Reregistration Eligibility Document (RED) Putrescent Whole Egg Solids

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
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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
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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
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APPENDIX B

Generic Data Requirement! for Putrescent Whole Egg Solids
and Data Citations Supporting Reregistration
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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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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.
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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
-------
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
-------
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
-------
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:
-------
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
-------
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
-------
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.
-------
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
-------
i
ATTACHMENT A

CHEMICAL STATUS SHEET
-------
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
-------
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
-------
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.
-------
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.
-------
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
-------
i
ATTACHMENT C

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

ProgrcM
leper ti
1

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

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

Progress
Reports
1

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

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

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

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

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

Progress
Deports
1

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

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

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

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

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

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.
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- 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).
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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*
-------
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.
-------
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.)
-------
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
-------
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 ' • .''«..
-------
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),
-------
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
-------
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
-------
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.

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 '
-------
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
-------
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
-------
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%.
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
I
ATTACHMENT F

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
._____________________________^___________ 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
-------
ATTACHMENT G

COST SHARE AND DATA COMPENSATION FORMS
-------
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
-------
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
-------
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
-------
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).
-------
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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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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