United States Prevention, Pesticides EPA738-R-97-001
Environmental Protection And Toxic Substances March 1997
Agency (7508W)
4»EPA Reregistration
Eligibility Decision (RED)
4-Chlorophenoxy-acetic
Acid (4-CPA)
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.SB,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
%^**^;c?
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
reregi strati on eligibility review and decisions on the pesticide chemical case 4-CPA which
includes the active ingredient 4-CPA acid. The enclosed Reregi strati on Eligibility Decision
(RED) 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 reregi strati on. The RED
includes the data and labeling requirements for products for reregi strati on. 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 are due 90 days from the date of this
letter. The second set of required responses are due 8 months from the receipt of this
letter. Complete and timely responses will avoid the Agency taking the enforcement action of
suspension against your products.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Franklin
Rubis at (703) 308-8184. Address any questions on required generic data to the Special Review
and Reregi strati on Division representative Tom Luminello at (703) 308-8075.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, 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 REOUESTS-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 reregi strati on) separately. You may delete uses
which the RED says are ineligible for reregi strati on. 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
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§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 PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
Bv 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 reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
4-CHLOROPHENOXYACETIC ACID
LISTB
CASE 2115
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
4-CPA REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 3
D. Regulatory History 3
III. SCIENCE ASSESSMENT 3
A. Physical Chemistry Assessment 3
B. Human Health Assessment 4
1. Toxicology Assessment 4
a. Acute Toxicity 4
b. Subchronic Toxicity 5
c. Developmental Toxicity 5
d. Mutagenicity 5
e. Reference Dose 6
2. Exposure Assessment 6
a. Dietary Exposure 6
b. Occupational and Residential 9
3. Risk Assessment 9
a. Dietary 9
b. Occupational 11
C. Environmental Assessment 11
1. Ecological Toxicity Data 11
2. Environmental Fate 12
a. Environmental Fate Assessment 12
3. Exposure and Risk Characterization 12
a. Exposure and Risk Characterization 12
b. Endangered Species 13
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 13
A. Determination of Eligibility 13
1. Eligibility Decision 13
2. Eligible and Ineligible Uses 14
B. Regulatory Position 14
1. Tolerance Reassessment 14
2. Endangered Species Statement 14
3. Personal Protective Equipment (PPE) for Handlers
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(Mixers/Loaders/Applicators) 14
V. ACTIONS REQUIRED BY REGISTRANTS 15
A. Manufacturing-Use Products 15
1. Additional Generic Data Requirements 15
2. Labeling Requirements for Manufacturing-Use Products 15
B. End-Use Products 16
1. Additional Product-Specific Data Requirements 16
2. Labeling Requirements for End-Use Products 17
C. Existing Stocks 18
VI. APPENDICES 21
APPENDIX A. Table of Use Patterns Subject to Reregistration 23
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 25
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 2115 28
APPENDIX D. Product Specific Data Call-In 32
Attachment 1. Chemical Status Sheets 45
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 46
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions
48
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 55
Attachment 5. List of All Registrants Sent This Data Call-in (insert)
Notice 57
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 58
APPENDIX E. List of Available Related Documents 65
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4-CPA REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Phyllis Johnson
George Keitt
Environmental Fate and Effects Division
Curtis Laird
Sharlene Matten
James Hetrick
Health Effects Division
William Smith
Mary Clock
John Leahy
Laura Morris
Marcia Van Gemert
Registration Division
Cynthia Giles-Parker
Mark Perry
Special Review and Reregi strati on Division
Tom Luminello
Kathy Davis
Policy Support and Projects Staff
Jean Frane
Biological Analysis Branch
Biological Analysis Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Reregi strati on Support Chemistry Branch
Risk Characterization and Analysis Branch
Occupational and Residential Exposure Branch
Occupational and Residential Exposure Branch
Toxicology Branch II
Fungicide-Herbicide Branch
Registration Support Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Office of Enforcement and Compliance Monitoring
Phyllis Flaherty
Agricultural Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
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.
HOT 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/1, 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
LOG Level of Concern
L OD L imit 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.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
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*j 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
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
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.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (referred to as "the Agency") has completed an
assessment of the potential human health and environmental risks associated with the pesticide uses
of 4-chlorophenoxyacetic acid, hereafter referred to as "4-CPA." The Agency has determined that
pesticide products containing this chemical as an active ingredient, labeled and used as specified in
this Reregistration Eligibility Decision document (RED), will not cause unreasonable risk to humans
or the environment. Therefore, the Agency has concluded that the products containing 4-CPA are
eligible for reregi strati on.
4-CPA is used in the food industry as a plant growth regulator to restrict root growth during
seed germination of mung beans. The product is used by preparing a diluted solution which is added
to the water bath to soak the beans. The beans are soaked for several hours, then washed several
times to remove the surface residues. The seeds are then germinated indoors for several days. After
sprouting, the hulls and roots are discarded. The sprouted portion of the beans are packaged and
sold for human consumption.
Studies suggest that 4-CPA has low subchronic mammalian toxicity, and with the exception
of ocular irritation, has moderate to low acute toxicity. However, 4-CPA is a severe eye irritant
when tested in rabbits and is a developmental toxin in rats. 4-CPA is considered practically non-
toxic to fish and is not likely to pose environmental fate concerns under the present limited use
pattern described above.
