United States
        Environmental Protection
        Agency
Prevention, Pesticides
And Toxic Substances
(75O8W)
EPA 738-R-94-004
April 1994
&EPA  Reregistration
         Eligibility Decision (RED)
         Periplanone  B

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.SK
                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                  WASHINGTON, D.C, 20460
CERTIFIED MAIL
                                                                               OFFICE OF
                                                                        PREVENTION, PESTICIDES AND
                                                                            TOXIC SUBSTANCES
                                                                            MAR 2 5 1994
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 Periplanone B.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of
the data base of this chemical, its conclusions of the potential human health and
environmental risks of the current product uses, and its decisions and conditions.under which
these uses and products will be eligible for reregistration.  The RED includes the data and
labeling requirements for products for reregistration. It may also include requirements for
additional data (generic) on the active ingredient(s) to confirm the risk assessments.

       To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED."  This summary also refers to other enclosed
documents which include further instructions.  You must follow all instructions and submit
complete and timely responses.  The first set of required responses are due 90 days from
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 Bill Wooge at (703)308-8794.

                                                      Sincerely yours,
Enclosures
                                                     Daniel M. Barolo, Diri
                                                     Special Review and
                                                      Reregistration Division
                                                                             :or
                                                                        Recycled/Recyclable
                                                                        Printed with Soy/Canola Ink on paper that
                                                                        contains at least 50% recycled fiber

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              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
             THE REREGISTRATION ELIGIBILITY DECISION
1.      DATA CALL-IN (DCI) OR "90-DAY RESPQNSE"-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 WAIVES 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 tune
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 hi 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 in 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-MONTH RESPONSES)

Bv U.S. Mail:

      Document Processing Desk (RED-SKRD-4115)
      Office of Pesticide Programs (H7504C)
      EPA, 401 M St. S.W.
      Washington, D.C.  20460-0001

By express:

      Document Processing Desk (RED-SRRD-4115)
      Office of Pesticide Programs (H7504C)
      Room 266A, Crystal Mall 2
      1921 Jefferson Davis Hwy.
      Arlington, VA 22202

6.    EPA'S REVTEWS--EPA will screen all submissions for completeness; those which
are not complete will be returned with a request for corrections.  EPA will try to respond to
data waiver and time extension requests within 60 days.  EPA will also try to respond to all
8-month submissions with a final reregistration determination within 14 months after the
RED has been issued.

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REREGISTRATION ELIGIBILITY DECISION

                Periplanone B

                   LISTD

                 CASE 4115
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REKEGISTRA'nON DIVISION

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                         TABLE OF CONTONTS
PERIPLANONE B REREGISTRATION ELIGIBILITY DECISION 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

m.   SCIENCE ASSESSMENT	  4
      A.   Physical Chemistry Assessment  	  4
      B.   Human Health Assessment	  4
           2.    Exposure Assessment  	  5
                 a.    Dietary Exposure	  5
                 b.    Occupational and Residential	  5
           3.    Risk Assessment		  5
      C.   Environmental Assessment	  6
           1.    Environmental Fate	  6
           2.    Ecological Effects	  6
                 a.    Ecological Effects Data	  6
                 b.    Ecological Effects Risk Assessment	  6

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	  6
      A.   Determination of Eligibility	  6
           1.    Eligibility Decision	  7
           2.    Eligible and Ineligible Uses  	  7
      B.   Regulatory Position .	  	  7
           1.    Labeling Rationale	,.	  8

V.    ACTIONS REQUIRED BY REGISTRANTS	  8
      A.   End-Use Products	  8
           1.    Additional Product-Specific Data Requirements 	  8
           2.    Labeling Requirements for End-Use Products	  9
      B.   Existing Stocks  .  . .	  9

VI.  APPENDICES	:	 11
      APPENDIX A. Table of Use Patterns Subject to Reregistration	 13
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
           to Make the Reregistration Decision	 17
      APPENDIX C. Citations Considered to be Part of the Data Base

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      Supporting the Registration of 4115	  25
APPENDIX D. List of Available Related Documents	  .  31
APPENDIX E	  35
      PR Notice 86-5	  37
      PR Notice 91-2	  57
APPENDIX F. Product Specific Data Call-In	  63
      Attachment 1. Chemical Status Sheet 	  77
      Attachment 2. Product Specific Data Call-In Response Forms (Form
            A inserts) Plus Instructions  	  81
      Attachment 3. Product Specific Requirement Status and
            Registrant's Response Forms (Form B inserts) and
            Instructions  	  87
      Attachment 4. EPA Batching of End-Use Products for Meeting Data
            Requirements for Reregistration	  97
      Attachment 5. EPA Acceptance Criteria  	101
      Attachment 6. List of All Registrants Sent This Data Call-In (insert)
            Notice	115
      Attachment 7. Cost Share Data Compensation Forms, Confidential
            Statement of Formula Form and Instructions	.  . 119
APPENDIX G. FACT SHEET	129

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PERIPLANONE B REREGISTRATTON ELIGIBIL][TY DECISION TEAM
Office of Pesticide Programs:

Biological and Economic Analysis Division

Janet Andersen
Linda Bass
John L. Faulkner
Steven Jarboe

Environmental Fate and Effects Division

Clay Beegle
Regina Hirsch
Jean Holmes

Health Effects Division

Flora Chow
Tom McClintock
Al Nielson

Registration Division

Teung Chin
Thomas EEwanger
Joanne Hayes
Phillip O. Hutton

Special Review and Reregistration Division

Kathy Davis
Bill Wooge

Office of Compliance Monitoring

Shruti Sanghav-i

Office of General Counsel
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate & Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Chemical Coordination Branch
Science Analysis Branch
Occupational & Residential Exposure Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Policy & Analysis Branch
Kevin J^ee
Pesticides Branch

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                  GLOSSARY OF TERMS AND ABBREVIATIONS

a.i.          Active Ingredient

CAS         Chemical Abstracts Service

CSF         Confidential Statement-of Formula

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

EP          End-Use Product

EPA         U.S. Environmental Protection Agency

FDA         Food and Drug Administration

FEFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food, Drug, and Cosmetic Act

GRAS       Generally Recognized As Safe as designated by FDA

HDT         Highest Dose Tested

LC50         Median Lethal Concentration. A statistically derived concentration of a
             substance that can be expected to cause death in 50% of test animals. It is
             usually expressed as the weight of  substance per weight or volume of water,
             air or feed,  e.g., mg/1, mg/kg or ppm.

