•V
United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
September 1992
Reregistration
Eligibility Document
(RED)
93-226
Nosema locustae
U.S.
. iitefTsrs
• to cede 3201
1 200 Pefitis
Uorar
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OCT 6 1992
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection
Agency has completed its reregistration eligibility decision on
the microbial pesticide active ingredient Nosema locustae (N.
locustae).
Enclosed is a Rereqistration Eligibility Document (RED) for
the microbial pesticide active ingredient N. locustae. The RED
is the Agency's evaluation of N. locustae*s data base, its
conclusions regarding human and environmental risks associated
with the current product uses, and its decisions and conditions
under which uses and products will be eligible for
reregistration. Also enclosed is the EPA RED facts and the
Pesticide Reregistration Handbook which provides instructions to
registrants on how to respond to any labeling and data
requirements specified in the RED and how to reregister products.
This RED identifies outstanding product specific data
requirements for end-use products only. These requirements are
listed on the Requirements Status and Registrant's Response Form.
which, along with the Data Call-In Response Form listing all of
your company's products subject to the RED, is included as an
Attachment. Instructions for completing both forms are contained
in the RED. All product specific data must be submitted and
found acceptable by EPA before a product can be reregistered.
In addition, in order to be reregistered, all product
labeling must be in compliance with format and content labeling
as described in 40 CFR 156.10 and all labeling changes imposed by
Pesticide Regulatory (PR) Notices, and any label changes imposed
by this RED. The Pesticide Reregistration Handbook contains
detailed instructions for compliance with the RED and must be
followed carefully.
There are several key points to remember in preparing your
response to the RED:
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Within 90 days of YourReceipt of ThisLetter
1. For each product which is subject to this RED, you must
complete, sign and submit the data call-in (DCZ) response forms
attached to the RED [Attachment B has forms for product specific
data]. Follow the instructions in those Attachments for
completing those forms and submit the forms to the appropriate
address specified on page 6 of the Product Reregistration
Handbook. Note that the DCI forms for product specific data are
to be sent to the Registration Division Product Manager named at
the end of this letter. The mailing distribution code for your
response is RED-RD-PM18.
2. With respect to the product specific acute toxicity
data requirements, EPA has created "batches" of products which
are toxicologically similar (Attachment D). If your product is
listed in a "batch" you have the option of participating in the
batch. If you wish to participate, you should consult with other
registrants in the batch and agree on who will provide data.
Carefully follow the instructions in Attachment C to assure that
one registrant is committing to provide the data while the others
offer to share in the cost of those data. Of course, if you do
not want to join the batch, you must commit to provide the data
on your own.
3. No time extensions will be granted for submitting 90-
day responses. If EPA does not receive a response for a product,
it may issue a Notice of Intent to Suspend that product.
4. Any requests for data waivers or time extensions to the
8-month deadline, detailed below, must be submitted as part of
your 90-day response. Such requests will not be considered in
the 8-month response.
within Biaht Months of the Date of This Letter
1. For each product, you must submit a completed
Application for Registration (EPA Form 8570-1), five copies of
the label and labeling revised as specified by the RED and in
accordance with current requirements, two completed copies of the
Confidential Statement of Formula (CSF) (EPA Form 8570-4), a
completed Certification with Respect to citation of Data (EPA
Form 8570-31), and data or references to data (see item 2 below).
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2. You roust submit or cite the required product specific
data as part of your commitment for reregistration. For most
products, you will probably be citing data which have already
been submitted to EPA. In these cases, you must submit a list of
the studies and the corresponding EPA identifier numbers (i.e.,
accession or MRID numbers). Before citing these studies, you
must make sure that they meet EPA'a current acceptance criteria
(Attachment £). Be sure to follow data formatting requirements
in PR Notice 86-5. Failure to adequately comply with the data
requirements specified in the RED may result in the issuance of a
Notice of Intent to Suspend a product.
3. The labeling and CSF which you submit for each product
must comply with PR Notice 91-2 (Appendix D). That notice
requires that the amount of active ingredients declared in the
ingredient statement must be stated as the nominal concentration
rather than the lower certified limit.
You have two options for submitting a CSF: (1) accept the
standard certified limits (see 40 CFR 158.175) or (2) provide
certified limits that are supported by the analysis of five
batches.
If you select the second option, you must submit or cite the
data for the five batches along with a certification statement as
described in 40 CFR 158.175(e).
4. Send your Application for Registration to the
Registration Division Product Manager in the Registration
Division who is assigned to the product, Phil Button. Use the
correct address shown on page 6 of the enclosed Product
Reregistration Handbook. Note that the mailing distribution code
for your response is RED-RD-PM18.
Questions on product-specific data requirements and labeling
should be directed to the Registration Division Product Manager
for N. locustae, Phil Button at (703) 305-7690. Questions on the
generic database must be directed to Sue Rathman, the Review
Manager in the Special Review and Reregistration Division at
(703) 308-8069.
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If necessary, the Agency will meet with registrants who have
questions about responding to the N. locustae RED; however/ only
one combined meeting will be held for all interested registrants.
If you want to meet with the Agency, you must contact Phil Button
within 30 days of your receipt of the RED.
If there are any requests for such a meeting, the Agency
will notify all registrants who requested a meeting of the
location, date and time. Requests for a meeting will not extend
the 90-day or 8-month response deadlines.
Sincerely,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Enclosures:
RED for N. locustae
DCI
EPA RED FACTS
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REREGISTRATION ELIGIBILITY DOCUMENT
CASE NAME:
Nosema locustae
ACTIVE INGREDIENT:
Nosema locustae
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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EPA N. locustae REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Paul Guillebeau
Environmental Fate and Effects Division
Leo LaSota
William Schneider
David Bays
Health Effects Division
Esther Saito
J. Thomas McClintock
Laura Morris
Judy Smith
Registration Division
Phil Mutton
Willie Nelson
Ian Blackwell
Sami Malak
Special Review and Reregistration Division
Sue Rathman
Barbara Briscoe
Carol Stangel
Policy and Special Projects Staff
Kennan Garvey
Office of General Counsel:
Steve Wolfson
Office of Compliance Monitoring:
Jonathan Packman
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TABLE OF CONTENTS
Page
GLOSSARY OF TERMS AND ABBREVIATIONS
EXECUTIVE SUMMARY
I. INTRODUCTION
H. CASEOVERVDZW
A. CHEMICAL OVERVIEW
B. USE PROFILE
C. REGULATORY HISTORY
ffl. SCDENCE ASSESSMENT OF N. locustae
A. PRODUCT IDENTITY/CHEMISTRY ASSESSMENT
B. HUMAN HEALTH ASSESSMENT
C. EXPOSURE ASSESSMENT
D. ENVIRONMENTAL ASSESSMENT
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. DETERMINATION OF ELIGIBILITY
B. ADDITIONAL GENERIC DATA REQUIREMENT
C. LABELING FOR MANUFACTURING-USE PRODUCTS
V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS
A. DETERMINATION OF ELIGIBILITY
1. Product Specific Data Requirements
2. Labeling Requirements for End-Use Products
iv
v
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2
2
2
3
3
3
4
5
6
8
8
8
8
9
9
9
9
11
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VI. APPENDICES
APPENDIX A - Use Patterns Subject to Reregistration
APPENDIX B - Generic Data Requirements for Reregistration and Data
Citations Supporting Reregistration
APPENDIX C - Citations Considered to be Part of the Data Base
Supporting Reregistration
APPENDIX D - PR Notice 91-2
APPENDIX E - Pesticide Reregistration Handbook
APPENDDC F - Product Specific Data Call-In
Attachment A - Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms (Form A) plus
Instructions
Attachment C - Requirements Status and Registrants1 Response Forms
(Form B) plus Instructions and PR Notice 86-5
Attachment D - EPA Groupings of End-Use Products for Meeting Data
Requirements for Reregistration
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrant(s) sent this DCI
Attachment G - Cost Share/Data Compensation Forms
Application for Registration
m
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GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
MCPA Microbial Pest Control Agent
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
The U.S. Environmental Protection Agency (EPA) has conducted a comprehensive
review of the available scientific data and other relevant information supporting the
reregistration requirements of the microbial pesticide active ingredient Nosema locustae (N.
locustae). EPA has concluded that the current approved uses of this microbial pesticide will
not result in unreasonable adverse effects to humans and the environment. Therefore, all
currently approved uses are eligible for reregistration.
In this Reregistration Eligibility Document (RED) EPA provides a summary of the
scientific assessment of these data and information, conclusions of the risks associated with
the current uses of this microbial pesticide, a description of these uses, and determination of
reregistration eligibility for each current use. EPA also provides product labeling and data
requirements that must be met by registrants to achieve product reregistration.
Products containing N. locustae 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, the EPA is requiring that product specific
data and revised labeling be submitted by the registrants within eight months of the issuance
of this document. After reviewing these data and the revised labels EPA will determine
whether or not the conditions of FIFRA 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 N. locustae in combination with
other active ingredients will not be reregistered until REDs are issued for all active
ingredients contained in that product.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to
be completed in nine years. There are five phases to the reregistration process. The first
four phases of the process focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and submission of data to fulfill the
requirements. The fifth phase is a review by the U.S. Environmental Protection Agency
(referred to as "the Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." thus, reregistration involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration of N.
locustae. The document consists of six sections. Section I is the introduction. Section II
describes N. locustae, its uses, data requirements and regulatory history. Section in
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV discusses the reregistration decision for N. locustae. Section V
discusses the reregistration requirements for N. locustae. Section VI is the Appendices
which support this Reregistration Eligibility Document. Additional details concerning the
Agency's review of applicable data are available on request.1
EPA's reviews of data on the set of registered uses
considered for EPA's analysis may be obtained from the OPP Public
Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
Chemical Name: Nosema locustae
Office of Pesticide Programs
Chemical Code: 117001
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 N. locustae is in Appendix A.
