United States
        Environmental Protection
        Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-94-005
April 1994
v>EPA Reregistration
        Eligibility Decision (RED)
        Hexadecadienol
        Acetates
                                Recycled/Recyclable
                                Printed witti SoyfCanoialnX on paper thai
                                contains at least 50% recycled fiber

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I
                     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                       WASHINGTON, D.C. 20460
                                                                            OFFICE OF
                                                                        PREVENTION, PESTICIDES
                                                                        AND TOXIC SUBSTANCES
 CERTIFIED MAIL
 Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
 reregistration eligibility review and decisions on the pesticide chemical case Hexadecadienol
 Acetates which includes the active ingredients (Z,E)-7,ll-Hexadecadien-l-yl acetate and
 (Z,Z)-7,ll-Hexadecadien-l-yl acetate.  The enclosed Reregistration 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
 reregistration.  The RED  includes the data and labeling requirements for products for
 reregistration.  It may also include requirements for additional data (generic) on the active
 ingredients to confirm the risk assessments.

       To assist you with a proper response, read the enclosed document entitled "Summary
 of Instructions for Responding to the RED".  This summary also refers to other enclosed
 documents which include  further instructions.  You must follow all instructions and submit
 complete and timely responses.  The first set of required responses are due 90 days from
 the date of this letter. The second set of required responses are due 8 months from the
 date of this letter.  Complete and timely responses will avoid the Agency taking the
 enforcement action of suspension against your products.

       If you have questions on the product specific data requirements or wish to meet with
 the Agency, please contact the Special Review and Reregistration Division representative
 Franklin Gee at (703) 308-8008.  Address any questions on required generic data to the
 Special Review and Reregistration Division representative Tom Myers at (703) 308-8074.

                                                      Sincerely yours,
Enclosures
                                                       >aniefKT. liarolo, Dire;
                                                      Special Review and
                                                       Reregistration Division
                                                                           :or

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              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
             THE REREGISTRATION ELIGIBILITY DECISION (RED)

1.    DATA CALL-IN (DCI) OR "90-DAY RESPONSE"-If generic data are required
for reregistration, a DCI letter will be enclosed describing such data.  If product specific
data are required, another DCI letter will be enclosed listing such requirements.  Complete
the two response forms provided with each DCI letter by following the instructions contained
in each DCI.  You must submit the response forms for each product and for each DCI
within 90 days of the date you receive the RED; otherwise, your product may be
suspended.

2.    TIME EXTENSIONS AND  DATA WAIVER REQUESTS   No time extension
requests will be granted for the 90-day response. Time extension requests may be submitted
only with respect to actual data submissions.  Requests for data waivers must be submitted as
part of the 90-day response.  Requests for time extensions should be submitted in the 90-day
response, but certainly no later than  the 8-month response date.  All data waiver and time
extension requests must be accompanied by a full justification.  All waivers and time
extensions must be granted by EPA in order to go into effect.

3.    APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You
must submit the following items for each product within eight months of the RED
issuance date (the cover letter date).

      a.     Application for Reregistration (EPA Form 8570-1). Use only an original
      application form. Mark it "Application for Reregistration." Send your Application
      for Reregistration (along with the other forms listed in b-e below) to the address listed
      in item 5.

      b.     Five copies of draft labeling which complies with the RED and current
      regulations and requirements. Only make labeling changes which are required by the
      RED and current regulations  (40 CFR 156.10) and policies.  Submit any other
      amendments (such as formulation changes, or labeling changes not related to
      reregistration) separately.   You may delete uses which the RED says are ineligible for
      reregistration. For further labeling guidance, refer 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; 703-487-4650).

      c.    Generic or Product Specific Data.  Submit all data in a format which
       complies with PR Notice 86-5, and/or submit citations of data already submitted and
       give the EPA identifier (MRID) numbers.  Before citing these studies, you must
      make sure that they meet the Agency's acceptance criteria (attached to the DCI).

       d.    Two copies of the  Confidential  Statement of Formula (CSF) for each basic
       and each alternate formulation.  The labeling and CSF which you submit for each
       product must comply with P.R. Notice 91-2 by declaring the active ingredient as the
       nominal concentration.  You have two options for submitting a CSF: (1) accept the
       standard certified limits (see  40 CFR §158.175) or (2) provide certified limits that are
       supported by the analysis of  five batches.  If you choose the second option, you must
       submit or cite the data for the five batches along with a  certification statement as
       described in 40 CFR §158.175(e).  A copy of the CSF is enclosed; follow the

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       instructions on its back.

       e-     Certification With Respect to Citation of Data.  Complete and sign this
       form (EPA form 8570-29) for each product.  Cite-all is not a valid option for
       reregistration.

 4.     COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE
       Comments pertaining to the content of the RED may be submitted to the address
 shown hi the Federal Register Notice which announces the availability of this RED.

 5      WHERE TO SEND ALL PCI RESPONSES (90-DAY) AND APPLICATIONS
 FOR REREGISTRATION (8-MQNTH RESPONSES)

 By U.S. Mail;

       Document Processing Desk (RED-SRRD-XXXX)*   * XXXX = the
       Office of Pesticide Programs (H7504C)    case code for the
       EPA, 401 M St. S.W.                 RED (see front
       Washington, D.C. 20460-0001           cover of RED)

 By express:

       Document Processing Desk (RED-SRRD-XXXX)*
       Office of Pesticide Programs (H7504C)
       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 tune extension requests within 60 days.  EPA will also try to respond to  all
8-month submissions with a final reregistration determination within 14 months after the
RED has been issued.

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REREGISTRATION ELIGIBILITY DECISION

           Hexadecadienoi Acetates

                    LIST D

                  CASE 4111
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS
 HEXADECADIENOL ACETATES R.E.D. TEAM	    i

 GLOSSARY OF TERMS AND ABBREVIATIONS  	ii

 EXECUTIVE SUMMARY	   iv

 I.    INTRODUCTION	   1

 H.    CASE OVERVIEW	   2
      A.    Chemical Overview	'.	   2
      B.    Use Profile	   2
      C.    Estimated Usage of Pesticide^ 	   3
      D.    Data Requirements	   3
      E.    Regulatory History	   3

.HI.   SCIENCE ASSESSMENT	"	   4
      A.    Physical Chemistry Assessment	   4
      B.    Human Health Assessment	   5
            1.     Toxicology Assessment ,.	   5
                  a.    Acute Toxicityt	   5
            2.     Exposure Assessment	   6
                  a.    Dietary Exposure	   6
                  b.    Occupational and Residential	   6
            3.     Human Risk Assessment	   6
      C.    Environmental Assessment .	   6
            1.     Environmental Fate	   6
                  a.    Environmental Chemistry, Fate and Transport	   6
                  b.    Environmental Fate Assessment	   7
            2.     Ecological. Effects  	   7
                  a.    Ecological Effects Data	   7
                       (1)    Terrestrial Data	   7
                       (2)    Aquatic Data  	   8
                       (3)    Non-Targetjtasects Data	 .   8
                  b.    Ecological Effects Risk Assessment	   8

 IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	   9
      A.    Determination of Eligibility .	   9
            1.     Eligibility Decision . /.	'.'.'.'.'.'.  10
            2.     Eligible and Ineligible Uses  	      10
                                       t
 V.    ACTIONS REQUIRED BY REGISTRANTS	  H
      A.    Manufacturing-Use Products	  \ i
            1.     Additional Generic Data Requirements	  11

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            2.     Labeling Requirements for Manufacturing-Use Products	  11
      B.     End-Use Products	  11
            1.     Additional Product-Specific Data Requirements  	  11
            2.     Labeling Requirements for End-Use Products	  12
      C.     Existing Stocks  	  13

VI.   APPENDICES	  15
      APPENDIX A. Table of Use Patterns Subject to Reregistration	  17
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
            to Make the Reregistration Decision	  23
      APPENDIX C. Citations Considered to be Part of the Data Base
            Supporting the Reregistration of Hexadecadienol acetates  	  29
      APPENDIX D. List of Available Related Documents	  37
      APPENDIX E	  41
            PR Notice  86-5	  43
            PR Notice  91-2	  63
      APPENDIX F. Generic Data Call-In	  69
            Attachment 1. Chemical Status Sheet  	- • • •  89
            Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
                  Instructions  	  93
            Attachment 3. Requirements Status and  Registrants' Response
                  Forms Inserts (Form B) plus Instructions	 .  98
            Attachment 4. List of Registrants) sent this DCI (Insert)  	105
      APPENDIX G. Product Specific Data Call-in   	107
            Attachment 1. Chemical Status Sheet  	123
            Attachment 2. Product Specific Data Call-In Response Forms (Form
                  A inserts) Plus Instructions 	125
            Attachment 3. Product Specific Requirement Status and
                  Registrant's Response Forms (Form B inserts) and
                  Instructions  	129
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	135
            Attachment 5. EPA Acceptance Criteria	139
            Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                  Notice	153
            Attachment 7. Cost Share Data Compensation Forms, Confidential
                  Statement of Formula Form and Instructions	155
      APPENDIX H. FACT SHEET	165

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                  HEXADECADIENOL ACETATES R.E.D. TEAM
Office of Pesticide Programs:

Biological and Economic Analysis Division

Eric Maurer
Paul Guillebeau

Environmental Fate and Effects Division

Regina Hirsch
Sharlene R. Matten
E. Brinson Conerly-Perks

Health Effects Division

Roy Sjoblad
J. Thomas McClintock
Al Nielson

Registration Division

JoAnne Hayes
Teung Chin
Willie Nelson

Special Review and Reregistration Division

Tom Myers

Policy and Special Projects Stafi?

Deborah Hartman

Office of Compliance Monitoring:

Beverly Updike

Office of General Counsel:

Kevin Lee
Economic Analysis Branch
Biological Analysis Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Science Analysis Branch
Science Analysis Branch
Occupational and Residential Exposure Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Accelerated Reregistration Branch

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                  GLOSSARY OF TERMS AND ABBREVIATIONS
a.i.

CAS

CSF

EEC


EP

EPA

FDA

FIFRA

FFDCA

GRAS

HDT
LD
   '50
LDIO

LEL

LOEL

MP

MPI
Active Ingredient

Chemical Abstracts Service

Confidential Statement of Formula

Estimated Environmental Concentration.  The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.

End-Use Product

U.S. Environmental Protection Agency

Food and Drug Administration

Federal Insecticide, Fungicide, and Rodenticide Act

Federal Food, Drug, and Cosmetic Act

Generally Recognized As Safe as designated by FDA

Highest Dose Tested

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.

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.

Lethal Dose-low. Lowest Dose at which lethality occurs

Lowest Effect Level

Lowest Observed Effect Level

Manufacturing-Use Product

Maximum Permissible Intake
                                         11

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


MOE        Margin Of Exposure (PAD)

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

N/A         Not Applicable

NPDES      National Pollutant Discharge Elimination System

NOEL       No Observed Effect Level

OPP         Office of Pesticide Programs

PADI        Provisional Acceptable Daily Intake

ppm         Parts Per Million

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

RED         Reregistration Eligibility Decision

RfD         Reference Dose

RS          Registration Standard

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

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

TGAI        Technical Grade Active Ingredient.

TMRC       Theoretical Maximum Residue Contribution.
                                        m

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EXECUTIVE SUMMARY
       The Environmental Protection Agency has completed an assessment of the potential
human health and environmental risks  associated with the pesticidal use of hexadecadienol
acetates hi the United States.

       Hexadecadienol  acetates  are registered  as  a sex-attractant pheromone of the pink
bollworm (Pectinophora gossvpiella, Saunders), and are applied to growing cotton to disrupt the
male-female mating behavior.

       The Agency has determined that the use of hexadecadienol acetates as currently registered
will not cause unreasonable risk to humans or the environment and that this use is eligible for
reregistration. The Agency is requiring additional confirmatory ecological effects  studies. A
freshwater fish study with the rainbow trout and a freshwater invertebrate study with Daphnia
magna are required to confirm that the risk to  freshwater fish and aquatic invertebrates are
minmal.

       Before reregistering the products  containing hexadecadienol  acetates,  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 for certain registrations.
After reviewing these data and any revised labels and finding them acceptable in accordance with
Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain
other active ingredients will be eligible for reregistration only when the other active  ingredients
are determined to be eligible for reregistration.
                                            IV

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 I.     INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
 to accelerate the reregistration of products with active ingredients registered prior to November
 1, 1984. The amended Act provides a schedule for the reregistration process to be completed
 hi 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 hi Phase 5 "the Administrator shall  determine whether
 pesticides containing such active ingredient are eligible for registration" before  calling in data
 on products and either reregistering products or taking "other appropriate regulatory action."
 Thus,  reregistration involves  a thorough review  of the scientific  data base underlying  a
 pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
 arising from the currently registered uses of the pesticide; to determine the need for additional
 data on health and environmental effects; and to determine whether the pesticide meets the "no
 unreasonable adverse effects" criterion of FIFRA.

 This document presents the Agency's decision regarding the  reregistration eligibility of the
 registered uses of hexadecadienol acetates. The document consists of six sections. Section I is
 the introduction. Section II  describes hexadecadienol  acetates,  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
hexadecadienol acetates. Section V discusses the reregistration requirements for hexadecadienol
acetates. 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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H.     CASE OVERVIEW

       A.    Chemical Overview

             The following active ingredients are covered by this Reregistration Eligibility
       Document:

       •     Common Name:     Hexadecadienol acetates
       •     Chemical Names:    (Z,E)-7,ll-Hexadecadien-l-yl acetate
                                 (Z,Z)-7,11-Hexadecadien-l-yl acetate
             CAS Registry Numbers:   52207-99-5 and 53042-79-8
             OPP Chemical Codes:     114101 and 114102
             Empirical Formula:       C18H34O2
             Trade and Other Name(s): Gossyplure
             Basic Manufacturers:     biosys and Mitsubishi International Co.
       B.     Use Profile

              The following is information on the current registered use with an overview of
       the use site and application methods.  This information is accurate as of December 16,
       1993.  A detailed table of the use of hexadecadienol acetates is in Appendix A.

              For 114101 and 114102:

              Type of Pesticide:    Biochemical (insect pheromone)
              Use Site:
Terrestrial Food/Feed (Cotton)
              Target Pest:   Pink Bollworm (Pectinophora gossypiella, Saunders)

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       Formulation Types Registered:    impregnated material
                                         emulsifiable concentrate
                                         water disperable granules (dry flowable)

              All of the hexadecadienol acetate formulations are contained, embedded
       or impregnated in a solid polymeric matrix or shell.

       Method and Rates of Application:

              Equipment -   solid matrix dispensers (capillary fibers), aerial and ground
                            sprayers

              Method -  by hand, aerial and ground broadcast
                     Impregnated  material   is  applied  as  400   or   more   twist
              dispensers/acre.   No maximum rate  indicated.   400-500  impregnated
              stakes per acre.

                     Microencapsulated formulations are sprayed as tank mix or alone
              by air or groimd equipment in water or oil mixtures.  Maximum rate is
              9 grams/ai/acre/application in an unspecified amount of diluent.
C.     Estimated Usage of Pesticide

       Hexadecadienol acetates are only registered for use on growing cotton against the
pink bollworm. Approximately 1 % of the cotton crop grown in California is treated with
hexadecadienol acetates.  Less than 100 pounds of the active ingredient are applied each
year.
D.     Data Requirements

       In addition to data requirements imposed to obtain the original registration of this
active ingredient, data were required in the reregistration Phase IV Data Call-In issued
on April 23, 1993.  Appendix B includes all generic data requirements identified by the
Agency for the currently registered use needed to support reregistration.
E.     Regulatory History

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             Pesticide products containing hexadecadienol acetates as active ingredients were
      first registered in the United States in 1978.  Currently, there are ten products registered
      to six companies.   These products employ the sex-attractant pheromone of the pink
      bollworm which are applied to fields of cotton to disrupt the  male-female  mating
      behavior.

