United States Prevention, Pesticides EPA 738-R-95-007
Environmental Protection And Toxic Substances December 1994
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Polybutene
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case polybutene . The
enclosed Reregi strati on Eligibility Decision (RED) contains the Agency's evaluation of the data
base of this chemicals, its conclusions of the potential human health and environmental risks of
the current product uses, and its decisions and conditions under which these uses and products
will be eligible for reregi strati on. The RED includes the data and labeling requirements for
products for reregi strati on.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED". This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses are due 90 days from the date of this
letter. The second set of required responses are due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of
suspension against your products.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Jean
Holmes at (703) 308-8008. Address any questions on required generic data to the Special
Review and Reregi strati on Division representative Mark Wilhite at (703)308-8586.
Sincerely yours,
Peter P. Caulkins, Acting Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI letter
(or four forms for the combined) by following the instructions provided. You must submit the
response forms for each product and for each DCI within 90 days of the date of this letter
(RED issuance date); otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response, but
certainly no later than the 8-month response date. All data waiver and time extension requests
must be accompanied by a full justification. All waivers and time extensions must be granted by
EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may delete uses
which the RED says are ineligible for reregi strati on. For further labeling guidance, refer to the
labeling section of the EPA publication "General Information on Applying for Registration in
the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If
you choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
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e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
Polybutene
LISTD
CASE 4076
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
POLYBUTENE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 3
III. SCIENCE ASSESSMENT 3
A. Physical Chemistry Assessment 3
B. Human Health Assessment 4
1. Toxicology Assessment 4
a. Acute Toxicity 4
b. Mutagenicity 5
2. Exposure Assessment 5
a. Occupational and Residential 5
3. Risk Assessment 6
C. Environmental Assessment 6
1. Ecological Toxicity Data 6
a. Toxicity to Terrestrial Animals 6
b. Toxicity to Aquatic Animals 8
2. Environmental Fate 9
a. Environmental Fate Assessment 9
b. Environmental Fate and Transport 9
3. Exposure and Risk Characterization 9
a. Exposure and Risk to Nontarget Terrestral Animals 9
(1) Birds 9
(2) Mammals 10
b. Exposure and Risk to Nontarget Aquatic Animals 10
c. Endangered Species 10
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 11
A. Determination of Eligibility 11
B. Determination of Eligibility 11
1. Eligibility Decision 11
2. Eligible and Ineligible Uses 12
C. Regulatory Position 12
1. Endangered Species Statement 12
2. Labeling Rationale 12
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V. ACTIONS REQUIRED BY REGISTRANTS 13
A. Manufacturing-Use Products 13
1. Additional Generic Data Requirements 13
2. Labeling Requirements for Manufacturing-Use Products 13
B. End-Use Products 13
1. Additional Product-Specific Data Requirements 13
2. Labeling Requirements for End-Use Products 14
C. Existing Stocks 14
VI. APPENDICES 15
APPENDIX A. Table of Use Patterns Subject to Reregistration 17
APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make
the Reregistration Decision 23
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 4076 31
APPENDIX D. List of Available Related Documents 37
APPENDIX E 41
PR Notice 86-5 43
PR Notice 91-2 61
APPENDIX F. Product Specific Data Call-In 67
Attachment 1. Chemical Status Sheet 81
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 83
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 89
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 93
Attachment 5. EPA Acceptance Criteria 97
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
Ill
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 113
APPENDIX G. FACT SHEET 123
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POLYBUTENE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Gabe Patrick
Bill Gross
Dohl Herzi
Environmental Fate and Effects Division
Sharlene Matten
Bill Erickson
Harry Craven
Larry Liu
Health Effects Division
Mary Clock
Bruce Kitchens
Pat McLaughlin
Registration Division
Shyam Mathur
Dave Ritter
Dan Peacock
Special Review and Reregi strati on Division
Mark Wilhite
Bruce Sidwell
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Occupational and Residential Exposure Branch
Toxicology Branch II
Registration Support Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ADI Acceptable Daily Intake. A now defunct term for refernce dose (RfD).
