing systems or closed tractor

cabs.

For each end-use product, PPE requirements for pesticide handlers are set during

reregistration in one of two ways: 
89

1. If EPA determines that no regulatory action must be taken as the result of the acute effects or

other adverse effects of an active ingredient, the PPE for pesticide handlers will be based on the

acute toxicity of the end-use product. For occupational-use products, PPE must be established

using the process described in PR Notice 93-7 or more recent EPA guidelines.

2. If EPA determines that regulatory action on an active ingredient must be taken as the result of

very high acute toxicity or to certain other adverse effects, such as allergic effects or delayed

effects (cancer, developmental toxicity, reproductive effects, etc.): 

# In the RED for that active ingredient, EPA may establish minimum or "baseline"

handler PPE requirements that pertain to all or most 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 the 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.

Personal protective equipment requirements usually are set by specifying one or more preestablished PPE units -- sets of items that are almost always required together. For example, if

chemical-resistant gloves are required, then long-sleeve shirts, long pants, socks, and shoes are

assumed and are also included in the required minimum attire. If the requirement is for two layers

of body protection (coveralls over a long- or short-sleeve shirt and long or short pants), the

minimum must also include (for all handlers) chemical-resistant footwear and chemical-resistant

headgear for overhead exposures and (for mixers, loaders, and persons cleaning equipment)

chemical-resistant aprons.

Occupational-Use Products

EPA has determined that regulatory action regarding the establishment of activeingredient-based minimum PPE requirements for occupational handlers must be taken for DCPA. 

 For handlers, the exposure/risk assessments assumed that chemical-resistant gloves were worn in

the following handler scenarios: (1) mixers/loaders using liquid formulations, (2) mixers/loaders

using wettable powder formulations, (3) mixer/loader/applicators applying by shaker can, and (4)

mixers/loaders/applicators applying by backpack sprayer. Therefore, chemical-resistant gloves

will be required for occupational handlers in these scenarios. 

EPA notes that the only data available for assessing exposure for cultivator mounted

granular spreaders (scenario V) were studies in which the applicator was inside an enclosed cab. 

The risk levels for this exposure scenario are quite low (9.4 x 10-9 for DCPA and 3.1 x 10-8 for

HCB for private applicators; and 9.4 x 10-8 for DCPA and 3.1 x 10-7 for HCB for commercial

applicators); therefore, enclosed tractor cabs will not be required for application of DCPA by

cultivator mounted granular spreaders.

WPS and NonWPS Uses: 
90

Since potential handler exposure is similar for WPS and nonWPS uses, there is only one

set of active-ingredient-based minimum (baseline) PPE requirements for occupational uses of

DCPA (specified in Section V). These requirements must be followed in the labeling of all DCPA

end-use products intended primarily for occupational use.
91

Homeowner-Use Products

EPA is not establishing minimum (baseline) handler PPE for DCPA end-use products that

are intended primarily for homeowner uses, because the Agency has determined that the

frequency, duration, and degree of exposure by such users do not warrant such risk mitigation

measures.

Entry Restrictions

Occupational-Use Products (WPS Uses)

Current registered uses of DCPA include uses within the scope, as well as uses outside the

scope of the Worker Protection Standard for Agricultural Pesticides (WPS).

Restricted Entry Interval -- Under the Worker Protection Standard (WPS), interim

restricted entry intervals (REI) for all uses within the scope of the WPS are based on 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

REIs established by the Agency prior to the promulgation of the WPS: (1) product-specific REIs

established on the basis of adequate data, and (2) interim REIs that are longer than those that

would be established under the WPS.

For occupational end-use products containing DCPA as an active ingredient, a 12-hour

restricted-entry interval will be established for each use of the product that is within the scope of

the Worker Protection Standard for Agricultural Pesticides (WPS). The basis for this

recommendation is that DCPA is categorized as toxicity category IV for acute dermal toxicity,

category IV for acute oral toxicity, category III for acute inhalation toxicity, category III for eye

irritation potential, and category IV for dermal irritation and the results of the post-application

risk assessment for agricultural crops indicates that regulatory action beyond the 12-hour REI is

not warranted. However, since DCPA and HCB are both quantifiable carcinogens, DCPA is not

a candidate for reducing the REI from 12 hours to 4 hours.

Early-Entry PPE -- The WPS establishes very specific restrictions on entry by workers to

areas that remain under a restricted-entry interval if the entry involves contact with treated

surfaces. Among those restrictions is a prohibition of routine entry to perform hand labor tasks

and the 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
92

based on the toxicity concerns about the active ingredient. The requirements are set in one of two

ways.

1. If EPA determines that no regulatory action must be taken as the result of the

acute effects or other adverse effects of an active ingredient, it establishes the

early-entry PPE requirements on the basis of the acute dermal toxicity category,

skin irritation potential category, and eye irritation potential category of the active

ingredient. 

2. If EPA determines that regulatory action on an active ingredient must be taken as

the result of very high acute toxicity or to certain other adverse effects, such as

allergic effects or delayed effects (cancer, developmental toxicity, reproductive

effects), it may establish early-entry PPE requirements that are more stringent than

would be established otherwise.

Since DCPA is classified as category IV for skin irritation potential and IV for acute

dermal toxicity, and EPA has determined that no regulatory action must be taken due to the acute

effects or other adverse effects of DCPA, the PPE for dermal protection required for early entry is

the minimum early-entry PPE permitted under the WPS: coveralls, chemical-resistant gloves,

socks, and shoes. Since DCPA is classified as toxicity category III for eye irritation potential, no

protective eyewear is required.

WPS Notification Statement:

Under the WPS, the labels of some pesticide products must require employers to notify

workers about pesticide-treated areas orally as well as by posting of the treated areas. The

reregistration process also may decide that a product requires this type of "double notification."

EPA has determined that double notification is not required for DCPA end-use products.

Occupational-Use Products (NonWPS Uses)

 Since EPA has concerns about immediate post-application exposures to persons after

nonWPS occupational uses of DCPA, it is establishing entry restrictions for all nonWPS

occupational uses of DCPA end-use products. For specific requirements, refer to Section V of

this document.

Homeowner-Use Products

Since EPA has concerns about immediate post-application exposures to persons after

homeowner applications of DCPA, it is establishing entry restrictions for all homeowner uses of

DCPA end-use products. For specific requirements, refer to Section V of this document.
93

Other Labeling Requirements

The Agency is also requiring other use and safety information to be placed on the labeling

of all end-use products containing DCPA. For the specific labeling statements, refer to Section V

of this document.
94

V. ACTIONS REQUIRED OF 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 DCPA for the above eligible uses

has been reviewed and determined to be substantially complete. However, confirmatory data are

required in the areas of residue chemistry, ecological effects, and occupational exposure, as listed

below. The Data Call-In Notice in the Appendices outlines the specific data requirements and the

time frames for submission of the data.

Guideline Study

133-3 Post-application dermal passive dosimetry exposure

133-4 Post-application inhalation passive dosimetry exposure

231 Dermal exposure study

232 Inhalation exposure study

171-4(b) Poultry Metabolism

171-4(e) Storage Stability

171-4(j) Cattle Feeding study

171-4(j) Poultry Feeding study (on reserve pending review of poultry

metabolism study)

71-4(a) Avian Reproduction - Quail

71-4(b) Avian Reproduction - Mallard duck

123-1(a) Seedling emergence

123-1(b) Vegetative vigor (using sensitive 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 regulations, PR Notices, and applicable policies. The MP

labeling must bear the following statement under Directions for Use:

"Only for formulation into a herbicide for the following use(s): 

 (fill blank only with those uses that are being supported by MP registrants)."

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:
95

(a) "This product may be used to formulate products for specific use(s) not listed on the MP

label if the formulator, use group, or grower has complied with U.S. EPA submission

requirements regarding the support of such use(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 (use)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.

2. Labeling Requirements for End-Use Products

PPE/Engineering Control Requirements for Pesticide Handlers

For sole-active-ingredient end-use products that contain DCPA, the product labeling

must be revised to adopt the handler personal protective equipment/engineering control

requirements set forth in this section. Any conflicting PPE requirements on the current labeling

must be removed. 

For multiple-active-ingredient end-use products that contain DCPA, the handler

personal protective equipment/engineering control requirements set forth in this section must be

compared to the requirements on the current labeling and the more protective must be retained.

For guidance on which requirements are considered more protective, see PR Notice 93-7.

Products Intended Primarily for Occupational Use (WPS and nonWPS)

Minimum (Baseline) PPE/Engineering Control Requirements

EPA is establishing minimum (baseline) PPE for some occupational uses of DCPA. These

minimum (baseline) PPE are listed below. PPE for all formulations not listed below will be based

on the toxicity of the end-use products as assessed during product reregistration. 
96

For liquid concentrate formulations:

Mixers and loaders must wear:

--Long-sleeve shirt and long pants,

--Socks plus shoes,

--Chemical-resistant gloves*.

For wettable powder formulations:

Mixers, loaders, and applicators must wear:

--Long-sleeve shirt and long pants,

--Socks plus shoes,

--Chemical-resistant gloves*.

--a dust mist respirator with a TC-21C filter

For applications using a shaker can or backpack sprayer:

Applicators must wear:

--Long-sleeve shirt and long pants,

--Socks plus shoes,

--Chemical-resistant gloves*.

* For the glove statement, use the statement established for DCPA through the

instructions in Supplement Three of PR Notice 93-7. 

Determining PPE Requirements for End-use Product Labels

The PPE that would be established on the basis of the acute toxicity category of the enduse product must be compared to the active-ingredient-based minimum (baseline) personal

protective equipment specified above. The more protective PPE must be placed on the product

labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.

Placement in Labeling

The personal protective equipment requirements must be placed on the end-use product

labeling in the location specified in PR Notice 93-7, and the format and language of the PPE

requirements must be the same as is specified in PR Notice 93-7.

Products Intended Primarily for Homeowner Use

Minimum (baseline) PPE Requirements

EPA is not establishing active-ingredient-based minimum (baseline) handler PPE for

DCPA end-use products that are intended primarily for homeowner use.
97

Determining PPE Requirements for End-Use Product Labels

Any necessary PPE for each DCPA end-use product intended primarily for homeowner

use will be established on the basis of the end-use product's acute toxicity category.

Placement in Labeling

The personal protective equipment requirements, if any, must be placed on the end-use

product labeling immediately following the precautionary statements in the labeling section

"Hazards to Humans (and domestic animals)."

Entry Restrictions

For sole-active-ingredient end-use products that contain DCPA, the product labeling

must be revised to adopt the entry restrictions set forth in this section. Any conflicting entry

restrictions on the current labeling must be removed. 

For multiple-active-ingredient end-use products that contain DCPA, the entry

restrictions set forth in this section must be compared to the entry restrictions on the current

labeling and the more protective must be retained. A specific time period in hours or days is

considered more protective than "sprays have dried" or "dusts have settled."

Products Intended Primarily for Occupational Use

WPS Uses

Restricted-entry interval:

A 12-hour restricted-entry interval (REI) is required for uses within the scope of the WPS

on all DCPA end-use products. 

Early-entry personal protective equipment (PPE):

The PPE required for early entry is: 

-- coveralls, 

-- chemical-resistant gloves, and

-- shoes plus socks.

Placement in labeling:

The REI must be inserted into the standardized REI statement required by Supplement

Three of PR Notice 93-7. The PPE required for early entry must be inserted into the standardized

early-entry PPE statement required by Supplement Three of PR Notice 93-7.
98

NonWPS uses

Entry restrictions:

The Agency is establishing the following entry restrictions for nonWPS occupational uses

of DCPA end-use products:

For liquid applications:

"Do not enter or allow others to enter the treated area until sprays have dried."

