United States ..ention, Pesticides
Environmental Protection .-><•«
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REREGISTRATION ELIGIBILITY DOCUMENT
PUTRESCENT WHOLE EGG SOLIDS
L1STD
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 REEEGBTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and pconornic Agalysis. Branch,
Bill Gross Biological Analysis Branch
Steve Jaiboe Biological Analysis Branch
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
Jim Yowell Occupational and Residential Exposure Branch
Tom McClintock 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 EUwanger Registration Support Branch
Special Review and Reregistration Division
Thomas Myers Accelerated Reregistration Branch
Kennan Garvey
Office of General Counsel
Mary Beth Cleaves
Office of Compliance Monitoring
Beverly Updike
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TABLE OF CONTENTS
Page
GLOSSARY OF TERMS AND ABBREVIATIONS I?
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
IL CASE OVERVIEW 2
A. CHEMICAL OVERVIEW 2
B. USE PROFILE 2
_ C. REGULATORY HISTORY 3
ID. SCIENCE ASSESSMENT OF PUTRESCENT WHOLE EGG SOLIDS 4
A. PRODUCT CHEMISTRY ASSESSMENT 4
B. ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT 4
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 6
A. DETERMINATION OF ELIGIBILITY 6
B. ADDITIONAL GENERIC DATA REQUIREMENT 7
C. LABELING FOR MANUFACTURING-USE PRODUCTS 7
V. ACTONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS 7
A. DETERMINATION OF ELIGIBILITY 7
1. Product Specific Data Requirements 7
2. Labeling Requirements for End-Use Products 7
u
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Eigs
VI. APPENDICES
APPENDIX A - Use Patterns Subject to Reregistration g
APPENDIX B - Generic Data Requirements for Rercgistration of
Putrescent Whole Egg Solids and Data Citations
Supporting Reregistration 11
APPENDIX C - Citations Considered to be Part of the Data Base
Supporting the Reregistration of Putrescent
Whole Egg Solids 15
APPENDS D - PR Notice 91-2 19
APPENDIX E - Pesticide Reregistration Handbook 23
APPENDK 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 E - EPA Acceptance Criteria
Attachment F - List of all Registrants) sent mil DCI
Attachment G - Cost Share/Data Compensation Forms
Application for Registration
iii
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I
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 General!/ Recognized As Safe
I.EL Lowest Effect Level
MRID Master Record Identification (number), EPA's system of recording and
tracking studies submitted to the EPA.
ppm Parts per Million
RED Reregistration Eligibility Document
IV
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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).-
Aceordingiy, 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 FJFRA 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 S "the Administrator snail
determine whether pesticides containing such 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)(Q 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 in 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
1 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 St, S.W., Washington, D.C. 20460.
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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 putrescent
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.
Emulsifiabie Concentrate at IS % 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 animals1 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 H. B. above. In 1985 EPA
exempted putrescent whole egg solids from the requirement of a 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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EH, SCIENCE
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, PROppCT CHEMISTRY ASSESSMENT
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 centrifugLng 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, fat 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, isopropanol and 1,1,1-trichloroethane. 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. EnvironiefitaJ ajri Hufflsn HffjJtf* 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 thai 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 is 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 thai 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
not 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.
TV. ' RISK MANAOIEM^NTJWP IffREfflSTRATION DECISION FOR
WHOLE EGG SOLIDS
A. Determination of J-Hgibiliy
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 coma; 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 Dafo
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. L-SfrclJP? Requirements for Manufacturing-Use Products of
Putrescent Whole E
There are no manufacturing-use products registered.
V. ACTIONS TOQT7|yE|> BY REGISTRANTS OF BfP-USE PRODUCTS
A. Determinationof 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.
.-1." Product Specific Data Requirements
The product-specific data requirements are stated in Attachment C.
2, Labeling Requirements for End-Use Products Containing
Putrescent ffihole Egg Solids
The labeli and labeling of all 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 Reregistration
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APPENDIX B
Generic Data Requirements for Putrescent Whole Egg Solids
and Data Citations Supporting Reregistration
11
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the ^registration 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 1), The data requirements are listed in the order of
appearance in 40 CFR Part 158. 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 .Bibliographic 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 (MRTD) number, but may be a OS number if no MRID number has been
assigned. Refer to the Bibliography Appendices for a complete citation of the study.
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APPENDIX B
Generic Data Supporting Guideline Requirements for Reregistration
of Putrescent Whole Egg Solid
Reauiremait
Putrescent Whole Egg Solids
Citation
PRODUCT CHEMISTRY
ISIR-IO Product Identity
151B-11 Manufacturing Process
151B-12 Discussion of Formation of Unintentional Ingredients
151B-13 Analysis of Samples
151B-15 Certification of Limits
15 IB- 16 Analytical Methods
151B-17(a) Color
151B-17(b) Physical State
151B-17(c) Odor
151B-17(d) Melting Point
151B-17(0 Density
151B-17(g) Solubility
151B-17(h) Vapor Pressure
1S1B-17Q) Stability
151B-I7(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 Rercgistration
of Putrescent Whole Egg Solids
Reauirement
Pubescent Whole Egg Solids
Citation
TOXICOLOGY
152B-10
152B-11
152B-13
1S2B-I4
152B-15
Acute Oral Toxkity In the Rat
Acute Dermal Toxicity
Primary Bye Irritation in the Rabbit
Primary Dermal Irritation
Dermal Sensitization
ECOLOGICAL EFFECTS
EPA waived 40 CFR Part 158 generic data requirements as discussed in section III,
ENVIRONMENTAL FATE
I
EPA waived 40 CFR Part 158 generic data requirements for reasons discuss d in section III.
42019401
42019402
42019403
42019404
42019405
The citations listed in the bibliography (Appendix Q were used to support these decisions.
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APPENDIX C
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Putreseent 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. IDENnFICATION 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 MMD entries. This
temporary identifier number ii also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by t 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 first submitter as author.
b. Document date. When the date appears as four digits with no question narks,
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 the document. When the dale 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.
12
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OFFICE OF PESTICIDE PROGRAMS
1EREGISTRATION 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 Toxitity, 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. Unpublished 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 Romanelli, P. (1991) Inedible Whole Egg Solids: Guinea Pig Dermal
Sensitizaiion - 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.
II
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i
APPENDIX D
PR Notice 91-2
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UHTTID STATES IHVWONHtHTAL »"OTICT>QN AOIMCY
, D.C.
ft IOTXCB ti-
»vz*u »*
___
NOTICI TO KAtfUFACTimiM , PRODUCERS, FORMUXATQRS »
AKO RlGISmwrrS Of PESTICIDES
ATTrKTIOK; Fersena laapenaibla for 'Federal legiatration of
. Pesticide Product*.
SU&JXCTt Accuracy of ftat»4 P»rc»nt«g«» for Ingr«di«nt«
X. fUKPOflt
The purpose of this ^notice is to -clarify the Office * of
Pesticide Program's policy with respect to the statement of
percentages in e pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(a)
•pacified in the ingredient atatement on tha label muat be atatad
aa the nominal concentration of such ingredient (a), as that term ia
defined in 40 CUt 151.153(i). Accordingly, the Agency his
establiehad the nominal concentration am the only acceptable label "
claim for the amount of active ingredient in the product.
• II. BACXfiJtOmfS
For some time the Agency has accepted tvo different methods' of
identifying on the label what percentage ie claimed for the
ingredient(s) contained in a pesticide* Some applicants claimed a
percentage which represented e level between the upper and the
lower certified limits. This waa referred to em the nominal
concentration* Other applicants claimed the lower limit as the
percentage of the ingredient (s) that would be expected to be
present ia their product at the end of the product'e shelf-life.
Unfortunately, this led to e great deal of confusion among the
regulated incostzy, the regulators, end the consumers es to exactly
how much of e fives ingredient was in e given product. The Agency
has established the nominal concentration es the only acceptable
le&ej. claim for the amount of active ingredient in the product.
Current regulations require that the percentage listed in the
active ingredient statement be es precise es possible reflecting
good sanufactuzing practice* 40 CPU 15«.10(g) (3). the certified
limits required for each active ingredient ere intended to
encompass any such 'good manufacturing practice* variations 40 cm
15l.l75(c)(3).
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I
2.
The upper end lower certified liaita, vhich Bust b* proposed in
connection with • product'* registration, rapreaent the amounts ef
an ingradiant that aay legally be preaent 40 CfK 131.175. Th« lower
certified liait i» used as the enforcaable lover liait for the
product coapositien according to FZfBA taetion 12(a)(i)(C), vhila
the noainal concentration appaarinf on tha label would ba the
routinaly achieved concantration usad for calculation of deaaaes
and dilution*.
Tha noainal coneantration would in fact stata tha fraataat
degree ef accuracy that is warrantad with respect to actual product
ceapesition because tha noainal eeneantration would ba tha amount
ef aetiva ingradiant typically found in tha product.
Zt ia iapertant for regiatrantc to not* that cartifiad liaita
for aetiva ingradianta ara net conaidarad to b* trada aaerat,
information undar rirRA aaction 10(b). In thia raapaet tha
eartifiad liaita will b* routinaly provided by I PA to Stataa for
•nforeaaant purpoaaa, ainca tha neainal concantration appearing* on
the label aay not represent the enforceable coapoaition for
- purposes of section 12(a){l)(C).
-III. MQUIMKZXTS
A« daacribad below under Unit V. * COKJUAKC* fCXICCLl,- all
currently registered products as well es all applications for nev
registration auat eoaply with this Motice by specifying the neainal
concentration expressed as a percentage by veight a* the label
claia in the ingredient(a) stataaent and equivalence statements if
applicable (e.g., eleaental araanic, aetallic xinc, salt ef an"
acid). Zn addition, the requiraaant for performing saaple analyses
of five or aore representative saaples Bust be fulfilled. Copies ef
the rav analytical data aust be subaitted, with the noainal
ingredient label claia. further information about the analysis
raquiraaent may b« found in the 40 Cfl 151.170. Ml products are
required to provide cartifiad liaits for each active, inert
ingredient, impurities ef toxicological significance(i.e., upper
liait (a) only) and on • ease by ease basis as specified by EPA.
Tha«e limits are to bo sat baaed on r%pr*sentativ* sampling and
chemical analysis(i.e., quality control} of the product.
The format of the ingredient statement «umt confer* to 40 cm
19f-l*l»eliiif Jtefuirament* For Pesticides end Devices.
After July It Its?* all pesticide infrm4ieiit etatementa aust
bo chafed to nomiftal
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IV. **ODCC7S THAT fttQUIM IPPICACY DATA
All pesticides art retired to be efficacious. Therefore
the certified lover limits say nee be lower then the minimum '
level to achieve efficacy. This is extremely important for
products which are intended to control peats which threaten tit*
public health, e.g., certain antimicrobial «nd red*ntieid«
products. R«ftr to 40 cm 2,51. §40.
In tnosa c*s*s vh*r« «ffie*cy li»iti btv« b««n ««t*bii«htd(
Agency will not icctpt ctrtifiad lover lialta which are below
that level for the «heU life of the product.
V. COKPLIAJfet SCHZOOLT
AJ described etrlier, the purpcee off this Notice is to sake
the refistratien process sore uniform and Bert Banageable for
both the agency and the regulate* community. It is the Agency's
intention te isplement the retirements of this notice as
saoothly as possible so as not to disrupt or delay the iganey's
high priority pro^rsas, i.e., reref istration, nev chemical, or
fast trick (PZPXA section J(c)(3)(l). Therefore,
applicants/registrants are eacpected to comply with th«
requiresents of this Hot ice as follovs«
(1) i«f inning July I, lf»i, all new product
refistratien* submittsd te the Mency
are te cosply witto t&e retirement* ef this
Kotics.
(2) t»f iatrmnt* having product* sutjact te
rere
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i
APPENDIX E
Pesticide Registration Handbook
21
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i
THE HANDBOOK IS NOT INCLUDED IN THIS COPY OF THE DOCUMENT
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i
APPENDIX F
Product Specific Data Call-in
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I **
w
T*_ .£?
3 UNfTED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 204*0
DATA CALL-IK NOTICE
CERTIFIED MAIL
Dear sir or Madam:
This Notic* requires you and other registrants of pesticide
products containing th« active ingredient identified in
Attachment A of this Notice, the Data Call-In Cnenieal 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 to
days after, you receive this Notice you Bust respond as set forth
in Section III below. Your response Bust state:
1. How you will comply with the requirements set forth in
this Notice and it* Attachments A through C; or
2. Why you believe you are exeapt from the requirements
listed in this Notice and in Attachment C,
Requirements Status and Registrant's Response Fern, (see
section III-B)i or
3. Why you believe EPA 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 from doing so, then the registration of your
product(s) subject to this Notice vill be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment B, pa ^a, pa. 11 -1 n S e seen s e Porn. as veil as a
list of all registrants who were sent this Notice (Attachment T).
The authority for this notice is section 3(c){2)(B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA), 7 B.S.C. section 13fa(c)(2)(B). Collection of this
information is authorized under the Paperwork Seduction Act by
0KB Approval No. 2070-0107 (expiration date 12-31-92).
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i
This Hoticc 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 cheaical 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 III - Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To Comply With
This Notice
Section v - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
• . The Attachments to this Notice arei __ _ _______ ._ --
A — palp* Call-Ir) Cheaieal Status, Sheet
B - pa? • -gf 4 1_- in^, j t-igsiii e ............. F_ojna
C - Re,gv4rettei\t_s _Sta_tuS- and. Registrant's Response
D - gfA gregpAtlg 9_t ST\$'"P*e P^Qfegts . f PIT
Tx eoloy Data euireaenta
_
£ - g^J| ^eeeptance Criteria
F - Plst_9^ _R*.gis_tir4nty_- Receiving Thia Kotjie*
G - gqs^ ?hftr* and Data C^cfnsatjpn Jorn«iJ_-And
SECTION I. WTfY_ _ YOP _ JUIE ...BZCE IVINS -_
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements arc being
imposed* You have been sent this Notice because you have
product («) containing the subject active ingredient.
StCTION 12. pAflA JRIQPIMO ^y_Ty^S_ MOTIFS
2I-A. PATH
The product specific data required by this Notice are
specified In Attachment Cf pfgu4.reg.ents Status a,n.d Regjat rank's
Response ygrg. Depending on the result! of the studies required in
this Notice, additional testing say be required.
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II-l. SCHEDULE FOR SUBMIS$|gp OF DATA
You arc required to submit th* data or othervi»« satisfy the
data requirements specified in Attachment C, Requirements States
ajpd Registrant's Response Fora. within the timefraaes provided.
Il-C. TESTING ..PROTOCOL
All studies required under this Kotic* must be conducted in
accordance with test standards outlined in the Pesticide Assess&ent
Guidelines for those studies for which guidelines have been
established.'
These EPA Guidelines are available from the national Technical
Information Service (HTIS) , Attn: Order Desk, S285 Port Royal load,
•Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization -for-£conomic
Cooperation and Development (OICD) are also acceptable if the OECD-
recommended test standards conform to those specified in, the
Pesticide Data Requirements regulation (40 CFR | 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR | 158. Normally, the Agency vill not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue K.W.,
Kssiiiftgton, D.C. 20006.
All new studies and proposed protocols submitted In response
to' this Data Call-In Notice Bust be in accordance with Good '
Laboratory Practices £40 CFR Part 160.3 (a) (6) ].