Type of Pesticide: Microbial insecticide
Mode of Action: Protozoan infection; infectious disease. Product must be eaten by insect to
be effective.
Use sites:
TERRESTRIAL FOOD + FEED CROP: Agricultural crops/soils (unspecified),
vegetables.
TERRESTRIAL FEED CROP: Rangeland.
TERRESTRIAL NON-FOOD + OUTDOOR RESIDENTIAL: Ornamental lawns and
turf.
TERRESTRIAL NON-FOOD: Fencerows/hedgerows.
Pests: Grasshoppers and Mormon crickets.
Formulation Types Registered: Bait/solid: 0.05% to 0.1 % A.I.
Bait/liquid: 0.05% A.I.
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Methods and Rates of Application:
The solid baits are applied by aircraft, ground spreader, or shaker can at rates up to
0.001 Ib A.I. per acre. Liquid formulations and some of the solids are diluted and mixed
with bran. The treated bran is applied at 1 Ib per acre by aircraft, ground spreader, or
shaker can.
Use Practice Limitations: None.
C. Regulatory History
The first registration of a product containing N. locustae was issued May 9, 1980.
N. locustae is a microbial pesticide, made from the spores of the protozoan of the same
name. There are presently six registered products containing N. locustae. These products
are solid bait and liquid formulations which are used to control grasshoppers and crickets in
crop, fields, lawns and turf, and fencerows and hedgerows.
III. SCIENCE ASSESSMENT
EPA has reviewed the scientific data base for N. locustae primarily relying on data
submitted by the registrants and information from published literature. These are cited in
Appendix C.
A. Product Identity/Chemistry Assessment
The active ingredient consists of spores from the protozoan, N. locustae (Canning), a
microsporidian belonging to the family Nosematidae, which is infectious to certain
grasshoppers and crickets. The life cycle of N. locustae includes a spore stage characterized
by spores of unicellular origin, a single sporoplasm and usually one long tubular polar
filament through which the sporoplasm emerges. Following ingestion by a susceptible host,
N. locustae spores penetrate the midgut epithelium, the vegetative forms replicate in the fat
body, and upon depletion of host tissue, sporulation occurs releasing viable spores. N.
locustae infections are generally diagnosed by the presence of spores in the fat body of
susceptible hosts. Spores which measure 3.5-5.5^ (mean of 5.2/0 in length by 1.5-3.5/*
(mean of 2.8/x) in diameter may be ellipsoidal, slightly-bent or kidney-shaped and refractive
to light. Triangulate and elongate megaspores (8.0/z in length) are also common.
Based on the data and information submitted all physical and chemical properties data
have been satisfied; consequently, no additional generic product identity data will be
required.
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B. Human Health Assessment
1. Toxicology Data Base
There is some preliminary evidence that N. locustae and other similar microorganisms
are not hazardous for mammals or humans. The toxicology data considered to support the
reregistration of N. locustae included acute studies, a 90-day feeding study, and an
intraperitoneal injection study in mice. No adverse effects were noted in any of these
studies. Although a pattern of clearance was not demonstrated in the acute toxicology studies
the results from the intraperitoneal study suggested that the N. locustae spores were
inactivated during passage through mice. Such inactivation was demonstrated using tissues
and peritoneal lavage fluid from treated mice which, upon bioassay, did not produce the
characteristic symptoms of the disease in grasshoppers. The subchronic and chronic studies
with microbial pest control agents (MCPAs) are required when acute exposure studies
indicate unusual persistence of the active microbial ingredient in the tissues, organs, or body
fluids of the test animal, in the absence of any signs of toxicity or pathogenicity. Therefore,
the lack of pathogenicity and toxicity in the 90-day feeding study with AT. locustae indicate
that even if unusual persistence were occurring, repeated dosing would not result in an
adverse outcome. It is more likely, however, that the lack of adverse effects in the 90-day
study support also the lack of persistence of N. locustae in the test animal.
Additional studies in support of the toxicology data base included injection of rabbits
with AT. locustae by the intracerebral or intraocular routes which did not result in any
detectable illness at the clinical, gross or histological levels. Based upon review of the
submitted data base all relevant toxicology requirements have been satisfied.
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A summary of the toxicology data base is provided below. The Guideline Reference
Numbers are as specified in Subdivision M of the Pesticide Testing Guidelines (October,
1982).
Toxicology Data Base
Guideline Study Results Acute Toxicology
Number Category
152A-10 Acute Oral IDs, (rat) > 2.3x10' spores IV
152A-11 *Acute Dermal LD» (g. p.) > 2.3x10'spores IV
152A-12 Acute Inhalation (rat) 10.2 mg/L M locustae IV
152A-13 *Primary Eye Irrit. (rabbit) 2.29xlOV0.1 ml IV
152A-14 'Primary Dermal Irrit. ID,,, > 2.3x10' spores IV
152A-15 'Delayed Hypersensit. (g.p.) Approx. 107 spores/inj. Sensitizer
Intraperitoneal (mice) No Adverse Effects Acceptable
152A-20 *90-Day Feeding (rat) No Adverse Effects Supplementary**
152B-33 *Intracerebral (mice/rabbits) 2.9xlO'/ml
152B-33 'Intraocular (mice/rabbits) 2.9xlO'/ml
•Currently, not required to support the registration of the TGAI of a microbial pesticide.
•'Classified as Supplementary because the spore dose level in the diet was not provided.
C. Exposure Assessment
1. Dietary Exposure
N. locustae is exempted from the requirement of a tolerance for residues in or on all
raw agricultural commodities (40 CFR 180.1041). Such an exemption was based on the
toxicology data base, the long and safe historical use of the MFC A, and the rapid
inactivation of the microorganism by light and temperature. Residue studies therefore are
not required.
2. Occupational and Residential Exposure
In Section n the Agency provided a brief description of the types of product
formulation, application methods and sites. The technical grade material or liquid
concentrate is formulated onto a wheat bran bait which is applied by ground equipment to
cole crops, orchards, forests, lawn and gardens for consumption by the target pests
(susceptible grasshoppers and crickets). Although small amounts of N. locustae will become
free from the bran bait, this amount is considered insignificant when compared to exposure
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during manufacturing. However, the efficacy of the product depends upon rapid ingestion of
the protozoan on the bait and the ability of the microorganism to replicate in the target pest.
Following application of N. locustae most, if not all, of the bait will be on the soil surface
and not available on the crop prior to harvest.
Based on the application methods, significant dermal and inhalation exposure to the
mixer/loader/applicator exists, i.e. ground boom applications to row crops. However, due to
the lack of lexicological concerns for N. locustae, no exposure data are required at this time.
3.
Risk Characterization
The potential risks to human and/or mammals from both nondietary/dietary and
occupational exposures are considered insignificant as supported by the existing toxicology
data base. Such data clearly demonstrated the lack of detectable dose-related effects at the
clinical, gross or histological levels and the inability of the microorganism to replicate or
accumulate in the tissues of the treated animals. In addition, N. locustae has not been shown
to replicate at temperatures above 35°C or able to infect and/or replicate in warm blooded
animals. Although N. locustae was a sensitizer when injected into guinea pigs, a dermal
sensitization study is no longer required for microbial pest control agents because it is
assumed that injection of foreign proteins is likely to elicit a response and that dermal
application would elicit no response. The reporting of any allergic reactions following
exposure is currently required by the revised 1989 Microbial Pesticide Guidelines
(Subdivision M of the FIFRA Testing Guidelines, NTIS PB 89-211676).
D. Environmental Assessment
1.
Environmental Fate
Since there are no ecological effects concerns from this naturally-occurring
microorganism, no environmental fate data are required. These studies are in Tier II and are
only needed if there are significant adverse effects seen in the Tier 1 ecological effects
studies.
2.
Ecological Effects
Sufficient studies were received to perform an ecological hazard assessment.
Although not all the studies were performed in accordance with the revised 1989 Microbial
Pesticide Guidelines (Subdivision M of the FIFRA Testing Guidelines, NTIS PB 89-211676),
(e.g. few controlled studies were carried out long enough to detect subchronic infection or
delayed pathogenicity), the Agency would not expect any adverse non-target effects from this
protozoan. No adverse effects have been reported from the many years of experience with
environmental releases of this microorganism. N. locustae has been tested and studied for 20
years, and has been registered and used in the field since 1980. Considering this experience,
in conjunction with acceptable acute studies, the Agency foresees no significant adverse
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effects on nontarget species or the environment from the registered uses of N. locustae.
Ecological Effects Data Base
Data
Requirements
154-16
Avian Acute Oral
Test Effects
Substance
Citation Fulfills Waiver
Guideline for Data
Requirements? Granted?