             The reregistration case contains four active  ingredients.  Two of the four are
      currently used in registered products.  The two registered ingredients are: (Z,E)-7,11-
      hexadecadien-1-yl acetate (chemical number 114101) and (Z,Z)-7,ll-hexadecadien-l-yl
      acetate (chemical number 114102).  The two active ingredients currently not in any
      registered products  are 7,11-hexadecadienl-yl acetate (chemical number 114103) and
      (E,Z)-7,ll-hexadecadien-l-yl acetate (chemical number 128914).

             All of the  hexadecadienol acetate formulations are contained,  embedded or
      impregnated in a solid polymeric matrix or shell.

             In March of 1994, the Agency published  hi the Federal Register, a final rule
      exempting from the requirement  of  a tolerance, residues of  arthropod pheromones
      resulting from  the  use  of  these substances hi retrievably-sized  polymeric matrix
      dispensers with an annual application limitation of 150 grams active ingredient per acre
      for pest control  hi or on all raw agricultural commodities.

             Presently, the  Agency  is  considering  a  policy  for  exempting arthropod
      pheromones used hi solid matrix dispensers which would exempt them from regulation
      under FIFRA because these uses of pheromones are not considered to pose any greater
      risk to human health or  the environment than those pheromone active  ingredients  hi
      traps.  Therefore, in the future, it is  conceivable that all solid matrix formulations  of
      arthropod with a limitation of 150 g a. i./A/year would be exempt from regulation under
      FIFRA.
HI.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

             The active ingredients,  (Z,E) and (Z,Z)-7,11 hexadecadien-1-yl acetates,  are
       biochemical pesticides which are chemically synthesized hi an 11-step process with the
       purity of several intermediate products determined by gas chromatography.  The end
       product, which contains both isomers (Z,E and Z,Z) is distilled and purity confirmed by
       gas chromatography.  During the manufacturing process of the technical grade material
       several unintentional ingredients (impurities) are synthesized as byproducts.  However,
       an upper certified limit for each impurity has been established and this limit is not to
       exceed 1%.   The other minor impurities (less than 0.1%) hi  the final product are
       structural isomers of the active ingredients and are not expected  to contain a toxic

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component or sensitizing agent.

       The pheromone solution, containing the technical grade material and inerts, is
then contained, embedded or impregnated in a solid polymeric matrix or shell.
B.
Human Health Assessment
       1.
       Toxicology Assessment
              The toxicological data base on hexadecadienol acetates is adequate and will
       support reregistration eligibility.

              a.     Acute Toxicity

                    All acute toxicology studies for the technical active ingredient have
              been submitted and adequately satisfy the requirements as set forth in 40
              CFR 158.690 for food/feed use. The folio whig results from toxicology
              studies have been submitted to support the reregistration of the active
              ingredient.
STUDY
Acute Oral LD50
Acute Dermal LD50
Acute Inhalation LC50
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Mutagenicity (Ames Assay)
RESULTS
> 5 gm/kg
> 2 gm/kg
> 2.5 mg/1
Slight Irritation*
Slight Erythema
Not a Sensitizer
Not Mutagenic
CATEGORY
IV
III
III
m
IV
N/A
N/A
 Mignt iritis and conjunctiva! irritation
                    Since  the  potential  for  nondietary and dietary  exposure  is
             considered  negligible,  because the active ingredients are  contained,
             embedded or impregnated in a solid polymeric matrix or shell, the other
             standard toxicology and developmental toxicity studies for reregistration
             have been waived.  Consequently, all toxicology data requirements have
             been satisfied.

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      2.     Exposure Assessment

             a.     Dietary Exposure

                   An exemption from  the  requirments  of a tolerance  has been
             established for residues of the active ingredient as specified in 40 CFR
             180.1043, in or on  the raw agricultural  commodity cottonseed when
             applied to cotton from capillary fibers.

                   This exemption does not includ the  microencapsulated material.

             b.     Occupational and Residential

                   Based on the fact  that  the  active ingredients  are  contained,
             embedded or impregnated  in a  solid polymeric matrix or  shell,  low
             exposure and lack of significant toxicological concerns, as demonstrated
             in the battery of acute toxicity studies, no exposure data are required.
      3.     Human Risk Assessment

                   The potential risks to humans from both nondietary and dietary
             routes  are considered negligible  because the  active ingredients  are
             contained, embedded or impregnated in a solid polymeric matrix or shell,
             low  exposure  and  lack  of  significant  toxicological  concerns,   as
             demonstrated in the submitted toxicology studies.  Residue data are  not
             required for the microencapsulated material because the active ingredient
             is applied at less than 20  g/ai/acre/application.
C.    Environmental Assessment

      1.     Environmental Fate

             The Agency is relying on data available hi the scientific literature to assess
      the environmental fate and transport of hexadecadienol  acetates used as  a
      pesticidal compound.

             a.     Environmental Chemistry, Fate and Transport
                    This biochemical has been discussed in the open literature (Henson,
             R.D.    Environmental  Entomology,  Vol 6,  Environmental Fate  of

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       Gossvplure).  An hydrolysis study revealed that one  degradate, 7,11-
       hexadecienol, was identified in minimal concentrations.  In attempts to
       study  its rate  of photodegradation,  the  compound  was applied to
       microscope   slides  which  were  placed  outdoors  for  24  hours.
       Volatilization was  so rapid that  no major degradates  were observed,
       suggesting that volatilization occurred more rapidly than photodegradation.

       b.     Environmental Fate Assessment

              As is common with pheromones, hexadecadienol acetate is used in
       minute quantities.  This highly volatile chemical disperses rapidly into the
       air  when  unconfined.     Hexadecadienol  acetate   is  applied  in
       retrievably-sized polymeric matrix dispensers (twist ties and impregnated
       stakes) to slow  its dispersal into the air.   By using these formulations,
       hexadecadienol acetate remains effective for up to 20 days.  Because there
       is no direct application of hexadecadienol acetate to the soil or water, soil
       and water contamination are not expected.

              Hexadecadienol acetate can also be microencapsulated and applied
       to foliage via broadcast, ground- and aerially-applications. These are water
       soluble formulations sprayed either as tank mixes or alone as emulsifiable
       concentrates or water dispersable granules.  By using these formulations,
       hexadecadienol acetate remains effective for up to 20 days.  Because there
       is potential for the microencapsulated material to reach soil or water, soil
       or water contamination  is possible.   However,  the microencapsulated
       hexadecadienol  acetate assumes the vapor  state  as it is released from
       microencapsulation, and  would rapidly disperse.  Therefore, the amount
       which would actually  be available in the ecosystem at any given time
       would be a small fraction of the amount applied.
2.     Ecological Effects
       a.      Ecological Effects Data
              (1)    Terrestrial Data

                    Technical hexadecadienol is considered to be practically
              non-toxic to bobwhite quail with an acute oral LD50 of greater than
              2000 mg/kg (MRID#s  42132901 and 42102708).   The dietary

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      toxicity to bobwhite quail is considered to be practically non-toxic
      with a dietary LC50 of greater than 5620 ppm (MRID# 41265801).

      (2)    Aquatic Data

             The toxicity of technical hexadecatiienol acetate to rainbow
      trout is tentatively characterized as pratically non-toxic with a 96-
      hour LC50 of greater than 120 ppm (MRID# 42132902).  The
      toxicity of technical hexadecadienol acetate to Daphnia magna is
      tentatively characterized as highly  toxic with a 48-hour EC50 of
      0.70 ppm (MRID# 42092501).  Both aquatic studies are considered
      to be  unacceptable and  need to be repeated according  to the
      guidelines  to   determine  the  toxicity  and  the  appropriate
      precautionary label information to ensure minimal risk to aquatic
      organisms.  The presence of an oily film  indicates  only  partial
      availability  of the test material in solution and requires analytical
      verification of the test concentration to be scientifically valid.
             The aquatic invertebrate life cycle test is reserved pending
      the results of a confirming freshwater invertebrate acute toxicity
      test.  However, based on the data submitted the ECSO = 0.7 mg/1.
      This  means that the experimental EC50  <  lmg/1  which  is the
      trigger point for the requirement of an invertebrate  life cycle
      study.  Therefore, if an acceptable acute invertebrate study results
      in an EC50 <  1 mg/1 than the aquatic invertebrate life cycle test
      may  be required.

      (3)    Non-Target Insects Data

             Hexadecadienol acetate is considered to be practically non-
      toxic to honey bees (MRID# 237758).
b.     Ecological Effects Risk Assessment

       A terrestrial risk assessment can be performed with the core acute
avian toxicity data and limited use and  application rate information on
hexadecadienol  acetate.    This  risk assessment  was  based on the
information provided by the emulsifiable concentrate formulation.  Aerial
and ground applications of hexadecadienol acetate emulsifiable concentrate
pose the greatest exposure threat to terrestrial organisms.

       Hexadecadienol acetate emulsifiable concentrate is  applied as a

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                     sex-attractant pheromone  to control the pink bollworm on cotton and
                     would indirectly contaminate avian food items.  The chemical is broadcast
                     applied as a ground- or aerial-spray.  The terrestrial risk assessment with
                     the emulsifiable concentrate indicates the  expected  residues would be
                     below all levels of concern for both non-target  and endangered  avian
                     species.

                           Only  a  preliminary  aquatic organism  risk  assessment  was
                     performed using the available supplemental acute freshwater toxicity data
                     and limited use  and application information on hexadecadienol acetate.
                     The available hazard data are not scientifically valid due to inappropriate
                     test procedures, notably improper  solubilization of the test material.
                     Aerial and ground  applications of  hexadecadienol acetate  emulsifiable
                     concentrate pose the greatest exposure threat to aquatic  organisms.

                           A direct  application model was  used to calculate the expected
                     estimated environmental concentration (EEC) for hexadecadienol acetate
                     emulsifiable concentrate.  Based on this exposure model, the nature of the
                     chemical (highly volatile),  the low application rate, and  using the
                     supplemental acute toxicity data, the preliminary risk assessment suggests
                     that adverse effects to freshwater organisms would be minimal.  However,
                     to confirm this conclusion, the acute freshwater fish study (72-1) and the
                     acute  freshwater invertebrate study with Daphnia (72-2)  need  to  be
                     repeated. The presence  of an oily  film in these two  studies suggests
                     toxicity  may actually be  higher  than indicated in the faulty studies.
                     Therefore,  the test  concentration requires  analytical verification to  be
                     scientifically valid.
                    Endangered Species

                           Based on the current use patterns and amount of active ingredient
                    used, potential adverse effects to avian and aquatic endangered species
                    would be minimal.  However, data on aquatic fish and invertebrates are
                    required to confirm this assumption.
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

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required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing hexadecadienol acetate active ingredients.
The Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all products containing hexadecadienol
acetate as me sole active ingredient. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility of
hexadecadienol acetates, and lists the submitted studies that the Agency found acceptable.
However, ecological effects data are required to confirm that the risk to both freswater
fish (rainbow trout) and aquatic invertebrates (Daphnia magna) will be minimal.

       The data identified in Appendix B were sufficient to allow the Agency to  assess
the registered uses of hexadecadienol acetates and  to  determine that hexadecadienol
acetates can be used without resulting in unreasonable adverse effects to humans and the
environment.  The Agency therefore finds that all products containing hexadecadienol
acetates as the sole 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  and the  data  identified in Appendix B.  Although the
Agency has found that all uses of hexadecadienol acetates 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 hexadecadienol acetates, 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 of  the four  active  ingredient
hexadecadienol acetates, the Agency has sufficient information on their potential effects
on human health.  The  Agency has determined that hexadecadienol acetate products,
labeled and used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment.   Therefore,  the
Agency  concludes that products containing hexadecadienol acetates for the currently
registered use are eligible for reregistration.
       2.     Eligible and Ineligible Uses

              The Agency has  determined that  the currently  registered  use  of
       hexadecadienol acetates is  eligible for reregistration.
                                     10

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V.    ACTIONS REQUIRED BY REGISTRANTS

      This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
      A.    Manufacturing-Use Products

             1.    Additional Generic Data Requirements

                   The generic data base supporting the reregistration of the eligible use
             hexadecadienol  acetate has been reviewed and determined to be substantially
             complete.    However,  ecological  effects data are required to  confirm the
             assumption that the risk to both freshwater  fish (rainbow trout) and aquatic
             invertebrates (Daphnia magna) will be minimal.

             2.    Labeling Requirements for Manufacturing-Use Products

                          Effluent Discharge Labeling Statements

                   All manufacturing-use products that  may  be contained  in an effluent
             discharged to the waters of the United States  or municipal sewer systems must
             bear the following revised effluent discharge labeling statement.

             "Do not discharge effluent containing this product into lakes, streams, ponds,
             estuaries, oceans or other waters  unless in accordance with the requirements of
             a National Pollutant Discharge Elimination  System (NPDES) permit and the
             permitting authority has been notified  in writing prior to  discharge. Do not
             discharge effluent containing this product to  sewer systems without previously
             notifying the local sewage treatment plant authority. For guidance contact your
             State Water Board or Regional Office of the EPA."

                   All affected products distributed  or sold by registrants and distributors
             (supplemental registrants) must bear the above labeling by October 1, 1995. All
             products distributed or sold by persons  other than registrants or supplemental
             registrants after October 1, 1997 must  bear  the correct labeling. Refer to PR
             Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.


      B.     End-Use Products

             1.     Additional Product-Specific Data Requirements
                                         11

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       Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made.  The product  specific data  requirements are listed in Appendix
G, the Product Specific Data Call-In Notice.

       Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new  studies.  If a  registrant believes that previously submitted data
meet current  testing standards, then study  MRID  numbers should  be cited
according to the instructions hi the Requirement Status and Registrants Response
Form provided for each product.

2.     Labeling Requirements for End-Use Products

       Based on the supplemental data, the following precautionary statement for
technical hexadecadienol acetate is needed for freshwater invertebrates.

"This product is highly toxic to freshwater  invertebrates.  Do not apply directly
to water,  or to areas where surface water is present or to intertidal areas below
the mean  high-water mark.   Drift and runoff may be hazardous to aquatic
organisms hi neighboring areas.  Do not contaminate water when disposing of
equipment washwater or rinsate"

       In addition, each label  must include the amount of active ingredient to be
applied per application; maximum number of applications per year and minimum
number of days between each application.

       The labels and labeling of all products must comply with EPA's current
regulations and  requirements as specified in 40 CFR §156.10.

       Any additional" end-use product precautionary  labeling  and  personal
protective equipment will be determined upon submission or citation and review
of acute toxicity studies conducted on the end-use product.

Worker Protection Standard

       Any product whose labeling reasonably permits use hi the  production of
an agricultural plant on any farm, forest, nursery, or greenhouse must .comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required
by the Worker Protection Standard (WPS), and PR Notice 9311, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed  in accordance
                              12

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       with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
       otherwise specifically directed in this RED, all statements required by PR Notices
       93-7  and 93-11 are to be on the product label exactly  as instructed  hi those
       notices.

              After April 21,  1994, except as otherwise provided hi PR Notices 93-7
       and 93-11,  all products within the scope of those notices must bear WPS PR
       Notice complying labeling when they are distributed or sold  by the  primary
       registrant or any supplementally registered distributor.

              After October 23, 1995, except as otherwise provided in PR Notices 93-7
       and 93-11,  all products within the scope of those notices must bear WPS PR
       Notice complying labeling when they  are distributed or sold by  any person.
C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products
for 50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes,  and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register.  Volume 56, No. 123, June 26, 1991.

       The Agency has determined that registrants may distribute and sell hexadecadienol
acetate 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.
                                    13

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VI.  APPENDICES
       15

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APPENDIX A. Table of Use Patterns Subject to
                Reregistration
                      17

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APPENDIX B.  Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          23

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                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Hexadecadienol acetates covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Hexadecadienol
acetates 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 hi 40 CFR Part 158.  the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.

       2.  Use  Pattern (Column 2).  This column indicates the use patterns  for which the
data requirements apply.  The following letter designations are used for the  given use
patterns:

                          A     Terrestrial food
                          B     Terrestrial feed
                          C     Terrestrial non-food
                          D     Aquatic food
                          E     Aquatic non-food outdoor
                          F     Aquatic non-food industrial
                          G     Aquatic non-food residential
                          H     Greenhouse food
                          I      Greenhouse non-food
                          J      Forestry
                          K     Residential
                          L     Indoor food
                          M    Indoor non-food
                          N     Indoor medical
                          O     Indoor residential

       3.  Bibliographic citation (Column 3). If the Agency has acceptable data hi 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 C.  Citations Considered to be Part of the
     Data Base Supporting the Reregistration of
              Hexadecadienol acetates
                        29

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                         GUIDE TO APPENDIX C

 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.