ZI-D. RJgGISTRAKTS RECEIVING PREVIOUS SECTION ? f Cj Cll;^ NOTICES
ISSUED BY THE ASEHCY
Unless otherwise noted herein, thj.f pafrar Call-in does no^ in
anv way supersede or change the req-uirfnentt of any previous pqta
call-lnfsi. or any other agreements entered into with the Agency
pertaining to such prior Notie*. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
JII-A. SCireOtJLZ FOR RZSPONPTNtj j*
The appropriate responses Initially required by this Notice
for product specific data oust be submitted to the Agency within 90
days after your receipt of this Notice. Failure to adequately
respond to this Notice within §0 days of your receipt will 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 NOIS due to
failure to coaply vith this Notice art presented in Section IV-A
and IV-S.
XZX-B. OPTIONS FOR itESPONSING TO THE AGENCY
The options for responding to thin Notice for product specific
data ar«: (a) voluntary canc«llation, fb) agree to satisfy the
product specific data requirements imposed by this Notice or (c)
request a data vaiver(s).
A discussion of how to respond if you choose the Voluntary
Cancellation option is presented below. A discussion of the
various options available for satisfying the product specific data
requirements of this Notice is contained In Section III-C. A
discussion of options relating to requests for data vaivers is
contained in Section III-D.
There are tvo forms that acceapany 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.. %espop*_e
Fog, and the B^e_qujLr aae_pts_ j|t _a.ty 3 . ftn4 A^glg^ta.nt ' s Sesponse f erm .
Attachment B and Attachment C. The Pa_t^ _C_a,j.l-_lji _Se«.aens.e. Fepa must
be submitted as part of every response to this Notice. In
addition, one copy of the %e_quj.rfne_ni^s St^agut and Registrant '»
aust be submitted for each product listed on the
_
Cal|-In getpease. Tora unless th* voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing the Data Call-in Response, form in
Attachment B) . Please note that the company's authorized
representative is required to sign the first page of the Bata';
^cj pense _Fqra and Re-gu^re ae nt;s Status _ and Jfoqi^fcpant ' s Response -
££23 {if this form is required} and initial any subsequent pages.
The foras contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions
or need assistance in preparing your response, call or vrite the
contact person (s) identified in Attachment A.
1. yeluntary Caneella^ipp * 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 vish to voluntarily cancel your product, you must
submit a completed CafLJC*?-}'"*" Response fgri- indicating your
election of this option. Voluntary cancellation is item number 5
en the f?_atft-_Pa41"Tft-RiigeP** -tora. Zf you choose this option, this
is the only form that you are required to complete.
Zf you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation aust be in accordance vith .the Existing Stocks
provisions of this 'Notice which are contained In Section IV-C.
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2. Sat|sfvine tfte_- P^odugt Spejcj_f ie.. Data ByoMirements of thj.g
There are various options available to satisfy the product
specific data retirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1
through i on the Requirements^ Sf qfruf and Reg4ft'rag1rt-V gespense Farp
and item numbers 7 a' and 7b on the p§ta Call_^%n._ Response Joja-
Deletion of a use(s) and the lev voluae/minor use option are not
valid options for fulfilling product specific data retirements .
3. He.gU-tft _fof jProduet Specific p_ata Waivers. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the EequireaenjLs Sjy&Bjj BB4
Registrant's Response _ y_e_rp. If you choose this option, you must
submit both forms as well as any other information/ data pertaining
to the option chosen to address the data retirement.
IIX-C .^TlgiyiKG TSf DATA R^flgIMygHffS_..QF_-T1t?8. _KQT ^e^
If" you acJcnowJ-edga on the Pifrf ga, ?. |-lp R,esBen.f i Form that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b) , then you Bust select one of the six
options on the Requirements Status_ a,i\d__|tejg;Lstrant_!s' %**Pon*f FOCTR
related to data production for each data requirement. Your option
selection should be entered under itea number 9, "Registrant
Response." The six options related to data production are the
first six options discussed under item f in the instructions for
completing the Reguirfa.e.n.$s Status fgd |lef j-straq^'f IfofPqWf Fons.
These six options are listed immediately belov vith information in
parentheses to guide registrants to additional Instructions
provided in this Section. The options are:
(1) I trill generate and submit data within the specified
tiaafraae {Developing Data)
(2 \ I have entered into an agreement with one or more
registrants to develop data jointly (Cost sharing)
(3) I have Bade offers to cost -share (Offers to Cost Share)
(4} Z aa submitting an existing study that has not seen
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I aa submitting or citing data to upgrade a study
classified by EPA mm partially acceptable and upgradeable
(Upgrading m Study)
(i) Z an citing an existing study that ZPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
option _ 3, . Pevelopino: Data »• Zf you choose to develop the
required data It must be in conference vita Agency deadlines and
with other Agency retirements as referenced herein and in the
attachments. All data generated and submitted must comply vith the
Good Laboratory Practice (CLP) rule (40 cm Part 160), b* conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conforaance with the requirements of PR Notice If -5.
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The time frames in the leouirementsStatus _and Registrant's
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports. The noted deadlines run
from the date of the receipt of this Hotiee by th« registrant, if
the data are not submitted by the deadline, each registrant is
subject to receipt of a notice of Intent to Suspend the affected'
registration(s).
If you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional time to meet
the requirements (s), you must submit a request to the Agency which
includes: (I) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your
request, the original deadline remains. ' normally, extensions can
be requested only in cases of extraordinary testing problems-beyond
the expectation or control of the registrant. Extension* will not
be given in submitting the 90-day responses. Extensions vill not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Option 2. Anrea to Share in Cost to Develop Data --Registrants
*ay PP!Y choose this option for acute toxicity data and certain
efficacy data and. only if EPA has indicated in the attached data
tables that your product and at least one other product are similar
for purposes of depending on the saa* data. If this is the case,
data may be generated for just one of the products in the group.
The registration ttmnhar of the product for which data vill be
submitted must be noted in the agreement to cost share by the
registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but
vill not be submitting the data yourself, you must provide the nane
of the registrant who vill be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been
formed. Such evidence Bay be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the parties that an agreement exists. The
agreement to produce the data need not specify all of the terms of
the final arrangement between the parties or the mechanism to
resolve the terms. Section 3(c)(2)(B) provides that if the parties
'cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer' to Share in the Cost of Data Development -»
this option only applies to acute 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 xeet 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 vith the data submission requirements of
this Notice. EPA has determined that as a general policy, absent
other relevant considerations, it will not suspend the registration
of a product of a registrant vho has in good faith sought and
continues to seek to enter into a joint data development/cost
sharing program, but the other registrant (s) developing the data
has refused to accept your offer. To qualify for this option, you
aust submit documentation to the Agency proving that you have Bade
an offer to another registrant (vho has an obligation to submit
data) to share in the burden of developing that data. You must
also submit to the Agency a completed EPA Fora 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment C. In addition, you aust demonstrate that the other
registrant to whom the offer vas made has net 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 mail receipt). Your offer Bust, in addition
to anything else, offer to share in the burden ef producing the .
data upon terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FIFRA section 3 (c) (2) (B) (iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a pafca
.
F_prjB and _,a •pe_gu,j.remen_ts. Status and Registrant's Response Forja
committing to develop and submit the data required by this Notice.
Zn order for you to avoid suspension under this option, you may
not vith draw your offer to share in the burdens ef developing the
data. In addition, the other registrant Bust fulfill Its
commitment to develop and submit the data as required by this
Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
veil as that of the other registrant vill normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame. In
such cases, the Agency generally vill not grant a time extension
for submitting the data.
Option 4 , ffttfeBifrtinf Pn Jty^*^^n? S£U3Y ~* Zf you choose to •
submit an existing study in response to this Notice, you aust
determine that the study satisfies the requirement* imposed by this
Notice. You aay only submit a study that has not been previously
submitted to the Agency or previously cited by anyone, existing
studies arc studies vhich predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade a study. (See
Option 5).
You should be avare that if the Agency determines that the
study is not acceptable, th* Agency vill require you to comply vith
this Notice, normally without am extension of the required data of
submission* The Agency may determine at any time that a study is
not valid and need* to be repeated.
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TP meet the requirements of the DCI Notice for submitting an
existing study, all of the fellovina three criteria gust be g"H9rl,Y
get;
a. You aust certify at the time that the existing study is
submitted that the rav data and specimens froa the study are
available for audit and review and you must identify where they
are available. This aust be done in accordance with
the requirements of the Good Laboratory Practice (GLPJ
regulation, 40 CFR Part ISO. As stated in 40 CFR ISO.3(j)
* '[r]av data* Beans any laboratory worksheets, records,
• memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
' necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data
*. -have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Raw data1 may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
autoaated instruments." The term "specimens*, according to 40
CFR lf0.3(k), means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed 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-
Kay 1984 studies by including an appropriate statement on or
attached to the study signed by an authorized official or
representative of th* registrant.
c. You Bust certify that each study fulfill* the acceptance
criteria for the Guideline relevant to the study provided in
the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to th*
Pesticide Assessaent Guidelines (PAG) or meets the purpose of
th* PAG (both available from NTIS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding
acceptable protocols. If you wish to submit the study, you
aust, in addition to certifying that the purposes of the PAG
are aet by the study, clearly articulate the rationale why you
believe the study Beets the purpose of the PAG, including
copies of any supporting information or data., It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG antf that necessary
rav data are usually not available for such studies.
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If you submit an existing study, you must certify that the
study meats all requirements of th« criteria outlined above.
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined abov» but does
contain factual indorsation regarding unreasonable adverse effects,
you aust notify the Agency of such a study. It such study is in
the Agency's files, you need only cite it along vith the
notification. If not in the Agency's files, you Bust submit a
summary and copies as required by PR Notice 86-5.
Option j^_ Spgrafling m Sfo^dy — • If a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency vill reviev the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you aay still be required to
submit new data normally without any time extension. Deficient,
'but upgradeable studies vill normally be classified as
supplemental. However, it is important to note ^that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study aay be upgraded, call or write the contact person listed in
Attachment A. If you submit data to upgrade an existing study you
aust satisfy or supply information to correct aJ4 deficiencies in
the study identified by IPA. You aust provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA..
Your submission must also specify the MRID number (s) of the study
which vou are attempting to upgrade and aust be in conformance with
fR 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
revieved by the Agency. You Bust provide the MRID number of the
data submission as veil as the KRID 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 comply vith
each of those criteria as veil as a certification regarding
protocol compliance vith Agency requirements.
Q g^ Citing Existing studies, •* If you choose to eite a .
study that has been previously submitted to EPA, that study Bust
have been previously classified by EPA as acceptable or it Bust be
a study which has net yet been revieved by the Agency. Acceptable
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10
toxicology studies generally will have been classified as "core-
guideline11 or "core minimum." For all other disciplines the
classification would be "acceptable." with respect to any studies
for which you wish to select this option you must provide the MRID
number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's
classification ef the study.
Zf you are citing a study ef which you are not the original
data subaitter, you aust submit a completed copy of EPA Fora
8570-31, Certification wj-th Reso«et_te Data Compensation.
Requirements.
• Registrants who select one of the above fi options aust aeet all
of the requirements described in the instructions for completing
the Data Ca 11 -In. Respensm Fora and the Requirements gtatus a,_nd
Registrant's Respors.se Form, as appropriate.
Xir-D MrQtJJEgTS FOR ffATA _WAIVERS
Xf you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies,
(Note: any supplemental data Bust be submitted in the format
required by PR Notice 86-5). This will be the qnly opportunity to
state the reasons or provide information in support ef your
request. Xf the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) ef .
F2FRA. Xf the Agency denies your waiver request, you aust choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
' and submit the option chosen on the peyyj.regents, Status and
Regiatrant's Response Fora. Product specific data requirements for
product chemistry, acute texieity and efficacy (where appropriate)
are required for all products and the Agency vill grant • waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request vill not automatically extend the
due dat* for the study In question. Waiver requests submitted
without adequate supporting rational* vill be denied and the
original due dat* vill remain in force.
XV. CONSEQUENCES OF FAIUM TO COMPLY WITH THIS NOTICl! .
XV-A NOTICE QP INTEHT TOStlSPENS
The Agency may issue a Notice of Intent to suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2){B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
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11
1. Failurt to respond as required by this Notice within 90
days of your receipt of this Notice.
2. Failure to submit on the required schedule an acceptable
proposed or final protocol if such is required to be submitted
to the Agency for review.
3. Failure to submit on the required schedule an adequate
progress report on a study if required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to take a required action or submit adequate
• information pertaining to any option chosen to address the data
requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs or
the formation of 'Task Forces, failure to comply with the terms
of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
waiver) .
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section III-c
of this Notice.
7. withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to vhoa 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 pat;a ClAl^lB Baspops/e; Form and a
eu.reet Status and Reistrant *s Resonse
b. Fulfill the eomaitaent 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 commit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any tiae following the issuance of tills
Mot lea. .
TS
The Agency may determine that a study (even If submitted within
the required time) is unacceptable and constitutes a basis for
-------
12
issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of
the following:
1. EPA requirements specified in the Data Call-In Notice or
other docuaents incorporated by reference (including, as
applicable, EPA Pesticide Assessaent Guidelines, Data Reporting
Guidelines, and CeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required
studies. Such requireaent* include, but are not limited to,
. those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals,
dose and effect levels to be tested or attained, duration of
. test, and, as- applicable, Good Laboratory Practices.
2. EPA' requirements regarding the submission of protocols (if
• applicable), including the incorporation of any changes
required by the Agency following review.
3. EPA requirements regarding the reporting of data, including
the Banner 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 86-3. All studies Bust b* submitted
in the fora of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS QE_StISPENDEa_01l CANCELLEP Pl^OD^gXS
ZPA has statutory authority to permit continued sal*,
distribution and use of existing stocks of a pesticide product
which has been suspended or cancelled if doing so would b*
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants
of existing stocks for a suspended registration whan a section
3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency
anticipatas granting registrants permission to sell, distribute, or
use existing stocks of suspended product(s) only In exceptional
circumstances. Zf you believe such disposition of existing stocks
of your product(s) which may be suspended for failure to comply
with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You aust also explain why an "existing
stocks" provision is necessary, Including a statement of the
quantity of existing stocks and your estimate of tfee time required
for their sals, distribution, and use. Unless you meet this burden
tha Agency will not consider any request pertaining to tne
continued sale, distribution, or use of your existing stocks aftar
suspension.
If you request a voluntary cancellation of your product(s) as a
response to this Notice and your product is in full compliance with
-------
13
ail Agency requirements, you vill 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
vill allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for vhicfa the Agency has particular
risk concerns vill be determined on a case-by-ease basis.
Requests for voluntary cancellation received af$er the 90 day
response period required by .this Notice vill not result in the
Agency granting any additional tiae to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unites vou deaonstrate to the Agency that you ere in full
coapliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six aonths before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner aust have been submitted to the
Agency, before EPA vill consider granting an existing stocks
provision.
SECTION V. R2SISTRAKTS' OBLIGATION TO REPORT POSSIBLE
••" ' UNREASONABLE _.ADVERSE EFFECTS
Registrants are reminded that FZFRA section «(a) (2) states that
if at any tine after • pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants Bust notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQPIRIE? AMP RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment A, the pata Call-In Chemical Status _She^.
