Umttd States          ..sntion, Pesticides
        Environment*! Protection   •-<•** 
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                      REREGISTRATION ELIGIBILITY DOCUMENT

                          PUTRESCENT WHOLE EGG SOLIDS

                                        IJSTD

                                       CASE 4079
                             ENVIRONMENTAL PROTECTION AGENCY
                                OFFICE OF PESTICIDE PROGRAMS
                          SPECIAL REVIEW AND REREGISTRATION DIVISION
                                    WASHINGTON, D.C.

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  PUTRESCENT WHOLE EGG SOLIDS REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Branch
Bill Gross           Biological Analysis Branch
Steve Jarboe         Biological Analysis Branch

Environmental Fate and Affects Division
Roy Bingham        Environmental Fate and Ground Water Branch
Betsy Grim          Science Analysis and Coordination Staff
Fred Betz           Science Analysis and Coordination Staff	

Health Effects Division
Jim Yowell          Occupational and Residential Exposure Branch
Tom McCUntock     Science Analysis Branch
Esther Saito         Chemical Coordination Branch

Registration Division
Rob Forrest         Insecticide-Rodenticide Branch
Bill Erickson         Insecticide-Rodenticide Branch
Mary Waller         Registration Support Branch
Tom Ellwanger       Registration Support Branch

Special Review and Reregistration Division
Thomas Myers       Accelerated Reregistration Branch

Policy and Special Projects ||aff
Kennan Garvey

Office of General Counsel
Mary Beth Cleave*

Office of Compliance Monitoring
Beverly Updike

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                     TABLE OF CONTENTS

                                                           Page


GLOSSARY OF TERMS AND ABBREVIATIONS                        iv

EXECUTIVE SUMMARY                                         v

L INTRODUCTION                                             1

IL CASE OVERVIEW                                          2

     A.   CHEMICAL OVERVIEW                                2

     B.   USE PROFILE                                       2

  _  C.   REGULATORY HISTORY         	                 3

m. SCIENCE ASSESSMENT OF PUTRESCENT WHOLE EGG SOLIDS       4

     A.   PRODUCT CHEMISTRY ASSESSMENT                      4

     B.   ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT       4

IV. RISK MANAGEMENT AM) REREGISTRAT1ON DECISION            6

     A.   DETERMINATION OF ELIGIBILITY                        6

     B.   ADDITIONAL GENERIC DATA REQUIREMENT               7

     C.   LABELING FOR MANUFACTURING-USE PRODUCTS           7

V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS      7

     A.   DETERMINATION OF ELIGIBILnY                        7

         1. Product Specific Data Requirements                         7
         2. Labeling Requirements for End-Use Products                  7
                               11

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       	                                                               Eags
VI.   APPENDICES

       APPENDIX A - Use Patterns Subject to Reregisteation                       8

       APPENDIX B - Generic Dita Requirements for Reregistration of
                      Pubescent Whole Egg Solids and Data Citations
                      Supporting Reregistration                                  11

       APPENDIX C - Citations Considered to be Part of the Data Base
                      Supporting the Reregistration of Pucrescent
                      Whole Egg Solids                                        15

       APPENDDC D - PR Notice 91-2                                          19

       APPENDIX E - Pesticide Reregistration Handbook                          23

       APPENDIX F - Product Specific Data Call-In                              57

            Attachment A - Chemical Status Sheet

            Attachment B - Product Specific DO Response Forms (Form A) plus
                          Instructions

            Attachment C - Requirements Status and Registrants' Response Forms
                          (Form B) plus Instructions

            Attachment D - EPA Groupings of End-Use Products for Meeting Data
                          Requirements for Reregistration

            Attachment £ - EPA Acceptance Criteria

            Attachment F - List of all Registrants) sent this DO

            Attachment G - Cost Share/Data Compensation Forms
                          Application for Registration
                                       ill

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                                           GLOSSARY OF TERMS AND ABBREVIATIONS



                          CAS        Chemical Abstracts Service

                          CFR        Code of Federal Regulations

                          CSF        Confidential Statement of Formula

                          EPA        U.S. Environmental Protection Agency

                          FDA        Food and Drug Administration

                          FIFRA      Federal Insecticide, Fungicide, and Rodenticide Act

                          GRAS       Generally Recognized As Safe

                          IJ-T-        Lowest Effect Level

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

                          ppm        Parts per Million

                          RED        Reregistraiion Eligibility Document
                                                                JV

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EXECUTIVE SUMMARY

       This Reregistration Eligibility Document (RED) addresses pesticide uses of putrescent
whole egg solids.  Products that contain putrescent whole egg solids are currently registered
for use as a repellent in conifer nurseries, open greenhouses, established forestry plantations,
ornamental woody shrubs and almond, fruit and citrus orchards. All products that contain
putrescent whole egg solids as an active ingredient and that are registered for these uses are
eligible for reregistration.

       The U.S. Environmental Protection Agency (EPA) has conducted a review of the
scientific data base and other relevant information supporting the reregistration of putrescent
whole egg solids and has determined that the data base is sufficient to allow the EPA to
conduct a risk assessment. All applicable toxicology, ecological and environmental effect
data requirements have been waived for this active ingredient.   However, EPA believes other
available information is sufficient to conclude that the currently registered uses of putrescent
whole egg solids will not result in unreasonable adverse effects to human health or the
environment  Putrescent whole egg solids is exempt from the requirement of a tolerance
when used as  an animal repellent in almond orchards (40 CFR part 180.1071).-

       Accordingly, EPA has determined that all products containing putrescent whole egg
solids as the active ingredient are eligible for reregistration and will be reregistered when
acceptable labeling and product specific data are submitted and/or cited.  Before reregistering
each product,  EPA is requiring that product specific data and revised labeling be submitted
by the registrants within eight months of the issuance of this document. In an effort to
reduce the time, resources, and number of animals needed to fulfill the acute toxicology data
requirements for putrescent whole egg solids containing end use products, EPA has attempted
to "batch* products considered to be similar with respect to acute toxicity testing
requirements.  However, this was not possible, so the registrant must individually satisfy the
data requirements for each of their products. After reviewing these data and the revised
labels, EPA will determine whether or not the conditions of FTFRA 3(c)(5) have been met,
that is,  whether  product composition and labeling are acceptable and the product's uses will
not cause unreasonable adverse effects to humans or the environment.  If these conditions are
met EPA will  reregister the product.  Any end-use products containing putrescent whole egg
solids in combination with other active ingredients will not be reregistered until the REDs for
all active ingredients contained in that product are Issued.

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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 first
                                    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 an
                                    EPA review of all data submitted to support reregistration.

                                          Section 4(g)(2)(A) of FIFRA states that in Phase 5  "the Administrator shall
                                    determine whether pesticides containing sucb active ingredient are eligible for
                                    reregistration"  before calling in data on products, section 4(g)(2)(B), and either
                                    reregistering products or taking "other appropriate regulatory action," sections
                                    4(g)(2)(C) and (D).  Thus, reregistration involves a thorough review of the scientific
                                    data base underlying a pesticide's registration.  The purpose of the 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 3(c)(5).

                                          This document presents the EPA's decision regarding the reregistration
                                    eligibility of the active ingredient putrescent whole egg solids. The document consists
                                 .- of five sections.  Section I is this introduction. Section H describes putrescent whole
                                    egg solids, its uses and regulatory history.  Section HI discusses the human health and
                                    environmental assessment based on the data available to EPA. Section IV discusses
                                    the reregistration eligibility decision for putrescent whole egg solids and Section V
                                    discusses product reregistration requirements.  Additional details concerning the
                                    review of available data are available on request1
                                   EPA's  reviews of  specific  reports  and Information on  the set of registered  uses
                                   considered for EPA's analyses may be obtained from: EPA, Freedom of Information,
                                   401 M SL, S.W., Washington, D.C. 20460.

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H.     CASE OVERVIEW
       A.    Chemical Overview
                   The following active ingredient is covered by this Reregistration
             Eligibility Document:

             Chemical Name: Putrescent Whole Egg  Solids

             CAS Number. 51609-52-0

             Office of Pesticide Programs Chemical Code:     105101
      B.     Use Profile
                   The following is information on the registered use with specific use
             sites and application methods. A detailed table of eligible uses of pubescent
             whole egg solids is in Appendix A.

             Type of Pesticide:   Repellent or Feeding Depressant

             Pests:               Black- and White-Tailed Deer, Roosevelt Elk and
                                 Mountain Beaver

             Use Sites:           Terrestrial Food/Feed Crop:  almond - not to be used
                                 within 30 days of harvest, and fruit and citrus orchards
                                 (unspecified) -  use only when trees are dormant.

                                 Terrestrial Non-Food Crop: ornamental and/or shade
                                 trees, ornamental woody shrubs and vines, established
                                 forestry plantations and conifer seedlings.

                                 Greenhouse Non-Food Crop: ornamental and/or shade
                                 trees.

                                 Outdoor Residential: ornamental and/or shade trees and
                                 ornamental woody shrubs and vines.

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                                         Formulation Types
                                         Registered:         End-use
                                         Form:
                    Dust at 36% active ingredient (a.i.)

                    Liquid - Ready to Use (RTU) at 5% a.i.

                    Emulsifiable Concentrate at 15% and 37% a.i.
                                         Methods of
                                         Application:
                    Dust:  The dust is applied to moist plants using a shaker
                    duster to apply a light coating of the dust on the target
                    plants.  If dry, the plants must be wetted.

                    Liquid: In nurseries or large greenhouses spray mixtures
                    are applied to runoff to ensure coverage of the target
                    seedlings.  For established forestry plantations,
                    ornamental woody shrubs, almond, fruit, and citrus
                    orchards a pressurized  hand-held or back-pack garden
                    sprayer is used and foliage is sprayed to achieve runoff.
                    For large trees spray is applied to lateral branches that
                    are potentially within the animals' reach.
                                  C.
REGULATORY HISTORY
                                               EPA registered the first putrescent whole egg solid-containing product
                                         on September 8,  1975.  The currently registered products are used as
                                         repellents in the sites identified in Section n. B. above.  In 1985 EPA
                                         exempted putrescent whole egg solids from the requirement of i tolerance
                                         when used as  an animal repellent in almond orchards (40 CFR 180.1071).
                                         Fresh eggs and egg products are Generally  Recognized As Safe (GRAS) (21
                                         CFR 170.3), by FDA.

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                              m.   SCIENCE ASSESSMENT O

                                           EPA has reviewed the scientific data base for putrescent whole egg solids
                                    relying on information submitted by the registrant.  These are cited in Appendix C.

                              A.    PRODUCT CHEKflSTRY ASSESSMElff

                                           Putrescent whole egg solids (inedible egg powder, dried whole egg, or
                                    powdered inedible egg solids), are produced from eggs which the USDA has declared
                                    inedible for human consumption due to cracked shells, excessive blood spots or other
                                    imperfections not conforming to standards set for food use.  The final product is
                                    highly proteinaceous (50-55%) containing fat (28-34%), vitamins and minerals.

                                           Putrescent whole egg solids are produced by centrifuging whole eggs (cracked
                                    or broken) to separate the shell from the liquid egg.  The liquid egg is pumped
                                    through a strainer to remove foreign material (shell pieces) then placed in a holding
                                    tank or passed through a pasteurizer.  Following pasteurization, the liquid is cooled,
                                    spray dried, bagged and stored until shipping.  At the time of use, the powdered eggs
                                    are hydrated which initiates the decaying process.  This is repugnant and acts to repel
                                    the target pests.

                                           Quality control procedures include testing for total protein, rat and solid
                                    content, nutritional composition and for the presence or absence of Salmonella
                                    (standard  requires complete absence),  yeast and mold (standard requires less than 10
                                    CFU/gm), and coliforms (standard requires less than 10 CFU/gm).

                                           Putrescent whole egg solids have a faint orange to beige color with a slightly
                                    malty odor.  The physical state of this material is described as a powder mixture of
                                    fine particles and loosely packed aggregates.   Putrescent whole egg solids are
                                    insoluble in water, petroleum distillate, bopropanol and 1,1,1-trichJoroethane.  The
                                    bulk density is calculated to be 0.514 gm/ml and the pH is 6.4 (10% solution of dried
                                    whole egg in water).

                             B.     Environmental and Human ffg||h Assessment

                                           EPA has developed a normative set of data requirements, set forth in the
                                    regulations (40 CFR part 158) and the Agency's Reregistration Phase 2 Technical
                                    Guidance Document  These data requirements must be addressed  for pesticide
                                    reregistration. These regulations and the guidance document specify the necessary
                                    data based on such factors including use sites, potential environmental and human
                                    (dietary and occupational) exposures, product formulation types, product application
                                    methods, and results of initial (Tier 1) studies. Due to the diverse nature and
                                    characteristics of pesticide products and their uses subject to reregistration, the
                                    Agency also recognizes the need to modify the data requirements for specific

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pesticides, including waiving certain data requirements, because such requirements are
inappropriate or unnecessary for reregistration.

       The case-specific approach to waive individual data requirements has served to
identify the appropriate data requirement sets for pesticide products.  Further, the
Agency believes there is a category of pesticide active ingredients for which a broadly
reduced set of data requirements are appropriate for reregistration. Specifically,
products in this category would be exempt from the generic data requirements for
toxicology, residue chemistry, human exposure, ecological effects, and environmental
fate on the active ingredient. The Agency believes there are numerous considerations
which, when taken together,  can form the basis for a conclusion that such a reduction
in data requirements is appropriate for a particular pesticide active ingredient, while
not compromising human  health or environmental safety.

       There are,  however,  certain data requirements which are essential and may not
be waived, Basic chemistry data on the active ingredient and formulated products are
required  for pesticides in this category so that the Agency has reasonable certainty of
the pesticide's identity and chemical/physical characteristics. Also, acute toxicology
studies for formulated products are required for the Agency to determine appropriate
product labeling for potential hazards to those who handle or apply such products.
However, these toxicology studies may be waived if an assessment of the product
formulation, including the inert ingredients,  indicates that such studies are
unnecessary to determine appropriate labeling.

       In considering putrescent whole egg solids for reregistration eligibility, the
Agency believes it is an active ingredient that should be considered for this broad
waiver of the generic data requirements. The considerations that lead the Agency to
this conclusion are as follows:

       Fresh eggs and egg products are Generally Recognized As Safe (GRAS) (21
CFR  170.3), by FDA.  Egg  solids are also recognized as a common human food or
significant component of a common human food.

       No reports of adverse effects have been submitted to the Agency for this active
ingredient There is no indication of any other significant adverse effects from
putrescent whole egg solids  to humans or the environment associated with its use as a
pesticide.

       This pesticide a used as a repellent in conifer nurseries, open greenhouses,
established forestry plantations, ornamental woody shrubs, almond, fruit, and citrus
orchards.  The active ingredient putrescent whole egg solids has t non-toxic mode of
action for its target pest.  This pesticide can be presumed non-persistent based on
knowledge of its composition. The egg solids' organic material is known to degrade
rapidly in the environment to elemental  constituents by normal biological, physical

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                                   and/or chemical processes that can be reasonably expected to exist where the pesticide
                                   is applied.

                                         Based on these factors the Agency does not believe generic data, beyond those
                                   data required to satisfy basic product identity and chemistry questions (refer to
                                   Appendix B), are necessary to determine if the current registered uses of this active
                                   ingredient pose unreasonable risks to humans or the environment.  Therefore, EPA is
                                   cot requiring the submission of additional generic data for the active ingredient
                                   putrescent whole egg solids.  However, EPA is requiring the submission of product
                                   specific data (product chemistry, acute toxicity and efficacy). The Agency believes
                                   that, based on the above factors, the uses of registered products  containing putrescent
                                   whole egg solids do not pose unreasonable risks to humans or the environment.
                            IV.    RISK MANAGEMENT AND REREGISTRATTOM DECISION FOR
                                   PUTRESCENT WffOLE EGC SOLIDS

                                   A.    Determination of I-flipbilitv

                                         Section 4(g)(2)(A) of FIFRA requires the Agency to determine, after
                                   consideration of relevant data concerning an active ingredient, whether products
                                   containing the active ingredient are eligible for reregistration.  For products
                                   containing putrescent whole egg solids as an active ingredient the Agency waived all
                                   generic data requirements except those for basic product identity and chemistry.
                                   These data were submitted and reviewed.  In addition to these data the Agency has
                                   considered the factors discussed above in Section HI, regarding the natural occurrence
                                   of putrescent whole egg solids, common use as a food item, and the lack of reported
                                   adverse effects information.  The Agency has completed its consideration  of these
                                   data and other factors and has determined this information is sufficient to  support
                                   reregistration of products containing putrescent whole egg solids as an active
                                   ingredient  The reregistration of particular products is addressed in Section V. of this
                                   document.

                                         Although the Agency has concluded that products containing putrescent whole
                                   egg solids are eligible for reregistration, the Agency may take regulatory actions in
                                   the future that would affect the continued registration of putrescent whole egg solid-
                                   containing products if significant information about this active ingredient and/or its
                                   products comes to the Agency's attention. Such regulatory action could include
                                   requiring the submission of additional data if the data requirements for registration (or
                                   the guidelines for generating such data) change.

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                                  B.    Additional Generic Data Requirements

                                        The generic data base supporting the reregistration of products containing
                                  putrescent whole egg solids has been reviewed and determined to be substantially
                                  complete for reregistration.

                                  C.    Labeling Reouircrnents for Kfanufkcturing-Use Products of
                                        Putrescent Whole Egg Solids

                                        There are no manufacturing-use products registered.
                                  v.    ACTIONS gF/)tr|rmm BY REGISTRANTS OF END-USE PRODUCTS

                                  A,    Determination of Eligibility

                                        Based on the reviews of the generic data for the active ingredient putrescent
                                  whole egg solids, the products containing this active ingredient are eligible for
                                  reregistration.  Section 4(g)(2)(B) of FIFRA calls for the EPA to obtain any needed
                                  product-specific data regarding the pesticide after a determination of eligibility has
                                  been made. The EPA will review these data when they have been submitted and/or
                                  cited and determine whether to reregister individual products.


                                 ••!•*    Product Specific Data Requirements

                                        The product-specific data requirements are stated in Attachment C.
                                  2,     Labeling Requirements for End-Use Products Containing
                                        Putrescent Wfrole Egg Solids

                                        The labels and labeling of ill products must comply with EPA's current
                                  regulations and requirements.  Instructions to comply with these requirements are
                                  contained in the Product Reregistration Handbook.

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                    APPENDIX A
Putrescent Whole Egg Solids Use Patterns Subject to Registration
                           I

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                                            APPENDIX B

                          Generic Data Requirement! for Putrescent Whole Egg Solids
                                 and Data Citations Supporting Reregistration
                                                   11

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                                                          GUIDE TO APPENDIX B

                                   Appendix B contains listings of data requirements which support the reregistration for
                            the pesticide covered by this Reregistration Eligibility Document,

                                   Appendix B contains generic data requirements that apply to the pesticide in all
                                   products, including data requirements for which a "typical formulation" is the test
                                   substance.

                                   The data table are generally organized according to the following format:

                                   I.Data Requirement (Column I). The data requirements are listed in the order of
                            appearance in 40 CFR Part 1S8. The reference numbers accompanying each test refer to the
                            test protocols set out in the Pesticide Assessment  Guidelines, which are available from the
                            National Technical Information Service, 5285 Port Royal Road, Springfield, VA  22161.

                                   2.Bib!iographic citation (Column 2).  If the EPA has acceptable data in its files, this
                            column lists the identifying number of each study.  This normally is the Master Record
                            Identification (MRID) number, but may be a GS  number if no MRID number has been
                            assigned.  Refer to the Bibliography Appendices for a complete citation of the study.
                                                                     12

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                                                  APPENDIX B

                           Generic Data Supporting Guideline Requirements for Reregistration
                                           of Putrcscent Whole Egg Solid
           Rcauiretnent
Putrescent Whole Egg Solids
        Citation
PRODUCT CHEMISTRY

451B-IO      Product Identity
151B-11      Manufacturing Process
15IB-12      Discussion of Formation of Unintentional Ingredients
151B-13      Analysis of Samples
151B-15      Certification of Limits
151B-16      Analytical Methods
151B-17(a)   Color
151B-17(b)   Physical State
151B-17(c)   Odor
151B-17(d)   Melting Point
151B-17(f)   Density
151B-17(g)   Solubility
151B-17(h)   Vapor Pressure
151B-17(i)   pH
151B-17(j)   Stability
151B-17(p)   Octanol/Watcr Partition Coefficient
         42072101
         42072101
         42072101
         42072102
         42072102
         42072102
         42072103
         42072103
         42072103
         42072103
         42072103
         42072103
         42072103
         42072103
         42072103
         42072103

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                                                APPENDIX B

                          Generic Data Supporting Guideline Requirements for Reregistration
                                         of Pubescent Whole Egg Solids
                                                                       Putrescent Whole Egg Solids
          Requirement	Citation
TOXICOLOGY

152B-10     Acute Oral Toxiciry in the Rat                                           42019401
1S2B-11     Acute Dermal Toxicity                                                 42019402
152B-13     Primary Eye Irritation in the Rabbit                                      42019403
152B-14     Primary Dermal Irritation                                !           .    42019404
1S2B-15     Dermal Serialization


ECOLOGICAL EFFECTS

GPA waived 40 CFR Part 158 generic data requirements as discussed in section ID.


ENVIRONMENTAL PATE
niiTMwn*ii*niOKiiiiM                                          (
                                                                 i
EPA waived 40 CFR Part 158 generic data requirements for reasons discus* I in  section HI.



The citations listed in the bibliography (Appendix C) were used to support these decisions.
42019405

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                                            APPENDIX C

                               Citations Considered to be Part of the Data Base
                         Supporting the Reregistration of Putrescent Whole Egg Solids

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                                                           GUIDE TO APPENDIX C

                             1.     CONTENT 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,
                                   will be included.