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking water)
lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as
a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the
test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight
of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants
in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Agency has completed its review of the target database for the pesticide polybutene,
and has concluded that the uses of polybutene as labeled and used as specified in this
Reregi strati on Eligibility Decision will not cause unreasonable risk to humans or the
environment and these uses are eligible for reregi strati on.
Polybutene is a non-drying, sticky polymer which is registered for use as a bird and
squirrel repellent. The unpleasant sticky sensation experienced by the target pests is the source of
the repellent action of these products. There are six registered products, five of which are
formulated as gels and one as a liquid to be applied in a high pressure spray or painted on with a
brush. Outdoor use sites include structures, fences, roofs, industrial and commercial areas, as
well as trees, shrubs and vines. Indoor sites include beams, girders and struts where birds can sit
or roost. Target pests include sparrows, starlings, gulls, blackbirds, pigeons, ravens, and
squirrels.
Before reregistering products containing polybutene, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. The amended Act provides a schedule for the reregi strati on process to be completed in nine
years. There are five phases to the reregi strati on process. The first four phases of the process focus
on identification of data requirements to support the reregi strati on 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
reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregi strati on" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregi strati on 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 reregi strati on eligibility of the
registered uses of polybutene. The document consists of six sections. Section I is the introduction.
Section II describes polybutene, its uses, data requirements and regulatory history. Section III
discusses the human health and environmental assessment based on the data available to the Agency.
Section IV presents the reregistration decision for polybutene. Section V discusses the requirements
for its reregistration. Finally, Section VI contains the Appendices which support this Reregistration
Eligibility Decision. Additional details concerning the Agency's review of applicable data are
available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Decision:
• Common Name: Polybutene
• CAS Registry Number: 9003-29-6
• OPP Chemical Code: 011402
• Empirical Formula: R3C-[C4H8]n-CH=CR2, where R=CH3
B. Use Profile
This section is a summary of the uses of the current products which were registered
at the time of the drafting of this document. The Agency provides a detailed description of
these uses in Appendix A. Sections IV and V describe any new modifications, including
changes to the use sites, application rates and restrictions, and use precautions, that are now
required for product reregi strati on or may be required for new or amended registration.
Type of Pesticide: Repellent
Use Sites: TERRESTRIAL NON-FOOD, OUTDOOR RESIDENTIAL:
Buildings and adjacent structures where birds land or roost, e.g., top
edges of girders, beams, ledges, windowsills, gutters, struts, supports,
trees, bushes shrubs and vines.
INDOOR NON-FOOD:
Areas where birds land or roost (e.g., beams, supports, girders, and
struts)
Target Pests: Birds, tree squirrels
Formulation Types Registered: Single Active Ingredient Products:
Ready-to-Use
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97.0%
93.5%
90.0%
80.0%
42.8%
Liquid Concentrate
49.0%
Method and Rates of Application: Applied as a bead strip to surfaces
with a ready-to-use tube or caulking
gun. Liquid product may be applied
evenly with a paint brush, or sprayed
on with a hand or pressure sprayer.
Use Practice Limitations: Do not apply to surfaces where small
protected bird species may become
entrapped, or where people walk or
stand. Do not apply in wet, damp, or
freezing conditions.
C. Regulatory History
Polybutene has been registered in the United States since 1960 for use as an insect
control agent, since 1963 as a a bird repellent, and as a tree squirrel repellent since 1967.
The insect repellents were eventually deregulated because their mode of action is more to
trap than repel. The reregi strati on phase 4 data call-in of July 1993 required only technical
chemistry and two aquatic toxicity studies to complete the database for reregi strati on. There
are currently six registered products and three companies with product registrations.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
TGAI: Polybutene
Molecular
weight: 320-420
Color: Clear, bright
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Physical
state: Viscous, non-drying liquid at room temperature
Odor: Odorless
Boiling
point:
Density:
Vapor
pressure:
Stability:
160°C; decomposes at higher temperatures
0.89 g/ml (7.51bs./gal.) at 37.TC
0.13 Torr (mm Hg) at 25°C
Stable. Technical grade polybutene is not sensitive to metals,
metal ions or sunlight. At elevated temperatures and extended periods
of time in the presence of oxygen, the technical polybutene changes
in color and its viscosity decreases.