LD50         Median Lethal Dose.  A statistically derived single dose that can be expected
             to cause death in 50% of the test animals when administered by the  route
             indicated (oral, dermal, inhalation). It is expressed as a weight of substance
             per unit weight of animal, e.g., mg/kg.

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

TJRT.         Lowest Effect Level

LOEL       Lowest Observed Effect Level

MP          Manufacturing-Use Product

MPI         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*t          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.

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EXECUTIVE SUMMARY

       The U.S. Environmental Protection Agency (hereafter referred to as the "Agency" or
"EPA") has completed its reregistration assessment of the available information on the
pesticide active ingredient Periplanone B.  Periplanone B is the specific sex pheromone of
the American cockroach, Periplaneta americana, and is used as a lure hi conjunction with
another pesticide toxicant, propoxur.

       The Agency has determined that the uses of Periplanone B as currently registered will
not cause unreasonable risk to humans or the environment and these uses are eligible for
reregistration.  The Agency is requiring a new Confidential Statement of Formula and
amended labelling but is not requiring any additional studies, generic or product specific.

       Before reregistering the product containing Periplanone B, the Agency is requiring
that revised labeling be submitted within eight months of the issuance of this document.
After reviewing the revised labeling and finding them acceptable in accordance with Section
3(c)(5) of FEFRA,  the Agency will reregister a product.  This product,  which also contains
propoxur as another active ingredient, will be eligible for reregistration only  when propoxur
is 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 in nine years. There are five phases to the
       reregistration process.  The first four phases of the process focus on identification of
       data requirements to support the reregistration of an active ingredient and the
       generation and submission of data to fulfill the requirements.  The fifth phase is a
       review by the U.S.  Environmental Protection Agency of all data submitted to support
       reregistration.

             FIFRA Section 4(g)(2)(A) states that in Phase 5  "the Administrator shall
       determine whether pesticides containing such active ingredient are eligible for
       reregistration" before calling in data on products and either reregistering products or
       taking "other appropriate regulatory action."   Thus, reregistration involves a
       thorough review of the scientific data base underlying a pesticide's registration.  The
       purpose of the Agency's review is to reassess the potential hazards arising from the
       currently registered uses of the pesticide; to determine the need for additional data on
       health and environmental effects; and to determine whether the pesticide meets  the
       "no unreasonable adverse effects" criterion of FIFRA.

             This document presents the Agency's decision regarding the reregistration
       eligibility of the registered uses of Periplanone B.  The document consists of six
       sections. Section I is the introduction.  Section n describes Periplanone B,  its uses,
       data requirements and regulatory history.  Section HI discusses the human health and
       environmental assessment based on the data available to the Agency.  Section IV
       presents the reregistration decision for Periplanone B.  Section V discusses the
       reregistration requirements for Periplanone B.  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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CASE OVERVIEW

A.    Chemical Overview

             The following active ingredient is covered by this Reregistration
      Eligibility Decision document:

           Common Name:    Periplanone B

           Chemical Name:    [!R*-(lR*,2R*,5S*,6E,10R*)]-(+/-)-8-
                               methylene-5-(l-methylethyl)-spiro(ll-oxicyclo
                               (8.1.0) unded-6-ene-2,2'oxiran]-3-one
             Synonym
                         (**)-Diepoxy-4(15),5-germacradiene-9-one
                         (**)=(1Z,5E)-1,10(14)
     CAS Registry Number:    61228-92-0

     OPP Chemical Code:      124801

     Empirical Formula:

     Basic Manufacturer:
                                      Hercon Environmental Company
B.    Use Profile
             The following is information on the currently registered uses with an
      overview of use sites and application methods.  This information is current as of
      December 16, 1993.  A detailed table of these uses of Periplanone B is in
      Appendix A.

      For Periplanone B:

      Type of Pesticide:  Pheromone (an attractant which influences the behavior
                         of individuals of a species)

      Use Sites:    INDOOR RESIDENTIAL: Household/domestic dwellings
                   indoor premises

                   OUTDOOR RESIDENTIAL: Household/domestic dwellings
                   outdoor premises.

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       Target Pests:
INDOOR NON-FOOD: liating establishment non-food areas
(non-food contact), commercial/institutional/industrial
premises/equipment (indoor), household/domestic dwelling
indoor non-food handling areas, food processing plant non-food
handling areas, food/grocery/marketing/storage/distribution
facility premises

TERRESTRIAL NON-FOOD USE:
Commercial/institutional/iindustrial premises/equipment (outdoor)

       Periplaneta americana (the American cockroach).
       Periplanone B has also been shown to attract other
       members of Periplaneta species (including P.
       austmlasiae, the Australian cockroach; P. brunnea, the
       brown cockroach; and P. julinginosa the smokybrown
       cockroach).
       Formulation Types Registered:
      Method and Rates of Application:
                    Impregnated material: < 0.001%
                    Periplanone B (combined with 10%
                    propoxur)

                           One or more bait tray (6.13 g total
                           net weight) per 100 square feet to
                           be replaced every 30 days or when
                           effectiveness is diminished
      Use Practice Limitations:
             There are currently no use practice limitations;
             however, through this document, amendments to
             specify maximum application rates and directions
             for replacement are required. See section V.A.2.
             of this document.
C.    Regulatory History
             The first pesticide products containing Periplanone B as an active
       ingredient were registered in 1984. One of these products currently has an active
       registration, the insecticidal bait, "Lure N Kill Roach and Ant Killer with Roach
       Sex Lure" (EPA Registration No. 8730-35) which contains, as active ingredients,
       0.001%   Periplanone   B   and   10%    Propoxur
       (2-(l -methylethoxy)phenolmethylcarbamate).  Because of Periplanone B' s nature
       as  an insect pheromone,  the Agency  required  reduced data  requirements
       appropriate for a biochemical pesticide.  The current end-use product is an open
       four-by-six inch tray containing a  trilaminate  bearing  Periplanone  B  and
       propoxur. Each bait tray contains less than one microgram of Periplanone B.

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HI.  SCIENCE ASSESSMENT

     A.    Physical Chemistry Assessment

           Below are basic physical chemistry characteristics of technical Periplanone B:

           Characteristics                    Results
     B.
           Color
           Physical State
           Odor
           Density
           pH
           Stability
                                White to Tan
                                Solid
                                None
                                0.78
                                 <1.0
                                Unstable*
* Very sensitive to light; degrades into biologically inactive compounds when
exposed to light and air.