Before reregistering the products containing 4-CPA, 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 reregi strati on
only when the other active ingredients are determined to be eligible for reregi strati on.
v
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VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. The amended Act provides a schedule for the reregi strati on process to be completed in nine
years. There are five phases to the reregistration process. The first four phases of the process focus
on identification of data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for 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 4-CPA. The document consists of six sections. Section I is the introduction.
Section n describes 4-CPA, 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 4-CPA. Section V discusses the reregistration
requirements for 4-CPA. 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.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Decision:
• Common Name: 4-CPA
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Structural Formula:
4-chlorophenoxyacetic acid
phenoxy
122-88-3
019401
C8H7C1O3
ci
O
4-CPA
o
• Molecular Weight:
• Basic Manufacturer:
B. Use Profile
186.6
A. H. Marks and Company Ltd.
The following is information on the currently registered uses with an overview of use
sites and application methods. A detailed table of the use of 4-CPA is in Appendix A.
For 4-CPA:
Type of Pesticide: Plant growth regulator
Use Group and Site: Indoor Food Crop: Mung beans
Formulation Types Registered: soluble concentrate/liquid and crystals
Method and Rates of Application:
Equipment - Direct pour or closed delivery systems.
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Method and Rate - 0.026 pounds of crystalline 4-CPA are dissolved in 1
liter of boiling water and added to 1150 gallons of
water in which 3500 pounds of mung bean seeds are
soaked.
Timing - Bean are soaked 5-8 hours before sprouting. Seeds are well
rinsed in water and allowed to germinate.
Use Practice Limitations: Do not feed treated hulls or bean parts to livestock.
C. Data Requirements
Appendix B includes all data requirements identified by the Agency for currently
registered uses needed to support reregi strati on.
D. Regulatory History
A pesticide product formulated with 4-CPA as an active ingredient was first
registered in the United States in October 1969. It was registered for use as a plant growth
regulator for mung beans and later as a fruiting bloom set for tomatoes.
A Data Call-in was issued in December 1984 for 4-CPA requiring chronic toxicology
data. A Data Call-In was issued in June 1987 to investigate possible DioxinVFuran formation
during the manufacturing process.
Under Phase 4 of reregi strati on, a Data Call-In was issued in June 1991 for data to
characterize the chemistry, human toxicity, and environmental fate of 4-CPA. Another Data
Call-In was issued in June 1994 to allow other end use product manufacturers a chance to
support the tomato use. As a result, the products labeled for use on tomatoes were
voluntarily cancelled, leaving two products labeled for use on mung beans.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
4-CPA is an odorless, light-colored powder with a melting point of 158-160°C. It
is stable at elevated temperatures (54°C) and on exposure to metals, but degrades (30% loss
in 24 hours) on exposure to sunlight.
All pertinent generic chemistry data requirements except preliminary analysis are
satisfied for the La Choy 4-CPA product. These data for preliminary analysis have been
required of the registrant and will be due to the Agency after the next production of the La
Choy technical. However, all data requirements are outstanding for the TGAIs of the other
registrant's 4-CPA product. Provided that the registrant submits the data required in the June
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1994 for the TGAIs of their products as confirmatory data, the Agency has no objections to
the reregi strati on of 4-CPA with respect to product chemistry data requirements. These
product chemistry data are due June, 1995.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on 4-CPA is adequate and will support
reregi strati on eligibility. The Agency required data on acute, subchronic feeding,
and developmental toxicology as well as mutagenicity studies. The results of the
subchronic studies in two species showed no adverse systemic effects. 4-CPA was
shown to be a developmental toxin causing decreases in fetal body weights and
inducing skeletal variations in rats. Because of the lack of overt toxicity in
subchronic dietary studies, the low volume/minor use status and the lack of acute
dietary exposure concerns of 4-CPA, described below, the Agency waived the
chronic toxicity, carcinogenicity, and reproductive effects studies normally required
for food-use chemicals.
a. Acute Toxicity
Table 1. Summary of acute toxicitv data on 4-CPA
Test
Oral LD50-rat
Dermal LD50— rabbit
Inhalation LC50— rat
Eye irritation— rabbit
Dermal irritation— rabbit
Dermal sensitization— guinea pig
Results
2,703 mg/kg
>2,000 mg/kg
>5.25 mg/L
severe irritation
non-irritating
non-sensitizing
Category
III
III
IV
I
IV
-
In an acute oral toxicity study in rats, the LD50 was 2,703 mg/kg
(guideline 81-1; MRTD 41837001). Clinical signs of toxicity were staggered
gait, hypoactivity, and absent pain reflex. An acute dermal toxicity study
with rabbits found the LD50 was greater than 2,000 mg/kg (guideline 81-2;
MRID 42522601). In an acute inhalation toxicity study with rats, 4-CPA had
an LC50 greater than 5.25 mg/L (guideline 81-3; MRID 42968201).
In rabbits, 4-CPA was a severe eye irritant (guideline 81-4; MRID
42339101). 4-CPA was non-irritating in a primary dermal irritation study
with rabbits (guideline 81-5; MRID 42306801). No sensitization occurred
in a dermal sensitization study with guinea pigs (guideline 81-6; MRID
42339102).