Quail
Pheasant
Duck
Avian injection
Pheasant
154-19
Fish
TicutLCjo
Trout LCjo
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
LD50 =
> 2,000 mg/kg
no mortality
no mortality
no mortality
no mortality
no mortality
247757
408143-04
Patuxent
Wildlife
408143-05
408143-06
247757
no (core-acute)
no (supplemental)
no (supplemental)
no (supplemental)
yes (core)
yes (core)
yes
N/A
yes
N/A
N/A
N/A
154-20
Aquatic Invertebrate
Daphnia magna
154-24
Honeybee
154-22
Non-target Plant
154-23 .
Non-target Insect
TGAI no mortality 247757 no (supplemental) yes
TGAI no mortality article no (supplemental) . yes
none submitted no
none submitted no
yes
yes
3.
Environmental and Ecological Risk Assessment
These studies show that N. locustae should not have an adverse effect on avian
species, aquatic invertebrates, and honeybees on an acute basis. The lack of adverse effects
reported from the many years of use and study of N. locustae in the field allows for
sufficient confidence to waive the subchronic infection and delayed pathogenicity data
requirements. In addition to the above studies, no pathogenicity or toxicity was documented
to freshwater trout.
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No beneficial nontarget insect studies were submitted. It is unlikely that nontarget
insects would be exposed to N. locustae at greater than naturally-occurring levels since the
spores and mycelium are formulated on wheat bran bait and applied directly to areas where
grasshopper infestation occurs, preferably when the grasshoppers are still nymphs. These
studies are waived. Nontarget plant studies were not submitted. These studies are also
waived since the Agency is not aware of any association of N. locustae with plant diseases
despite extensive analysis of agricultural diseases by academia, government and industry.
IV.
RISK MANAGEMENT AND REREGISTRATION DECISION FOR N. Locustae
A. Determination of Eligibility
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. 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 N. locustae 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 N. locustae are eligible
for reregistration, the Agency may take regulatory actions in the future that would affect the
continued registration of N. /ocitffoe-containing products if significant information about this
active ingredient and/or its products comes to the Agency's attention. Such regulatory action
could include requiring the submission of additional data if the data requirements for
registration (or the guidelines for generating such data) change.
B.
Additional Generic Data Requirements
The generic data base supporting the reregistration of products containing N. locustae
has been reviewed and determined to be substantially complete for reregistration. No further
generic data are required.
C. Labeling Requirements For Manufacturing-Use Products Of N. locustae
No manufacturing-use products are registered.
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V.
ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS
A. Determination Of Eligibility
Based on the reviews of the generic data for the active ingredient N. locustae, the
products containing this active ingredient are eligible for reregistration. Section 4(g)(2)(B) of
FIFRA calls for the Agency to obtain any needed product-specific data regarding the
microbial pest control agents after a determination of eligibility has been made. The Agency
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 Agency is requiring certain product chemistry and toxicology studies to be
submitted for end-use products. These specific data requirements are stated in Attachment C.
2.
Labeling Requirements For End-Use Products
The labels and labeling of all products must comply with the Agency's current
regulations and requirements. Follow the instructions in the Product Reregistration
Handbook with respect to labels and labeling.
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APPENDIX A
Use Patterns Subject to Reregistration
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-------
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APPENDIX B
Generic Data Requirements for Reregistration and
Data Citations Supporting Reregistration
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for the
pesticide covered by this Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to the pesticide in all products,
including data requirements for which a "typical formulation" is the test substance.
The data tables generally are organized according to the following format:
l.Daja Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. The reference numbers accompanying each test refer to the
test protocols set 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 (MRID) number, but may be a GS number if no MRID number has been
assigned. Refer to the Bibliography Appendices for a complete citation of the study.
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APPENDIX B
Generic Data Supporting Guideline Requirements for
Reregistration of N. locustae
Requirement
Citation
PRODUCT CHEMISTRY
151 A- 10 Product Identity
15 1 A- 1 1 Manufacturing Process
151 A- 12 Discussion of Formation of
Unintentional Ingredients
151A-13 Analysis of Samples
15 1 A- 15 Certification of Limits
151A-16a Color
151A-16b Physical State
151A-16c Odor
151A-16d Density or sp. Gravity
151A-16e Ph
151A-16f Stability
151A-16g Storage Stability
151A-16h Viscosity
151A-16i Miscibility
151A-16J Corrosion Characteristics
TOXICOLOGY
152A-10 Acute Oral Toxicity/Pathogenicity
152A- 1 1 Acute Dermal Toxicity
152A-12 Acute Pulmonary Toxicity/Pathogenicity
152A-13 Acute Intravenous Toxicity/Pathogenicity
42243201
42245801
42243201
42245802
42243201
42245803
42243202
42245804
42243202
42245804
42245805
42245805
42245805
42245805
42245805
42245805
42245805
42245805
42245805
42245805
74175
135114
72638
42245806
74176
42245807
141791
42245808
42245809
42260101
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152A-14 Primary Eye Irritation/Infection
152A-15 Hypersensitivity Incidents
42245810
42260101
42245811
ECOLOGICAL EFFECTS
154A-16 Avian Acute Oral
Pheasant
Duck & Pheasants
154 A- 17 Avian respiratory
Pheasant
154A-19 Freshwater fish
Trout
t
154A-20 Aquatic Invertebrate
Daphnia magna
154A-24 Honeybee
154A-22 Non-target Plant
154A-23 Non-target Insect
42245812
94269008
42245813
42245814
423 1490 1
42245815
waived
waived
ENVIRONMENTAL FATE
EPA waived 40 CFR Part 158 requirements for reasons discussed in section HI.
RESIDUE CHEMISTRY
EPA waived 40 CFR Part 158 requirements for reasons discussed in section HI.
HUMAN EXPOSURE
EPA waived 40 CFR Part 158 requirements for reasons discussed in section HI.
The citations listed in the bibliography (Appendix C) were used to support these decisions.
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APPENDIX C
Citations Considered to be Part of the Data Base
Supporting the Reregistration
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GUIDE TO APPENDIX C
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the EPA the EPA has sought to identify documents
at a level parallel to the published article from within the typically larger volumes in
which they were submitted. The resulting "studies" generally have a distinct title (or
at least a single subject), can stand alone for purposes of review, and can be described
with a conventional bibliographic citation. The EPA has attempted also to unite basic
documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or MRID number. This number is unique
to the citation, and should be used at any time specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies; see paragraph 4(d)(4) below for further explanation. In a few
cases, entries added to the bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifier number is 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 a description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the EPA could confidently identify one, the EPA has
chosen to show a personal author. When no individual was identified, the
EPA has shown an identifiable laboratory or testing facility as author. As a
last resort, the EPA has shown the first submitter as author.
b. Document date. When the date appears as four digits with no question marks,
the EPA took it directly from the document. When a four-digit date is
followed by a question mark the bibliographer deduced the date from evidence
in the document. When the date appears as (19??), the EPA was unable to
determine or estimate the date of the document.
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c. Title. In some cases, it has been necessary for EPA
bibliographers to create or enhance a document title. Any such editorial
insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the EPA in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received,"
(2) Administrative number. The next element, immediately following the
word "under," is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter, following the phrase
"submitted by." When authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," standing for "Company
Data Library." This accession number is in turn followed by an
alphabetic suffix which shows the relative position of the study within
the volume. For example, within accession number 123456, the first
study would be 123456-A; the second, 123456-B; the 26th, 123456-Z;
and the 27th, 123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
42243201 Vinje. E. (1992) Product Identity and Composition: Nosema locustae. Unpublished
study prepared by Bozeman Bio-Tech. 4 p.
42243202 Vinje, E. (1992) Analysis and Certification of Product Ingredients: Nosema Locustae.
Unpublished study prepared by Bozeman Bio-Tech, Inc. 3 p.
42245801 Merrill, L. (1992) Product Identity and Disclosure of Ingredients: Nosema locustae.
Unpublished study prepared M & R Durango Inc. 8 p.
42245802 • Merrill, L. (1992) Manufacturing Process: Nosema locustae. Unpublished study prepared
by M & R Durango Inc. 10 p.
42245803 Rainnie, D. (1988) Bacterial and Fungal Contaminants of Nosema locustae Spore
Suspension: Lab Project Number: R-86-0018. Unpublished study prepared by
University of Saskatchewan, Tox. Research Center. 36 p.
42245804 Merrill, L. (1992) Analysis of Samples and Certification of Limits: Nosema locustae.
Unpublished study prepared by M & R Durango Inc. 37 p.
42245805 Merrill, L. (1992) Physical and Chemical Properties: Nosema locustae. Unpublished
study prepared by M & R Durango Inc. 16 p.
42245806 Rainnie, D. (1988) Acute Dermal Infectivity of Technical Grade Nosema locustae
Canning Spore Suspensions to Sprag-ue-Dawley Rats: Lab Project Number:
R-86-0018. Unpublished study prepared by Univ. of Saskatchewan, Tox. Research
Center. 38 p.
42245807 Rainnie, D. (1988) Acute Respiratory Infectivity of Technical Grade Nosema locustae
Canning Spore Suspensions to Sprague-Dawley Rats: Lab Project Number:
R-86-0018. Unpublished study prepared by Univ. of Saskatchewan, Tox. Research
Center. 45 p.
42245808 Rainnie, D. (1991) Study of Intraperitoneal Infectivity and Toxicity of Nosema locustae
Spore Suspension in CD-I Mice: Lab Project Number: R-86-0018. Unpublished
study prepared by Univ. of Saskatchewan, Tox. Research Center. 82 p.