Human Health Assessment

1.    Mammalian Toxicology Data Base

             Acute mammalian toxicology studies on the currently registered
      end-use product have been  submitted and adequately satisfy the generic
      and product-specific requirements as set forth in 40 CFR 158.690.
STUDY
Acute Oral LD50
Acute Dermal LD50
Acute Inhalation LC50
Primary Eye Irritation
Primary Dermal Irrit.
Dermal Sensitization
Mutagenicity (Ames Assay)
RESULT
>5 gm/kg
>2gm/kg
>1.68mg/l
No Irritation
Moderate Irritant
Not a Sensitizer
Not Mutagenic
CATEGORY
IV
m
m
IV
m
N/A*
N/A*
                  *Not Applicable

                        The acute mammalian toxicology studies for the end-use product
                  were accepted in lieu of studies on pure Periplanone B because of (i) the

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       difficulties of synthesizing of the compound;  (ii) the quantity of the
       compound needed for all required, testing; (iii) the rapid degradation of the
       compound; (iv) a worst case exposure scenario that revealed insignificant
       exposure (2.92 ngm) under ideal conditions; (v) no adverse effects  have
       been reported for workers exposed to amounts  that are estimated to be
       106-fold greater than to the user; and (vi) less than 15 gm of compound
       have been produced from 1984 to present.

              Except for the acute mammalian toxicology data  and the Ames
       mutagenicity assay, the Agency waived the remaining toxicology studies.
       Because the potential for human exposure from non-dietary and dietary
       routes  is  considered  negligible,  the   remaining  toxicology   (i.e.
       immunotoxicity  study  [152B-18], 90-day oral study [152B-20]   and
       developmental toxicity [152B-23]) have been waived. Consequently, all
       mammalian toxicology  data  requirements have  been satisfied.    No
       additional information and/or data are required at this time.  In the event
       that the technology for manufacturing and/or synthesizing the compound
       allows  increased levels of  synthesized product, and/or the use pattern
       changes such as to increase the likelihood of exposure, the Agency may
       reevaluate the need for toxicology testing on the technical grade material.

2.     Exposure Assessment

       a.     Dietary Exposure

                    The potential for  dietary exposure to Periplanone  B is
              considered negligible because of the application method (restriction
              from contamination  of food)  and the ultra-low amounts in the
              formulation.

       b.     Occupational and Residential

                    Based on low exposure  and lack of significant toxicological
              concerns, as demonstrated  in the battery  of acute mammalian
              toxicity  and  mutagenicity studies,  there are  no  exposure  data
              required by the Agency.

3.     Risk Assessment

              The potential risks to humans  from both non-dietary and dietary
       routes of Periplanone B are considered negligible based on the application
       methods (low  volume of bait),  low exposure  and lack  of significant
       toxicological  concerns,  as  demonstrated in  the  submitted toxicology
       studies. Based on the lack of toxicological concerns the Agency has no

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                    additional data for protection of human health from Periplanone B.
       C.    Environmental Assessment
             1.     Environmental Fate

                           Environmental fate data are not required for biochemicals that have
                    no adverse effects observed in acute toxicology testing of fish, birds and
                    aquatic invertebrates.  Because all ecotoxicological data requirements have
                    been waived, no environmental fate data are required for Periplanone B.

             2.     Ecological Effects

                    a.     Ecological Effects Data

                                 The Agency has waived all standard data requirements for
                           ecological effects for the following reasons: Periplanone B is used
                           primarily in indoor  areas; a small quantity  (0.7 micrograms) of
                           this chemical is contained within each tray; Periplanone B is  a
                           synthetic duplicate of the natural sex pheromone of Periplaneta
                           americana; and Periplanone B rapidly and completely degrades to
                           biologically inactive compounds  when it is  exposed to light and
                           air.

                    b.     Ecological Effects Risk Assessment

                                 The environmental exposure  is expected to be negligible
                           when Periplanone B is used according to the directions on the
                           label; therefore, the ecological risk is expected to be negligible.

IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility

                    Section 4(g)(2)(A) of ECFRA calls for  the Agency to determine, after
             submission of relevant data concerning an active ingredient, whether products
             containing the active ingredients are eligible for reregistration.  The Agency has
             previously identified and required the  submission of the generic (i.e. active
             ingredient specific) data required to support reregistration of products containing
             Periplanone B active ingredients. The Agency has completed its review of these
             generic and other data, and  has determined that they are sufficient to support
             reregistration of all products containing Periplanone B. Appendix B identifies the
             generic data requirements that the Agency reviewed as part of its  determination

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       of reregistration eligibility of Periplanorte B, and lists the submitted studies that
       the Agency found acceptable.

              The data identified in Appendix B were sufficient to allow the Agency to
       assess the registered uses of Periplanone B and to determine that Periplanone B
       can be used without resulting in unreasonable adverse effects to humans and the
       environment.  The Agency therefore finds that the currently registered product
       containing Periplanone  B  as  the  sole active  ingredient will be  eligible for
       reregistration  when Propoxur,  the other active ingredient,  is  eligible.   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 currently registered uses of
       Periplanone B  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  Periplanone B,
       if new information comes to the Agency's attention or if the data requirements for
       registration (or the guidelines for generating such data) change.

       1.     Eligibility Decision

                    Based on the reviews of  the generic data for the active ingredient
              Periplanone B, the Agency has sufficient information on the potential
              health and environmental effects of Periplanone B.  The Agency has
              determined that Periplanone B products,  labeled and used as specified in
              this  Reregistration  Eligibility   Decision  document  will  not  pose
              unreasonable risks or adverse effects to humans or the  environment and
              therefore they are eligible for reregistration.

       2.     Eligible and Ineligible Uses

              The  Agency  has determined  that  all  currently registered  uses of
              Periplanone B are eligible for reregistration.

B.     Regulatory Position

              The following is a summary of the regulatory positions and rationales for
       Periplanone B.   Where labeling revisions are imposed, specific language is set
       forth in Section V of this document.
                                     7

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             1.     Labeling Rationale

                          In order to remain in compliance with FIFRA, it is the Agency's
                   position that the labeling of the currently registered pesticide product
                   containing Periplanone B must comply with the Agency's current pesticide
                   labeling requirements.  The Agency has determined that labeling must be
                   changed to   give a specific maximum  application  rate and specific
                   directions for replacement. Application directions such as:

                          "USE ONE BAITED TRAY PER  100 SQUARE  FEET OF
                          SURFACE TO BE TREATED.' USE MORE IF INFESTATION
                          IS WIDESPREAD. REPLACE INSECTICIDAL BAITS AFTER
                          30 DAYS OR WHEN EFFECTIVENESS IS DIMINISHED TO
                          PREVENT COCKROACH REINFESTATION."

                   are considered too general.  Because no upper limit is given, excessive
                   application of the product may occur.   Because the statement  "when
                   effectiveness is diminished" could be considered to be  subjective, it is
                   possible that the user may again apply the pesticide  product excessively.
                   A specific replacement schedule or more information on determining when
                   the "effectiveness is diminished" must be given.  A maximum application
                   rate and frequency must be given.