All response* to this Notice (other than voluntary cancellation
requests) aust include a completed pata^ gall-In Response; Fern, and a
completed pegu,ireajmtf ^t*^P IBtf Pf-?Mtr, *»$<_P_R*^P°r'*>. fog^
(Attachment B and Attachment C) and any other documents required by
this Notice, and should ba submitted to the contact person(s)
identified in Attachment A. If the voluntary cancellation option is
ehosan,- only tha fiat a CaH-^n, R^jfgapaa _ygrn need be submitted.
-------
i
14
The Offic« of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic S\ibstances (OPTS), 1PA, will b« aonitoring thi
data feeing generated in response to this Notic*.
Sincerely yours,
Dani«l M. Barolo, Director
Special R«vi«w and
R*r*gistration Division
Attachments
A
B
C
0
E -
P
G
Sh et
- Ciia_
£I>A
of Reoistans
- Cost
_ __ __ .
Specif ie_ Data. Rgoert fora
-------
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-In Notice because you have products containing
putreseent 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 Notjge. (2)
Attachment B, the Data Call-In Response Fprm, (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 fo^1 Retepstration. (5)
Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of All Registrant^) 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-la. Instructions and guidance accompany each form.
DATA JtEQUIHEDJY THIS
The additional data requirements needed to complete the database for putrescent whole
egg solids are listed in the Requirements Statm 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.
INQUIRIES AND RESPONSES TQ 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
-------
i
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Thomas Myers at (703) 308-8074, All responses to
this Notice should be submitted to;
Chemical Review Manager Thomas Myers
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistratioa Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D,C. 20460
RE: Putresceot Whole Egg Solids
-------
i
ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
-------
SPECIFIC INSTRUCTIONS FOR COHPL1TIKS
TH2 DATA CALL-IN RISPQHSI POEM
Pro3uet gaeifie Data
This form im designed to be used to respond to call-ins for
gtrttric and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Pill out this fora *ach tint you arc
responding to a data call-in for which EPA has sent you tha fern
•ntitlad "R«quir«»«nts Status and Hafistrant's 9aspensa.N
Itaas 1-4 vill hava b««n praprintad on tha fora. Itana S
through 7 Bust ba cosplatad by tha registrant as appropriate.
Ztaas • through 11 nust ba eeaplatad by tha registrant bafora
subaitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 ainutes per response, including time
for reviewing instructions, searching existing data sources, . .
fathering and aaintaining tha data needed, and completing and
reviewing the collection of information. Sand comments regarding
tha burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, FM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to tha Office of Kanageaent and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
i
INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC CATA
Item 1-4. Already completed by ZPA.
Item 5. If you with to voluntarily cancel your product, answer
*y*B." If you choose this option, you will not have to
provide the data required by the Data Call-In Notice
and you will net hava to complete any oth*r forms.
Further sale and distribution of your product after the
effective date of cancellation must be in accordance
with the Existing Stocks prevision of the Data Call-In
Notice (Section IV-C). , ;
Itea 6. Not applicable since this fora calls in product
specific data only. However, if your product i*
identical to another product and you qualify for a data
exemption, you must respond with MyesH to Item ?a (HP)
or 7b (EP) en this fora, provide the IPA registration .
numbers of your source(s) and couplets and submit the
"Generic Date, Exemption" form) you would- not complete .
the "Requirements Status and Registrant's Response"
— form. Examples of such products-include repackaged
products and Special Local Needs (Section 24c) products
which are identical to federally registered products.
Item 7a. For each manufacturing use product (MP) for which you
wish to maintain registration, you aust agree to
satisfy the data requirements by responding "yes."
Item -7b. For each end use product {EP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes.11 If you are
requesting a data waiver, answer "yes" beret in
addition, en the "Requirements Status and Registrant's
Response" fora under Item 0, you must respond with
Option 7 (Waiver Request) for each study for which you
are requesting a waiver. Se* Item f with regard to
identical products and data exemptions.
Items t-11. Self-explanatory.
MOTH ifott a*y provide additional information that does net
fit en this for* in a signed letter that accompanies
this fox*. For example, you smy wish to report that
your product la* already seen transferred to another
company or that you hava already voluntarily cancelled
thi* product. For these cases, please *upply all
relevant detail* so that If A can ensure that, it*
record* ere correct.
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
MB No. 2070-OlOf
Approval Expires 12-31-92
INSTRUCTIONS: Plena typ* or print in ink. PU»«« read carefully tlw attached instructions *nd supply the information requested on this form.
Ill* additional ih*ct(f) If necettary.
1. CoMpany nm» ami Address
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
2. Case f and Dane
4079 Putrescent whole egg solids
3. Date and Type of DC]
PRODUCT SPECIFIC
«. CM Product
Registration
4866-8
5. I Niali t»
cancel Mill
product r*fll»-
tration volun-
tarily.
6. Generic Data
6*. I an eltimog a Generic
Data Exertion because I
obtain the actira ingredient
froai the source EPA regii-
tration matter litted belcm.
N.A.
6t. 1 agree to satisfy Generic
Data requirements as indicated
on the attached fora entitled
"Requirements Statu* and
Registrant's Response."
N.A.
?. Product Specific Oat*
7a. My product is a HUP and
{ agree to satisfy the HUP
requirements on the attached
font entitled "Requirements
Status and Registrant's
Response."
n>. Ny product is an CUP ti>
} agree to safisfy the Eur
requirements on the attati
forn) entitle*! "Requifemeist
Status and In ;Hvcr«r>t's
Response."
S. Certification
I certify that tM statement* Bade on thli for» and all attachments are true, accurate, and coaplete.
I aeknowledse that any knowingly falae or Misleading stateawnt a*y be punishable by fine, imprisonment
or both under applicable Ian.
Sinnature and Title o* Company's Authoriied •epfegentative _ -
10. Mane of Coapany Contact
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Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: *l*M* type or print in Ink. Pleat* read carefully the attached instructions and supply the information requested
uae additional •h**t(t) If ntcasaary.
1. Coapany MM and Addrei* 2. Case • and Najae
I NT AGRA, INC. 4079 putrescent whole egg solids
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MH 55420
4. EPA Product
Registration
4866-9
S. 1 Hfth to
cancel this
product refia>
t ration volun-
tarily.
A. Centric Data
6a. 1 a» cdiBiag a Generic
Data Exeafition because I
obtain the active ingredient
from the source f* regis-
tration nuatwr lilted below.
N.A.
6i». 1 a^ree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirenents Status and
Registrant's Response."
N.A.
?. Product Specific
form Approved
OMB Mo. 2070-0)07
Approval Expires 12-31-92
an this (or».
3. Date and Type of DCI
PRODUCT SPECIFIC
Data
7a. Ny product is a HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification
1 certify that the «tat««it. m* on thi« for. and all attachewnw are true accurate, and e««»let«.
1 acknowledge that an* knoMlnfly f»t«« w ulaleadini »tate««nt My be pu,irtJ>l« by fine. lnprls«wwrt
or both under appi icabla lau.
Signature and Title of Coapany'* *uthorti«d iepresentat ive_ , ____^
10. Nan* of Company Contact
7b. My product is an i .r and
1 agree to satisfy tin 1 UP
requirements or* the ntlnt.htt
form entitled "Requir munis
Status and Registrant's
Response."
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Page 1 of 1
United States Environmental Protection Agency
Washington, D. c. 20460
DATA CALL-IN RESPONSE
Form Approved
OHB No. 2070-010?
Approval lupires 12-31-92
INSTRUCTIONS: Picas* type or print In Ink. PttM* read carefully the attached instructions and supply the information requested on this tarn.
Us* additional sheet(i) if nac«*«ary.
1. Coapeny MMB and
INTAGRA, INC.
8500 PILLS BURY AVE. SOUTH
MINNEAPOLIS KN 55420
2. Case i and Name
4079 Putrescent whole egg solids
3. Date and Type of OC1
PRODUCT SPECIFIC
4. EPA Product
••filtration
4866-10
S, I wish to
cancel thU
product refltt-
tration volun-
tarfly.
6. Generic Data
6a. ] am claiming a Generic
Data Cxeiapt ion because I
obtain the active ingredient
from the source EPA regis-
tration nuaber listed below.
N.A.
6b. | agree to satisfy Generic
Data requirements as indicated
on the attached fora entitled
"Requirements Status and
Registrant'* Response."
N.A.
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 Registrant's
Response."
7b. My product ii an (UP ai«
I agree to satisfy the tuP
requirements on the attfti.hr-
form entitled "Requirement-.
Status and Registrant's
Response."
8. Certification
1 certify that th* atateaant* nede on this fona and all attachawrta are true, accurate, and complete.
I acknowledge that any knowingly false or Misleading atateawrt a»y be puni.hable by fine, inprisonment
or both under applicable law.
Signature and Title of Coapeny'a Author I jed Representative, , ... , . _
10. HaaK of Company Contact
-------
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
OMB Ho. 2070-0107
Approval Expires 12-11-92
INSTRUCTIONS: F>l«as* type or print In Ink. Pica** read carefully th* attached instructions and supply the information requested on this lorn.
UM additional *h*et(i) If necessary.
f. Coapany neat* and Addre**
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MM 55420
2. Case • and Dane
4079 Putrescent whole egg solids
3. Date and Type of DCI
PRODUCT SPECIFIC
*. EPA Product
Registration
5. I Mf*H to
cancal this
product reflls-
t rat ion
tarlly.
&. Gemrfc.Data
6a. I m clatnidi • Centric
Data £ (leapt ion because I
obtain the active ingredient
froai the aource EP* regit*
tration nuater listed below.
6b, I agree to satisfy Generic
Data reojuirenents as indicated
on the attached fora entitled
"Requirements Status and
Registrant's Mesponse."
7. Product Specific Data
7a. My product is a MUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant'*
Response."
7b. My product is un I'.i ..:
I agree to satisfy the- I .IP
requirements on the attache!
form entitled "Retiremen
Status and Registrant's
Bespon&e."
4866-11
N.A.
N.A.
I. Certification
and
I cart If y Uiat th« atataawits Mda on thU fora> and all attacha*nti are tru«, accurate,
I acknowledge that any knoMlngly falwt or plileading «tate»ent My b* pwiishable by fine, iapri»on«ent
or both under applicable Ian.
Signature and Title of Coapwry'* Author tied Representative - . ...... .......... _
10. Kaa* of Coapany Contact
-------
Page 1 of
United States Environmental Protection Agency
Washington, D, c. 20460
DATA CALL-IN RESPONSE
Farm Approved
OMB No, 2070-0107
Approval E»ptre* tZ il 92
iHSIMJCTlQMS: Plea** typ« or print In Ink. H*M* re»d carefully the ittached instructions and supply the tnforeation requested on this form,
UM additional (heetU) If necessary.
1. Coapany nee* and Addreaa
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS UN 55420
2. Case i Mid Ha«e
4079 Putrescent whole egg solids
J. Date and type of OCt
PRODUCT SPECIFIC
4. EPA Product
•••UtMtlon
OR88001100
S. I nl»h to
cancel thl»
product regis-
tration volt*i-
t«riiy.
A. Ccnerlc Data
&a. I •» claiM>B « Generic
Data Ex**ption tecaus* I
obtain the acttv* Ingredient
fro* th« aowrce EM regis-
tration r>u*btr lilted
N.A.
6b.Iagree to satisfy Ceheric
Data re<|uireaient* *a indicated
on the atlnched fora entitled
"RequiroBents Status and
•egittranl's Response,"
N.A.
I. Product Specific Data
It. My product i» > HUP and
I agree to satisfy the HUC
reciuireraenls on the attached
for« entitled *«equirtmtnts
$t*tus and Registrant's
tesponse."
/b. Ny product t^ &n HJi( an
I ayree to iati^fy the i III'
requireinents tm the att.nl..
Status and Regislrmtt '
Response."
I. Certification
I eertlfv tMt the; atateaKnte awte an this low and all attacha*ntt are true, accurate, and «*plete
1 acknZledge ttot any kno-ingly f.l.. or *l«leading itateajent a.y be puniahable br Hne, i«pr.so«»ent
or both under applicable lay.
Signature and title of Company'* tothoriied Representative
10. MaaK of Company Contact
11. Phone
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Page 1 oJ 1
United States Environmental Protection Agency
Washington, D. C. 20460 I
DATA CALL-IN RESPONSE
IttSTRUCTIONS: Plea** typt or print In ink. Pleaae raad carefully the attached instructions and supply the information requested
Uae addition*! ahaet(a) if necaaaary.
1, Caapany nmm «nd Addreaa . 1. CMC t and HUM
INT AGRA, INC. ' 4079 Putrescent whole egg solids
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MM 55420
4. CM Product
Registration
WA88000400
5. 1 Milk to
cancel ttila
product raflt-
tration volun-
tarily..
ft. tanerfc Data
6a. 1 aa claiaiiag a Ccncric
Data f»e«f»tlgn bccawa I
obtain tba aetiv* ingredient
frM tb« tourc* €PA reflU-
t rat ion nuatwr llstad balcm.
N.A.
Ab. | agree to satisfy Generic
Hat* requirement* »s indicated
on the attached fora entitled
"Requirements Status Mid
Registrant'! lesponse.*
N.A.
(
;
7. Product Specific
Form Approved
(1MB No. 207Q-0107
Approval Expires \? 51 -W
-------
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
FORMS (Form B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
-------
i
INSTRUCTIONS FOR C0MFI.ITIKS
TIE *tSUI«£KENTf fTATOB AND HEOZiTRAHf'• RtSPONSl
Troduet fpaetfia Data.
• This fora It designed to be used for registrants to
to call-ins for generic »nd product-specific data *« pert of
EPA'* reregistration program under the r«d*ral insecticide
Fungicide and Rodentieide Act. Although the ffica *" th* •*"•
both product tpaelfie and g*n«ric data, ^r^«truetioM for
coapltting tha forms diffar slightly. Spacifically, options for
satisfying product spaeifie data raqnairaaants do not includa (i)
dalation of usas or (2) rtquast for a lev volujaa/ninor usa
vaivar. Thasa instructions ara for coaplation of produe^
spaeifie d«t| raqpjiraaants.
tPA has davalopad this fora individually for aach data call-
in addrassad to aach registrant, and hat preprinted this fora
with a number of items, po NQf use this fora for any other
activa ingredient.
Ztea* 1 through I (inclusive) vill hava bean preprinted on
tha fora. You Bust conplate all other itens en this fora by
typing or printing legibly.
Public reporting burden for this collection of information
is estiaated to avarage 30 ainutas per response, including tiae
for reviewing instructions, searching existing data sources,
gathering and naintaining tha data needed, and conpleting and
reviewing the collection of information* Sand consent* regarding
the burden estinate or any other aspect of this collection of
information, including »uggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 X St., I.W., Washington, B.C. 204fOf and
to tha Office of Management and Budget, Paperwork Reduction
Project 2070*0107, Washington, D.C. 20503.
-------
I
IKSTSUCTIONS fOR 'COMJL1TIKS THE *RIQUIR£MZNTS STATUS
RIGISTRANT'S RESPONS1" fORM FOR IAOD9CT SFIGZfXC
Itaa 1-3 Conpleted fey r?A. Hot* the uaifve Idtatiflar
assigned by I?A in Itta S. Tills nuaher must be «»td ia
tsa triasaifctal docuatat for aay data subalssieas in
_ ^ response to this Data Call -In Hotiee.