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b. Subchronic Toxicity
In a 13-week oral toxicity study, 4-CPA was given to Crl:CD BR
VAF/Plus rats at doses of 0, 100, 2000, or 8000 ppm in the diet (0, 6.6, 132,
or 517 mg/kg/day for males; 0, 8.0, 153, or 626 mg/kg/day for females). The
NOEL was 2000 ppm. The LOEL was 8000 ppm, based on decreased body
weight gain in both sexes, decreased food consumption in females, increased
urine volume in females, and increased incidence of slight hepatic
lymphohistiocytic infiltrates and slight individual hepatocellular necrosis in
males (guideline 82-1; MRTD 42902501).
4-CPA was given to beagle dogs for 13 weeks in the diet at 0, 20,
100, or 500 ppm (0, 0.8, 3.3, or 18.6 mg/kg/day for males; 0, 0.8, 4.0, or
17.4 mg/kg/day for females). The NOEL was 500 ppm. The only effect
found was decreased body weight gain and food consumption during the first
four weeks at the highest dose, which may have been related to palatability
(guideline 82-1; MRID 42968301).
c. Developmental Toxicity
4-CPA was administered to Crl:CD BR VAF/Plus rats by gavage at
0, 150, 300, 600, or 1000 mg/kg/day on gestation days 6-15. The NOELs for
maternal and developmental toxicity were 150 mg/kg/day. The maternal
LOEL, 300 mg/kg/day, was based on tremors, uncoordinated movements,
recumbent posture, languidness, cold body, and decreased body weight gain.
The highest dose also showed increased mortality. Fetal body weights were
decreased at 600 and 1000 mg/kg/day. Skeletal variations were seen at the
developmental LOEL of 300 mg/kg/day and at higher doses. The skeletal
variations manifested as increased unossified sternebrae, seventh cervical
ribs, and misaligned sternebrae (guideline 83-3; MRID 42322602).
d. Mutagenicity
4-CPA tested in an in vitro mammalian mutation assay did not induce
forward mutations in mouse lymphoma cells (guideline 84-2; MRID
41837004).
In the Ames Salmonella/mammalian-microsome reverse mutation
assay, 4-CPA was not mutagenic, with and without activation (guideline 84-
2; MRTD 41837002). Also, this chemical was not clastogenic in an m vivo
mouse micronucleus assay (guideline 84-4; MRID 41837003).
e. Reference Dose
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A Reference Dose (RfD) of 0.006 mg/kg/day has been established,
based on the NOEL of 500 ppm highest dose tested (HDT) in the subchronic
toxicity study in dogs. The uncertainty factor is 3000, including factors of
10 for inter-species extrapolation, 10 for intra-species variability, 10 for
extrapolation from subchronic to chronic exposure, and 3 for the lack of
reproductive toxicity data.
2. Exposure Assessment
a. Dietary Exposure
An acute dietary risk assessment is not required since no acute dietary
toxicity end-point of concern has been identified, but we have an RfD for
chronic exposure.
Tolerances are expressed as the combined residues of 4-
chlorophenoxyacetic acid (4-CPA) and its metabolite 4-chlorophenol (4-CP)
in/on mung bean sprouts at 2.0 ppm and in/on tomatoes at 0.05 ppm (40 CFR
§180.202). Tolerances for residues of 4-CPA in animal commodities have
not been established and are not needed because the mung beans are not a
feed item. No food/feed additive tolerances have been established nor are
they needed because there are no animal feed items associated with mung
beans. An adequate enforcement method is available for the determination
of residues of 4-CPA and 4-CP in/on plant commodities.
The Agency has concluded that the 4-CP metabolite of 4-CPA,
present in the residue at less than 1%, is not of risk concern and no longer
needs to be regulated. The Agency will propose under a separate Federal
Register notice that 4-CP be excluded from the tolerance expression
(guideline 171-4(a); MRID 42819602).
The registrant has submitted a petition (PP#2E04120) for a reduction
in the tolerance for mung bean sprouts to 0.2 ppm. Data submitted by the
registrant indicate that residues will not exceed this level when 4-CPA is
used on sprouting mung beans according to label instructions. Therefore, the
Agency will amend the existing tolerance from 2 ppm to a level of 0.2 ppm
through proposed and final notices in the Federal Register. The Agency used
the existing tolerance level in its dietary risk assessment, described below,
since it represents a conservative estimate of total residues of 4-CPA, both
free and conjugated, and the proposed revision was not final at the time of
the assessment.
The established tolerance on tomatoes will be revoked. No other
party has expressed an interest in supporting this use and all registrations for
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tomato uses are cancelled.
Plant Metabolism
The qualitative nature of the residue in plants is adequately
understood based on a mung bean sprout metabolism study. The residue of
concern in mung bean sprouts is 4-CPA, both free and conjugated.
Animal Metabolism
Because there are no animal feed items associated with mung bean
sprouts, animal metabolism studies are not required (guideline 171-4(b)).
Residue Analytical Methods - Plants and Animals
An adequate enforcement method is available for determination of
residues of 4-CPA and the metabolite 4-CP in/on plant commodities. The
Pesticide Analytical Method (PAM) Vol. II lists a GC method with
microcoulometric detection and a detection limit of 0.02 ppm (Method I;
Sec. 180.202).