                             2.     UNITS OF ENTRY. The unit of entry in this bibliography is called a  "study". In
                                   the case of published materials, this corresponds closely to an article. In the case of
                                   unpublished materials submitted to the EPA the EPA has sought to identify documents
                                   at a level parallel to the published article from within the typically larger volumes in
                                   which they were submitted. The resulting 'studies'  generally have a distinct title (or
                                   at least a single subject), can stand alone for purposes of review, and can be described
                                   with a conventional bibliographic citation. The EPA has attempted also to unite basic
                                   documents and  commentaries upon them, treating them as a  single study.

                             3.     IDENTIFICATION OF ENTRIES. The entries in this bibliography  are sorted
                                   numerically by Master Record Identifier, or MRID number.  This number is unique
                                  - to the citation, and should be used at any time 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 MRDD entries.  This
                                   temporary identifier number is also to be used whenever specific reference is needed.

                             4.     FORM OF ENTRY.  ID 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 standards of the American National Standards Institute
                                   (ANSI), expanded to provide for certain special needs.

                                   a.     Author.  Whenever the EPA could confidently identify one, the EPA has
                                          chosen to show a personal author.  When no individual was identified, the
                                          EPA has shown an identifiable laboratory or testing facility as author.  As a
                                          last resort, the EPA has shown the fint submitter as author.

                                   b.     Document date. When the date appears as four digits with no question marks,
                                          the EPA took it directly from the document   When a four-digit date is
                                          followed by a question mark the bibliographer deduced the date from evidence
                                          in die document When the date appears as (19??), the EPA was unable to
                                          determine or estimate the  date of the document

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i
                                   c.     Title. In some cases, it has been necessary for EPA
                                         bibliographers to create or enhance a document title.  Any such editorial
                                         insertions are contained between square brackets.


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

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

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

                                         (3)   Submitter. The third element is the submitter, following the phrase
                                               "submitted by." 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," standing 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. For example, within accession number 123456, the first
                                               study would be 123456-A; the second, 123456-B; the 26th, 123456-Z;
                                               and the 27th, 123456-AA.
                                                                      12

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                       OFFICE OF PESTICIDE PROGRAMS
                   REREGISTRATION ELIGIBILITY DOCUMENT
                                 BIBLIOGRAPHY
(1)   42019401 Gabriel, D. (1991) Inedible Whole Egg Solids: Acute Oral Toxicity, Single
      Level - Rat: Lab Project Number: 91-7279A. Unpublished study prepared by Biosearch
      Inc. 10 p.

(2)   42019402 Gabriel, D. (1991) Inedible Whole Egg Solids: Acute Dermal Toxicity, Single
      Level - Rabbits: Lab Project Number: 91-7279A.  Unpublished study prepared by
      Biosearch Inc.  12 p.

(3)   42019403 Bielucke,  J. (1991) Inedible Whole Egg  Solids: Primary Eye  Irritation -
      Rabbits: Lab Project  Number: 91-7279A. Unpuba^ed study prepared by Biosearch Inc.
      13p.

(4)   42019404 Romanelli, P. (1991) Inedible Whole Egg Solids: Primary Skin Irritation -
      Rabbits: Lab Project  Number: 91-7279A. Unpublished study prepared by Biosearch Inc.
      9p.

(5)   42019405  RomaneUi, P.  (1991) Inedible Whole Egg Solids: Guinea Pig  Dermal
      Sensitization - Modified Buehler Method: Lab Project Number: 91-7279A. Unpublished
      study prepared  by Biosearch Inc. 20p.

(6)   42072101 Meinen, V. (1991) Product Identity and Composition of Inedible Dried Whole
      Egg.  Unpublished study prepared by MGK Co. 27 p.

(7)   42072102 Meinen, V. (1991) Analysis and Certification of Product Ingredients for
      Inedible Dried Whole Egg,  Unpublished study prepared by MGK Co.  12 p.

(8)   42072103 Meinen, V. (1991) Product Chemistry of Inedible Dried Whole Egg (Physical
      and Chemical  Characteristics): Lab Project  Number.  333-334.  Unpublished  study
      prepared by MGK Co.  13 p.

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i
                                   APPENDIX D
                                    PR Notice 91-2

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                  UHTT1D fTATU ENV1KONUIHTAL FROTICTION AOINCY
                            WA&HMOTOM, O.C.
              NOTICE TO KANUrACTUHZXS,  PRODUCERS, FOJWLATORS,
                       AND RIGISTIAKTS  07 PESTICIOtS
 ATTBfTIONt  Parsons Jtasponsible for Federal Xafistration of
        ,     Pesticide Products.

 SU&JZcrs    Accuracy of Stated Percentages for Ingredients
             Statement
 **
      The  purpes* of  this notice  is to -clarify the  Office • of
 Pesticide  Program's  policy  with  respect  to the  atatemant of
 percentages  in  a  pesticide's   label's   ingredient   statement.
 Specifically,  the  amount  (percent by  weight)  of  ingredient(a)
 specified in the ingredient statement on the label muat ba stated
 aa the nominal  concentration of such ingredient (*), as that term is
 defined  in  40  CTR  I5l.l53(i).  Accordingly,   the Agency has
 established the nominal concentration as the only acceptable label
 claim for th* Amount of active ingredient in the product.

• II.  BAGKfiROUKD

      For some tima th* Agancy has accepted two different methods of
 identifying  on th*  label what  pereentag*  i*  claimed for  the
 ingredient!*) contained in a pesticide.  Seme applicants claimed  e
 percentage which represented  a  level between th* upper  and  the
 lower certified  limits.   This  was referred to as th*  nominal
 concentration*  Other applicants claimed th* low*r limit as the
 pereentag* of  the  ingredient(s) that  would b* expected to be
 present in tb*ir product  at tha  end of  the product1* shelf-life.
 Unfortunately,  this led to *  great deal of confusion  among  the
 regulated industry,  th* regulators, and the consumers as to exactly
 how much of • giv*n  ingredient we* in a  given product.  The Agency
 has established the nominal concentration as th* only aeeaptabl*
 label claia for the aaount of active ingredient la the product.

      Current regulation* require that the percentage listed in th*
 active ingredient statement bo as precise as possible  reflecting
 food manufacturing  practice*  40 CfH 154.10(g)(5).  Th* certified
 limits  required for  each active  ingredient  ar* intended  to
 encompass any *uch "food manufacturing practieo* variations 40 erst
 15l.l75(c)(J).

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i
 The upper  end  lover certified limits,  which must be proposed In
 connection vith « product** reg istration, represent the amounts of
 an ingredient that may legally ba present 40 CI1* 131.173. Tht lov*r
 certified  liait  is  used as the  enforceable  lover liait  for the
 product coapoeition according to flFEA  section  12(a)(i)(C), while
 the  noninal  concentration appearing on the label would  be the
 routinely achieved  concentration used for calculation of dosages
 and dilution*.

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

      Xt is iaportant for registrants to  not* that certified liaits
 for  active  ingredients  are  not  considered to  b* trade secret'.
 information  under  rZFRA section  10 (b) .  In  this  respect  the
 certified liaits will be routinely  provided  by IPX to States for
 enforcement purposes, sine* the  noainal  concentration appearing on
 the  label  may  not  represent  th*_*nforceabl* coapoeition  for
 purposes ef section 12(a)(l)(C>.

-III. WQUIMKZWTS

      As described belov under Unit V. * CTMCTLIAXCI SOUDOll," all
 currently registered products a* well •• mil application* for new
 registration »ust ceaply with this Hotice by specifying the noainai
 concentration expressed  *•  a percentage  by weight a*  the  label
 claim in the  ingredient (s) stateaent and equivalence statements if
 applicable (e.g.,  eleaental  arsenic,  aetallic tine,  salt  of an"
 acid) . In addition, the requirement for performing *aapl* analyses
 ef five or *ora representative saapl** aust be full i Had. Copies of
 th* rav analytical data  aust  ba  submitted  with  th*  noainal
 ingredient  labal  claiji. Further information  about  the analysis
 requirement may b«  found in th* 40 CfX 131.170. All products ar*
 r*quir*d to  provida certified limits for *ach activ*,   inert
 ingredient,  impuritias  ef toxieolofical *igrnificanc*(i.*.»  upper
 limit (a)  only) and  en  a cas* by casa  basis as sp*elfl*4 by  IP A.
 These limit* ar*)  to ba set based  MI r*B**a*at*Uv* sampling and
 chemical analysis(i.*., quality control) of  th* product.
            m*
     Tba format of tha  inched ient *tat«m*nt »u*t conform to 40 erm
              H*quirem*nt* For Pesticide* and D*vic*s.

                                                    atat*manta mu*t
                              Aftar July 1.  litT, all p**ticida
                            eha&f *d to nominal concantxation.

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 17.  F10WC7S THAf JUQCZU imGACY

      All pesticides ar* required te be  efficacious.  Therefore
 the certified lever limit* may net b* lower  then the minimy»  '
 level to achieve efficacy.  This is *rcremely  important for
 products which ere intended to control  pests which threaten th*
 public health, e.f., certain antimicrobial and rodent icide
 products.  R«ftr te 40 cm
      In these easts vh*r« sfficaey limits  htv« b*«n «stabiishtd,
 ths Agency will not tcctpt certified  lover li»its which are belev
 that level for the shelf life of the  product.

 V.  COK?LIXHCt SOaOCLT

      As described earlier, the purpcse of  this Motice is te sake
 the registration process more tuiifera and  «ore manafeable for
 both the agency and the rtg\il»t*d cosaunity.  It  is the Agency's
 intention te ispleaent th* requirements of this netie* ss
 ssoothly as possible so as net te disrupt  or delay the Agency's
 high priority programs, i.e., reregistration, nev chemical, or
 fast track (Finu section 3(c)(3)(i).  Tberefore,
 applicants/registrants are eicpected to comply with th*
 requirements of this Notice as followsi

           (1)   8«ginningf July i, l»tl, all nev  product
                registrations submitted te th* Agency
                are te comply with th* requirements  of this
                Kotice.

           (2)   tegistrants having product* subject  to
                rsregistration under FlflU section 4 (a)  are te
                comply with th* r*quire»«jit* of  this Hotic* when
                specific product* are called in  by th* Agency
                under Pea** V of th* Xeregistration  fregraa.

           (3)   All other producta/application*  that ar*
                not subject te (1} and (2)  aheve will have until
                July 1, !•*?, te comply with thi* Mot ice.
                fuch application* should net* •Conversion
                to iroainal concentration* en th* application
                fen. These type.* ef aa*ndB*nts vill net b*
                baj)dled as -fast Track" applications but
                will b* handled a* rout In* re^uaat*.

VI.  ro> fOim» »TOJWATIO»
     Contact Tyron*  JUkan for Infermatlea 99 <|u*«tien* concerning
thi* nctic*  Oil  (703)  357-1024.
                                 Ann* I. Ufidjay,  Director
                                 Itegistration Division (H-790S

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i
                                        APPENDIX E
                                 Pesticide Registration Handbook

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THE HANDBOOK IS NOT INCLUDED IN THIS COPY OF THE DOCUMENT

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i
                                       APPENDIX F
                                   Product Specific Data Call-in

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i
                       3         UNfTED STATES ENVIRONMENTAL PROTECTION AGENCY
                       *                   WASHINGTON. D.C.  20*80
                                        DATA CALL-IN NOTICE

                                                                          OP* CIO*
                                                                       PIITCOC SAND TOXIC
                  CIKTIFIEP MAIL                                         IUMTANCU
                  Dear  Sir or Madam:


                  This  Notice requires you and other registrants of pesticide
                  products containing the active ingredient identified in
                  Attachment A of this Notice, the Data Call-in Chemical Status
                  Sheet. to submit certain 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 §0
                  days  after, you receive this Notice you Bust respond as set forth
                  in Section III belov.  Your response must state:

                       1. Hew you will comply with the requirements set forth in
                         this Notice and its Attachments A through 6} or

                       2. Why you believe you are exempt from the requirements
                         listed in this Notice and in Attachment C,
                         Requirements Status and Registrant'a 'Response Fern, (see
                         section III-B); or

                      3. Why you believe IPA should not require your submission
                         of product specific data in the manner specified by this
                         Notic* (see section III-D).

                      Zf 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 froa 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 B,  pa^a Call-In Response Fora, as veil as a
                 list  of all  registrants vho were sent this Notice (Attachment F).

                      The authority for this Notice is section 3(c)(2)(B) of the
                 Federal Insecticide,  Fungicide and Rodenticide Act as amended
                 (FIFRA),  7 D.S.C.  section 13fa(c)(I)(!).  Collection of this
                 information  is  authorized under the Paperwork Reduction Act by
                 OMB Approval No.  2070*0107 (expiration date 12-31-92).

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

      Section I   - Why You Axe Receiving This Notice
      Section II  - Data Required By This Notice
      Section IZZ - Compliance Kith 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 ares    _________ ____ --
      A  - 'pai^a. ,-Qall-Ir? , Chemiea^_ Status S^fe.fc
      B  - Data Call -In, Response Fora
      C  - pegtf4r_*-$*rit-«-.-S-t_atuSiT and. Registrant's Response _F_ojnn
      D  - EPA. grouping rof. ,-En.d-yse Products fer__fftf tiny Acute
           Toxicology Data Requirements for _Rereg istration
      £ -  EP^ _ Acceptance Crater j.a
      F  — f,j.s"fc of Registrants Receiving This Notice
      G  • Cost Share and Data .Compensation Farms. and Product
           Specific ...... Data  Reort Torn
 SECTION z.   HHty_jfgy_,A|j;_^gCTIYiy[s ,?HI§

      The Agency has reviewed existing data for this active
 ingredient  and rtevaluated 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 Hot ice because you have
 product (s)  containing Che subject active ingredient.
SECTION II.  BATA _Fffl?rRZP HX_TPrJr NOTICE

II-A.  PATA
     The product specific  data required by this Notice are
specified in Attachaent  C,  Requirements Status and Registrant's
Response Fora.  Depending  on the results of the studies required  in
this Notice, additional  testing may be required.

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 II-B.  SCHSSUU FOR SUBMISSION OF

      You are required to submit the data or otherwise  satisfy the
 data requirements specified in Attachment C,  Reguiregents  Status
 ajid_ Registrant's Response Fera. within the tiaefraaes  provided.


 2I-C.  TESTING .PROTOCOL

      All studies required under this Notice Bust 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 (KTZS) , Attn: Order Desk, S28S Port Royal Road,
•Springfield, Va 22161 (tel: 703-487-4f50) .

      Protocols approved by the Organization -for-Zconomic
 Cooperation and Development (OZCD) ara also acceptable if  the OECD-
 recomaended test standards confers to those specified  in. the
 Pesticide Data Requirements regulation (40 CFR f 138.70).  When
 using the OECD protocols, they should be modified as appropriate  so
 that the data generated by the study vill satisfy the  requirements
 of 40 CFR I 1S8.  Normally, the Agency vill not extend deadlines
 for complying vith data requirements vhen the studies  vere not
 conducted In accordance vith acceptable standards.  The OECD
 protocols are available from OICD, 1750 Pennsylvania Avenue  N.w.,
             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} ).

 II-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3fe\mfl\  NOTICES
        ISSUED BY T^iE AGENCY

        Unless otherwise noted herein, th ftp _Da£a  Calfc-In does not^ in
 any way supersede er ehanfe the remiigfaen^s^of  any previous paj;p
 Call-Infsi.  or any other agreements entered into vith the Agency
 pertaining to such prior Notice.  Registrants must comply vith the
 requirement* of all Notices to avoid Issuance of a Notice of Intent
 to Suspend their affected products.


 SlCTIOH XXX.   COMPLIANCE WITH REQUIREMENTS  OF THIS NOTICE

 IXI-A.   g THEPffLE FPi* ** s ^Q^P^W^ TP
     The appropriate responses initially required by this Notice
for product specific data Bust be submitted to the Agency within 90
days after your  receipt of thim Motice.   Failure to adequately
respond to this  Notice within 90 days of your receipt vill be a
basis for issuing  a  Notice of Intent to  Suspend (NOIS) affecting

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 your products. This and other bases for issuance of NOZS due to
 failure to comply with this Notice are presented in Section IV-A .
 and IV-B.

 III-8.  OPTION^ JOR_ R^ffPOKDING _. TO THE, AGENCY

     Th* options for responding to this Kotic* for product >p*cific
 data ares (a) voluntary cancellation, (b)  agree to satisfy the
 product specific data requirements imposed' by thi» Notice or (c)
 request a data waiver (s).

     A diicu»»ion of how to respond if you choose the Voluntary
 Cancallation option is presented below.-  A discussion of the
 various options available for satisfying the product specific data
 requirements of this Notice is contained in Section III-C.  A
 discussion of options relating to requests for data vaivers is
 contained in Section III-D.

     There are tvo forms that accompany this Notice of which,
 depending upon your response,  one or both Bust be used in your
 response to the Agency.  These forms are the Data-Call-in Response
 Zojcs,  and the ReguJ.reaents ^St^tus aq4 AtgArtr.ft.n't ' » Respen^ e _ Fgrre .
 Attachaent B and Attaehaent C.  The Data Call-in Response fgrj aust
 be submitted as part of every response to this Notice.  In
 addition, one copy of the ^equjLreirients Status and Registrant's
          FOI*T|_ must be submitted for each product listed en the
              _
     rc;al J.- jpjr Response Forrp 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 Rtsponse form in
 Attachaent B) .   Please note 'that the company's authorized
 representative  is required to sign the first page of the Data pall-
 |n ..... jyejtpense Feraf and Re-guirenents Status and Ref istrant _'j_ Rfscense-
 Forp (if  this form is required)  and initial any subsequent pages.
 The forms contain separate detailed instructions en the response
 options.   Do not alter the printed material.  If you have questions
 or need assistance in preparing your response, call or vrite the
 contact person (s)  identified in Attachaent A.

     1. Voluntary Cancellation * You Bay avoid the requirements of
 this Notice by  requesting voluntary cancellation of your product (s)
 containing the  active Ingredient that is the subject of this
 Notice.   If you wish to voluntarily cancel your product, you must
 submit a  completed Oata Cal?.-Tn Response? gri- Indicating your
 election  of this option.   Voluntary cancellation is itea number S
 on  the Data Call-In. Response fern. If you choose this option, this
 is  the only fora that you are required to complete.

     It you  choose  to voluntarily cancel your product, further sale
 and distribution of  your  product after the affective date of
 cancellation aust  be in aceordanea with the Existing Stocks
provisions  of this Notice which are contained in Section IV-C.

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     2. gatisfvina ^fte product ....... Specific Oata^_Reguiremen.ts _ef_ thj.s.
 Notice.  There are various option* available to satisfy the product
 specific data requirement* of thi» notice.   These option*  ere
 discussed in Section III-C of this Notice and comprise options  1
 through i on the Requirements Status and Registrant ' * Response  Fora,
 and item numbers 7a and 7b on the pat a Ca,AV-Ijn ....... Response Fqrpa.
 Deletion of a use(s) and the low volume/minor use option are not
 valid options for fulfilling product specific data retirements .

     3. Re(TuefV.fpr ..Preduct ...... Specific Data Waiver*.  Waivers for
 product specific data are discussed in Section III-D of this Notice
 and are covered by option f on the Requ i reae, nts_ S tatttt ,,.104
 'Registrant ' s Response ...... F_o_ra.  If you. choose this option, you aust
 submit both ferns as veil as any other information/data pertaining
 to the option chosen to address the data requirement.
 III"C  SATISFYING THE DATA REQUJpyEK^S OF THIS

      If you acknowledge on the Pata ca|4-Ip ....... Response Form that you
 agree to satisfy the product specific data requirements (i.e.  you
 select option 7 a or 7b) ,  then you aust select one of the six
 options on the Requirements Status and Registrant's Response Forsi
 related to data production for each data requirement.  Your option
 selection should be entered under itea number S,  "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 $tatus and Registrant's Response Form.
 These six options are listed immediately belov with information in
 parentheses to guide registrants to additional instructions
 provided in this Section.  The options are:

      (I)   I vill generate and submit data within the specified
           tine frame (Developing Data)
      (2)   Z 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)   Z aa submitting or citing data to upgrade a study
           classified by EPA as partially acceptable and upgradeable
           (Upgrading a Study)
      (S)   Z aa 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 l.  Develppino- Data —  if you choose to develop the
required data  It oust be  in eonformance with Agency deadlines and
vith other Agency requirements as referenced herein and in the
attachment*.  All data generated and submitted must comply vith the
Good Laboratory  Practice  (GLP)  rule (40 CIS Part 160), be conducted
according to the Pesticide Assessment Guidelines (PAS) , and be in
conformance with the requirements of PR Notice ii-S.

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     The time frames in the Reouirements Status _and Registrant's
 Res.ponse._Fcrm are th* time frames that the Agency in allowing for
 the submission of completed study report*.  The noted deadlines run
 from the date of the receipt of  this Hotice by the registrant,  if
 the data are not submitted by the deadline, each registrant is
 subject to receipt of a Notice of Intent to Suspend the affected
 registration(s).

     If you cannot submit the data/reports to the Agency in the time
 required by this Notice and intend to seek additional time to aeet
 the requirements(s),  you must' submit a request to the Agency vhich
 Includes: (1)  a detailed description of the expected difficulty and
 (2) a proposed schedule including alternative dates for seating
 such retirements 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 vill
 respond to your  request in writing.  If EPA does net grant your
 request,  th* original deadline remains.  Normally, extensions can
 b* requested only in cases of extraordinary testing problems beyond
 the expectation  or control of the registrant.  Extensions vill not
 b* given in submitting th* 90-day responses.  Extensions vill not
 b* considered if the  request for extension is not made in a timely
 fashion;  in no event  shall an extension request b* considered if it
 is submitted at  or after the lapse of th* subject deadline.