                          The Agency has also  determined that use sites described  on the
                   labeling must be clarified in order to reflect the non-food use of the active
                   ingredient.

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.    End-Use Products

             1.     Additional Product-Specific Data Requirements

                          Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any
                   needed product-specific data regarding the pesticide  after a determination
                   of .eligibility  has  been made.   The Agency is only requiring  a new
                   Confidential Statement  of Formula (EPA Form 8570-4) and amended
                   labelling as additional product  specific data  on the currently registered
                   product.  No other additional data are required at this tune.

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      2.     Labeling Requirements for End-Use Products

                   The labels and labeling of all products must comply with EPA's
             current regulations and requirements as specified in 40 CFR 156.10 and
             described in the Pesticide Reregiistration Handbook. As stated in Section
             IV, the Agency has determined that labeling must be changed to give a
             specific maximum application rate and specific directions for replacement.
             Application rate directions must read:

                   "USE  ONE BAITED TRAY PER  100  SQUARE FEET OF
                   SURFACE TO BE TREATED OR UP TO X TRAYS PER 100
                   SQUARE FEET IF INFIiSTATION IS WIDESPREAD. "

             Documentation of the rationale behind the correct number of trays per 100
             square feet must be submitted with the amended labelling.  Replacement
             directions must read:
                   "REPLACE INSECTICIDAL BAITS AFTER 30 DAYS TO
                   PREVENT COCKROACH REINFESTATION."

            If more information on determining when "effectiveness is diminished" is
            given and a maximum  replacement schedule is given in the product
            labeling (eg. "do not replace product more often than every x days"), the
            Agency may consider the current replacement directions acceptable.

                   To emphasize the non-food use of the active ingredient, the use site
            section should read something similar to:

                   "FOR USE IN HOMES.  FOR USE IN NON-FOOD AREAS OF
                   SCHOOLS, THEATERS, WAREHOUSES, MOTELS, HOTELS,
                   AND COMMERCIAL, INDUSTRIAL AND INSTITUTIONAL
                   ESTABLISHMENTS.  FOR USE IN NON-FOOD AREAS OF
                   RESTAURANTS   AND   FOOD-HANDLING
                   ESTABLISHMENTS."

            The word  "RESrOENTIAL" must also  be added before  the  word
            "KITCHEN" in the directions for use.

B.    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

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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
Periplanone B 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.
                             10

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VI.   APPENDICES
       11

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12

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APPENDIX A,  Table of Use Patterns Subject to
                Reregistration
                     13

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14

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APPENDIX B.  Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          17

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18

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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 4115 covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to 4115 in all products, including
data requirements for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1. Data Requirement (Column 1).   The data requirements are listed in the order in
which they appear in 40 CFR Part 158.  the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.

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

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

       3. Bibliographic citation (Column 3).  If the Agency has acceptable  data in its files,
this column lists the identifying number of each study.  This normally  is the Master Record
Identification (MRCD) 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.
                                          19

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20

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24

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APPENDIX C.  Citations Considered to be Part of the
   Data Base Supporting the Reregistration of 4115
                       25

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26

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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 hi 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.

roENTIFICATION OF ENTRIES.  The entries in this bibliography are sorted
numerically  by Master Record Identifier, or "MRED 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
                                   27

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

(2)   Administrative number.  The next element immediately following the
      word "under" is the registration number, experimental use permit
      number, petition number, or other administrative number associated
      with the earliest known submission.

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

(4)   Volume Identification (Accession Numbers).  The final element in the
      trailing parentheses identifies the EPA accession number of the volume
      in which the original submission of the study appears. The  six-digit
      accession number follows the symbol "CDL," which stands  for
      "Company Data Library." This accession number is in turn followed
      by an alphabetic suffix which shows the relative position of  the study
      within the volume.
                             28

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                                BIBLIOGRAPHY
MRID
CITATION
00114227    Herculite Products, Inc. (1982) Chemicid Study of X-It Brand Insecticidal
             Baits. (Compilation; unpublished study received Sep 1,  1982 under 8730-35;
             CDL:248289-A)

00124121    Brusick, D.; DeGraff, W. (1982) Mutagenicity Evaluation of L 29042-1 in the
             Ames Salmonella/Microsome Plate Test: Genetics Assay No. 6678; LBI Safety
             No. 8174. Final rept.  (Unpublished study received Jan 3, 1983 under
             8730-38; prepared by Litton Bionetics, Inc., submitted by Herculite Products,
             Inc., New York, NY; CDL:249144-A)

00144520    Jagannath, D.  (1984) Mutagenicity Evaluation of Periplanone B (PPB) in the
             Ames Salmonella/Microsome Plate Test: Final Test: Project No. 20988.
             Unpublished study prepared by Litton Bionetics, Inc. 27 p.

00151910    Reagan, E. (1985) Acute Oral Toxicity Study of Roach Killer 2GA125 in
             Spraque-Dawley Rats: Study No. 8532A.  Unpublished study prepared by
             Food & Drug  Research Labs., Inc.  23 p.

00151911    Reagan, E. (1985) Acute Dermal Toxicity Study of Roach Killer 2GA125 in
             New Zealand White Rabbits: Study No. 8532A. Unpublished study prepared
             by Food & Drug Research Labs., Inc.  23 p.

00151912    Biesemeier,  J. (1985) Acute Inhalation Toxicity Study of Roach Killer
             2GA-125  in Sprague-Dawley Rats: Study No. 4532A. Unpublished study
             prepared by Food & Drug Research Labs., Inc.  53 p.

00151913    Reagan, E. (1985) Primary Dermal Irritation Study of Roach Killer 2GA-125
             in New Zealand White Rabbits: Study No.8532A.  Unpublished study prepared
             by Food & Drug Research Labs., Inc.  4 p.

00151914    Reagan, E. (1985) Primary Eye Irritation Study of Roach Killer 2GA125 in
             New Zealand White Rabbits: Study No. 8532A. Unpublished study prepared
             by Food & Drug Research Labs., Inc.  '44 p.