 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.

 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.

 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
                                    31

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the date from the evidence contained in the document.  When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.

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.

Trailing parentheses.  For studies submitted to the Agency in the past, the
trailing  parentheses include (hi addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1)


(2)
(3)


(4)
Submission date.  The date of the earliest known submission appears
immediately following the word "received."

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.

Submitter.  The third element is the submitter.  When authorship is
defaulted to the submitter, this element is omitted.

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.
                              32

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                                 BIBLIOGRAPHY
 MRID
CITATION
 00083061    Brusick, DJ. (1977) Mutagenicity Evaluation of Gossyplure: LBI Project No.
             2683.  Final rept.  (Unpublished study received Sep 9, 1977 under 36638-1;
             prepared by Litton Bionetics, Inc., submitted by Conrel, an Albany
             International Co., Needham Heights, Mass.; CDL:096345-K)

 00109904    Barker, R. (19??) Is Gossyplure Safe to Honey Bees?  (U.S. Dept. of
             Agriculture, Science and Education Administration, Carl Hayden Bee Research
             Center; unpublished study; CDL:237758-B)

 00138848    Shapiro, R. (1983) Ames Mutagenicity Test: Z,Z,Z, E-7, 11-hexadecadienyl
             Acetate: Report No. T-3466. (Unpublished study received Jan 19, 1984 under
             8730-41; prepared by Product Safety Labs, submitted by Herculite Products,
             Inc., New York, NY; CDL:252281-B)

 00138849    Wo, C.; Shapiro, R.  (1984) Modified Eye Irritation: Z,Z,Z, E-7, 11-
             hexadecadienyl Acetate: Rabbits: Report No. T-3479.  (Unpublished study
             received Jan 19,  1984 under 8730-41; prepared by Product Safety Labs,
             submitted by Herculite Products, Inc., New York,  NY; CDL:252281-C)

 00138851    Costello, B.; Moore,  G.  (1983) Acute Oral Toxicity -  Rats: Disrupt Lure in
             Kill PBW Powder: Project No.  83-3858A. (Unpublished study received Jan
             19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted by Herculite
             Products, Inc., New York,  NY; CDL:252281-E)

 00138852    Costello, B.; Moore, G.  (1983) Acute Dermal Toxicity - Rabbits: Disrupt
             Lure in Kill PBW Powder:  Project No. 83-3858A.  (Unpublished study
             received Jan 19,  1984 under 8730-41; prepared by  Bioresearch Inc., submitted
             by Herculite Products, Inc., New York, NY; CDL:252281-F)

00138853    Costello, B.; Moore, G. (1983) Primary Skin Irritation - Rabbits: Disrupt Lure
             in Kill  PBW Powder: Project No.  83-3858A.   (Unpublished study received Jan
             19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted by Herculite
             Products, Inc., New York, NY; CDL:252281-G)

00138854    Hershman, R.; Moore, G. (1983) Primary Eye Irritation - Rabbits: Disrupt
             Lure hi Kill PBW Powder: Project No. 83-3858A.  (Unpublished study
             received Jan 19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted
             by Herculite Products, Inc., New York, NY; CDL:252281-H)
                                        33

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                               BIBLIOGRAPHY
MRID
CITATION
00138855     Wo, C.; Shapiro, R. (1983) EPA Acute Oral Toxicity: Gossyplure Powder:
             Rats: Report No. T-3450.  (Unpublished study received Jan 19, 1984 under
             8730-44; prepared by Product Safety Labs, submitted by Herculite Products,
             Inc., New York, NY; CDI/.252282-D)

00138856     Wo, C.; Shapiro, R. (1984) Guinea Pig Sensitization (Buehler): Gossyplure
             Powder: Report No. T-3480.  (Unpublished study received Jan 19, 1984 under
             8730-41; prepared by Product Safety labs, submitted by Herculite Products,
             Inc., New York, NY; CDL:252281-F)

00146520     Mitsubishi International Corp. (1985) MC 982 (Pink Boll Worm Pheromone
             Dispensers): Product Chemistry. Unpublished compilation. 16 p.

00153222     Phillips Chemical Co. (1985) Pesticide Registration Application for Phillips 66
             Technical Pheromone Gossyplure: Product Chemistry Data. Unpublished study
             24 p.

00157582     Mitsubishi International Corp. (19??) Manufacturing Process: Product
             Chemistry for Pink Boll Worm Pheromone. Unpublished compilation. 42 p.

00160402     Mitsubishi International Corp. (1984) Product Chemistry Data of Pink Boll
             Worm Pheromone Technical.  Unpublished compilation. 12 p.

00160981     Mitsubishi International Corp. (19??) Complete Chemical Description of Pink
             Boll Worm Pheromone Technical. Unpublished compilation. 19 p.

40885402    Hart, G. (1988) Acute Oral Toxicity Screen with Microencapsulated
             Gossyplure in Albino Rats. Unpublished study prepared by Riker/3M.  11 p.

41265801     Grimes, J.;  Jaber, M. (1988) Technical Pheromone Gossyplure:  A Dietary
             LC50 Study with the Bobwhite: Project No. 251-101. Unpublished study
             prepared by Wildlife International Ltd.  17 p.

41476903    Terrill, J. (1989) Acute Inhalation Toxicity Study with Technical Pheromone
             Gossyplure in the Rat: Lab Project Number: HLA STUDY No.  652-225.
             Unpublished study prepared by Hazleton Labs America, Inc.  42 P.

42092501    Graves, W.; Peters, G. (1991) Pink Bollworm Pheromone: A 48-Hour  Acute
             Toxicity Test with the Cladoceran (Daphnia magna):  Final Report: Lab Project

                                         34

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                               BIBLIOGRAPHY
MRID
CITATION
            Number: 322A-101.  Unpublished study prepared by Wildlife International
            Ltd.  22 p.

42102708    Campbell, S.; Lynn, S. (1991) Acute Oral Toxicity Study of Isomate291
            Pheromone in Bobwhite Quail: Lab Project Number: 322-101. Unpublished
            study prepared by Wildlife International Ltd.  19 p.

42132901    Campbell, S.; Lynn, S. (1991) Pink Bollworm Pheromone ZZ-7, 11-16AC
            50%, 11-6AC 50%: An Acute Oral Toxicity Study with the Northern
            Bobwhite: Lab Project Number: 322-101.  Unpublished study prepared by
            Wildlife International  Ltd.  18 p.

42132902    Campbell, S.; Lynn, S. (1991) Pink Bollworm Pheromone: A 96-Hour Static
            Acute Toxicity Test with the Rainbow Trout  (Oncorhynchus mykiss): Final
            Report: Lab Project Number: 322A-103.  Unpublished study prepared  by
            Wildlife International  Ltd. 20 p.
                                       35

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APPENDIX D. List of Available Related Documents
                      37

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       The following is a list of available documents related to Hexadecadienol acetates.  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 Hexadecadienol acetates
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.     Hexadecadienol acetates RED Fact Sheet

       4.     PR Notice 86-5 (included in this appendix)

       5.     PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
             Statement
                                         39

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APPENDIX E. PR Notices 86-5 and 91-2
                  41

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PR Notice  86-5
      43

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  \
   o
                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, D.C. 20460

                                  July 29, 1986
                              PR NOTICE 86-5
                                                      OFFICE OF

                                                 PREVENTION, PESTICIDES
                                                 AND TOXIC SUBSTANCES
 Attention:
 Subject:
    NOTICE  TO PRODUCERS, FORMULATORS, DISTRIBUTORS
                    AND  REGISTRANTS

          Persons responsible  for Federal  registration of
          pesticides.

          Standard format  for  data submitted under the
          Federal Insecticide,  Fungicide,  and Rodenticide
          Act  (FIFRA)  and  certain provisions of the Federal
          Food, Drug,  and  Cosmetic Act  (FFDCA).
 I.
Purpose
      To require data to be submitted to the Environmental
 Protection Agency (EPA)  in a standard format. This Notice  also
 provides additional guidance about, and illustrations of,  the
 required formats.

 II.   Applicability

      This PR Notice applies to all data that are submitted to EPA
 to satisfy data requirements for granting or maintaining
 pesticide registrations,  experimental use permits, tolerances,
 and related approvals under certain provisions of FIFRA and
 FFDCA.   These data are defined in FIFRA §10(d)(1).  This Notice
 does not, apply to commeircial,  financial, or production
 information,  which are,  and must continue to be, submitted
 differently under separate cover.

 III.  Effective Date

      This notice is effective on November 1, 1986. Data formatted
 according to this  notice  may be submitted prior to the effective
 date.   As of the effective date, submitted data packages that do
 not  conform to these requirements may be returned to the
 submitter for necessary revision.

 IV.   Background

      On September  26,  1984,  EPA published proposed regulations in
 the  Federal Register (49  FR 37956)  which include Requirements for
•Data Submission (40  CFR §158.32), and Procedures for Claims of
 Confidentiality of Data (40 CFR §158.33).  These regulations
                                45

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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality.  No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.

     OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.

V.   Relationship of this Notice to Other OPP Policy and Guidance

     While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves.   "Data reporting" guidance
is now under development in OPP, and will specify how the _ study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be compatible with submittal format
requirements described in this Notice.

     OPP has also promulgated a policy  (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3.  The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly  incomplete application
packages.  As of the effective date of  this Notice, _the_screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.

     OPP has also established a public  docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards  (see
40 CFR  §154.15 and  §155.32).  To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please  refer to Page 10 for more information about this
requirement.

     For several years, OPP has required that each application
for registration or other action include a list of all applicable
data requirements and an indication of  how each is satisfied--the
statement of the method of  support for  the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party.  That requirement is not altered by this notice, which
applies only to data  submitted with an  application.

VI.  Format Requirements

     A  more detailed  discussion of these format requirements
follows the index on  the next page, and samples of  some of the
requirements are attached.  Except for  the language of  the two
alternative forms of  the Statement of Data Confidentiality Claims
 (shown  in Attachment  3) which  cannot be altered, these  samples
are illustrative.   As  long  as  the  required information  is
included and clearly  identifiable, the  form  of  the  samples may be
altered to reflect  the  submitter's preference.

                                46

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                             - INDEX-
A.   Organization  of  the  Submittal  Package	   3

B.   Transmittal Document	  .   4

C.   Individual Studies  	   4

     C. 1  Special Considerations for  Identifying Studies  .  .   5

D.   Organization  of  each. Study Volume	6

     D. 1  Study Title Page	7
     D. 2  Statement  of Data Confidentiality Claims
                   (based  on FIFRA §10(d)(1) )   	   8
     D. 3  Confidential Attachment   	   8
     D. 4  Supplemental Statement of Data Confidentiality
            Claims  (other than those based on FIFRA §10(d)(1))  8
     D. 5  Good Laboratory Practice Compliance Statement   .  .   9

E.   Reference to  Previously Submitted Data  	 .9

F.   Physical Format  Requirements & Number of Copies   ....   9

G.   Special Requirements for Submitting Data to the Docket   10

                             **************

A.   Organization of  Submittal Package

     A "submittal package" consists of all studies submitted at
the same time for review  in support of a single regulatory
action, along with a  transmittal document and other related
administrative material  (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4,  8570-20, etc.) as appropriate.

     Data submitters  must  organize each submittal package as
described in this Notice.  .The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume.  Each study included in the submittal package must then
be bound separately.

     Submitters sometimes provide additional materials that are
intended to clarify,  emphasize, or otherwise comment to help
Product Managers and  reviewers better  understand the submittal.

        If such materials relate to one study,  they should be
     included as an appendix to that study.

     - If such materials  relate to more than one study  (as for
     example a summary of all studies  in a discipline)  or to the
     submittal in general, they must be included in the submittal
     package as a separate study (with title page and statement
     of confidentiality claims).
                                                            Text  Example
                                                            Page    Page
17

11
17

12

13
15

14
16
                                47

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B.
Transmittal Document
     The first item in each submittal package must be a trans-
mittal document.  This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e.,  a registration application,
petition, experimental use permit (EUP), §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing  (usually by
Guideline reference number) the data requirement(s) addressed by
each one.  The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter.  See Attachment 1 for an example of an
acceptable transmittal document.

     The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.

     The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, . . . . of the petition or application, as defined in 40 CFR  180.7
and 158.125,  (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.

     When a submittal package supports a tolerance petition_and
an application for a registration or an EUP,  list the petition
studies first, then the balance of the studies.  Within these two
groups of studies follow the instructions above.

C.   Individual Studies

     A study  is the report of a single scientific  investigation,
including all supporting analyses required for logical complete-
ness.  A study should be identifiable and distinguishable by a
conventional  bibliographic citation including author, date,  and
title.  Studies generally correspond in scope to  a  single Guide-
line requirement for supporting data, with some  exceptions dis-
cussed in section C.I.  Each study included in a  submittal
package must  be bound as a separate entity.   (See  comments on
binding studies on page 9.)

     Each study must be consecutively paginated,  beginning from
the  title page as page 1.  The  total number of pages in the  com-
plete study must be shown on the study title  page.   In addition
 (to  ensure that  inadvertently separated pages can be reassociated
with the proper  study during handling or review)  use either  of
the  following:

     -  Include  the total number of pages in the  complete  study on
     each page  (i.e., 1 of  250, 2 of 250,  ...250  of 250).

     -  Include  a company name or mark and  study  number on each
     page of  the study, e  g  , Company Name-1986-23.   Never  reuse
     a  study  number for marking the pages  of  subsequent  studies.

                                48

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      When a  single  study  is extremely long,  binding it in mul-
 tiple volumes is permissible  so  long as  the  entire study is pag-
 inated  in a  single  series, and each  volume is plainly identified
 by the  study title  and  its position  in the multi-volume sequence.

 c-!  Special Considerations for  Identifying  Studies

      Some studies raise special  problems in  study identification,
 because they address Guidelines  of broader than normal scope or
 for other reasons.

      a-  Safety Studies.   Several Guidelines  require testing for
 safety  in more than one species. In  these cases each species
 tested  should be reported as  a separate  study, and bound
 separately.

      Extensive supplemental reports  of pathology  reviews,  feed
 analyses,  historical control  data, and the like are often assoc-
 iated with safety studies.  Whenever possible these should be
 submitted with primary reports of the study,  and  bound with the
 primary study as appendices.  When such  supplemental  reports are
 submitted independently of the primary report, take care to fully
 identify the primary report to which they pertain.

      Batteries of acute toxicity tests,  performed on  the same end
 use product and covered by a  single  title page, may be bound
 together and reported as a single study.

      k-  Product Chemistry Studies.   All  product  chemistry data
 within  a submittal package submitted in  support of  an end-use
 product  produced from registered manufacturing-use  products
 should be bound as a single study under  a single  title  page.

      Product chemistry data submitted in  support  of a  technical
 product, other manufacturing-use product,  an  experimental  use
 permit,   an import tolereince petition, or  an end-use product
 produced from unregistered source ingredients, should be bound  as
 a single study for each Guideline series  (61, 62,  and  63)  for
 conventional pesticides, or for the equivalent subject  range  for
 biorational pesticides.   The first of the  three studies  in a
 complete product chemistry submittal for  a biochemical pesticide
 would cover Guidelines 151-10, 151-11, and 151-12; the  second
would cover Guidelines 151-13, 151-15, and 151-16; the  third
would cover Guideline 151-17.  The first study for a microbial
pesticide would cover Guidelines  151-20,   151-21,  and 151-22; the
 second would cover  Guidelines  151-23 and  151-25;  the third would
 cover Guideline 151-26.

     Note particularly that product chemistry studies are likely
to contain Confidential  Business  Information as defined in FIFRA
 §10(d) (1) (A), (B),  or (C), and if so must be  handled as described
in section D.3.  of  this  notice.
                               49

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     c.  Residue Chemistry Studies.   Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code.  The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully.  Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from_ processing a
single crop.  When more than one commodity is derived from a
single crop  (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study.  When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.