Itea 4. The guideline reference imabers of studies required to
support the product's continued registration art
id«ntifi«d. Thsss 9uldslintS| In addition to th»
r«quir«m«nts specified in the Kotice, govern the conduct
of the recjuired studies. Kote that series fi and t2 in
product chtaletry are nev listed under 40 C7H 158.115
- through 151,110, fubpart C.
I tea 3. The study title aieoc'iated vita the guideline reference
nuaber is idtntified.
• * ' »
Ztaa f. The use pattern (s) of the pesticide associated with the
product specific refulreaents is (are) identified. 7or
aost product specific dati represents, all use patterns
are covered fey the data reo^jireaents. In the ease of
efficacy data, the refuired studies only pertain to
product,* vhich have the use sites and/or pests indicated.
Itea ?. The substance to be tested is identified by IPA. For
product specific data, the product as formulated for sale
and distribution is the test substance, except ia rare
cases. ••-.-••
Itea t. The due date for submission of each study is identified.
It is noraally based on • lent&s, after issuaaee of tie
Jleref istratioa ilif ibility Cocviaaat unless IPA.determines
that s longer tiae period is necessary*
i Itaa 9* later fniy'*" of tie folloviag rsspoase oedes *»* —...»
» flats, gefyigiaeafr to saov lev you iatead to coaply vita
, toe data yefuiraaeats listed ia this table. fuller
descriptions of each option aro contained ia the Data
, Call-la. Xotico.
1 l. z vill generate and aubait data by the specified duo data
t (Developiag Data) * By indicating that Z have chosen this
option. Z certify that Z vill coaply vita all the
i reiuireaants pertaining to the conditions for oubaittal
1 of this study as outlined in the Data Call-In Votlee.
* ' .
2. Z have ontaroi into an agreeaent vita one or acre
registrants to develop data Jointly (Cast Saariag). Z
aa submitting a oopy of this sfreeaaat and a ccapleted
"certificatioa Wit a Baspeot to Data eoapeasatisa
lefuireaeats* fera. Z understand that this option is
available ealy for acute toxicity or certain efficacy
-------
i
data and ealy if I PA indicataa In an attachment to this
Notice that my product la aiailar enough to anothar
product to qualify for this option.. I certify that
anothar party in tha agreeaant is cows itt ing ta submit
or provide tha retired data; if tha required study 'is
net aubaittad en tima, ay product may be subject to
suspension, ' ' • • , . " .' •
3. Z htva aade of fare to share in tha coat to develop data
(Of f ara to Coat f htra) . Z understand that* this option
is available only for aeuta texieity or eartain affieaey
data and only if I PA indicataa in an attaehaant to this
Cat a Call-in Kotiea that ay product is siallar anough to
anethar product to qualify for this option* Z aa
•ubaitting avidtaea that Z have aade aa effar to anothar
rafiatrant (who has an obligation ta subait data) to
shara in tha coat of that data. Z aa also submitting • '
cocplatad "Cartifieatioa of Offer to Cost faare ia tha
Sevelopaeat Data" fora. Z aa including « copy of ay
offar and proof of tha othar ragiatrant's racaipt of that
effar* Z aa idantifying tha -party which is eonnitting
to submit or provida tha required data 7 it tha rtfuirad
study is net subaittad en tiaa, ay product aay ba sub j act
to suapansion. Z understand that othar tarms under
Option 3 in tha Cata Call-in Kotiea (Saction III-C.l.) *
as vail.
4. By tha spaeifiad due data, Z vill *uJbait an axiiting
study that lias net baan subaittad praviously to tha
Agancy by anyona (Subaittiag aa txistiaf Study). Z
eartify that this study vill aaat all tha rafuiraaants
for subaittal of axisting data outlinad in Option 4 in
tha Data Call-in Kotiea (faction III-C.l.) and vill aaat
tha attachad aeeaptanca critaria (for a cut a texicity and
product chaaistry data). Z vill attach tha tiaadad
supporting information along vith this raapensa. Z also
eartify that Z hava datarainad that this study vill fill
tha data rafuiraaant for vhich 2 hava indicatad this
ehoiea.
*
9. Iy tilt spaeifiad dua data, I vill subait or cits data to
upgrade a study claaaifiad by tha Agancy as partitlly
accaptabla and upgradable (9pgrali&f a Itudy).- Z vill
subait avidaaoa tf tba Agaaey'a rtviav indicating that
tha study »ay ba upgraded and what information is
rtcuirad ta do fle. Z vill provide tha HMD or Accaasion
number eC tha atudy at tha due data. I undaratand that
the conditions for this option outlined Option S in the
Data Call-in Jfotica (Saction III-C.l.) apply.
f . »Y the 'specified dua date, Z vill cite an axisting study
that tha Agency h*s classified as acceptable er an
existing atudy that has baan subaittad but not reviewed
by tha Agancy (Citiag aa txiatiag itudy) . Zf Z aa citing
-------
anothar ragiatrant's study, X undarstand that this option
•is «v*ii«bl« *alj for acuta toxicity or eartain slzicaey
dtta md cnly if tha cittd study vas eonduetad on ay
product,, an identical product or a product vhich l?x has
*group«dn vith on* or »ora "eth«r product* for purpaaa*
of dfpamding on tha stsa data. I may al»o choeca this
option it I *a citing »y evn data. Xn »ithar east, X
viil provid* tht XXZO or loe§s*lea »uab*r(») for tha
citad, data on a «Produet fpacifie Oata R«port" font or
in A siallar format. • Xf X cits anothar. raf i»trant'»
data, X vill »ybmit a coapl«t*d «c*rtific»tion »it^
Xasptet To fiata Coafaasatlos Itfuiraatata11 fem.
+ . * • *
?« X r*5u««t ft vaivir for , thia atudy bacauaa it is
ir.ippropriata for »y product (Yaivar Itfuaat). X am
' attaching « coapiata justification for this rtquast,
including tachrsfcal r«*»on«, data and r«f«ranc»* to
ralavant Z?A Tagulations, fuidtlinas or polielas. [Hota:
any supplasantaX data au»t to* subaittad in th* format
ra*y provida additioaal ioforaatioa that doa* not fit
, en this for* ia ft signad Xattar that *cconpani«* this
fora, for *xaspla, you «*y visa to report that your
. product has alraady baan transfarrad to *noth*r eoapany
or that yea hav* alrtady voluntarily cancallad this
* product* For th««a ca>ts( plaata supply all ralavant
detail* so that IfA eaa *naur* that It* raeords ar*
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Page 1 of 2
United States Environmental Protection Agency Form Approved
Washington. D. C. 20460 i
OHB Ho. 2070-010?
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-51-92
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheetCs} If necessary.
1. Cospeny maw and Address
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
*. Guideline
Requircswnt
•uabsr
151B-10
1518-11
151B-12
151B-15
1518-17 (b)
1518-17(1)
1518-17(1)
i51B-17(n)
the attached instructions and simply the informatioo requested on this fom.
2. Case • and Na*e 3, Date and Type of OCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
IDf 4866-RD-1904
EPA Reg. No. 4866-8
5. Study Title
Prod Ghea) - •iodieaiical
Product Identity
Hanufacturin* process
Discussion of formation of
Wignt*nti«f*l |r»rdi«nt»
Certification of lisiits
Analytical anthod*
Physical state
(tensity
Storage stability
Viscosity " <•>
Misciblllty (°I
Corrosion cttsrecterfstks
> i
i
! 1
Progress
Reports
t
2
3
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
A C IJK
A C IJK
A C IJK
A C IJK
A C ' IJK
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
S, Time
Franc
8 mos .
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Reg.M .,,1
Response
10. Certification
1 certify that MM statasients swde on this for» and all attachments are true, accurate, and eouplete.
1 acknowledge that any knowingly false or .(.Lading stat«*nt My be punishable by fine, i*pri»«in*nt
or both inder applicable law.
Signature and Title of Company's *uthorf«ed •*pre»entatlve
12. Haw of Company Contact
-------
Page 2 of 2
United States Environmental Protection Agency form Droved
Washington, D. C. 20460
OMB no. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expire* 12-J1-92
IHSIKUCTtOHS: Please type or print In tilfnt* ' <»»!.
Initial to Indicate certification as to information on this page
(full text of certification is on page one).
the attached instructions and supply the information requested on this torn.
2, Case • and Name J. Date and !ype of DCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
ID# 4866-RD-1904
EPA Reg. No. 4866-8
?
0
0
Progress
Reports
1
2
]
6. Use
Pattern
A C UK
A C 1JK
A C UK
A C UK
AC UK
A C UK
A C IJK
AC IJK
7, Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
8. Time
frame
8 mos.
8 mos.
8 mos,
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Ri-.pGose
• Date
-------
Page 1 of 1
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
Kay: HP • Mmif*CtuHng-UM product; IP » snd-use product; provided fonulators purch»*« their active ingredient(s) froa a registered source, they need not submit or cfte
date pertaining to th* purchased product. [NOTE: If • product ii • 100 percent repackage of another registered product that is purchased, *nd any use for the product doe:,
not differ froai those 0f th* purchased and registered source, users are not subject to any data requirements Identified In the tables.]; TEP = typical end-use product;
TGAI * technical trade of the active ingredient; PA I • "pure* active ingredient; PAIR* * "pure" active ingredient, radiolnbeled.
Use Categories Beys
A - Terrestrial food crop • • Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - A<*j«tlc nonfood outdoor
P - Aquatic nonfood Industrial i - Aquatic nonfood residential M • Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor I * Indoor food H - Indoor nonfood M - Indoor Medical O - Indoor residential
Footnotes: ITht foltwliw note* arc referenced In colum two 0. Study Title) of the wauiREKiiTS siAius AND reeismAHT'S RESPONSE fori«.j
Prod
6 Required If test substance la dl»p*r»ible ititli Mater.
7 Required If product contains combustible liquids.
• Required If product Is • liquid.
9 Required If product is an e»ul»lf table liquid and is to be diluted with petroleua solvents.
Acute Tonic • •iochoeiical
S Required If the product consists of, or under conditions of use results in, an Inhalable material (e.fl., a*s, volatile lubstance, or aerosol/port IcuUteK
4 Retired If repeetad contact with hwan skin results under conditions of use.
% Incidents lust be reported, If they occur.
Efficacy * Vertebrate Control A*nts
Out to ««.tlon» concemlna the effectiveness of vertebrate anie.1 repellents and the suitability of label directions for such products, "•istr-nt, of
request voluntary cancellation of their registrations.
-------
Page* 1 of 2
United States Environmental Protection Agency farm Approved
Washington, D. C. 20460
« am HO. 2oro-oio7
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
" Approval expires 12 31-92
IHSTRUCTIOKS: Please type or print In Ink. Pt«s*e read carefully the attached instructions and supply the information requested on this form.
Use additional sheet (s) If necessary.
1. Coapeny MM and Address 2. Case • and NBM 3, Date and Type of DCI
INTAGRA, INC. 4079 Putrescent whole egg solids PRODUCT SPECIFIC
8500 PILLSBURY AVE. SOUTH IO# 4866-RD-1905
MINNEAPOLIS UN 55420 EPA Reg. No. 4866-9
4. Guideline
•equlreBBflt
Ikater
15'lB-lb""' ""
15lB-ll-::-.'':'V'.:':^
151B-12
151B-15
151B-17(b)
«*'«'• «»»'J*i>l;:':s:'L;: "-v
1518-17(1)
iSlB^i*! !•! •;"--"-f'':
151B-17(n)
S. Study Title
frod the* - •fodwarical
-•.l--':'' •' -• '- '• • ' •• ' • '•/'
Product Identity
•'••• Itanufacturintf proccc» '
Biscusaton of fonaation of
unvrtentional inBrdielits
Certification of lints
Physical state
'••'''is«il'ity^:' ': '' ' : ' •''''''
pM (6)
fls^^lltltV ;.. r-w\
Storage stability
1 Viscosity •>•'•''• '-: • ' •' -•• f ll - -
NiMlblllty m
1
|
^
t
Profress
Reports
1
?
3
6. Use
Pattern
A C UK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
AC UK
A C UK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
7. feat
substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
8. Time
Frame
8 mos.
8 MOS.
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos .
9, Registrant
«ci.pOn&e
I
f
i
10. Certification
I certify that the state-ant. Bade on this for. end all ettadwwrts are true accurate, and «*p»ete.
1 acknoNledge that any knowingly felse or Misleading, state-em My be punishable by fine, l«pris«l»ent
or both under applicable Ian.
SlBnaturo and Tltl* of Cwifflny'* ^Mfhnrlied Representative . '__, . _ ._ .
1 ' I 1* Bh~— lh.*-r • 1
12. Hane of CoajMny Contact
-------
Page 2 of 2
United States Environmental Protection Agency For™ Approved
Washington, D. C, 20460
ONB Ho. 20?0-010r
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
*pprov«l Expire* 12-51-92
INSTRUCTIONS: Please type or print In ink. Haase read carefully the attached instructions and supply the information requested on Ms torn.
UM additional aheetd) if necessary.
1. Coapany na»e and Mdreaa 2. Case * md N«M 3. Date and Type of DC1
INTAGRA, INC. 4079 Putrescent whole egg solids PRODUCT SPECIFIC
8500 PILLSBUR¥ AVE. SOUTH IDg 4866-RD-1905
MINNEAPOLIS MN 55420 EPA Reg. No. 4866-9
«. Guideline
tCtplreBent
Nurtier
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
152B-16
96-19
S. Study Tltl*
Aorte Toni<; ^JiodieBrfcal,
Acute oral tOKicity
Acute derawl tonic Ity
•cut* inhalation (31
Primary aya irritation
Primary denaal irritation
ftarawl aanaitiiatlon (4)
Kyp^MmittvUy Incident. <5J
ffffUfflf ^Wtdbnrte.Cofffro^ Ao«nt»
Irowalng aniaal repel lanti (Mj
?
0
0
Progress
Reports
1
2
1
6. Uc«
Patterri
A C , IJK
A C IJK
AC , IJK
A C IJK
AC 'UK
A C IJK
A C I IJK
1
AC IJK
?. lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
8. Time
Frame
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 raos.
9. Regii,t«mil
Response
Initial to indicate certification as to information on thit p«a« Date
(full text of certification it on page one}.
-------
Page 1 of l
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIOHS FOR GUIDELINE REQUIREMENTS
Case t and Nave: 4079 Putrescent whole egg solids
HP * nenulacturlng-ute product; £P • snd-tsw product; provided formula tor* purchase their active Ingredient (s) fro» a registered source, they need not submit or cite
data pertaining to th« purchased product. {NOTE t If • product (• a 100 percent repackage of mother registered product that Is purchased, and any use for the product does
not differ frcai those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TCP * typical end-use product;
TGA! • technical grade of the active Ingredient; Ml * "pur** active ingredient; PA IRA * •pure" «• live ingredient, radiolabeled.
UM Catemrlea Hoy*
A - Terrestrial food crop I - Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
f - Aquatic nonfood Industrial t - Aqustle nonfood residential H - Greenhouse food crop i - Greenhouse nonfood crop J - forestry
K - Residential outdoor I - Indoor food N • Indoor nonfood H - indoor Medical 0 - Indoor residential
|?h« following notes art referenced In Colusn tin (5. Study Title) of the REQUIREMENTS STATUS AW REGISTRANT'S RESPONSE form.]
6 tequlrad if test substance is dlsperstbU with inter.
7 Required if product contains coatous tibia liquids.
• Required If product Is • liquid.