00155480    Hercon Division, Health-Chem Corp. (1985) Product Chemistry of Lure N
             Kill Liquid Pump Spray.  Unpublished compilation. 6 p.
                                        29

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30

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APPENDIX D. List of Available Related Documents
                      31

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32

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       The following is a list of available documents related to 4115.  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 4115 and are included in the EPA's Office of
Pesticide Programs Public Docket.
       1.

       2.

       3.

       4.

       5.
Health and Environmental Effects Science Chapters

Detailed Label Usage Information System (LUIS) Report

4115 RED Fact Sheet

PR Notice 86-5 (included in this appendix)

PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
                                          33

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34

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APPENDIX E.  PR Notices 86-5 and 91-2
                  35

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36

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PR Notice  86-5
      37

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38

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               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, arid  illustrations of, the
required formats.

II.  Applicability

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

III. Effective Date

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

IV.  Background

     On September 26, 1984, EPA published  proposed  regulations in
the Federal Register (49 FR 37956) which include  Requirements for
Data Submission  (40 CFR 158.32), and Procedures  for Claims of
Confidentiality of Data '(40 CFR 158.33).  These regulations
                                39

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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.

                                40

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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
                                41

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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) datci
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 at 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.

                                42

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          a single study is extremely long, binding it in mul-
tiple volumes is permissible so long cis 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.I  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.

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

     Product chemistry data submitted in support of a technical
product,  other manufacturing-use product, an experimental use
permit, an import tolerance petition,  or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61,  62, and 63)  for
conventional pesticides,  or for the equivalent subject range for
biorational pesticides.   The first of the three studies in a
complete 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.
                                43

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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
Confidentiality
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   Paige 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)
                                44

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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).

 3-    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.
                                45

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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)(l) 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 arid
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."  Ah 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.

                                46

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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 o'f Copies 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.)
                                47

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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.
                        mm.99 W. Akrman
                       Acting Director,
                       itegi strati 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
                                48

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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
                                49

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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)

                         50

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                           ATTACHMENT 3

            STATEMENTS  OF DATA CONFIDENTIALITY CLAIMS

1. No claim of  confidentiality under  EIFRA 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  610(d)(1)(A),  (B), or  (C).
  Company
  Company Agent:

  	Title
Typed Name
Date:
                     Signature
2. Claim of confidentiality under  FIFRA  10(d)(1)(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.
                                51

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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.
                                52

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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 1  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

   6
  12
 100
            14
            25
            19
REASON FOR THE DELETION

Identity of Inert Ingredient
                                                FIFRA REFERENCE

                                                10 (d) (1) (C)
                                                      IT
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)(1)(A)
                                     53

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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	______^	^_____ 
                                      54

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                            ATTACHMENT 7,
                    FORMAT OF THE SUBMITTAL  PACKAGE
                      Transmittal  Document.
LEGEND
                                       of Support Statement,
                               Othor materials about the
                                 -
                    FORMAT QP SUBMITTED STUDIES
                                             ,  ublttltt<*    unique
                                      pyscal  entities,  accordino
                                      to the format  below?       9
             Study title page,

                 Statement of Confidentiality Claims.

                    
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56

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PR Notice  91-2
      57

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58

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        1
        a
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

                                59

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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.

     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.
                                60

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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.
                                61

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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.
                                   t-Xr"* " *   ^  O-^r''jX^C
                                 Ann* E.
                                 Registration  Division  (H-75O5
                                62

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APPENDIX F. Product Specific Data Call-In
                   63

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64

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                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice  requires you  and other registrants of pesticide products  containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as  noted  herein to the U.S. Environmental Protection
Agency (EPA, the Agency).  These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section HI 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 m-B); or

Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section TTT-D)
       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension.  We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).

       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).
     This Notice is divided into six sections and seven Attachments.  The Notice itself contains

                                          65

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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 n -  Data Required By This Notice
       Section HI-  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 Reregistration
       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

n-A.  DATA REQUIRED

       The product  specific data requked by this  Notice are specified  hi  Attachment 3,
Requirements Status and Registrant's Response Form.  Depending on the  results of the studies
required in this Notice, additional testing may be requked.

n-B.  srTTHDTTT;R FOR SUBMISSION OF DATA

    You are requked  to submit the data or otherwise satisfy the data  requkements specified in
Attachment 3, Requkements Status and Registrant's  Response Form, within the time frames
provided.
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H-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 thait 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 3(c](T>(B) NOTICES
     ISSUED BY THE AGENCY

     Unless otherwise noted herein, this Data Call-in does not in any way supersede or change the
requirements of any previous Data Call-Ms), 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 m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

m-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.

m-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

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requkements of this Notice is contained in Section m-C.  A discussion of options relating to
requests for data waivers is contained in Section ffl-D.

       There are two forms that accompany this Notice of which, depending upon your response,
one or both must  be used in your response to the Agency.  These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must
be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2).  Please note that the company's
authorized  representative is required to sign the first page of the Data Call-in Response Form and
Requirements  Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options.  Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.

       1. Voluntary Cancellation - You may avoid the requkements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If  you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option.  Voluntary cancellation is item number 5
On the Data Call-in Response Form. If you choose this option, this is the only form that you are
required to complete.

       If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section IV-C.
       2.  Satisfying the Product Specific Data Requirements of this Notice  There are various
options available to satisfy the product specific data requirements of this Notice.  These options are
discussed  in Section m-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.

       3.  Request for Product Specific Data  Waivers.  Waivers for product specific data are
discussed  in Section m-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.

IH-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

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 six options on the Requirements Status and Registrant's Response Form related to data production
 for each  data  requirement.   Your option selection should be  entered under  item number 9,
 "Registrant Response." The six options related to data production are the first six options discussed
 under item 9 in the instructions for completing the Requirements Status and Registrant's Response
 Form.  These six options are listed immediately below with information in parentheses to guide
 registrants to additional instructions provided in this Section.  The options are:

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

       Option 1. Developing  Data  If you  choose to develop the required  data it must be in
 conformance with Agency deadlines and with other Agency requirements as referenced herein and
 in the attachments.  All data generated and submitted must comply with the Good Laboratory
 Practice  (GLP) rule (40 CFR Part 160),  be conducted  according to the Pesticide Assessment
 Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.

       The time frames in the Requirements Status and Registrant's Response Form are the time
 frames that the Agency is allowing for the submission of completed  study reports.  The noted
 deadlines  run from the date of the receipt of this Notice by the registrant.   If the  data are not
 submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
 affected registration(s).