      Option 2. AoreatoShare inCost to Develop Data --Registrants
 »»y only  choos*  this  option for  acute toxicity data and certain
 efficacy  data  and only if EPA has indicated in th* attached data
 tables  that your product and at  least one other product ar* similar
 for purposes of  depending on th* saae data.  If this is th* case,
 data may  b* generated for just on* of th* products in th* group.
 The registration M3«h«y of th* product for vhich data vill b*
 submitted must b* noted in th* agreement to cost share by th*
 registrant  selecting  this option.  If you choos* to enter into an
 agreement to share  in th* cost of producing th* required data but
 vill not  b* submitting th* data  yourself, you Bust provide th* name
 of th*  registrant who will b* submitting th* data.  You Bust also
 provide EPA vita documentary evidence that an agreement has been
 formed.   Such evidence Bay be your letter offering to join in an
 agreement and the other registrant1* 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 tens of
 the final arrangement betveen 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 8h*-r*t_.jiHlJtllft Cost of Data Development  -•
This option only applies  to acute toxieity 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

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 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 net 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(•)  developing the data
 has refused to accept yeur offer.  To qualify for this  option, you
 Bust submit documentation to-the Agency proving that  you have Bade
 an offer to another registrant (who has an obligation to submit
 data) to share in the burden of developing that data.  You  Bust
 also sub-sit to the Agency a completed EPA Fora 8570-32,
 Certification of Offer to Cost Share in the Development of  Data,
 Attachment C.  In addition, you Bust demonstrate that the other
 registrant to vhom the offer vas made has not accepted  your offer
 to enter into a costsharing agreement by including  a  copy of your
 offer.and proof of the other registrant's receipt of  that offer
 (such as a certified sail 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 aust net 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 subaitting a pat a	.Call-in. Resoenqe
 form and,,» •Raquireinents .Status and _ Registrant *f 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 subnit the data as required by this
 Notice.   If  the other registrant fails to develop the data  or for
 soae  other reason  is subject to suspension,  yeur registration as
 well  as  that of the other registrant will normally  be subject to
 initiation of suspension  proceedings,  unless you coranit to  submit,
 and do subait the  required data in the specified time fraae.  In
 such cases,  the Agency generally vill not grant a tine  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 nust
 determine that  the study  satisfies the requirements imposed by this
 Notice.  You  nay only submit a study that has not bean  previously
 submitted to  the Agency or previously cited by anyone.  Ixisting
 atudies are studies  which predate issuance of this  Notice.  Do not
 use this option  if you ara submitting data to upgrade a study.  (See
 Option 5).

    You should ba  avara that if the  Agency determines that  the
 study is not acceptable,  the Agency  vill require you  to comply vith
this Notice, normally  without  am  extension of the required  data  of
submission.  The Agency Bay determine at any time that  a study  is
not valid and needs  to ba repeated.

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                                a

    To meet the requirements  of the DCI Notice for submitting an
existing study, all  of  the  following three criteria must b« eltaUy
net;

    a. You nust certify at  the tiae that th* existing study is
    submitted that the  raw  data and specimens from the study are
    available for audit and review and you Bust identify where they
    are available.   This Bust be done in accordance with
    the requirements of the Good Laboratory Practice (CLP)
    regulation, 40 CFR  part 160. As stated in 40 CTR 160.3(j)
    * '[r]av data* Beans any  laboratory worksheets, records,
 •   aeaoranda,  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.   Zn  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 data1 aay 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),  aeans  "any  material derived from a test system
    for examination  or analysis."

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

    c.  You Bust certify  that  each study fulfills the acceptance
    criteria for the Guideline relevant to the study provided i
    the FIFRA Accelerated Reregistration Phase J Technical Guidance
    and that the  study has been conducted according to the
    Pesticide Assessment Guidelines (PAG) or aeets the purpose of
    th* PAG  (both available from NTIS).  A study not conducted
    according to th* PAG nay b* submitted to th* Agency for
    consideration If the registrant believes that th* study clearly
   meets th* purpose of th* PAG.  The registrant is referred to 40
   CFR 158.70 which states the Agency's policy regarding
   acceptable protocols. If you wish to submit th* study, you
   must, in addition to certifying that th* purposes of th* FAG
   are net by th* study, clearly articulat* th* rational* why you
   believe the study meets th* purpos* of th* PAG, including
   copies of any supporting information or data., It has b**n th*
   Agency's *xp*ri*nc* that studies completed prior to January
   1970 rarely satisfied th* purpos* of th* PAG and that necessary
   rav data are usually net available for such studies.

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     Zf you submit an existing study, you Bust certify  that the
 •tudy meets all requirements of the criteria outlined  above.

     If you know of a study pertaining to any requirement  in this
 Notice which does not aeet the criteria outlined abova but does
 contain factual information regarding unreasonable adverse effects,
 you Bust 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 Bust submit a
 suaaary and copies as required by PR notice  86-5.
     Option $. gpgra diner a stjujjy """ If * study has been classified
 as partially acceptable and upgradeable, you nay submit data  to
 upgrade that study.  The Agency vill 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.  Zf you have
 questions regarding the classification of a study or whether  a
 study aay be upgraded, call or write the contact person listed in
 Attachment A.  Zf you submit data to upgrade an existing study you
 Bust satisfy or supply information to correct All deficiencies in
 the study identified by IPA.  You must provide a clearly
 articulated rationale of how the deficiencies have been raaedied or
 corrected and why the study should be rated as acceptable to  EPA.
 Your submission must also specify the KRID n umber (s) of the study
 which VQU are attempting to upgrade, and aust be in conformance with
 PR Notice 86-5.

     Do net 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 Bust provide the KRID number of  the
data submission as veil as the  KRIS 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 aust  be accompanied by  a certification that you coaply with
each of those criteria as veil  as a certification regarding
protocol compliance with Agency requirements.


    Option ,irf _jgj.t,ilTig Existing- Studies -» If you clioose to cite  a .
study that has  been previously  submitted to IPA, that study Bust
have been previously classified by IPA as acceptable o? it aust be
a study which has  not yet been  reviewed by the Agency.  Acceptable

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                                 10

 toxicology studies gentrally will  have been  classified as  "cere-
 guideline" or "cor* minimum."  For all other disciplines the
 classification vould be "acceptable."  With  respect to any studies
 for which you wish to select this  option you must provide  the KRID
 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 ere citing e study of which you ere not the original
 data submitter, you must submit a  completed  copy of EPA fora
 §570-31, Certif ieation yj^th .Respect ^a Data  Cenpensa^ien.
   •  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 Fora and the Requirenents  Status and
 Registrant's ..... Response Fora,  as appropriate .

 III-D  REQUESTS FgR OXTA UA.IVESS

     Zf you request a vaiver for product specific data because you
 believe it is inappropriate,  you aust attach a complete
 justification for the request,  including technical reasons,  data
 and references to relevant EPA regulations,  guidelines or policies.
 (Note: any supplemental data  aust be submitted in  the format
 required by PR Notice 86-5)*   This will be the Qnjy  opportunity  to
 state the reasons or provide  information in  support . of your
 request.  Zf the Agency approves your vaiver request, you will not
 be required to supply the data pursuant to section 3(c)(2)(B) of
 FIFRA.  Zf the Agency denies  your vaiver 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 aust indicate
" and submit the option chosen  on the Requirements _ status  and,
 Registrant's Response Fora.   Product specific  data requirements  for
 product chemistry,  acute toxieity and efficacy (where appropriate)
 are required for all products and the Agency vill  grant  a vaiver
 only under extraordinary circumstances.  You should  also be  aware
 that submitting a vaiver request vill not automatically  extend the
 due date for the study in question.   Waiver  requests submitted
 without adequate Supporting rationale vill be  denied end the
 original due date vill renain in force.

 IV.   CONSEQUENCES OF FAIUPRZ  TO COMPLY WITH  THIS NOTICE

IV-A NOTICE OF INTENT ^O SUSPEND

    The  Agency nay issue e 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 vhich may  be the basis for
issuance  of a  Notice of Intent to Suspend include, but are  not
liaited  to,  the folloving:

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                                                 II
t
i                     l.  Failure to respond as required by this  Notice  within  so
                     days of your receipt of this Notice.

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

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

1                     4.  Failure to submit on the required schedule  acceptable
                     data as required by this Notice.
!
                     S.  Failure to take a required action or submit adequate
k                    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  terns
                    of an agreement or arbitration concerning joint data
                    development or failure to comply  with any terms of a  data
                    waiver).

 I                   6.  Failure to submit supportable certifications as to  the
 |                   conditions of submitted studies,  as required, by Section III-c
 1                   of this  Notice.

 '                  7. Withdrawal of an offer to share in the cost  of  developing
                    required  data.
  I
     S.  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 either  to:

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

      b.  Fulfill the commitment  to develop  and submit the  data  as
      required by this Notice,* or

  •  e.  Otherwise take appropriate steps to meet  the requirements  -
     stated in this Notice,  unless you coaait to  submit  and  da
     submit the required  data in the specified time frame.

     S.  Failure to take  any required or appropriate steps,  net
    mentioned above,  at  any tiae following the issuance of  this
    Notice.

XV-B.  BASIS ,FJ?R OETERHIKATIOK  THAT
                   The Agency may determine that a study  (even  if  submitted  within
               the required time) is unacceptable and constitute*  a  basis  for

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                                 12

 issuance of a Notice of Intent to  Suspend.  The ground* 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 tasted or attained, duration of
   .  test, and, mm applicable,  Good Laboratory Practices.

     2.  EPA requirements regarding the submission of protocols  (if
   *  applicable),  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 Bust be submitted
     in the fora  of a final report;  a preliminary report will not be
     considered to fulfill  the  submission requirement.

 IV-C  EXISTINS STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

     EPA has statutory authority to permit continued sal*,
 distribution  and  usa of existing stocks of a pesticide1 product
 which  has been suspended or  cancelled if doing so veuld be
 consistent with the  purposes of the Act.

     The  Agency has determined  that such disposition by registrants
 of existing stoeJts for a suspended registration vhen a section
 3(c)(2)(B)  data request is outstanding would generally not b*
 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  Hotice  should  be permitted, you have the burden of
 clearly demonstrating  to EPA that  granting such permission vould 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 i» in full compliance  with

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                                  13

  ail Agency requirements, you will have, under aost 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 stock* of voluntarily cancelled products
  containing an active ingredient for which the Agency has particular
  risk concerns will be determined on a ease-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 tiae to sell, distribute, or use
  existing stocks beyond a year from the date the 90 day response was
  due unl.p its you demonstrate to the Agency that you art in full
  compliance with all Agency retirements, 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 bean conducting the study in  an
  acceptable and good faith manner Bust have been submitted to the
 Agency, before EPA will consider granting an existing stock*
 provision.


 SECTION V.   REGISTRANTS'  OgLIGATIpN TO RJTPQRT POSSIBLE
         ""* ' UNREASONABLE ADVERSE EFFECTS

    Registrants  are reminded  that FZFRA 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 oust  notify the
 Agency  of any factual  information they have, froa whatever source,
 including but not  limited to  interim or preliminary results of
 studies, regarding unreasonable adverse effect* on man or the
 environment.   This requirement continue* a* long a* the  product*
 are registered by  the  Agency.


 SECTION VI.   INQUIRIES AKP RESPONSES TO THIS NPT^gE

    Zf you have any  questions  retarding the requirement* and
 procedures established  by this Notice,  call the contact  person(*)
 listed  in Attachment A, the Data Call-In Chemical fttatus sheet.

    All responses  to this Notice (other than voluntary cancellation
 requests) must include  a  completed Data Call-in Response Ferq  and  a
 completed Requirements  Status  and Registrant's Response  Fenj
 (Attachment B and Attachment C)  and  any other document*  required by
this Notice, and should be  submitted to the contact person(*)
identified in Attachment A. It the voluntary cancellation option  is
chosen,  only the gft* Call-In  Response  Fora need be submitted.

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                                 14
    The Offic« of Compliance Monitoring (OCH)  of the Office of
Pesticides and Toxic Substances (OPTS), EPA, vill b« monitoring the
data being generated in response to this notice.
                             Sincerely yours.
                            .Daniel M. larolo, Director
                             Special Review and
                               leregistration Division
    A  •
    B  •
    C  «
    D  •

    I -
    F  -
    G  -
               Attachments

Pata Call-In Chejajeal Status Sheft
Data Call-In
Requirements gta^uf and Registrant's Response  Feya
    grouping of _En.d*ysf PrQ_dyqtf for Meeting
           Data fieqriirenents for
EPA ^Ac^^ange Critera
and
                             _
                     cai  nsaton. Frms.  and
          _   _
         Soecific  Data  Reoort Forai

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i
                                           ATTACHMENT A




                                       CHEMICAL STATUS SHEET

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                                 ATTACHMENT A

  PUTRESCENT WHOLE EGG SOLIDS: DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent  this Data Call-la Notice because you have products containing
putrescent whole egg solids.

       This attachment, the Data Call-in Chemical Status Sheet, contains a point of contact for
inquiries.  This attachment is to be used in conjunction with (1) the Data Call-In Notice. (2)
Attachment B, the Data Call-In Response Form. (3) Attachment C, the Requirement Status and
Registrant's Response Form for product specific data, (4) Attachment D, EPA Grouping of End-
Use Products  for  Meeting  Acute Toxicology Data  Requirements  for  Reregistration.  (5)
Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of All Registrantfs^ sent this
Data Call-In Notice, and (7)  Attachment G» the Cost Share and Data Compensation Forms for
product specific data,  and Product  Specific  Data Report Form for  use  in replying  to this
putrescent whole egg solids Data Call-In.  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete  the database for putrescent whole
egg solids are listed in the Requirements Status and Registrant's Response Form. Attachment
C.

       The Agency has concluded that product specific data are needed for putrescent whole egg
solids. The required additional data are listed in Attachment C.

       Depending on the results of the studies required in this Notice, additional testing may be
required.

                   ESPONSES TO THIS NOTICE
      If you  have any questions regarding the product specific data requirements  and
procedures established by this Notice, please contact Rob Forrest at (703) 305-6600.  All
responses to this Notice should be submitted to:

                   Document Processing Desk (RED/RD/PM-14)
                   Office of Pesticide Programs
                   U.S. Environmental Protection Agency
                   401 M Street S.W.
                   Washington, B.C. 20460

                   RE: Putrescent Whole Egg Solids

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                                 If you have any  questions regarding the generic data requirements  and  procedures
                           established by this Notice, please contact Thomas Myers at (703) 308-8074,  AH responses to
                           this Notice should be submitted to;

                                              Chemical Review Manager Thomas Myers
                                              Accelerated Reregistration Branch (H7508W)
                                              Special Review and Reregistration Division
                                              Office of Pesticide Programs
                                              (U.S. Environmental Protection Agency
                                              401 M Street S.W.
                                              Washington, D.C. 20460

,                                              RE: Putresceot Whole Egg Solids
*                                            »
f

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i
                                               ATTACHMENT B

                             PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
                                             PLUS INSTRUCTIONS

-------
I „  «-
                  sfieinc  XNiTiBCTioHi FOR COMPLZTIHO
                     THt BAIA CALL-IK R28POKSI  TOUM

                         Preflue% gpeeifie Pat*


         This  form is designed to bs used to respond to call-ins for
    generic and product  specific data for the purposs of
    raragictarinf  pt»ticid«§ under  tha Faderal Insecticide Funficida
    and Rodenticide Act.  Fill out  thii fora aach tiaa you ara
    responding to  a data call-in for which EPA haa aant you tha fern
    antitlad "RaquiraaantB  Statua and Registrant'a Rasponsa."

         Itaas 1-4 will  hava baan praprintad on tha fora.  Itaas S
    through 7  aust ba coaplatad by  tha registrant as appropriata.
    Items • through 11 aust ba coaplatad by tha registrant bafora
    subaitting a responsa to tha Agency.

         Public reporting burden for this collection of information
    is  astiaatad'to average 15 ainutas par response, including tiaa
    for reviewing  instructions, searching existing data sources,   ,  ,
    gathering  and  aaintaining tha data needed,  and completing and
    reviewing  tha  collection of information.  Sand comments  regarding
    tha burdan astlaata  or  any other aspect of  this collection of
    information, including  suggesting for reducing this burdan,  to
    Chief,  Information Policy Branch, PM-223, U.S. Environmental
    Protaction Agency, 401  M St., S.W., Washington, B.C.  20460;  and
    to  tha  Office  of Management and Budget, Paperwork Reduction
    Project 2070-0107, Washington,  B.C. 20503.

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i
                        INSTRUCTIONS FOR COMPLETING TK1 "DATA CALL-XH RESPONSE" FORH FOR
                        PRODUCT SP1CIFIC DATA

                        Item 1-4. Already eonpleted by ZPA.

                        It«B 5.   If you wish to voluntarily cancel  your product, anavar
                                 "yea.*  if you choose this option,  you vill not hava to
                                 provide the data required  fay th« Data  Call-In Hotiea
                                 and you vill not hava to couplete  any  othar forms.
                                 Further aala and distribution of your  product aftar tha
                                 •ffactiva data of eaneallation must ba in  aceordanca
                                 with tha Existing Stocks provision of  tha  Data Call-In
                                 Notiea (faction IV-C).

                        Item 6.   Hot applicable since this  fora calls in product
                                 spacifie data only.  Hovavar, if your  product  is
                                 idantieal to anothar product and you qualify  for  a data
                                 exemption, you must raapond with "yes" to  Item 7a (HP)
                                 or 7b (IF) en this fora, provida tha EPA registration
                                 numbara of your sourea(s)  and complete and submit tha
                                 "Generic Data Exemption* fermr you would not  complata .
                                 tha "Requirements Status and Registrant's  Response"
                        —     '   fora.  Examples of such products- includa • rapackagad
                                 products and Spacial Local Kaads (Saction  24c) products
                                 which ara idantieal to fadarally ragistarad products.

                        Itan 7a.  For aach aanufacturing usa product (MP) for which you
                                 wish to maintain ragiatration, you aust agraa to
                                 satisfy tha data requirements by rasponding "yes."

                        Ztaji -7b.  For aach and usa product (IP) for which you wish  to
                                 maintain ragiatration, you must agraa  to satisfy  tha
                                 data raquiramanta by rasponding "yaa."  If you ara
                                 raguasting a data waivar,  ansvar "yas" hara;  in
                                 addition, on tha "Raquiranants Status  and Ragistrant'a
                                 Raaponaa" form undar Xtss 9, you must  respond with
                                 Option 7 (Waivar Raquaat)  for asch study for which you
                                 ara requesting a waiver.  See Item € with regard to
                                 identical products and data exemptions.

                       Iteas l-il.   Self-explanatory.

                                 You may provide additional information that does not
                                 fit en this fora in a signed letter that accompanies
                                 this fora,  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, pleese supply all
                                 relevant details so that IPX can ensure that, its
                                ' records are correct.

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                                                                                                                                Page   1  of
                            United States  Environmental  Protection Agency
                                              Washington,  D.  C.  20460
                                              DATA  CALL-IN RESPONSE
                                                                                                       Form Approved

                                                                                                       OMB NO. zero-Dior

                                                                                                       Approval Expires 12-51-92
INSTRUCT IMS: Plcata type or print in ink.  H*as* rmd carefully the attached instructions and supply the information requested on this form
IK* additional ili**t(S) if mcMMry.
1. CoMparry MM and Address
   INTAGRA,  INC.
   8500  PILLSBURY AVE.  SOUTH
   MINNEAPOLIS  NN   55420
                                      2. Case t and Name
                                        4079    Putrescent whole  egg  solids
                                                                             . Date and Type of OC1
                                                                               PRODUCT  SPECIFIC
4. fM Product
Ivglstratlon
4866-8
S. I ulsii to
cancel thli
product regis-
tration volun-
t»rily.
6. Generic Data
                                     6a.  I an claiming a Generic
                                     Data Exception because I
                                     obtain th« active ingredient
                                     tram th* source EPA regis-
                                     tration nuaber listed below.
                       N.A.
                             6b. t agree to satisfy Centric
                             Oat* requirements as indicated
                             on the attached fora entitled
                             "Requirements Statin end
                             Icgistrant's Response."
                                 N.A.
                                                          7. Product Specific Data
1m, My product is a HUP and
I  agree to satisfy the HUP
requirements on the attached
for* entitled "Requirements
Status 'and Registrant's
Response."
7b. Hy product is »n [UP m
I  agree to suMsfy the EUl
requirement;, on the attu.)
form enlilttti
Status and di
Response,'1
8. Certification
I certify that th« »tate»*nli Bad* on this fora and all attachaenti are true, accurate, and coaplete.
1 aclUNMtcdg* that any kniwingly falaa or •tileading atatoamt a»y be punishable by fine, iaprisonment
or both under applicable l*H.
         and Htl« of Coapany's *uthorfi«d lepr«»entatlv*	
                                                                                                            9. Date
10. Haac of Coapany Contact
                                                                                                                      ntoer

-------
                                                                                                                                Page   1  of    1
                            United  States Environmental Protection  Agency
                                             Washington,  D.  C.  20460
                                             DATA  CALL-IN RESPONSE
INSTRUCTIONS; *l«*s* typa or print In Ink. Pl*asa read carefully the attached instructions and supply the information requested on this fora.
UM additional ifcMtft) if
                                                                                                       form Approved

                                                                                                       OMB No. 2070-OW

                                                                                                       Approval fitplre* 12-31-92
1. Coapany MHH ml Afddreia
   INTAGRA,  INC.
   8500  PILLSBURY AVE.  SOUTH
   MINNEAPOLIS  MK  55420
                                     2. Cm • and Maa*
                                        4079    Putrescent whole  egg solids
                                                                            J. Date and Type of DCI
                                                                              PRODUCT SPECIFIC
4. EPA Product
t*gfstr*tlan
5, 1 Mith to
cancel thU
product regll-
tration volun-
tarily.
6. Generic Data
                                     to.  I •• cl»imng • Generic
                                     Oat* Exemption because I
                                     obtain tlw active ingredient
                                     fro* the source tPA regis-
                                     tration nuitoer listed below.
                             6b. I agree to satisfy Generic
                             Data requirements at indicated
                             on the attached for* emitted
                             •Requirenents Status and
                             Registrant'! Response,11
7. Product Specific Data
7a. Hy product is • HUP and
I agree to satisfy the HUP
requirements on the attached
for* entitled *Require«ents
Status and Registrant's
Response."
7b, HY product is an I iC ami
I agree to satisfy th. iUP
requirements on the i>ttm.hii
form entitled "RpquninitfXi
Status and Registrant's
Response."
4866-9
                       N.A.
                                 N.A.
8. Certification
I certify.that the •titewtti a»d* on this fora and all •ttactants ar* true, accurate, tod eoaptet*.
1 acknoMlcdgc that any knowingly fat»« or *f«ltadMt «ay be puniahablc by fine, imprisonment
or botN WKfcr •pplicabl* lav.
Sipwtur* and Title of Coapcny't Aothorded Representative,
                                                                                                            9. Date
10. M«M of Coipany Contact
                                                                                                            11, Phone Nuifcer

-------
                                                                                                                                  Page    1  of   1
                            United  States  Environmental  Protection Agency
                                              Washington,  D.  c.  20460
                                              DATA CALL-IN RESPONSE
                                                                                                                     Form Approved

                                                                                                                     OMB Ho. 2070-010?