Residue data submitted in response to the Phase 4 Data Call-In and
in support of the petition (PP#2E04120) for a reduction in the established
tolerance for the combined residues of 4-CPA and 4-CP in/on mung bean
sprouts were collected using two residue analytical methods for determining
the residue analytical methods for determining residues of 4-CPA (Method
C 023.00) and 4-CP (Method 024.00). Both 4-CPA and 4-CP are isolated by
liquid/liquid extraction, cleaned up by ion exchange, and separated and
quantitated by HPLC using a C-18 column and UV detection (225 nm). The
limit of detection of these methods is 10 ppb. The registrant indicated (in
their petition for a reduced tolerance) that these methods were suitable for
enforcement purposes. However, the present limited use of 4-CPA does not
merit expenditure of further resources on an independent laboratory
validation and Agency method validation trial for inclusion in PAM Vol II.
Although the existing analytical methods do not release and measure
residues of conjugated 4-CPA, they are considered adequate for enforcement
and data collection because of the limited use of the pesticide.
Analytical methods for animal commodities are not required since
there are no animal feed items associated with mung beans and no direct
animal uses of 4-CPA.
The Agency required that 4-CPA and its metabolites be tested
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through multiresidue method Protocol B. The FDA PESTDATA data base
dated January 1994 (PAM Vol. I, Appendix I) indicates that 4-CPA is
completely recovered (>80%) using multiresidue method PAM Vol. I
Section 402 using the E2 extraction procedure but that there is only a small
recovery (<50%) when the El extraction procedure is used. PAM Vol. I
Section 402 is the multiresidue method for acids and phenols and
corresponds to what was previously designated Protocol B (guideline 171-
4(c); MRID 43326801).
Storage Stability
Residue data for 4-CPA from the magnitude of the residue studies are
supported by adequate storage stability data. Residues of 4-CPA are stable
in/on mung bean sprouts stored at -15° C for 69 days and in canned mung
bean sprouts stored frozen for 57 days.
Storage stability data for residues of the metabolite 4-CP will not be
required as the Agency has determined that these residues should no longer
be regulated (guideline 171-4(e); MRID 43326801).
Magnitude of the Residue in Plants
The data for magnitude of the residue in/on mung bean sprouts are
adequate for tolerance reassessment. The magnitude of the residue studies
from the original petition for the mung bean sprouts tolerance (PP#360) are
not considered here because the raw agricultural commodity was not
analyzed and there were problems with the analytical method used to
generate the residue data (guideline 171-4(k); MRID 42551004).
Data are not available for the tomato use. The established tolerance
will be revoked because the use is cancelled.
Magnitude of the Residue in Processed Food/Feed
The data for magnitude of the residue in processed food/feed have
been evaluated and are adequate for mung bean sprouts. Mung bean sprouts
are considered a raw agricultural commodity in Table II (June 1994) of
Subdivision O of the Pesticide Assessment Guidelines, and thus there is no
need to establish a food additive tolerance.
Magnitude of the Residue in Milk. Meat. Poultry, and Eggs
Data pertaining to magnitude of the residue in milk, meat, poultry,
and eggs are not required because there are no animal feed items associated
-------
with mung beans (guideline 171-4(j)).
Confined/Field Rotational Crops
Confined and field rotational crop studies are not required. The
registered use of 4-CPA on mung beans as a soak treatment does not lend
itself to subsequent crop rotation as the mung beans are treated and harvested
entirely indoors (guidelines 165-1 and 165-2).
b. Occupational and Residential
As described previously, 4-CPA is a plant growth regulator
formulated as a soluble concentrate liquid (containing 100 percent a.i.). The
4-CPA product is applied to mung beans in a soak tank. 4-CPA is first
mixed in boiling water, then the dissolved solution is poured into the soak
tank. 4-CPA is applied at 0.008 Ib ai/1,000 Ib mung beans.
A short and intermediate term (1-7 days) occupational exposure
assessment is not required because of a high maternal and developmental
toxicity LOEL [300 mg/kg/day].
The products containing 4-CPA are intended primarily for
occupational use. The registered use is not likely to involve application at
residential sites.
At this time, the registered use of 4-CPA is outside the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS), due to the
industrial setting for application of the pesticide.
3. Risk Assessment
a. Dietary
Based upon the review of the toxicology data base for 4-CPA, there
is no endpoint of concern identified for acute dietary exposure. Therefore,
an acute dietary risk assessment was not conducted.
The Agency used a RfD of 0.006 mg/kg/day for its Dietary Risk
Evaluation System (DRES) chronic exposure analysis. This RfD is based
upon the NOELs of 18.58 and 17.41 mg/kg bwt/day for males and females,
respectively, from the subchronic toxicity study in dogs described above. An
uncertainty factor of 3000 was applied.
(1) Residues
-------
4-CPA residues included in this dietary analysis were from 4-
CPA's uses on mung bean sprouts and tomatoes since there currently
are established tolerances for these two commodities. The Agency
used tolerance values established in 40 CFR § 180.202 and the Office
of Pesticide Program's Tolerance Index System (TIS): mung beans
at 2.0 ppm and tomatoes at 0.05 ppm. As discussed above the
Agency intends to make the following changes in the tolerance
statement: first, the tolerances are to be based upon 4-CPA residues
only because the 4-CP metabolite has been determined to not be of
toxicological concern; second, the tolerance for mung beans will be
reduced from 2.0 ppm to 0.2 ppm; and, third, the tolerance for
tomatoes will be revoked since there is no corresponding U.S.
registration for use on this commodity. There are no proposed or
pending tolerances for 4-CPA. Mung beans have no associated
animal feed items, therefore, there are no meat, milk, egg and poultry
tolerances.