B. Human Health Assessment
1. Toxicology Assessment
The generic toxicological data base on polybutene is adequate and will
support reregi strati on eligibility.
a. Acute Toxicity
Acute Toxicity Data
Test
Oral LD,n-Rat
Dermal LD,n-Rabbit
Eye Irritation-Rabbit
Dermal Irritation-Rabbit
Dermal Sensitization-Guinea pig
Results
LD,n>5.0g/kg
LD,n >2.0 g/kg
irritating
not irritating
not sensitizing
Category
IV
III
II
IV
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In an acute oral toxicity study with rats, the LD50 for polybutene was
greater than 5.0 g/kg, a limit dose, which is classified as toxicity category IV
(MRID 41772401). The LD50 was greater than 2.0 g/kg, a limit dose, for
acute dermal toxicity with rabbits, which is toxicity category III (MRID
41772402).
A primary eye irritation study with rabbits resulted in transient
corneal opacity and iritis at 24 and 48 hours, with conjunctival irritation
through day 10, for washed eyes, or day 14, for unwashed eyes. The effects
cleared after these times. The test material is classified as toxicity category
II (MRID 41772403). A primary dermal irritation study with rabbits resulted
in virtually no irritation, which is toxicity category IV (MRID 41772404).
A test for dermal sensitization with guinea pigs was negative (MRID
41772405). The test material in these acute studies contained 97%
polybutene. The requirement for an acute inhalation toxicity study, has been
waived because of the viscosity and unlikelihood of respirable particles of
polybutene.
b. Mutagenicity
A test for mutagenicity, the XPRT forward mutation assay in Chinese
hamsters, was negative (MRID 43076603). An in vivo bone marrow
micronucleus test with mice was negative for clastogenic or aneugenic effect
(MRID 43076604). The test material in these studies contained 97%
polybutene. Additional information is required on an Ames study to upgrade
it to acceptable.
2. Exposure Assessment
a. Occupational and Residential
The potential for exposure to the mixer/loader/applicator is low when
using polybutene products in accordance with label instructions. There is a
low potential exposure to persons entering treated sites after application is
complete.
Post-application exposure data were not required, since polybutene
is not applied foliarly or applied directly to the soil and since there is a low
potential for dermal exposure to reentry workers. Polybutene does not trigger
the toxicological criteria and does not trigger the post-application exposure-
potential criteria. Based on the use patterns for this chemical the potential for
post-application exposure should be minimal.
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3. Risk Assessment
Polybutene does not trigger Agency toxicological concerns except for
eye irritation. In the absence of toxicological triggers, no further
toxicological human exposure data are required to support the reregistration
of polybutene.
At this time there are no engineering control requirements, such as
closed systems, currently required on labeling for polybutene. There are no
special toxicological concerns for polybutene that warrant the establishment
of active-ingredient-based minimum personal protective equipment (PPE)
requirements. However, when end-use product acute toxicity data are
received, PPE requirements may be upgraded if necessary.
Except for its eye irritation properties, there are no toxicological
endpoints of concern for workers and homeowners exposed to polybutene.
The potential for exposure to the mixer/loader/applicator is low when using
polybutene products in accordance with label instructions. Risk to workers
and homeowners from exposure to polybutene is therefore expected to be
negligible.
C. Environmental Assessment
1. Ecological Toxicity Data
The ecotoxicological data base is adequate to characterize the toxicity
of polybutene to nontarget terrestrial and aquatic organisms when used on terrestrial
nonfood sites.
a. Toxicity to Terrestrial Animals
In order to establish the toxicity of polybutene to birds, the following
tests are typically required using the technical grade material: one avian
single-dose oral (LD50) study on one species (preferably the mallard duck or
bobwhite quail); two subacute dietary studies (LC50), with one species of
waterfowl (preferably mallard duck) and one species of upland game bird
(preferably bobwhite quail). However, because polybutene repels birds
primarily through an adverse tactile response to the sticky end-use materials,
only the dietary study for bobwhite quail was required.