For granular applications:

"Do not enter or allow others to enter the treated area until dusts have settled. If soil

incorporation is required following the application, do not enter or allow others to enter

the treated area (except those persons involved in the incorporation) until the

incorporation is complete. If the incorporation is accomplished by watering-in, do not

enter or allow others to enter the treated area until the surface is dry following the

watering-in."

Placement in labeling:

If WPS uses are also on label -- Follow the instructions in PR Notice 93-7 for

establishing a Non-Agricultural Use Requirements box, and place the appropriate nonWPS

entry restrictions in that box.

If no WPS uses are on the label -- Place the appropriate nonWPS entry restrictions in

the Directions for Use, under the heading "Entry Restrictions."

Products Intended Primarily for Homeowner Use

Entry restrictions: The Agency is establishing the following entry restrictions for all

homeowner uses of DCPA end-use products: 

Entry Restrictions for Home Use Products

For liquid and granular formulations:

"This product must be watered in following application. Do not allow persons or pets to

enter the treated area until the grass is dry following watering-in."

Placement in labeling: Place the appropriate entry restrictions in the Directions for Use,

under the heading "Entry Restrictions."
99

Other Labeling Requirements for End-Use Products

Products Intended Primarily for Occupational Use

The Agency is requiring the following labeling statements to be located on all end-use

products containing DCPA that are intended primarily for occupational use:

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."

User Safety Requirements:

{Registrants: select this if coveralls are required for pesticide handlers on the enduse product label:}

"Discard clothing or other absorbent materials that have been drenched or heavily

contaminated with this product's concentrate. Do not reuse them."

{Registrants: select this always:}

"Follow manufacturer's instructions for cleaning/maintaining PPE. 

If no such instructions 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. As

soon as possible, wash thoroughly and change into clean clothing."

Engineering Controls:

"When handlers use closed systems, or enclosed cabs or aircraft in a

manner that meets the requirements listed in the Worker Protection

Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the
100

handler PPE requirements may be reduced or modified as specified in the

WPS."

Soil Incorporation Statement:

Registrants must add the following statement to their labeling in the "Agricultural Use

Requirements" box immediately following the restricted entry interval:

"Exception: if the product is soil-incorporated, the Worker Protection Standard,

under certain circumstances, allows workers to enter the treated area if there will

be no contact with anything that has been treated."

Products Intended Primarily for Home Use

Application Restrictions

"Do not apply this product in a way that will contact any person or

pet, either directly or through drift. Keep people and pets out of

the area during application."

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."

{Registrants: select this only if gloves and/or protective eyewear are required for

homeowner users:}

# "Users should remove protective clothing and equipment

immediately after handling this product. Wash the outside of

gloves before removing. Keep and wash protective clothing

and equipment separately from other laundry."

ADDITIONAL LABELING REQUIREMENTS

The use directions for DCPA on beans prohibit grazing in treated areas and the feeding of

treated plant material or refuse to livestock. Under current Agency policy, label restrictions

prohibiting the feeding of bean forage and straw/hay to livestock are inappropriate. The registrant

must delete restrictions prohibiting the feeding of bean forage and hay/straw to livestock from all

labels. However, the registrant may restrict the uses of DCPA on beans to those varieties that are

used for human consumption only.
101

When end-use product DCIs are developed (e.g., at issuance of the RED), EPA should

require that all end-use product labels (e.g., multiple active ingredient labels, SLNs, and products

subject to the generic data exemption) be amended such that they are consistent with the basic

producer labels.

3. Groundwater Advisory

All DCPA end-use products must continue to bear the following groundwater advisory:

Tetrachloroterephthalic acid, a breakdown product of Dacthal, is known to leach through

soil as a result of agricultural and turf uses and has been found in groundwater which may

be used for drinking water. Users are advised not to apply Dacthal to sand or loamy sand

soils where the water table (groundwater) is close to the surface and where those soils are

very permeable, i.e. well drained. Your local agricultural agencies can provide further

information on the type of soil in your area and the location of groundwater used for

drinking water. 

a. Surface Water Advisory

All DCPA end-use products must bear the following surface water advisory:

DCPA can contaminate surface water through spray drift. Under some conditions,

DCPA may also have a high potential to contaminate surface water through runoff

(via both dissolution in runoff water and adsorption to eroding soil) for several

weeks post-application. Users are advised not to apply Dacthal to poorly draining

or wet soils with readily visible sloping towards adjacent surface waters, frequently

flooded areas, areas over-laying extremely shallow groundwater, areas with in-field

canals or ditches that drain to surface water, areas not separated from adjacent

surface waters with vegetated filter strips, and highly erodible soils.

b. Spray Drift Labeling

The following language must be placed on each label for products which 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.
102

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 Information.

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.]

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 produces larger droplets than other orientations and is the

recommended practice. Significant deflection from horizontal will reduce droplet

size and increase drift potential.
103

! 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 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
104

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 smoke from a ground source

or an aircraft smoke generator. Smoke that layers and moves laterally in a

concentrated cloud (under low wind conditions) 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 from the sensitive areas).

C. Tolerance Revocation and Import Tolerances

The use of DCPA on pimentos is being voluntarily canceled as part of the Agency's

reregistration eligibility decision regarding this pesticide. It is the Agency's policy to propose

revocation of a tolerance, and/or food/feed additive regulation, following the deletion of a related

food use from a registration, or following the cancellation of a related food-use registration. As a

result, any parties interested in supporting the tolerance/regulation for import purposes in the

absence of a registered U.S. use should notify the Agency as soon as possible. 

In responding, the Agency will provide detailed information on the outstanding data

requirements for these tolerances and/or regulations. The Agency will consider commitments

made to generate data to support such tolerances/regulations and the timeliness of data

submissions in its assessment of whether the tolerances/regulations should be retained. Persons

interested in establishing a new tolerance for import purposes only, or retaining a current

tolerance for import purposes following cancellation of the related use, must submit a petition,

along with the appropriate supporting data.

D. 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.
105

The Agency has determined that registrants may distribute and sell DCPA 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.
106
107

VI. APPENDICES
108
109

APPENDIX A. Table of Use Patterns Subject to Reregistration

APPENDIX A - Table of Use Patterns Subject to Reregistration

Appendix A is 169 pages long and is not being included in this RED. Copies of Appendix A are

available upon request per the instructions in Appendix E.
110
111

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

GUIDE TO APPENDIX B

Appendix B contains listings of data requirements which support the reregistration

for active ingredients within the case DCPA covered by this Reregistration Eligibility Decision

Document. It contains generic data requirements that apply to DCPA 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.
112
113

APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

PRODUCT CHEMISTRY

61-1 Chemical Identity ALL DATA GAP

61-2A Start. Mat. & Mnfg. Process ALL 00156951, 40958804,

41054801, 41241801, DATA

GAP

61-2B Formation of Impurities ALL 00156951, 40958808

62-1 Preliminary Analysis ALL Partially Satisfied

62-2 Certification of limits ALL DATA GAP

62-3 Analytical Method ALL DATA GAP

63-2 Color ALL 41054802

63-3 Physical State ALL 40958812

63-4 Odor ALL 40958814

63-5 Melting Point ALL 41054804

63-6 Boiling Point ALL WAIVED

63-7 Density ALL 40958816

63-8 Solubility ALL 41155701, 40958818

63-9 Vapor Pressure ALL 41054805, 40958819

63-10 Dissociation Constant ALL WAIVED

63-11 Octanol/Water Partition ALL 40958820

63-12 pH ALL 40958821

63-13 Stability ALL 41155703

63-14 Oxidizing/Reducing Action ALL DATA GAP

63-15 Flammability N/A

63-16 Explodability ALL 41155703

63-17 Storage stability ALL 40958822

63-18 Viscosity N/A

63-19 Miscibility N/A

63-20 Corrosion characteristics ALL DATA GAP
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

114

63-21 Dielectric breakdown volt N/A

64-1 Submittal of Samples N/A

ECOLOGICAL EFFECTS

71-1A Acute Avian Oral - Quail/Duck ALL 

 

41155705

71-1B Acute Avian Oral - Quail/Duck

TEP 

N/A

71-2A Avian Dietary - Quail ALL 41155706

71-2B Avian Dietary - Duck ALL 41155707

71-3 Wild Mammal Toxicity N/A

71-4A Avian Reproduction - Quail A, B, C, D,

E, F, J, K

DATA GAP

71-4B Avian Reproduction - Duck A, B, C, D,

E, F, J, K

DATA GAP

71-5A Simulated Field Study RESERVED

71-5B Actual Field Study RESERVED

72-1A Fish Toxicity Bluegill A, B, C, D,

E, F, J, K

41054827

72-1B Fish Toxicity Bluegill - TEP N/A

72-1C Fish Toxicity Rainbow Trout ALL 00107142, 41054826

72-1D Fish Toxicity Rainbow TroutTEPALL 41054826

72-2A Invertebrate Toxicity ALL 40098001

72-2B Invertebrate Toxicity - TEP ALL 40098001

72-3A Estuarine/Marine Toxicity - Fish ALL 40098001

72-3B Estuarine/Marine Toxicity -

Mollusk

A, B, C, D,

E, F, J, K

40098001

72-3C Estuarine/Marine Toxicity -

Shrimp

A, B, C, D,

E, F, J, K

40098001

72-3D Estuarine/Marine Toxicity FishTEPN/A
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

115

72-3E Estuarine/Marine Toxicity

Mollusk - TEP

N/A

72-3F Estuarine/Marine Toxicity

Shrimp - TEP

N/A

72-4A Early Life Stage Fish N/A

72-4B Life Cycle Invertebrate N/A

72-5 Life Cycle Fish N/A

72-6 Aquatic Organism

Accumulation

N/A

72-7A Simulated Field - Aquatic

Organisms

N/A

72-7B Actual Field - Aquatic

Organisms

N/A

122-1A Seed Germination/Seedling

Emergence

A, B, C, D,

E, F, J, K 

41054829, 41564901,

PARTIALLY SATISFIED 

122-1B Vegetative Vigor A, B, C, D,

E, F, G, J,

K

41440101, SUPPLEMENTAL

122-2 Aquatic Plant Growth A, B, C, D,

E, F, G, J,

K

41054829, 41155714,

42882401, 41836101,

42836102, 42836103 

123-1A Seed Germination/Seedling

Emergence

A, B, C, D,

E, F, G, J,

K

DATA GAP

123-1B Vegetative Vigor A, B, C, D,

E, F, G, J,

K

DATA GAP

123-2 Aquatic Plant Growth RESERVED

124-1 Terrestrial Field RESERVED

124-2 Aquatic Field RESERVED

141-1 Honey Bee Acute Contact A, B, C, D,

J, K

00009181

141-2 Honey Bee Residue on Foliage N/A

141-5 Field Test for Pollinators N/A
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

116

TOXICOLOGY

81-1 Acute Oral Toxicity - Rat ALL 41054808, 41054808,

41054809, 41155710 

81-2 Acute Dermal Toxicity -

Rabbit/Rat

ALL 41054811, 41054812,

41054813, 41155709

81-3 Acute Inhalation Toxicity - Rat ALL 00127905, 41054814,

41155710, 41750101

81-4 Primary Eye Irritation - Rabbit ALL 00163578, 41054815,

41054816, 41155711

81-5 Primary Dermal Irritation -

Rabbit

ALL 41054817, 41054818, 41155712

81-6 Dermal Sensitization - Guinea

Pig

ALL 00150207

81-7 Acute Delayed Neurotoxicity -

Hen

N/A

82-1A 90-Day Feeding - Rodent ALL 00100773, 41064801,

41767901, 41790901

82-1B 90-Day Feeding - Non-rodent N/A

82-2 21-Day Dermal - Rabbit/Rat ALL 41231803, 41231804, 41231805

82-3 90-Day Dermal - Rodent N/A

82-4 90-Day Inhalation - Rat N/A

82-5A 90-Day Neurotoxicity - Hen N/A

82-5B 90-Day Neurotoxicity - Mammal N/A

83-1A Chronic Feeding Toxicity -

Rodent

ALL 40958701, 41349101, 41750102

83-1B Chronic Feeding Toxicity - 

Non-Rodent

ALL 00083584

83-2A Oncogenicity - Rat ALL 42731001

83-2B Oncogenicity - Mouse ALL 40958701, 41349101

83-3A Developmental Toxicity - Rat ALL 00160685

83-3B Developmental Toxicity - Rabbit ALL 41054820, 41064802, 41838301

83-4 2-Generation Reproduction -

Rat

ALL 41750103, 41905201
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

117

84-2A Gene Mutation (Ames Test) ALL 00100775

84-2B Structural Chromosomal

Aberration

ALL 41054821, 41054822,

41054823, 41054824,

41054825, 41038301

84-4 Other Genotoxic Effects ALL 41054822, 41054824, 42038301

85-1 General Metabolism ALL 42155501, 42155502.