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^2245809 Shadduck, J. (1980) Maximum Challenge Safety Tests of Nosema
locustae in Mice and Rabbits: Lab Project Number. Unpublished study prepared
by Southwestern Medical School. 55 p.
42245810 Fink, R. (1973) Eye Irritation-Rabbits Nosema locustae Spore in Saline Suspension:
Final Report: Lab Project Number: 183-195. Unpublished study prepared by
Hazleton Laborator
42245811 Rainnie, D. (1988) Investigation of the Development of Delayed Hypersensitivity of
Technical Grade Nosema locustae Canning Spor Suspensions in Albino Guinea Pigs:
Lab Project Number: R-86-0018. Unpublished study prepared by Univ. of
Saskatchewan, Tox. Research Center. 35 p.
42245812 Rainnie, D. (1988) Acute Oral Infectivity of Technical Grade Nosema locustae Canning
Spore Suspension to Ring-necked Pheasant Chicks: Lab Project Number:
R-86-0018. Unpublished study prepared by Univ. of Saskatchewan, Tox. Research
Center. 50 p.
42245813 Rainnie, D. (1988) Maximum Hazard of Infectivity of Technical Grade Nosema locustae
Canning Spore Suspension to Canning-necked Pheasant Chicks: Lab Project
Number: R-86-0018. Unpublished study prepared by Univ. of Saskatchewan, Tox.
Research Center. 79 p.
42245814 Rainnie, D. (1988) Maximum Hazard of Infectivity of Technical Grade Nosema locustae
Canning Spore Suspension to Rainbow Trout Fingerlings: Lab Project Number:
R-86-0018. Unpublished study prepared by Univ. of Saskatchewan, Tox. Research
Center. 59 p.
42245815 Menapace, D.; Sackett, R.; Wilson, W. (1977) Adult honey bees are not susceptible to
infection by Nosema locustae. Journal of Economic Entomology 71(2):304-306.
42260101 Shadduck, J. (1992) Maximum Challenge Safety Tests of Nosema locustae in Mice and
Rabbit. Unpublished study prepared by Southwestern Medical School. 51 p.
42314901 Bozeman Bio-Tech, Inc. (1992) The Acute Toxicity of Nosema locustae Canning Spores
to Daphnia magna Straus Maximum Level Testing: Lab Project Number:
10058-DM. Unpublished study prepared by Biospherics, Inc. 31 p.
94269001 Vinje, R. (1992) Bozeman Bio Tech. Phase 3 Summary of MRJD 00074175. Acute Oral
- Rats. Prepared by Hazleton Laboratories, Inc. 5 p.
94269002 Vinje, E. (1992) Bozeman Bio Tech. Phase 3 Summary of MRID
00072638. Acute Dermal Toxicity - Guinea Pigs. Prepared by
Hazleton Laboratories, Inc. 6 p.
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APPENDIX D
PR Notice 91-2
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
PR NOTICE 91-2
OFFICE Of
PESnCOCS AND TOXIC
SUBSTANCES
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient (s), as that term is
defined in 40 CFR 158.153 (i). Accordingly, the Agency has
established the nominal concentration as the only acceptable label
claim for the amount of active ingredient in the product.
II. BACKGROUND
•
For some time the Agency has accepted two different methods of
identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient (s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to exactly
how much of a given ingredient was in a given product. The Agency
has established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
Current regulations require that the parcantage listed in the
active ingredient statement be as precise as possible reflecting
good manufacturing practices 40 CFR 156.10 (g) (5). The certified
limits required for each active ingredient are intended to
encompass any such "good manufacturing practice** variations 40 CFR
158.175{c)(3).
Printed on (bey** Piper
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3.
XV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lover limits nay not be lover then the minimum
level to achieve efficacy. This is extremely important for
products vhich are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 158.640.
Zn those cases vhere efficacy limits have been established,
the Agency will not accept certified lover limits vhich are belov
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. Zt is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, nev chemical, or
fast track (FZFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all nev product
registrations submitted to the Agency
are to comply with the requirements of this
Notice.
(2) Registrants having products subject to
reregistration under PZFRA section 4(a) are to
comply with the requirements of this Notice vhen
specific products are called in by the Agency
under Phase V of the Reregistration Program.
(3) All other products/applications that are
not subject to (1) and (2) above vill have until
July 1, 1997, to comply with this Notice.
Such applications should note "Conversion
to Nominal Concentration" on the application
form. These types of amendments vill not be
handled as "Past Track" applications but
vill be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 557-5024.
Anne E. Lindsay, Director
Registration Division (H-7505
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APPENDIX E
Pesticide Reregistration Handbook
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APPENDIX F
Product Specific Data Call-in
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20490
DATA CALL-IN NOTICE
KSTCOCS AND TOXIC
CERTIFIED MAIL SUBSTANCES
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in Chemical Status
Sheet. to submit certain product specific data as noted herein to
the U.S. Environmental Protection Agency (EPA, the Agency).
These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90
days after you receive this Notice you must respond as set forth
in Section III below. Your response must state:
1. How you will comply with the requirements set forth in
this Notice and its Attachments A through G; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment C,
Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission
of product specific data in the manner specified by this
Notice (see section III-D).
If you do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment B, DataCall-In Response Form, as well as a
list of all registrants who were sent this Notice (Attachment F).
The authority for this Notice is section 3(c)(2)(B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by
OMB Approval No. 2070-0107 (expiration date 12-31-92).
Prmt on ftfcrcwa Pv*'
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This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section Z
Section ZZ
Section ZZZ
- Why You Are Receiving This Notice
- Data Required By This Notice
• Compliance With Requirements Of This
Notice
Section IV * Consequences Of Failure To Comply With
This Notice
Section V - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI — Inquiries And Responses To This Notice
The Attachments to this Notice are:
A
B
C
D
£ -
F
6
Data Call-in Chemical Stafojs Sheet
pqfra .Call-Iq Response Fora
Requirements S^a,tuq and Registrant's Response
E.PA Grouping of fold -Use Produces , for Meeting Acute
Toxicology Qata Requirements for Re registration
EP Acetance
Prut
Lj. st pf Registrar^? Receiving .Tfeis Notice
Cost Share and J>ata' Compensation Forms, and
Specific Data Report Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency*has reviewed existing data for this active
ingredient and reevaluated the data.needed to support continued
registration of the subject active.ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements are being
imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are
specified in Attachment C, Requirements status andRegistrant's
Response Fern. Depending on the results of the studies required in
this Notice, additional testing may be required.
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II-B. ffc^WM pqp SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements Status
and Registrant's Response Fora, within the timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical
Information Service (NTIS) , Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR f 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 S 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W. ,
Washington, D.C. 20006.
All new studies and proposed protocols submitted in response
to this Data Call-In Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160. 3 (a) (6) ].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcW2WB^ NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in
anv way supersede or chance the requirements of anv previous Data
Call-ln.jt.fi. or any* other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.
SECTION III. CQjlPLIANeE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHE FOR RESPONDING TO TE AGENCY
The appropriate responses initially required by this Notice
for product specific data must be submitted to the Agency within 90
days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a Notice of Intent to Suspend (NOIS) affecting
-------
your products. This and other bases for issuance of HOIS due to
^failure to comply with this Notice are presented in Section IV-A
mnd IV-B.
III-B. OPTIONS FOR RESPONDING TO THE ACEMCY
The options for responding to this Notice for product specific
data are: (a) voluntary cancellation, (b) agree to satisfy the
product specific data requirements imposed by this Notice or (c)
request a data 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 waivers is
contained In Section XII-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in, Response
Fora, and the Requirements Status and Registrant's Response form.
Attachment B and Attachment C. The Data Call-In Response Form must
be submitted as part of every response, to, this Notice. Xn
addition, one copy of the Requirements Status and Registrant's
Response Form must be submitted for each product listed on the
Data Call-in Response Form unless the voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing the pafra gall-In Response Form in
Attachment B). Please note that the company's authorized
representative is required to sign the first page of the Data Call-
in Response Form and Requirements Status and Registrant's Response
Fjyas (if this form is required) and initial any subsequent pages.
The forms contain separate detailed instructions on the response
options. Do not alter the printed material. Xf you have questions
or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment A.
1. Voluntary cancellation - You nay 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. Xf you wish to voluntarily cancel your product, you must
submit a completed Data Call-in Response Form, indicating your
election of this option. Voluntary cancellation is item number 5
on the Data call-in Response Form. Xf you choose this option, this
is the only form that you are required to complete.
Xf you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section XV-c.
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2. Satisfying the Product: Specific Data Requirements of thip
Notice. There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and coaprise options 1
through 6 on the Requirements Status and Registrant's Response Porn
and item numbers 7 a and 7b on. the Data Call-In Response Porn.
Deletion of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirenents.
3. Request for Product Specific Data Waivers. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the Requirements Status and
Reqistrant's Response Pqrn. If you choose this option, you oust
submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
III-C SATISFYING THE DATA REQUIREMENTS Of THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b), then you must select one of the six
options on the Recfulrenents Status and Registrant's Response Form
related to data production for each data requirement. Your option
selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form.
These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered, into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6} I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
Option l,. Develflpinp Data — If you choose to develop the
required data it must be in conformance with Agency, deadlines and
other Agency requirements as referenced herein and in the
tachments. All data generated and submitted must comply with the
Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformance with the requirements of PR Notice 86-5.