Wild mammal testing is required on a case-by-case basis, depending
on the results of the lower tier studies such as acute and subacute testing,
intended use pattern, and pertinent environmental fate characteristics. For
polybutene wild mammal testing, the available acute oral toxicity in the rat
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study was used.
A honey bee acute contact LD50 study is required if the intended use
will result in honey bee exposure. Because the proposed use patterns are not
likely to expose honey bees, these data were not required.
(1) Avian, Acute Oral Toxicity
Avian Acute Oral Toxicity Findings
Species
Bobwhite quail
% Test
Material
100
LDso
>2150mg/kgai
Conclusions
practically nontoxic
The avian acute oral LD50 of greater than 2150 mg/kg of active
ingredient for bobwhite quail indicates that technical polybutene is
practically nontoxic to birds on an acute oral basis. The guideline
requirement for the avian acute oral LD50 study is fulfilled (MRID
43076601).
(2) Avian, Subacute Dietary Toxiciy
Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
% Test
Material
100
LC50
>5000 ppm ai
Conclusions
practically nontoxic
The avian dietary LC50 of greater than 5000 ppm for bobwhite quail
indicates that technical polybutene is practically nontoxic to birds on a
dietary basis. No mortality was reported for either species at the highest
level tested. The guideline requirement is satisfied (MRID 43133001).
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(3) Mammalian Toxicity
Mammalian Acute Oral Toxicity Findings
Species
Rat (small wild mammal surrogate)
LDso
>5000 mg/kg
Conclusion
practically nontoxic
The available mammalian data indicate that technical
polybutene (97% a.i.) is practically nontoxic to small
mammals on an acute basis (MRID 41772401).
b. Toxicity to Aquatic Animals
In order to establish the toxicity of an outdoor-use pesticide to freshwater
fish, the minimum data required on the technical grade of the active ingredient are
two freshwater fish toxicity studies. One study should use a coldwater species
(preferably the rainbow trout) and the other a warmwater species (preferably the
bluegill sunfish). A reduced fish toxicity data set has been specified for polybutene.
Because of the use pattern, sticky nature of the products, and manner in which
products are applied, the potential for exposure of aquatic environments to
polybutene is likely to be low. Therefore, only the fish acute toxicity test for
rainbow trout was required.
The minimum data requirement to establish acute toxicity to freshwater
invertebrates is a 48-hour acute study with the technical material. Test organisms
should be first instar Daphnia magna or early instar amphipods, stoneflies, or
mayflies.
Acute toxicity testing with estuarine and marine organisms is required when
an end-use product is intended for direct application to the marine/estuarine
environment or is expected to reach this environment in significant concentrations.
The uses of polybutene are not likely to result in exposure to the estuarine
environment. Therefore, no data were required.
(a) Freshwater Fish
One range-finding acute toxicity test with the rainbow trout was
submitted. The test material was insoluble and formed a surface slick in the
test vessel throughout the trial, which resulted in unacceptably low levels of
dissolved oxygen. Additional testing has indicated that the solubility of
polybutene is not enhanced by using any of EPA's recommended solvents.
Moreover, the only known analytical method for polybutene is reported to
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have a Limit of Quantitation at 300 ppm. Attempts to validate a Total
Organic Carbon method to confirm an adequate level of sensitivity were
inconclusive. The Agency believes the appropriate means of increasing the
solubility of polybutene have been exhausted and that further testing would
not establish an LC50 value. Therefore, the requirement for a fish toxicity
test with the rainbow trout is waived (MRTD 43382702).
(b) Freshwater Invertebrates
One range-finding acute toxicity test with Daphnia magna was
submitted. Solubility of the test material was a problem. For the reasons
cited above for the freshwater fish study, the Agency waives the requirement
for an aquatic invertebrate study (MRID 43382701).