(2) Chronic Exposure
In the DRES chronic analysis, tolerance level residues were
used to calculate the Theoretical Maximum Residue Contribution
(TMRC) for the overall U.S. population and 22 population
subgroups. The exposure estimates were then compared to the RfD
for 4-CPA to calculate estimates of chronic dietary risk.
Although uses on tomatoes have been voluntarily canceled,
the tolerances have not been revoked at the time of this analysis.
Therefore, tomatoes - whole, tomatoes - juice, tomatoes - puree,
tomatoes - paste, and tomatoes - catsup were included in this DRES
analysis at the tolerance level of 0.05 ppm. In addition, although the
Agency intends to reduce the tolerance for mung beans from 2.0 ppm
to 0.2 ppm, this analysis was conducted using the currently published
tolerance of 2.0 ppm. Anticipated residues and percent crop treated
data were not required and therefore, not used in this analysis
because of the results presented below.
The results (TMRC and % RfD) of the DRES chronic
analysis for the U.S. population and two most sensitive subgroups are
displayed in Table 2.
Table 2. Population subgroup chronic dietary analysis for 4-CPA
Subgroup
Exposure (TMRC) (mg/kg/dav)
%RfD
10
-------
U.S. Population
Children (1-6 years old)
Children (7-12 years old)
8.60x 10'5
1.57 x lO'4
1.34 x lO'4
1.43
2.62
2.24
The U.S. population and all of the DRES population
subgroups have TMRCs for chronic dietary risk well below the RfD
when published tolerances are considered. Therefore, it appears that
chronic dietary risk is not of concern for this chemical.
b. Occupational
The Agency believes that the potential for exposure to 4-CPA during
pesticide handling operations exists, but is low. Further, the toxicological
criteria for requiring an exposure assessment were not triggered. An
endpoint of 300 mg/kg/day (LOEL) was identified for short term and
intermediate term occupational exposure. A risk assessment was not
required because of this high LOEL and the potentially low worker exposure
associated with the growing of mung beans.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency has waived most of the ecotoxicity data requirements for the
reregistration of the mung bean use, because the use is carried out entirely indoors,
resulting in practically no exposure to non-target organisms. The Agency concludes
that the available data, summarized below in Table 3, are adequate for determining
the ecological toxicity and labeling of this chemical. No further data are required for
labeling or for ecological risk characterization.
Table 3. Ecological Effects Toxicology Data
Available Toxicity Findings
11
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Species
Rat
Bluegill
Sunfish
Test
Material
4-CPA (100 % ai)
4-CPA, Diethanol-
amine salt (2 % ai)
Results
LD50 = 2703
(2191 - 3335) mg/kg
96-Hr LC50 =
> ISOppm
MRID
418370-01
ABL Test
No. 657
Toxicity
Category
Practically
Non-toxic
Practically
Non-toxic
The above data indicate that 4-CPA, 100% active ingredient (ai) is practically
non-toxic to small mammals on an acute oral basis (MRID 41837001) and 4-CPA,
diethanolamine salt, in a 2% formulation, is practically non-toxic to warm water fish
(ABL Test No. 657).
The fish test is considered a supplemental study because it is based on a
summary report for a related formulation. However, considering the unique use
pattern, this study provides enough useful information for characterizing the toxicity
of 4-CPA.
2. Environmental Fate
a.
Environmental Fate Assessment
Hydrolysis data were the only data required to support the indoor use
(e.g., root suppression of mung bean sprouts) of 4-CPA. From an acceptable
study, parent 4-CPA was stable (t1/2 > 30 days) to abiotic hydrolysis in three
buffer solutions (guideline 161-1; MRID 42819601). No additional
environmental fate data are required to support the use of 4-CPA on mung
beans.
4-CPA is expected to be mobile in soil and aquatic environments
because it will be an anion (dissociated carboxylic acid) in most
environments. The soil partitioning coefficient (Kd) for 4-CPA cannot be
estimated from structural analysis. Disposal of 4-CPA-treated water, after
treatment of mung beans, should be in compliance with a NPDES permit.
Exposure and Risk Characterization
a. Exposure and Risk Characterization
Because the use of 4-CPA on mung beans is limited in scope and is
completely indoors, the Agency has not performed a risk characterization for
nontarget organisms. The presently registered use provides for essentially
no exposure to nontarget organisms. Further, the disposal of wastes will be
12
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into landfills or publicly-owned sewage treatment facilities, thereby
precluding exposure to nontarget organisms. Therefore, the use of 4-CPA
on mung beans is unlikely to pose a risk to nontarget organisms.
b. Endangered Species
As discussed above, the presently registered use provides for virtually
no exposure to endangered species. Therefore, risks to such organisms are
unlikely.
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
ingredients 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 4-CPA as an active ingredient. 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 4-CPA. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of 4-CPA, 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 use of 4-CPA and to determine that 4-CPA can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing 4-CPA as the active ingredient are eligible for reregistration.
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 4-CPA are eligible for reregistration, it
should be understood that the Agency may take appropriate regulatory action, and/or require
the submission of additional data to support the registration of products containing 4-CPA,
if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient 4-CPA, the
Agency has sufficient information on the health effects of 4-CPA and on its potential
13
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for causing adverse effects in fish and wildlife and the environment. The Agency
has determined that 4-CPA products, labeled and used as specified in this
Reregi strati on Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, the Agency concludes that
products containing 4-CPA for the mung bean use are eligible for reregi strati on.