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The tine frames in the Requirements Status and Registrant's
Response Fopn are the time frames that the Agency is allowing for
the submission of completed study reports. The noted deadlines run
from the date of the receipt of this Notice by the registrant. If
the data are not submitted by the deadline, each registrant is
subject to receipt of a Notice of Intent to Suspend the affected
registration(s).
If you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional time to meet
the requirements (s), you must submit a request to the Agency which
includes: (1) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
• your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can
be requested only in cases of extraordinary testing problems beyond
the expectation or control of the registrant. Extensions will not
be given in submitting the 90-day responses. Extensions will not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Option 2. Agree to Share in Coat to Develop Data —Registrants
may only choose this option for acute toxicity data and certain
efficacy data au& only if EPA has indicated in the attached data
tattles that your product and at least one other product are similar
for purposes of depending on the same data. If this is the case,
data may be generated for just one of-the products in the group.
Tttfe registration n^l^tT of the product for which data will be
submitted must be noted in the agreement to cost share by the
registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name
of the registrant Jrtio will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the parties that an agreement exists. The
agreement to produce the data need not specify all of the terms of
the final arrangement between the parties or the mechanism to
resolve the terms. Section 3(c)(2)(B) provides that if the parties
cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development —
This option only applies to acute toxicity and certain efficacy
data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been
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unsuccessful, you nay request EPA (by selecting this option) to
exercise its discretion not to suspend your registration(s),
although you do not comply with the data submission requirements of
this Notice. EPA has determined that as a general policy, absent
other relevant considerations, it will not suspend the registration
of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data
has refused to accept your offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made
an offer to another registrant (who has an obligation to submit
data) to share in the burden of developing that data. You must
also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment 6. In addition, you must demonstrate that the other
registrant to whom the offer vas made has not accepted your offer
td 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 must, in addition
to anything else, offer to share in the burden of producing the.
data upon terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-In Response
Form and a fteouirenents Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
Zn order for you to avoid suspension under this option, you may
not -withdraw your offer to share in the burdens of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study •»• If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously
submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade a study. (See
Option 5).
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply with
this Notice, normally without an extension of the required date of
submission. The Agency may determine at any time that a study is
not valid and needs to be repeated.
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8
To meet the requirements of the DCI Notice for submitting an
existing study, all of the follovingthree criteria must be clearly
net;
a. You aust certify at the tine that the existing study is
submitted that the raw. data and specimens from the study are
available for audit and review and you aust identify where they
are available. This aust be done in accordance with
the requirements of the Good Laboratory Practice (GLP)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
* 'Crjaw data1 means any laboratory worksheets, records,
• memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
~ necessary for the reconstruction and evaluation of the report
_. of that study. In the event that exact transcripts of raw data
''. -have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Raw data1 may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40
CFR 160.3(k), means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after Kay 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the
existing study that such GLP information is available for post-
May 1984 studies by including an appropriate .statement on or
': attached to the study signed by an authorized official or
• representative of the registrant.
c. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided in
the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the
; Pesticide Assessment Guidelines (PAG) or meets the purpose of
the PAG (both available from KTZS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding
acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are net by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including
copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied .the purpose of the PAG and that necessary
raw data are usually not available for such studies.
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If you submit an existing study, you Bust certify that the
study meets all requirements of the criteria outlined above.
Zf you know of a study pertaining to any requirement in this
Kotice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you aust notify the Agency of such a study. Zf such study is in
the Agency's files, you need only cite it along with the
notification. Zf not in the Agency's files, you Bust submit a
summary and copies as required by PR Notice 86-5.
Option S. Upgrading astudy — Zf a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. Zf 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 will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. Zf you have
questions regarding the classification of a study or whether a
study aay be upgraded, call or write the contact person listed in
(Attachment A* Zf you submit data to upgrade an existing study you
aust satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the KRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies aust be accompanied by a certification that you comply with
each of those criteria as veil as a certification regarding
protocol compliance with Agency requirements.
Option 6. citing Existing Studies — Zf you choose to cite a
that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
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10
toxicology studies generally vill have been classified as "core-
guideline" or "core minimum." For all other disciplines the
classification vould be "acceptable." With respect to any studies
for which you wish to select this option you must provide the MR ID
number of the study you are citing and, if the study has been
reviewed by the Agency, you Bust provide the Agency's
classification of the study.
Zf you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Form
8570-31, Certification with Respect to Data Compensation
Requirements.
* Registrants who select one of the above 6 options must meet all
of the requirements described in the instructions for completing
the pata^ Call-in Response Form and .the Requirements Status and
Registrant's Response Form, as appropriate.
ZZZ-D REQUESTS FOR DATA WAIVERS
Zf you request a waiver for product specific data because you
believe it is inappropriate, you oust attach a complete
justification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5). This will be the only opportunity to
.state the reasons or provide information in support of your
request. Zf the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) of
FZFRA. Zf the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
and submit the option chosen on the Requirements status and
Registrant's Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency will grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will &££ automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
ZV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
ZV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Zntent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Pata Call-in Notice, pursuant to
FZFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Zntent to Suspend include, but are not
limited to, the "following:
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11
1. Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
2. Failure to submit on the required schedule an acceptable
proposed or final protocol 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 whom you have tendered an offer
to share in the cost of developing data and provided proof of
the registrant's receipt of such offer either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form;
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
• c. Otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you commit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
IV-B. BASIS FOR PETESMIMATIQW THAT SUBMITTED STUDY IS
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
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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 documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required
studies. Such requirements include, but are not limited to,
. those relating to test .material, test procedures, selection of
species, number of animals, sex and distribution of animals,
. ' dose and effect levels to be tested or attained, duration of
.. , test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols
applicable), including the incorporation of "any changes
required by the Agency following review.
(if
3. EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR
PRODUCTS
_ EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide product
which has been suspended or ^cancelled* if doing -so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants
of existing stocks for a suspended registration when a section
3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or
use existing stocks of suspended product (s) only in exceptional
circumstances. If you believe such disposition of existing stocks
of your product (s) which may be suspended for failure to comply
with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required
for their sale, distribution, and use. Unless you meet this burden
the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product (s) as a
response to this Notice and your product is in full compliance with
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13
all Agency requirements, you will have, under most circumstances,
one year from the date your 90 day response to this Notice is due,
to sell, distribute, or use existing stocks. Normally, the Agency
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 which the Agency has particular
risk concerns vill be determined on a case-by-case basis.
Requests for voluntary .cancellation received after the 90 day
response period required by .this Notice vill not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that .you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA vill consider granting an existing stocks
provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT
UNREASONABLE ADVERSE EFFECT^
Registrants are reminded that FIFRA section 6(a)(2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQUIRIES AND 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 Data Call-In chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-in Response Fern and a
completed RequirementsStatus and Registrant's Response Form
Attachment B and Attachment C) and any other documents required by
is Notice, and should be submitted to the contact person(s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the pata Call-InResponse Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours,
A -
B •
C -
D -
E -
F •
6 -
Daniel M. Barolo, Director
. ' Special Review and
Reregistration Division
Attachments
Data Call-in Chemical Status Sheet
Data Call-in Response Form
Requirements Status and Registrant's Response Forjn
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rereoistratign
EPA Acpepta^ce Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms. and Product
Specific Data Report Form
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ATTACHMENT A
CHEMICAL STATUS SHEET
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ATTACHMENT A
N. locustae: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have products containing N.
locustae.
This attachment, the Data Call-in Chemical Status Sheet, contains a point of contact for
inquiries. This attachment is to be used in conjunction with (1) the Data Call-In Notice. (2)
Attachment B, the Data Call-In Response Form. (3) Attachment C, the Requirement Status and
Registrant's Response Form for product specific data, (4) Attachment D, EPA Grouping of End-
Use Products for Meeting Acute Toxicology Data Requirements for Reregistration. (5)
Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of All Registrantfsl sent this
Data Call-In Notice, and (7) Attachment G, the Cost Share and Data Compensation Forms, for
product specific data, and ProducUSpecific Data Report Form for use in replying to this name
of chemical Data Call-In. Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for name of chemical
are listed in the Requirements Status and Registrant's Response Form. Attachment C.
The Agency has concluded that product specific data are needed for name of chemical.
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 TO THIS NOTICE
If you have any questions- regarding the product specific data requirements and
procedures established by this Notice, please contact Phil Button at (703) 305-7690. All
responses to this Notice should be submitted to:
Document Processing Desk (RED/RD/PM-18)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: N. locustae
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If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Sue Rathman at (703) 308-8069. All responses to this
Notice should be submitted to:
Chemical Review Manager Sue Rathman
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: N. locustae
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ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
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SPECIFIC INSTRUCTIONS FOR
THE DATA CALL-IN RESPONSE FORM
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response.11
Items 1 -4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and
address.
Item 2. This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are
also responsible for informing the Agency of your
response regarding any product that you believe may be
covered by this data call-in but that is not listed by
the Agency in Item 4. You must bring any such apparent
omission to the Agency's attention within the period
required for submission of this response form.
Item 5. Check this item for each product registration you wish
to cancel voluntarily. If a registration number is
listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on
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the Requirements Status andRegistrant's Response Form
for any product that is voluntarily cancelled.