2. Environmental Fate
a. Environmental Fate Assessment
Polybutene is a highly stable polymeric substance, with a molecular weight
ranging from 420-2,500 g/Mole. The compound is resistent to physical or chemical
change due to aging or temperature. The presence of double bonds in the polymeric
chain appear to provide the chemical its inherent stability.
b. Environmental Fate and Transport
There were no environmental fate data requirements for polybutene
reregi strati on due to its physical properties and use patterns. A data waiver
was granted for the hydrolysis data requirement based on the polymeric
nature of the compound and the limited exposure in the environment.
3. Exposure and Risk Characterization
a. Exposure and Risk to Nontarget Terrestral Animals
(1) Birds
Based on the nature of the test material, toxic exposure is not
likely. However, small birds contacting the sticky material may be
temporarily trapped and their feathers coated with gel, rendering
them unable to fly. The Agency has some data indicating that such
incidents occasionally occur. These incidents can be fatal for small
birds, but such incidents generally involve only one or several
individuals. Risk to most nontarget birds from the gel materials also
is probably alleviated by the fact that the use sites for these products
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are principally urban commercial and industrial buildings where
small legally protected bird species (Federal Migratory Bird Treaty
Act) are unlikely to be very common.
The Agency is concerned that the liquid formulation of
polybutene poses some risks to small nontarget bird species. This
concern exists because the liquid product can be sprayed to the point
of runoff on trees, shrubs, bushes, vines, etc. where a variety of small
legally protected bird species could be present. However the liquid
product is sold through commercial channels and is not generally
available to retail customers and homeowners. This marketing
practice thus limits the potential of the product to adversely impact
birds protected by the Federal Migratory Bird Treaty Act, since it is
used primarily by commercial applicators.
(2) Mammals
The Agency does not anticipate any undue risks to wild
mammals from the registered uses of polybutene. Polybutene is
practically nontoxic to rats on an acute oral and dermal (LD50 >2000
mg/kg) basis. Moreover, mammals would not be likely to consume
polybutene because of the nature and consistency of the products.
Small, scansorial animals such as tree squirrels and chipmunks might
be exposed via their feet if they walk across a treated site. However,
the material is a repellent and is most likely to simply deter them
from the site than to be lethal.
b. Exposure and Risk to Nontarget Aquatic Animals
Because of the use sites and the sticky composition and insolubility
of the end-use materials, contamination of water bodies is not expected to
occur. Therefore, no undue risk to aquatic animals is anticipated from the
registered uses of polybutene.
c. Endangered Species
The Endangered Species Protection Program is expected to become
final in the near future. Limitations in the use of polybutene may be required
to protect endangered and threatened species, but these limitations have not
been defined and may be formulation specific. If necessary, the Agency
would initiate a consultation with the Fish and Wildlife Service in
accordance with the species-based priority approach described in the
Program. After completion of consultation, registrants will be informed if
any required label modifications are necessary. Such modifications would
10
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most likely consist of the generic label statement referring pesticide users to
use limitations contained in county bulletins.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing polybutene active ingredients. The Agency has
completed its review of these generic data, and has determined that the data are sufficient
to support reregistration of all products containing polybutene. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of polybutene, and lists the submitted studies that the Agency found
acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of polybutene and to determine that polybutene can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing polybutene as the active ingredients are eligible for
reregistration. The reregistration of particular products is addressed in Section V of this
document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable studies
to generate such data, published scientific literature, etc. and the data identified in Appendix
B. Although the Agency has found that all uses of polybutene are eligible for reregistration,
it should be understood that the Agency may take appropriate regulatory action, and/or
require the submission of additional data to support the registration of products containing
polybutene, if new information comes to the Agency's attention or if the data requirements
for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
polybutene, the Agency has sufficient information on the health effects of
polybutene and on its potential for causing adverse effects in fish and wildlife and
the environment.
11
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Based on that information, the Agency concludes that products containing
polybutene for all uses are eligible for reregi strati on. The Agency has determined
that polybutene products, labeled and used as specified in this Reregi strati on
Eligibility Decision, will not pose unreasonable risks or adverse effects to humans
or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of polybutene are eligible for
reregi strati on.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for polybutene.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program", as mentioned in section III.C.3.C of this document) to identify
all pesticides whose use may cause adverse impacts on endangered and threatened
species and to implement mitigation measures that will eliminate the adverse
impacts. The program would require use modifications or a generic product label
statement, requiring users to consult county-specific bulletins. These bulletins would
provide information about specific use restrictions to protect endangered and
threatened species in the county. Consultations with the Fish and Wildlife Service
will be necessary to assess risks to newly listed species or from proposed new uses.