42155503, 42723201,

43052201, 43723202, 43723203 

85-2 Dermal Penetration ALL 42651501, 42651502

86-1 Domestic Animal Safety N/A 

OCCUPATIONAL/RESIDENTIAL EXPOSURE

132-1A Foliar Residue Dissipation A, B, C, D,

H, I, J, K

DATA GAP [DCI’S issued

September 1992 and October

1995]

132-1B Soil Residue Dissipation N/A

133-3 Dermal Passive Dosimetry

Exposure

A, B, C, D,

H, I, J, K

DATA GAP [DCI’s issued

September 1992 and October

1995]

133-4 Inhalation Passive Dosimetry

Exposure

A, B, C, D,

H, J, K, L,

M, N, O

DATA GAP [DCI issued

October 1995

231 Estimation of Dermal Exposure

at Outdoor Sites

N/A

232 Estimation of Inhalation

Exposure at Outdoor Sites

N/A

233 Estimation of Dermal Exposure

at Indoor Sites

N/A

234 Estimation of Inhalation

Exposure at Indoor Sites

N/A

ENVIRONMENTAL FATE

160-5 Chemical Identity N/A

161-1 Hydrolysis All 00114648

161-2 Photodegradation - Water A, B, C, D,

E, F, G, J

41508607
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

118

161-3 Photodegradation - Soil A, B, C, J 41508608

161-4 Photodegradation - Air N/A

162-1 Aerobic Soil Metabolism A, B, C, D,

E, H, I, J,

K

41648801

162-2 Anaerobic Soil Metabolism A, B, C 00114651, 41648802

162-3 Anaerobic Aquatic Metabolism N/A

162-4 Aerobic Aquatic Metabolism N/A

163-1 Leaching/Adsorption/

Desorption

A, B, C, D,

E, F, G, H,

I, J, K

41648803. 41648804,

41648805, 42262602

163-2 Volatility - Lab RESERVED

163-3 Volatility - Field RESERVED

164-1 Terrestrial Field Dissipation A, B, H, I IN REVIEW 

164-2 Aquatic Field Dissipation RESERVED

164-3 Forest Field Dissipation RESERVED

164-5 Long Term Soil Dissipation A, B, C, D,

E, J, K

IN REVIEW

165-1 Confined Rotational Crop A, B, C, D IN REVIEW

165-2 Field Rotational Crop RESERVED

165-3 Accumulation - Irrigated Crop N/A

165-4 Bioaccumulation in Fish A, B, C, D,

E, F, G, J

41155716, 41197602

165-5 Bioaccumulation - Aquatic

NonTarget

N/A

166-1 Ground Water - Small

Prospective

N/A

166-2 Ground Water - Small

Retrospective

N/A

166-3 Ground Water - Irrigated

Retrospective

N/A

201-1 Droplet Size Spectrum RESERVED

202-1 Drift Field Evaluation RESERVED
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

119

RESIDUE CHEMISTRY

171-4A Nature of Residue - Plants A, B, D, H,

K, L

00058377, 00114677,

40259101, 42298301, 42298302

171-4B Nature of Residue - Livestock A, B, D, H,

L

00057629, DATA GAP

171-4C Residue Analytical Method -

Plants

A, B, D, E,

K, L

00010026, 00114642,

00114643, 00114644,

OO114654, 00121864,

00123748, 40259001,

41550701, 42155505,

42155506, 42155507,

42155508, 42155509,

42155510, 42218904,

42218905, 42245701,

42271801, 42218901,

42218906, 43406401, DATA

GAP

171-4D Residue Analytical Method -

Animal

A, B, D, H,

K

00058378, 00114643,

43406401, DATA GAP

171-4E Storage Stability A, B, D, E,

H, K, L

00121864, 41750107,

42218901, 42444001, DATA

GAP

171-4F Magnitude of Residues - Potable

H2O

N/A

171-4G Magnitude of Residues in Fish N/A

171-4H Magnitude of Residues -

Irrigated Crop

N/A

171-4I Magnitude of Residues - Food

Handling

N/A

171-4J Magnitude of Residues -

Meat/Milk/Poultry/Egg

A, B, D, H,

K

00038919, 00058378,

00114643, DATA GAP

171-4K Crop Field Trials 

Root and Tuber Vegetables

Group

- Horseradish A, B, D, H,

K

00058377
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

120

- Potatoes A, B, D, H,

K

00018299, 00090259, 00114678

- Radish, root A, B, D, H,

K

00121864

- Rutabagas A, B, D, H,

K

PP3E1388

- Sweet potato A, B, D, H,

K

00090259, 00114678, 00114681

- Turnip root A, B, D, H,

K

00090259

- Yams A, B, D, H,

K

00090259, 00114678, 00114681

Leaves of Roots and Tuber

Vegetables Groups

- Radish, tops A, B, D, H,

K

00121864

- Turnip, tops A, B, D, H,

K

00090259

Bulb Vegetables Group

- Garlic A, B, D, H,

K

00090259, 00130562

- Onions (green and dry bulb) A, B, D, H,

K

00090259, 00114631,

00114681, 42155508

Leafy Vegetables Group 

(except Brassica)

- Cress, upland A, B, D, H,

K

00033087, 00090259

- Lettuce A, B, D, H,

K

00033087, 00090259, 42155506

- Parsley A, B, D, H,

K

41550701, DATA GAP

Brassica Leafy Vegetables

Group
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

121

- Broccoli A, B, D, H,

K

00090259, 00114681

- Brussels sprouts A, B, D, H,

K

00090259

- Cabbage A, B, D, H,

K 

00090259, 00114681

- Cauliflower A, B, D, H,

K

00090259, 00114681

- Collards A, B, D, H,

K

00090259

- Kale A, B, D, H,

K

00090259

- Mustard greens A, B, D, H,

K

00090259

Legume Vegetables (succulent or

dried) Group

- Beans, succulent and dried A, B, D, H,

K

00017975, 00058377,

00090259, 00114678

- Peas A, B, D, H,

K

00017975, 00058377,

00090259, 00114678

- Soybeans A, B, D, H,

K

00017975, 00058377,

00090259, 00115678 

Foliage of Legume Vegetables

Group

- Beans, forage and 

hay/straw

A, B, D, H,

K

0090259, 00114678, Data Gap

- Soybeans, forage and hay A, B, D, H,

K

00058377

Fruiting Vegetables (except

cucurbits) Group

- Eggplant A, B, D, H,

K

00090259, 42155510

- Peppers A, B, D, H,

K

00090259, 00114680, 42155510
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

122

- Pimentos A, B, D, H,

K

00090259, 00114680, 42155510

- Tomatoes A, B, D, H,

K

00090259, 00114679,

00114680, 42218904, 42218905

Cucurbit Vegetables Group

- Cucumbers A, B, D, H,

K

00090259, 42155507,

- Cantaloups A, B, D, H,

K

00090259, 42218903

- Honeydew melons A, B, D, H,

K

00090259, 42218903

- Squash (summer and 

winter)

A, B, D, H,

K 

00090259, 42245701

- Watermelons A, B, D, H,

K

00090259, 42218903

Small Fruits and Berries Group

- Strawberries A, B, D, H,

K

00090259, 42155509

Cereal Grains Group

- Corn, field and pop A, B, D, H,

K

00072099

Forage, Fodder, and Straw of

Cereal Grains Groups

- Corn, forage and fodder A, B, D, H,

K

00072099

Miscellaneous Commodities

- Cottonseed A, B, D, H,

K

00114642, 00114678, 00114681

171-4(l) Magnitude of the Residues in Processed Food/Feed

- Beans (succulent/dried) A, B, D, H,

K

42218902

- Corn, field A, B, D, H,

K
Data Supporting Guideline Requirements for the Reregistration of DCPA

REQUIREMENT USE

PATTERN

CITATION(S)

123

- Cottonseed A, B, D, H,

K

42218906

- Potato A, B, D, H,

K

42271801

- Soybeans A, B, D, H,

K

- Tomatoes A, B, D, H,

K

42218905

171-5 Reduction of Residues N/A

171-6 Proposed Tolerance N/A

171-7 Support for Tolerance N/A

171-13 Analtyical Reference Standard N/A
124
125

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

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 as (19??), the Agency was unable to determine or estimate the

date of the document.
126

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

______________________________________________________

127

00009181 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of 

Pesticides on Apiculture: Project No. 1499. (Unpublished study received Jul 29,

1976 under 352-342; prepared by Univ. of California--Riverside, Dept. of

Entomology, submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;

CDL:224800-C)

 

00010026 Manning, P.B.; Olney, C.E.; Quinn, J.G.; et al. (1963) Direct gas chromatographic

method for herbicide residues suitable for electron-capture detection. Pesticide

Research Bulletin 3(2):6-8. (Also~In~unpublished submission received Sep 1963

under 464367; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:

101380-A).

00107142 McCann, J. (1972) ¢Dacthal G-2.5 Herbicide: Rainbow Trout (Salmo gairdneri)*:

Test No. 481. (U.S. Agricultural Research Service, Pesticides Regulation Div.,

Animal Biology Laboratory; unpublished study; CDL:130357-A)

00017975 Stallard, D.E. (1970) Residue Analyses and Procedure: ¢Linuron*. (Unpublished

study received Feb 17, 1970 under 677-285; submitted by Diamond Shamrock

Agricultural Chemicals, Cleveland, Ohio; CDL:004253-U)

00018299 Stallard, D.E. (1970) Residue Analyses and Procedure. (Unpublished study

received Nov 12, 1970 under unknown admin. no.; submitted by Diamond

Shamrock Agricultural Chemicals, Cleveland, Ohio; CDL:123816-E)

00033087 Manning, P.B.; Kerr, T.W.; Olney, C.E.; et al. (1964) ¢Residue Study*. 

(Unpublished study including published data, received Jan 14, 1965 under

100-471; prepared in cooperation with Univ. of Rhode Island, Agricultural

Experiment Station and Gaspro, Ltd., submitted by Ciba-Geigy Corp.,

Greensboro, N.C.; CDL: 000459-F)

00038919 Gutenmann, W.H.; Lisk, D.J. (1966) Metabolism of Daconil and Dacthal

pesticides in lactating cows. Journal of Dairy Science 49 (10):1272-1276. 