2. Eligible and Ineligible Uses
The Agency has determined that the mung bean use of 4-CPA is eligible for
reregi strati on.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for 4-CPA.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
Existing tolerances of 2.0 ppm and 0.05 ppm are currently established for 4-
CPA and its metabolite 4-chlorophenol in or on mung beans and tomatoes,
respectively, per 40 CFR §180.202. The Agency will amend the tolerance
expression to include only 4-CPA, reduce the tolerance on mung beans to 0.2 ppm,
and revoke the tolerance on tomatoes for the reasons discussed above.
2. Endangered Species Statement
The Agency has no concerns about the exposure of threatened and
endangered species to 4-CPA.
3. Personal Protective Equipment (PPE) for Handlers
(Mixers/Loaders/Applicators)
For each end-use product, PPE requirements for pesticide handlers will be
set during reregistration in one of two ways:
• If the Agency has no special concerns about the acute 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.
• If the Agency has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such as
allergic effects or delayed effects (cancer, developmental toxicity,
reproductive effects, etc.):
14
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• In the RED for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE requirements
that pertain to all or most occupational end-use products
containing that active ingredient.
• These minimum PPE requirements must be compared with
the PPE that would be designated on the basis of the acute
toxicity of 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.
The Agency has no special concerns about the effects of this active
ingredient under the current use pattern. Little exposure is expected and the
toxicological data do not suggest a need for active-ingredient-based PPE,
with the exception of requiring eye protection for the product which contains
100% active ingredient because of the corrosive effects observed in the acute
study. PPE for the product containing 0.0015% 4-CPA will be based on the
acute toxicity of the end-use product.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of 4-CPA for the above
eligible use has been reviewed and determined to be substantially complete.
Additional preliminary analysis data are required and are due to the Agency at the
next production of the La Choy product.
Additional product chemistry data are required of the Luigino product.
These requirements have been issued in the Data Call-In of June 1994. These data
are due June 1995.
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
15
-------
Directions For Use:
"Only for formulation into a Plant Growth Regulator for the following use:
mung bean."
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 a
user group:
(a) "This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding the support of such use(s)."
(b) "This product may be used to formulate products for any additional use(s)
not listed on MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding the support of such use(s)."
The following label statement is required on all manufacturing-use products
(PR Notice 93-10):
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water unless this product is specially identified and
addressed in a NPDES permit. Do not discharge effluent containing this product to
sewer systems without previously notifying the sewage plant authority. For
guidance, contact your State Water Board or Regional Office of the EPA."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Product chemistry and acute toxicology data are required. However, since
the end use product is nearly 100% technical material, and the registrant so chooses,
they may rely on some of the data generated for the TGAI and cite those MRIDs.
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
16
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instructions in the Requirement Status and Registrants Response Form provided for
each product.
2. Labeling Requirements for End-Use Products
Personal Protective Equipment (PPE) for Handlers (Mixer/Loaders and
Applicators)
At this time there are no engineering control requirements, such as closed
systems, currently required on labeling for 4-CPA products. Due to the potential for
eye irritation (Toxicity Category 1), the Agency is requiring that handlers of the
100% 4-CPA product wear protective eyewear. However, there are no other special
toxicological concerns about 4-CPA that warrant the establishment of active-
ingredient-based handler PPE requirements. Therefore, the PPE for handlers will
be based on the acute toxicity of the end-use product. Due to the potential for eye
irritation (Toxicity Category 1), the Agency is requiring that handlers wear
protective eyewear.
To protect handlers of the 100% 4-CPA product, the following language
must be located on the label:
"Applicators and other handlers must wear goggles."
Entry Restrictions for Occupational-Use Products
All of the registered uses of 4-CPA are outside the scope of the Worker
Protection Standard for Agricultural Pesticides (WPS). Therefore, there are no
reentry restrictions. The Agency is requiring the following labeling statements to be
located on all end-use products containing 4-CPA 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:
"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."
17
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User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
• "Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash thoroughly
and change into clean clothing."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of
label changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement
of Policy;" Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell 4-CPA 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.
18
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19
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20
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VI. APPENDICES
21
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22
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Date 02/23/95 ) Time 08:35
4444444444444444444444444444444444
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
APPENDIX A ) CASE 2115, [4-CPA, and salts] Chemical 019401 [4-CPA, and salts]
J44444444444444444444444444444444444444444444444444
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed Disallowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
LUIS 1.6 ) Page 1
Use
Limitations
Codes
BEAN SPROUTS, MUNG
Soak., Seed., 1150 gal tank.
Tank size unspec.
Cr NA
SC/L NA
Use Group: INDOOR FOOD
3 ppm1 * NA NA 3 ppm NA NA NA
0.3 ppm2 * NA NA 0.3 ppm NA NA NA
CAL G16 G95
CAL
1 Standard procedure: 9-12 grams of crystalline 4-CPA are dissolved in 1 liter of boiling water and added to 1150 gal of water to soak 3500 Ib of mung bean seeds.
2 2 fl oz of product are added to each 3 1/3 qt of seed soak solution. Volume of soak solution depends on amount of seed per batch.