D.   Organization of Each Study Volume

     Each complete study must include all applicable elements in
the list below, in the order indicated.   (Also see Page 17.)
Several of these elements are further explained in the_following
paragraphs.   Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element

Study Title Page

Statement of Data
Conf i dent i ality
Claims

Certification  of Good
Laboratory Practice
Flagging  statements
Body of  Study
Study Appendices

Cover Sheet  to Confi-
dential Attachment
When Required                 Example

Always                        Page 12

One of the two alternative    Page 13
forms of this statement
is always required

If study reports laboratory   Page 16
work subject to GLP require-
ments

For certain toxicology studies (When
flagging requirements are finalized.)

Always - with an English language
translation if required.

At submitter's option

If CBI is claimed under FIFRA
§10 (d) (1) (A) ,  (B) , or  (C)
CBI Attachment
Supplemental  Statement
of Data  Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d) (1) (A) ,  (B) , or  (C)     Page 15

Only  if confidentiality is    Page 14
claimed on a basis other than
FIFRA §10 (d) (1) (A) ,  (B) , or  (C)
                                 50

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 D.I.  Title Page

      A title page is always required for each  submitted study,
 published or unpublished.   The title page must always be freely
 releasable to requestors;  DO NOT INCLUDE CBI ON THE TITLE PAGE.
 An  example of an acceptable title page  is on page 12 of this
 notice.   The following information must appear on the title page:

 a.    Study title.   The study title should be as descriptive as
 possible  It must clearly identify the substance(s) tested and
 correspond to the name of  the data requirement as it appears in
 the Guidelines.

 b-    Data requirement addressed.   Include on the title page the
 Guideline number(s)  of the specific requirement(s) addressed by
 the study.

 c.    Author(s).   Cite only individuals  with primary intellectual
 responsibility for the content of the study.   Identify them
 plainly as authors,  to -distinguish them from the performing
 laboratory,  study sponsor,  or other names that may also appear on
 the title page.

 d.    Study Date.   The title page  must include  a single date for
 the study.   If parts of  the study were  performed at different
 times, use only the date of the latest  element in the study.

 e-    Performing Laboratory Identification.  If the study reports
 work  done by one or more laboratories,  include on the title-page
 the name  and address of  the performing  laboratory or
 laboratories,  and the laboratory's internal project number(s)  for
 the work.   Clearly distinguish the laboratory's project
 identifier from any other  reference  numbers provided by the study
 sponsor or submitter.

 f•    Supplemental  Submissions.   If the  study is a commentary on
 or supplement  to another previously submitted study,  or if it
 responds  to  EPA questions  raised  with respect to an earlier
 study, include on  the title  page  elements a. through d.  for the
previously submitted study,  along with  the EPA Master Record
 Identifier  (MRID)  or Accession number of  the earlier study if you
know  these numbers.   (Supplements  submitted in the same submittal
package 'as the primary study should  be  appended to and bound with
the primary  study.   Do not  include supplements to more than one
study under  a  single  title page).

9;    Facts  of Publication.   If the  study is a reprint of a pub-
lished document,  identity  on  the  title page all relevant facts of
publication, such  as  the journal  title,  volume, issue,  inclusive
page numbers,  and  publication  date.
                                51

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D.2. Statements of Data Confidentiality Claims Under FIFRA
     §10(d)(1).

     Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33  (b) and  (c)   (See
Attachment 3).  These statements apply only to claims of data
confidentiality based on FIFRA §10(d) (1) (A),   (B), or  (C) .  Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(1) data confidentiality  (§158.33(b)) or
to waive such a claim (§158.33(c)).   In either case, the
statement must be signed and dated,  and must include the typed
name and title of the official who signs it.   Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions  (see NOTE Pg 13) .

D.3. Confidential Attachment

     If the claim is made that a study includes  confidential
business information as defined by the criteria  of FIFRA
§10(D) (1) (A) ,  (B), or (C)   (as described in D.2.  above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).

     The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment."  An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet.  Paginate the Confidential Attachment
separately from the body of the study, beginning with page_1  of X
on the title page.  Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s)  in the main body of the study on which it is  cited,
and with a reference to the applicable passage (s) of FIFRA
§10(d)(1) on which the confidentiality claim  is  based.

D.4. Supplemental Statement of Data Confidentiality Claims  (See
     Attachment 4)

     If you  wish to make a claim of confidentiality for  any
portion of a submitted study other than described by  FIFRA §10(d)
 (1) (A) ,  (B) ,  or  (C) , the following provisions apply:

     - The  specific information to which the  claim applies must
     be clearly marked in the body of the  study as subject to a
     claim of confidentiality.

     - A Supplemental Statement of Data Confidentiality  Claims
     must be submitted, identifying  each passage claimed confi-
     dential and describing in detail the  basis for the  claim.
     A list  of the points  to address in such  a  statement  is
     included in Attachment 4 on  Pg  14.

     - The  Supplemental Statement of Data  Confidentiality Claims
     must be signed and dated and must include  the  typed name and
     title  of the official who signed it.

                                52

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 D.5.  Good Laboratory Practice Compliance  Statement

      This statement is required if the  study contains  laboratory
 work  subject to GLP requirements specified in 40  CFR 160.   Sam-
 ples  of these statements are shown in Attachment  6.

 E-    Reference to Previously Submitted  Data

      DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY  BEEN  SUBMITTED
 FOR ANOTHER PURPOSE unless EPA specifically requests it.    A copy
 of  the  title page plus the MRID number  (if known) is sufficient
 to  allow us to retrieve the study immediately for review.   This
 prevents duplicate entries in the Agency  files, and  saves you
 the cost of sending more copies of the  study.  References to pre-
 viously submitted studies should not  be included  in  the transmit-
 tal document,  but should be incorporated  into the statement of
 the method of support for the application.

 F.    Physical Format Requirements

      All elements in the data submittal package must be on
 uniform 8 1/2 by 11 inch white paper, printed on  one side only in
 black ink,  with high contrast and good  resolution.   Bindings for
 individual studies must be secure,  but  easily removable to  permit
 disassembly for microfilming.   Check  with  EPA for special
 instructions before submitting data in  any medium other than
 paper,  such as film or magnetic media.

 Please  be particularly attentive to the following points:

      •     Do not include frayed or torn pages.

      •     Do not include carbon copies,  or  copies in other  than
           black ink.

      •     Make sure that photocopies  are clear, complete, and
           fully readable.

      •     Do not include oversize  computer printouts or fold-out
           pages.

      •     Do not bind any documents with glue or binding tapes.

      •     Make  sure  that  all pages  of each study,  including any
           attachments  or appendices, are present and in correct
           sequence.

     Number  of  Conies  Required  - All submittal packages except
those associated with  a  Registration Standard or Special Review
 (See  Part  G  below) must  be provided In three complete,  identical
copies.    (The proposed regulations  specified two copies;  three
are now being  required to  expedite and reduce the cost  of
processing data  into the OPP Pesticide Document Management System
and getting  it into review.)
                                53

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G.   Special Requirements for Submitting Data to the Docket

     Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised.  This
fourth copy will become part of the public docket for the RS or
SR case.  If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three.  When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice.  The following
special preparation is required for the fourth copy.

     •    Remove the "Supplemental Statement of Data
          Confidentiality Claims".

     •    Remove the "Confidential Attachment".

     •    Excise from the body of the study any information you
          claim as confidential, even if it does not fall within
          the scope of FIFRA §10(d)(1)(A),  (B), or  (C).  Do not
          close up or paraphrase text remaining after this
          excision.

     •    Mark the fourth copy plainly on both its cover and its
          title page with the phrase  "Public Docket Material -
          contains no information claimed as confidential".

V.    For Further Information

     For further information contact  John Carley, Chief,
Information Services Branch, Program  Management and Support
Division,  (703) 305-5240.
                      f a«n«S W. Akvrman
                      /Acting? Birvctor,
                       iteg is trait ion Division
Attachment  1.
Attachment  2.
Attachment  3.
Attachment  4.

Attachment  5.
Attachment  6.
Attachment  7,
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
                                54

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                          ATTACHMENT  1

       ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*

 1-   Name and address of submitter  (or  all  joint  submitters**)
+Smith Chemical Corporation
 1234 West Smith Street
 Cincinnati, OH 98765
-and-
Jones Chemical Company
5678 Wilson Blvd.
Covington, KY 56789
-Smith Chemical Corp will act as sole agent for all submitters.

2.   Regulatory action in support of which  this package  is
     submitted

Use the EPA identification number  (e.g. 359-EUP-67) if you  know
it.  Otherwise describe the type of request  (e.g. experimental
use permit, data call-in - of xx-xx-xx date).

3.   Transmittal date

4.   List of submitted studies

     Vol 1.    Administrative materials - forms, previous corres-
               pondence with Project Managers, and so forth.

     Vol 2.    Title of first study in the  submittal  (Guideline
               No. )

     Vol n     Title of nth study in the submittal  (Guideline
               No.)

     *    Applicants commonly provide this  information in a tran-
          smittal letter.  This remains an acceptable practice so
          long as all four elements are included.

     *    Indicate which of the joint submitters is empowered to
          act on behalf of all joint submitters in any matter
          concerning data compensation or subsequent use or
          release of the data.
Company Official:.
Company Name:.
Company Contact:
                    Name
          Signature
                    Name
          Phone
                                55

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                   ATTACHMENT 2

SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY

                    Study Title

   (Chemical name)  -  Magnitude of Residue on Corn

                  Data Requirement

                  Guideline 171-4

                       Author

                   John C. Davis

                 Study Completed On

                  January 5,  1979

               Performing Laboratory

            ABC Agricultural Laboratories
                 940  West Bay Drive
                Wilmington,  CA 39897

               Laboratory Project  ID

                      ABC 47-79
                     Page 1 of X
    (X is the total number of pages in the study)

                          56

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                           ATTACHMENT 3

             STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

 1.  No claim of confidentiality under FIFRA §10(d)(1)(A),(B),  or
 (C) .

        STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
   No  claim of confidentiality is made for any information
   contained in this study on the basis of its falling within
   the scope of FIFRA 6§10(d)(1)(A),  (B),  or (C).
   Company
   Company Agent:

  	Title
Typed Name
Date:
                     Signature
2.  Claim of  confidentiality under FIFRA §10 (d) (l)-(A),  (B) ,  or
 (C) .

             STATEMENT OF DATA CONFIDENTIALITY CLAIMS
   Information claimed confidential  on the  basis of  its  falling
   within  the  scope  of FIFRA §10(d)(1)(A),  (B), or  (C) has been
   removed to  a confidential appendix,  and  is  cited  by
   cross-reference number in the  body of  the study.
  Company:
  Company Agent:

  	Title
Typed Name
Date:
                     Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy  that no permanent tolerance, temporary
tolerance, or request  for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method.  These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy  by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
                                57

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                          ATTACHMENT 4

      SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     For any portion of a submitted study that is not described
by FIFRA §10(d) (1) (A),  (B) ,  or (C) ,  but for which you claim
confidential treatment on another basis,  the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:

     •    Identify specifically by page and line number(s) each
          portion of the study for which you claim
          confidentiality.

     •    Cite the reasons why the cited passage qualifies for
          confidential treatment.

     •    Indicate the length of time--until a specific date or
          event, or permanently--for which the information should
          be treated as confidential.

     •    Identify the measures taken to guard against undesired
          disclosure of this information.

     •    Describe the extent to which the information has been
          disclosed, and what precautions have been taken in con-
          nection with those disclosures.

     •    Enclose copies of any pertinent determinations of
          confidentiality made by EPA, other Federal agencies, of
          courts concerning this information.

     •    If you assert that disclosure of this information would
          be likely to result in substantial harmful effects to
          you, describe those harmful effects and explain why
          they should be viewed as substantial.

     •    If you assert that the information in voluntarily sub-
          mitted, indicate whether you believe disclosure of this
          information might tend to lessen the availability to
          EPA  of similar information in the future, and if so,
          how.
                                58

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                                ATTACHMENT  5

             EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS

Example  1.  (Confidential  word  or phrase  that  has been  deleted
from the study)
   CROSS REFERENCE NUMBER l.  This cross  reference number is  used in the  study
                             in place of the following words or phrase at  the
                             indicated volume and page references.
   DELETED WORDS OR PHRASE:	

   PAGE     LINE  REASON FOR THE DELETION
                                    TIP* Gil "
      6
     12
    100
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE

§10(d) (1) (C)
Example 2.  (Confidential  paragraph(s)  that have been  deleted  from the  study)
  CROSS REFERENCE NUMBER 5. This  cross reference number  is used  in the study
                           in place of the  following paragraph(s) at the
                           indicated volume and page references.
   DELETED PARAGRAPH(S) :
 PAGE
  20.
            Reproduce  the  deleted paragraph(s) here
LINES REASON FOR THE DELETION                   FIFRA REFERENCE

2-17  Description of the  quality control process   §10(d)(1)(C)
Example 3.  (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NUMBER  7. This cross reference number noted on a place-
                         holder page is used in place of the following
                         whole pages at the indicated volume and page
                         references.

  DELETED PAGE(S):  are  attached immediately behind this page.

  PAGE LINES      REASON FOR THE DELETION                   FIFRA REFERENCE

  20.  2-17 Description  of the product manufacturing process   §10(d)(l)-(A)
                                     59

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                                 ATTACHMENT 6.

                  SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1
     This study meets the requirements for 40 CFR Part 160

           Submitter ——	—	

           Sponsor   	—	
           Study Director
Example 2.
    This study does not meet the requirements of 40  CFR Part 160, and differs
    in the following ways:
    1..

    2.

    3.
          Submitter_

          Sponsor	
          Study Director_
Example 3.
    The  submitter of this study was neither the sponsor of this study nor
    conducted  it,  and does  not know  whether it  has been  conducted  in
    accordance with 40 CFR Part 160.

           Submitter  	_^________	-	
                                       60

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                           ATTACHMENT  7.
                   FORMAT OF  THE  SUSMITTAL PACKAGE
LEGEND
                     Transraittal  Document.

                        Related  Administrative Materials
                        (e.g., Method of Support statement, etc.)


                              Other materials about the submittal
                              (e.g., summaries of groups of studies
                              to aid in their review).

                                     Studies, submitted as unique
                                     physical entities, according
                                     to the format below.
                    FORMAT OF SUBMITTED STUDIES
                   ^^"•""•••"      -


            Study  title page.


                Statement  of Confidentiality Claims.

                    GLP and  flagging*  statements - as appropriate.

                         Body of  the study, with English
                         language translation if required.
                             Appendices to the study.

                                 Title Page of the Confidential
                                 Attachment.

                                      Confidential Attachment.
                                          Supplemental statement
                                          of Confidentiality Claims,

                                      * When flagging requirements
                                        are finalized.
                Documents which must be submitted as
                appropriate to meet established requirements.

                      Documents submitted at submitter's option.
                            61

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PR Notice  91-2
      63

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£ **  \
v»'
               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, D.C. 20460
                                                         OFFICE OF
                                                      PREVENTION, PESTICIDES
                                                      AND TOXIC SUBSTANCES
                          PR NOTICE 91-2

         NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
                   AND REGISTRANTS OF  PESTICIDES

ATTENTION:  Persons Responsible  for  Federal  Registration of
Pesticide Products.

SUBJECT: Accuracy of  Stated Percentages  for Ingredients
Statement

I. PURPOSE:

     The purpose  of this notice  is  to clarify the Office of
Pesticide Program's policy  with  respect  to  the statement of
percentages in a  pesticide's  label's  ingredient statement.
Specifically, the amount  (percent by weight) of ingredient(s)
specified in the  ingredient statement'on the label must be stated
as the nominal concentration  of  such  ingredient (s) , as that term
is defined in 40  CFR  158.153 (i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount  of active  ingredient in the product.