(Also~In~unpublished submission received Feb 25, 1976 under 6F1749; submitted

by Diamond Shamrock Agricultural Chemicals, Cleveland, Ohio; CDL:096457-K)

00057629 Reno, F.E.; Stanovick, R. (1974) Final Report: Meat and Milk Residue Study in

Dairy Cows: Project No. 200-223. (Unpublished study received on unknown date

under 3F1417; prepared by Environmental Sciences Corp., submitted by Diamond

Shamrock Agricultural Chemicals, Cleveland, Ohio; CDL:093787-C)

00058377 Diamond Shamrock Agricultural Chemicals (1973) ¢Residue Studies of Dacthal in

Various Crops*. (Compilation; unpublished study received Jun 29, 1973 under

3F1417; CDL:093787-D)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

128

00058378 Szalkowski, M.B. (1973) Evaluation of the Potential for Dacthal and Its

Metabolites To Accumulate in Chicken Eggs and Tissues during 30 Days of

Dietary Exposure. (Unpublished study received Jun 29, 1973 under 3F1417;

submitted by Diamond Shamrock Agricultural Chemicals, Cleveland, Ohio;

CDL:093787-E)

00072099 Diamond Shamrock Corporation (1968) Hexachlorobenzene Residue Data.

(Compilation; unpublished study received Dec 10, 1968 under 9F0780;

CDL:091340-C)

00083584 Hazleton, L.W.; Dieterich, W.H. (1963) Final Report: Two-year Dietary

Feeding--Dogs. (Unpublished study received Dec 15, 1963 under PP0411;

prepared by Hazleton Laboratories, Inc., submitted by Diamond Shamrock

Agricultural Chemicals, Cleveland, Ohio; CDL:090443-T)

00090259 Hazleton Laboratories (1963) ¢Residue Data for Cabbage and Various Other

Crops Treated With Dacthal*. (Compilation; unpublished study received Dec 18,

1963 under PP0411; CDL:090445-A)

00100773 Goldenthal, E.; Wazeter, F.; Jessup, D.; et al. (1977) Ninety Day Toxicity Study in

Rats: ¢DTX 76-0010*: 239-044. (Unpublished study received May 12, 1982

under 677-290; prepared by International Research and Development Corp.,

submitted by Diamond Shamrock Agricultural Chemicals, Cleveland, OH;

CDL:247439-A)

00100775 Kouri, R.; Parmar, A.; Kuzava, J.; et al. (1977) Activity of DTX77-0004 in the

Dominant Lethal Assay in Rodents for Mutagenicity: Project No. T1077. Final

rept. (Unpublished study received May 12, 1982 under 677-290; prepared by

Microbiological Assoc., submitted by Diamond Shamrock Agricultural Chemicals,

Cleveland, OH; CDL:247439-C)

00114631 Diamond Shamrock Agricultural Chemicals (1973) Residue Data: ¢Dacthal*. 

(Compilation; unpublished study received May 10, 1973 under 677-166;

CDL:004224-B)

00114642 Diamond Alkali Co. (1967) Results of Tests on the Amount of Residue

Remaining: ¢Dacthal*. (Compilation; unpublished study received Jan 9, 1968

under 8F0640; CDL:091112-B)

00114643 Diamond Alkali Co. (1964) ¢Study: Dacthal Residue on Selected Crops. 

(Compilation; unpublished study received on unknown date under PP0411;

CDL:092698-A)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

129

00114644 Diamond Alkali Co. (1967) ¢Residues of Dacthal in Cottonseed*. (Compilation;

unpublished study received Dec 28, 1967 under 8F0640; CDL:092934-A)

00114648 Szalkowski, M. (1975) The Effect of Light, Temperature, and pH on the

Hydrolysis of Dacthal. (Unpublished study received Mar 23, 1976 under 3F1417;

submitted by Diamond Shamrock Chemical Co., Cleveland, OH; CDL:095189-D)

00114649 Duane, W. (1976) Aerobic Soil Metabolism of Dacthal. (Unpublished study

received Mar 23, 1976 under 3F1417; submitted by Diamond Shamrock Chemical

Co., Cleveland, OH; CDL:095189-F)

00114651 Duane, W. (1976) Anaerobic Soil Metabolism of Dacthal. (Unpublished study

received Mar 23, 1976 under 3F1417; submitted by Diamond Shamrock Chemical

Co., Cleveland, OH; CDL:095189-H)

00114654 Interregional Research Project No. 4 (1975) Results of Tests on the Amount of

Residues Remaing, Including a Description of the Analytical Methods Used:

¢Dacthal*. (Compilation; unpublished study received Nov 21, 1975 under

6E1711; CDL:095363-A)

00114677 Limpel, L. (1962) Letter sent to Diamond Alkali Co. dated Sep 13, 1962;

Radioautographic studies of HCB and Dacthal applied to cotton plants. 

(Unpublished study received Nov 21, 1962 under unknown admin. no.; prepared

by Boyce Thompson Institute for Plant Research, Inc., submitted by Diamond

Shamrock Agricultural Chemicals, Cleveland, OH; CDL:119453-A)

00114678 Diamond Shamrock Agricultural Chemicals (1962) Summary of Status of Residue

Data: ¢Dacthal*. (Compilation; unpublished study received Nov 21, 1962 under

677-139; CDL:119455-A)

00114679 Stallard, D. (1961) Dacthal Herbicide Residue Studies on Tomatoes. (Unpublished

study received Dec 12, 1961 under unknown admin. no.; submitted by Diamond

Shamrock Agricultural Chemicals, Cleveland, OH; CDL:119456-A)

00114680 Diamond Shamrock Agricultural Chemicals (1961) ¢Study: Dacthal Residue on

Selected Crops*. (Compilation; unpublished study received Oct 31, 1961 under

unknown admin. no.; CDL:119457-A)

00114681 Diamond Shamrock Agricultural Chemicals (1962) ¢Study: Dacthal Residue on

Selected Crops*. (Compilation; unpublished study received Dec 10, 1962 under

unknown admin. no.; CDL:119459-A)
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

130

00121864 Diamond Shamrock Agricultural Chemicals (1981) The Results of Tests on the

Amount of DCPA Residues Remaining in or on Radish, Including a Description of

the Analytical Method Used. (Compilation; unpublished study received Dec 17,

1982 under 677-166; CDL:071286-A)

00123748 Priddle, W.; Stallard, D.; Skinner, W. (1964) Determination of Residues of

Dacthal Herbicide in Vegetables and Agronomic Crops. (Unpublished study

received Apr 10, 1973 under 3E1388; prepared by Diamond Alkali Co., submitted

by Interregional Research Project No. 4, New Brunswick, NJ; CDL:093701-A)

00127905 Thackara, J.; Rinehart, W. (1977) An Acute Inhalation Toxicity Study of

DTX-77-0049 in the Rat: Project No. 77-1933. (Unpublished study received Apr

18, 1983 under 677-457; prepared by Bio/dynamics, Inc., submitted by Diamond

Shamrock Agricultural Chemicals, Cleveland, OH; CDL:250016-A)

00130562 Jespersens Lab (1975) ¢Efficacy of Dacthal on Garlic*. (Compilation; unpublished

study received Feb 5, 1981 under 667-166; CDL:244287-A)

00150207 Auletta, C. (1984) Dermal Sensitization Study (Closed-patch Repeated Insult) in

Guinea Pigs with Technical Dacthal: Report Number 5285-84. Unpublished study

prepared by Bio/dynamics, Inc. 78 p.

00156951 SDS Biotech Corp. (1986) Dacthal 1.92 F: Technical DCPA Impurity: Response

to EPA Letter of January 15, 1986: ?Results and Analyses for 2,3,7,8-TCDD#. 

Unpublished compilation. 213 p.

00158011 Major, D. (1985) A 30-day Oral Intubation Study in Rats with

Tetrachloroterephthalic Acid: SDS 954: Document No. 665-5TX-84-0007001. 

Unpublished study prepared by SDS Biotech Corp. 269 p.

00160685 Ford, W. (1986) A Teratology Study in Rats with Technical DCPA: Document

No. 712-5TX-85-0039-003: Report SDS-893. Unpublished study prepared by

SDS Biotech Corp. in cooperation with Argus Research Laboratories, Inc. 194 p.

00163578 Major, D. (1983) Primary Eye Irritation Study in Albino Rabbits with 90%

Dimethyl-T: Document No. 628-5TX-83-0042-002. Unpublished study prepared

by SDS Biotech Corp. in cooperation with SISA Toxicological Laboratories, Inc. 

54 p.

40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and

Data Base 410 Chemicals and 66 Species of Fresh-Water Animals. US Fish &

Wildlife Service; Resource Publication (160): 579 p. 
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

131

40259001 Schuldt, P.; Burchfield, H.; Stallard, W.; et al. (1961) Colorimetric determination

of micro amounts of dimethyl tetrachloroterephthalate. Contributions from Boyce

Thompson Institute for Plant Research, Inc. 21:163-173.

40259101 Limpel, E. (1961) Memorandum sent to Diamond Alkali Co. dated Dec 4, 1961:

Studies with Dacthal Herbicide, Tagged with ?Carbon 14# and ?Carbon 136#,

Applied to Field Grown Crops. Prepared by Boyce Thompson Institute for Plant

Research, Inc. 13 p.

40958701 Lucas, F.; Killeen, J. (1988) A Combined Chronic Toxicity and Tumorigenicity

Study in Mice with Technical DCPA: Document No. 1098-85-0057-TX-002. 

Unpublished study prepared by Huntingdon Research Centre, Ltd. in cooperation

with Ricerca, Inc. 2276 p.

40958801 Burton, R. (1988) 75% Dimethy-T: Product Identity and Disclosure of

Ingredients. Unpublished study prepared by Fermenta Plant Protection Co. 7 p.

40958802 Burton, R. (1988) 90% Dimethyl-T: Product Identity and Disclosure of

Ingredients. Unpublished study prepared by Fermenta Plant Protection Co. 7 p.

40958803 Burton, R. (1988) Dacthal 1.92F: Product Identity and Disclosure of Ingredients. 

Unpublished study prepared by Fermenta Plant Protection Co. 8 p.

40958804 Resetar, J. (1985) DCPA Technical: Description of Beginning Materials and

Manufacturing Process. Unpublished study prepared by Fermenta Plant Protection

Co. 74 p.

40958808 Magee, T. (1989) Formation of Impurities in DCPA Technical. Unpublished study

prepared by Ricerca, Inc. 12 p.

40958812 Sweetapple, G. (1988) DCPA Technical--Determination of Physical State: Lab ID:

Document No. 1081-88-0113-AS-001. Unpublished study prepared by Ricerca,

Inc. 30 p.

40958814 Sweetapple, G. (1988) DCPA Technical--Determination of Odor: Lab ID:

Document No. 1081-88-0114-AS-001. Unpublished study prepared by Ricerca,

Inc. 31 p.

40958816 Sweetapple, G. (1988) DCPA Technical--Determination of Bulk Density:

Document No.: 1081-88-0227-AS-001. Unpublished study prepared by Ricerca,

Inc. 35 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

132

40958817 Sweetapple, G. (1988) DCPA Manufacturing-use Products--Determination of

Density: Document No.: 1081-88-0236-AS-001. Unpublished study prepared by

Ricerca, Inc. 38 p.

40958818 Formanik, J.; Walls, G. (1988) Solubility of DCPA (SDS-893) in Water:

Document No.: 1609-87-0046-AS-002. Unpublished study prepared by Ricerca,

Inc. 23 p.

40958819 DePablo, R.; Harrington , D. (1984) Vapor Pressure of Dimethyl

Tetrachloroterephthalate. Unpublished study. 6 p.

40958820 Banzer, J.; Korsch, B.; Cryberg, R. (1987) Octanol/Water Partition Coefficient

Studies: DCPA. Unpublished study. 17 p.

40958821 Thomas, E. (1988) DCPA Technical--Determination of pH: Document No.

1081-88-0121-AS-001. Unpublished study prepared by Ricerca, Inc. 35 p.

40958822 Sweetapple, G. (1988) DCPA Manufacturing-use Products--Determination of

Impact Explodability: Document No.: 1081-88-0131-AS-001. Unpublished study

prepared by Ricerca, Inc. 32 p.

41054801 Burton, R. (1989) Submission of Additional Information Description of Beginning

Materials and Manufacturing Process: DCPA Technical: Doc. No.

PC-89-RPB-001-01. Unpublished study prepared by Fermenta Plant Protection

Co. 11 p.

