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

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       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

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             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

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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

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       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
                                           28

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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).
                                          32

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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.
                                            33

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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


                                           34

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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.
                                             35

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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

                                            36

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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.
                                            37

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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

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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.
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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
                                           44

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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.
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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

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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

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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.
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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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59

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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
                                                  61

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62

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                         United States Environmental Protection Agency
                                     Washington, DC 20460
                               CERTIFICATION WITH RESPECT TO
                            DATA COMPENSATION REQUIREMENTS
                                                                              2
\


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)
                                                           63

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64

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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
                                         65

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