9 Raqulrod If product Is an eaulsff iefate liquid and Is to be diluted uith petrotetai solvents.
Acute) Toxic
3 Required If the product consists of, or under conditions of use results in, an InhalaWe Mtlrial (e.g., pas, volatile substance, or aerosol/particulate).
« Required If rape*tad contact ulth nuMsn skin results wider conditions of use.
S Incldsnts aust be reported. If they occur.
Efficacy - Wrtaftrat* Control Asjents
50 ££.t.r»w^ '! ~.!!ficacy
requasTvotintBry cancel let I on *f tll«lr registrations.
-------
Page 1 of 2
United States Environmental Protection Agency fora Approved
Washington, D. C. 20460
, ONB Mo. 20TO-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-51-92
INSTRUCTIONS: Picas* typt or print In Iflfc. Pt*a*a read carefully the attached instructions and supply the information requested on this form.
UM additional •hwtfs) if nacwMrr.
1. Coapany na*> and Addrwi 2. Case * and Haw • 3. Date and Type of Del
INTAGRA, INC. 4079 Putrescent whole egg solids PRODUCT SPECIFIC
8500 PILLSBURY AVE. SOUTH IDf 4866-RD-1906
MINNEAPOLIS MN 55420 EPA Reg. No. 4866-10
*. Guidallna
Requiraamt
ituBbtr
151B-10
1S1B-11
151B-12
151B-15
1518-16
151B-17(b)
151B-17fi)
1518* 1? (Jcl
151B-17 (I)
1S1B»17 f»i
151B-17(n)
S. Study Titta
Prod OMB - lioctnicil
Product Identity
Nanufacturlnd profos
Oi ecu** ion of fonMtlon of
unintentional ingrdientt
Certification of Haiti
Analytical Mthod*
Physical »tate
(ttnaity :
pM «i)
flaaiMbllity (71
Storaaa stability
ViBcotltY W>
Niscibility <°>
Corrotion cnaractaristio -::- • •
R
o
\
Progress
Reports
1
2
J
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
A C IJK
A C IJK
AC IJK
A C IJK
A C IJK
f, lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Resist.. ,. .
Response
^
10. Certification
1 certify that tfca statement* MdB on title for* and all attachments ar« true, accurate, and eoaplete.
1 •cknoiilcdgc that any knoiiinjly MM or •{•leading ttateMnt My be puiiihabU by fine, invrlsotwent
or both under appl icabla Ian.
Slomtura and TltU of Company'* Huthoriied Reiwesentative . .
12. Naa» of Coapany Contact
-------
Page 2 of 2
United States Environmental Protection Agency form Approved
Washington. D. C. 20460
• OHB HO. zoro-oior
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
^^ Approval Expires 12-31 -«
INSTRUCTIONS: Please type or print In tnk. Please read carefully
Uae additional »heet(s) If nacesaary.
1. Coapany iwaa and Address
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
4. Goldellna
Requirsasnt
**t»r
152B-11
152B-13
l52B-i4:;i::;:;:::::;;::^>
152B-15
>wffi£&t&!-1^'-
S. Study Title
Acute Tonic • piochenical .'/ .-,
Acute dental toxic Ity
Prfawry ay* Irritation
;V?rilini! ssjrtpil Irritation .. :J- •.:..•...
Deraatl aansltlistfon (4)
•;«i::-jlypw»amltivltjf,;liwlda|«»,::::/.: ,'• ''
^f f Jcacv - yertebrate Contnrt ftW?? :' ':
:5::; - |ripf|t>i;i«liiii;:'re|i«tl«ntf: •
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AMD KEY DEFINITIONS FOE GUIDELINE REQUIREMENTS
Case f and Naae: 4079 Putrescent whole egg solids
Key: HP • awlufactor Ing-use product; EP * and-use product; provided fomulators purcha*e their active lngredient{sl from a registered source, they need not submit or citr
data pertaining to the purchased product.[NOTE: If a product Is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ fro* those of the purchased and registered source, users are not subject to any data requirements identified in the tables.); IEP - typical end-use product;
TGAI • technical trade of the active Ingredient; Ml « "pure" active ingredient; PAIR* * "pure" active ingredient, ndioiabeted,
Us* Categoric* Key:
A • terrestrial food crop • • Terrestrial food feed crop C • Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F • Aquatic nonfood Industrial 6 - Aquatic nonfood residential H • Greenhouse food crop I - Greenhouse nonfood crop J • Forestry
K * Residential outdoor I • Indoor food N - Indoor nonfood • - Indoor Medical 0 - Indoor residential
Footnotes; [The following notes are referenced in eoluan tuo (5. Study Title} of the lEOUIREHEMTS sUius AW) REGISTRANT'S RESPONSE form.]
•rod Chen » ItodMBleal
6 Required If test substance Is disperslble with water.
7 Required if product contains coafcu* tibia liquids.
• Required if product I* a liquid.
9 Required if product is an essilslfiable liquid and Is to be diluted with petroleus solvents.
Acute) Ionic • •iecfcaarical
J Required if the product consists of, or under conditions of use results in, an inhalable material (e.g., gas, volatile substance, or aerosol/particulate).
* Required if repeated contact ulth kuaan skin results under conditions of use.
I Incidents aust be reported. If they occur.
Efficacy * Yertabrete Control
date can be provided
request voluntary cancellation of their registration*
-------
Page 1 of 2
United States Environmental Protection Agency For* Approved
Washington, D. c. 20460
\ UHB HO. ^U/0-U1U/
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
IKSTHJCTlCttS: Please type or print In ink. Please read carefully
Uae additional aheet(a) If necessary.
1. Conpany na«a and Mdreaa
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
4. guideline
RecBjtreMtnt
mt^Rpvi
151B-10
151B-U
151B-12
151B-15
•* «£« *» _ »i £_
X3J.U JIO
151B-17(b)
1518-17(1)
1S1B-17W
151B-17(1|
151B-17(n)
Approval Expires 12-51-92
the attached Instructions and supply the information requested on this form.
2. Case * and HMR i. Date and Type of OCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
IDf 4866-RD-1907
EPA Reg. No. 4866-11
S. Study Title
Prerf Cheer- liodMical
Product identity
ManqfecturfnO process : . ;
Discussion of fonMtfon of
* * -11
wiw(rici(!n**QWl" iflpi^oHffUp.- •,;:,, •
Certification of li«it»
Analytical «ethcd» vj- ,
Physical atate
»ana|ty ' 4^ '•";-.;-;
pi (6}
HaWMblUt* , •: ::;.;; in.'.''-,-
Storage atabillty
Viacoettv W
Nlaclbillty (91
\
0
C
0
t
Progress
Reports
1
2
3
6. Use
Pattern
A C UK
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
A C IJK
A C UK
7. test
Substance
EP
EP
EP
EP
EP
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 rnos.
8 mos.
B BIOS.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
j
IB. Certification
I certify that the state—fit, aede on thit for* end all attachments are true, accurate, and complete.
I acknowledge that any knowingly falee or •{•leading ststeneot aay be punishable by fine, lit>rl«onaent
or both under applicable leu.
Signature ant Title of Coapany'a Author lied «epre«entat!ve
12. Maa* of Company Contact
' 13. PNone Muifcer
-------
Page 2 of
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
form Approved
{MB Ho. 2070-0107
Approval Expires 12-31 92
INSTRUCTIONS: Pleas* typa or print In Ink. Pleas* read carefully the attached instructions and supply the information requested on this torn.
UM additional «h**t(*} if n*c****ry.
1. CoifMny mm and Addre*a
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
2. Case » and Name
4079 Putrescent whole egg solids
EPA Reg. No, 4866-11
3. Date and Type of OCI
PRODUCT SPECIFIC
1D# 4866-RD-1907
*. SuidtUnt
ReqMiraaent
5. Study fill*
Progress
Reports
6. Use
Pattern
7. lest
Substance
8. lime
Frame
9, Registrant
Response
Acute
- liocheaical
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
Acute oral toxtclty
Acute derwat tontcity
fccut« inhalation
PrlBBry «V« irritation
Prlwry •
A C
A C
A C
A C
A C
A C
A C
A C
UK
UK
IJK
IJK
IJK
IJK
IJK
IJK
EP
EP
EP
EP
EP
EP
EP
EP
8 mos.
8 mos.
8 mos,
8 mos.
8 mos.
8 mos.
8 mos.
8 mos,
Initial to indicate certification as to information on thi» page
-------
Page 1 of
United States Environmental protection Agency
Washington, D. C, 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Naae; 4079 Putrescent whole egg solids
Key: HP • a»nufscturlng-uae product; If • «nd-u§» product; provided foraiilators purchase their active tngredient(s) from a registered source, they need not submit or cite
data pertaining to ttm purchased product.(NOTE: If • product It • 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ fro* tkOM of tb* purchased and registered source, users are not subject to any data requirements identified in the tables.]; ItP - typical end-use product;
TGAI * technical grade of the active Ingredient; MI • "pure" active ingredient; PAIRA « "pure" active ingredient, radiolabeted.
UM C*te*orls* Key:
A - Terrestrial food crop • * Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Induatrlal 6 - Aquatic nonfood residential N - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor I * Indoor food • N - Indoor nonfood N - Indoor Medical o - indoor residential
Footnotes: ITlM following note* are referenced In coluan tuo (5. Study title) of the REQUIREMENTS STATUS AM> REGISTRANT'S RESPONSE form.)
•rod Che* - RIodkSBlccl
» Required If test substance is disperslble Mith Hater.
r Required If product contain* coafcustlbla liquids.
I Required If product !• • liquid.
V Required If product Is an esultifisbte, liquid and Is to be diluted with petroleua solvents.
Acute) fwlc - flodMsrical
I Required If the product consists of, or under conditions of use results In. an inhslabie eatirial (e.g., gas, volatile substance, or aerosol/paniculate).
4 Required If repeated contact with huasn skin results under conditions of use. I
% Incidents aust bs reported, If they occur. I
Efficacy - vertebrate Control Ajents
'
request voluntary cancellation of their registrations.
-------
Page 1 oi :'
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
IISTRUCTIQNS: Please type or print In Ink. PIMM rtad carefully
Us* additional sfteet(s) if neceisary.
t. Company na»» ml Address
INTAGRA, INC. .
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS Mil 55420.
4. GuldatlM
R«fjlr*Mnt
•uaber
151B-10
151B-11
151B-12
151B-15
1518-16
15 18- 17 (b)
1518-17 (t)
1518-17(1)
1518-17 W
1518-17(1)
151B-17(n)
the attached instructions and supply the information requested
2. Case * and Name
4079 Putrescent whole egg solids
EPA Reg. No. OR88001100
S. Study Title
Pfodj Oie*} - piocheaiical
product Identity
Nanufacturlnf process
Discuss I on of formation of
Ki«at«nttonal ingrdiant*
Certification of liailt*
'JlfH|||f^|(sl aji||iai|(
Physical state
(toraae stability
Nitclbllfty (9)
|
o
Progress
Reports
1
2
I
6, Use
Pattern
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
A C IJK
7, Test
on this form.
3. Date and
Form Approved
OMB No. ZQ70~010?
Approval Entires 17-S1-VZ
Type of OCI
PRODUCT SPECIFIC
IDf 1021-RD-1902
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that tha .tata»wt. nada on thl. fona and all attach-entt are true accurate, and _""P«««-
I •cbiwlcdga that any knowingly falM or •itlcading statement nay toe punishable by fine, imprisonment
or both under applicable Ian.
Signature and litU of Company'! Author tied Representative.
12. Naa* of Company Contact
8. t
ime
frame
8 mos .
8 mos.
8 mos .
8 mos.
8 (DOS.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
t. Re.j,.,,,...,
Re&puiiM.-
IS. Phone Number
-------
Paqe 2 of 2
United States Environmental Protection Agency farB Approved
Washington, 0. C. 20460
OMB Ha. 2070-010?
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
1 Approval expires 12-J1-9Z
1HSTMJCT IMS: Plaasa typ* or print fn ML, flaaaa raad carafui ly
Us* additional shMt(>> if nacassary.
1. Company HMM and Address
INTAGRA, INC.
8500 PILLSBURY AVE. SOOTH
MINNEAPOLIS UN 55420
4. Guidallna
iNflifVMlK
152B-10
152B-11
1521-12
152B-13
152B-14
152B-15
the attached instructions and supply the information requested on this fora.
2. Case * and N«aw J. Date and Type of OCI
4079 Putrescent whole egg solids PRODUCT SPECIFIC
ID# 1021-RD-1902
EPA Reg. No. OR88001100
S. Itudy Till*
fleuta Tonic - pjoc*e«ical
Acutt oral toxlcfty
•cut* denaal toxlcity
AeuU inhalation (J> •.'
primary aya Irritation
^lawfcJiftiauMprllwMsii;;:;1 • ;•-• :.r - • -
Oaraal sansltitatlon (41
trowing ania*)! r*pallan<(« (50)
k
Progress
Reports
1
2
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
A C IJK
Initial t» indicate ratification as to information on this page
(full text of certification is on page one).
7. Test
EP
EP
EP
EP
EP
EP
EP
EP
8. line
Fram^
8 mos .
8 mos.
8 mos.
8 mas.
8 mos,
8 mos.
8 raos .
8 mos.
9. Registrant
Rtipofv.c
Date
-------
Page 1 of I
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEPIMATIOMS FOR GUIDELINE REQUIREMENTS
Case f and Nane: 4079 Putrescent vhole egg solids
Key: HP •'SMraifacturlng-uss product; I* • end-use product; provided foreulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product. [NOTE: If a product is a 100 percent repackage of another registered product that it purchased, and any use for the product does
not differ fro* those of the purchased and registered source, users are not subject to any data requireawnts identified In the tables.]; TEP - typical end-use product;
TGAI « technical grade of the active Ingredient; PAI * •pure*' active ingredient; PMRA * "pure" active ingredient, radiolabeled.
Use Categories Key:
A * terrestrial food crop • - Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
f • Aquatic nonfood Industrial 6 - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - forestry
K • Residenttal outdoor 1 - Indoor food M - Indoor nonfood N - Indoor Medical 0 • Indoor residential
Footnotes: [The following note* are referenced In coluwi tm
-------
Page 1 of .'
United States Environmental Protection Agency
Washington, D. c. 20460
i
BBQUIRBfENTS STATUS AND REGISTRANT'S RESPONSE
ittSTkUCUOMt: MMM typa or print In Ink. »laa*« raad carefully
Uw additional afoot (•) If nacoaaary.
1. Coaponr mat and M**M
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS MN 55420
4. Suldallna
ftrt»r
151B-10
1518-11
1518-12
1518-15
1518-17 (b)
1518-17(1)
1518-17(1)
1518-17 (n)
tM attached Instruction* and supply the information requested
t. £••• ff and HMC
4079 Putrescent whole egg solids
EPA Reg. No. WA88000400
§. Ilia* TH1*
•rad ON* - lf«%«rf«l
Product idantlty
DlacuMlon of formation of
C*rtlflc«tl«n of lf*itt
aralvttcal Mthoiti
Physical SUM
# . **> .
t tor at* »tabillty
MwiWIIty (9)
A
o
1
Progrts*
Reports
t
2
3
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
A C IJK
A C UK
AC IJK
A C UK
A C IJK
forra Approved
UttH Mo. 2070-Q10?
AfH>ro»al Expires 12-11-Vi
on thi^ form.