41054802 Sweetapple, G. (1989) DCPA Technical Determination of Color: Doc. No.

1081-88-0112-AS-001. Unpublished study prepared by Ricerca, Inc. 26 p.

41054804 Sweetapple, G. (1988) DCPA Technical Determination of Melting Point: Doc. No.

1081-88-0115-AS-001. Unpublished study prepared by Ricerca Inc. 24 p.

41054805 Lorence, P.; Walls, G. (1989) DCPA Determination of Vapor Pressure: Doc. No.

1081-88-0105-AS-001. Unpublished study prepared by Ricerca, Inc. 68 p.

41054808 Shults, S.; Roblin, M.; Killeen, J. (1989) Acute Oral Toxicity Study in Rats with

Technical DCPA: Doc. No. 3224-89-0001-TX-001. Unpublished study prepared

by Ricerca, Inc. 19 p.

41054809 Shults, S.; Major, D. (1982) Acute Oral Toxicity Study in Albino Rats with

Dacthal W-75: Doc. No. 567-5TX-82-0012-002. Unpublished study prepared by

Diamond Shamrock Corp. 41 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

133

41054811 Shults, S.; White, T.; Killeen, J. (1989) Acute Dermal Toxicity Study in Albino

Rabbits with Technical DCPA: Doc. No. 3224-890002-TX-001. Unpublished

study prepared by Ricerca, Inc. 25 p.

41054812 Shults, S.; Major, D. (1987) Acute Dermal Toxicity Study in Albino Rabbits with

Dacthal W-75: Doc. No. 567-5TX-82-0013-002. Unpublished study prepared by

Diamond Shamrock Corp. 51 p.

41054813 Shults, S.; Wilson, N.; Killeen, J. (1987) Acute Dermal Toxicity (LD50) Study in

Albino Rabbits with Dacthal Flowable Herbicide: Doc. No.

1475-87-0008-TX-001. Unpublished study prepared by Ricerca, Inc. 23 p.

41054814 Shults, S.; Wilson, N.; Killeen, J. (1988) Acute Inhalation Toxicity of Dacthal

Flowable Herbicide: Doc. No. 1475-87-0015-TX002. Unpublished study prepared

by Huntingdon Research Centre Ltd. 19 p.

41054815 Shults, S.; Roblin, M.; Killeen, J. (1989) Primary Eye Irritation Study in Albino

Rabbits with Technical DCPA: Doc. No. 3224-890004-TX-001. Unpublished

study prepared by Ricerca, Inc. 27 p.

41054816 Shults, S.; Wilson, N.; Killeen, J. (1987) Primary Eye Irritation Study in Albino

Rabbits with Dacthal Flowable Herbicide: Doc. No. 1475-87-0010-TX-001. 

Unpublished study prepared by Ricerca, Inc. 31 p.

41054817 Shults, S.; White, T.; Killeen, J. (1989) Primary Dermal Irritation Study in Albino

Rabbits with Technical DCPA: Doc. No. 3224-890003-TX-001. Unpublished

study prepared by Ricerca, Inc. 18 p.

41054818 Shults, S.; Wilson, N.; Killeen, J. (1987) Primary Dermal Irritation Study in Albino

Rabbits with Dacthal Flowable Herbicide: Doc. No. 1475-87-0009-TX-001. 

Unpublished study prepared by Ricerca, Inc. 17 p.

41054820 Chun, J.; Lucas, F.; Killeen, J. (1989) A Teratology Study with Technical DCPA

in Rabbits: Proj. ID 87-3204. Unpublished Ricerca Document

1116-87-0067-TX-002 prepared by Bio/dynamics Inc. 775 p.

41054821 Mizens, M.; Killeen, J. (1988) Salmonella/Mammalian-Microsome Plate

Incorporation Mutagenicity Assay (Ames Test) with and without Metabolic

Activation with Technical Dimethyl Tetrachloroterephthalate (DCPA): Proj. ID

T5554.501014. Unpublished Ricerca Document 1488-87-0029-TX-002 prepared

by Microbiological Associates Inc. 178 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

134

41054822 Mizens, M.; Killeen, J. (1988) L5178Y TK+/Mouse Lymphoma Forward Mutation

Assay with Technical Dimethyl Tetrachloterephthalate (DCPA): Proj. ID

T5554.701020. Unpublished Ricerca Document 1488-87-0030-TX-002 prepared

by Microbiological Associates, Inc. 170 p.

41054823 Mizens, M.; Killeen, J. (1988) In vitro Chromosomal Aberration Assay in Chienese

Hamster Ovary (CHO) Cells with Technical Dimethyl Tetrachloroterephthalate

(DCPA): Proj. ID T5554.337002. Unpublished Ricerca Document

1488-87-0031-TX-002 prepared by Microbiological Associates, Inc. 130 p.

41054824 Mizens, M.; Killeen, J. (1988) Unscheduled DNA Synthesis Assay in Rat Primary

Hepatocytes with Technical Dimethyl Tetrachloroterephthalate (DCPA): Proj. ID

T5554.380009. Unpublished Ricerca Document 1488-87-0032-TX-002 prepared

by Microbiological Associates, Inc. 137 p.

41054825 Mizens, M.; Killeen, J. (1988) In vitro Sister Chromatid Exchange (SCE) Assay in

Chinese Hamster Ovary (CHO) Cells with Technical Dimethyl

Tetrachloroterephthalate (DCPA): Proj. ID T5554.334001. Unpublished Ricerca

Document 1488-87-0033-TX-002 prepared by Microbiological Associates, Inc. 

135 p.

41054826 Shults, S.; Wilson, N. (1989) Static, Acute Toxicity (LC50) Study in Rainbow

Trout with Technical DCPA (Dimethyl 2,3,5,6-Tetrachloroterephthalate): Doc.

No. 690-5TX-84-0046-002. Unpublished study prepared by SDS Biotech Corp. 

64 p.

41054827 Shults, S.; Wilson, N. (1985) Static, Acute Toxicity (LC50) Study in Bluegill with

Technical DCPA (Dimethyl 2,3,5,6-Tetrachloroterephthalate): Doc. No.

690-5TX-84-0047-002. Unpublished study prepared by SDS Biotech Corp. 64 p.

41054829 Shults, S.; Wilson, N. (1985) Algal Growth Inhibition Study in Scenedesmus

subspicatus with Technical DCPA (Dimethyl 2,3,5,6-Tetrachloroterephthalate):

Doc. No. 688-5TX-84-0049-002. Unpublished study prepared by SDS Biotech

Corp. 54 p.

41064801 Ford, W. (1986) A 90-Day Dietary Study in Mice with Technical DCPA:

Document No. 696-5TX-84-0082-002. Unpublished study prepared by SDC

Biotech Corp. 705 p.

41064802 Mizens, M. (1985) A Teratology Dose Range-Finding Study in Rats with

Tetrachloroterephalic Acid (SDS-954): Document No. 687-5TX-84-0034-002. 

Unpublished study prepared by SDS Biotech Corp. 120 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

135

41155701 Rose, K. (1989) DCPA--Determination of Solubility: Document No.

1081-88-0117-AS-001. Unpublished study prepared by Fermenta ASC Corp. 57

p.

41155702 Lorence, P.; Walls, G. (1989) DCPA--Determination of Octanol/Water Partition

Coefficient: Project ID 1081-89-0012-AS. Unpublished study prepared by

Ricerca, Inc. 40 p.

41155703 Sanders, J. (1989) DCPA--Determination of Stability: Project ID

1081-88-0122-AS-001. Unpublished study prepared by Ricerca, Inc. 48 p.

41155705 Shults, S.; Roblin, M.; Killeen, J. (1989) Acute Oral Toxicity (LD 50) Study in

Bobwhite Quail with Technical DCPA: Project ID 230112. Unpublished study

prepared by Wildlife International Ltd. 61 p.

41155706 Shults, S.; Roblin, M.; Killeen, J. (1989) Dietary (LC50) Study in Bobwhite Quail

with Technical DCPA: Project ID 230-110 and 890018. Unpublished study

prepared by Wildlife International Ltd. in association with Ricerca, Inc. 113 p.

41155707 Shults, S.; Roblin, M.; Killeen, J. (1989) Dietary (LC50) Study in Mallard Ducks

with Technical DCPA: Project IDs 230-111 and 890017. Unpublished study

prepared by Wildlife International, Ltd. in association with Ricerca, Inc. 114 p.

41155709 Major, D.; Laveglia, J.; Killeen, J. (1983) Acute Dermal Toxicity (LD50) Study in

Albino Rabbits with 90 percent Dimethyl-T: Document No.

628-5TX-83-0040-002. Unpublished study prepared by SISA Toxicological

Laboratories, Inc. 72 p.

41155710 Banzer, C. (1977) An Acute Inhalation Toxicity Study of DTX-77-0049 in the

Rat: Document No. 000-5TX-77-0049-001. Unpublished study prepared by

Bio/Dynamics, Inc. 18 p.

41155711 Major, D.; Laveglia, J.; Killeen, J. (1983) Primary Eye Irritation Study in Albino

Rabbits with 90 percent Dimethyl-T: Document No. 628-5TX-83-0042-002. 

Unpublished study prepared by SISA Toxicological Laboratories, Inc. 76 p.

41155712 Major, D.; Laveglia, J.; Killeen, J. (1983) Primary Dermal Toxicity Study in Ablino

Rabbits with 90 percent Dimethyl-T: Document No. 628-5TX-83-0041-002. 

Unpublished study prepared by SISA Toxicological Laboratories, Inc. 62 p.

41155714 Hughes, J. (1989) The Toxicity of DCPA (Dacthal/Dimethyl

Tetrachloroterephthalate) to Selenastrum capricornutum: Project ID

140101-1100-1. Unpublished study prepared by Malcolm Pirnie, Inc. 26 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

136

41155715 Szalkowski, M.; Marciniszyn, J.; Killeen, J. (1981) Accumulation, Distribution and

Depuration of ¢Carbon 14*-Residues of... (Dacthal, DS-893) in Channel Catfish

(Ictalurus punctatus) Under Static Aquatic Conditions: Document No.

139-4EI-81-0015-002. Unpublished study prepared by Analytical Bio Chemistry

Laboratories, Inc. 76 p.

41155716 Szalkowski, M.; Stallard, D.; Killeen, J. (1980) Accumulation, Distribution and

Depuration of ¢Carbon 14*-Dacthal (DS-893) in Bluegill Sunfish (Lepomis

macrochirus) under Flow Through Aquatic Conditions: Document No.

141-3EI-79-0138-001. Unpublished study prepared by Analytical Bio Chemistry

Laboratories, Inc. 40 p.

41197602 Szalkowski, M.; Marciniszyn, J.;Killeen, J. (1981) Characterization and

Quantitation of (Carbon-14)-Residues in Water and Fish Exposed to

(Carbon-14)-dimethyl 2,3,5,6-Tetrachloroterephthalate (Dacthal, DS-893) in a

Flow Through Aquatic System: Document No. 142-4EI-81-0017-002. 

Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 80 p.

41231803 Lucas, F.; Chun, J.; Killeen, J. (1989) A 21-Day Repeated Dose Dermal Toxicity

Study in Rats with Technical DCPA: Project ID 880231. Unpublished study

prepared by Ricerca, Inc. in association with Experimental Pathology Laboratories,

Inc. and WIL Research Laboratories, Inc. 289 p.

41231804 Lucas, F.; Roblin, M.; Killeen, J. (1989) A Pilot 21-Day Repeated Dose Dermal

Toxicity Study in Rats with Technical DCPA: Project ID 88-0229. Unpublished

study prepared by Ricerca, Inc. 53 p.

41231805 Lucas, F.; Roblin, M.; Killeen, J. (1989) A Dose Range-finding Study for a 21-Day

Repeated Dose Dermal Toxicity Study in Rats with Technical DCPA: Project ID

88-0230. Unpublished study prepared by Ricerca, Inc. 57 p.