II. BACKGROUND

     For some time the Agency has accepted  two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in  a pesticide.  Some applicants claimed a
percentage which  represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed  the lower limit as the
percentage of the  ingredient(s) that would be expected to be
present in their  product at the end of the product's shelf-life.
Unfortunately, this led to  a great deal  of  confusion among the
regulated industry, the regulators, and  the consumers as to
exactly how much  of a given ingredient was  in a given product.
The Agency has established  the nominal concentration as the only
acceptable label  claim for  the amount of active ingredient in the
product.

     Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices  40 CFR 156.10(g) (5) .  The
certified limits  required for each active ingredient are intended
to encompass any  such "good manufacturing practice"  variations 40

                                65

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CFR 158.175(c)(3).

     The upper and lower certified limits,  which must be proposed
in connection with a product's registration,  represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.

     The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.

     It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States_for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).

III. REQUIREMENTS

     As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable  (e.g., elemental arsenic, metallic  zinc,
salt of an acid) . In addition, the requirement for performing
sample analyses of five or more representative samples must  be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based  on
representative  sampling and chemical analysis(i.e., quality
control) of  the product. v

     The format of the ingredient statement must conform to  40
CFR 156-Labeling Requirements For Pesticides and Devices.

     After July 1,  1997, all pesticide ingredient Statements must
be changed to nominal concentration.
                                66

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IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.

     In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

     As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B).  Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

     (1)   Beginning July 1,  1991,  all  new product registrations
          submitted to the Agency are  to comply with the
          requirements of this Notice.

     (2)   Registrants having products  subject to reregistration
          under FIFRA section 4 (a)  are to comply with the
          requirements of this Notice  when specific products are
          called in by the Agency under Phase V of the
          Reregistration Program.
                               67

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     (3)  All other products/applications that  are not subject to
          (1) and  (2) above will  have  until July 1,  1997,  to
          comply with this Notice.  Such applications should note
          "Conversion to Nominal  Concentrations on the
          application form. These types Or amendments will not be
          handled as "Fast Track" applications  but will be
          handled as routine  requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on  (703) 308-7031.
                                   \ZC* ~  •* • £7 - -d-iivC-*
                                  Ann* E.  t,irwisay,  Director
                                  Registration Division (H-7505
                                 68

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APPENDIX F. Generic Data Call-In
              69

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                          GENERIC DATA CALL-IN NOTICE
 CERTIFIED MAIL
Dear Sir or Madam:
This  Notice requires you and other registrants of pesticide products  containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency).  These data are necessary to maintain the continued registration of your produces)
containing this active ingredient(s).  Within 90 days after you receive  this Notice you must
respond as set forth in Section III below.  Your response must state:
1.
2.
3.
how you will comply with, the requirements set forth in this Notice and its Attachments
1 through 4; or,

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,

why you believe EPA should not require your submission of data hi 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 4).

       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
(expiration date 12-31-92).
                                          71

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    This Notice is divided into six sections and five 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
       Section II
       Section HI
       Section IV
       Section V

       Section VI
Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This Notice
Consequences Of Failure To Comply With This Notice
Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Inquiries And Responses To This Notice
    The Attachments to this Notice are:
       Attachment 1 -
       Attachment 2 -
       Attachment 3 -
       Attachment 4 -
Data Call-In Chemical Status Sheet
Data Call-in Response Form
Requirements Status And Registrant's Response Form
List Of All Registrants Sent This Data Call-In Notice
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the  subject active  ingredient(s).   This
revaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s).  You have been sent this Notice because you
have produces) containing the subject active ingredients).

SECTION II. DATA REQUIRED BY THIS  NOTICE

       A.     DATA REQUIRED

              The 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
       hi this Notice, additional testing may be required.

       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 tune frames provided.
                                          72

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       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, 1750  Pennsylvania  Avenue N.W.,
       Washington, D.C. 20006.

             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)].
       D-    REGISTRANTS  RECEIVING  PREVIOUS  SECTION  3(cY2)(E~)  NOTICES
             ISSUED BY  THE AGENCY

             Unless otherwise noted herein, this Data Call-In does not in any way supersede
       or change the requirements of any previous Data Call-InCs^. 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

      A.     SCHEDULE FOR RESPONDING TO THE AGENCY

             The appropriate responses initially required by this Notice 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 hi Section IV-A and IV-
      B.
                                        73

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       B.    OPTIONS FOR RESPONDING TO THE AGENCY

       The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption,  (4)  agree to satisfy the  data requirements
imposed by this Notice or (5) request a data waiver(s).

       A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available  for satisfying the data requirements of this
Notice is contained hi Section III-C. A discussion of options relating to requests for data
waivers is contained hi Section III-D.

       There are two forms that  accompany this Notice of which, depending upon your
response, one or both must be used hi your response to the Agency. These forms are
the Data-Call-in Response Form (Attachment 2)  and the Requirements  Status and
Registrant's Response Form (Attachment 3). The Data Call-in Response Form must be
submitted as part of every response to this Notice.  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 hi preparing  your response, call or write the contact person identified hi
Attachment 1.

       1.    Voluntary Cancellation - You may avoid the  requirements of this Notice
       by  requesting voluntary  cancellation of your product(s)  containing the active
       higredient(s)  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 choose to  voluntarily  cancel  your  product, further sale and
       distribution of your product after the effective date of cancellation must be hi
       accordance with the Existing Stocks  provisions of this Notice which are contained
       hi Section IV-C.

       2.     Use  Deletion  - You may  avoid  the  requirements  of this Notice by
       eliminating the uses of your product to which the requirements apply.  If you
       wish to amend your registration to delete uses, you must submit the Requirements
       Status and Registrant's Response Form, a completed application for amendment,
       a copy of your proposed amended labeling, and all other information required for
       processing the application. Use deletion is option number 7 on the Requirements
       Status and Registrant's Response Form. You must also complete a Data Call-in
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 Response Form by signing the certification, item number 8. Application forms for
 amending registrations  may  be obtained from  the Registration Support and
 Emergency Response Branch, Registration Division, (703) 308-8358.

        If you choose to  delete the use(s) subject to this Notice or uses subject to
 specific data requirements, further sale, distribution, or use of your product after
 one year from the due date of your 90 day response, must bear an amended label.
 3.     Generic Data  Exemption - Under section 3(c)(2)(D)  of FIFRA, an
 applicant for registration of a product is exempt from the requirement to submit
 or cite generic data concerning an active ingredient(s) if the active ingredient(s)
 in the product is derived exclusively from purchased, registered pesticide products
 containing the active ingredient(s).  EPA has concluded, as an exercise of its
 discretion, that it normally will not suspend the registration of a product which
 would qualify  and  continue to qualify for the generic data exemption in section
 3(c)(2)(D) of FIFRA.  To qualify, all of the following requirements must be met:

       a.     The  active ingredient(s) in your registered product must be present
       solely because  of  incorporation of another registered  product  which
       contains the subject active ingredient(s) and is purchased from a source
       not connected with you; and,

       b.     every  registrant  who is  the  ultimate   source  of  the  active
       ingredient(s) in your product subject to this DCI must be in compliance
       with the requirements of this Notice and must remain in compliance; and

       c.     you  must have  provided  to  EPA an  accurate  and current
       "Confidential Statement of Formula" for each of your products to which
       this Notice applies.

       To apply for the Generic Data Exemption you must submit a completed
Data  Call-In Response  Form. Attachment  2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the  Data Call-In Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements  Status  and Registrant's Response  Form.   Generic Data
Exemption cannot be selected as an option for product specific data.

       If you are granted a Generic Data Exemption, you rely on the efforts of
other  persons to provide the Agency with the required data.  If the registrant(s)
who have committed  to generate  and  submit the required data fail  to take
appropriate steps to meet the requirements  or are no longer in compliance with
this Data Call-In Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate  proceedings to suspend the registrations
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      of both your and their product(s), unless you commit to submit and do submit the
      required data within the specified time. In such cases the Agency generally will
      not grant a time extension for submitting the data.

      4.     Satisfying the Data Requirements of this  Notice  -   There are various
      options available to satisfy the 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 option 6b and 7 on
      the Data Call-In Response Form. If you choose option 6b or 7, you must submit
      both forms as well as any other information/data pertaining to the option chosen
      to address the data requirement.

      5.     Request for Data Waivers.  Data waivers are discussed in Section III-D
      of this Notice and are covered by options 8 and 9 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.

C.    SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

      If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), 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 hi this Section. The options are:

       1.    I  will generate and submit data  within the  specified tune  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),
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 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
 hi 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 hi  conformance with the
 requirements  of PR Notice 86-5.  In addition, certain  studies require Agency
 approval of test protocols in advance of study initiation.   Those studies for which
 a protocol must be submitted have been identified in the Requirements Status and
 Registrant's Response Form and/or footnotes  to the  form.   If you wish to use a
 protocol which differs from the options discussed in Section II-C of this Notice,
 you must submit a detailed description of the proposed protocol and your reason
 for wishing to use it.  The Agency may choose to reject  a protocol not specified
 hi Section II-C.  If the Agency rejects your protocol you will be notified in
 writing, however, you  should be aware that rejection of a proposed protocol will
 not be a basis for extending the deadline for submission  of data.

       A progress report must be submitted for each study within 90 days from
 the date you are required to commit to generate or undertake some other means
 to address that study requirement, such as making an offer to cost-share or
 agreeing to share hi the cost of developing that study. A 90-day progress  report
 must  be submitted for all studies. This 90-day progress  report must include the
 date the study was or will be initiated and, for studies  to be started within 12
 months of commitment, the name and address of the laboratory(ies) or individuals
 who are or will be conducting the study.

       In addition, if the tune frame for submission of a final report is more than
 1 year, interim reports must be submitted at  12 month intervals from the date you
 are required to commit to generate or otherwise address  the requirement for the
 study. In addition to the other information specified hi the preceding paragraph,
 at a minimum, a brief description of current activity on and the status of the study
 must be included as well as a full description of any problems encountered since
 the last progress report.

       The tune frames in the Requirements  Status and Registrant's Response
 Form are the tune frames that the Agency is allowing for the  submission of
 completed study reports or protocols.  The noted deadlines run from the date of
the receipt of this Notice by the registrant.  If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent  to Suspend the
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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 requirement(s), you
must submit a request to the Agency which includes:  (1) a detailed description
of the expected  difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis.  You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing.   While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains.  Normally, extensions
can be  requested only in cases  of extraordinary testing problems  beyond the
expectation, or  control  of the registrant.   Extensions will not be given in
submitting the 90-day responses.  Extensions will not be considered if the request
for extension is not made in a timely fashion; in  no event shall an extension
request be considered if it is  submitted at or after the lapse  of the  subject
deadline.

Option 2. Agreement to Share hi Cost to Develop Data  -

       If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide
the name of the registrant who will be  submitting the  data.  You must also
provide EPA with documentary evidence that an agreement has been formed.
Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties  or the mechanism to resolve
the terms.  Section 3(c)(2)(B) provides that if the parties cannot resolve the terms
of the agreement they may resolve their differences through binding arbitration.

Option 3. Offer to Share in the Cost of Data Development -

       If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice.  EPA has determined that as  a
general policy, absent  other relevant considerations, it  will not  suspend the
registration of a product of a  registrant who has hi 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
mat you have made an offer to another registrant (who has an obligation to submit
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 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.  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.

       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:
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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(7) " 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(7), 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.

c.     You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the  study has been
conducted according to the Pesticide Assessment Guidelines  (PAG) or
meets the purpose of the PAG (both available from  NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes  that the study clearly  meets the
purpose of the  PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols.  If you wish to
submit the study, you must, in addition  to certifying that the purposes of
the PAG are met by the study, clearly  articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data.  It has been the Agency's experience that
studies completed prior to January 1970  rarely satisfied the purpose of the
PAG  and that necessary raw data are usually not available for such
studies.
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               If you submit an existing study, you must certify that the study
        meets all requirements of the criteria outlined above.

               If EPA has previously reviewed a protocol for a study  you are
        submitting, you must identify  any action taken by  the  Agency on the
        protocol and must indicate, as  part of your certification, the manner in
        which all Agency comments, concerns, or issues were addressed in the
        final protocol and study.

               If you know of a study pertaining to any requirement hi this Notice
        which does not meet the criteria outlined above but does contain factual
        information regarding unreasonable adverse  effects, you  must notify the
        Agency of such a study.  If such a  study is in the Agency's files, you
        need only cite it along with the notification.  If not in the  Agency's files,
        you must submit a summary and copies as required by PR Notice 86-5.

 Option 5. Upgrading a Study -

        If a study has been classified as partially acceptable and upgradeable, you
 may  submit data to  upgrade that study.   The Agency will review the  data
 submitted and determine if the requirement is satisfied. If the Agency decides the
 requirement is not satisfied,  you may still be required to submit new  data
 normally without amy 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.

       The criteria  for submitting an existing study, as specified in Option 4
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      above, apply to all data submissions intended to upgrade studies.  Additionally
      your submission of data intended to upgrade studies must be accompanied by a
      certification that you comply with each of those criteria as well as a certification
      regarding protocol compliance with Agency requirements.

      Option 6. Citing Existing Studies —

             If you choose to cite a study that has been previously submitted to EPA,
      that study must have been previously  classified by EPA as acceptable or it must
      be  a  study which has not  yet been reviewed by the Agency.  Acceptable
      toxicology studies generally will have been classified as "core-guideline" or "core
      minimum."  For ecological effects studies, the classification generally would be
      a  rating of "core."   For  all  other disciplines  the classification would be
      "acceptable." With respect to any studies for which you wish to select this option
      you must provide the MRID  number of the study you are citing and, if the study
      has been reviewed by the Agency, you must provide the Agency's classification
      of the study.

             If you are citing a study of which you are not the original data submitter,
      you must submit a completed copy of EPA Form 8570-31, Certification with
      Respect to  Data Compensation Requirements.

D.    REQUESTS FOR DATA WAIVERS

      There are two types of data waiver responses to this Notice.  The first is a request
for a low volume/minor use waiver and the second is a  waiver request based on your
belief that the data requirement(s) are inapplicable and do not apply to your product.

       1.     Low Volume/Minor Use Waiver -  Option R nn the Requirements Status
      and Registrant's Response Form.  Section 3(c)(2)(A) of FIFRA requires EPA to
      consider the appropriateness of  requiring data  for low  volume,  minor use
      pesticides.  In implementing this provision EPA considers as low volume
      pesticides only those active  ingredient(s) whose total production volume for all
      pesticide registrants is small.  In determining whether to grant  a low volume,
      minor use waiver the Agency will consider the extent, pattern and volume of use,
       the economic incentive to conduct the testing, the importance of the pesticide, and
       the exposure and risk from use of the pesticide. If an active ingredient(s) is used
       for both high volume and low volume uses, a low volume exemption will not be
       approved.  If all uses of an active ingredient(s) are low volume and the combined
       volumes for all uses are also low, then an exemption may be granted, depending
       on review of other information outlined below. An exemption will not be granted
       if any registrant of the active ingredients) elects to conduct the testing.  Any
       registrant receiving a low volume minor use waiver must remain within the sales
       figures in their forecast supporting the waiver request hi order to remain qualified
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for such waiver.  If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports.  The Agency will respond to
requests for waivers in writing.