S. Date and Type of DC!
PRODUCT SPECIFIC
IDi 1021-RD-1903
7. lest
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
It. c«rttficatlon
1 c*rtif.y !*•* U»" -tiTiair" titrit on tht« fora and all Mtact»*nt» aro true, »ccur»t«, and coapute.
Signature and fltla of Company's *utfcorli«d Kepr«s»tatl»« —
12. **•* of Coapany Contact
8. lime
frame
8 mos .
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 BIOS.
8 mos »
8 mos.
8 mos.
8 mos.
9. Urgivuaiu
(te^ponsi;
11. uate
1J. Phone Nutter
-------
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
IHSmuCTIOJtt: *lo*M type or print in ink. Please read carefully
lit* additional aha«t«) If nace*aary.
1. Caapany MM and Addroaa
INTAGRA, INC.
8500 PILLSBURY AVE. SOUTH
MINNEAPOLIS UN 55420
4. Guideline
RoqutroMnt
152B-10 :,.;,V.. -I/;,
152B-11
152B-12
152B-X3
152B-15
S. Study f itlt
Acvtf >e,fa • Ijocfrpoiicaf •--•
Acut* oral loxlcity
Acute deraat to*icity
.Acute inhalation ,_;.';. :,: '..*: SS»
rriaary eye irritation
frlnwir dero»Mrr»iatlon 'j;*/^
»enail •atMitiutlon <*)
• i ' ' t' t ' •'.:. '^••^"'••'VBftl '
vT^SiW-WP- JSa?T^PJl--'-SSlRi -™*?S • ••*???'
the attached instructions and supply the information requ<-it«J
2. Case * and NOM
4079 Putrescent whole egg solids
EPA Reg. No. WA88000400
• i
A
)
Progress
Reports
1
2
I
6. Use
Pattern
A C , UK
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 a* to information on thi» page
Cfull tent o» certification i* on pose onej.
7. lest
Substance
Page 2 of :\
Form Approved
OMB No. 2070-010?
Approval £npires t? 1! -92
on this turn.
3. D.I ic and iype of DC1
PRODUCT SPECIFIC
1U# 1021-RD-1903
EP
EP
EP
EP
EP
EP
EP
EP
6. lime
frame
8 mos .
8 mos.
8 raoa.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos.
9 Kein * i (.inl
-------
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AMD KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case t and Naae: 4079 Putrescent whole egg solids
Kays HP • ••mtfwtliring-tM* product} H> * «ntf*UM product; provided foreulatorc purchase their active ingrcdient(c) from * registered source, they need not submit or cite
data partainin*. to the purdlaaadj product.WOTE: If * product It * 100 percent repackage of mother registered product that is purchased, and any use for the product does
not differ Iran the** Of the; purchaeed end registered source, users are not subject to any data requirements identified in the tables.]; IIP ~ typical end-use product;
Ttti « technical troda of tl» »ctl»» inorodiant; PAI » «pur«" active ingredient; P*IB* - "pure" aitive ingredient, r«iiolabeled.
UW Cateejor <•• ftr-
A - Terr*»tri«l fond crop • - lefreatrial food feed crop C - Terrestrial nonfood crop D * Aquatic food crop E - Aquatic nonfood outdoor
f • Aqucttc nonfood Industrial i * Aortic nonfood retidentlal N - Greenhouse food crop I - Greenhouse nonfood crop J • Forestry
K * tea idem I at outdoor I - Indoor food N * Indoor nonfood V • Indoor Medical 0 • Indoor resident iat
POOtnOt68: ni»e follOMim not*s are referenced In coluwi two (5. Study title} of the REQUIREMENTS STATUS MID REGISTKAHI'S RESPONSE (orm.l
6 •tqutrod If tact aubatanca la dlspanibla with water,
? Required If product contain* coaituatiMe liquids.
I Kecajlred If product la a liquid.
f Required If product la on taul*(flabl* liquid and la to be diluted Mitti petroleue solvents.
Acut* Taailc - ttodMarical
I Required if the product comlsts of, or ««ter conditions of use results in. an iohalable Mt*rial («.»., gas. volatile *utetance, or aerosol/particuUte).
4 Required If repeated contact with hu»an akin results under conditions of use. !
S Incidents wet be reported. If they occur.
-------
I
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
I, B.C. Z04t9
JUl 231986
PR NOTICE 86-5 ««t*t«l»M*»*T*HtC»W»«TAllct*
NOTICE TO PRODUCERS, rORKULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention! Persons responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the p*d*ral
Insecticide, Fungicide, and Rodenticide Act (PXFRA)
and certain provision* of the Federal Food, Drug,
and Coc..ietle Act CFFDCA).
Z. Purpose
To require data to be submitted to the InvironsMntal
Protection Agency (EPAI in a atandard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Netie* applies to all data that are aub»itted to EPA
to satisfy data requirements for granting or Maintaining pesticide
registrations* experimental use permits, tolerances, and related
approvals under certain provisions of F1FRA and FFDCA. Thes«
data are defined in FIFRA $10{d)(l). This Notice does not apply
to commercial, financial, or production information, which" are,
and must continue to be, submitted differently under separate
cover.
III. Effective Date
This notice is effective on November 1, 19lf. Data formatted
according to this notie* may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the submitter
for necessary revision.
XV. Background .
On ieptember 21* IfM* EPA published proposed regulations
In the Federal Register <4f FH 37ISI) which include Requirements
for Data Submission (40 Cfft f151.32»» and Procedures for Claims
of Confidentiality ef Data (40 CFR flSI.33). These regulationa
-------
specify the format for data submitted to EPA under Section 3 of
FIFRA and sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of cnnfiden-
• alit-y. ;;- entitl .its i l.i-.a - -f iia..- i j'. i c/ are c.-ii'^id,
either by the proposed regulation or by this notice.
OPP is waking these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new requirements.
V. Relationship of this Notice to Other Off Policy and Guidance
While this Notice contains requirements for organizing and
'formatting submittals of supporting data, it does not address
the substance of test reports themselves. "Data reporting*
guidance is now under development in QPP, 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.
opp has also promulgated a policy (PR Notice ff-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under PIFRA $3. The objective of
the screen is to avoid the additions! costs and prolonged delays
ssociated with handling significantly incomplete application
packages. As of the effective date of this Notice, the »creen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes dead-
line.s for inserting into the docket documents submitted in con-
nection with Special Reviews and Registration Standards (see
40 CFR I1S4.15 and f155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for mere information about this requirement.
Per 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 tht method of support for tht application. Typically,
many requirements art satisfied by reftrenct to data previously
submitted—either by tht applicant or by another party. That re-
quirement is not alttred by this notice, which applies only to
data submitted with an application.
VI* PoraatRequirements
A more detailed discussion of thest format requirements
follows tht indtx on tht next page, and samples of some of tht
requirements art attached. Except for tht language of tht two
alttrnativt fen* of tht Statement of Data Confidentiality Claims
(shown in Attachment 3} which cannot be altered, thest samples
art illustrative. As long as the required information is included
and clearly identifiable, tht fora of tht samples may bt altered
to reflect tht tubmitttr'sj prtierenct.
-------
i
- INDEX -
**
-------
B. TrjngTM Veal Document
The first item in each lubmittal package must be *
.Tifrl .'-?»--.-. "v i • •:* -•••"- -;d-r,r i : .es the i-jiP.ii.T ;r •'.'.
joint submitters? tht regulatory action in support of which the
package is being •admitted— i.e. , a registration application,
petition, experimental use permit (SUP), i3(c)(2HS) data call-in,
S6(a)(2> submittsl, or a special review; the transmittal date;
and a list of all individual studies included in the package in
the order of their appearance,, showing (usually by Guideline
reference number) the data requirement^ s) addressee) by each one.
The EPA-assigned number for the regulatory action (e.g. the
registration, £UP, or tolerance petition number) should be
included in the transmittal document as veil, 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
sjbmictal package supporting a registration application should
be subdivided by discipline* reflecting the order in which data
requirements appear in 40 CFH 158.
The list of included studies in the transmittal of a data
submittal package supporting • petition for tolerance or an
application for an CUP should be subdivided into sections A. B*
C,.... of the petition or application, as defined in 4Cf CFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for • registration or an EUP, list the petition
studies first, then the balance of the studies, within these
two groups of studies follow the instructions above.
C. lr»d^y^du_al_ StuJ ie*
A study is the report of a single scientific investigation,
including all supporting analyse* required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author* date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exception* dis-
cussed in section C.I* Each study included in a submittal package
must be bound a* a separate entity. (See coonent* on binding
studie* on page f»)
Each study suist be) consecutively paginated* beginning from
the titl* page a* page) 1. The total number of page* in the com-
plete study must be shown en the study title page* In addition
(to ensure that inadvertently separated page* can be reassociated
with the proper study during handling or review) use either of
the foil owing i
- Include the total number of pages in the complete study
on each page (le., I of 230, 2 of 280. ...250 of 2501*
- Include a company nans or mark and study number on each
page of the study* e.g.. Company Na»e*291i*23. Never reuse
a study number for Marking the pagss of subsequent studies.
-------
i
When • tingle study is extremely long, binding tt in multipl*
volumts is ptrmissibl* to long as th« e~t*re *tu*?y i* ?e~in*f»*
.-. ^ «ir.,i« **.;»•« «c,o «av.i ^olum« is plainly identified by th«
study title end it* position in the, multi-volume sequence.
C.I SpeeiJi_Coni_idtTations for. Identifying Studiei
Some studies raise special problems in study id«ntifiettien,
because they Address Guidelines of broader than normal scope or
for other reasons.
a. saftty Studies. Several Guidelines require testing for
saftty in nore than ons species. In these ease* each species
tested should b* reported as a separate study, and bound
separately.
Extentiv* supplemental report* of pathology reviews, feed
analysts, historical control data, tnd the like are often aasoc- •
iated with safety studies. Whenever possible the** should be
submitted with primary reports of the study, and bound with the
primary study a* appendices, when such supplemental reports are
submitted independently of the primary report, take care to fully
_identify the primary report to which they pertain.
latteries of acute toxicity tests, performed on the sane end
us* product and covered by a single titl* page, may b* bound
together and reported a* a single study,
*~ ' • •
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted In support of an end-use
product produced from registered manufacturings** product*
should b* bound a* a *ingl* 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 from unregistered source ingredients, should be
bound as a single study for each Guideline eeries (61, 62,
and 63) for conventional pesticide*, or for the equivalent
subject range for biorational pesticide*. The first of the
three) studias in a covplets product chemistry submittal for
a biochemical pesticide would cover Guidelines 131-10, 151-11,
and 151-121 the second would cover Guidelines 151-13, 151-15,
and 151-161 the third would cover Guideline 151-17, The
first s««4y for • microbial pesticide would cov*r Guidelines
151-20, 151-21, and 151-22; the second would cov*r Guidelines
151-23 and 151-25i the third would cov*r Guid*lin* 151-26.
Net* particularly that product ch*mi*try studies are
likely to contain Confidential Business information as defined
in rifJU |10(d)(l)(A), (»), or (C), 'and if so must be handled
as described in section 0.3. of this notice,.
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fi
c, Reaidue_Cheffist_ry Studies. Guidelines 171-4, 153-3,
*id 'M-i \, (1), or (C)
Only' if confidentiality is
claimed on a basic other than
P2FR4 510
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i
D.I Titl* P§ge
A title pay* i* Always required for each sabiitted study,-
published or unpublish*d. Th* title pag* mast always bt freely
relaasabl* to requestorsr 00 NOT INCLUDE CBI ON THE TIT LIE PAGE.
An example of an aceaptabi* title pag« is on page 12 of this
notice. The following information mast Appear on the titlt
page i
a. Stuciv title* The study title should ba as deseriptiv* • *
. possible, it maat claarly identify th* substaneaCs) tastad and
correspond to th* nan* of the data requir*»*nt as it appears
in the Guideline*.
b. Data requirement addressee. Include on th* title page the
Guideline number(s) of thV"specific requirement(s) addressed by
th* study,
c. . Author
-------
D.2. Statements of Data Conf ident ial i ty Claim under FIFRA $10(
-------
p._5 «??f1 ".if-strry ?^acti-o Compliance Statement
This statement is required if the study contains laboratory
work subject to CLP requirements specified in 40 CPU 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBHIT A STUDY THAT HAS PREVIOUSLY iCEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the HRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of -the study* References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method oil 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 whit* paper, printed on on* aid* only in black
ink, with high contrast and good resolution, findings 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 pointai
o Do not include frayed or torn pagaa.
* e Do net include careen copiea, or copies in ether than
black ink.
o Make sure that photocopies are clear* complete, and fully
readable. • •
o Do not include oversit* computer printouts or fold-out pages.
o Do net bind any documents with glue or binding tapes.
o Make 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' packages except
those 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 copiesi three
are now being required 'to expedite snd reduce the cost of proces-
sing data into the OPP Pesticide Document Management System and
getting it into review.)
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i
C. Spec!alRequirements for Submitting Data toth*Oeektt
Data suomittal packages associated witn a Registration Stan-
dard or Special Review must be provided in feyr copies, from on*
of which all material claioed as CBI has b«eri= -excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
th* fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
o Remove the 'Supplemental Statement of Data Ccnfidentiality
Claias1.
o Remove the 'Confidential Attachment1.
o Exciae from th* body of th* study any information you claim
as confidential, even if it doea not fall within the scope
of CIFRA SlO(d)UHA), (8), or (C). Do not clos* yp or
paraphrase t*xt remaining after this excision.
.o Mark th* fourth copy plainly on both its cov*r and its title
page with the phrase "Public Docket Material - contain* no
information claimed a* confidential"*
v.
For Further^Ligoraat ion
For further information contact William C. Crocs*, Chief,
Information Services Branch, program Management and Support
Division, (703-S57-2613).
«c W. Ak*ns«n
Acting Director,
**fiaeration oiviaion
Attachment 1
Attachaant 2
AttaefUMnt t
Attachaant *
Attaenaant i
Attachaant *
Attachaant ?
Saaipla Tranaaittal Document
Sasple Titi* Pag* for « Newly Subnitted Study
Statananta of Data Confidentiality Claiat
Supplaaantal Statement of Data Confidentiality Claims
fiaaplaa of Confidential Attachaenta
Sample Good Laboratory Practice Statenenta
Format Diagraa* for Suboittal Packagaa and Studies
10
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ATTACHMENT 1.
ILEM1NTS TO BE INCLUDED IN THE TRANSM1TTAL DOCUMENT*
1* Nam a and addraagof luhmitttr {or all joint subnittara**}
TSmith ChtmicAl Corporation Jonas Chtmienl Company
1234 w*at Smith Straat -and- 3678 Milton Slvd
Cincinnati, OH 98765 Cevington, K* 56789
TSmith Charaical Corp. will act a« sol* agant for all subtiitttei,
2. Kaoylatory action in support eC which this paehaqa ia aubmittad
US* th» EPA idtntification njmb«r («.g. 359-CUP-«7) if you
it now it Othcrvit* daaerib* th* typa of r*qy*»t («.g. *xp*ri-
m«ntal ua* parrnit, data call-in - of xx-xx-xx data).
3. Tran»»ittal data
4. Lltt of aubnittad atudiaa
Vol 1. Adniniatrativa matariala * fonaa, previous corra»-
pondanca with Projtct Managara, and ao forth*
vei 2. Titla of first study in tha submittal (Cuidallna NO.)
-^ '" *
• *
voi ft. Ticl* of nth atady in th* autaittal (Guidalina No.)