                                                                                                                     Approval Expire! 12-51-92
INSTRUCT I CMS:  Please type or print  In Ink.  Please read carefully the attached instructions and supply the information requested on this form.
UM additional Bhe*t(»)  if necessary.
1. CoacOTy MM and Address
   INTAGRA,   INC.
   8500  PILLSBURY AVE,  SOUTH
   MINNEAPOLIS  MN   55420
                                                   2. Case • and None
                                                      4079   Putrescent whole  egg  solids
                                                                             5. Date and Type of OCI
                                                                               PRODUCT  SPECIFIC
4. EP» Product
legistration
4866-10
             3. I wish to
             cancel this
             product rtflis*
             trat ton volun-
             tarily.
*. Generic Data
                                     6a. I aa claiming a Generic
                                     Data Eneaptlon because I
                                     obtain the active ingredient
                                     1rom the source EPA regis-
                                     tration nuabcr lilted below.
                                    N.A.
                             6b.  | agree to satisfy Generic
                             Data requireeients ai  indicated
                             on the attached fora  entitled
                             "Requirements Status  and
                             Registrant's Response."
                                 N.A.
7.  Product Specific Data
?a. My product is a HUP and
I  agree to satisfy the HUP
requirements on the attached
fona entitled "iequire«ients
Status and Registrant's
Response."
7b. My product ii an tUP ai>
I  agree to satisfy the tUP
rtXjuircnients '^J the ottntht
form enlitU-d "RCT^uirtincfil'.
Status and Hfgistront's
Response."
8. Certification
1 certify that th« »tat««tnts aw* «n thl* foni and all attachawnta are trye, •eeurate, end conplete.
1 ac knout edga that any knowingly f»la« or »l a leading atataatnt nay b« puniahable by fine,  iiijrisonBent
or both under applicable I at*.
Siptature and Titl« of Co«pany*B »uthorlied lepresentative	,	         .—
 10.
of Company Contact
                                                                                                             9. Date
                                                                                                                        mber

-------
                                                                                                                                 Page   1  of   1
                            United States  Environmental  Protection  Agency
                                              Washington,  D. C.  20460

                                              DATA  CALL-IN  RESPONSE
                                                                                                        form Approved


                                                                                                        OMB Ho. 2070-QtOr

                                                                                                        Approval Expires (2-31-92
INSTRUCTIONS: Please type or print In Ink.  Please read carefully tht attached instructions and supply the information requested on this form.
UM additional sheet(i> If necesaary.
1. CoajMfiy MM and Addr*u
   INTAGRA,   INC.
   8500 PILLSBURY  AVE.  SOUTH
   MINNEAPOLIS  MN    55420
                                      2. Case • and Has*
                                        4079   Putrescent  whole egg solids
                                                3. Date and Type of DCI
                                                  PRODUCT SPECIFIC
*. EPA Product
Registration
S. I Hit* to
cancel thia
product regls-
tration volun-
tarily.
                                     6. Centric.Data
                                     6». I aai cleimiwg » Centric
                                     Data Exemption because I
                                     obtain the active Ingredient
                                     from the source EPA regie*
                                     tration nuaber listed below.
pb,  1 agree |o satisfy Generic
Data reo^iire«ents as indicated
on the attached for* entitled
•Rrcfiireoefits Status and
Negistfant'c Response."
                             7. Product Specific Data
7a. My product is * HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and ftegistrant'*
Response.,*
7b. Hy product is an Kit  ••
I agree to satisfy the NJP
rt<|uire«rkents on the attache*
form entitled "Requirements
Status and Registrant's
Response. *'
4866-11
                       N.A.
    N.A.
I. Certification
I certify that the atat«a*nta awfe on thla fen and all attachment! are true,  accurate, and coaplete.
I •cknouledg* that any knoiilngly f«l»« «r ailaUadfna «tatea»nt may be punishable by fine, i«priao««nt
or both under applicable Iw.
Siinature and Title of Cuapany'i Hythorlied tepresentatlve	        _—   .. .          	-
10. Kaa* of Coapany Contact
                                                                                                            V. Date
                                                                                                                Phone Nuitoer

-------
                                                                                                                                Page   1  of    1
                            United  States Environmental  Protection  Agency
                                             Washington,  D.  c.  20460
                                             DATA  CALL-IN RESPONSE
                                                                                                       Form Approved

                                                                                                       OMB No, 2070-0)07

                                                                                                       Approval Expire* 12 5' •?.'
INSItUCTlMS: M*M* typ* or print in Ink.  H
U*t additional atOTtCa) If mcMMry.
                       read carefully the attached instructions «od supply the information requested on this form.
1. Caajpwy MM and Addre*a
   INTAGRA,  INC.
   8500  PILLSBUR¥ AVE.  SOUTH
   MINNEAPOLIS UN   55420
                                     2. Cat* • and Haw
                                        4079    Putrescent whole  egg solids
                                                                            I. Date and type of DCI
                                                                              PRODUCT SPECIFIC
4. EM Product
!«•I»tration
OR88001100
I. I *l»h to
cmcil thU
product r«»l«-
tration volui-
t»rily.
                                     6. tirwrlc Dati
6».  1 •• cl*i*i«g• Generic
Dit* En*ptian bacaia* I
otat»ln the activ* ingredient
fro« tht •ourc« EM regli-
trat ion nudtaw timted below.
                       N.A.
6b.1•grec to satisfy Geheric
D*t* refy the till'
requirements **i Ihc dlt,KK>
for« entiHit
Status and R
Response."
                                                                                                            It. Phone

-------

United States Environmental Protection Agency
Washington, D. C. 20460 i

DATA CALL-IN RESPONSE






INSTRUCT IONS: •(•**« type or print In Ink. HMM r**d carefully the attached instruct ions *nd supply the information requested
VM Add) It oral atteetd) If nece*Mry-
1. Coepeny MM end Addre** - . 2. CMC f mi *mm


INTAGRA, IHC. ' 4079 Putrescent whole egg solids
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
4. f PA Product
••filtration





WA88000400

5. 1 Hlsh to
COTCOl tills
product r«fli-
tratlan volun-
tarlly.




6. C«vrlc D«U
6«. i !• clitMMi • Generic
Pat* fxc^Hlan because 1
obtain the vctiw Ingredient
Irom tlM tourc* CM regU-
t ration nutter listed betoti.

N.A.

6b. I agree to satisfy Generic
Hit* requirements H indicated
on the Mtoched fora entitled
•Requirements Status and
Registrant'! •espome,"

N.A.
1
!


T. Product Specific
1*. tty product
is a
Page 1 ot I
form Approved
(MB Ho. 2070-0107

Approval Expires }2 M-9,»
on this torn.

S. Date and Type of DCI
PRODUCT SPECIFIC


Data
mH> and
1 agree to satisfy the HUP
requirenents on the
attached
fora entitled "Retirements
Status and Registrant's
Response.1*


•. certification
1 certify that the ttatea*nta mm* m thli for* end ell ettechewMi ere true, cccurate, «nd t(»plete.
1 BCtnaMlcda* that wiy know • ,11*1
1 aaree to satisfy thr I ui'
requirements on the nli.i, tii-,1
form entitled "Requi 1 1 iin-nts,
Status and Registrant':,
Response , "


9. Date




11. Phone Number

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i
                                               ATTACHMENT C

                        PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
                                       FORMS (Form B) PLUS INSTRUCTIONS
                                                    AND
                                               PR NOTICE §6-5

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i
                                      •1ECIF1C IWSTRDCTlOUi FOR COMfLITIKS
                              THI RtQUIfitMtNTf  iTATUI A*B HEGISTRXKT ' • RtSPONSt TOW

                                              Troduet tptetfia Pat*


                           •  Thit fora it dasignad to ba us«d for ragittrantt to respond
                        to call-ins for ftn*rle and produet-spaeific  data at part of
                        IPA'a raragiatration program undtr  tha radaral  Xnsacticida
                        Fungicida and lodsntieida Act.   Although tha  for* i» tha saaa fer
                        both product specific and gan*rie data,  ^n>truetion« for
                        compltting tha forsa dlffar slightly.  Cpaeif ically, options for
                        satisfying product specific data rafuiraaanta do not includa  (i)
                        dalatien of uaaa or (2) rafuast for a lev veluaa/alnor  usa
                        vaivar.  Thaaa instructions ara for coaplation  of
                        spteifie data
                             IPA has davalopad this fora Individually for aaeh data call-
                        in addrassad to aaeh ragistrant,  and has praprintad this fora
                        with a nunbsr of Itams.  PQ NOf usa this form fer any othar
                        aetiva ingrsdiant.

                             Itaaa I through I (inclusiva)  will hava baan praprintad on
                        tha fora.  You Bust conplata all othar itaaa en thia fora by
                        typing or printing  lagibly.

                             Public raporting burdan for this collaction of inforaatien
                        is astinatad to avaraga 30 ainutas  par rasponsa, including tiaa
                        for raviaving instructions, aaarching axiating data eourcaa,
                        gathering and aaintaining tha data  naadad,  and complating and
                        raviaving tha collactien of information,  land comnants ragarding
                        tha burdan aatimata or any othar aapaet of this collaction of
                        Information,  including auggasting fer raducing this burdan^ to
                        Chiaf,  Znforaation  Policy Branch, PK-223, U.I. Environnantal
                        Protsction Ag«ncyt  401 If It.,  I.W., Wishington, D.C. J04IO; and
                        to tha  offiea of Kanagaiaant and ludgat, Paparvork laduction
                        Projsct 2070*010?,  Washington,  D.C. 20303.

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a
                      INSTRUCTIONS  f8R  'COKPUTIXfi   IHl  "RIQUIRSMINTS  STATUS
                      RXSISTJUXT'S RXSPOHS1" JORH FOR fSODiCT iflCIf 1C CAT*  , .

                      Ztaa 1-3  Conpleted by I?A.   Hott the «aif«e  ifaatifiar tusia*
                                asaigrned  fey rPX In Xtaa 3.  This nuxber BUS*  be us*d in
                                the traaaaittal  decuaaat for  any  data suiaiaaiaaa in
                                response  to tills Cata Call-in notice.
                              * *            •                *    *

                      Ittm 4.   Tha guideline reference  nuabers of  studies required to
                               support   the   product's  continued   ragiitration  ara
  i                             Idtntifiad.    Thas*  guSdalin**,  IA  addition to tht
  !                 •            racjuiramanta spacifiad in tha Hotica, fovarn tha conduct
                               of tha racjuirad atudias.  Hots that sarias •! and  <2 in
  !                  •           product chaaiatry  ara nov liatad undar 40 CTTt 151.155
  ,                   '          through 151,110, fuhpart C.

  f                    Jtaa 5.   Tha  study titla aaaociata'd 'vith tha guidalina rafaranea
                               nuabar is idantifiad.
                      Ztaa f.   Tha u«a pattam(a) of tha paatielda asaoeiatad vith
                               product spaeiflc rafuiraaants is (ara}  Idantifiad.   For
                               ao»t product apacific data ratpilraaants, sll uaa pattarns
                               sra covarad  fey  tha data rafuirasants.   In tha  cssa of
                               afficacy  data,  tha  raejuirad studias only partain  to
  )                             product.* vhich hava tha uaa sltas and/or pasts indicatad.

                      Itaa ?.   Tha aubatanca to  ba  tasta'd is idantifiad fey I?A.   for
                               product spaeifie data, tha product as foraulatad for sal*
                               and distribution is tha tast subatanca, axcapt  in  rar*
  i                             cases. •-•.•'••

                     Itaa I.   Tha dua data for submisaion of aach study is idantifiad.
                               It is noraally baaad en •  »»atbs. aftar issuasos of taa
                               Xaraglatratioa Ilifibility Docuaaat unlaas XPA^datarainas
                               that * lenfar tlaa pariod is nacaaaary.

  i                   Itaa t.   fatar enlf ana •! taa follevi&f raapoaaa  oodas fsy aae!>
  i                            g»ta _gaep|i_rfgaat to saov how you iataad to  coaply  vita
  .                            tat 4*t*  ra^jiraaaata liatad  la  this tabla.   fullar
                               dascriptions ef saeh option  ars contained in tha  Data
  ,                            C*ll-Ifl.Kotic«.

  '                      1.    2 vill ganarata »nd subait data by the spacifiad dua data
  ,                            (Davalopiag Data) .  By Indicating that X hava chosan this
                               option,  Z  cartify that Z vill coaply  vith all  tha
   )                            rajuiraaants  partaining to tha condition*  for submittal
   '                            of this study as outlined in tha Data Call-In Kotiea.
                                                               *           *
                         2.    z  have  entered  Into an  agreement vith  one  or  son
                               rtgistranta  to develop data  jointly (Cost fhariag).   Z
                               aa  subnittlng *  copy ef this agraaaaat and a coapleted
                               "Certification  With  Xaapect   to  Bata   Coapanaatiea
                               Ia
-------
i
                                 data end only if IPA indicates In an attaehsent to this
                                 Kotice  that my  product  is aiailar  anough  to anothar
                                 product  to qualify for  this  option, .  I  certify -that '*'
                                 another party in tha agreeaent i* comaitting to subait
                                 or provide  tha required ditt; if tha  required study is
                                 not  aubaitted  en tiae,  ay product aay be  subject to
                                 suspension.      • '     •        • .  .     *   ,'  •  •

                           3.    Z hava aada offers to shara in tha eoat to develop data
                                 (Offers to  eoat  fhira) .  Z underatand that' this option
                                 is available only for aeuta toxicity or cartain affieacy
                                 data and only if IFA indicates in an attachment to this
                                 Cata Call-in Ketiea  that ay product is alallar anough to
                                 another product  to  qualify  for  this  option*    I aa
                                 aubaitting evidence  that  Z lava atda aa offar to anothar
                                ragistrant  (vho  has an obligation to subait data) to
                                shara in tha coat of that data*   Z IB alto subaitting •
                                eosplatad "Certification  of Offar to  Cost fhara is tha
                                fiavalopaaat Data" fora.  Z aa including a  copy of ay
                                effar and proof of tha other registrant's receipt of that
                                of far.   Z aa identifying tha  party which is  committing
                                to aubreit or provide tha  required datai is tha required
                                study is not subaitted en  tiae, ay product aay be subject
                                to suspension.   Z  understand that  ether  taras under
                                Option  3 in the Data Call-In  Kotice  (lection III-C.l.)  *
                          '*"     apply ss vail*

                           4*    By tha specified due  date, Z vill  subait  an exicting
                                study that  has  not been subaitted  previously  to the
                                Agency  by  anyone (fubaittiag aa Zxistiag »tudy) .   Z
                                certify  that this study vill aeet All tha represents
                                for subaittal of existing data outlined in Option  4 in
                                the Data Call-In Kotice (Section III-C.l.) and vill  aest
                                the attached acceptance criteria (for acute texicity and
                                product  cheaistry data).   Z vill attach  tha needed
                                supporting information along vith this responss.   Z  also
                                certify that 1 hava determined that this study vill  fill
                                tha data requireaent  for vhich X  have) indicated  this
                                choiea.
                                                         •

                          S*    §y the specified due data, Z vill subs it or cite data to
                                upgrade a  study clasaified by tha Agency as  partially
                                acceptabla and upgradable (Upgrading a ftoif).*  Z  vill
                                •usait evidence  at  tbe Agency's rariev indicating  that
                                tha  study  aay ba   upgraded  and  vhat  inforaation is
                                required to do so.  Z vill provide tha XXID or Accession
                                number of tha atuoy  at tha  due data.   Z understand  that
                                tha conditions for this option outlined Option S  in the
                                Data Call-in Hotica  (faction III-C.l.) apply.
                          i.   »y the 's^acif ied due data, Z vill cite an existing study
                               that  tha  Agency has  classified  as acceptable  or an
                               existing study that has been subaitted but cot reviewed
                               py tha Agancy (Citing aa tsistiaf ituay).  Zf Z aa citing

-------
                            another ragistrant's study, Z understand that this option
                           •is availabla ealj for acute toxieity or certain efficacy
                            data and only if the citad  study  vas conducted en ay
                            product,, an idantical product er a product which I?A has
                            •groupad" vita one  er acre'"ether products  for purposes
                            of dapending en the  SIB a data.  Z Bay also choose this
                            option  if Z  aa citing ay  evn data.  In either ease,- Z
                            vill provide  the X»ID er  fteeaaaioa  auaierCsi for the
                            eited. data en a  "Product Specific Data Report"1 fora or
                            in a similar feraat. • Zf  Z cite another. rsgistrant's
                            data,  Z vill  subait a coapleted  "Cartifieatiea Vita
                           Kaspect Te Sate Coa;aa»atioa Xa^uiraaaats"  fera.
                  t                          .                    »    ,  *
                      7.   Z  refuest  a vaiver for . this  study  because  it  is
                           inappropriate for ay product (Vaiver lafuast).   Z aa
                           attaching a  cooplata justification  for this  reguast,
                           including technical  reasons, data and  references to
                           relevant EPA ragulations, guidelines er policies.  [Nota:
                           any  suppleaental data Bust  be  subaittad in the  feraat
                           raijuired by P.H.  Kotiee i«-SJ.  Z understand  that this
                           is ay oaly opportunity te state the reasons er provide
                           information  in support  of ay raguest.   Zf the Agency
                           approves ay vaiver request,  Z vill sot be raqfuirad. te
                           supply the data pursuant te Section 3(c)(a) (B)  of fXflUU
                           Zf the Agency denies ay vaiver request,  Z aust eaeese a
                           aethod of aeeting the data raguireaenta ef this  Notice
                           by the due date stated by this Hotice.   In  this ease, Z
                           aust, vithin  99  days ef  ay receipt of  the  Agency's
                           vrittan decision, subait a  revised  "JUfuireaents Status-
                           end Registrant's Response*  Fera  indicating tha  eptien
                        •   chosen*  •  Z  else  understand  that  the deadline  for
                           subaissien ef data  as specified by  tha original data
                           call-in  notice vill  net change,   (

                Zteas 10-13.   Self-explanatory.          *

                           tea aay provide additioaal  i&fonatioa that dees net fit
,                          en  this fen in a signed  letter that accoapanies this
                          fen.   for exaaple, you aay vish te  raport that your
                          product has already been transferred te another coapany
                          er  that yen  have already voluntarily  cancelled tfcis
'                          product,   for these ease*, please  supply all  relevant
                          details so that If*  can  ensure that its  records are
                          correct
                                 *

-------


United States Environmental Protection

Agency




Washington, D. C. 20460 i





REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print In Ink. Please read carefully
Use additional sheetCa} If neceaaary.
1 . Coapeny MM and Address
INT AGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
*. Guideline
t«sj|re»tnt
Muaber


151B-10
1518-11
1518-12

151B-15
151B~1$
151B-17 \
^3-i»*5 •» r *.**•*
1518-17(1)
153,B~l7 (Jc I
1518-17(1)
15 IB- 17 (n)




the attached inttructions and supply the information requested

2. Case f and Moat
4079 Putrescent





whole egg solids


EPA Reg. No. 4866-8
S. Study Title
Prod Ow» - •Jochnaf cal
Product Identity
Hanvifactgrtng proctts
Olacuision of fonattlon of
unmtentlontl lnBrdl«nt»
Certification of Malta
Analytical •wthods
Physical state
Oensity
pH (61
rieaMabilfty C71
Storage stability
Hlsclbillty <»)
Corroalon character f»tU»















|

1-














ProgrcM
leper ti
1















2















I















6. Use
Pattern




A C
A C
A C

A C
A C
A C
A C
A C
A C
A C
A C
A C
A C '

UK
IJK
IJK

IJK
1 UK
1 IJK
IJK
IJK
IJK
IJK
IJK
IJK
IJK
7, Test


on this forn.

3. Date and
Page 1 of 2
Form Approved

ma NO. 20/0 o to;

Approval Expires 12-51-92


Type of OCI
PRODUCT SPECIFIC
IDf 4866-RD-1904


Substance



EP
EP
EP

EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the statements Bade on this for* and all attach-enta are true, accurate, and confute.
1 acknotttcdje that any knowingly falae or Misleading stateeent awy be punishable by f !n«. i«prUom.ent
or both umter applicable Ian.
Sipieture end Tiflt of C«n»"y'« author! led Icpresvntatlve




12. iae» of Company Contact
















tl.



11.

















8. Time
Frm



le



8 mos .
8 mos.
8 mos.