       If you cannot submit the data/reports to the Agency in the time required by this Notice and
 intend to seek additional tune to meet the requirements(s), you must submit a request to the Agency
 which includes:  (1) a detailed description of the expected difficulty and (2) a proposed schedule
 including alternative dates for meeting such requirements on a step-by-step basis. You must explain
 any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing.  While EPA is considering your request, the original deadline remains.   The Agency
 will respond to your request in writing.  If EPA does not grant your request, the original deadline
remains.   Normally, extensions can be requested only  hi 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

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

       Option 3. Offer to Share in the Cost of Data Development  This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to  enter into an agreement or amend an existing agreement to meet the
requirements of this  Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s),  although you do not comply
with the data submission requirements of this Notice.  EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in  the burden
of developing that data.  You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7.  In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into  a cost sharing agreement by including  a copy of your  offer  and proof of the other
registrant's receipt of that offer (such as a certified mail receipt).  Your  offer must, in  addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer.  The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-in Response  Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.

       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.

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Do not use this option if you are submitting data to upgrade a study. (See Option 5).

      You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission.  The Agency may determine at any time that a study is not valid and needs to
be repeated.

      To meet the requirements  of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:

      a.     You must certify at the time that the existing study is submitted that the raw data and
             specimens from the study are available for audit and review and you must identify
             where they are available.  This must be done in accordance with the requirements
             of the Good Laboratory Practice (GLP) regulation, 40 CFR Part  160. As stated in
             40  CFR  160.3(j)  "  'raw  data'  means  any laboratory worksheets,  records,
             memoranda,  notes, or exact  copies  thereof, that are  the  result of  original
             observations and activities of a study and are necessary for the reconstruction and
             evaluation of the report of that study. In the event that exact transcripts of raw data
             have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
             verified accurate by signature), the exact copy or exact transcript may be substituted
             for the original source as raw data.  'Raw data' may include photographs, microfilm
             or microfiche copies, computer printouts., magnetic media,  including  dictated
             observations,  and  recorded data  from  automated  instruments."   The term
             "specimens", according to 40 CFR 160.3(k), means "any material derived from a
             test system for examination or analysis."

      b.     Health and safety studies completed after May 1984 must also contain  all GLP-
             required  quality  assurance  and  quality  control  information,  pursuant  to  the
             requirements of 40 CFR Part 160.  Registrants must also certify at the time of
             submitting the existing study that such GLP information is available for post-May
             1984 studies by including an appropriate statement on or attached to the study signed
             by an authorized official or representative of the registrant.

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

       Option 5. Upgrading a Study -- If a study has been classified as partially acceptable and
upgradeable,  you may submit data to upgrade that study.  The Agency  will review the data
submitted and determine if the requirement is satisfied.  If the Agency decides the requirement is
not satisfied,  you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies  will normally be classified as supplemental.  However, it is
important to  note that not all studies classified as supplemental  are upgradeable.   If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA.  You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.

       Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.

       This option should also be used to cite data that has been previously submitted to upgrade
a study, but has  not yet been reviewed by the Agency.  You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.

       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 requkements.

       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.
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       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,,

m-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 P'R Notice 86-5).   This will be the  only
opportunity to state the reasons or provide information in support of your request.  If the Agency
approves your waiver request, you will not be required to supply  the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and  submit the option  chosen  on the  Requirements Status  and Registrant's
Response Form.   Product  specific  data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products; and the Agency would grant a waiver only
under extraordinary circumstances.  You should also be aware that submitting a waiver request will
not automatically extend the due date for the study in question.  Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in force.

IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH THIS  NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

       The Agency may issue a Notice of Intent to  Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements  of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B).  Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:

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

      2.      Failure to submit on the required schedule an acceptable proposed  or final protocol
              when such is required to be submitted to the Agency for review.

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

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

      5.      Failure to take a required action or submit adequate information pertaining to any
              option chosen to address  the data  requirements (e.g., any  required  action or
              information pertaining to  submission or citation of existing  studies  or offers,
              arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
              failure to comply with the terms of an agreement or arbitration concerning joint data
              development  or failure to comply with any terms of a  data waiver).

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       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 in the cost of
             developing data and provided proof of the registrant's receipt of such offer or failure
             of a registrant on whom you rely for a generic data exemption either to:

             a.     inform EPA of intent to develop and submit the data required by this Notice
                    on a Data Call-In Response Form and a Requirements Status and Registrant's
                    Response Form:

             b.     fulfill the commitment to develop and submit the data as required by this
                    Notice; or

             c.     otherwise take appropriate steps to meet the  requirements stated in this
                    Notice, unless you commit to submit and do submit the required data in the
                    specified time frame.

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

IV-B.  BASIS FOR DETERMINATION  THAT SUBMITTED STUDY IS
UNACCFJPTABLE

       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.
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IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.

       The Agency has determined  that such disposition by  registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes.  Accordingly, the Agency anticipates granting  registrants
permission to sell,  distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for  failure to comply with this Notice  should be permitted, you have the  burden of
clearly demonstrating to EPA that granting such permisision 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 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.

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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(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.

      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,
                                                           ,
                                       Daniel M. Barolo, Director
                                       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  End-Use  Products for  Meeting  Acute  Toxicology Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
                77

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PERIPLANONE B DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have a
product containing Periplanone B.

       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
Periplanone B.  This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2), (3)  the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria  (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Periplanone B 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 Periplanone B are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on Periplanone B are needed for specific products.  These data
are required to be submitted to the Agency within the time frame listed. These data are needed
to fully complete the reregistration of all eligible Periplanone B products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic database of Periplanone B, please
contact Bill Wooge at (703) 308-8794.
       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.

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

             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: Periplanone B
                                           79

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r
                                                      80

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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                        81

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82

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INSTRUCTIONS  FOR COMPLETING THE  "DATA CALL-IN RESPONSE"  FORM FOR
PRODUCT SPECIFIC DATA

Item 1-4.     Already completed by EPA.

Item 5.      If you wish to voluntarily cancel  your product, answer "yes".  If you choose this
             option, you will not have to provide the data required by the Data Call-in Notice and
             you will not have to complete any other forms.  Further sale and distribution of your
             product after the  effective date of cancellation must be in accordance with the
             Existing Stocks provision of the Data Call-in Notice (Section IV-C).

Item 6.      Not applicable since this form calls in product specific data only. However, if your
             product is identical to another product and you qualify for a data exemption,  you
             must respond with "yes" to Item 7a  (MUP) or 7B (EUP) on this form, provide the
             EPA 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.