Item 6a. Check this item if this data call-in is for generic
data as indicated in Item 3 and if you are eligible for
a Generic Data Exemption for the chemical listed in
Item 2 and used in the subject product. By electing
this exemption, you agree to the terms and conditions
of a Generic Data Exemption as explained in the Data
Call-in Notice.
If you are eligible for or claim a Generic Data
Exemption, enter the EPA registration Number of each
registered source of that active ingredient that you
use in your product.
Typically, if you purchase an EPA-registered product
from one or more other producers (who, with respect to
the incorporated product, are in compliance with this
and any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you
nay complete this item for all products listed on this
form. If, however, you produce the active ingredient
yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered),
you may not claim a Generic Data Exemption and you may
not select this item.
Item 6b. Check this Item if the data call-in is a generic data
call-in as indicated in Item 3 and if you are agreeing
to satisfy the generic data requirements of this data
call-in. Attach the Requirements Status and.
Registrant's Response Form that indicates how you will
satisfy those requirements.
Item 7a. Check this item if this call-in is a data call-in as
indicated in Item 3 for a manufacturing use product
(MUP), and if your product is a manufacturing use
product for which you agree to supply product-specific
data. Attach the Requirements Status and Registrants*
Response Form that indicates how you will satisfy those
requirements.
Item 7b. Check this item if this call-in is a data call-in for
an end use product (EUP) as indicated in Item 3 and if
your product is a end use product for which you agree
to supply product-specific data. Attach the
Requirements Status andRegistrant's Response Form that
indicates how you will satisfy those requirements.
Item 8. This certification statement must be signed by an
authorized representative of your company and the
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Item 9.
Item 10.
person signing must include his/her title. Additional
pages used in your response must be initialled and
dated in the space provided for the certification.
Enter the date of signature.
Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. Enter the phone number of your company contact.
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ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
(FORMS B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
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SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORK
Product specific Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA*s reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same
for both product and generic data, instructions for completing
the forms differ slightly. Specifically, options for satisfying
product specific data requirements do not include (1) deletion of
uses or (2) request for a low volume/minor use waiver. These
instructions are for completion of product specifie data
requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. You must complete all other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Itorn 1-3 completed by EPA. Note the unique identifier number
assigned by EPA in Item 3. This number must be used in
the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to
support the product's continued registration are
identified. These guidelines, in addition to the
requirements specified in the Notice, govern the
conduct of the required studies. Note that series 61
and 62 in product chemistry are nov listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5* The study title associated with the guideline reference
number is identified*
Item 6. The use pattern(s) of the pesticide associated with the
product specific requirements is (are) identified. For
most product specific data requirements, all use
patterns are covered by the data requirements. In the
case of efficacy data, the required studies only per-
tain to products which have the use sites and/or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For
product specific data, the product as formulated for
sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is
identified. It is normally based on 8 months after
issuance of the Reregistration Eligibility Document
unless EPA determines that a longer time period is
necessary.
Item 9. Enter only one of the following response codes for each
data requirement to show how you intend to comply with
the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data
Call-in Notice.
1. I will generate and submit data by the specified due
date (Developing Data). By indicating that I have
chosen this option, I certify that I will comply with
all the requirements pertaining to the conditions for
submittal of this study as outlined in the Data Call-In
Notice.
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I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing). I
an submitting a copy of this agreement and a completed
•Certification With Respect To Data Compensation
Requirements*1 form. I understand that this option is
available only for acute toxicity or certain efficacy
data only if EPA indicates in an attachment to this
Notice that my product is similar enough to another
product to qualify for this option. I certify that
another party in the agreement is committing to submit
or provide the requirement data; if the required study
is not submitted on time, my product may be subject to
suspension.
I have made offers to share in the cost to develop data
(Offers to Cost Share). Z understand that this option
is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an
attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for
this option. I am submitting evidence that I have make
an offer to another registrant (who has an obligation
to submit data) to share in the cost of that data. I
am also submitting a completed "Certification of Offer
to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other
registrant's receipt of that offer. I am identifying
the party which is committing to submit or provide the
required data; if the required study is not submitted
on time, my product may be subject to suspension. I
understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well.
By the specified due date, I will submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study). I.
certify that this study will meet all the requirements
for submittal of existing data outlined in Option 4 in
the Data Call-In Notice (Section III-C.l.) and will
meet the attached acceptance criteria (for acute
toxicity and product chemistry data). I will attach
the needed supporting information along with this
response. I also certify that I have determined that
this study will fill the data requirement for which I
have indicated this choice.
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By the specified due date, Z vill «ubait or cite data
to upgrade a study classified by the Agency as
partially acceptable and upgradable (Upgrading a
Study). X vill submit evidence of the Agency's reviev
indicating that the study nay be upgraded and what
information is required to do so. X vill provide the
MRID or Accession number of the study at the due date.
X understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section.
XXX-C.l.) apply.
By the specified due date, X vill cite an existing
study that the Agency has classified as acceptable or
an existing study that has been submitted but not
revieved by the Agency (Citing an Existing Study). Xf
X am citing another registrant's study, X understand
that this option is available only for acute toxicity
or certain efficacy data and only if the cited study
vas conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other
products for purposes of depending on the same data. X
may also choose this option if X am citing my own data.
Xn either case, X vill provide the MRID or Accession
number(s) for the cited data on a "Product Specific
Data Report" form or in a similar format. Xf X cite
another registrant's data, X vill submit a completed
"Certification With Respect To Data Compensation
Requirements" form.
X request a vaiver for this study because it is
inappropriate for my product (Waiver Request). X am
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. X understand
that this is my only opportunity to state the reasons
or provide information in support of my request. Xf
the Agency approves my vaiver request, X vill not be
required to supply the data pursuant to Section
3(c)(2)(B) of FXFRA. Xf the Agency denies my vaiver
request, X must choose a method of meeting the data
requirements of this Notice by the due date stated by
this Notice. Xn this case, X must, within 30 days of
my receipt of the Agency's written decision, submit a
revised "Requirements Status and Registrant's Response'1
Form indicating the option chosen. X also understand
that the deadline for submission of data as specified
by the original data call-in notice vill not change.
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Items 10*13 Self-explanatory.
NOTE; you nay provide additional information that does not
fit on this form in a signed letter that accompanies
this form. For example, you may wish to report that
your product has already been transferred to antoher
company or that you have already voluntarily cancelled
this product. For these cases, please supply all
relevant details so that EPA can ensure that its
records are correct.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
11 29
PR NOTICE 86-5
OFFICE Of
PESTICIBC* AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and certain provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format* This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of FIFRA and FFDCA. These
data are defined in FIFRA SlO(dHl). This Notice does not apply
to commercial, financial, or production information, which are,
and must continue to be, submitted differently under separate
cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the submitter
for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations
in the Federal Register (49 FR 37956) which include Requirements
for Data Submission (40 CFR $158.32), and Procedures for Claims
of Confidentiality of Data (40 CFR §158.33). These regulations
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-------
specify the format foe data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address
the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how
the study objectives, protocol, observations, findings, and
conclusions are organized and presented within the study report.
The data reporting guidance will be compatible with submittal
format requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
•April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes dead-
lines for inserting into the docket documents submitted in con-
nection with Special Reviews and Registration Standards (see
40 CFR S154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this requirement,
For several years, OPP has required that each application for
registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied—the
statement of the method of support for the application. Typically,
many requirements are satisfied by reference to data previously
submitted—either by the applicant or by another party. That re-
quirement is not altered by this notice, which applies only to
data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is included
and clearly identifiable, the form of the samples may be altered
to reflect the submitter's preference.
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- INDEX -
Text Example
Page Page
A. Organization of the Submittal Package ........ 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C.I Special Considerations for Identifying studies. . 5
D. Organization of each study Volume .......... 6 17
D.I Study Title Page 7 12
D.2 Statement of Data Confidentiality Claims
(based on FIFRA S10(d)(l}) . . 8 13
D.3 Confidential Attachment ..... 8 15
D.4 Supplemental Statement of Data Confidentiality
Claims [other than those based on FIFRA §10(d)(l)] 8 14
D.5 Good Laboratory Practice Compliance Statement . . 9 16
£. Reference to Previously Submitted Data ....... 9
F. Physical Format Requirements & Number of Copies ... 9
G. Special Requirements for Submitting Data to the Docket 10
A.
**************
Organization of Submittal Package
A 'submittal package' consists of all studies submitted at
the same time for review in support of a single regulatory action,
along with a transmittal document and other related administrative
material (e.g. the method of support statement/ EPA Forms 8570-1,
8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUP), S3(c)(2)(B) data call-in,
§6(a){2) submittal, or a special review; the transmittal date;
and a list of all individual studies included in the package in
the order of their appearance, showing (usually by Guideline
reference number) the data requirement(s) addressed by each one.
The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be
included in the transmittal document as well, if it is known to
the submitter. See Attachment 1 for an example of an acceptable
transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should
be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these
two groups of studies follow the instructions above.