8 mos.
8 mos.
8 mos.
8 mos.
8
8
8
8
8
8
lite



'hone Nuttier
mos.
mos.
mos.
mos.
mos.
mos.
9. «egi!»! .Mil
fespunsc






















-------


Page 2 of 2
United States Environmental Protection Agency Far« Approved
Washington, D. c. 20460
t»B Mo. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Empires 1Z-3I-92
INS1MKT1CWS: rims* type or print In ink. P»aa»« read carefully
UM additional aheat(a) If naeeaaary.
1. Coapany naaw and Addraas
1NTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MH 55420
4. Culdellna
lequlreawnt
kuaber
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
152B-16 /,:
96-19
%. Study Tltl*
Acute Jl :. :.:.
Oera»l aansltliatlon <*)
•raw*tn4 ani«al r*pellenU (SO)
the attached instructions and supply the information requested on this form.
2. Case • and Narae J. pate and lype of DCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
IDf 4866-RD-1904
EPA Reg. No. 4866-8


I

Progress
Reports
1

2

3

6. Use
Pattern
A C IJK
A C IJK
A C IJK
A C UK
A C IJK
A C IJK
A C IJK
A C IJK
Initial to indicate certification as to information on this page
(full lent of certification i* on page one).
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
6. Time
frame
8 mos.
8 mos.
8 mas,
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response

Date

-------
                                                                                                                                       Page    1 of    l
                                          United  States  Environmental  Protection Agency
                                                           Washington,  D.  C.  20460
                                  FOOTNOTES  AND KEY DEFINATIONS  FOR GUIDELINE REQUIREMENTS
                                      Case  f  and Naae:  4079   Putrescent  whole  egg  solids
Bey: HP * aBnufacturlng-uae product;  tt « end-use product; provided fonulator* purchase their active Ingredlcnt(s) froi • registered source, they need not submit or cltt
dats pertaining to the purchased product.OKIff: If • product It • 100 percent repackage of another registered product that is purchased, end any use for the product doe%
not differ froa those of  the purchased end registered source,  users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGA1 • technical grade of tha actlva  Ingredient; PAI • "pure" active ingredient; PAIR* « "pure11 active ingredient,  radiolabeled.
MM Cate*orie* Icy:
  A - Terrestrial food crop        •  - Terrestrial food feed crap     C - Terrestrial nonfood crop     D - Aquatic  food crap          f - Aquatic nonfood outdoor
  F - Hepatic nonfood Industrial   S  - Aquatic nonfood residential    N * Greenhouse food crop        1 - Greenhouse nonfood crop     J - Forestry
  I • Residential outdoor         L  * Indoor food                   N - Indoor nonfood              M - Indoor Medical              0 - Indoor residential

Footnotes:  ITH* follow Ing notw wrt r*f>rtnc*d In colwn two (5. study Title* of the MEOUIREHENIS SIAIUS MID BEGISIKANI-S RESPONSE fom.|


rrod Qtm - iloclnarical

 6  Required If test •ufaatance li di«p»r»ibla Kith water.
 7  iequlrad if product contain* coatjuallbl* liquidi.
 •  Requlrad If product la a liquid.
 9  Requlrad If product ti Ml •audiflabU liquid and I• to be diluted with petrolew solvent*.


Unit* iwdc • •iodiodcal

 I  Required If tbt product comllts  of, or under eondltlona of use result* in. an inhalable •aterial (e.g., a»s, volatile lubstance,  or aerosol/partIcuUte).
 ft  Required If repeated  contact nlth buiam aklti rtwilts under conditions of use.
 %  Incidents «u»t b* reported, If they occur.


Efficacy - Vcrtafcrat* Control taants

SO  Out to ouestlom concerning the effectiveness of vertebrate anl«l repellents and the  suitability ol label directions for such products, registrants of
    DMtleldsTeont.lBlni Putrwcint  Uhole Egg Solids aust Indicate th. Mudie. upon Jiteh the claim »*de for their products are based.  Such studies in EPA»»
    St. ha.Ta.rbI cited by MID ma*er or^ieces.ion nu*tr. Studi«s not In EP*'» data base aust ba sutaitted In the appropriate for«at.  If no eff ic«ey
    data eWbTprowldsd  to iubstantteta the claiM -ade for their products, rtslstrints »ust co»*it to Bener«te such d*ta.  delete the relevant cl.ifs,  or
    raquest voluntary cancellation of their reslatratlons.

-------

United States Environmental Protection Agency
Washington, D, ,c. 20460
*
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE







INSTRUCTIONS: Please type or print In Ink. Mea*e read carefully the attached instructions and supply the infornation requested
UM addition*! ahaet(e) If necasMry.
1. Coapeny naa» and Addreti 2. Case f and Naa*


INT AGRA, INC. 4079 Putrescent whole egg solids
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420 EPA Reg, No. 4866-9
4. Guideline
Requirement
•uabar


1S1B-10
151B-11
151B-12

151B-15
1518-1$
1518-17 (b)
1,518** 17 (£)
1518-17(1)
15lB«»l7()Cj
1518-17(1)

1518-17 (n)

S. Study Tlti*



Prod OMB - piocfcearical
Product identity
Manufacturing process _,; ^'. .;.•
Discussion of fonaition of
unintentional ingrdient» r
Certification of Units
Analytical •athoch
Physical atata
ftttwlty
PR 16)
Flaajaabflity (7|
Storage stability
Wlacoalty l«)
Hlacibllity (V)
. Cortoaion charact«r|«tic« ' •'.. ':-:
|
n
§
I















Progress
Reports
1
















2
















3
















6. Use
Pattern



A C UK
A C IJK
A C IJK

A C IJK
A C UK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
7. leit









on this form.

I. Date and
Page* l of 2
Form Approved

OMB No. 2070-0107

Approval Expires 12-51-92


Type of DC I
PRODUCT SPECIFIC
ID# 4866-RD-1905


Substance



EP
EP
EP

EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that th» atatea»nta Mda on thla fona and all attachment* are true, accurate, end coaplete.
I acknowledge that any knowingly falae or •(•leading atateaient a*y be puniahable by fine, iaprlsonaent
or both under applicable lay.
Signature and lltle of Coapany'e Author lied Representative 	 	 	 __ 	
12. Haaw of Ccapany Contact



































8. Time
fran



t



8 nos.
8 mos.
8 mos.


8 mos.
S mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Set-ponse

r

i













11. Date
IJ. Phone Nuitoer

-------
United States Environmental Protection Agency for* Appi-owd
Washington, D. C. 20460
an Ho. 2070-0107
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
Affirovil Expires !2-31-92
INSTMJCTIOJfS: Pi**** type or print In Ink. f>l*as* read carefully th« Attached Instructions end simply the mformation requested on this fom.
UH additional aheetd) if neceiiary.
1. Company mat* and ftddrtai Z. Case • and NMM 5. Date and Type of OCI
INTAGRA, INC. 4079 Putrescent whole egg solids PRODUCT SPECIFIC
8500 PILLSBURY AVE. SOUTH Wj 486G-RD-1905
MINNEAPOLIS UN 55420 EPA Reg. No. 4866-9
4. Gufd*Un*
IvptrtBvnt
IM^xr
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
J.52B-16
96-19
S. Study TltU
Acute to«|c. - piodtcflca|
Acute oral tonic ity
Acute dereal tonicity
Acute inhalation ()}
Priaary *ya Irritation
PrlMry deraal Irritation
Demi aenaittutlon (4)
Kyper»*mit1v«ty Incident* <5l
ffflftlY "Vertebrate Cor^fol Aaenfn
•rowilno fnlfil repellantt (50)
LOtO-OLJO-.

Progress
Report*
1

2

3

6. Use
Pattern
A C , UK
A C IJK
AC » IJK
A C IJK
A C ' IJK
A C IJK
A C ; IJK
A C IJK
Initial to Indicate certification aa to tnforaation on this pag*
(full text of certification is on paoe one}.
7. lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
8. Time
Franc
8 mos.
8 mos .
8 BIOS.
8 mos.
8 mos.
8 mos.
8 MOS.
8 mos.
9. Regiitfiinl
Response

Date

-------
                                                                                                                                     Page   1  of    1
                                         United States  Environmental  Protection Agency
                                                         Washington,   D.  C.  2O460
                                FOOTNOTES AND  KEY  DEFINATIOHS  FOR  GUIDELINE  REQUIREMENTS
                                     Case  t and  Name:  4079   Putrescent  whole  egg  solids
UTfi NP • MmifactwIlVUM product; tf « and-W* product; provided foraulators. purchase their active lngredient(s} fro» • registered source, they need not siAralt  or cite
date pertaining to the purchased product. UK>TE: If • product 1« • 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ fro» thome of tha purchuad and regtttered aource, users are not  Bit j eel  to any data requireiaents identified in the tables.]; IEP « typical end-use product;
TGAi • Mdmlcal grade of tha active ingredient; PAI « "pure" active ingredient; PAIR* * "pure" »• tive ingredient, radiolabeted.
IM Categoric* Keyi
                                                                C - Terrestrial nonfood crop
                                                                H • Greenhouse food crop
                                                                H - Indoor nonfood
A • lerraatrtal food crop
t • Aquatic nonfood Industrial
K - tasfdanttal outdoor
                                   Terrwlrial food feed crop
                                   Asiatic nonfood residential
                                   Indoor food
D - Aquatic food crop
1 » Greenhouse nonfood crop
H * Indoor Medical
E -  Aquatic nonfood outdoor
J -  forestry
0 -  Indoor resident ml
                [In* following nott*  art referenced In coluan two 0. Study Titto of the RCOUIREMENTS STATUS ANO REGIStiMT's RESPONSE for*.]
          - BlodMorf

 »  Required If teat sueatanc* i* disperaibla with water.
 7  laqulrod If product contains coabuatlble llqutda.
 •  teqjlred If product Is • liquid.
 9  lequlrad If product la on eaulalflable liquid and la to be diluted with petrol.
                                                                             i aolvents.
Acuto toxic -

 i  laquirod If th* product eonalats of, or under conditions of uaa remits in. an Inhalabte
 4  laqulred If rapaotad contact Kith hUMn akin romults under conditions of use.
 i  Incidonta Wit ba reported, If thay occur.
                                                                                        •rial (e.g.,  pas, volatile tubstunce, or aerosol/particulate).
Efficacy -

50  Due tc
           Verteferato Control agents
    data

    raqjaat votumary cancellation of their reglatrationa.

-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE






INSTRUCTIONS: Please type or print In Ink, Please read carefully the attached instructions and simply the inforantion requested
Ua* additional sheet  if necessary.
1. CoBpeny mm and Address 2. Case * and Nan*


INTAGRA, INC. 4079 Putrescent whole egg solids
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420 EPA Reg. No. 4866-10

4. Guideline
Requirement
Muter



151B-10
1S1B-11
151B-12

151B-15
1518-16
1518- 17 stanc<



EP
EP
EP

EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the stateaenti aerie on title forar and all attachawnts are true, accurate, and coaplete.
t acknowledge that any knwinjly falaa or nialeading statement any be punishable by fine, iiBprisoraent
or both inter applicable leu.
Signature and Title of Company's Author! led Representative 	 	
12. Meat of Coapany Contact






















11.







on this for*.

I. Date end
farm Approved

OMB No. ZOfO-0107

Approval Eipircs 12-31-92


Type of DCI
PRODUCT SPECIFIC
ID/ 4866-RD-1906
























8. time
Fran



8
8
a



inos.
mos.
8 mos.


8 mos.
8 mos.
8 inos .
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8
8
Date


mos.
mos.

9. ReglM! ,,. t
Resportse








•











13. Phone Nunfcer

-------


Paqe 2 of 2
United States Environmental Protection Agency fonB Approved
Washington, D. C. 20460
* OMB Ho. 7070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expire* 12-31-9?
INSTRUCT IttfS: Plea»t type or print In Ink. Pleaae read carefully
UM additional ah*«t<») if nacmaary.
1. Coapany naa» and Addreta
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
4. Gttidatlna
Requiraaant
•uafaer
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
152B-J.6
96-19
5. Study lltla
Actlte.Tanjc - fiochewical .V ;, . .:. '
Acut* oral fonlcItyV'/... .•_,..,
Acute daraal toxkity
Acute lt*al*Mon^ : .'••-. : '- V'V &\.-. '.•••••'•,'
Prlewry eye Irritation
Prlawy daraal irritation' : .;, .. V:;: . .: . ... .
Oeravt •antitixatlon (*)

the attached Instructions and supply the infomation requested on this fora.
Z. Case • and Nane ], Date and Type of DCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
ID# 4866-RD-1906
EPA Reg. No. 4866-10


I

Progress
Deports
1

2

5

6. Use
Pattern
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
Initial to indicate certification at to information on this pate
(full text of certification i* on pafl« one).
7. lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
8. lime
frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9, (legist rant
Response t

Date

-------
                                                                                                                                        Page    1 of
                                          United  States  Environmental  Protection  Agency
                                                           Washington,  D.  C.  20460
                                  FOOTNOTES AMD KEY  DEPINATIONS  FOR GUIDELINE REQUIREMENTS
                                      Case f and Naae:  4079   Putrescent  whole  egg  solids
Key: HP • BBnufacturlng-UM predict; I" • end-use product; provided foreutators purchase thefr active Ingredtentit} from • registered source,  they need not submit or  cite
(tot* pertaining to the purchased product. [NOTE; If • product it a 100 percent repackage of  another registered product that li purchased, and any use for the product iloes
not differ fro* those of  the purchased end registered source, users are not ntoject to any  date requirements identified in the tables,]; !EP = typical  end-use product;
TCAI « technical grade of the active Ingredient; PA I • "pure" active ingredient; PAIR* « "pure" active Ingredient, radiotabeled.
UM CM**orl«* Key:
  A * terre«tr1al food crop        I - Terrestrial food  feed crop    C - Terrestrial nonfood crop     D - Aquatic food crop           E -  Aquatic nonfood outdoor
  f • Aquatic nonfood Industrial   G * Aquatic nonfood residential   H - Greenhouse food crop         I - Greenhouse nonfood crop     J •  Forestry
  i » Residential outdoor         I * Indoor food                  H * Indoor nonfood              • - Indoor Medical             0 -  Indoor residential

                      fotlOMlnS DM** »r« referenced In calm tuo (5. Stutty Title) of the lEOUIRCNENTS SIATUS MH) REGISTRANT'S RESPONSE for*.]
•rod ttM -  •lack—leal

 a  lequlrad if twt tube t arc e  I* ditpertibla «ith nat«r.
 ?  Requirad if product contains coBtaMtibla liquids.
 •  lequlred If product la a liquid.
 9  Required if product I* an eaulslf labl* liquid and l«  to be diluted tilth petroleu* iolvents.
ftcut* Ionic -  liocheaiical

 %  Required If the product consist* of. or under conditions of use results in, an inhalable eiaterial (e.a.. Has,  volatile substance, or aerosol/paniculate),
 «  Required If repeated contact tilth huaan skin results under conditions of use.
 5  Incidents  eust be reported. If they occur.


Efficacy - Vertebrate Control •0enta

M  Bu. to options concarfiina tN« effectiwnes* of vertebrate  ania.1 repellenta and the suitability of label directions for such products, registrants of
3V  ww «« ««*•          	w_	^ t  	....j. _„,,  jndicite the studies upon which the el.IBS axle for their nroducts »r« based.  Such  studies in EPA's
                                          ^v«i..«. .	Studies net in EP*'« data base Bust be submitted in the appropriate format.  If no efficacy
    __       „      _                     cUia» a-be  for their products, registrants aust eoaiaitjto generate such data, delete the relevant elates, or
    raque*T voluntary cancellation of their reaistratlons.

-------




United States Environmental Protection Agency
Washington, D, c. 20460

1


REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

IttSTtUCTIONS: fleata typ* or print in ink. Plea** read carefully
UM additional ah«at(a> If necaaaary.
1. Coapany naaa and Addrma
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MM 55420
4. Guidatina
••tytlnMnt
tMfcar


151B-10
151B-11
151B-12

1518-15
151B-16
15 18-17 (b)
15 IB** 17 {fj
1518-17(1)
UUJEKttfk)
1518-17(1)
151B-17(»)
1518-17 (n)
151B-17(o)


the attached instructions and supply the information requested

2. Case • and Mane


4079 Putrescent whole egg solids

EPA Reg. Mo. 4866-11
S. Study TCtla
Prod OMB - fiodieaical
Product identity
Manufacturing procet*
Biacutalon of foraatlon of
tnantantlonal (n^rdicnta
Certification of U«it»
Analytical «athe















11. Date








-------
. 	 ,, Page 2 of 2
United States Environmental Protection Agency form approved
Washington, D. C. 20460


OKB Mo. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

Approval Expires l?-51-92
INSTRUCTIONS: Hen* typ* or print In Ink. Picas* rtad carefully the attached instructions and supply the information requested on this form.
UM additional aha«t(a) If necvaaary.
1. Cwpany MB Mil Addraaa 2, Case * and NMW

3. Date and Type of DCI
INTAGRA, INC. 4079 Putrescent whole egg solids PRODUCT SPECIFIC
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420 EPA Reg. No. 4866-11
*. Guldtlfra
•equlraamt
Muter


152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
152%16

96-19
S. Study Titl*



^cutf Tod^fe - liochewical
Acut* oral t o*l city
Acute dtnwl tMicity
Aorta Inhalation (3)
Prlmry «y« irritation
friwry dtnaal Irritation
taMl tanaltliatlon (*)
•yparaamltUlry Incident. c§>
|fffefw*v|:'f|ft«lirrt« Contro^ .Mwntt '.
IroMint .«M' w»M«t« tW


0
I










Progress
Reports
1











?











I











6. Use
Pattern
ID# 4866-RD-1907






A C ! IJK
A C i IJK
A C ! IJK
A C IJK
AC1 IJK
A C i IJK
A C | IJK


i
A C IJK
Initial to indicate certification as to infonwtion on this p«9e
(full text of certificau '. on page one).
1. Test
Substance



EP
EP
EP
EP
EP
EP
EP

EP
6. Time
Frame



8 KIO5,
8 mos.
8 mos.
8 mos .
8 mos.
B mos.
8 mos.

8 mos.
9, Brylitiui-l
Hesjjonse












Date

-------
                                                                                                                                     Page    1  of
                                         United  States Environmental  Protection Agency
                                                          Washington,  D.  C.  20460
                                 FOOTNOTES  AND KEY  DEFINATIONS  FOR GUIDELINE REQUIREMENTS
                                     Case  /  and Na»e:  4079   Putrescent  whole  egg  solids
Keys NP * •nufactwrlng-UM product; IP • end-use product; provided formiiatort purchase their active ingredient(s)  fro* • registered source, they need not  submit or cite
data pertaining to the purchased product.(HOT!: If * product Is « 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ fro* tkoM of the purchased and registered source,  users ire not inject to any data requireawnts identified in the tables.]; HP - typical end-use product;
TCAI " technical grada of the active Ingredient; Ml • "pura"  active ingredient; PA1RA - "pur*" active ingredient, radiolabeled.
Us* CatqorlaB Key:
  ft - Terrestrial food crafi       • * T*rmtrt*l food feed crop     C - Terrestrial nonfood crop     0 -  Aquatic food crop           E - Aquatic nonfood  outdoor
  f . Aquatic nonfood Industrial   6 - Aquatic nonfood residential    M - Greenhouse food crop        I -  Greenhouse nonfood crop     J - Forestry
  K - Residential outdoor         I * indoor food                  M • Indoor nonfood             H -  Indoor Medical             0 - Indoor residential

Footnotes:  ITU* follwlni not** arc referenced In colun two (S. Study litle) of the ftEQUIREMEMIS STATUS AMD  RtClSTRANI'S RESPONSE form.)


Prod
    inquired If test aubatanca Is disptrstbie ttfth Meter.
    tayitnd If product contains coaiwmtlble liquids.
    lequ!r*d If product Is • liquid.
    Required If product is m aau(*lfiab(c liquid and  Is to be diluted with petrolew solvents.
*a«* f«ifc •

 S  Required if the product consist! of, or wider conditions of use results In. an inhslabl. Mt«rial (e.t., ««*, volatile substance, or aerosol/paniculate).
 4  ••quired If repeated contact Hlth huasn akin results undtr conditions of use.
 S  Incidents swat be reported. If they occur.                                             |


Efficacy - Vart*brat* Control ivsnts




    request voluntary cancellation of their registrations.

-------




United States Environmental Protection Agency
Washington, D. C. 20460




REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

IISttUCfiMS: f>t«M* type or print In Int. Plaaaa rtad carefully
Uaa additional efcaaU*) if necesaary.
1. Caapany nae» ml Address
INT AGRA, INC. ;
. 8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
4. Guideline
Itqufraaant
•water


,- -
151B-10
151B-11
151B-12
ISlB-isT"'''''"''
isia-i^Ss^-
151B-i7(b)
*51»fi7(flM:W:v
1518-17(1)
isiB*:iiCfc)tv :*::,
1518-17(1)
151B-17 (»)
151B-17(n)
iijitrrtoi;;. •


the attached instructions and supply the informtton requested

2. Case 1 and Haw


4079 Putrescent whole egg solids

EPA Reg. No. OR880O1100
S. Study Title
Prod Cheai - liochaaical
Product identity
Hanufacturtng procecs
Piscuaalon of foraatlon of
• unintentional ingrdiert* ^ :
Certification of lla.lt*
• ; '«i«»(jrttftl: '*ty*!*.->\ } I " VJ.-1 . • ..
Physical Hate
v::»^?^:'J:|lM-'v:;: ;:-•;. -..-
pN (6)
fiaMMMty •.•?.,,:•.<, -;: |TI •
Itoraaa liability
.-»»»W«lt»J^yi: -\ •- :,-.• '««
Hlaclbllity (9>
,, C)wrwl«n,ffi«ri|.M?lftic« ,:













r
0
§
I













Progress
Reports
1














2














I














6. use
Pattern



A C IJK
A C UK
A C UK
A C UK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C UK
A C IJK
A C IJK
A C UK
7, lest




on thib form.

}. Date and
Page ] ol «'
form Approved
UMB Mo. 20?0 010?