Item 7a.      For each manufacturing use  product (MUP)  for which you wish to maintain
             registration, you must agree to satisfy the data  requirements by responding "yes."
                                             '                                  V.
Item 7b.      For each end use product (EUP) for which you wish to maintain registration,  you
             must agree  to satisfy the data requirements  by  responding  "yes."  if  you are
             requesting a  data  waiver,  answer "yes" here;  in addition,  on the "Requirements
             Status and Registrant's Response" form under Item 9, you must respond with option
             7 (Waiver Request) for each study for which you are requesting a waiver. See item
             6 with regard to identical products and data exemptions.

Items 8-11.   Self-explanatory.

       Note: You may provide additional information that does not fit on this form in a signed letter
       that accompanies this form.  For example,  you may wish to report that your product has
       already been transferred to another 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.
                                           83

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84

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86

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Attachment 3. Product Specific Requirement Status and
  Registrant's Response Forms (Form B inserts) and
                    Instructions
                         87

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88

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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 toxicity or certain efficacy data and only if EPA
 indicates in an attachment to this notices 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).

                              89

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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 tune, my product may be
subject to suspension.  I understand that  other terms under Option 3 in the Data
Call-in Notice (Section EI-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.1.) 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 IQ-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

                               90

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              request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
              FEFRA.  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.
                                            91

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96

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       97

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98

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There is only one product; therefore, no batching is necessary.
                                           99

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100

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Attachment 5. EPA Acceptance Criteria
                 101

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102

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                                  SUBDIVISION D
Guideline

Series 61
Series 62
Series 63
Study Title

Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
                                        103

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                                  61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.

2.


3.
          Name of technical material tested (include product name and trade name, if appropriate).

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

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

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

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

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

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

9. _    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which may be present at >_ 0.1% or was found at >_ 0.1% by product analyses  and (2) certain
          lexicologically significant impurities (see #3).
                                                  104

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                           62 Analysis and Certification of Product Ingredients
                                        ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information hi items 6, 7, and 8.

Does your study meet the following acceptance criteria?
 1.

 2.
 3."
 4.
 5."
 9.
10.
Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1%.
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 dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
fresh and  stored samples must be analyzed.].
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 lexicologically
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.
                                                  105

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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 hi 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 hi 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 hi lbs/ft3
          or Ibs/gallon.]

63-8 Solubility
    	  Determined hi 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 hi 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 hi mm Hg (torr) or other conventional units

63-10 Dissociation Constant
    	  Experimental method described
    	  Temperature of measurement specified (preferably about
           20-25C)
                                                  106

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63-11 Octanol/water Partition Coefficient
    	   Measured at about 20-25 C
    	   Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
           77350)
    	   Data supporting reported value provided
63-12 pH
           Measured at about 20-25 C
           Measured following dilution or dispersion in distilled water
63-13 Stability
   	   Sensitivity to metal ions and metal determined
   	   Stability at normal and elevated temperatures
   	   Sensitivity to sunlight determined
                                                  107

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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
                                                  108

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                                   81-1 Acute Oral Toxicity in the Rat
                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 young adult rats/sex/group.
 3.	Dosing, single oral may be administered over 24 hrs.
 4.*	Vehicle control if other than water.
 5.	Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
 6.	Individual observations at least once a day.
 7.	Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
 8.	Individual daily observations.
 9.	Individual body weights.
10.	Gross necropsy on all animals.
                    Criteria marked with an * are supplemental and may not be required for every study.
                                                  109

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                      81-2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig


                                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
 1.	Identify material tested (technical, end-use product, etc).
 2,	At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 6.*	Vehicle control, only if toxicity of vehicle is unknown.
 7.	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours before dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nomrritating cover to retain test material and to prevent
        ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                   110

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                                81-3 Acute Inhalation Toxiciity in the Rat
                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
        Identify material tested (technical, end-use product, etc).
        Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
        or contains particles of inhalable size for man (aerodynamic diameter 15 /tm 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.
                                                  Ill

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                                81-4 Primary Eye Irritation in the Rabbit


                                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of <2 or >11.5.
 3.	6 adult rabbits.
 4.	Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5.	Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
 6.	Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.	Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.*	Individual daily observations.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                   112

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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 > 11.5.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4 hours.
 6.	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8.	Application site covered with a gauze patch held hi 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.
                                                  113

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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 _>.!!.5.
3.	One of the following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	Complete description of test.
5.*	Reference for test.
6.	Test followed essentially as described in reference document.
7.	Positive control included (may provide historical data conducted within the last 6 months).
                    Criteria marked with an * are supplemental and may not be required for every study.
                                                  114

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Attachment 6. List of All Registrants Sent This Data Call-in (insert)
                              Notice
                               115

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116

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Attachment 7. Cost Share Data Compensation Forms, Confidential
          Statement of Formula Form and Instructions
                            119

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120

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Instructions for Completing the Confidential Statement of Formula


          The Cor^dential 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.


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



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             n.
  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 FJ?A 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 PPer  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.
                                                 123

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124

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    r/EPA
United States  Environmental Protection Agency
            Washington,  DC 20460
   CERTIFICATION  OF OFFER TO COST
SHARE IN THE  DEVELOPMENT  OF DATA
Form Approved

OMB No.  2070-0106
         2074MI057
Approval  Expire*  3-31-96
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 'completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions tor reducing this burden, to Chief, information Policy
 Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget. Paperwork Reduction Project (2:070-0106), Washington, DC 20503.
 Please fill In blanks below.
  Compuny Nunu-
                                                  Company Xuniber
  Product IXii
                                                                            KPA Keg. No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodentictde Act (FIFRA), if necessary. However, my company would prefer to
 enter into an agreement with 6ne or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and included an
 offer to be bound by arbitration decision under section 3{c}{2}(B){iii) of FIFRA if final agreement on  all
 terms could not be reached otherwise.  This offer was made to the following firm(s) on the following
 date(s):
  Nam of Rnn()
                                                   Data of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that 1 have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or Imprisonment or both under applicable law.
 Sign*lure of Company'*  Authorized Raprsentatlv
                                                  Data
 Name and  Title (Please Type or Print)
 EPA FtM-m 8570-32 (S/91)   RcplacmsEPA Form 8580, which is obsolete
                                                125

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126

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      &EPA
                         Unlttd states Envlronmontal Protection Agency
                                     Washington,  DC 20460

                            CERTIFICATION WITH RESPECT TO
                         DATA  COMPENSATION REQUIREMENTS
   Public reporting burden for this collection of information is estimated to
   time for reviewing instructions, searching existing data
           I and reviewing the collection of information.
OMB M*.
2070-0107
2070-00*7
      3-51-96
             .~i a .j__i  a		T-"/t " " . *.!., Tvasnmgion, uu U4t>u
             and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