23
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Date 02/23/95 ) Time 08:35 APPENDIX A ) CASE 2115, [4-CPA, and salts] Chemical 019401 [4-CPA, and salts] LUIS 1.6 ) Page
44444444
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
PRL : PRESSURIZED LIQUID
RTU : LIQUID-READY TO USE
SC/L : SOLUBLE CONCENTRATE/LIQUID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
CAL : Do not contaminate water, food or feed.
G16 : Do not feed treated seed to livestock.
G95 : Do not feed to livestock.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
24
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case 2115 covered by this Reregi strati on Eligibility Decision Document. It
contains generic data requirements that apply to 2115 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 31 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.
25
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of 4-CPA
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
I
I
I
I
I
I
I
I
I
I
I
I
I
I
42025301
42025301
42025301
124265
124265
42363301
124265
42363301
124265
42363301
42363301
42018501
42363301
42363301
26
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Data Supporting Guideline Requirements for the Reregistration of 4-CPA
REQUIREMENT
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity - Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
82-1A 90-Day Feeding - Rodent
82-1B 90-Day Feeding - Non-rodent
83-3A Developmental Toxicity - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal Aberration
84-4 Other Genotoxic Effects
ENVIRONMENTAL FATE
161-1 Hydrolysis
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4C Residue Analytical Method - Plants
171-4E Storage Stability
171-4K Crop Field Trials
USE PATTERN
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
CITATION(S)
41837001
42522601
42968201
42339101
42306801
42339102
42902501
42968301
42322602
41837002
41837004
41837003
42819601
42819602
43326801
43326801
42551004
27
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APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 2115
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
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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.
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.
29
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BIBLIOGRAPHY
MRID
CITATION
41837001 Glaza, S. (1991) Acute Oral Toxicity Study of 4-Chlorophenoxyacetic Acid in Rats:
Final Report: Lab Project Number: HLA/00801531. Unpublished study prepared by
Hazleton Laboratories America, Inc. 53 p.
41837002 Lawlor, T. (1990) Mutagenicity Test on 4-Chlorophenoxyacetic Acid in the
Salmonella/Mammalian-Microsome Reverse Mutation Assay (Ames Test) with a
Confirmatory Assay: Lab Project Number: 12447-0-401R. Unpublished study
prepared by Hazleton Laboratories America, Inc. 33 p.
41837003 Murli, H. (1991) Mutagenicity Test on 4-Chlorophenoxyacetic Acid in vivo
Micronucleus Assay: Lab Project Number: 12447-0-455PO. Unpublished study
prepared by Hazleton Washington, Inc. 23 p.
41837004 Young, R; Cifone, M. (1991) Mutagenicity Test on 4-Chlorophenoxyacetic Acid in
the L5178Y TK (plus/minus) Mouse Lymphoma Forward Mutation Assay with
Independent Repeat: Lab Project Number: 12447-0-431. Unpublished study
prepared by Hazleton Laboratories America, 32 p.
42306801 Glaza, S. (1992) Primary Dermal Irritation Study of 4-Chlorophenoxyacetic Acid in
Rabbits: Lab Project Number: HWI 20200490. Unpublished study prepared by
Hazleton Wisconsin, Inc. 21 p.
42322601 Kenwood, S. (1992) Range-finding Teratology Study with 4-Chlorophenoxyacetic
Acid in Rats: Final Report (Supp.): Lab Project Number: 6341-100. Unpublished
study prepared by Hazleton Wisconsin, Inc. 93 p.
42322602 Kenwood, S. (1992) Teratology Study with 4-Chlorophenoxyacetic Acid in Rats:
Final Report (Supp.): Lab Project Number: 6341-101. Unpublished study prepared
by Hazleton Wisconsin, Inc. 253 p.
42339101 Glaza, S. (1992) Primary Eye Irritation Study of 4-Chlorophenoxyacetic Acid in
Rabbits: Lab Project Number: HWI 20200491. Unpublished study prepared by
Hazleton Wisconsin, Inc. 36 p.
42339102 Glaza, S. (1992) Dermal Sensitization Study of 4-Chlorophenoxyacetic Acid in
Guinea Pigs—Closed Patch Technique: Final Report: Lab Project Number: HWI
20200492. Unpublished study prepared by Hazleton Wisconsin, Inc. 33 p.
42522601 Glaza, S. (1992) Acute Dermal Toxicity Study of 4-Chlorophenoxyacetic Acid in
Rabbits: Final Report: Lab Project Number: HWI 20700133. Unpublished study
30
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prepared by Hazleton Wisconsin, Inc. 28 p.
42551004 Ruiz, R. (1990) 4-CPA Magnitude of Residue Study: Lab Project Number: C1883:
C1888: C1906-7: 3307/3331. Unpublished study prepared by Hunt-Wesson, Inc.
45 p.
42819601 Atkins, R. (1993) Hydrolysis of (carbon 14)- 4-Chloro- phenoxyacetic Acid at pH
5, 7 and 9: Lab Project Number: 736: 1514. Unpublished study prepared by PTRL
East 66 p.