* Applicants commonly provida this information in a trans-
mittal lattar. This raniains an accaptabla practica so
long as all four alamanta ar« includad.
•« Indicate which of tha joint submittars is anpowarad to
act en b«halK of all joint aubnittars in any mattar eon-
carning data coapanaation or subsaquant us*) or ralaaaa
of th* data*
Coa^any Official!
Ham* Signatuc*
Conpany Mamt . • ._•._ • _ ^
Ccaipany Contactt _. • _.
Nan* Phona
II
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I
ATTACHMFVT 2,
SAMPLE STUDY TITLE PAGE FOH A NEWLY SUBMITTED STUDY
Study TjtIt
(Chtmieal nant) - Magnitud« of Rttidj* on Corn
Pita B«quir«««nt
Guidtlin* 171-4
Author
John C. Davis
Study Cemplttad On
January 5, 1979
Ptrtorn ing Laboratory
ABC Agricultural Laboratori««
940 Mctt Bay Drive
Wilmington* CA 39897
Laboratory Project ID
ABC 47-79
Pag« 1 of X
1* th« total nunb«r of pag«* in th« study)
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i
st.vswEsr 3.
CT OKI* OONfIDDfflALIW CLWHS
1. NO claim of confidential icy under Firm J10(d) (1) (A) ,(B) , or (C)
of NO CM* coNFiw*nN.rr!f
No claim of confidentiality is made for any information contained in thie
on the bui» of ita fining within the aeopv a£ FifRA |lQtd)UHJO» (B), or (C).
dsnpany
Qjnpany A0*nts
Titi»
D»t«t
Siqnatur*
2. Clai* o£ confidentiality under PIFIA ilO(d)(l)(A), (B), or (C).
or aw* CDNnnwriALirt CLWMB
Inforraetion elainvd confidential on the basi* of its falling within the acop*
of »FM $10(d}(l)(A), (B), or (C) ha* hMn nn0w>ed too « confidential appendix,
and i* cited by croi»-r*fer«nc* rurtaar in the body of the sfeifty.
Oanpanyt _^_^>^_^.^^^__-_^___>i^-^-i^.^-1_^-^_^__^_^_____
Tltla
Otat
8ionatut%
Ndtt Applieanta for pec««nent or tan^orary tolaranoe* should not* that it
Is QPP policy that no pacnamnt tolaranoe, tamDorazy tolaranoe, or raquMt for
an *mvj**ii •MBjption inoorporatina an analytical wthod, can ba apprevart
»I!«M th» applicant waiva* all claiM of confidentiality for the analytical
aBttatf, TtwS analytical avthods an publisha* 4n the rm Mttieida Analyt-
ical Hatteda Nanual, ant €haf*fO£* cannot ba claiMd aa confidential. Gff
iaplaminta tfiia policy by Ewtuming tubmittad analytical **thod*> for «Hieh
liiich confidentiality clalM hav* bean amia, to tha av±»ittar, to obtain
the coof idtntiality waivar bafcr* thay can ba
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ATTACHMENT 4,
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of * submitted study that it not described
by FIFRA SlO(d)(1), (§!, or (C), bat for which you claim
confidential treatment on another basis, tht following informa-
tion must bt included within a Supplemental Statement of Data
Confidentiality ClaUir
e Identify specifically by page and line numberdi each
portion of the study for which you claia confidentiality.
o Cite the reasons why the cited passage qualifies for
confidential treatment.
o Indicate the length of tiw«---jntil a specific date or
•vent, or permanently—for which the information should
be treated as confidential,
•o Identify the measures taken to guard against undesired
disclosure of this information.
o Describe the extent to which the information has been
_ disclosed, and what precautions have been taken in con-
nection with those disclosures*
o Enclose copies of any pertinent determinations of confi-
dentiality »ade by EPA, other Federal agencies, or courts
concerning this information.
p 'If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why they
•hoyId be viewed as substantial.
o If you assart that the information is voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EFA of similar information in the future, and if so, how.
14
-------
EXAMPLES Of SSVESAL CCNFZCEWIM.
Ex«pl« 1 (Cantidtntial *ard er chrast that has bttn dtltttd fron tht study)
CROSS REFERBCE NUKBE1 1
DCLETtD WORDS OR PHRASE t
TM» cross rtfiPtnc* numbtr is as«d in tht
in pl*c* of th* following words or phrase *t th*
indicated uoluw and pag« r»f«r»no*i,
Glyool
»CE UNI MASON FOB TOE DCUTICN
€ 14 Identity of tn*rt Innr«di»nt
28 25 •
100 19 "
flFRA
Exanplt 2 (Conf idtntial pajragraphts? that havw bs«n citltttd Iron tht study»
OOSS.fsTEROCf tiJMiER S This cross r*f*r*nc* nvmtwr is os*d in th* study
in piact of th* following paragrapha) at th*
indicated wijas and pag* rtftrtncts.
{
( Mprodue* th* dtlttad paragraph h*r*
{
td.-LIMES REASON PO TOT DCLETICN
20 4-T7 Otscription of th* quality control preots*
REftJENCE
1 TConfidtritial
that haws bstn dslttsd froa th* study)
7 this cross r*f*r*nc* nurtb*r notsd on a plact-holdtr
psg* is u**d in plac* of th* following wnol* pag*s
at th* indicated volkJB* and pag* r*f*r*nc*s,
ar» attacf>«3 inR*diat*ly bshind this pag*.
KEA3CN fCHTHI ECimCK . HFIA MTCTOCE
Inscription of product manufacturing proosM flO(d)
-------
6.
6AHPLE GOOD LAiORATOR* PRACTICE STATEMENTS
Eximpl* 1.
This stjdy metes the requirements for 40 CFR Part 160
Submitter
Sponsor ____^____________________—__
Study Director
Example 2.
This study does not meet the requirements of 4C
Part 160, and differs in Che following vayst
1.
2.
3.
Submitter
Sponsor
Stjdy Director
Example 3.
The •ubsUtter Of this study was neither the sponsor of this
study nor conducted it, and does not fcnov whether it has
been conducted in accordance with 40 CFB Part ISO.
Submitter '
1«
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i
ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Tr»n«mitt*l Document.
Related Administrative Materials
(*.g.» M*ehod of Support statement, ttc.)
Ottier materials about th* submittal
(*.g.» *ummarles of group* of ttuditt
to aid in thtir r»vi«w).
»ub«tttt<*
* when flagging requirements
are; finalised.
LEGEND
Documents which mus^ be submitted as
appropriate to meet established requirements.
'1
I Documents submitted at submitter's option.
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I
ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATTON
-------
i
aacasTCK HOT TO BKTCH SND-OSE HCDDCES CCUIAINING wnaEsoan1
OF MEETING ACDIE IQXZCTIY
SOLIDS FOR RIKRJatSi
RERSG3STOATICW
DMA KEQDXREMQtlS
IDG
TOR
In an effort to reduce the tine, resources and number of animals needed 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
ccBjxasition and biological activity), type of formulation (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 acute toxicity or the Agency lacked sufficient information for
ftecisiqn mxing purposes. Registrants of these products are responsible for
meeting the acute toxicity data requironents for each product.
Registrants most generate all the required acute toxicologies! studies for
each of their products. If a registrant chooses to rely, upon previously
submitted acute toxicity data, he/she nay do so provided that the data base is
complete and valid by today's standards (see acceptance criteria attached).
In deciding how to moot the product specific data requirements, registrants
mist follow the directions given in the Data Call-In Notice and its attachments
appended to the BED. The OCX notice contains two response forms which are to be
completed and submitted to the Agency within 90 days of receipt. The first fora,
"Data call-In
fOC
asks whether the- registrant will meet the data
?8fiMKtB StHtUS flUTC
required for each
Registrant's Response," lists the product specific data
product, including the standard six acuta taxicity test*. A registrant mist
select ana 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
tiiolA egg solid* could not be batched, registrants cannot choose from the
ramining option*: Cost sharing (Option 2) or Often to Cost Share (option 3} .
Table I.
Containing Putrescent ttnle Egg Solid*
IN t*fl. *».
4&M-S
4&M-9
4SM-10
4666-11
X Putrwc*m who it Iff
Solid*
1S.O
5.0
17.0
36.0
fonulttlon typi
Liquid
Liquid
Liquid
Dun
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i
ATTACHMENT E
EPA ACCEPTANCE CRITERIA
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I
Subdivision M
Guideline Ref. No, U'.B-tO
December :4, 1989
15IB-10 Product Idenury
ACCEPTANCE CRITERIA
Does ytnir study axset die fallowing acceptance criteria?
I. __ Product ume and trade nirae (if different)
1 __ Name, nominal concentration, and certified limits Cupper and tower) for each active
ingredient and eacb ititerttir>nalty-added. men ingredient
3. Name and upper certifies .mit for each impurity or each group of impurities present ai
>0,i% by weight and for certain toncologically significant impurities (e.g., mierobiai ioxins.
diojons. nuroiammes) present at N.*<
composition, properties or toxicity
9. _. Genus anil species (and strain, subspecies, isolate, etc., if applicable) from which the
biochemical was isolated or wi;h which it is commonly associated
10. _ Specificity of biochemical activity, the mode of action, and Meld rates at which the
biochemical is active'proposed (units at A, etc.)
U. __ Similarity to ihe aaturally-ocmmng biochemical, if noi derived from s biological enun
11 _ AH updated Confidential Statement of Formula must be provided (EPA Form 85~i)-4 rev
mi).
13. __ Any known or suspected hazards of the biochemical to man, the environment, or nonurgct
specks. • •
Criteria mtrtod wit* • * an ntpptanenui and may not be requited tor every study.
C-215
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i
M
Guideline Ref. No.
:4. 1989
15 IB- 11 Mjmufaciuruig Process
ACCEPTANCE CRITERIA
Docs your irody steel ine foUowiag acceptance criteria?
I. _ Description of manufacturing process or extraction/isolation steps if obtained from a
biological entity.
2. _ Statement of whether bitch or continyous process, if applicable
3. _ Relative amount of beginning ma ten a Ls and order in which they tre added
4. __ Description of equipment
5. ___ Description of physical conditions (temperature, pH, pressure, humidiry) controlled in each
step and the parameters that are maintained
6. ___ Statement of whether process involves intended chemical reactions
7. _ F!o* chin with chemical equations for each intended chemical reaction
&. ^ _ Duration of each step of process
9. ___ Description of purification procedures
i®- .._ Description of measures taken 10 assure quality of final product including identity of the
biological source, if applicable
1 *• -- A clear presentation of the stage at which inerts are intentionally added, if and when any
concentration is effected, the material so b« used as the manufacturing use product ;M*K
whether MP registration is sought, and whether a TGAi/MP is soM And/or shipped.
Criteria marked wliii • • m supplemental and may not b« required tor every iwdy.
C-216
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i
SuBCiv.i.cr M
Guideline Ref. NO. l:;3-i;
December ;i. I9g9
15 IB-12 DacaMioa of Fomuuoa of Unintended lagxoiknts
ACCEPTANCE CRITERIA
Does your study mow tie following acceptance criteria?
1. _ Discussion of formation of impunsia buc 0,1% or *u found it a 0.1% by product
and (2) certain toxicologicaily significant impurities present at < 04% by weight
Criteria marked wttfc a * m Mpptanntti and may not N reqaif** fef ewry
C417
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i
Guideline Ref, No
151B-D Ao*Ma of Stapfei
ACCOTANCE CRITERIA
Does y«ur «udy meet tlte (bUowing aaaeptaaoe criteria?
1- . Five of more representative samples (fetiches in cas« of batch process) analyzed for each
active ingredient and til impurities present »i > 0,1%
2, _ Degree of accountability or closure j> 0 98<%
3- .-..__,- Analy«» condoned for oenain irace towc impurities »t lo*er than 0.1% (examples.
nuroiafflines tn the ease of products containing dmitroiftiiines or oantaining secondan.' or
ternary amines/ilkanolafnines plus nitntes; polyhalogenated dibenzodionns and
dibetizofurans) (N'ote that in (fte case of nurosamines both fresh »nU stored samples should
be analyzed. 1
4. _CT-_ Complete and detailed description of each step in analytical method used to arulyte aixne
samples
5. __ Siaiement of precision and accvracv of analytical method used to analyze above samples
6. n mjr Identities jic! quantities (incUding mean and standard deviation) provided for each
ingredient
7- ; ; ; "Ow ten natertal is to be the purest pesticidal grade commercially produced prior to
intentional addition of snera. Generally, this twt material is the same as that used t^t
certain nnnurget and human hazard testing and is identical to, or equivalent to the Uv
AAV ditferences Iron the test su&suncc u&ed for hazard ustiBf should be noted
Criteria marked with « * am sapptemtatal and may BOI be raqeiiwl tor
C41S
-------
n M
Guideline Ref. No. !5i3-^
December 14, 1949
1518-15 Certification of Limits
ACCEPTANCE CRITERIA
Does your study ami (fee foUowuf acceptance criteria?
1- .__ Upper and lover certified limits proposed for each active ingredient and intentionally added
men along with explanation of how the limits were determined
2. ___ Upper certified limit propoied tor each impurity present at j 0.1% and for eeniin
toncologicaily signifiaai impurittes at < 0.IT: along with erpliruiton of how each limit is
determined
3. Analytical methods to vtrify certified limits of each active ingredient and impurities (laiier
not required if exempt from requirement of tolerance or if generally recognized as safe by
FDA) are fully described
4. __ Analytical methods to verify certified limits validated as to their precision and accuracy
Criteria muted wilt • « if» Mpptemtnui and nay not be requind lor «vt*y itudy.
C-219
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I
Guideline Ref, So if :3-
Dtcem&cr *4. j*
S51B-17 p&ysiaU aad Chemical Properties
ACCEPTANCE CRITERIA
Does your srudy neet tie faUoviig aocepuoce criteria?
A. Color
mjr, Verbal description of coloration (or lack of it)
___ Any intentional coloration also reported in terms of Munsetl color system
3. Physical State
.,„. Verbal description of physical state provided using terms such as "solid, granular.
volatile liquid*
__ Based OB visual inspection at about 20-2J*C
C. Odor
_„_ Verbal description of odor for tack of it) using terms such as "garlic-like,
characteristic of aromatic compounds*
_._^_. Observed at room temperature
D. Melting Point
______ Reported in *C
_ Any observed decomposition reported
E Boinf Point
.____. Reported in *C
__,_i Pressure ander which B.P. measured reported
. Any observed decoa»po*uiori reported
\ F» Density. Bulk Density, Specific Gravity
_^. Measured at about 2C-1»*C
t ..._^ Oensity/tmlk density reported in fm! oj the specific gravity of liquids reported with
I reference to water at 2.TC (NOTE: For a solid in paniculate form a measurement
of bulk deattty nay be .ubsi.iuted for measurement of density.)
C. Solubility
__ OeteroUaed IB distilled water, n-ocunoi and rrpreseBtauve polar and non-polar
sohvflca, iadudini those used in formulations and analytical metftods for the
pettkad*
_ Meatvred at abotit 20-Z5-C
___t Reported ia f/lQOnl (oilier units like ppm acceptabk if jparinfly soluble)
H. Vapor Preuure
_._L_ Meatured at *2S*C (or calculated by extiapoladon from measttrementj made at
Criteria marked wftb a * art jupplemeatal aad may not be required for every study.
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i
Subdivision y
Ouideline Ref- No. 15154-
D«cemb«f 24.