Approval Expires 17-S1-VZ


type of DC!
PRODUCT SPECIFIC
IDt 1021-RU-1902


Substance



EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that tha ttatewt* writ on thU fora and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or Misleading atateaant "ay
or both tauter applicable tail.
Signature and title of Coapany'* Authorised iepres«ntati»*_ 	
be punltliable by fine, iapriKoment


12. Mat of Company Contact






























8, 1

ime
frame



8
8
8
8
8
8
8
8
8
8
8
8
8



ItlOii .
mos.
mos.
mos.
mos.
mos.
mos .
mos.
mos.
mos.
mos.
mos.
mos.
V. KC'JIMI ,. i!
Rt?sjx>iu.f















11. Date









"TI7"W10C» (limber'

-------


Paqe 2 ol 2
United States Environmental Protection Agency for* Approved
Washington, D. c. 20460
OMB No. 2070-0107
REQCriKEMENTS STATUS AND REGISTRANT'S RESPONSE
J Approval Expires 12- J1 92
l*STMCfiONS: N*M* typ« or print In li*. *ia»»* r«Hl cwatutly
Uw addition*! *he*t<>) If MCM****.
1, Coayany MM will *ddr*M
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS UN 55420
4. Guldalfn*
152B-10
152B-11
J.52B-12
152B-13
152B-14
152B-15
§6-19
the attached imtructions and Mfiply the information requested on this lorn.
2, Caie t and MM* J. pute and Type of OCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
lOt 1021-RD-1902
EPA Reg. No. OR88001100
S. ttudr T«l«
Afifff l^lle - Pfodmicfl
Acute oral toxic fty
•cut* derail tonlclty
tout* {ntoUtian ; -\- <3>
priaary ay* Irritation
Ovnail Mfwltiutlon <*>

(

Progress
ieports
1

1

5

6. Us*
Pattern
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
AC UK
Initial to Indicate certification a* f* information on this P«9«
(full tent of certification it on |M*t one).
T. Test
S list ante
EP
EP
EP
EP
EP
EP
EP
EP
B. lime
Framt;
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos,
8 nos.
8 mos.
9. RcgiMrant
Rciporv.u

Date

-------
                                                                                                                                         Page   1  of    1
                                          United States  Environmental  Protection Agency
                                                            Washington,  D.  c.  20460
                                  FOOTNOTES AND  KEY  DEFINATIONS  FOR  GUIDELINE  REQUIREMENTS
                                      Case  f and  Nane:  4079   Putrescent  whole egg solids
teyi H> "•aanufacturinj-uis product; Il» » end-use product;  provided foraulatorg purchase their active ingredientisj froa « registered source,  they need not submit or  cite
dat* pertaining to the purchased product.[VOTE: if a product  Is a 100 percent repackage of another registered product that it purchased, and any use for the product doe*
not differ  fro* those of the purchased and registered source, users are not subject to any date requtrea*ms  identified In the tables.],- tEP = typical  end use product;
TCAI ' technical grade of the active Ingredient; PAl * 'pure1* active ingredient; PA1DA > "pure" active ingredient, radiolsbeled.
Uea Categories Weft
  A * Terrestrial food crop       • - Terrestrial food feed  crop     C - Terrestrial  nonfood crop    D - Aquatic food crop           E -  Aquatic nonfood outdoor
  F * Aquatic nonfood Industrial   1 - Aquatic nonfood residential    N - Greenhouse food crop        1 - Greenhouse nonfood crop     J -  forestry
  I * Residential outdoor         I * indoor food                   N - Indoor nonfood              N - Indoor Medical              0 -  Indoor residential

                 [The following notes are referenced In col nan tM <5. Study Title) of the KEWIREHEMTS STATUS AND REGISTRANT'S  RESPONSE forn.J


Prod Oia* - glodMaical

 *  Required if test substance  Is dlspersible with water.
 7  Required if product contains coafaustibl* liquids.
 •  Required If product is a  liquid.
 9  Required if product Is an saut si flattie liquid and Is to be diluted with petroleua solvents,


tout* talc - •iocheaica!

 S  Required if the product consists of, or under conditions  of use results  in, an inhalable material (e.g.,  gas, volatile substance, or aerosol/part icuUte),
 4  Required if repeated contact Mith huaan skin results under conditions of use.
 5  Incidents aust be reported. If  they occur.
Efficacy - Vertafarate Control

SO Due to queatlom concerning the effect I vtntM of vertebrate aninai repellent* and the suitability of  label directions for tuch products, registrants of
    peaticidee containing Putrefleent Whole Egg Solids au»t indicate the studies upon which the claias Made for their product* ere based.  Such studies in EPA's
    data b*»* aary be cited by MID nuaber or accession nuabar.  Studies not  in EPA'i date base aust be sutaitted in the appropriate fomt.   If no efficacy
    data can be provided to substantiate the claie* Made) for their products, registrants aust cosmti to generate such data, delete the relevant claims,  or
    request voluntary cancellation of their registrations.

-------




United States Environmental Protection Agency
Washington, D. c, 20460




REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

IHnMCTlOK! Plaaee type or print III ink. Ma*** read carefully
UM additional alMMU) If nacaaaory.
I* CflMpBRp IMH flRdl AcklraM
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MM 55420
4. tufoMlm
••^itMaWHl
a*w
&y-\&v$^£«-:«-.
151B-10
m**im^&
151B-12
'-•%"•:•%. *"•'•£<:, ,;.'•>?:;.',•;,' .,..;>-; ..;- >:'1- i: V -| - I
151B-15
.^iililMitei
151B-17(b)
^iiiilliiPifeii
l51B-17(i)
i^iaiiilflsg's
1S1B-17I1
ii*s*til»L&^i
151B-17(n
m^^i^im^
S. ttudy I|tl*


Prod OMB - Kodwaiol
Product identity
• jfii»rfptwiiW'»«K*M ; :. . ,; ; • v. :; . :
OlacuMlon of foraatlon of
'-: "': *'" •'Itftivitenttami inordlanta ' •
Certification of liaite
«l«ililiiil:«Wi* O^^-/sS> •'•'-, '
•ky»lcal itata
.'fpflli^ '.<•••• "^'-;' ': "r/' 'I\;V;. :::- • • ,
pt m
::^ii«MHMty • '••;. '/;; ••".':---:.rovat Expires \£ 5

lype of DC1
PRODUCT SPECIFIC
ID# 1021-RD-19Q3


Substance

EP
EP
EP

EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
It. Certification
1 certify that tha »tateaante Mde on Oil* fora and all Mtacfaamt* are true, accurate, and coeplet*.
1 acknowledge that any kmwir«ly fataa or •Ulaading »t*t«Mnt My
or betk «mkr appH cable Iw.
Slptatura and Title of Coapany't Authorized lepraentatiM 	
be |juni*hable by fine, iapriioment


12. turn of Caopany Contact




























a. i
Fran

8
8
8

8
8
8
8
8
8
8
8
8
8

line
e

mos .
mos.
mos.

mos.
mos.
mos.
mos.
mos .
mos.
mos.
mos.
mos.
mos.
9. BrgiiU^
Beiponii.'














11. Date



13. P



hone Muitx-'r





-------


Pacio 2 t
United States Environmental Protection Agency for. Approved
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE ™ "° 207° OW
Approval Expires 1?-$1 -9f
INSTRUCTIONS: Ma*** type or print In Ink. PI**** read carefully
UM additional an*et<>> If nartttary.
1 . Company MBM and Addrtwa
I NT AGRA, INC.
8500 PILLSBURY AVE, SOUTH
MINNEAPOLIS NN 55420
4. iuliMInt
152B-10
152B-11
152B-12
152B-13
JI2B-J.4
152B-15
M-M
th» attached instructions and supply the information requested on this (aim.
2, C««* • and Haae j [),,[,, anlj jvfv ot Oc|
4079 Putrescent whole egg solids PRODUCT SPECIFIC
1U/ 1021-RD-1903
EPA Reg. No. MAB8000400
1. Study Iiti«
A«it* Toxic- Iff^iiifffl •-.-
Acute oral tonlclty
taut* dtrval toalcity
, Acute Inhalation 0)
Priaary eye Irritation
frltawy 4^Ml IrrliliJen
D*nM( MMltiutlon 14)

•
i \
.

Progresi
Reports
1

2

I

6. Use
Pattern
A C , IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
Initial to Indicate certification M to information on thie page
Cfull text of certification U an page one).
7. lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
B. line
trumc
B mos .
H mos.
8 mas.
H mos .
B mos.
8 mos.
8 mos,
8 mos.
Q !H»*ti i « i r r tl

Date

-------
                                                                                                     Page   1 of
                               United  States  Environmental Protection Agency
                                            Washington,  D. C.  20460
                         FOOTNOTES  AND KEY DEFINATIOHS  FOR GUIDELINE REQUIREMENTS
                             Case §  and Have; 4079  Putrescent whole egg  solids
Kayi tf * Bjanufacturing-i«« product; ft • tntf-iM product; provided forauUtors purchase their active inaredient(s) Iron • registered source, they need not sulnit or cite
dsta partalnlnf to tin purdtaaad product. (NOTE: If a product l» • 1M percent repackage of another registered product that is purchased, and any use for the product does
not d(ff*r frog Mima of tlM purchM«d and registered Mure*, usors, ar» not subject to any data requirements identified in the tables.]; JO" - typical end-use product;
TSAi * twtallcal K«<*» «' tta actlwt Ingredient; MI ' "pur*" act in ingredient; PAIR* « "pure1 an we ingredient, r*diolabeled.
 A - TMTMtrlll food crop      1 * T»rre»trtal food fead crop    C - Terrestrial nonfood crop   0 - Aquatic food crop        C - Aquatic nonfood outdoor
 9 - «9»tlc nonfood Industrial   • - Aquatic nonfood residential   N - Greenhouse food crop      I - Greenhouse nonfood crop    J • Forestry
 K * •Midajttlsi outdoor       L - Indoor food              H * Indoor nonfood          H - Indoor Medical          0 - Indoor residential

Footnotes: tl«* follwfiv note* «•• nf*ranc«d In coluan two (5. study title} of the KEauiREMEHlS STATUS AND REGISTRANT'S RESPONSE faro.]
Prod OH. - •lodM.tail

 A tequlrdl If twt w^Mtanc* IB dltperaible with uater.
 7 ••qulrad If product contain* coa*ui title liquid*.
 • •axplrad if product l» • liquid.
 9 Itaqulrad if product li an aajuUifiable liquid and !• to be diluted uitti petraltw solvents,
AcuU Tostc -
 I Kaqulnd if tfc* produel conal.ta of, or infer condition, of «« r««ilt. in, M irtial*l« -t*ri.l <«.»., g.«. vol.tlle sitotance, or aerosol/part i
 4 laquirad If rapaatad contact with huwi akin raaultl under condition, of use.
 S Ineldam. aut to Mp«rt«l, If t««» oeeur.
efficacy - T*»t«to»ta Control
 •gasMESS^gSS^gsls^SiS"
                         of ttair r««i«r.tl

-------
I
                                    UNITED STATES CNVIBONMENTAL PROTECTION *GENCV
                        «  ^ ' / '  »

                                                           O.C. 204«0

                                                                             JUL 29]98S
                                                  BB ll/I^T^. Of  *
                                                  PR NOTICE 86-5           *«TM»»M *•• »»m« tw*«T**ct>
                                  NOTICE TO PRODUCERS,  PORHULATORS,  DISTRIlUTORi
                                                 AND REGISTRANTS

                          Attentions  Persons responsible for F«d«r«l  r«gittr»tion of
                          Subjects    Standard format for data »ubmitt«d  under  the  f«dtr*l
                                      Ini«cticid«,  Fungicide,  and  Rodent icide Act (flfRA)
                                      and certain previsions of the  Federal  rood. Drug,
                                      and Coc..ietic  Act (PfOCA).

                          I.    Purpose

                               To require data to be submitted to  the CnvlronsMntal
                          Protection Agency (EPA!  in a standard fornet.   This Notice  also
                          provides additional  guidance about,  and  illustrations of, the
                          required fenats.

                          II.   ADDlieabilitv

                               This PR Notice  applies to all data  that are sub* it ted  to  EPA
                          to satisfy data requirements for granting  or Maintaining  pesticide
                          registrations,  experimental use permits, tolerances,  and  related
                          appcovala under certain provisions of FIFRA and PFDCA. These)
                          data  are defined in  FIFRA flO(dMl).  This Notice  does not  spply
                          to commercial,  financial, or production  information,  whTel  are,
                          and siyst continue to be,  submitted differently under  separate
                          cover.

                          III.  Effective  Pat*  •

                               This notica it  effective en November  1» 19li.  Data formatted
                          according to this notice  may be submitted  prior to the effective
                          dat*.   AS of the effective data, submitted data packages that do
                          not conform to  these requirements may be returned to the submitter
                          for necessary revision.

                          XV.   Background      .

                              On  September 21, 1114* tPA published  protest* regulations
                          in the  Federal  Register <4f FR 37956) which include Requirements
                          for Data Submission  (40 CFR 1131.32), and  Procedures  for Claims
                         of Confidentiality of Data (40 CPU 1131.33).  These regulations

-------
                         specify tht format for d*ta submitted to EPA under Section 3 of
                         FIFRA and section! 408 and 401 of  FFDCA,  ind procedures which
                         mait be followed to make and substantiate claims of confiden-
                         * alitj.  Ns entitl   .it 5  •> l.f.a  •:  "f ide..- lal i c/ are cnj'^sd,
                         either by the proposed reflation  or by  this notice.

                              QPP is making these requirement! 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 Cor organising 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 Deport.
                         The data reporting guidance will be  compatible with  submittal
                         format requirements described in this Notice.

                              OFF has alto promulgated a policy (PR Notice  16*4 dated
                         April IS,  1196)  that provides for early  screening  of  certain
                         applications for registration under FXFRA 13.   The objective  of
                         the screen is to avoid the additional costs and prolonged  delays
                          ssociated with handling significantly incomplete  application
                         packages.   As of the effective date  of this Notice,  the  hcreen
I                         will include in its criteria for acceptance of application
i                .         package* the data formatting requirements described  herein.

,                              Off has alsb established a public docket  which  imposes  dead-
I                         line.* for  inserting into the docket  documents  submitted  in eon*
>               *          nection with Special Reviews end Registration  Standards  (see
                         40 Cm <1S4.15 and 1155.32).   To meet these deadlines, OPP is
|                         requiring  an additional copy of any data submitted to the  docket.
i                         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,
I                         many requirements are satisfied by reference to data previously
                         submitted—either by the applicant or by another party.   That re*
|                        quirement  is not altered by this notice, which applies only to
                         dat* •utoitted witn *n application.
                        Vf»   format  Mouirements

                              A more  detailed discussion of these format requirements
                        follows  the  index on the next page, and samples of some of the
                        requirements ar* attached.  Except for the language of the two
                        alternative  fens of the Statement of Data Confidentiality Claims
                        (shown  in Attachment 1} which cannot be altered, these samples
                        are  illustrative.  As long as the required information is included
                        and  clearly  identifiable, the font of the samples may be altered
                        to reflect the) submitter's preference.

-------
                          -  INDEX -



 A, Organisation of  the  Submittal Package . ,	     3    i?

 i, Transraittal  Document  .,  	 .........     4    n

 C. Individual Studies   	 .....  	     4

    C.I Special  Conaiderationt  for Identifying Studies.  .     S

 D. Organiiation of  *ach Study  Volume	     6    U

    D.I Study Titl*  Pag*	     7    12

    D.2 Statement of Data Confidentiality Claim*
         (based  on P1FIA flO(d)d))	     I    13
    D.3 Confidential  Attachment	     •    is

    D.4 Supplemental  Statement  of Data Confidentiality
         Claimi  {other than  those baaed on FIFRA flQ(dHl)]   S     14
    D.5 Good  Laboratory  Practice Compliance statement .  .     f     16

 E.  Reference  to Previously  Submitted Data  .......     9

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

 C.  Special Requirement* for Submitting Data to the Docket  10

                          •••*••••••»*••
 A,   Organisation of	Submittal Package

     A 'submittal package1  consists of all studies submitted at
 th*e same tin* for review in support of a single regulatory action,
 along  with a  tranmittal document and other related administrative
 material (e.g.  the method of support statement, tPA Jonas 1570-1,
 8570-4, 8570-20, etc.)  as appropriate.

     Data substitter* siust organise each subsiittal package as
described in this notice.   The transmittal and any other admin-
 istrative material auat b* grouped together in the first physical
volume.  Each study  included in the submittal package must  then
be bound separately.
     •ubaitters sosMtlstea provide additional sMteriala that are
intended to clarify, enphasUe, or otherwise} eoMwnt to help
Product Manager* and reviewers better understand the •ubtUttai*

  -  If *uch material* relate to one study, th*y should b*
     included •* an appendix to that study.     ,            ,

     ff such Material! relate to more than one study (a*  for
                                      in ^
exaaple a aumary  of  all studies in a discipline) or to the
•ubnittal in general,  they  suat be included in the aubsiittal
package aa a aaparate atudy (with title page and atateaent
of confidentiality claiaa).

-------
 B.    Transffittal  Document
      The first  item  in  each  sabmittal packag* mjst be a trans-

 joint submitters?  the regulatory action in support of which the
 package  is  being  submitted—i.e.» a registration application,
 petition, experimental  use permit (EUP), $3(c)(2)(B) data call-in,
 S6(aS(2) Sabmittal,  or  a  special review; the transmittal date;
 and a list  of  all  individual studies  included in the package in
 the ordtr of  their appearance, shewing (usually by Guideline
 r«ftrtnc* number}  the data requirement^•) addressed by each one.
 The EPA-aisigned  number for  the regulatory action (e.g. the
 registration, CUP, or tolerance petition number) should be
 included in the transmittal  document  as well, if it is known to
 the submitter.  See  Attachment 1 for  an example of an acceptable
 transmittal document.

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

      The list of  included studies in  the transmittal of a data
 submittal package  supporting a petition for tolerance op an
 application for an EUP  should be subdivided into sections A,  B,
 C,.... of the petition  or application, as defined in 4Q"cFR
 180.7 and 158.12$, (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 tha 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 b*  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 a* a aaparate entity*   (See cements on  binding
 stadias on page •*}

     Each study siust be consecutively paginated* beginning from
 the titl* page a* pag*  1*  The total  number of  pages  in  the com-
plete study siust be  shown on the study titl* peg**   In addition
 {to ensure that inadvertantly separated pages can be  reassociated
with the proper study during handling or reviaw)  use  either of
the followingi

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

     * Includ* « company  nave or mark and  study njmber on each.
       page  of the study* **g«* Company Name-ltlt-23.  Never reuse
       a  study number for marking the pages  of  subsequent studies.

-------
       When  •  single  stady  is extremely long, Binding it in multlplt
  volumes  it permissible »o  long at th» t«t pe~S**:->-<
  ,-. 4 s.r.vi«  »•.!«», ana eawn «*ol«me is plainly identified By the
  study title  and  its position in the multi-volume sequence.


  C.I   Special Considerations forIdentifying Studies

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

       a.  Safety Studies.  Several Guidelines require testing for
  safety in  more than one species,  in these eases 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.

       •atteries of acute texicity tests* performed on the same end
  use product and covered by a single title page* may be bound
  together and reported as a tingle study,
•** *                                     -   •
      b.    ProductChemistry Studies.  All product chemistry data
  within a •uon it t a i paex ages ubmi1 fed in support of an end-uae
  product produced iron registered manufacturing-use products
  should be bound a* a single study under a single title page.

      Product chemistry data submitted in support of a techni-
 cal product*  other manufacturing-use product, an experimental
 us* permit, an import tolerance petition, or an end-use  prod-
 uct produced treat unregistered source ingredients* should be
 bound at a tingle study for each Guideline  series  (€1. 12,
 and <3) for conventional pesticides, or for the equivalent
 subject range for biorational pesticides*   The first  of  the
 three studies in a complete product chemistry subnittal  for
 a biochemical pesticide would cover Guidelines 151-20* 151-11,
 and 151-13t the) second would cover Guidelines 151*11* 151-15*
 and 151-lif the third would cover Guideline 151-17.   The
 first stttdy for a microbial pesticide would covet  Guidelines
 131-20, 131-21, and 131-22* the second would cover Guidelines
 151-21 and 1S1*2S| the third would cover Guideline 151-21.

      Note particularly that product chemistry  studies ace
 likely to contain Confidential Business Information  as defined
 in  FIPRA llCKdXIHA), (B), or  (C), 'and if so must be handled
 as  described in section O.I. of this  notice.

-------
c.
          Re s idue
                       1 1 ry  5 t ud i e » .
r*sigj« enemisiry -requirements  mj
levtl below that  of  the  Guideline
however, of limiting a  stjdy  to
tigation still  applies  fully
                                      Guidelines 171-4, 153-3,
                                   ro?»;  ttj'lies addressing
                                   c  cn*s a* aetidea at «
                                   cod«,   The general principle,
                                 tht  report of a single
                                Data  should b*
                                                       inves-
                                 ,. 	....  ...  treated  as  a
                                  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  resi-
dues resulting from treatnent of a  single crop or  from proces-
sing a single crop,  when more than one commodity  is derived
from a single crop (such as beet tops and beet roots)  residue
data on ell such commodities should be reported as a single
study,  when multiple field trials  are associated  '                     Example

                         Always                            Page 12

                         One of  the two alternative       fage 13
                         forms of  this  statement
                         is always required. '

                         Zf stuay  reports laboratory      Page 16
                         work  subject to CLP require*
                         merits

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

                         Always  -  with an English language
                         translation if required.

                         At submitter's option
                         If CBI is claimed under rir*A
                         ilOCdHIHA), (11, or (C)
                         Zf CHI is claimed under
                        ,  <10(d)(l)(A), (5), or  (C)

                         Only* if confidentiality  it
                         claimed on a basis) other than
                         FIFIU flO(dHl) (A),  (8),  or  (C)
                                                           Page IS


                                                           Page 14

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I
                             D.I  Titl* Page

                                  A eitl« pay* is always rtqjir«d for *ach  *jbnitt*
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 D,2* Statement* of  Data Cant idtnt lality  Claim under FIFJU $10()
 or to waive such a  claim (S 153.33(c ) ).   In either case, the
 statement must be signed and  dated, and  most  include the typed
 n«rt and title of the official  Mho signs it.  Do not make CBI
 claims with respect to analytical  methods associated with petitions
 for tolerances or emergency  exemptions  (see NOTE Pg 1.1).

 D.3. Confidential Attachment

      If the claim is made that  •  study  includes confidential  busi-
 ness 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 stjdy  and confined  to  a separate
 study-specifie Confidential  Attachment.  Each passage  of CBI  so
'isolated mast  be identified  by  a  reference njmber  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 mast be identified By a
 co_yer sheet  fully identifying the  parent study, and must be clearly
 marked 'Confidential Attachment.'   An  appropriately annotated
 photocopy of the parent study title page nay  b* 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 mast  b* assoc-
 iated with • specific cross  reference  to that  page(s)  in  the main
 body of the  study on which it is  cited,  and tilth a reference to  the
 applicable passage(s) of FIFRA  flO(dUl) on which  the  confidentiality
 claim it based.