       To  apply for a low volume, minor use waiver,  you must submit the
following information,  as applicable to your product(s), as part of your 90-day
response to this Notice:

       a.      Total  company  sales (pounds  and  dollars)  of  all  registered
       product(s) containing the active ingredient(s). If applicable to the-active
       ingredient(s),  include foreign  sales for  those products  that  are  not
       registered in this country but are applied to sugar (cane or beet),  coffee,
       bananas, cocoa, and other such  crops. Present the above information by
       year for each of the past five years.

       b.      Provide an estimate of the sales (pounds and dollars) of the active
       ingredient(s) for each major use site.  Present the  above information by
       year for each of the past five years.

       c.      Total direct production cost of product(s)  containing the active
       ingredient(s) by year for the past five years. Include information on raw
       material cost, direct labor cost, advertising, sales and marketing, and any
       other significant costs listed separately.

       d.      Total, indirect production cost (e.g. plant overhead, amortized plant
       and equipment) charged to product(s) containing the active ingredients)
       by year for the past five years.  Exclude all non-recurring costs that were
       directly related  to the  active  ingredients), such as costs  of initial
       registration and any data development.

       e.     A list of each data  requirement for which you seek a waiver.
       Indicate the type of waiver  sought  and  the estimated cost to you (listed
       separately for each data requirement and associated test) of conducting
       the testing needed to fulfill each of these data requirements.

       f.     A list of each data requirement for which you are not seeking any
       waiver  and the estimated cost to you  (listed separately for each data
       requirement and associated test) of conducting the testing needed to fulfill
       each of these data requirements.

      g.     For each of the next ten years, a year-by-year forecast of company
       sales (pounds and dollars) of the active  ingredient(s),  direct production
      costs of product(s) containing  the active  ingredients) (following the
      parameters in  item c above), indirect production costs of product(s)
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             containing the active ingredient(s) (following the parameters in item d
             above),  and  costs  of data  development pertaining  to  the  active
             ingredient(s).

             h.     A description of the importance and unique benefits of the active
             ingredient(s) to users.  Discuss the use patterns and the  effectiveness of
             the active ingredient(s) relative to registered alternative chemicals and
             non-chemical control strategies.  Focus on benefits unique to the active
             ingredients), providing information that is as quantitative as possible.  If
             you do not have quantitative data upon which to base your estimates, then
             present the reasoning used to derive your estimates. To assist the Agency
             in determining  the  degree  of importance of the  active  ingredient(s)  in
             terms of its  benefits,  you should provide information on  any  of the
             following factors, as applicable to your produces):

                    (1)    documentation of the usefulness of the  active ingredient(s)
             in Integrated  Pest Management, (b) description of the beneficial impacts
             on the environment of use of the active ingredient(s), as opposed to its
             registered alternatives, (c)  information on the breakdown of the active
             ingredient(s)  after use and on its persistence in the environment, and (d)
             description of its usefulness against a pest(s) of public health significance.

       Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.

       2.    Request for Waiver of Data  -Option 9 on the Requirements Status and
       Registrant's Response Form.   This option  may be used if you  believe that a
       particular data requirement should riot apply because the corresponding use is no
       longer registered  or the  requirement is inappropriate.   You must  submit  a
       rationale explaining why  you believe the data requirements should not apply.
       You must also submit the current label(s) of your produces) and,  if  a current
       copy of your Confidential Statement of Formula is not already on file  you must
       submit a current copy.

              You will be informed of the Agency's decision in writing.  If the Agency
       determines  that the data  requirements  of  this Notice  do  not apply to your
       produces),  you  will not be  required to supply  the data  pursuant to  section
       3(c)(2)(B).  If EPA determines that the data are required for vour productCsX you
       must choose a method of meeting the requirements of this Notice within the time
       frame provided bv this Notice.  Within 30 days of your receipt of the  Agency's
       written decision, you must submit a revised Requirements Status and Registrant's
       Response Form indicating the option chosen.
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IV-   CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

      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.
             2.
             3.
             4.
            7.

            8.
 Failure  to respond as required by this  Notice  within 90 days  of your
 receipt of this Notice.

 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.

 Failure to submit on the required schedule an adequate progress report on
 a study as required by this Notice.

 Failure to submit on the required schedule acceptable data as required by
 this Notice.

 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).

 Failure  to submit  supportable certifications  as to the conditions  of
 submitted studies, as required by Section III-C of this Notice.

 Withdrawal of an offer to share in the cost of developing required data.

 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: or,

b.     fulfill the commitment to develop  and submit the data as required
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             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
             hi the specified tune frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at
       any time following the issuance of this Notice.
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.

 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 Federal Insecticide, Fungicide,  and
 Rodenticide Act.
                                     86

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              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 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(s) 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 hi the Agency granting any additional tune 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  hi 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  mformation 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 mformation  regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the mformation
to the Agency. Registrants must notify the Agency of any factual mformation 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.
                                          87

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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 listed in Attachment 1, the Data Call-in Chemical Status Sheet.

       All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Response  Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified hi
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 (QCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.

                                              Sincerely yours,
                                              Daniel M. Barolo,
                                              Special Review
                                                and Reregistration Division

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Attachment 1. Chemical Status Sheet
                89

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-------
 Hexadecadienol acetates DATA CALL-IN CHEMICAL STATUS SHEET

 INTRODUCTION

       You have been sent this Generic Data Call-In Notice because you have product(s)
 containing Hexadecadienol acetates.

       This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
 by this  notice,  and point of  contact  for  inquiries pertaining  to the  reregistration of
 Hexadecadienol acetates.  This attachment is to be used hi conjunction with (1) the Generic Data
 Call-In Notice, (2)  the Generic  Data Call-In  Response Form  (Attachment 2), (3) the
 Requirements Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this
 DCI (Attachment 4), (5) the EPA Acceptance  Criteria (Attachment 5), and (6) the Cost Share
 and Data Compensation Forms in replying to this Hexadecadienol acetates Generic Data Callln
 (Attachment F). Instructions and guidance accompany each form.

 DATA REQUIRED BY THIS NOTICE
       The  additional  data requirements needed  to complete the  generic  database for
 Hexadecadienol acetates are  contained hi the Requirements Status and Registrant's Response.
 Attachment C.   The  Agency  has concluded that  additional product chemistry  data on
 Hexadecadienol acetates are needed. These data are needed to fully complete the reregistration
 of all eligible Hexadecadienol acetates products.

 INQUIRIES AND RESPONSES TO THIS NOTICE

       If you  have any questions  regarding the  generic data requirements and procedures
established by this Notice, please contact Tom  Myers at (703) 308-8074.

       All responses to this Notice for the generic data requirements should be submitted to:

             Tom Myers, Chemical Review Manager
             ARE
             Special Review and Registration Division (H7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C.  20460
             RE:  Hexadecadienol acetates
                                         91

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-------
Attachment 2. Generic DCI Response Forms Inserts (Form
                 A) plus Instructions
                         93

-------

-------
 SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM

       This Form is designed to be used to respond to call-ins for generic and product specific
 data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
 Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
 has sent you the form entitled  "Requirements Status and Registrant's Response."

       Items  1-4 will have been preprinted on the form Items 5 through 7 must be completed
       by the registrant as appropriate Items  8 through 11 must be completed by the registrant
       before submitting a response to the Agency.

       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 suggesting for reducing this burden,  to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503.
INSTRUCTIONS

       Item 1.

       Item 2.


       Item 3.

       Item 4.
      Item 5.
This item identifies your company name, number and address.

This item identifies the ease number, ease name, EPA chemical number
and chemical name.

This item identifies the date and type of data call-in.

This item identifies the EPA product registrations relevant to the data
call-in.   Please note  that you are  also responsible for informing the
Agency of your response regarding any product that you believe may be
covered by this data call-in but that is not listed by the Agency hi Item 4.
You must bring any such apparent  omission to the Agency's attention
within the period required for submission of this response form.

Cheek this  item for each product registration  you wish to  cancel
voluntarily.  If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate hi Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
                                          95

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Item 6a.      Check this item if this data call-in is for generic data as indicated in Item
              3 and if you are eligible for a Generic Data Exemption for the chemical
              listed in Item 2 and used in the subject product.    By electing this
              exemption, you agree to the terms  and conditions of a Generic Data
              Exemption as explained in the Data Call-in Notice.

              If you are eligible for or claim a Generic Data Exemption, enter the EPA
              registration Number of each registered source of mat active ingredient that
              you use in your product.

              Typically, if you purchase an EPA-registered product from one or more
              other producers (who, with respect to the incorporated  product, are in
              compliance with this and-any other outstanding Data Call-In Notice), and
              incorporate that product into all your products, you may complete this
              item for all products listed  on this form  If, however, you produce the
              active ingredient yourself, or use any unregistered product (regardless of
              the fact that some of your sources are registered), you may not claim a
              Generic Data Exemption and you may not select this item.

Item 6b.      Check this Item if the data call-in is a generic data call-in as indicated hi
              Item 3 and if you are agreeing to satisfy the generic data requirements of
              this  data call-in.    Attach the  Requirements  Status and Registrant's
              Response Form that indicates how you will satisfy those requirements.

Item 7a.      Check this item if this call-in if a data call-in as indicated in Item 3 for  a
              manufacturing use product (MUP), and if your product is a manufacturing
              use product for which you agree to supply product-specific data.  Attach
              the Requirements  Status and Registrants' Response Form that indicates
              how you will satisfy those requirements.

Item To.      Check this  item if this call-in is a  data call-in for an end use product
               (EUP) as indicated hi Item 3 and if your product is an end use product for
              which you agree to supply product-specific data. Attach the Requirements
               Status and Registrant's Response Form that indicates how you will satisfy
              those requirements.

 Item 8.       This certification statement must be signed by an authorized representative
               of your company and the person  signing must include his/her title.
               Additional pages used hi your response must be initialled and dated in the
               space provided for the certification.

 Item 9.       Enter the date of signature.
                                     96

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Item 10.      Enter the name of the person EPA should contact with questions regarding
             your response.

Item 11.      Enter the phone number of your company contact.
                                 97

-------


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Attachment 3. Requirements Status and Registrants'
 Response Forms Inserts (Form B) plus Instructions
                       98

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  SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
  REGISTRANTS  RESPONSE FORM

  Generic Data

  This  form  is designed to be used for registrants to respond to call-in-  for  generic  and
  product-specific data as part of EPA's reregistration program under the Federal Insecticide
  Fungicide and Rodenticide Act.  Although the form is the same for both product specific and
  generic data, instructions  for completing the forms differ slightly.  Specifically, options for
  satisfying product specific data requirements do not include (1) deletion of uses or (2) request
  for a low volume/minor use waiver.   These instructions  are for completion of generic data
  requirements.

  EPA has developed this form individually for each data call-in addressed to each registrant and
  has preprinted this form with a number of items. DO NOT use this form for any other active
  ingredient.

 Items 1 through 8  (inclusive) will have been preprinted on the form. You must complete all
 other items on this form by typing or printing legibly.

 Public reporting burden for this collection of information is  estimated to average 30 minutes per
 response, including time for reviewing instructions, searching existing data sources,  gathering
 and maintaining the data needed,  and completing and reviewing the collection of information
 Send comments  regarding the burden estimate or any other aspect of this collection of
 information, including suggesting for reducing this burden, to Chief, Information Policy Branch
 PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460^
 and to  the  Office  of Management and Budget, Paperwork Reduction  Project  2070-010?'
 Washington, D.C. 20503.

 INSTRUCTIONS
Item 1.

Item 2.


Item 3.

Item 4.



Item 5.
This item identifies your company name, number, and address.

This item identifies the case number, case name, EPA chemical number and
chemical name.

This item identifies the date and type of data call-in.

This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-in Notice, govern the conduct of the required studies.

This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports  are required to be
                                          99

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Item 6.
submitted in connection with the study.   As noted in Section III of the Data
Call-in Notice, 90-day progress reports are required for all studies.

      If an asterisk appears in Item 5, EPA has attached information relevant to
      this guideline  reference  number to  the  Requirements  Status  and
      Registrant's Response Form.

This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
                    A.
                    B.
                    C.
                    D.
                    E.
                    F.
                    G.
                    H.
                    I.
                    J.
                    K.
                    L.
                    M.
                    N.
                    O.
                          Terrestrial food
                          Terrestrial feed
                          Terrestrial non-food
                          Aquatic food
                          Aquatic non-food outdoor
                          Aquatic non-food industrial
                          Aquatic non-food residential
                          Greenhouse food
                          Greenhouse non-food crop
                          Forestry
                          Residential
                          Indoor food
                          Indoor non-food
                          Indoor medical
                          Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing.  A brief description of each code follows.
                    EP
                    MP
                    MP/TGAI

                    PAI
                    PAI/M
                    PAI/PAIRA

                    PAIRA
                    PAIRA/M
                    PAIRA/PM

                    TEP
                    TEP   *
                           End-Use Product
                           Manufacturing-Use Product
                           Manufacturing-Use Product and  Technical Grade
                           Active Ingredient
                           Pure Active Ingredient
                           Pure Active Ingredient and Metabolites
                           Pure Active  Ingredient or Pure Active Ingredient
                           Radiolabelled
                           Pure Active Ingredient Radiolabelled
                           Pure Active Ingredient Radiolabelled and Metabolites
                           Pure Active  Ingredient Radiolabelled  and Plant
                           Metabolites
                           Typical End-Use Product
                           Typical End-Use Product, Percent Active Ingredient
                           Specified
                                          100

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                    TEP/MET
                    TEP/PAI/M

                    TGAI/PAIRA

                    TGAI
                    TGAI/TEP

                    TGAI/PAI

                    MET
                    IMP
                    DEGR

       *See: guideline comment
                           Typical End-Use Product and Metabolites
                           Typical End-Use Product or Pure Active Ingredient
                           and Metabolites
                           Technical Grade Active Ingredient or Pure Active
                           Ingredient Radiolabelled
                           Technical Grade Active Ingredient
                           Technical Grade  Active  Ingredient  or  Typical
                           End-Use  Product
                           Technical Grade Active Ingredient or Pure Active
                           Ingredient
                           Metabolites
                           Impurities
                           Degradates
Item 8.
Item 9.
This item identifies  the time  frame allowed for submission of the study or
protocol identified in item 2. The tune frame runs from the date of your receipt
of the Data Call-In Notice.

Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-In Notice contains a fuller description of each of these options.
             1.
             2.
             3.
       (Developing Data) I will conduct a new study and submit it within the
       time frames specified in item 8 above. By indicating that I have chosen
       this  option, I  certify that  I  will  comply  with  all the requirements
       pertaining to the conditions for submittal of this study as outlined in the
       Data Call-In Notice and that I will provide the protocol and progress
       reports required hi item 5 above.

       (Agreement to Cost Share) I have entered into an agreement with one or
       more registrants to develop data jointly. By indicating that I have chosen
       this  option, I  certify that  I  will  comply  with  all the  requirements
       pertaining to sharing hi the cost of developing data as outlined in the Data
       Call-In Notice.

       (Offer to Cost Share) I have made an offer to enter into an agreement with
       one or more registrants to develop data jointly. I am submitting a copy of
      the form "Certification of Offer to Cost Share in the Development  of
      Data" that  describes this offer/agreement.  By  indicating that I have
      chosen this option, I certify that I will comply with all the requirements
      pertaining to making an offer to share hi the  cost of developing data  as
      outlined hi the Data Call-In Notice.
                                         101

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Item 10.
4.     (Submitting Existing Data) I am submitting an existing study that has
       never before been submitted to EPA. By indicating that I have chosen this
       option, I certify that this study meets all the requirements pertaining to the
       conditions  for submittal of existing data outlined  in  the Data Call-in
       Notice and I have attached the needed supporting information along with
       this response.

5.     (Upgrading a Study) I am submitting or citing data to upgrade a study that
       EPA has classified as partially acceptable and potentially upgradeable. By
       indicating that I have chosen this option, I certify that I have met all the
       requirements pertaining to the conditions for submitting or citing existing
       data to upgrade a study  described in  the  Data Call-in Notice. I am
       indicating on attached correspondence the Master Record Identification
       Number (MRID) that EPA has assigned to the data that I am citing as well
       as the MRID of the study I am attempting to upgrade.

6.     (Citing a Study) I am citing an existing study that has been previously
       classified by EPA as acceptable, core, core minimum, or a study that has
       not yet  been reviewed by the  Agency.  I am providing the  Agency's
       classification of the study.

7.     (Deleting Uses) I am  attaching an application for amendment to my
       registration deleting the uses for which the data are required.

8.     (Low Volume/Minor Use Waiver  Request)  I have read the statements
       concerning low volume-minor use data waivers in the Data Call-In Notice
       and I request a low-volume minor use waiver of the data requirement.  I
       am attaching a detailed justification  to support  this  waiver request
       including, among other things, all information required to support the
       request. I understand that, unless modified by the Agency in writing, the
       data requirement as stated in the Notice governs.