C.
individual studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal package
must be bound as a separate entity. (See comments on binding
studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study
on each page (ie., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e.g., Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
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-------
When a single study is extremely long, binding it in multiple
volumes is permissible so long as the entire study is paginated
in a single series, and each volume is plainly identified by the
study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
. Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study,
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a techni-
cal product, other manufacturing-use product, an experimental
use 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 series (61, 62,
and 63) for conventional pesticides, or for the equivalent
subject range for biorat'ional pesticides. The first of the
three studies in a complete product chemistry submittal for
a biochemical pesticide would cover Guidelines 151-10, 151-11,
and 151-12; the second would cover Guidelines 151-13, 151-15,
and 151-16; the third would cover Guideline 151-17. The
first study for a microbial pesticide would cover Guidelines
151-20, 151-21, and 151-22; the second would cover Guidelines
151-23 and 151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are
likely to contain Confidential Business Information as defined
in FIFRA SlO(d)U)(A), (B), or (C), and if so must be handled
as described in section D.3. of this notice.
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-------
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a
single study and bound separately for each analytical method,
each report of the nature of the residue in a single crop or
animal species, and for each report of the magnitude of resi-
dues resulting from treatment of a single crop or from proces-
sing a single crop. When more than one commodity is derived
from a single crop (such as beet tops and beet roots) residue
data on all such commodities should be reported as a single
study. When multiple field trials are associated with a
single crop, all such trials should be reported as a single
study.
/
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed 'example* cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required.
If study reports laboratory Page 16
work subject to GLP require-
ments .
For certain toxicology studies. (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
S10(d)(l)(A), (B), or (C)
If CBI is claimed under FIFRA
S10(d)(l)(A), (B), or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA S10(d)(l)(A), (B), or (C)
Page 15
Page 14
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D.I Title Page
A title page is always required for each submitted study,
published or unpublished. The title page mast always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLK PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title
page:
a.. Study title. The study title should be as descriptive as
possible, it must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears
in the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number{s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the utudy. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or laboratories,
and the laboratory's internal project number(s) for the work.
Clearly distinguish the laboratory's project identifier from any
other reference numbers provided by the study sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier study,
include on the title page elements a. through d. for the previously
submitted study, along with the EPA Master Record Identifier (MRID)
or Accession number of the earlier study if you know these numbers.
(Supplements submitted in the same submittal package as the primary
study should be appended to and bound with the primary study. Do
not include supplements to more than one study under a single
title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished document, identify on the title page all relevant facts
of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
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-------
D.2. Statements of Data Confidentiality Claims Under FIFRA S10(d)(l).
Each submitted study must be accompanied by one of the two
alternative forms of the Statement of Data Confidentiality Claims
specified in the proposed regulation in $158.33 (b) and (c).
(See Attachment 3) These statements apply only to claims of data
confidentiality based on FIFRA S10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b))
or to waive such a claim ($158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with petitions
for tolerances or emergency exemptions (see NOTE pg 13).
0,3. Confidential Attachment
If the claim is made that a study includes confidential busi-
ness information as defined by the criteria of FIFRA §10(d)(1)(A),
(B), or (C) (as described in D.2. above) all such information must
be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so
isolated must be identified by a reference number cited within the
body of the study at the point from which the passage was excised
(See Attachment 5).
The Confidential Attachment to a study must be identified by a
cover sheet fully identifying the parent study, and must be clearly
marked 'Confidential Attachment.1 An appropriately annotated
photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the
body of the study, beginning with page 1 of X on the title page.
Each passage confined to the Confidential Attachment must be assoc-
iated with a specific cross reference to the page(s) in the main
body of the study on which it is cited, and with a reference to the
applicable passage(s) of FIFRA §10(d){l) on which the confidentiality
claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA S10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be
clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name
and title of the official who signed it.
8
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D.5 Good Laboratory Practice Compliance statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Referenceto Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform
8 1/2 by 11 inch white paper, printed on one side only in black
ink, with high contrast and good resolution. Bindings for indi-
vidual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
o Do not include frayed or torn pages.
o Do not include carbon copies, or copies in other than
black ink.
o Make sure that photocopies are clear, complete, and fully
readable.
o DO not include oversize computer printouts or fold-out pages.
o Do not 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 G below) must be provided in three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of proces-
sing data into the OPP Pesticide Document Management System and
getting it into review.)
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-------
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
o Remove the 'Supplemental Statement of Data Confidentiality
Claims1.
o Remove the 'Confidential Attachment*.
o Excise from the body of the study any information you claim
as confidential, even if it does not fall within the scope
of FIFRA S10(d)(l)(A) , (B), or CO. Do not close up or
paraphrase text remaining after this excision.
o Mark the fourth copy plainly on both its cover and its title
page with the phrase "Public Docket Material - contains no
information claimed as confidential".
V.
For Further Information
For further information contact William C. Grosse, Chief,
Information Services Branch, Program Management and Support
Division, (703-557-2613).
ames W. Akerman
'Acting Director,
Registration Division
Attachment 1.
Attachment 2.
Attachment 3.
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
10
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ATTACHMENT 1.
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
!• Name and address of submitter (or all joint submitters**)
. *Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
^Smith Chemical Corp. will act as sole agent foe all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you
know it Otherwise describe the type of request (e.g. experi-
mental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
*
•
•
Vol n. Title of nth study in the submittal (Guideline No.)
* Applicants commonly provide this information in a trans-
mittal letter. This remains an acceptable practice so
long as all four elements are included.
** Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter con-
cerning data compensation or subsequent use or release
of the data.
Company Official:
Company Name:
Company Contact:
Name
Signature
Name
Phone
11
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ATTACHMENT 2.
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
12
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ATTACHMENT 3.
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10{d)(l)(A),(B), or (C)
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this study
on the basis of its falling within the scope of FIFRA S10(d)(l)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA S10(d)(l)(A), (B), or (C)»
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling within the scope
of FIFRA SlO(d)(l)(A), (B), or (C) has been removed to a confidential appendix,
and is cited by cross-reference number in the body of the study.
Conpany:
Company Agent: Typed Name Date:
Title ' Signature
NOTE: Applicants for permanent or temporary tolerances should note that it
is OPP policy that no permanent tolerance, temporary tolerance, or request for
an emergency exemption incorporating an analytical method, can be approved
unless the applicant waives all claims of confidentiality for the analytical
method. These analytical methods are published in the FDA Pesticide Analyt-
ical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which
which confidentiality claims have been made, to the submitter, to obtain
the confidentiality waiver before they can be processed.
13
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ATTACHMENT 4.
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA S10(d)(l)(A), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
o Identify specifically by page and line number(s) each
portion of the study for which you claim confidentiality.
o Cite the reasons why the cited passage qualifies for
confidential treatment.
o Indicate the length of time—until a specific date or
event, 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 made by EPA, other Federal agencies, or courts
concerning this information.
o If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why they
should be viewed as substantial.
o If you assert that the information is voluntarily sub-
. mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
14
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ATTACHMENT 5.
EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS
(Example 1 (Confidential word or phrase that has been deleted frcm the study)
CROSS REFERENCE NUMBER
DELETED WORDS OR PHRASE:
This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
Ethylene Glycol
PAGE LINE REASON FOR THE DELETION
FIFRA REFERENCE
6
28
100
14
25
19
Identity of Inert Ingredient
Example 2 (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH(S):
Reproduce the deleted paragraph(s) here
PAGE LINES REASON FOR THE DELETION
20 4-17 Description of the quality control process
FIFRA REFERENCE
Example 3 (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number noted on a place-holder
page is used in place of the following whole pages
at the indicated volume and page references.
DELETED PAGE(S): are attached immediately behind this page.
PAGE(S) REASON FOR THE DELETION FIFRA REFERENCE
33-41 Description of product manufacturing process
15
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Study Director
Example 2.
This study does not meet the requirements of 40 CFR
Part 160, and differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director
Example 3.
The submitter of this study was neither the sponsor of this
study nor conducted it, and does not know whether it has
been conducted in accordance with 40 CFR Part 160.
Submitter
16
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document.
Related Administrative Materials
(e.g., Method of Support Statement, etc.)
Other materials about the submittal
(e.g. , summaries of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, according
_^ to the format below.
FORMAT OF SUBMITTED STUDIES
Study title page.
Statement of Confidentiality Claims.
_.. GLP and flagging* statements - as appropriate.
Body of the study, with English
-••" language translation if required.
Appendices to the study.
Title Page of the Confidential
-•'•" Attachment.
Confidential Attachment.
Supplemental Statement
—• of Confidentiality Claims,
* When flagging requirements
are finalized.
Documents which must be submitted as
appropriate to meet established requirements.
1
Documents submitted at submitter's option.
17
LEGEND
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REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
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3. Date and Type of DC!
PRODUCT SPECIFIC
ID# 54735-RD-2347
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BOZEMAN BIO-TECH INC
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any or all of these studies
the inert ingredients in the
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ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATION
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EPA'S BATCHING OF END-USE PRODUCTS CONTAINING N. locustae AS THE
ACTIVE INGREDIENT FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of end-use products containing the active ingredient
N. locustae, the Agency has batched products which can be considered similar in terms of acute
toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information described above, and
frequently acute toxicity data on individual end-use products has been found to be incomplete.
Notwithstanding the batching process, the Agency reserves the right to require, at any time,
acute toxicity data for an individual end-use product should the need arise.
Registrants of end-use products within a batch may choose to cooperatively generate, submit
or cite a single battery of six acute lexicological studies to represent all the products within that
batch. It is the registrants* option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
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participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Table 1
Batch
1
EPA Reg. No.