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

      If you  vish to make a claim of confidentiality for any
 portion of a submitted study  other than described  by  FIFRA ilO(d)
 (1HA), (B), or (Of the following provisions applyt

   *   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) basit for the claim.
      A  list  of the)  points to address in such a statement  is
      included  in Attachment 4 on fg 14.

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

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i
                                                                    i StaTtntnt

                                  This statement is r*quir*d if the study contains  laboratory
                              work subject to CLP requirements specified in 40 CFR ISO.  Sam-
                              pi** of thas* atatem*nts are shown in Attachment i.

                              E»   Reference to Previously Submitted Data

                                  DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN  SUBMITTED
                              FOR ANOTHER PURPOSE unlesa EPA specifically requests it.  A copy
                              of the title page plus the MRZD 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 mere 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
                              S 1/2 by 11 inch white paper, printed on one aide only in black
                              ink, with high contrast and good resolution.  Bindings for indi-
                              vidual studies must be secure, but easily removable to permit
                              disassembly for microfilming.  Check with tPA 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 pointss

                               o  Do not include frayed or torn pages.

                             * o  Do not include esrbon copies, or copies in  ether than
                                  black ink.

                               e  Make sura that photocopies are clear* complete, and fully
                                  readable,

                               o  Do net include oversits computer printouts  or fold-out pages.

                               o  Do met bind! any documents with glue or binding tapes.

                               o  Hake sure that all pages of each study* including any attach-
                                  ments or appendices* are present and  in correct sequence.

                                  Number of Copies Required * All submittal' paekagee eseept
                             these associated with a Registration Standard or Special Review
                             (see Part 6 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 proces-
                             sing  data into the OPP Pesticide Document  Management  System and
                             getting  it into review.)

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 G.    SpecialRequirements  for  SubffittjLng Data to the Pcektt

      Data  auomittal  packages associated with a Registration Stan-
 dard or Special  Review must be provided in four copies, from one
 of  which all  material claimed  at CBI has b*en excised.   This
 fourth copy will  become  part of the public docket for the RS or
 SS  ease,   if  no  claims of  confidentiality are made Cor ene 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 *« CBI,  the  first  three copies will include the CBI
 material as provided in  section D of this notice.  The following
 special preparation  is required Cor the fourth copy.

  o  Remove the  'Supplemental Statement of Data Confidentiality
      Claias1.

  o  Remove the  'Confidential Attachment1.

  o  Excise from  the body  of the study any information you claim
      as confidential, even if  it doe* not fall within the scope
      of  riPRA f10(d)(1>(A), (B), or (C).  00 not close up or
      paraphrase text remaining after this excision.

 .o   Mark  the  fourth copy  plainly on both its cover and it* title
      page  with the phrase  'Public Docket Material - contain* no
      information  claimed a* confidential*.
v.
for further tifortaation
     For further information contact William C. Crosse, Chief,
Information Service* Branch, program Management and Support
Division,  (703-557-2613).
                          t James H* Akerman
                           /Acting  Director*
                           ftegiatratlon Division
Attachment 1
Attachment 2
Attachment 1
Attachment 4
Attachment 3
Attachment •
Attachment 7
         Sample Transmittal Document
         Sample Title Page for * Newly Submitted  Study
         Statements of Data Confidentiality Claims
         Supplemental Statement of Data Confidentiality Claim*
         Samples of Confidential Attachment*
         Sample Good Laboratory practice  statements
         format Diagram* for Subnittal Packages and Studies
                                10

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                           ATTACHHENT  1.

       ELEMENTS TO BE INCLUDED IN THE  TRANSHITTAL DOCUMENT1



 l» Nama and address of subn_itt*r (or  mil  joint sub»ittar§**>

     'Smith Ch*micai Corporation         Jonas Ch*mie«l Company
      1234 w*st Smith Str**t      -and-  567U Wilson tlvd
      Cincinnati,  OH 98765              Covington, KY 56789

     fSmith Chemical Corp. will aet  as sol* ag*nt for all submitters.

 2. Btqulatorv action in uppert  ef  which  this package it submitted

    Us* the EPA identification nymb*r  («.g. 359-CUP-«7)  if you
    know it Otherwise d»icrib« eh* typ*  of r«qu*at  («.g. *xp*ri-
    m«ntal us* ^*rmit, data call-in  -  of xx-xx-xx d«t«).

 3. Transfflittal dat*

 4. Lilt of subnitt«d atudi*s

    vol 1.  Administrative materials - fon»s,  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 th* suimittal (Guideline No.)

    *    Applicants cownonly provide this information in a trans-
        mittal  letter*   This revs ins an acceptable practice so
        long as all four *l*aants ar* included.

    **   Indicate which  of the joint submitters is empowered te
        aet  en  behalf ef all joint submitter* in any matter con-
        earning data compenaation er subsequent use er release
        of the  data*
Cosipany official!
                   Naae                    Signature

Coapany Manet  .       -
Company Contacti
                                                   Phone


                                11

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i
                                                               2.
                                  SAMPLE STUDY  TITLE PAGE FOR A NEWLY SUBMITTED STUDY

                                                     Study JT.it lj
                                    (Ch*raical nam») -  Magnitude of K«tidu« on Corn

                                                   Data
                                                   Guid*lin* 171-4
                                                        Author
                                                    John C. Davia
                                                  Study CoripVittd On ___
                                                   January 5, 1979
                                                 PtrfonainQ Laboratory
                                             ABC  Agricultural Laboratories
                                                  940 W*tt lay Drive
                                                 Wilmington, CA 3919?
                                                 Laboratory Fro j«et ID
                                                      ABC 47-79
                                                     Pag* 1 of l
   I                                  fX 1«  the  total  nyab*r of pag«* tn th« study}
   I                       '              •             .''«..

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                  ffTATSMEKIS Of DMA CQWIceNPTlALm OAlHS
1,  fto claim of conJidentlAiiey under FXFM SlH(d) (1) (A) ,(B) ,  or  (C)
                            of NO DM* ooKFinwriALrnr CLAWS
   No cUin of confidentiality It neda for tny infoewtion contained in tnii etjriy
   on the bacU of it* falling within the tecv* of FXfftA J10(d)(l)(0>), (B), or (C).
                               TVOtd. H«n»
                                DlUi

                              Siqrmtur*
2.  a»i« of confidentiality und»r film llO(d)(l)(A),  (B), or (C).
or DK»
                                                   CLMW
   Infom»tion clainvJ confidential on eh* btflU of its  falling within CM •cop*
   of  FIFRA $IO((J)(1)(A),  
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                        ATTACHMENT  4,

    SUPPLEMENTAL STATEMENT OP DATA  CONFIDENTIALITY CLAIMS
     for any portion  of  a submitted  itjdy  that  is not described
by FIFRA SlO(d)(I)(A),  (B)»  or  ,  bat  for which you claim
confidential treatment  on another  butt, the  following infonta-
tion mast be included within a  Supplemental Statement of Data
Confidentiality  Claiitst

  o  Identify specifically by page and line number!•; each
     portion of  tht study for which  you  claim confidentiality.

 *o  Cite the reasons why the cited  passage, qualifies for
     eonfidsntial  treatment.

 o  Indicate the  length of  tine—until  s  specific date or
     event,  or permanently-*for which the  information should
     be  treated  as confidential.

  o  Identify the  measures taken to  guard  against  andesired
     disclosure  of this  information.

 o  Describe the  extent to  which  the information  has besn
   _ disclosed,  and what precautions have  besn  taken in con-
     nection with  those  disclosure*.

 o  Enclose copies of  any pertinent determinations  of  confi-
     dentiality  made by  EPA. other Federal agencies, or courts
     concerning  this  information.

 p  2f  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  b* viewed as substantial.

 o  Zf  you  asssrt that  the  information  is voluntarily  sub*
     aitted,  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.
                              14

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I
                                                     DWrtPLES Of SEVERAL CCNf ICENTtW.

                                 Dcamole 1  (Confidential word er phrase that has been deleted fron  the stody)
                                 CflDSS JCFERQCE  NUMBER
                                         NQRC6 OR PHRAStx
                            This cross nffsnnes nunb*r Is ^s«d in th*
                             in plan of th* fallowing words or phrase at  th*
                             indieatsd «oljt» and peg* rtftevnets.

                                      Civcol
  «    14
 28    25
100    19
                                               REASON POit TOE r*TJTION
                                                Identity oC inert Ingredient
                                                             FIFR*
flO(dHlHC)
                                        I   (Confidential paraqrac^(«) that have been deleted fron th* study)
                                OCS5.1WERGCI WMBER   S    This cross reference nj«ber is osed in the stoJy
                                                              in place of th* following paragraph(s) st th*
                                                              indicated wluiae and page references.
                                    {
                                    (              Mprodue* th* deleted paragraph*s) h*r*  .
                                    (

                                   jjCf.XngS  MASON rOKTBl OCLtTICll       _                  riFW	

                                   20   4-J7   Description of th* quality control process        J10(d)(l)(C)
                                                               that hav* b**n d*l*t*d Croa th* study)
                                                                                                                  "I
                                                              this cross reference njt*j*r noted on a place-holder
                                                              peg* is used in placa> of th* following whole pages
                                                              at th* indicated volun* and pag* r*fi*r*nos*.
                                               t  •!• attach** iaw*diat*ly bsfiind thi* pag*.

                                                      FOP -na
                                                   riptlon of product manufacturing proossa
                                                                        IS

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            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS


 Cxamplt  1•
    This  study meats the rtqjireratnts for 40 CFR Part  160

      Submitter 	

      Sponsor 	
      Study Director
Example 2.
  This study does not meet the requirement* of 4C
  Part 160, and differs in tht following waysi
  1.

  2.

  3.
     Submitter

     Sponsor
     Study Director
Example 3,
   The subvitter 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 CPU Part 160.

     SubJtttter	'	

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i
                                                    ATTACHMENT 7.
                                            FORMAT OF THE SUiMlTTAL  PACKAGE
                                             .Traftsmittal Document.
                                L<-n.
Related Administrative Materials
(e.g., Method of Support Statement,  etc.)
                                                       Other Materials about the subnlttal
                                                 j "~""~ (e.g. • swnmarlas of groups of  stadias
                                             """*K to aid 1ft their review).
                                                              Studies, subfflitted as unique
                                                              physical entities, according
                                                              to the format below.
                                              FORMAT Of SUBMITTED STUOtCS
                                       Study title  page.
                                           Statement of Confidentiality Claims.
                                               GL?  and flagging* statements - as appropriate.
                                                   •ody of the study,  with English
                                                   language translation if required*
                                                       Appendieee to the study.
                                                           Title Page  of the Confidential
                                                           Attachment.
                                                        *i   _..  confidential Attachment.
                                                        „>• —1       Supplemental Statement
                                                             ,.——  of Confidentiality claims,
                                                            _j      •    *
                                                         x*"    * When flagging requirement*
                                                        '          are finalised.
                            LEGEND
                                            Documents which «us^ be submitted as
                                            appropriate  to most established requirements.
                                            i     oboiswnts submitted at submitter's option.
                                            J             IT

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I
                                                ATTACHMENT D

                                 EPA GROUPING OF END-USE PRODUCTS FOR MEETING
                                     DATA REQUIREMENTS FOR REREGISTRATION

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i
                                    HaCiSTQM HOT TO 1KTCH SHD-05E HtUUCIS CTtHMNING  HJlHESCENr WOLE  EEC
                              SPUES  FCR  RIKKbttfii  Of   MffiTING   AO7IE  TCDCtCTOf   DR2A  KBQUlKfcMQns
                              KERBG3STRAHON
                                    In an effort to reduce the time, resources and number of animals rxaar^j to
                              fulfill  the acute  toxicity data  requirements  for reregistration of  end-use
                              products containing the active ingredient putrescent whole egg solids, the Agency
                              considered batching end-use products.   This process involves  grouping  similar
                              products for purposes of  acute toxicity.   Factors considered in  the  sorting  '
                              process  include each product's  active and inert ingredients (identity,  percent
                              ocmposition and biological activity),  type of foraulation (e.g.,  eoulsifiable
                             'concentrate,  aerosol,  wettable powder,  granular,  etc.), and  labeling {e.g.,
                              signal word, use classification, precautionary labeling, etc.).

                                    However, batching of  end-use  products containing putrescent whole  egg
                            '  solids was not possible after considering the available information described
                              above.   The  table below lists  all the end-use products containing putrescent
                              whole  egg solids.  These products were either considered not to be similar for
                              purposes. of  acuta toxicity or  the  Agency lacked sufficient  information  for
                              decision Baking purposes.   Registrants of  these products are responsible for
                             meeting  the acute toxicity data requirenents for each product.

                                   Registrants mast generate all the required acuta toxicological studies for
                             each of  their products.    If  a registrant chooses to rely,  upon previously
                             submitted acute tcodcity data,  he/she my do so provided that the data base is
                             complete and valid by today's standards  (see acceptance criteria attached).

                                  In deciding how to meet the product specific data requirenents, registrants
                             oust follow the directions given in the Data Call-in Notice and its attachments
                             appended to the RED. The OCX Notice contains two response forms which are to be
                             completed and submitted to  the Agency within 90 days of receipt. The first form,
                             "Cats  Call-in Response,"  asks whether  the-  registrant will nest the  data
                             requirements  fee  each  product.   The nsecnd  font,  •'•Requirements Status and
                             Registrant's Response," lists  the  product specific data required for  each
                             product,  including the standard six acute  tenacity tests.  A registrant must
                             select one of the following  options; Developing Data (Option 1), Submitting an
                             Existing Study (Option 4), Upgrading an Existing Study  (option 5) or Citing an
                             Existing study (Option 6).  Since the end-use products containing putrescent
                             whole  egg  solids oguld not be batched, registrants  cannot  choose  from the
                             remaining options:  Cost snaring (Option 2)  or Offers to Cost Share (Option 3).
                             Table Z.
Containing Putrescent Whole Bgg Solids
EPA WMB* IMfo
4466-B
Utt-f
OM-tO
OM-11
S Putrncmt Moi* f«t
Set Ids
1S.O
5.0
17.0
36.0
fofmiUtfon typ«
Liquid
Liquid
Liquid
feat

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     ATTACHMENT E



EPA ACCEPTANCE CRITERIA

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I
                                                                                                                            Siihdiiisign M
                                                                                                                Guideline Ref. No, 1559-10
                                                                                                                        December 24, S9g9


                                                                              15 IB-10 Product Ideoyry

                                                                             ACCEPTANCE CRITERIA

                                          Does your study Beet tlie foUovifif acceptance criteria?

                                           I. ___   Product name and trade name (if different)
                                           1 ___   Namt.  nominal concentration, and certified limits fupper and lower) for each active
                                                    ingredient and each  iment^nally-added inert ingredient
                                           3. __   Name and upper certifies  .mit for each impurity or each group of impurities present at
                                                    £0.1*%  by weight and for certain lexicologically significant impurities (e.g.. microbial toxins.
                                                    dioans. nurosamiiies} present  at <0 l"c
                                           4 	   Purpose of each active ingredient and each intentionally-added  inert
                                           - —	   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, __   Product name, trade name, and common name (if established)  for eacb active ingredient
                                           7- —   Molecular, structural, and empirical formulas, molecular weight or weight range, and any
                                                    company assigned experimental or internal code  numbers for eacb active ingredient
                                           8. _      Description of eacb  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
                                                    ___,   T-Lhmcal specifications or data sheets by which manufacturer or supplier J^ni-H.-*
                                                           com position, properties or toiicity
                                           9 —_   Genus ana species (and strain, subspecies, isolate, etc.. if applicable) from which the
                                                    biochemical was isolated or with which it is commonly associated
                                          W- __   Specificity of biochemical activity, the mode or action, and field rates at which the
                                                    biochemical is active/proposed (units aiiA. etc.)
                                          11.   	   Similarity 10 toe niturally-occumng biochemical, if not derived from • biological emm
                                          I- ——   Aa updated Coafldential Statement of Formula must be provided (EPA  Form 85~u-4 rev
                                                    mi).
                                          13.	   Any known or suspected hazards of the biochemical to man, the environment, or nonurga
                                                    species.                                    •               .
                                         Criteria marked vitfc a " art supplemental and may not be required tor every study.

                                                                                       C-215

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i
                                                                                                                                  i0n M
                                                                                                               Guideline Ref. No. 1513-u
                                                                                                                       D««mt>er 24, 19S9


                                                                           151B.11 Maau&cturijjg Proem

                                                                            ACCEPTANCE CRITERIA

                                         Does your study meet the folkwuf acceptance criteria?

                                          I-    _   Description of manufacturing process or extractions-isolation itepi if obtained from a
                                                   biological entity.
                                          1    ..,   Statement of whether bitch or continuous process, if applicable
                                          3* ___   Relative amount of beginning materials and order in which they are added
                                          * ___   Description of equipment
                                          5.     T   Description of physical conditions (temperature, pH, pressure, humidity) controlled in each
                                                   itep and the  parameten that are maintained
                                          6.  		   Statement of whether process involves intended chemical reactions
                                          7- _   Fto* chan with chemical equations  for each  intended chemical  reaction
                                          *• —   Duration of each  step of process
                                          9. __   Description of purification procedures
                                         I0- ___   Description of measures taken to assure quality of final product including identity of the
                                                   biological source,  if applicable
                                         '!•   •-    A cjear presentation of the stage at *hich meets are intentionally added, if and when any
                                                   concentration is effected, the  material to  b« used as the manufacturing use product ;M").
                                                   whether HP  reguuauon is sought, and whether a TGAI'MP  is  sold and/or skipped.
                                         Criteria marked wttH a * ant ftrppkmenttl and nay oot bt required lor every study.

                                                                                       C-216

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I
                                                                                                                        SuDUi^ ,};or M
                                                                                                            Guideline R«f.  NO 1:13.1;
                                                                                                                    December ;a, 1939
                                                             ISIB-12 DaoBiioo of Fonniuoo of UaiBieaded lagredieim

                                                                          ACCEPTANCE CRITERIA

                                         Does yoor study neei ibe foUowuig acceptaaoe criieni?

                                          I- ___  Diiciasioii of formation of impurities base4 on established chemical theory addressing , u
                                                  each impunry which may be present at > 0.1% or *« found at 2 04% by product
                                                  and (2) certain toficologicaily sigiullcant impurities present at  < 0.1% by weight
                                        Criteria marked vitl • * «t
and may not to repaired tor wtry sn%.

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I


 I
                                                                                                                       iuPOr.-,ii,.-n M
                                                                                                          Guideline Ref. No  . :":3.;j
                                                                                                                   Decem&er I-i,  ;9gg


                                                                       151&-L3 Analysis o( Staple*

                                                                       ACCEPTANCE CRITERIA

                                    Does your study meet tbe toUowing aaxpuace criteria?

                                     !• —.   Five or more representative  samples (batches In caw oC batch process) analyzed for each
                                              active ingredient and all impurities present at > 0,1%
                                     -• _-.   Depte of acasunubiiity or closure 5t a ^^
                                     3- ——   Analyses conduaed for certain trace toxic impurities at lower than 0.1% (examples,
                                              nttroiamtnes in the cue of products containing dmitroanUines or containing secondary or
                                              tertiary amines/allunolamines plus nitrnes; polvhalogenated dibcnzodionns and
                                              dibenzofurans)  (Note that in the case of nnrosammes both fresh and stored samples should
                                              be analyzed.)
                                     4 _.     Complete and detailed description of. each step in analytical method used  to analyse abo<.e
                                              samples
                                     5. ___   Statement of precision and accuracy of analytical method used to anaryw above samples
                                     6 __   Identities »nd quantities (including mean and standard deviation) provided for each analyzed
                                              ingredient
                                     7- _   The  test material ii to be the purest pesticidal grade commercially produced pnor to
                                              intentional addition of inerts.  Generally, this test material is the same as that used f^r
                                              certain nnntarget and human hazard testing and is identical to, or  equivalent to the
                                              grade.   *jw differences from the test substance used for hazard testing should be noted
                                   Criteria marted witii a * an sopplmraial and an? IKK bt reqoi«d lor tvwy itady.

                                                                                  C21S

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                                                                      Guideline Ref.  No. 1513.n
                                                                              December Z4, 1949


                                  131B-13 Certification of Limiia

                                   ACCEPTANCE CRITERIA

 Does your irody tneei ibe foUowuig acceptance criteria?

  1. __  Upper and lower certified  limits proposed for  each active ingredient and intentionally added
          men along with explanation  of now the limits were determined
  2. ___  Upper certified limit proposed tor each impurity present at j 0.1% and for certain
          toncologicalty npujfleaot impuriues at < 0.1T: along with  explanation of how each limit is
          determined
  3    	  Anaryiical methods to verify  certified  limns of each active  ingredient and impurities {tatter
          not  required if exempt from  requirement of tolerance or if generally recognized as ufe by
          FDA) are fully described
  4.   __  Analytical methods to verify  certified  limits validated as to their precision and accuracy
Criteria mirind wit* • * an «ppkm«ul and nay aot te raqoini tor tvwy Mudy.

                                              C-219

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                                                                                                                       Subdivision
                                                                                                           Guideline Ref, No.  If:3-;
                                                                                                                   Dtcsmtxr «.J. t.e


                                                                  I51B-17 Phj/iM-J and Cbeioical  Properties

                                                                        ACCEPTANCE CRITERIA

                                     Does your stud; meet ihe foUowug acaepiaace  criteria?