41241801 Burton, R.; Mizner, D.; Pudwill, C.; et al. (1989) Isomer Specific Analyses for

Polychlorinated Dioxins/Furans in Dimethyl Tetrachloroterephthalate

?DCPA--DACTHAL#: Document No. PC-89-RPB-003001. Unpublished study

prepared by Fermenta ASC Corp. in cooperation with California Analytical

Laboratory. 671 p.

41349101 Serrone, D.; Lucas, F.; Killeen, J. (1990) A Chronic Opthalmology Study in Rats

with Technical DCPA: One Year Interim Report: Lab Project Number: 88/0042. 

Unpublished study prepared by Ricerca, Inc. 62 p.

40958801 Burton, R. (1988) 75% Dimethy-T: Product Identity and Disclosure of

Ingredients. Unpublished study prepared by Fermenta Plant Protection Co. 7 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

137

40958802 Burton, R. (1988) 90% Dimethyl-T: Product Identity and Disclosure of

Ingredients. Unpublished study prepared by Fermenta Plant Protection Co. 7 p.

40958803 Burton, R. (1988) Dacthal 1.92F: Product Identity and Disclosure of Ingredients. 

Unpublished study prepared by Fermenta Plant Protection Co. 8 p.

41416801 Burton, R.; Mizner, D.; Luksemburg, W. (1990) Additional Information for the

Study: "Isomer Specific Analysis for Polychlorinated Dioxins/Furans in Dimethyl

Tetrachloroterephthalate (DCPAdacthal)": Document No.: PC-90-RPB-011-001. 

Unpublished study prepared by Enseco, Inc. in cooperation with Fermenta ASC

Corp. 87 p.

41440101 Backus, P.; Crosby, K.; Schollenberger, (1990) Effect of DCPA on Vegetative

Vigor of Plants (Tier 2): Lab Project No: 89-0128. Unpublished study prepared by

Ricerca, Inc. 29 p.

41508607 Korsch, B. (1990) A Photolysis Study of ¢Carbon 14*-Dimethyl

Tetrachloroterephthalate in Water: Lab Project Number: 89-0366:

349689-0366-EF-001: SDS-893. Unpublished study prepared by Ricerca, Inc. 

119 p.

41508608 Korsch, B. (1990) A Photolysis Study of ¢Carbon 14*-Dimethyl

Tetrachloroterephthalate on Soil: Lab Project Number: 89-0365:

349589-0365-EF-001: SDS-893. Unpublished study prepared by Ricerca, Inc. 

115 p.

41550701 Baron, J. (1988) DCPA: Magnitude of Residue on Parsley: Lab Project Number:

IR-4 4005. Unpublished study prepared by Ricerca Inc. 123 p.

41564900 Fermenta ASC Corp. (1990) Submission of Phytotoxicity Data in Support of

DCPA Registration Standard. Transmittal of 1 study.

41564901 Backus, P.; Crosby, K. (1990) Effect of DCPA on Seed Germination/ Seedling

Emergence (Tier 2): Lab Project Number: 89-0129: 332289-0129-BE-001. 

Unpublished study prepared by Ricerca, Inc. 193.

41648801 Doran, T. (1990) Response to EPA Review: Aerobic Soil Metabolism of Dacthal:

Lab Project Number: 000/3EF/76/2083/001. Unpublished Study prepared by

Ricerca, Inc. 76 p.

41648802 Doran, T. (1990) Response to EPA Review: Anaerobic Soil Metabolism of

Dacthal: Lab Project Number: 000/3EF/76/2082/001. Unpublished study prepared

by Ricerca, Inc. 40 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

138

41648803 Korsch, B. (1988) Adsorption and Desorption of Dimethyl

Tetrachloroterephthalate to Soils: Lab Project Number: 1701/87/0099/

EF/001/001. Unpublished study prepared by Ricerca, Inc. 64 p.

41648804 Korsch, B.; Kapostasy, W. (1990) Adsorption and Desorption of Monomethyl

Tetrachloroterephthalate to Soils: Lab Project Number: 1736/88/0005/EF/001. 

Unpublished study prepared by Ricerca, Inc. 8 p.

41648805 Korsch, B.; Kapostasy, W. (1989) Adsorption and Desorption of

Tetrachloroterephthalic Acid to Soils: Lab Project Number: 1735/

88/0004/EF/001. Unpublished study prepared by Ricerca, Inc. 64 p.

41648806 Eilrich, G.; Hurto, K. (1990) Dissipation Study of Foliar Dislodgeable Residues of

DCPA and HCB Following Application of Dacthal W-75 Turf to Turfgrass: Lab

Project Number: EF/90/RPB/019/001. Unpublished study prepared by A&L Great

Lakes Laboratories, Inc. 2145 p.

41750101 Shults, S.; Killeen, J. (1990) Acute (Four-Hour) Inhalation Toxicity (LC50) Study

In Rats with Technical DCPA: Lab Project Number: 89-0267:

3418-89-0267-TX-003. Unpublished study prepared by Huntingdon Research

Center Ltd. 69 p.

41750102 Benz, G.; Lucas, F.; Killeen, J.; et al. (1990) A Chronic Opthalmology Study In

Rats With Technical DCPA: Lab Project Number: 88-0042:

3018-88-0042-TX-003. Unpublished study prepared by Ricerca, Inc. 767 p.

41750103 Benz, G.; Lucas, F.; Lovell, R. (1990) A Two Generation Reproduction Study in

Rats with Technical DCPA: Lab Project Number: 173088-0176-TX-003: 88-0176. 

Unpublished study prepared by Ricerca, Inc. 2408 p.

41750107 Formanik, J. (1990) Determination of Residues of DCPA (Dimethyl

Tetrachloroterephthalate, SDS-36991), Its Degredation Products And HCB On

Tobacco: Lab Project Number: 3423-89-0262: 3-89-0262 CR-001-001. 

Unpublished study prepared by Ricerca, Inc. 50 p.

41767901 Lucas, F.; Benz, G. (1991) A 90-Day Feeding Study in Rats with Technical

DCPA: Lab Project Number: 89-0208. Unpublished study prepared by Ricerca,

Inc. and Experimental Path. Labs., Inc. 689 p.

41790901 Lucas, F.; Killeen, J. (1990) A 28-Day Feeding Study in Rats with Technical

DCPA: Lab Project Number: 89-0034. Unpublished study prepared by Ricerca,

Inc. 222 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

139

41838301 Lucas, F. (1991) Identification of Material Tested in the Study, "A Teratology

Study with Technical DCPA in Rabbits" (...). Unpublished study prepared by

Ricerca, Inc. 13 p.

41905201 Lucas, F. (1991) Report Addendum Number One: A Two Generation

Reproduction Study in Rats with Technical DCPA: Lab Project Number:

1730-88-0176-TX-003-002. Unpublished study prepared by Ricerca, Inc. 17 p.

42038301 ISK Biotech Corp. (1991) Information to Upgrade Mutagenicity Studies with

DCPA (.. ): Lab Project Number: TX-91-RPB-042-001. Unpublished study. 14 p.

42052601 Yeh, L. (1991) DCPA: Test Substance Characterization: Lab Project Number:

1081-91-0073-AS. Unpublished study prepared by Ricerca, Inc. 60 p.

42052602 Douglass, M. (1991) Dimethyl Tetrachloroterephthalate (...) Reference Substance

Characterization: Lab Project Number: 1081-900394-AS: 168-A. Unpublished

study prepared by Ricerca, Inc. 55 p.

42052603 Douglass, M. (1991) Methyl Pentachlorobenzoate (...) Reference Substance

Characterization: Lab Project Number: 1081-90-0387-AS: 168A. Unpublished

study prepared by Ricerca, Inc. 55 p.

42052604 Douglass, M. (1991) Dimethyl 2,3,5-Trichloroterephthalate (...) Reference

Substance Characterization: Lab Project Number: 108190-0386-AS-001: 168A. 

Unpublished study prepared by Ricerca, Inc. 55 p.

42052605 Yeh, L. (1991) 4-Carbomethoxy-2,3,5,6-Tetrachlorobenzoic Acid (...) Reference

Substance Characterization: Lab Project Number: 108191-0158-AS-001: 168A. 

Unpublished study prepared by Ricerca, Inc. 51 p.

42052607 Douglass, M. (1991) Dimethyl 3,5,6-Trichloro-2-Methoxyterephthalate (...)

Reference Substance Characterization: Lab Project Number:

1081-90-0390-AS-001: 168A. Unpublished study prepared by Ricerca, Inc. 55 p.

42052608 Douglass, M. (1991) Hexachlorobenzene (...) Reference Substance

Characterization: Lab Project Number: 1081-90-0391-AS-001: 168A.

Unpublished study prepared by Ricerca, Inc. 50 p.

42155501 Medvedeff, E.; Liu, Y.; Marciniszyn, J.; et al. (1991) Study to Identify the

Metabolites of ¢Carbon 14*-DCPA in Rats: Lab Project Number:

3411-90-0321-AM-001. Unpublished study prepared by Ricerca, Inc. 98 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

140

42155502 Magee, T.; Marciniszyn, J.; Killeen, J. (1991) Study to Determine the Major

Routes of Elimination Following a Single Oral Dose of ¢Carbon 14*-DCPA: Lab

Project Number: 3782-90-0355-AM-001. Unpublished study prepared by Ricerca,

Inc. 136 p.

42155503 Ho, M.; Marciniszyn, J.; Killeen, J. (1991) Study of the Biliary Excretion of

Radiolabel Following Oral Administration of ¢Carbon 14*-DCPA to Male

Sprague-Dawley Rats: Lab Project Number: 3417-91-0088-AM-001. 

Unpublished study prepared by Ricerca, Inc. 109 p.

42155505 King, C.; Prince, P.; Ballee, D. (1991) Determination of Residues of DCPA, Its

Degradation Products and HCB on Broccoli: Lab Project Number:

3806-90-0125-CR-001. Unpublished study prepared by Ricerca, Inc. 123 p.

42155506 King, C.; Prince, P.; Ballee, D. (1991) Determination of Residues of DCPA, Its

Degradation Products and HCB on Celery: Lab Project Number:

3808-90-0127-CR-001. Unpublished study prepared by Ricerca, Inc. 160 p.

42155507 Ballee, D.; Cassidy, P.; Dillon, K. (1991) Determination of Residues of DCPA, Its

Degradation Products and HCB on Cucumbers : Lab Project Number:

3809-90-0128-CR-001. Unpublished study prepared by Ricerca, Inc. 213 p.

42155508 King, C.; Prince, P.; Ballee, D. (1991) Determination of Residues of DCPA, Its

Degradation Products and HCB on Green Onions: Lab Project Number:

3810-90-0129-CR-001. Unpublished study prepared by Ricerca, Inc. 231 p.

42155509 Formanik, J. (1991) Determination of Residues of DCPA, Its Degradation

Products and HCB on Strawberries--1990: Lab Project Number:

3811-90-0130-CR-001. Unpublished study prepared by Ricerca, Inc. 140 p.

42155510 King, C.; Prince, P.; Ballee, D. (1991) Determination of Residues of DCPA, Its

Degradation Products and HCB on Sweet Peppers--1990: Lab Project Number:

3812-90-0131-CR-001. Unpublished study prepared by Ricerca, Inc. 477 p.

42218901 Rose, C. (1992) Residues of DCPA, It's Manufacturing Impurity HCB and It's

Degradation Products in Crops from a Stability Study: One Year Interim Report:

Lab Project Number: 3692-90-0314. Unpublished study prepared by Ricerca, Inc.

392 p.