36488-3
36488-7
46149-2
54735-5
% N. locustae
0.049%
0.08%
0.05%
0.001%
Formulation Type
wettable powder
wettable powder
bait / dust
bait
Table 2 lists those products the Agency was unable to batch. These products were either
considered not to be similar to other products for purposes of acute toxicity or the Agency
lacked sufficient information for decision making. Registrants of these products are responsible
for meeting the acute toxicity data requirements for each product.
Table 2
EPA Reg. No.
46149-01
54735-3
% N. locustae
0.10%
0.05%
Formulation Type
emulsifiable concentrate
ready-to-use solution
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ATTACHMENT E
EPA ACCEPTANCE CRITERIA
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and
trade name, if appropriate)
2. Name, nominal concentration, and certified limits (upper and
lower) for each active ingredient and each intentionally-
added inert ingredient
3. Name and upper certified limit for each impurity or each
group of impurities present at > 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.1%
4. Purpose of each active ingredient and each intentionally-
added inert
5. Chemical name from Chemical Abstracts index of Nomenclature
and Chemical Abstracts Service (CAS) Registry Number for each
active ingredient and, if available, for each intentionally-
added inert
6. Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
7. Description of each beginning material in the manufacturing
process
EPA Registration Number if registered; for other
beginning materials, the following:
Name and address of manufacturer or supplier
Brand name, trade name or commercial designation
Technical specifications or data sheets by which
manufacturer or supplier describes composition,
properties or toxicity
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8. Description of manufacturing process
Statement of whether batch or continuous process
Relative amounts of beginning materials and order in
which they are added
Description of equipment
Description of physical conditions (temperature,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
Description of measures taken to assure quality of final
product
9. Discussion of formation of impurities based on established
chemical theory addressing (1) each impurity which may be
present at > 0.1% or was found at > 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
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61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at > 0.1%
2. Degree of accountability or closure > ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4. Complete and detailed description of each step in analytical
method used to analyze above samples
5. Statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8. Upper certified limit proposed for each impurity present at
> 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
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9- Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10« Analytical methods (as discussed in #9} to verify certified
limits validated as to their precision and accuracy
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62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Number of representative samples analyzed for all active
ingredients and all impurities at > 0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of toxic impurities which were analyzed for
levels <0.l%.
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
'5. Statement of precision and accuracy of method(s) in item #4.
6. Chemical name and quantities observed (range,, mean, standard
deviation) for each ingredient (actives and impurities)
analyzed in item #1.
7. Proposed upper and lower certified limits for each active
ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at
>=0.l% and certain toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
10. Statement of precision and accuracy of method(s) in item #9
(may reference item #5 if applicable).
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of
Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° c
63-4 Odor
Verbal description of odor (or lack of it) using terras
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in C°
Any observed decomposition reported
63-6 Boiling Point
Reported in C°
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in
g/ml or the specific gravity of liquids reported with
reference to water at 20° c. [Note: Bulk density of
registered products may be reported in Ibs/ft or
Ibs/gallon.]
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63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about 20 - 25" C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° c
Experimentally determined and description of procedure
provided .(preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in C°).
5. Indication of boiling point (in C°) .
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 young adult rats/sex/group
3. Dosing, single oral may be administered over 24 hrs.
4..* Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category
or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-1 Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 animals/sex/group
3.i Rats 200-300 gin, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6..1 Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours
before dosing
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8. Preparation of application site
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
12. Summarization of body weights
13.. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Product is a gas., a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
15 urn or less).
3. At least 5 young adult rats/sex/group
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6. Chamber temperature, 22" C (±2), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing
zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. Statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure
5. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal or
21 days (whichever is shorter).
individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the
conjunctival sac of one eye per animal
5. Dose administered
6. Note whether solid or granular test material has been ground to
a fine dust
7. State whether eyes were washed and at what time post
instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation
before dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior
to dosing
7. Application site approximately 6 cm.
8. Application site covered with a gauze patch held in place
with nonirritating tape
9. Material removed, washed with water, without trauma to
application site
10. Application site examined and graded for irritation at 1,
24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.i Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified
time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State times post application when site was graded for
irritation
11. Individual observations for day of dosing and individual
daily observations thereafter
12. Significance of changes from Acceptance Criteria.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
dose your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5.± Reference for test.
6. Test followed essentially as described in reference
document.
7. Positive control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
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81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
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_
3.*
8.*
81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Study performed on an organophosphate cholinesterase
inhibiting compound.
Technical form of the active ingredient tested.
Positive control utilized.
Species utilized, domestic laying hen 8-14 months of age,
Dosing oral by gavage or capsule (dermal or inhalation
may be used).
An acute oral LD is determined.
Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
Dosed animals may be protected with atropine and/or 2-
PAM.
Sufficient test animals so that at least 6 survive.
Negative (vehicle) control group of at least 6 hens
Positive control of at least 4 hens, (if used)
Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
Observation period 21 days after each dose.
Individual daily observations.
Individual body weights.
Individual necropsy not required.
Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
_brain, including medulla oblongata
"spinal cord; upper cervical, mid-thoracic and
"lumbro-sacral regions
tibial nerve; proximal regions and branches
sciatic nerve
Criteria marked with a * are supplemental and may not be required
for every study.
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ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
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ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
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&EPA
Unittcf States Environmental Protection Agency
Washington, DC 10460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OHt No.
Appnvsl EipIrM 12-11 -tj
Public reporting burden for this collection of information is tstlmattd to avtragf 15 minutM ptr response, including
time for rtvitwing instructions, starching existing data sourcts, gathsring and maintaining the data needed, and
oomplttlng and rtvJtwing thf collection of information. Sand commtnts regarding the burden tstimatt or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief. Information Policy
Branch. PM-223, U.S. Environmental Protectbn Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (20704106). Washington, DC 20503.
Please flu la blanks below.
Company Nwnt
Product N»»e
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentieide Act (FIFRA), if necessary. However, my company would prefer to
tnttr into an agreement with ont or more registrants to davelop jointly or share in the cost of developing
My firm has offered in writing to anter into such an agreement. That offer was Irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(Hl) of FIFRA if final agreement on ail
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nam* •( Plrn(«>
tot* •! Oftar
IcerttythailamcUyautnorizedtorecmertthec havemadeon
this term and al attachments therein are true, accurate, and complete, (acknowledge ttiat any knowingly false or
misleading statement may be punfrhibie by fine or impflsonmem or bom pno^r applicable law.
IsigMtur*
N«IM Ml*
•t Company'* Aulli»rii«e' R»pr»»tnlati««
TlUt (Pteaat Ty»* er
DIM
MM)
Ef»A
II7042
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v-
tf-
-------
United Statts Environmental Prottctlon Agency
•A BMBiBm m Washington, DC 20460
^fi"3f l""lMF\ CERTIFICATION WITH RESPECT TO
^^ fcii M * DATA COMPENSATION REQUIREMENTS
I Public reporting burden for this collection of information is estimated to average 15 m
time for raviawing instructions, starching existing data courcas, gathering and mainta
oomplating and raviawing tha ooflaction of information. Sand oommants ragarding tN
aspad of this collection of information, including suggestions for radudng this burden
Bunch, PM-223, U.S. invlronmantaJ Protection Agency, 401 M St.. S.W., Washingto
of Managamant and Budget, Paperwork Reduction Project (2070-0106), Washington
Please fin in blanks Mow.
Ceapeny Na«e
Produce Name
form Approved
OVB No. M70-01P8
Approval fipltM 12-1142
mutes per response, including
ning the data needed, and
i burden estimate or any other
, to Chief, information Policy
n. DC 20460; and to the Office
, DC 20503.
EPA
Reg. No.
1 Certify thai:
For each study cited in support of registration or registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
That for each study died in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am tha original data submitter, or I have obtained the written permission ot the original data submitter, or I
have notified in writing the oompany(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance wtth sections 3(c)(i)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount ot
compensation due, I any. The companies I have notified are:
I ] The companies who have submitted the studies fisted on the back of this form or attached
shafts, or indicated on tha attached •Requirement! Status and Registrants' Response Form.'
3. Thai I have previously compfledwth section 3 and 3(c)(2)(D).
Signature
Oete
NMM an* Title (Pleeee Type er MM)
(er* H70-I1 (4-10)
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4
i
I US Environmental Protection Agency Registration Standard lor:
1 " Washington. DC 20460
Lj>EPA Product Specific
IT Data Report
Registration
Guideline No.
Sec. 156.120
Product
Chemistry
81-1
81-2 (z)
«1-2(M
82-1
62-2
62-3
63-2
83-3
63-«
63-5
634
63-7
6M '
63-9
63-10
63-11
^ 63-12
W 63-13
63-14
63-19
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-3
81-6
Nam* of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulh-dtntity, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
pH
Stability
Oxidizing/reducing reaction
Ftammability
Explodability
Storage stability
Viscosity
Miseibiiity
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toiitity, rat
Acute dermal toxiettv. rabbit /rae/g.pig
Acute inhalation toxibty, rat
Primary eye irrttattoft. rabbit
'rim^ry derma! {filiation
Dermal senarttsatfon
Testing not
required for my
product listed
above
{ONK*M/QW)
.
EPA Registration Numoer
I am complying, with
Data Requirements bv •
Citing MR ID No.
Submitting Data
(Mxchta)
(Ctoc* CMlow)
form Approved
OMB #2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
Certification
I certify that the statements i have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
»
[Typed Name and Tin*
Signature
•
Data
EPA Form 89* (Rev. 5-M) Previous edition is obsolete.
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