                                     A. Color
                                               ,_,_,_,.   Verbal desalpuon of colontion (or lack of ii)
                                               .iri_i.   Any intentional coloration also reported in terms of MuoveU color system

                                     3. Physical State
                                               rrm.   Verbal description of physical state provided using tertns such as "solid, granular.
                                                      volatile liquid"
                                               _rnr.   Based on visual inspection at about 20-25*C

                                     C. Odor
                                               _rimT   Verbal deseripiton of odor for lack of it) using tertm  such  u 'gartic-Iike,
                                                      cnaracttrutic of aromatic compounas*
                                               ___   Observed at room temperature

                                     D. Melting Point
                                                 t     Reported in *C
                                               ___.   Any observed decomposition reported

                                     E.  Boing Point
                                               —   Report*! in *C
|                                               _,_,_,_,   Pfesjure under which B.P. rneaiured reported
'                                                   .   Any ob»«ived decomposition reported

\                                    F-Density. Bulk Deniiry, Specific Gravlrv
                                               	   Measured at about 2C-2J*C
 i                                              ___   Dentlry/bolk density rt ported in f/rnl  oj the specific gravity of liquids reported wuh
 I                                                    refereaet to water at 2TC  {NOTE: For a solid in  paniculate form a meuurcmoni
                                                      of bulk dtattty may be ..ub»t.tuted for measurement of density.)

                                    C. Solubility
                                                 L     Oturmiaed ta itistiUed water, n-ocunol and represeatatrve polar and non -polar
                                                      *otv*ao, iadtMiiai Uiou used in  formulations and analytical meihods for the
                                                      pettidd*
                                              _   Maasurtd « atom 20>2S*C
                                                 ..,   Reported ia |/lOOml (other units like ppm acceptable if $paria|ly soluble)

                                    H. Vapor Pressure
                                               _____   Measured at »2S*C (or calculated by  extrapolation  from measurements made at


                                    Criteria  marked with a • are supplemental and  may not  be required tor every study.

                                                                                  C-220

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i
                                                                                                                           Subdivision M
                                                                                                              Guideline Ref. No. iSia.p
                                                                                                                      December ^ 1989
                                        I. pH
                                        J. Stability
                                                          higher temperature if pressure too low to measure at Z5"C)
                                                          Experimental procedure described
                                                          Reported in mm Hg (torr) or oihcr conventional uniis
                                                          Measured at ibout 20-25*C
                                                          Measured following dilution or dispersion in distilled water
                                                  „	„    Sensitivity to metal ioru ind meia! determined
                                                  __„,    Stability si normal »nd elevated temperatures
                                                  __    Sensitivity to sunlight determined

                                        K. Flammadility
                                                  _      Rash point  reported in *F or 'C
                                                  _„.    Rame extension or flame  projection reported to nearest centimeter or nearest inch	
                                        L. Storage Stability
                                        M. Viscosirv
                                       N. Miwability
                                                          Product stored in its commercial pacltage or imaller one of same construction and
                                                          materials
                                                          Amount of active ingredient determined in product at begmniog and end of text
                                                          period (duration of at  least one year nr. for a product which degrades sufficient
                                                          duration to support expiration date)
                                                          Any deterioration or degradation products determined
                                                          Product examined for physical changes at end of teat
                                                          Product stored it about 20-25'C (and 50*$ relative humidity if permeable packaging i
                                                          pj under warehouse conditions reflecting expected storage
                                                          Report includes duration and conditions of storage, quantitative analyses of *<.-we
                                                          ingredient, and identification of any deterioration, degradation  products, or
                                                          change* (and consequences of latter on safe  handling and use of product)
                                                         Determined at about 20-15'C
                                                         Reported ia pooea, stokes, or other conventional units
                                                                    i *l about 20-23*C
                                                         Prodaa mted with petroleum solvents whose composition reflects those on u&ei and
                                                         at rate oa label
                                                         MbMvt ""tfnfitr* tor separation after 30 minutet
                                       Criteria marked with • * are stppimtatat and nay not be required tot ev*ry study.

                                                                                      C-221

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                                                                                 Subdivision M
                                                                     Guideline R«f. %-0. 1513.;?
                                                                             December ;j


O- Corrosion Chancteristics
            r_     Dau on corrosion characteristics provided (experimental method described) or -
                  reasonable explanation given for Sack of corrosive ness biscd on nature of product
                  (e.g., iack of extreme pH; unreactive)

P, OctanoL'waier Panit.'on Coefficient
          __   Measured at a&oui 20-25'C
          ___   Experimentally determined and description of procedure pvided (preferred method-
                  45  Fed. Regater 77350)
          —__.   Dau supporting reported vilue provided
Criteria marked wftli • * art Mpptenntil aad nuy not b* reqoind tot every

                                              O222

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                                                                                   Subdivision M
                                                                       Guideline Ref, So. 15!3-io
                                                                               D««mb«r 24. 1989


                                   132E-IO Acute Onl Totsary

                                    ACCEPTANCE CRITERIA

 Doa yoor study meet U» foilcnriaf acceptance criteria?

  '•    ,:-   Technical form of the active infrediem tested, (for ^registration only)
  2,' __	,	   At least S young adult rau/ie»group
  3, ____   Dosing, single oral do$« or  in fractions over 24 hours.
  J.*       Vehicle control  if other than water.
  5.    _   Dos«s tested, sufflcient to determine a toucity catagy or a limit dose (5000  m&Yg).
  6. ___   (ndivjduai observations at least once a. day.
  ~   	   Observatioa  period to Last at least U days, or until all test animals  appear normal whichever
           is longer.
  8  ___   Individual daily observittons.
  9.'       Individual body wtights.
 10.*       Cross necropsy on all animals.
Criteria marled with • * an wpptetnestai tad nay aoi be required tor every study.

                                               C-223

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                                                                       Guideline Ref. So  t;i3-u
                                                                               December  1*. '/.S?


                                  152B-U .Acute DerraaJ Torieity

                                    ACCEPTANCE CRFTERIA

 Docs your study meet Ute following aceeptaace criteria?

  '•   = „    Technical form of the tctive ingredient tested, (for rereguiration only)
  -•*___   At I6*51 5 antmals/s«/group
  3.*       Rats 200-300 gin, rabbits 2.0-3.0 kg or guinea pigs 350-450 fin.
  *• —_   Dosing, single dermal
  5   	:_„.    Dosing duration at Iea« 24 hours.
  6.*       Vehicle control, only if toricity of vehicle is unknown.
  "• ——   DOMS tested, sufficient to determine a io*icoty  catagory or • limit do$« (2000 mjlcg}.
  8- —.   Application itte clipped or lhaved ai  least 24 hours before dosing
  9. ___   Application site at  least 10^ of body surface area.
 10. __   Application site covered with a porous nuntrmaung cover to retain test material and to
           prevent ingesiion.
 11. _,_„,    Indtvidual cbservitions at least one* 3 day.	
 I—  _. _.„  - QbjerwitMi  period to last at least U aay*.-of-ttatil alljteu jnimals appear normal whichever
           is longer.
 13, ___   Individual dairy observations.
 u.'       Individual hody weights.
 15. *_ „   Grow neut)pty on  atl
Criteria matted with a * an nppteaeatal and may not be required tor every study.

                                               C-224

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I
                         ,                                                                                                   Subdivision M
                                                                                                                Guideline Ref.  So, 1S2B-12
                                                                                                                        December 24,  1989


                                                                          152B-U Acute  labaJaiJoii Torxaty

                                                                            ACCEPTANCE CRITERIA

                                          Does your irody meet the foUoviag accepuaoe criteria?

                                          1. ___  Technical form of the active ingredient tested, (for  reregiitration only)
                                          2. ___  Product is a gu, a solid which  may produce a significant vapor hazard based on  toxicnv  and
                                                   expected use or contains particles of innalable size  for man (aerodynamic diameter 15  um or
                                                   less),
                                          3.'       At least 5 young adult rais/sexjroup
                                          4."   _JL  Dosing, at least 4 hours by inhalation.
                                          5.*       Chamber  air flow dynamic, at least  10 air changw-Tiour. at least 19%  oxygen content.
                                          *• ——  Chamber  temperature, 22* C (±2*), relative humidity 40-60%,
                                          ?.    _   Monitor rat* of air flow,
                                          8.    .   Monitor actual concentrations of test material in breathing zone.
                                       _ 9- ——  Motor .irodynamic panicle size for aerosols.	
                                          l°- _^  Doses tested, lufficient  to determine a  toxicny category or a limit dose (5 mg/L actual
                                                   concentration of rejpirable lubjuncei.
                                          !J    --.   Individual observationi at least  once a  day.
                                          12.   _=  Observation period to last at least 14 days, or until all test animals appear normal «huhf^ef
                                                   is longer.
                         j                13. ____  Individual dairy otaervitions.
                                          14.'	  Individual body weights.
                                          15.'       Gross necropsy on UJ animals.
                                         Criteria marted wlUi • * m rappkoteflui and oaf not be required tor every study.

                                                                                       O225

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                                                                      Guideline R«f, NO.
                                                                                           1>8(
                                  152S43 Prtauuy Eye Irritation

                                    ACCEPTANCE CRITERIA

 Docs your study meet tie fcUkmag acsepuaoe criteria?

  1  _._..-,   Technical form of the ictive ingredient tested, (for reregutmion only)
  1 ___   Study not required if material is corrosive, causes severe  tfennal irritation or has a pH of < 2
           or ^ 11.5.
  3.*,	   6 idult rtbbiu
  4  _—.   Dosinf. inatillatioa into the conjuncttval sac of one eye per animal.
  S.'       Dose, O.I ml if a liquid; 0-1 ml or not more than 100 m| if a lolid, paste or   rticulate
           sufriunce.
  6  __   S01"3 or P*»ut
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I
                                                                                                                            u&Uivs.on M
                                                                                                               Guideline Ref. No. i«:s-u
                                                                         1523-14 Primary Dermal LTTILIUOB

                                                                            ACCEPTANCE CRITERIA

                                         Does your study meet the following Hcepuoae
                                          1.     .   Technical terra of the active ingredient tested (for reregiitrauon only)
                                          2. ___   Study not required if material is corrosive or has a pH of $ 2 or 2 H.S.
                                          3. •       6 adult animals.
                                          •*• _^_   Do«ni« single deraiai.
                                          '•   __   Dosing duration 4 hours.
                                          6. __   Application site ihaved or clipped at least 24 hour prior 10 dosing.
                                          7 __   Application lite approximately 6 cmj.
                                          8- ___   Application site covered *Tih a gauze patch  held in  place with  Qonimuung tape
                                          9, _^_   Material removed, wished with *ater, without trauma to application sat
                                         10. __   Application site examined and graded for irritation at 1, 24, 4S and 72 hr, then daily until
                                                   normal or  14 days (whichever is shorter).
                                         II.*       Individitfl observations for the entire day of dosing.
                                         12.*       Individual daily oB«rvations.
                                         Criteria nurfcetf wftfe • * an Mppteawaul aM my not b« rcqHind for ev«y ttodjr.

                                                                                      C.ZZ7

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                                                                                   Subdivision M
                                                                       Guideline Ref. NO  ::1B~15
                                                                               December  24, 1989
                                      152S-15 Hypeneniitiviry

                                    ACCEPTANCE CRITERIA

 Does yoiir imdy aeei tbe following acceptaace criteria?

  '• —   Technical form of the aaivt  ingredient tested, (for rere|istration only)
  2. ____   Study not required if material U corrosive or  has a pH of $ 2 or s U.S.
  3- . .-,   One of Uae following meihodi is utilized*.
            ,„._„_ Freund's complete adjuvant test
             ...   Guinea pig maximization tesi
           ___ Split adjuvini technique
             , , Buehler test
                Open epieuianeous test
           _____ MJuer optimiatioa  test
                Footoad technique ia pinea  pig
             _  Other tesi accepted  &y OECD tspeciM
 4.	   Complete descripiioa of tesi
 5.' _,_._   Reference for test.
 6  _   Test folkrwed ewentially as described in reference document
 ?.*	   Positive control included.
Criteria muted witfc • * an wppitgttaiat and may not tw required tat tvtrj *tudy.

                                               C-Z2S

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I
                                                ATTACHMENT F




                              LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

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                        ._____________________________^___________	                    Page   1  o t
                             United States Environmental Protection  Agency
                                         Washington,  O.  C. 20460
                         LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
                           Case t and Mane;  4079  Putrescent whole egg solids
Co. Nr.   Company Maae         •   Additional Name      Address             City & state       Zip
          UIACU, IK.                                       BiOQ PIUSBUH AVI. SOUTH     HHMIAPOLIS HM

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            ATTACHMENT G




COST SHARE AND DATA COMPENSATION FORMS

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United States Environmental Protection Ag»ney
^ C^eQJ\ Wsshlngion, OC 20460
^ijiui«»|«tff% CERTIFICATION WITH RESPECT TO
^•^ ••• M 1 DATA COMPENSATION REQUIREMENTS
Form Approve
OUS No. 2079-0101
Public reporting ourdtn for trus- collection of irtormitisn is estimated to averigt 1 5 minutti p«r rtsponi*; including
time for reviewing instructor!!, searching existing data sources, gathering and maintaining tne data needed, ana
completing and reviewing the collection of information. Send comments regarding ine burden estimate or any other
aspect of this collection of information, (needing suggestions lor reducing this burden, to Chief, information Policy
Branch, PM-223, U.S. Environmental Protection Agercy, 401 M St., S.W., Washington, DC 2W60; and to the 0«ee
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks b*iow.
CMS** Hem
Produce N*nt
1 Certify that:

EPA
E«g. Ho.


t.
For each study cited in support ol registration or reregisiration under tfie Federal insecticide, Fungicide and
Rodenicide Aa (FiPRA) inat is an exciustvi use study, I »m the ongnai data submitter, or I nave obtained the   "
written permission of the original data su&nitter to cite that study.

That for eadi study died in sypcon of registration or ^registration under FIPRA that is NOT an exclusive use
study, I am the original data submitter, or 1 nave obtained the written permission of the original data subrrorer or i
have notified in wrting the oompany(ies) that submrned data I have cited and nave offered to: (a)  Pay
compensation for those data in accordance with sections 3(c)OKD) and 3(c)(2)(D) of F1FRA; and (b! Commence
negotiation to determine which data are subject to the compensation requirement ol FIFfU and the amount ot
compensation due, I any. The companies t nave notified art:
    1 3  The companies who have tubmMad tht studies listed on the back of (Mi (em or aitacntd
        sheets, or indicated on trtt attach*! "Requirements Status and Registrants' Response Form,*
3.  TTiailriav»previowt1ycorrpl*dwths«ction3(c)(i)(D)of
    registration or itfttfatfaitep undtf BPHA.

•l|MMr*
§*i*
NWM wi fill* (Mm* tyf* *r PrttM}
GENERAL OFFER TO PAY: I htftby offer and agre* to pay compensatton to *h«f pertont, w«h regard to the
registraiion or rertgisiraiion of my producu, to tht efltm required by FlFRA iMUon 3(6)0HOI »< 3<0(2)(D).
Sf|«eur*
                                                                             Pat*

         aa?t*i f+tat

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      P/EPA
United States Environmental Protection  Agency
            Washington,  DC 30460
   CERTIFICATION OF  OFFER TO  COST
SHARE  IN THE  DEVELOPMENT  OF  DATA
farm  *ppro»»a


OKI  Ns, »?0-fliSi

Approtll Elplrtl 12-31-12
   Public reporting burfli.1 for this collection el information it esimated to average 1S minutes ptr response, including
   time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
   completing and reviewing the collection of information, Stnd oommtnti rtgirdingtht burttn tstimiti sr any oth«r
   isp*ct of this collection 9) trtormation, including suggestion* for reducing this burdtn, to Cfutf, irtomution Policy
   iranen, PM-223, U.S. EnvironmintaJ Prettetton Aflincy, 401 M St., S.W.. Washington, DC 204SO; and to the Oflict
   ol Managemtn and Budget, Paperwork Reduction Project (2C7(XnQ6), Wasnington, DC 20503.

   Please fill in  blankt below.
   C«mpin)r Hint
   Product Kaa«
                                                EPA Reg. So.
  1 Certify that:

  My company is willing re develop and submit she data required by EPA under the authority of the Federal
  insecticide. Fungicide and Rodamieida Act (FiFRA). if necessary, Hewavar, my company would prefer to
  enier into an agreement with one or more registrants to develop jointly or share in the cost of developing
  data.

  My firm has offered in writing to antar into such an agreement. That offer was irrevocaWa and included an
  offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FiFRA if final  agreement on at!
  terms could not bt reached  otherwise.  This offer was made to the following firm(s) on the following
  date(s):
   Name *f
                                                                            §eie *l Offer
 Certification-

 I ctfUry th« I am dory authorize* to repr»*ert the c^^                                       have made on
                                     aewrate, andc^^   I acknowledge thai any knowingry fatta or
 misieadi'is ttautmn may bt punWwttt 6y flnt or Impiiswiinirt or both unflff ippiteiMt i«».
1 lifiieiHre •( CMpaity'e AnilieiiMtf MeffMenuiv*
Dete
Neew MI« Tltte (Please Tfpv M PrlM)
IPAPem M7MS

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WMflington. DC 20*80
V>EPA Product Specific
Data Report
=.
Ste. 158.120
Product
Qwnistry
•1.1
•1-2 (p"S
«'-2fb)
a-i
•2-2
8J-3
«3-2
83-3
83-1
S>5
SM
83-T
•34
«3-9
«3-lO
8>n
63-12
«3-'3
83*14
53.15
»1«
83-17
•Ht
«J-1»
•MO
43-21
StC. 158.135
Toxicology
•1-1
«i-a
•>4
•14
•14
•14
n*mt of TMI

U*ntrry gf #Qtv)'*reii «ut» .
Odor
M*lting potm
teiltng poiM
Otnfcty. Buik4*n«m or io»o
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                    United States
                    Environmental Protection
                    Agency
                     Office of Prevention, Pesticides 21T-iQGx
                     And Toxic Substances       June 1992
                     [H-750SW)
4>EPA   R.E.D.   FACTS
                    Putrescent  Whole   Egg
                    Solids
         Pesticide
    Reregistration
    All pesticides sold or used in the United States must be 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, showing 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
undue hazards to human health or the environment.
    When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Document, or RED, This
fact sheet summarizes the information in the RED for putrescent whole egg
solids.
      Use Profile      Putrescent whole egg solids are an active ingredient in pesticide
                   products registered for use as animal repellents to protect a variety of trees
                   and shrubs. These products are used in nurseries, large greenhouses and
                   forestry plantations, on a variety of forest, fruit and nut trees, conifers and
                   ornamental woody shrubs.  They are applied in dust or liquid form to
                          or full-grown trees and shrubs to repel black- and white-tailed
                   deer, Roosevelt elk, and mountain beaver.
      Regulatory      EPA, registered the first pesticide product containing putrescent whole
          History  ett solids as an active ingredient in 1975. Currently, six repellent
                   products containing this active ingredient are registered. In 1985, EPA
                   exempted putrescent whole egg solids from the requirement of a tolerance
                   when used as an animal repellent in or on almonds (see 40 CFR
                   180.1071),  Fresh eggs and egg products are "generally recognized as
                   sale," or GRAS (see 21 CFR 170.3).

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I
                                Human Health
                           And Environmental
                                   Assessment
      Although EPA has developed a set of daa requirements for
 reregistration, the Agency believes there is a category of pesticides for
 which a reduced set of data requirements are appropriate.  Such pesticides
 may be exempt from the usual generic data requirements for toxicology,
 residue chemistry, human exposure, ecological effects and environmental
 rate, without compromising human health or environmental safety.
 However, some data requirements (such as basic product identity and
 product chemistry data) usually are essential, and generally will not be
 waived,
      Putrescent whole egg solids are in this category of pesticides, and
 EPA is waiving most of the generic data requirements for their
 reregistration. Egg solids are a common human food. Putrescent whole
 egg solids (including inedible egg powder,  dried whole egg and powdered
 inedible egg solids) are produced from eggs that the U.S. Department of
 Agriculture has declared inedible for human consumption due to cracked
 shells or imperfections.  They are, therefore,  a natural product, high in
protein, fat,  vitamins and minerals.
      Used as pesticides, putrescent whole egg solids have a non-toxic
 mode of action for repelling animals.  They are presumed  to be non-
persistent since they are organic and are known to rapidly  degrade in the
environment. EPA has received no reports of adverse effects resulting
 from their use.  The Agency believes that no significant adverse effects to
humans or the environment are associated with the use of putrescent whole
egg solids as pesticides.
                              Additional Data        EPA is not requiring the submission of additional generic data for the
                                      Required   active ingredient putrescent whole egg solids. However, EPA is requiring
                                                   the submission of product specific data (product chemistry, acute toxicity
                                                   and efficacy). These studies are being required now, through the RED.
                             Product  Labeling
                           Changes Required
     The labels of putrescent whole egg solid pesticide products must
comply with EPA's current pesticide labeling requirements.
                                    Regulatory         +  The registered animal repellent uses of putrescent whole egg
                                   Conclusion   solids are not likely to cause unreasonable adverse effects in people or the
                                                   environment, and are eligible for reregistration.
                                                         •  The six registered products that contain putrescent whole egg
                                                   solids as  their only active ingredient will be reregistered once product-
                                                   specific data and amended labeling are received and accepted by EPA.

                                     For More        EPA is requesting public comments on the Reregistration Eligibility
                                  Information   Document (RED) for putrescent whole egg solids during a 60-day time
                                                   period, as announced in a Notice of Availability published  in the

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i
                                                    Register.  To obtain a. copy of the RED or to submit written comments,
                                                    please contact the Public Response and Program Resources Branch, Field
                                                    Operations Division (H-75Q6C), Office of Pesticide Programs (OPP), US
                                                    EPA, Washington, DC 20460, telephone 703-305-5805,
                                                         In the future, the putrescenl whole egg solids RED will be available
                                                    from the National Technical Information Service (NTIS), 5285 Port Royal
                                                   "Road, Springfield, VA 22161, telephone 703^87-4650.
                                                         For more information about putrescent whole egg solids or about
                                                    EPA's pesticide reregistration program, please contact the Special Review
                                                    and  Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
                                                    20460, telephone 703-308-8000.  For information about reregistration of
                                                    individual putrescent whole egg solids products, please contact the
                                                    Registration Division, PM-14 (H-7505C), 0PP, US EPA, Washington, DC
                                                   20460, telephone 703-305-6600.
                                                         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
                                                   •(NFTN).  Call toll-free 1-800-858-7378,  24 hours a day, seven days a
                                                   week, or Fax your inquiry to 806-743-3094.

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