Please fill In blanks below.
                                                                           20460; and to the (tet
                                                                       Company Numbr
                                                                    K7A
                                                                                 Mo.
  have
 1 *  S^I^fJl0^ Jflff?-rt ** "W* ot weflisiratton under tht Federal Insecttaidt. Fungicide and
     RodentKde Act (FIFRA) that is an exclusive use study, t af n ihe original data submitter, or I have obtained the
     wntten permission of the original data submitter to cite that study.                        oorameo me

 2.  That to' ach study tiled in support ol registration or ^registration under FIFRA tnat is NOT an exclusive use
                         * $ubmiltf ' * ! "*" <*' ained th ^w Psmiisston of the original data submitter, or I
                         company(ies) that submitted datii 1 nave cited and have offeredV fa] Pav

                                      *Sh SeC>tonS 3(C)(1)(D) ** 3{C)(2)<0) ol FIFRA: ""  requirement ot RFRA and the amount of
                   ,  any. The companies I have notified are: (check one)
    IJ  The companies who have submitted the studies listed on the back of tni form or attached
        sheets, or indicated on the attached Requirements Status and Registrants' Response Form.-

 3.  That t have previously complied wth section 3(c)(i){0) of FIFRA for the studies I have cited
    registration or ^registration under FIFRA.


Date

 SSS^ FFER T? P*Y: 'htriby Gtltr 8nd aflrw to pay "'"^watton to other persons, with regard 10 me
 registration or registration of my products, to the eent required by FIFRA sections 3(C)<1)(D) and 3{c)<2)(D).
 Kama n4 TIU* (PICM Typ* or Print)
EPA Form U70-11  (4-0)
                                               127

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128

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APPENDIX G. FACT SHEET
          129

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130

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United States
                 Environmental Protection
                 Agency
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)
EPA-738-F-94-004
April 1994
                 R.E.D.    FACTS
                 Periplanone  B
     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 Periplanone B.
   Use Profile
     Periplanone B, a biochemical pesticide, is the specific sex-attractant
pheromone of the American cockroach, Periplaneta americana.  It
currently is used as a lure or bait in conjunction with another pesticide
(propoxur) in one registered pesticide product.  Periplanone B has an
extremely low use rate of less than one microgram per bait.  It is
impregnated into bait material that is pressed onto an open four-by-six inch
tray.  One of these bait packages is used per 100 square feet of area to be
treated.
   Regulatory       Periplanone B was first registered as a pesticide in the U.S. in 1984.
      History  Currently, only one product is registered which contains this active
                ingredient, "Lure N Kill Roach and Ant Killer with Roach Sex Lure,"
                which contains 0.001 % Periplanone B and 10%  propoxur. Because of its
                nature and extremely low usage rate, EPA applied a reduced set of data
                requirements for reregistration of Periplanone B.

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Human Health
  Assessment
Toxicity
     Acute mammalian toxicity studies on the currently registered end use
product indicate that Periplanone B is of low acute toxicity.  It is placed in
Toxicity Category IV, indicating the lowest level of acute toxicity,  for
acute oral and primary eye irritation effects.  It is slightly to moderately
toxic in acute dermal, acute inhalation and primary dermal irritation
studies, and has been placed in Toxicity Category m for these effects. It
is not a skin sensitizer and does not cause mutagenic effects.  Because the
potential for human exposure to Periplanone B is negligible, all other
toxicology data requirements are waived.
Dietary Exposure
     The potential for dietary exposure to Periplanone B is considered
negligible because of its application method-its labeling prohibits
contamination of food-and because of the ultra-low  amounts in the single
.registered product.
Occupational and Residential Exposure
     Since use of Periplanone B results in little exposure and does not
pose significant lexicological concerns, no exposure  data are required.
Human Risk Assessment
     The potential risks to humans from use of Periplanone B are
considered negligible due to the pesticide's application method (low volume
use in  a bait product), low dietary and non-dietary exposure, and low level
of toxicity.
Environmental
  Assessment
 Environmental Fate
      No environmental fate data are required for biochemicals like
 Periplanone B,  which cause no adverse effects in acute toxicology tests of
 fish, birds and aquatic invertebrates.
 Ecological  Effects
      EPA waived all ecological effects data requirements for Periplanone
 B because this biochemical is used primarily indoors in very small
 quantities; is a synthetic duplicate of a natural sex pheromone; and rapidly
 and completely degrades to biologically inactive compounds when exposed
 to light and air.
 Ecological  Effects  Risk Assessment
      Both environmental exposure and ecological risk are expected to be
 negligible when Periplanone B is used according to label directions and
 precautions.
                                                       132

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Additional  Data        The data base for Periplanone B is considered complete, and EPA is
        Required   nt requiring any additional generic or product specific studies. Only a
                     new Confidential Statement of Foimula and revised labeling must  be
                     submitted for reregistration of the product containing this pesticide.
  Product  Labeling
Changes Required
                          The single registered product containing Periplanone B must comply
                    witn EPA's current pesticide product labeling requirements. In addition:
                    Application Rates - Product labeling must be revised to include a specific
                    maximum application rate:
                          "Use one baited tray per 100 square feet of surface to be treated or
                          up to X trays per  100 square feet if infestation is widespread. "
                    Documentation of the rationale behind the maximum number of trays per
                    100 square feet must be submitted.
                    Replacement Directions - Labels must read:
                          "Replace insecticidal baits aifter 30 days to prevent cockroach
                          infestation. "
                    Emphasize Non-Food Use - Use isite labeling should say,
                          "For use in homes, for use in non-food areas of schools,  theaters,
                          warehouses, motels, hotels, and commercial, industrial and
                          institutional establishments.  For use in non-food areas of restaurants
                          and food-handling establishments. "
                    Directions for Use - Add the word  "residential" before "kitchen."
     Regulatory
     Conclusion
                             Use of the currently registered pesticide product containing
                       Periplanone B in accordance with approved labeling will not pose
                       unreasonable risks or adverse effects to humans or the environment.
                       Therefore, all uses of this product are eligible for reregistration.  This
                       product will be reregistered once the required revised labeling is received
                       and accepted by EPA, and when the other active ingredient in the product
                       also is eligible for reregistration.
       For More
    Information
                            EPA is requesting public comments on the Reregistration Eligibility
                       Decision (RED) document for Periplanone B during a 60-day tune 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.
                                                      133

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     Following the comment period, the Periplanone B 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 Periplanone B RED, or reregistration of individual products containing
Periplanone B, 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.
                                    134

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