42218902 Balle, D. ; Cassidy, P. ; Dillon, K. (1991) Residues of DCPA, It's Degradation

Products and HCB on Succulant Beans and Cannery Waste--1990 Processing

Study: Lab Project Number: 3817-90-0136-CR-001: 90-0136. Unpublished study

prepared by Ricerca, Inc. 112 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

141

42218903 Formanik, J. (1991) Determination of Residues of DCPA, It's Degradation

Products and HCB on Cantaloupee--1990: Lab Project Number: 3807-90-0126. 

Unpublished study prepared by Ricerca, Inc. 374 p.

42218904 Formanik, J. (1991) Determination of Residues of DCPA, It's Degradation

Products and HCB on Tomatoes--1990: Lab Project Number: 3814-90-0133. 

Unpublished study prepared by Ricerca, Inc. 234 p.

42218905 Formanik, J. (1991) Determination of Residues of DCPA, It's Degradation

Products and HCB on Tomatoes--1990 Processing Study: Lab Project Number:

3818-90-0137. Unpublished study prepared by Ricerca, Inc. 193 p.

42218906 Rose, C. ; Zgodinski, J. (1992) Determination of Residues of DCPA, It's

Degradation Products and HCB on Cottonseed--1990 Processing Study: Lab

Project Number: 3816-90-0135. Unpublished study prepared by Ricerca, Inc. 207

p.

42245701 Formanik, J. (1991) Determination of the Residues of DCPA (Dimethyl

Tetrachloroterephthalate, SDS-893), It's Degradation Products and HCB on

Summer Squash--1990: Lab Project Number: 3813-90-0132. Unpublished study

prepared by Ricerca, Inc. 495 p.

42262601 Liu, Y.; Magee, T.; Marciniszyn, J.; et al. (1992) Study to Evaluate the

Distribution, Excretion and Pharmacokinetics of ¢Carbon 14*-DCPA in Rats: Lab

Project Number: 90-0487: 3787-900487-AM-001. Unpublished study prepared by

Ricerca, Inc. 502 p.

42271801 Cassidy, P.; Dillon, K.; Ballee, D. (1991) Residues of DCPA (Dimethyl

Tetrachloroterephthlate, SDS-893), It's Degradation Products and HCB on

Potatoes--1990 Processing Study: Lab Project Number: 3815-90-0134. 

Unpublished study prepared by Ricerca, Inc. 240 p.

42298301 Korsch, B.; Doran, T. (1992) A Plant Metabolism Study with ¢carbon

14*-Dimethyl Tetrachloroterephthalate (carbon 14-DCPA) on Onion: Lab Project

Number: 3286-89-0336-EF-001. Unpublished study prepared by Ricerca, Inc. 

389 p.

42298302 Korsch, B.; Doran, T. (1992) A Plant Metabolism Study with ¢carbon

14*-Hexachlorobenzene (carbon 14-HCB/DCPA) on Onion: Lab Project Number:

3348-89-0339-EF-001. Unpublished study prepared by Ricerca, Inc. 302 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

142

42444001 Ver Hey, M. (1992) Food and Drug Administration Pesticide Analytical Manual,

Volume 1 Testing of 2,3,5,6-Tetrachloroterephtalic Acid (TPA): Final Report: Lab

Project Number: ISK-1178. Unpublished study prepared by Colorado Analytical

Research and Development Corp. 164 p.

42651501 Ho, M.; Johnson, D.; Leveglia, J. (1993) Dermal Absorption of (carbon 14)-

Hexachlorobenzene in Male Sprague-Dawley Rats: Effects of Varying

Concentrations in Dacthal W-75: Lab Project Number: 3699-90-0318-AM-001:

90-0318. Unpublished study prepared by Ricerca, Inc. 235 p.

42651502 Liu, Y.; Savides, M.; Johnson, D.; et al. (1993) Dermal Absorption of (carbon

14)-DCPA in Male Sprague-Dawley Rats: Effects of Varying Concentrations: Lab

Project Number: 3416-91-0322-AM-001: 91-0322. Unpublished study prepared

by Ricerca, Inc. 418 p.

42723201 Liu, Y.; Marciniszyn, J.; Killeen, J.; et al. (1992) Study of the Distribution,

Excretion and Pharmacokinetics of Radiolabel following Repeated Oral

Administration of DCPA to Sprague-Dawley Rats: Lab Project Number:

3415-90-0331-AM-001. Unpublished study prepared by Ricerca, Inc. 507 p.

42723202 Liu, Y.; Marciniszyn, J.; Killeen, J.; et al. (1993) Study of the Distribution,

Excretion and Pharmacokinetics of Radiolabel following Repeated Oral

Administration of DCPA to Sprague-Dawley Rats: Report Amendment No. 1: Lab

Project Number: 3415900331AM001001. Unpublished study prepared by

Ricerca, Inc. 26 p.

42723203 Liu, Y.; Savides, M.; Johnson, D.; et al. (1993) Study to Identify the Metabolites

of (carbon 14)-DCPA in Rat Urine: Lab Project Number: 3886-91-0100-AM-001. 

Unpublished study prepared by Ricerca, Inc. 188 p.

42731001 Lucas, F.; Mizens, M.; Laveglia, J. (1993) A Combined Chronic

Toxicity/Oncogenicity Study in Rats with DCPA: Lab Project Number:

3339-90-0005-TX-006. Unpublished study prepared by Ricerca, Inc. 6562 p.

42836102 Hughes, J.; Balcom, P. (1993) The Toxicity of DCPA Technical to Anabaena

flos-aquae: Lab Project Number: B038-033-1. Unpublished study prepared by

Malcolm Pirnie, Inc. 24 p.

42882401 Hughes, J.; Balcom, P.; Alexander, M. (1993) The Toxicity of DCPA Technical to

Navicula pelliculosa: Lab Project Number: B038-033-2. Unpublished study

prepared by Malcolm Pirnie, Inc. 25 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

143

43052201 Andre, J. (1993) Supplemental Data to Study of the Distribution, Excretion, and

Pharmacokinetics of Radiolabel following Repeated Oral Administration of DCPA

to Sprague-Dawley Rats: Lab Project Number: TX-93-JCA-001-001:

3415-90-0331-AM-001-001. Unpublished study prepared by Ricerca, Inc. 11 p.

43192401 Mayo, H.; Owens, E. (1994) Dacthal Data Call-in Samples: Supplement to MRID

#40402101: Lab Project Number: PC/94/HM/001/ 001. Unpublished study

prepared by ISK Biosciences Corp. 13 p.

43406401 Formanik, J. (1994) Method for the Determination of Residues of DCPA and Its

Degradation Products in Milk and Beef Fat: Lab Project Number:

6065/94/0163/MD/001: 94/0163. Unpublished study prepared by Ricerca, Inc. 52

p.
144
145

APPENDIX D. Combined Generic and Product Specific Data Call-In

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 6; 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 5).

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 
146

information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107

and 2070-0057 (expiration date 3-31-99).

This Notice is divided into six sections and six 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

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 (Form A)

3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status and

Registrant's Response Forms with Instructions (Form B)

4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data

Requirements for Reregistration

5 - List of Registrants Receiving This Notice

6 - Cost Share and Data Citation 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 ingredient(s).

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.
147

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:

703-605-6000).

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 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).
148

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 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.
149

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 Registrant'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 Registrant'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.

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
150

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
151

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 Registrant's Response

Form (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 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. of this Notice and comprise options 1

through 6 of item 9 in the instructions for the product specific Requirements Status and

Registrant’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. 
152

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:

(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

guidelines 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
153

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 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
154

request EPA (by selecting this option) to exercise its discretion not to suspend your

registration(s), although you did 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 6. 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.

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:
155

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 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

submission of 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

documents 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.

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.
156

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 a 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.
157

If you are citing a study of which you are not the original data submitter, you must 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 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 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.
158

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

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:
159

(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.

(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
160

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.

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.
161

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.

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:

a. 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 Registrant’s

Response Form.

b. Fulfill the commitment to develop and submit the data as required by this

Notice; or
162

c. 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 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,
163

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.

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
164

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 A. Rossi, 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 - List of Registrants Receiving This Notice

6 - Confidential Statement of Formula, Cost Share and Data Citation Forms
165

Attachment 1. Chemical Status Sheets

DCPA DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

You have been sent this Product Specific Data Call-In Notice because you have product(s)

containing DCPA.

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 DCPA.

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) a list of registrants receiving this DCI (Attachment

5) and (6) the Cost Share and Data Citation Forms in replying to this DCPA Product Specific Data

Call-In (Attachment 6). Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

The additional data requirements needed to complete the database for DCPA are contained

in the Requirements Status and Registrant's Response, Attachment 3. The Agency has concluded that

additional data on DCPA 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 DCPA products.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding this product specific data requirements and procedures

established by this Notice, please contact Venus Eagle at (703) 308-8045.

All responses to this Notice for the Product Specific data requirements should be submitted

to:

Venus Eagle

Chemical Review Manager Team 81

Product Reregistration Branch

Special Review and Reregistration Branch (7508C)

Office of Pesticide Programs

U.S. Environmental Protection Agency

Washington, D.C. 20460

RE: DCPA
166

DCPA DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

You have been sent this Generic Data Call-In Notice because you have product(s) containing

DCPA.

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 DCPA. 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 3), (4) a list of registrants receiving this DCI (Attachment 5), and (5) the Cost Share

and Data Citation Forms in replying to this DCPA Generic Data Call In (Attachment 6). Instructions

and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

The additional data requirements needed to complete the generic database for DCPA are

contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has

concluded that additional product chemistry data on DCPA are needed. These data are needed to

fully complete the reregistration of all eligible DCPA 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 Jill Bloom at (703) 308-8019.

All responsades to this Notice for the generic data requirements should be submitted to:

Jill Bloom, Chemical Review Manager 

Reregistration Branch, II

Special Review and Registration Division (7508C)

Office of Pesticiafde Programs

U.S. Environmental Protection Agency

Washington, D.C. 20460

RE: DCPA
167

Attachment 2. Combined Generic and Product Specific Data Call-In Response Forms (Form A inserts) Plus Instructions

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 2137, 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.
168

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 Call-In 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 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.
169

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic and Product Specific Data Call-In

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.

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.
170

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 canceled this product. For these cases, please supply all

relevant details so that EPA can ensure that its records are correct.

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.
171

Attachment 3. Generic and Product Specific Requirement Status and Registrant's Response Forms (Form B inserts) and Instructions

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 2137, 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.
172

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.
173

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

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
174

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 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.
175

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.

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,
176

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. 

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
177

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 this product. For these

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.
178

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

EPA'S BATCHING OF DACTHAL; DCPA; DIMETHYL TETRACHLOROTEREPHTHALATE; PRODUCTS FOR 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 DCPA as the active

ingredient, the Agency has batched products which can be considered similar 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. 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 registrant's 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 generate the

data for a batch, he/she must use one of the products within the batch as the test material. 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 referenced,

registrants must clearly identify the test material by 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,
179

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.

Sixty-two registered products were found which contain DCPA as the active ingredient. 

There are only two wettable powder products. One, EPA Reg. # 228-222, will not be

batched because it contains 25% AI. The other, EPA Reg. # 4-296, will not be batched because it

is a wettable powder product containing 75% AI.

One product, EPA Reg. # 50534-10, will not be batched because of insufficient CSF. 

The remaining products have been placed into three Tables.

Table I consisting of three batches in accordance with the active and inert ingredients, type of

formulation, and current labeling. Table II consists of unbatched fertilizer products. Table III

consists of miscellaneous unbatched products.

TABLE I

Batch 1 identifies concentrated and/or technical products.

Batch 2 identifies those products with low levels of DCPA.

Batch 3 identifies emulsifiable concentrate products.

TABLE II

These fertilizer-containing products are not being batched. Formulations may change,

which would also change their acute toxicity. The Agency is developing a policy for the

regulation of fertilizers containing pesticides.

TABLE III

Miscellaneous unbatched products.