9.     (Request for Waiver of Data) I have read the statements  concerning data
       waivers other than low volume minor-use data waivers in the Data Call-in
       Notice and I request a waiver of the data requirement. I  am attaching  an
       identification of the basis for this  waiver and a detailed justification to
       support this waiver  request. The justification includes,  among  other
       things, all information required to support the request. I  understand that,
       unless modified by the Agency in writing, the data requirement as stated
       in the Notice governs.

This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
                                           102

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Item 11.

Item 12.
Enter the date of signature.


Enter the name of the person EPA should contact with questions regarding your
response.
Item 13.      Enter the phone number of your company contact.
                                        103

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                          105

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APPENDIX G. Product Specific Data Call-in
                  107

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                                DATA CALL-IN NOTICE
  CERTIFIED MATT.
 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 She**  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.
       2.
       3.
How you will comply  with the requirements set forth in this Notice and its
Attachments A through  G; or

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                                          	'

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 produces) 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).

       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
(expiration date 12-31-92).
                                         109

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    This Notice is divided into six sections and seven Attachments.  The Notice itself contains
information and instructions applicable to all Data Call-in Notices.  The Attachments contain
specific chemical information and instructions.  The six sections of the Notice are:

       Section I  -   Why You Are Receiving This Notice
       Section II -   Data Required By This Notice
       Section IH-   Compliance With Requirements Of This Notice
       Section IV -  Consequences Of Failure To Comply With This Notice
       Section V -  Registrants' Obligation To Report Possible Unreasonable Adverse
                   Effects
       Section VI -  Inquiries And Responses To This Notice

    The Attachments to this Notice are:

       1  -   Data Call-In Chemical Status Sheet
       2 -   Product-Specific Data Call-In Response Form
       3 -   Requirements Status and Registrant's Response Form
       4 _   EPA  Grouping of End-Use  Products  for  Meeting  Acute Toxicology  Data
             Requirements for Reresistration
       5 -   EPA Acceptance Criteria
       6 -   List of Registrants Receiving This Notice
       7 _   Cost Share and Data Compensation Forms,  and Product Specific Data Report
             Form


 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 H. DATA REQUIRED BY THIS NOTICE

 H-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.

 II-B.  SCHEDULE FOR SUBMISSION OF DATA
                                           110

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     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,  1750  Pennsylvania Avenue  N W
 Washington, D.C. 20006.                                                           '  "'

       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)].

 n-D- REGISTRANTS RECEIVING PREVIOUS SECTION 3fc₯2₯B^ NOTTrFS
      ISSUED BY THE AGENCY                                	

      Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
 requirements of any previous Data Call-In(s), or any other agreements entered into with me 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 IH.  COMPLIANCE WTTH RFQUIREMFNTS OF THIS NOTTPF

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.
                                         Ill

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III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       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 HI-C.  A discussion of options relating to
requests for data waivers is contained in Section ffi-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 hi 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 hi Section IH-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.
                                             112

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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.

 HI-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)
        (2)

        (3)
        (4)

        (5)

        (6)
I will generate and submit- data within the specified time frame (Developing Data)
I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified  by EPA as partially
acceptable and upgradeable (Upgrading a Study)
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 hi 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 registrations).

       If you cannot submit the data/reports to the Agency hi the time required by this Notice and
intend to seek additional time to meet the requirements^), you must submit a request to the Agency
which includes:  (1) a detailed description of the expected difficulty and (2) a proposed schedule
                                           113

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including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing.  While EPA is considering your request, the original deadline remains.  The Agency
will respond to your request in writing.  If EPA does not grant your request, the original deadline
remains.  Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.

       Option 2. Agreement to Share in Cost to Develop Data ~ 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 hi 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 then- differences through binding arbitration.

        Option 3. Offer  to Share hi 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 hi good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrants) 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 hi 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 hi 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
                                             114

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 develop and submit the data required by this Notice by submitting a Data Call-in Response Form
 and a Requirements Status and Registrant's Response Form committing to develop and submit the
 data required by this Notice.

       In order for you to avoid suspension under this option, you may  not withdraw your offer
 to share in the 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 hi
 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(3)  "  'raw data' means  any laboratory  worksheets,  records,
             memoranda,  notes, or  exact  copies  thereof, that  are the  result of original
             observations and activities of a study and are necessary for the reconstruction and
             evaluation of the report of that study. In the event that exact transcripts of raw data
             have been prepared (e.g., tapes which have been transcribed verbatim, dated,  and
             verified accurate by signature), the exact copy or exact transcript may be substituted
             for the original source as raw data.  'Raw data' may include photographs, microfilm
             or microfiche  copies,  computer printouts,  magnetic media,  including  dictated
             observations,  and  recorded data  from  automated  instruments."   The term
             "specimens", according to 40 CFR 160.3(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
                                          115

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             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.

      c.     You must certify that each study fulfills the acceptance criteria for the Guideline
             relevant to the study provided in the FIFRA  Accelerated Registration 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.
                                            116

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        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.

        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 hi 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
                                           117

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IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

TV-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:

              Failure to respond as required by this Notice within 90 days of your receipt of this
              Notice.
1.


2.


3.


4.

5.
              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.

              Failure to submit on the required schedule an adequate progress report on a study
              as required by this Notice.

              Failure to submit on the required schedule acceptable data as required by this Notice.

              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 m-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 hi 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
                     nn 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
                                            118

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        9.
       Notice, unless you commit to submit and do submit the required data in the
       specified time frame.

Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
 !V-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 produces) 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
                                           119

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quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use.  Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full  compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks.  Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted.  Any sale, distribution or use of stocks of voluntarily cancelled products
containing an  active ingredient for which the  Agency has  particular risk concerns  will  be
determined on 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 RESPONSF.S TO THIS NOTICE

       If you have  any questions regarding the requirements and procedures established by this
 Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.

       All responses to this Notice (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.
                                            120

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       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,
                                              M. Barolo,
                                       Special Review and
                                         Reregistration Division
Attachments

       1  -
      2  -
      3  -
      4  -

   •   5  -
      6  -
      7  -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA  Grouping  of  Fjid-Use  Products  for  Meeting
T* _ .  •        ff  •—*.     .gi
Acute  Toxicology  Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Date Compensation Forms, and Product Specific Data Report Form
                                         121

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Attachment 1. Chemical Status Sheet
               123

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HEXADECADIENOL ACETATES DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Hexadecadienol acetates.

       This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Hexadecadienol acetates.  This attachment  is to be used hi 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 Hexadecadienol
acetates 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 Hexadecadienol
acetates are contained hi the Requirements Status and Registrant's Response. Attachment 3.
The Agency has concluded that additional  data on Hexadecadienol acetates are needed for
specific products. These data are required  to be submitted to the Agency within the tune frame
listed.  These data are needed to fully complete the reregistration of all eligible Hexadecadienol
acetates products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic database of Hexadecadienol acetates,
please contact Tom Myers at (703)  308-8074.
       If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008.
  (703) 308-8184.
       All responses to this Notice for the Product Specific data requirements  should be
        submitted  to:
             Frank Rubis
             Chemical Review Manager  Team 81
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
              Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: Hexadecadienol acetates
                                           124

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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                        125

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 INSTRUCTIONS  FOR COMPLETING THE "DATA  CALL-IN  RESPONSE" FORM  FOR
 PRODUCT SPECIFIC DATA
 Item 1-4.

 Item 5.
Item 6.
              Already completed by EPA.

              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).

              Not applicable since this form calls hi 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 reregistration 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.

              For  each manufacturing  use product (MUP) for which you  wish to  maintain
              registration, you must agree to satisfy the data  requirements by responding  "yes."

              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 that you have already voluntarily cancelled this product.
      For these cases, please supply all relevant details so that EPA can ensure that its records
      are correct.
Item 7a.
Item 7b.
                                          127

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Attachment 3. Product Specific Requirement Status and
  Registrant's Response Forms (Form B inserts) and
                    Instructions
                        129

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 INSTRUCTIONS   FOR   COMPLETING  THE   "REQUIREMENTS   STATUS   AND
 REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
 Item 1-3.
 Item 4.
 Item 5.

 Item 6.
Item 7.
Item 8.
Item 9.
 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.

 The guidelines 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.

 The study title associated with the guideline reference number is identified.

 The use patters (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.

 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.

 The due date for submission of each study is identified.  It is normally based on 8
 months after  issuance  of the Reregistration  Eligibility Documents  unless  EPA
 determines that a longer time period  is necessary.

 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.

 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 on for acute toxiciry 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 my be  subject to suspension.

3.     I have made offers to share in the cost to develop data (Offers to Cost Share).

                             131

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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
require 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 HI-C.l.) apply as well.

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 ffl-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.

5.      By  the  specified due date, I will submit or cite  data  to upgrade  a  study
classified by the Agency as partially acceptable and upgrade (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.l.) apply.

 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 (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)
 number (s) for the  cited data on a "Product Specific Data Report"  form or in a
 similar format.  If I  cite another registratrant's data, I will  submit a completed
 "Certification With Respect To Data Compensation Requirements" form.

 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

                                132

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              request, I will not be require 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 chosen.  I also understand that the deadline
              for submission of data as specified by the original data cal-in notice will not change.

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 cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
                                           133

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       135

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         EPA'S DECISION ON BATCHING PRODUCTS CONTAINING HEXADECADIENOL ACETATE FOR PURPOSES OF MEETING
 ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

         In an effort to reduce the time,  resources and number of animals needed to fulfill the acute toxicity data requirements for
 reregistration of products containing the active ingredient hexadecadienol acetate,  the Agency considered batching products  This
 process involves grouping  similar products for purposes of acute toxicity.  Factors considered in the sorting process include each
 product's active and inert ingredients (identity, percent composition and biological activity), type of formulation (e g  emulsifiable
 concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary l'abelin« etc)
 Note that the Agency is not describing batched products as "substantially similar" since some products within a batch may^ot be
 considered chemically similar or have identical use patterns.

         Using available information, batching has been accomplished by the process described in the preceding paragraph  Acute
 toxicity data on individual products has frequently been found to be incomplete.  Notwithstanding the batching process the Agency
 reserves the right to require, at any time, acute toxicity data for an individual product should the need arise.

         Registrants of products within a batch may choose to cooperatively generate,  submit or cite  a single battery of six acute
 toxicological studies to represent all the products within that batch.  It is the registrants' option to participate in the process with all
 other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute
 toxicological studies for each of their own products. If a registrant chooses to rely upon previously submitted acute toxicity data
 he/she may do  so  provided that the data base is complete and valid by today's standards (see acceptance criteria attached) the
 formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since
 submission  and acceptance  of the acute toxicity data.  Regardless of whether new data is  generated or existing data is cited the
 registrant must clearly identify the material tested by its EPA  registration number.  If more than one Confidential Statement of Formula
 (CSF) exists for a  product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF.

         In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-in
 Notice and its attachments  appended to the RED.   The DCI Notice contains two response forms which  are to be completed and
 submitted to the Agency within 90 days of receipt. The first form, "Data Call-in Response", asks whether the registrant will meet the
 data requirements for each product.  The second form, "Requirements Status and Registrant's Response", lists the product specific data
 required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
 whether  he/she will provide the data or depend on someone else to do so.   If a registrant supplies the data to support a batch of
 products, he/she must select one of the  following options:  Developing Data (Option 1), Submitting  an Existing Study (Option 4)
 Upgrading an Existing Study (Option 5), or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must
 choose among:  Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6).  If a registrant does
 not want to participate in a batch, the choices are Options  1, 4, 5 or 6. However, a registrant should know that choosing not to
 participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3)
 those studies.

        Table I  lists the batched products.  (The notations beside the active percentages indicate the different isomers of the active
present in the formulation.)
Table I.
                                     Table 1: Batched Hexadecadienol Acetate Products
            Batch
            No.

              1
EPA Reg. No.

  ====
   50675-2
                             67250-2
% of Hexadecadienol Acetate
                                                              49.8 (Z,Z)
                                                              47.2 (Z,E)
                                                              49.2 (Z,Z)
                                                              43.5 (Z,E)
Formulation Type


     liquid
                                                                        liquid
                                                           137

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Table  II lists the products which could not be batched.  For the purposes of acute toxicity batching, these products were not
considered similar, or their similarity could not be determined with the information available.  The registrants of these products
are responsible for meeting the acute toxicity data requirements specified in the data matrix for end-use products.
Table  II.
Table II: Non-Batched Products
EPA Reg. No.
10350-25
36638-12
36638-1
50675-5
53871-1
56336-1
67250-3
67250-4
% of Hexadecadienol Acetate
10.0 (Z,Z)
10.0 (Z,E)
10.0 (Z,Z)
10.0 (Z,E)
3.8 (Z,E)
3.8 (Z,Z)
43.0 (Z,Z)
. 44.0 (Z,E)
0.316 (Z,Z)
0.316 (Z,E)
40.4 (Z,Z)
40.4 (Z,E)
63 (Z,E) & (Z,Z)
48.8
Formulation Type
microencapsulated
liquid
microencapsulated
liquid
impregnated fibers
dispenser tube
microencapsulated
liquid
water dispersable solid
granules
solid beads
solid stakes
                                                             138

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Attachment 5. EPA Acceptance Criteria
                139

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                                          SUBDIVISION D
Guideline

Series 61
Series 62
Series 63
Study Title

Product Identity arid Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
                                               141

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                                         61 Product Identity and Composition
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?

j, _    Name of technical material tested (include product name and trade name, if appropriate).

2. _    Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each intentionally-added
          inert ingredient.

3.        Name and upper certified limit for each impurity or each group of impurities present at >. 0. 1 % by weight and for certain
  "        lexicologically significant impurities (e.g., dioxins,  nitrosamines) present at <0.1%.

44 _    Purpose of each active ingredient and each intentionally-added inert.

5.        Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Registry Number
  '        for each active ingredient and, if available, for each intentionally-added inert.

6 _    Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned experimental
          or internal code numbers for each active ingredient.

7.        Description of each beginning material in the manufacturing process.
          _ EPA Registration Number if registered;
                for other beginning materials, the following:
          _ Name and address of manufacturer or supplier.
                Brand name, trade name or commercial designation.
          - Technical specifications or data sheets by which manufacturer or supplier describes  composition, properties or
                toxicity.

 8. _ Description of manufacturing process.
          _ Statement of whether batch or continuous process.
                Relative amounts of beginning materials and order  in which they are added.
                Description of equipment.
          - Description of physical conditions (temperature, pressure, humidity) controlled in each step and the parameters that
                are maintained.
                Statement of whether process involves intended chemical reactions.
                Flow chart with chemical equations for each intended chemical reaction.
          ~~~ Duration  of each step of process.
          ~~  Description of purification procedures.
          _  Description of measures taken to assure quality of final product.

  9         Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which may be
  ' -    present at >. 0. 1 % or was found at _>_ 0. 1 % by product analyses and (2) certain lexicologically significant impurities (see
           03).
                                                           142

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                                    62 Analysis and Certification of Product Ingredients
   _
 3.
                                                ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered.  Use a table to present the information
1H Items 0, /,  3X1G o.

Does your study meet the following acceptance criteria?

 1'	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all impurities
         present at _>_ 0.1 %.                                                                                       r
         Degree of accountability or closure _>_ ca 98%.
         Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the case of products
         containing  dinitroamlines or  containing secondary  or tertiary amines/alkanolamines plus nitrites-   polyhalogenated
         dibenzodioxms and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored samples must be analyzed ]
         Complete and detailed description of each step in analytical method used to analyze above samples.
         Statement of precision and accuracy of analytical method used to analyze above samples.
         Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient
         Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with explanation
         of how the  limits were determined.
         Upper certified limit proposed for each impurity present at >. 0.1 % and for certain toxicologically significant impurities
         at <0.1 % along with explanation of how limit determined.
         Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt from
         requirement of tolerance or if generally recognized as safe by FDA) are fully described.
         Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy
 4.
 5."
 6."
 7.
 9.
10.
                                                         143

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                                       63 Physical and Chemical Characteristics

                                               ACCEPTANCE CRITERIA


The following criteria apply to the technical grade of the active ingredient being reregistered.

Does your study meet the following acceptance criteria?