42819602 O'Neal, S. (1993) Metabolic Fate and Distribution of (carbon
14)—4-Chlorophenoxyacetic Acid in Bean Sprouts: Lab Project Number: 617: 1517:
008906. Unpublished study prepared by PTRL East, Inc. 86 p.
42968201 Nachreiner, D. (1993) 4-Chlorophenoxyacetic Acid: Acute Dust Inhalation Toxicity
Study in Rats: Revised Report: Lab Project Number: 92N1192 REVISED: 92N1192.
Unpublished study prepared by Union Carbide and Plastics Co., Bushy Run Research
Center. 58 p.
42968301 Kenwood, S. (1993) 13-Week Dietary Toxicity Study with 4-Chlorophenoxyacetic
Acid in Dogs: Final Report: Lab Project Number: HWI 6341-108. Unpublished
study prepared by Hazleton Wisconsin, Inc. 400 p.
43326801 Ruiz, R. (1994) Addendum to 4-CP Test Method: (4-CPA). Unpublished study
prepared by Hunt Wesson, Inc. 42 p.
43326802 Ruiz, R. (1994) Addendum to 4-CP Test Method: (4-CP). Unpublished study
prepared by Hunt Wesson, Inc. 42 p.
31
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
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 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific 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, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific 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, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 6).
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The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-96).
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 VT -Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
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 Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
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 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD protocols,
they should be modified as appropriate so that the data generated by the study will satisfy the
requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying with
data requirements when the studies were not conducted in accordance with acceptable standards.
The OECD protocols are available from OECD, 2001 L 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 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2yB^ NOTICESISSUED 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(sX 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
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for 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
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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 chose 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. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must be
submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). 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.
1. 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
the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions of
this Notice which are contained in Section IV-C.
2. 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 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on 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.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 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 — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
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. 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
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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 — 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. 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 — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed 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.
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In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burdens 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 will normally 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:
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(j) " '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(k), 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 must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
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c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregi strati on Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually 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 you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in the Agency's files, you need only
cite it along with the notification. If not in the Agency's files, you must submit a summary and
copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also 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.
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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 all other disciplines
the classification would be "acceptable." With respect to any studies for which you wish to select
this option you must provide the MRID number of the study you are citing and, if the study has
been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
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 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.
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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
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.
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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 would generally 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
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
42
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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 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.
43
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregi strati on Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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4-CPA DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing 4-CPA.
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 reregi strati on of 4-CPA.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2) the
Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements Status and
Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), (6)
a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share and Data Compensation
Forms in replying to this 4-CPA Product Specific Data Call-In (Attachment 7). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for 4-CPA are contained in
the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on 4-CPA 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 reregi strati on of
all eligible 4-CPA 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 C.P. Moran at (703) 308-8590.
All responses to this Notice for the Product Specific data requirements should be submitted to:
C.P. Moran
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 4-CPA
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you must
respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the EPA
registration numbers of your source(s); you would 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.
Item 7a. 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." 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. See Item 6 with regard to identical
products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. 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.
46
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47
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item 3.
This number must be used in the transmittal document for any data submissions
in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's continued
registration are identified. These guidelines, in addition to the requirements specified
in the 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. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements is
(are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies only
pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the product
as formulated for sale and distribution is the test substance, except in rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). 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. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
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. By the specified due date, I will also
48
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submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. 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 also submitting a completed
"Certification of Offer to Cost Share in the Development Data" form. 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 (Section III-
C.l.) apply as well. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to show
what data compensation option I have chosen. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
5. By the specified due date, I will submit or cite data to upgrade a study classified by the
Agency as partially acceptable and upgradable (Upgrading a Study). I will submit
evidence of the Agency's review indicating that the study may be upgraded and what
information is required to do so. I will provide the MRID or Accession number of the
study at the due date. I understand that the conditions for this option outlined Option
5 in the Data Call-In Notice (Section III-C. 1.) apply. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
6. By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency
49
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(Citing an Existing Study). If 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 EPA
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) for the cited data on a "Product Specific
Data Report" form or in a similar format. By the specified due date, I will also submit:
(1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be submitted in the format required by P.R. Notice 86-5].
I understand that this is my only opportunity to state the reasons or provide information
in support of my request. If the Agency approves my waiver request, I will not be
required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency
denies my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30 days
of my receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating 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. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. 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.
50
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51
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52
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53
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54
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EPA'S BATCHING OF 4-CHLOROPHENOXYACETIC ACID 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 reregi strati on of products containing 4-chlorophenoxyacetic acid 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
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological
studies for each of their own products. If a registrant chooses to 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, 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
55
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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.
Two products were found which contain 4-chlorophenoxyacetic acid as the active ingredient.
Both products have been placed into the "no batch" category in accordance with the active and inert
ingredients, type of formulation and current labeling. The following table identifies the products
addressed in this document.
Table 1 (No batch)
EPA Reg. No.
8906-1
62469-1
% 4-Chlorophenoxyacetic acid
99.99
0.0015
Formulation Type
Solid
Liquid
56
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Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice
57
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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.
58
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60
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, 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 Maine
Product Name
Company Number
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
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 firm(s) 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
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
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Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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APPENDIX E. List of Available Related Documents
The following is a list of available documents related to 2115. It's purpose is to provide a
path to more detailed information if it is needed. These accompanying documents are part of the
Administrative Record for 2115 and are included in the EPA's Office of Pesticide Programs Public
Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. 2115 RED Fact Sheet
4. PR Notice 86-5
5. PR Notice 91-2 - pertains to the Label Ingredient Statement
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