TABLE I

Batch 1 (Concentrates)

 A representative database for these products is summarized here:
180

Data Required Toxicity Category Classification

Acute Oral (§81-1) IV A

Acute Dermal (81-2) III A

Acute Inhal. (81-3) IV A

Eye Irr. (§81-4) III A

Dermal Irr. (§81-5) IV A

Dermal Sens. (§81-6) Non-sensitizing A

* Denotes data review available

EPA Reg. # % Active Ingredient Formulation Type

2-296 90.0 G

407-338 100.0 G

677-290 75.3 G

9198-24 75.3 G

11684-2 75.3 G

50534-1 79.0 G

50534-20 79.0 G

50534-28 75.0 G

50534-113* 90.0 G

Batch 2 (low levels of DCPA).

A representative database for these products is summarized here:

Data Required Toxicity Category Classification

Acute Oral (§81-1) IV G

Acute Dermal (81-2) IV G

Acute Inhal. (81-3) IV G

Eye Irr. (§81-4) IV G

Dermal Irr. (§81-5) IV G

Dermal Sens. (§81-6) Non-sensitizing G
181

* Denotes data review available

EPA Reg. # % Active Ingredient Formulation Type

4-300 6.7 G

16-42 6.7 G

239-2532* 13.3 G

407-317 5.0 G

407-416 6.7 G

512-237 9.2 G

538-128 5.0 G

538-235 5.0 G

557-1998 5.75 G

572-193 6.4 G

572-237 6.9 G

588-235 5.6 G

769-911 5.6 G

802-441 5.0 G

829-165 5.0 G

961-273 5.0 G

961-278 6.7 G

1386-610 5.0 G

2217-617 2.5 G

7001-275 5.0 G

8590-377 5.0 G

8660-22 7.0 G

8660-33 2.3 G

8660-62 2.5 G

8660-98 5.0 G

9198-1 2.9 G
EPA Reg. # % Active Ingredient Formulation Type

182

10107-82 5.0 G

10107-86 2.5 G

10370-272 3.4 G

32802-14 3.5 G

32802-27 5.6 G

33955-474 2.5 G

50534-3 5.6 G

50534-17 3.4 G

Batch 3 (emulsifiable concentrate products).

There are no toxicity data for these products.

EPA Reg. # % Active Ingredient Type of Formulation

1769-246 6.0 EC

50534-187 21.4 EC

TABLE II (Fertilizers; not batched)

Table II identifies products that were not batchable, but were not placed in a "No Batch"

group; The products in this category contain significant amounts of fertilizer. Many of these

fertilizer components may change from time to time as the registrant sees fit.

Since as much as 96% of these formulations may vary, the Agency does not believe it is

possible to batch them. Since the formulation of these products may vary, a set of acute toxicity

studies conducted on one of them may not consistently represent that product's acute toxicity

potential. Registrants of products in Table II who certify that they do not vary the inert or

fertilizer components of their products may request that their products be batched with other

similar products. The Agency does not believe that requesting acute data on all fertilizer

combinations is sensible. The Agency is in the process of developing a policy that addresses

labeling for these products.

No toxicity studies are available for these products.
183

EPA Reg. # % Active Ingredient Formulation Type

238-157 3.9 G

538-87 6.3 G

802-503 4.0 G

802-576 2.6 G

3234-28 3.3 G

7001-270 3.1 G

8378-13 5.0 G

3442-TNE 3.2 G

8660-100 6.7 G

10107-4 2.0 G

11648-2 1.2 G

32802-6 4.7 G

32802-17 6.8 G

42957-83 4.7 G

TABLE III Miscellaneous products not batched, either because of dissimilar concentrations of

AI or lack of formulation information.

No toxicity studies are available for these products.

EPA Reg. # %AI Type of Formulation

228-222 25.0 WP

4-296 75.0 WP

50534-10 NA NA

Key

EC = Emulsifiable Concentrate

FC = Flowable Concentrate

G = Granular

WP = Wettable Powder
184
185

Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice

THIS PAGE MUST BE REMOVED PRIOR TO PRINTING AND REPLACED WITH

THE REGISTRANT LISTING PRODUCED FROM THE DCI MODULE.
186

Attachment 6. Cost Share, Data Citation Forms, Confidential Statement of Formula Form and Instructions

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. 
187
188
189

United States Environmental Protection Agency

Washington, D.C. 20460

Certification of Offer to Cost 

Share in the Development of Data

Form Approved

OMB No. 2070-0106,

2070-0057

Approval Expires

3-31-99

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:

My company is willing to develop and submit the data required by EPA under the authority of the Federal

Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to

enter into an agreement with one or more registrants to develop jointly or share in the cost of developing

data.

My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an

an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all 

terms could not be reached otherwise. This offer was made to the following firms on the following

date(s):

Name of Firm(s) Date of Offer

Certification:

I certify that I am duly authorized to represent the company named above, and that the statements that I have made

on

this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or

misleading statement may be punishable by fine or imprisonment or both under applicable law.

Signature of Company’s Authorized Representative Date
190

Name and Title (Please Type or Print)
191

EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obselete
192

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

 WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration

and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send

comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE

Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. 

Do not send the completed form to this address.

Certification with Respect to Citation of Data

Applicant's/Registrant's Name, Address, and Telephone Number EPA Registration Number/File Symbol

Active Ingredient(s) and/or representative test compound(s) Date

General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158) Product Name

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to

submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).

I am responding to a Data-Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should

be used for this purpose).

SECTION I: METHOD OF DATA SUPPORT (Check one method only)

I am using the cite-all method of support, and have included with this form

a list of companies sent offers of compensation (the Data Matrix form

should be used for this purpose).

I am using the selective method of support (or cite-all option

under the selective method), and have included with this form a

completed list of data requirements (the Data Matrix form must be

used).

SECTION II: GENERAL OFFER TO PAY

 [Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements] 

I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA. 

SECTION III: CERTIFICATION

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the

application for registration, the form for reregistration, or the Data-Call-In response. In addition, if the cite-all option or cite-all option under the selective method is

indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product or an identical or

substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data

requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and

uses . 

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained

the written permission of the original data submitter to cite that study.

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original data

submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for

compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have

offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commence negotiations to determine the

amount and terms of compensation, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in

accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with

FIFRA. 

I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I acknowledge that any

knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.

Signature Date Typed or Printed Name and Title

EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.
193

Form Approved OMB No. 2070-0060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of

information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not

send the form to this address.

 DATA MATRIX

Date EPA Reg No./File Symbol Page of

Applicant’s/Registrant’s Name & Address Product

Ingredient

Guideline Reference Number Guideline Study Name MRID

Number

Submitter Status Note

Signature Name and Title Date

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Public File

Copy
194
195

Form Approved OMB No. 2070-0060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of

information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC

20460. Do not send the form to this address.

 DATA MATRIX

Date EPA Reg No./File Symbol Page of

Applicant’s/Registrant’s Name & Address Product

Ingredient

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Signature Name and Title Date

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy
196

INSTRUCTIONS FOR DATA MATRIX

INSTRUCTIONS: Identify all data submitted or cited and all submitters from whom permission has been received or to whom offers to pay have been sent by entering sufficient

information in the attached matrix (photocopy and attach additional pages as necessary). Complete all columns; omission of essential information will delay approval of the

registration/reregistration. On each page enter the date, Applicant's/Registrant's name, EPA Registration Number or application file symbol of the product, ingredient, page number, and

total number of pages.

The Data Compensation Form entitled "Certification with Respect to Citation of Data" and the Data Matrix will be publicly available, except for the Guideline Reference Number, Guideline

Study Name, and MRID Number columns after the registration/reregistration of this product has been granted or once this form is received in response to a Data-Call-In Notice. However,

the information in the Guideline Reference Number, Guideline Study Name, and MRID Number columns is available through the Freedom of Information Act in association with the EPA

Registration Number.

Ingredient: Identify the active ingredient(s) in this product for which data are cited. The active ingredient(s) are to be identified by entering the chemical name and the CAS registry

number. Begin a new page for each separate active ingredient for which data are cited. If bridging data from a related chemical or representative test compound are cited, enter the

identity of that chemical/representative test compound including the EPA Registration Number/File Symbol if appropriate.

If the cite-all method is used for all data supporting this particular ingredient, enter "CITE-ALL" in the Guideline Reference Number column and leave the Guideline Study Name

column blank. If the cite-all method is used for a particular Guideline Reference Number enter "CITE-ALL" in the MRID Number column on the line for that Guideline Reference Number. 

In either case, enter all submitters to whom offers to pay have been sent on subsequent lines. [Note: if the selective method of support is used and written authorization (letter of

permission) is provided, the individual Guideline Reference Number, Guideline Study Name, and MRID Number columns must still be completed.] Otherwise:

Guideline Reference Number: Enter on separate lines in numerical order the Guideline Reference Numbers from 40 CFR Part 158 for all studies cited to support the

registration/reregistration for this ingredient.

Guideline Study Name: For each Guideline Reference Number cited, enter the corresponding Guideline Study Name. 

MRID Number: For each individual study cited in support of a Guideline Reference Number and Guideline Study Name, enter the Master Record Identification (MRID) Number listed in

the Pesticide Document Management System (PDMS). Enter only one MRID Number on each line. Note that more than one MRID Number may be required per Guideline Reference

Number. Note: Occasionally a study required to maintain a registration/reregistration is not associated with a Guideline Reference Number and Guideline Study Name. In such case,

enter the MRID Number(s) for the study(ies).

Submitter: Using the most recent Data Submitters List, identify the Original Data Submitter with their current address for each study cited. The EPA assigned company number or other

abbreviation may be used. Clearly explain any variations (alternate addresses, data owners not on the Data Submitters List, etc.) in footnotes to this table.

Status: Enter one of the following codes for each study cited, as appropriate:

OWN: I am the Original Data Submitter for this study.

EXC: I have obtained written permission of the Original Data Submitter to cite this exclusive-use study in support of this application.

PER: I have obtained the permission of the Original Data Submitter to use this study in support of this application.

OLD: The study was submitted more than 15 years ago and all periods of compensation have expired.

PL: The study is in the public literature.

PAY: I have notified in writing the Original Data Submitter or, if the cite-all method is used, all companies listed in the most current Data Submitters List for this ingredient,

and have offered (a) to pay compensation in accordance with FIFRA sections 3(c)(1)(F) and/or 3(c)(2)(B), and (b) to commence negotiations to determine the amount

and terms of compensation, if any, to be paid for the use of the study(ies).

GAP: This Guideline data requirement is a data gap as defined in 40 CFR sections 152.83(a) and 152.96.

FOR: I am taking the formulator's exemption for this ingredient only. Other columns of this line should be marked "NA". However, if this product is to be

registered/reregistered for additional uses for which the purchased EPA registered ingredient is not supported, additional data must be submitted or cited here to support

those uses.
197

Note: If additional explanation is needed, enter a footnote number in this column and attach the corresponding explanation. 
198

APPENDIX E. List of Available Related Documents
199

The following is a list of available documents for DCPA that may further assist you in

responding to this Reregistration Eligibility Decision document. These documents may be obtained

by the following methods:

Electronic

File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader.

Electronic copies are available on our website at www.epa.gov/REDs, or contact

Connie Childress at (703) 308-8074.

1. PR Notice 86-5.

2. PR Notice 91-2 (pertains to the Label Ingredient Statement).

3. A full copy of this RED document.

4. A copy of the fact sheet for DCPA.

The following documents are part of the Administrative Record for DCPA and may included

in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not

available electronically, but may be obtained by contacting the person listed on the Chemical Status

Sheet.

1. Health and Environmental Effects Science Chapters.

2. Detailed Label Usage Information System (LUIS) Report.

The following Agency reference documents are not available electronically, but may be

obtained by contacting the person listed on the Chemical Status Sheet of this RED document.

1. The Label Review Manual.

2. EPA Acceptance Criteria

3. Appendix A - Table of Use Patterns Subject to Reregistration