1. pH
I Stability
higher temperature if pressure too low to measure at IS'C)
Experimental procedure described
Reported in mm Hf (torr) or other conventional uniu
Measured at about 20-25*C
Measured following dilution or dispersion in distilled water
_„ Sensitivity to metal tons and meia! determined
___ Stability ai normal and elevated temperatures
_ Sensitivity to sunlight determined
K» Rammability
__ Flash point reported in *F or *C
. Flam* extension or flame projection reported to nearest centimeter or nearest inch
L Storage Stability
M. Viscosit*
S. Miidbililf
Product stored in its commercial package or smaller one of same construction and
materials
Amount of active ingredient determined in product at beginning and end of texi
period (duration of at least one year or 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 test
Product stored at about 20-25'C (and 50% relative humidity if permeable packaging)
31 under warehouse conditions reflecting expected storage
Report includes duration and conditions of storage, quantitative analyses of *« me
ingredient, and identification of any deterioration, degradation products, or prmicat
changes {and consequences of latter on safe handling and use of product)
Determined at about 20-2S*C
Reporud la potset, stoke*, or other conventional units
« about 20-25*c
Product atad *ita petroleum solvents whose oonpottttoa reflects those on label and
« rats oil WMl
Mtaw* tomlnrd for separation after 30 minutes
Criteria marked with • • irt sspptoaeaiil and any not be required tor every stody.
C-221
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M
Guideline R«f, NO !5s3-i"
D*cember 14, 1989
O. Corrosion Characteristics
___ Data on corrosion characteristics provided (experimental method de*cnb«d) or
reasonable explanation given for lack of eorrosiveness based on nature of
(e.j., jack of ertreme pH; unreactivej
P. OctanoL'waser Partition Coefficient
Measured at about 20-25'C
___ Experimetiully deiermined and desaiption of procedure pvided (preferred method-
45 Fed, Register 77350)
Data supporting reported value provided
Criteria narfcwl wftb « • if» iappktn«aul «ad mty not bt requind tor every «ady.
C-ZS
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I
Subdivision M
Guideline Rsf. No. 15:3-10
December 24. 1989
I52B-IO Acute Oral Tenacity
ACCEPTANCE CRITERIA
Docs your study meet tte toitowmg tcceftuce criteria?
I- __ Technical fora of the active ingredient tested, (for registration only)
-•*__ At least 5 young adult rats/ses/froup
3. __ Dosing, single oral dose or in fractions over 24 hours.
4.* Vehicle control if other than water.
5. _ Doses tested, sufficient to determine a toxinty caiagy or a limit dose (1000 Rig/kg).
6. __ Individual observations at least once a. day,
7. Observation period to last at least U days, or until all test animals appear normal whichever
is longer,
8. Individual daily observations,
9.* Individual body weights,
to.* Gross necropsy on all iniraalf.
Criteria marked with t « an mppkmeattl ud may not be required for every study.
C-223
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I
Guideline Ref, No 15;S-| [
1528-11 Acute DennaJ Toociry
ACCEPTANCE CRITERIA
Does your study meet (fee feUcwtag wcepuace criteria?
1, ___ Technical form of the active ingredient tested, (for reregisintion only)
2.' At least 5 ini»als*ex'group
3.* RJU 200-300 fm, rabbits 10-3,0 kg or guinea pigs 350-450 fta.
4 ___ Dosing, stngli dermiL
5. _, Dosing (Juritton « least 24 hours.
6.' Vehicle control, only if toxiciiy of vehicle is unknown.
7. __ Doses tested, sufficient to determine a io*icoty catagory or i limit dose (2000 mg,Kgj.
8. Application stte clipped or shaved ai least 14 hours before dosing
9- .-.—. Application site it least 10^ of body surface area.
10. ___ Application site covered with a porous nunirnuung cover to retain test material and to
prevent ingest ion.
11. __.__ Individual Ptoservitioni n least one* 3 day.
12, . - ObserwiM period to last at iea&i U aa^.-w-wmi-aiLtejt jjimats appear normal whichever
is longer.
13. _^^ Individaal daily ob«fvitions.
14.'___ Indrvldual Body weights.
15.* Gnm necropsy on all animals.
Criteria nartod «itb a * an mpptentaiai and may not be required foe evtty study,
C-224
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E
, Subdivision M
Guideline Ref. S'o. iJIB-II
December 14, 5989
1528-12 Acute lohaiaUon Tenacity
ACCEPTANCE CRITERIA
Doa your study meet tie following accepuoce criteria?
L ___ Technical form of the active ingredient tested, (for rerefistration only)
~ __ Product is a gas, a solid which may produce a significant vapor hazard bued on toucuy and
expected use or contain* particles of inhaiable size for man (aerodynamic diameter IS um or
less).
3.* At least 5 young adult rau/jex/poup,
4.* Dosinj. at least 4 hours try inhalation.
5.* _ Chamber air flow dynamic, at least 10 air changesdiour, at least 19% oiygen content.
6. Chamber leinptrutire, 22* C (±2*), relative humidity 40-60%.
7. ^_ Monitor rate of air flow.
8. . Monitor actual concentrations of teat material in breathing zone.
_ 9. _ Motor .(jrodyuaniie panicle lize for aerosols. ———
10, _.. Doses tested, sufficient to determine a toiicity category or a limit dose (S m§/L actual
concentration of respirable substance).
U. .L Individual observations at least once a day.
1- __ Otwervation period to last at least 14 days, or until ail test animals appear normal *h
is longer.
i 13. __ Endividuai daily observations.
v 14.' Individual body weights.
IS.* Cross necropsy on aJI animals.
Criteria ouurtat with • * vt npptemcaul and may sot be required for every study.
C-225
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\
Guideline Ref, s'o. 15:3-1
December 24. 198
1523-13 Primary Eye tirttauos
ACCEPTANCE CRITERIA
Does yooi study ami tbe foUowtfig acocptaace cntcru?
I ____ Technical form of the active ingredient tested, (for reregistnuton only)
1 __ Study not required if material is corrosive, causes severe denml irritation or his a pH of < ;
or i 1U.
3.* 6 adult rabbits
4. ____ Dosing. insiilSauoB into the conjunctiva! iac of one eye per animal.
$.'___ Dose, 0.1 fnl if a liquid; 0.1 ml or aot more than 100 m| if a solid, paste or .'ticulate
suMuDce.
6. __._ Sotid or granular test material ground to a fine dusi.
7. ^_^ Eyes not wasfted for at teasi 24 hours.
S. Eyes examined and graded for irritation before dosing and at 1, 24, 48 and 72 hr, then daily
until eyes art normal or 2! days (whichever is shorter).
*)• ^_-, ladividual daily
Criteria aurtod witk a * «n sa^Hacatal tad may not bt requirwl for «*ety
• C-226
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i
Guideline Ref. No. l-:3-u
Decem&cr 14. 1989
152B-14 Primary Denna! Imtatkm
ACCEFTANCE CRITERIA
Does your »«fy owe* tfce foUowing accepuace criteria?
I. . Technical form of the active ingredient tested (for reregistration only)
2. . Study not required U material is corrosive oc has a pH of $ 2 or i 11.5.
3.* 6 adult animals,
4. ___ Dosinf. single dermal.
5- __ Dosing duration 4 hours.
6- ^^ Application site shaved or clipped at least 24 hour prior to dosing.
?. __ Application site approximately 6 cnr.
8. _ Application site covered with a gauze patch held in place with nonimuting tape
9. __ Material removed, washed with water, *uhoui irauma to application site
10. __ Application site examined and graded for irritation at 1. 24, 48 and 12 hr, then daily until
normal or 14 days (whichever is shorter),
11.* Individual observations for the entire day of dosing,
12.* Individual daily observations.
Criteria mtttod will a * an sapptooeaul and may not bt required for every study.
C-227
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SubuiMsion M
Guideline Ref. No ::;3-S5
December *4. ;9§9
152B-15
ACCEPTANCE CRTTERJA
Does your itudy meet tbe fbUowuif acceptance criteria?
I. _. __ Technical form of the active ingredient tested, (for reregistration only)
2. ___ Study not required if material a corrosive or has a pH of $ 2 or > 11.5.
3, . One of die following methods is utilized;
.. Freund's complete adjavini test
_L_I Guinea pi| maxifflizition test
____„ Split adjuvint technique
^^^ Suehler test
_ Open epioiuneous test
_ir_iL_ K4uer optmjLanon test
_ Footpad technique in guinea pif
_ Other t«t accepted &y OECO (speciM ____ ____I1_1
•J. ^_ Complete descnption of test
5.' . .. Referenc* for test.
6. ___ Test foliowAd euentially ai described in reference document
7." Positive control included.
Criteria markad «itb a * an s^pKowattl and may wn t* required tor tvtir study.
C-22S
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ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
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Page l ot
United States Environmental Protection Agency
Washington, D. c. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case t and Name: 4079 Putrescent whole egg solids
Co. Mr. Company Nafta • Additional Name Address city & state zip
MTMBft, IK. B5W HUSBWU *¥£. SOUTH MMHEArailS KM SS420
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I
ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
-------
United States Environmental Protection Agtney
4Hi Wt*ir\i\ Washington, DC 10410
^Hf •"" Mp«X CERTIFICATION WITH RESPiCT TO
^^ •"•« •* » DATA COMPENSATION REQUIREMENTS
Fern Apprevta
Qua Na. aora.gisf
Public reporting ourdtn (or tr«s- eoliectjon o» information is estimated to average 1 5 m nutei per response; including
time for reviewing instructions, searching *xisting data sources, gathering and mairrta nmg the data needed, and
completing and reviewing the coiled ion ot information. Send comments regarding the burden estimate or any other
aspect ol this collection ot information, (needing suggestions for reducing this burden, to Chief, information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washir^ton, DC 2W60: and to the 0«*e
oi Management and Budget, Paperwork Reduction Protect (2070-0106), Washington. DC 20503.
Pieaae fill in blanks below.
C««».fty *.m.
Product Naat
> Certify that:
EPA
Rtg. No.
1.
tacn study eittd in support of registration or rtngistration under the Federal insecticide, Fungicide and
Act (FiFftA) tnat is an exclusive use study, I am the original data submitter, or I have obtained tne "
permission of tne original data submitter to cite tnat study.
That for each study cited m support of registration or registration under F1FRA that is NOT an exclusive use
study. I am tht original data submitter, or 1 nave obtained the written permission of tht original data submitter, or i
nave notified in wriing the company(its) tnat submitted data I have crted and have offered to: (a) Pay
compensation lor those data in accordance with sections 3(c)(i](D) and 3(c)(2)(D) oi FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FlFRA and the amount oi
compensation due, I any. The companies I have notified are:
[] Tht companies who Ittvt submniacl mt studies fisted on the back of this tonn CK attached
sheet*. Of Micated on tht attached •Requirements Status and Registrants' Response Form,'
3. That I have prev*x^eeflpe^wtJiseaion3 3<0(2)(D).
"•—
Naa* Mi TIH*
Oat*
(Pieaae Tfps *r PtlM}
If A
f«.t«t
-------
F/EPA
United Suits Environmtntai Protection Agincy
Waihlngton, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Farm Approv«<3
OM| Ha, 3670-0101
Ap»'OVil Eigirti 12-Jl-l}
Public rtporting burden for tntf coiitction ol information it ijtimattd to avtragi 15 rrunytti per rt sponst, including
time for rtvitwing instructions. Marching aiisting diti sources, gilftf nng and maintaining the data needed, and
completing and rtviewing tht celltdion ot Mormat'on. Stnd comm«nts rtgarding tha burdan astimita or any olhtr
asptct of inis cotl«c5cn ot information, including suggtstions for rtducing this burdtn, to Chiaf, information Policy
Branch, PM-223, U.S. EnvironmtntaJ Proitctcn Agtncy, 401 M St., S.W . Washington. DC 20460: and to the Of ce
of Managtman and Sudgti, Paptrwerk RtcSoctJon Projtet (2Q7CHJ106), Witrtington, DC 2C503.
Pfaasa nil in blanks baiow.
C*mpift)f Nin»
Pro-duct N*m« •
EPA Rtg. Ho.
i Cartify that:
My company is willing to dtvtlop and tubmi! tha data raqyirad by EPA undtr thi authority of tha Ftdtral
insacticida, Fungicidt md Rodamicidt Act (FiFRA). if nactssan/. Howtvar, my oomptny would praftr to
•ntar into an agratmtnt with ona or mora rtgistrants to davalop jointly or than in tha cost of dfvaioping
data.
My firm has offarad in writing to tntar into such an agraamant. That offar was irravocabi* and included an
orfar to tn bound by arbitration decision undtr saction 3(c)(2)(B)(iti) of FiFRA if final agraamtm on ail
terms could not ba reached otherwise. This offer was made to the following firm(s) on the following
dams):
N«ffl« •( Hrm(u)
Btw *t Olftf
Carttfieatten-
cenJry that lam duly authorized to repcesert the oon^any named above, and that the sUttements that 1 have made on
Ihts form and al attachments therein am ttut, aecuratt, and oonpiett. lt«Jtfiow1i^Qttf«ainfluwwin9ly«aJseof
misleading SJatamanj may be purUeftattt by fine Of inprisewmmotbomyftdtfapplleaWiliw.
•ifiiaiiira *l C««»iny't Autl«*riMtf HaprasMtatfv*
Data
N>IM ane Una (MtaM Tyt« at MM)
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i
Wwfiifigton. DC 20440
vvPRA Product Specific
%**-' ^ Data Reoort
^•flimtion
GuXjififlt SO
Ste. 158.120
Product
Chemistry
ti.i
. •i-ar.i
•i-^fljj
aj-i
^ *2-2
82-3
«3-2
S3.3
83-*
8»S
S3-4
83-7
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43-9
•3-10
83-11
S3-) 2
83-13
83-14
KJ-iS
a-lC
83-17
ao-n
0-19
•340
83-J1
Stt. 1M.J33
Tox»CO*OOY
•1-1
si-a
•14
•1-4
•14
•14
N«rn« of Titt
!3*Rtny of lnorMi*nn
Sttumtm of aempoution
OiCutxen of (wmation of inerMiini*
Priiimmvy ina/ytii
Cctifieatien o* iimtn
Aflilylic*/ m*thMI for «ftj 5y •
Deng MS ;0 No
SuSWAng D»u
i*AAie/«0j
/QtK* M«o*j
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^0~- *C3'3vta
;.MS *^:•^oci•
s»S"M M.JM9
i^o* £P*U»«
Onljr)
Aec*uien
«wm6«r|
U»i7»»d
•
C*nine«tion
certify that th« stitfm*nts i hav» madt on this form and afl attadmants tharato are
trua, acewata, and conpJttt. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or Doth under applicable taw.
tPA Hm MM*
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I
United Scates
Environmental Protection
Agency
Office of Prevention, Pest
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I
Human Health
And Environmental
Assessment
Although EPA has developed a set of data 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 toxieity
and efficacy). These studies are being required now, through the RED.
Product Labeling
Changes Required
Regulatory
Conclusion
The labels of putrescent whole egg solid pesticide products must
comply with EPA's current pesticide labeling requirements.
• The registered animal repellent uses of putrescent whole egg
solids ire 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 Mora &PA » 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 federal
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i
Register. To obtain a copy of the RED or to submit written comments,
please contact the Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
In the future, the putrescent whole egg solids RED will be available
from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 703-487^650,
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), OPP, 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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