63-2 Color
          Verbal description of coloration (or lack of it)
    	  Any intentional coloration also reported in terms of Munsell color system

63-3 Physical State
          Verbal description of physical state provided using terms such as "solid, granular, volatile liquid
    ~~~""  Based on visual inspection at about 20-25°  C
63-4 Odor
           Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic compounds"
           Observed at room temperature
63-5 Melting Point
    	   Reported in °C
    	   Any observed decomposition reported

63-6 Boiling Point
    	   Reported in °C
    	   Pressure under which B.P. measured reported
    ~~~"   Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity
           Measured at about 20-25° C                                                                  *  .^   *
    	   Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with reference to
           water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or Ibs/gallon.]


 63'8      Determined in distilled water and representative polar and non-polar solvents, including those used in formulations and
           analytical methods for the pesticide
    	  Measured at about 20-25° C
    	  Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

 63-9 Vapor Pressure                                                                                 ._            ,
           Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure too low to
           measure at 25° C)
    	  Experimental procedure described
    	  Reported in mm Hg (torr) or other conventional units

 63-10 Dissociation Constant
    	  Experimental method described
    	  Temperature of measurement specified (preferably about
           20-25°C)

 63-11 Octanol/water Partition Coefficient
    	  Measured at about 20-25° C                                                               .    __,„,.
    	  Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77J50)
    ~~"~~~  Data supporting reported value provided
                                                           144

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63-12
           Measured at about 20-25° C.
           Measured following dilution or dispersion in distilled water
63-13 Stability
   	   Sensitivity to metal ions and metal determined
   	   Stability at normal and elevated temperatures
   	   Sensitivity to sunlight determined
                                                          145

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                                                  SUBDIVISION F
Guideline          Study Title

 81-1          Acute Oral Toxicity in the Rat
 81-2          Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3          Acute Inhalation Toxicity in the Rat
 81-4          Primary Eye Irritation in the Rabbit
 81-5          Primary Dermal Irritation Study
 81-6          Dermal Sensitization in the Guinea Pig
                                                         146

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                                           81-1 Acute Oral Toxicity in the Rat


                                                ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 !•	Identify material tested (technical, end-use product, etc).
 2.	At least 5 young adult rats/sex/group.
 3.	Dosing, single oral may be administered over 24 hrs.
 4.*	Vehicle control if other than water.
 5-	Doses tested, sufficient to determine a toxiciry category or a limit dose  (5000 mg/kg).
 6.	Individual observations at least once a day.
 7-	Observation period to last at least  14 days, or until all test animals appear normal whichever is longer
 8.	Individual daily observations.
 9.	Individual body weights.
10.	Gross necropsy on all animals.
                           Criteria marked with an * are supplemental and may not be required for every study.

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                              81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
                                                ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?

 1%	Identify material tested (technical, end-use product, etc).
 2.      At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 g.*	Vehicle control, only if toxicity of vehicle is unknown.
 7]	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 g/      Application site clipped or shaved at least 24 hours before dosing.
 9.      Application site at least 10% of body surface area.
 10.       Application site covered with a porous nonirritating cover to retain test material and to prevent

          Individual observations at least once a day.
          Observation period to last at least 14 days.
          Individual body weights.
          Gross necropsy on all animals.
                               Criteria marked with an * are supplemental and may not be required for every study.
                                                             148

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                                         81-3 Acute Inhalation Toxicity in the Rat
                                                ACCEPTANCE CRITERIA
 Does your study meet the following acceptance criteria?
 1.
 2."

 3.
13.
14.
     . Identify material tested (technical, end-use product, etc).

     ' S?T ^f3 Ti' 5 SOHd ThiCh ^ PI'°dUCe a siSnificant vaP°r ^ard based on toxicity and expected use or contains
      particles of mhalable size for man (aerodynamic diameter 15 /an or less).
	At least 5 young adult rats/sex/group.
•	Dosing, at least 4 hours by inhalation.
	Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content
	Chamber temperature, 22° C (+2°), relative humidity 40-60%.
	Monitor rate of air flow.
	Monitor actual concentrations of test material in breathing zone.
	Monitor aerodynamic particle size for aerosols.
._  Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable substance).

•	  Individual observations at least  once a day.
      Observation period to last at least 14 days.
      Individual body weights.
      Gross necropsy on all animals.
                                                        149

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                                       81-4 Primary Eye Irritation in the Rabbit
                                               ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
 1.	Identify material tested (technical, end-use product, etc).
 2.      Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of <2 or J>_11.5.
 3.	6 adult rabbits.
 4.	Dosing, instillation into the conjunctival sac of one eye
        per animal.                                                                  .
 5.      Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
 6.      Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 g.	Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.*    Individual daily observations.
                              Criteria marked with an * are supplemental and may not be required for every study.
                                                            150

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                                          81-5  Primary Dermal Irritation Study

                                                ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1-	Identify material tested (technical, end-use product, etc).
 2-	Study not required if material is corrosive or has a pH of <2 or JM1.5.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4 hours.
 6-	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8-	Application site covered with a gauze patch held in place with nonirritating tape.
 9-	Material removed, washed with water, without trauma to application site.
10.	  Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days (whichever
        is shorter).
11.*	  Individual daily observations.
                           Criteria marked with an * are supplemental and may not be required for every study.

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                                      81-6 Dermal Sensitization in the Guinea Pig

                                               ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.    Identify material tested (technical, end-use product, etc).
2.~" Study not required if material is corrosive or has a
      pH of <2 or Ml.5.
3.	One of the following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	Complete description of test.
5.*	Reference for test.
6.    Test followed essentially as described hi reference document.
7.    Positive control included  (may  provide historical data conducted within the last 6 months).
                              Criteria marked with an * are supplemental and may not be required for every study.
                                                           152

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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
                                  153

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Attachment 7. Cost Share Data Compensation Forms, Confidential Statement of
                     Formula Form and Instructions
                                 155

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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.



               d.



               e.


               f.


               g-


              h.


              i.



              j-



              k.

              1.


              m.




              n.
  The CSF must be signed, dated and the telephone number of the responsible party
  must be provided.


  All applicable information which is on the product specific data submission must
  also be reported on the CSF.


  All weights reported under item 7 must be in pounds per gallon for liquids and
  pounds per cubic feet for solids.

  Flashpoint must be in degrees Fahrenheit and flame extension in inches.

 For  all active  ingredients, the EPA Registration Numbers  for  the  currently
 registered source products must be reported under column  12.

 The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
 common names for the trade names must be reported.

 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.
 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).

 All the items under column 13.b.  must total 100 percent.

 All items under columns 14.a. and 14.b. for the active ingredients must represent
 pure active form.


 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.

When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete  for that specific formulation.
                                                 159

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        /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
  s^rs?18 instajctjr- srrc.hing existing data s°urces- 9atherfn9a™«m*wS»
  complet.ng and reviewingi the collection of information. Send comments regarding the burden estimate
  ^^S^^JSSSS^^S"0 ST f°r redUCing this bu?den'to Chief« 'nformaono
  Branch, PM-223. US. 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:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide. Fung,c,de 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
                    wSngto e"ter into sucn an agreement. That offer was irrevocable and included an
     s ™d nnt r     "JTT dfCISi°Tnhunder section 3{c)(2}(B)(iK) of FIFRA if final agreement on all
 terms could not be reached otherw.se. This offer was made to the following firm(s) on the following
  Name of Firm(s)
                                                                          Date of Offer
Certification;

I certify that 1 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 Sng y fatee or
misleading statement may be punishable by fine or imprisonment or both under applkS law
Signature of Company's Authorized Representative
Name and Title (Please Type or Print)
                                                                         Dale
EPA Form 8570-32 (5/91)   Replaces EPA Form 8580, whieh is obsolete
                                             161

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-------
      &EPA
i"«^	
United States EnvJronmantal Prouetlon Agency
          Washington,  DC 20460
   CERTIFICATION WITH RESPECT TO
 DATA COMPENSATION  REQUIREMENTS
F«m Afftmv*

OH* N*. 2070-0X07
       2070-0057
       CxplfM 3-31-96
                                                                       .


   Pleas* fill In blanks btlow.
  ICartifythat
  "

    II  Jheeonpaniw who hav* submitted tht studies Gsted
       snwts. or MOM on th» attached -Requirements Status w


  Signature
 Nam« «i4 Tilto (PIMM TyM «r MM)
 Signature
              £
 Nam* and TItte (PIMM Typ. or Print)
EPA Form M70-J1 (440)
                                      163

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APPENDIX H. FACT SHEET
          165

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                    United States
                    Environmental Protection
                    Agency
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)
EPA-738-F-94-005
April 1994
&EPA    R.E.D.   FACTS
                    Hexadecadienol
                    Acetates
         Pesticide      All pesticides sold or distributed in the United States must be
    Reregistration  registered by EPA, based on scientific studies showing that they can be
                    used without posing unreasonable risks to people or the environment.
                    Because of advances in scientific knowledge, the law requires that
                    pesticides which were first registered years ago be reregistered to ensure
                    that they meet today's more stringent standards.
                        In evaluating pesticides for reregistration, EPA obtains and reviews a
                    complete set of studies from pesticide producers, describing the human
                    health and environmental effects of each pesticide. The Agency imposes
                    any regulatory controls that are needed to effectively manage each
                    pesticide's risks.  EPA then reregisters pesticides that can be used without
                    posing unreasonable risks to human health or the environment.
                        When a pesticide is eligible for reregistration, EPA announces this
                    and explains why in a Reregistration Eligibility Decision (RED) document.
                    This fact sheet summarizes the information in the RED for hexadecadienol
                    acetates, including the active ingredients (Z,E)-7,ll-Hexadecadien-l-yl
                    acetate and (Z,Z)-7,ll-Hexadecadien-l-yl acetate, which are marketed
                    under the trade name Gossyplure.
      Use Profile
     Hexadecadienol acetates are sex-attractant pheromones of the pink
boHworm, Pectinophora gossypiella. Saunders, registered only for use on
growing cotton to disrupt the male-female mating behavior. They are used
in small quaintities-less than 100 pounds of the active ingredients are
applied each year, and only about 1 % of the California cotton crop is
treated with these biochemical pesticides.
     Some products of this pheromone are applied in retrievably-sized
polymeric matrix dispensers (twist ties and impregnated stakes).  There are
also end-use products which are microencapsulated and applied to foliage
via broadcast, ground- and aerially-applications.  These are water soluble
                                      167

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Regulatory
    History
                   fbimulations sprayed as either tank mixes or alone as emulsifiable
                   concentrates or water dispersable granules.

                        Hexadecadienol acetates were first registered as pesticides in the U.S.
                   i*1 1978-  Currently, 10 products are registered by six companies. The
                   reregistration case contains four active ingredients, however two are not in
                   any registered products.
                        The hexadecadienol acetate formulations classified as solid matrix
                   dispensers soon may be exempted from regulation as pesticides because
                   they pose little risk to human health or the environment.
Human Health
   Assessment
 Environmental
   Assessment
                Toxicity
                     Hexadecadienol acetates generally are of low acute toxicity. They
                are placed in Tbxicity Category IV, indicating the lowest level of acute
                toxicity, for acute oral and primary dermal effects.  For acute dermal,
                acute inhalation and primary eye irritation effects, hexadecadienol acetates
                are placed in Toxicity Category ffl.  Since the potential for human
                exposure to these pesticides is  considered negligible, all other standard
                toxicology studies are waived.
                Dietary Exposure
                     Hexadecadienol acetates  may be present in the diet at low  levels, but
                these residues are considered to be negligible and are not believed to pose
                human health risks.  An exemption from the requirement of a tolerance has
                been established for residues of the active ingredient in or on the raw
                agricultural commodity cottonseed when applied to cotton from capillary
                fibers (see 40 CFR 180.1043). This exemption does not include the
                microencapsulated active ingredient.
                Occupational and Residential Exposure
                      Since hexadecadienol acetates are contained, embedded or
                impregnated in a solid polymeric matrix or shell, cause little exposure, and
                do not pose significant lexicological concerns, no exposure data are
                required.
                Human Risk Assessment
                      Based on their application methods, insignificant dietary and non-
                dietary exposure and relatively low toxicity, the hexadecadienol acetates'
                potential risks to humans are considered negligible.

                Environmental  Fate
                      Hexadecadienol acetates are highly volatile and rapidly disperse into
                air.  They are used in minute  quantities in impregnated materials (stakes or
                twist ties) or as microencapsulated material which is applied to foliage via
                broadcast, ground- and aerially-applications. Because there is potential for
                                           168

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                         the microencapsulated material to reach soil or water, soil or water
                         contamination is possible.  However, since the microencapsulated
                         hexadecadienol acetate assumes the vapor state as it is released and rapidly
                         disperses, the amount which would actually be  available in the ecosystem
                         at any given time would be a small fraction of the amount applied.
                         Ecological Effects
                              Technical hexadecadienol is practically non-toxic to bobwhite quail,
                         rainbow trout and honey bees.  It is tentatively characterized as highly
                         toxic to freshwater invertebrates.  However, two aquatic studies are
                         considered unacceptable and must be repeated as confirmatory data.

                         Ecological Effects Risk Assessment
                             Hexadecadienol acetate emulsifiable concentrate residues on treated
                         food and forage items are expected to be below  all levels of concern for
                        both non-target and endangered avian species.  A model used to calculate
                        the expected environmental concentration (EEC) of hexadecadienol acetate
                        emulsifiable concentrate in water indicates that adverse effects to aquatic
                        species would be unlikely.  Because it is highly volatile and is used in very
                        small amounts, EPA believes that the risk to freshwater aquatic organisms
                        will be minimal. However, the Agency is requiring acute toxicity data on
                        both freshwater fish and aquatic invertebrates to confirm this assumption.
   Additional Data
                  The generic data base for hexadecadienol acetates is substantially
Required   complete.  However, EPA is requiring additional ecological effects studies
             as confirmatory data.  The Agency also is requiring product specific data
             including product chemistry and acute toxicity studies, revised Confidential
             Statements of Formula (CSFs) and revised labeling for reiegistration of
             pesticide products containing hexadecadienol acetates.
  Product  Labeling
Changes Required
                  All hexadecadienol acetate end-use products must comply with EPA's
            current pesticide product labeling requirements.  In addition:
            Protection of Freshwater Invertebrates - All end-use products must bear
            the following precautionary statement:
                  "This product is highly toxic to freshwater invertebrates.  Do not
                  apply directly to water, or to areas where surface water is present or
                  to intertidal areas below the mean high-water mark.  Drift and runoff
                  may be hazardous to aquatic organisms in neighboring areas.  Do not
                  contaminate water when disposing of equipment washwater or
                  rinsate."
            Application Rates - Product labels must include the amount of active
            ingredient to be applied per application, the maximum number of
            applications per year, and the minimum number of days between each
            application.
                                              169

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                Worker Protection Standard (WPS) - Any product whose labeling
                permits use in the production of an agricultural plant on any agricultural
                establishment (farm, forest, nursery or greenhouse) must comply with the
                labeling requirements of EPA's Worker Protection Standard (WPS).  See
                PR Notice 93-7, "Labeling Revisions Required by the Worker Protection
                Standard (WPS)," and PR Notice 93-11, "Supplemental Guidance for PR
                Notice 93-7."  Unless specifically directed in the RED, all statements
                required by the WPS and reflected in these two PR Notices must be
                included on product labeling.
 Regulatory
Conclusion
     The use of currently registered pesticide products containing
hexadecadienol acetates in accordance with approved labeling will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all currently registered products are eligible for reregistration.
These products will be reregistered once the required confirmatory generic
data, product specific data, revised Confidential Statements of Formula and
revised labeling are received and accepted by EPA.
   For More
information
     EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for hexadecadienol acetates during a 60-day
time period, as announced in a Notice of Availability published in the
Federal Register.  To obtain a copy of the RED document or to submit
written comments, please contact the Pesticide Docket, Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
     Following the comment period, the hexadecadienol acetates RED
document will be available from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
     For more information about EPA's pesticide reregistration program,
the hexadecadienol acetates RED, or reregistration of individual products
containing hexadecadienol acetates, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000.
     For information about the health effects  of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN).  Call toll-free 1-800-858-7378,  from 8:00 am to 6:00 pm Central
Time,  Monday through Friday.
                                       170

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