In the future, the Agency plans to publish a description of the Endangered
Species Program in the Federal Register and have enforceable county-specific
bulletins available. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this time
through the RED. Rather, any requirements for product use modifications will occur
in the future under the Endangered Species Protection Program.
2. Labeling Rationale
In order to remain in compliance with FIFRA, it is the Agency's position that
the labeling of all pesticide products containing polybutene must comply with the
Agency's current pesticide labeling requirements.
12
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Because of the Agency's concern for the potential harm to non-target bird
species, especially small birds covered by the Federal Migratory Bird Treaty Act, a
warning statement on the label is required to clarify this risk.
Because of the nature of the liquid formulation product and its application
method, the Agency considered classifying this product as a Restricted Use pesticide,
to be applied by trained, certified applicators only. However, the liquid product
covered in this document is already sold through commercial channels and is not
generally available to retail consumers and homeowners. It is sold only in one gallon
units and is generally applied using equipment, such as a boom and pressure spray
gun, that are not used by home owners. It is therefore believed that a restricted use
classification for this product would have little impact on risk to non-target species.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of polybutene for the
above eligible uses has been reviewed and determined to be substantially complete.
Some additional information is required to upgrade one of the mutagenicity studies
to acceptable. Otherwise, no additional generic data are required at this time.
2. Labeling Requirements for Manufacturing-Use Products
There are no manufacturing use products registered.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to
conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the
13
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instructions in the Requirement Status and Registrants Response Form provided for
each product.
2. Labeling Requirements for End-Use Products
All polybutene products must contain the following statement in the
ENVIRONMENTAL HAZARDS section of the label:
"Small birds may become fatally entrapped by this tacky repellent. To reduce
hazards to legally protected species, and to avoid noncompliance with the
Federal Migratory Bird Treaty Act, follow all instructions in the Directions
For Use."
At this time, all of the registered uses of polybutene are out of the scope of
the Worker Protection Standard for Agricultural Pesticides (WPS). The personal
protective equipment for products which contain polybutene will be determined by
the toxicity of the end-use product.
The Agency is requiring the following labeling statement to be located on the
liquid formulation product:
"Do not apply liquid products in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be in
the area during application."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of
label changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement
of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell [add chemical
names here] products bearing old labels/labeling for 26 months from the date of issuance of
this RED. Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of this RED. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and existing
stocks requirements applicable to products they sell or distribute.
14
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VI. APPENDICES
15
-------
16
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
17
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18
-------
Date 12/22/94 ) Time 11:38
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
APPENDIX A ) CASE 4076, [Polybutene resins] Chemical 011402 [Polybutene]
4<
Form(s) Min. Appl.
LUIS 1.6 ) Page 1
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
AGRICULTURAL/FARM STRUCTURES/BUILDINGS AND EQUIPMENT
RTU NA
Indoor premise treatment., When needed.,
Paintbrush.
Spray., When needed., Hand held sprayer. RTU
Spray., When needed., Pressure sprayer. RTU
NON- FOOD/NON- FEED
NA
NA
Use Group: INDOOR FOOD
UC * NS NS
UC
UC
NS
NS
NS
NS
NS
NS
NS NS
NS
NS NS NS
NS NS NS
AGRICULTURAL UNCULTIVATED AREAS
Strip treatment., When needed., Aerosol can. PRL NA
Strip treatment., When needed., Caulk gun. RTU NA
Strip treatment., When needed., Knife or RTU NA
spatula.
Strip treatment., When needed., Not on RTU NA
label.
RTU NA
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Strip treatment., When needed., Caulk gun. RTU NA
ORNAMENTAL AND/OR SHADE TREES
Bark treatment., Early spring., Hand held RTU NA
sprayer.
Bark treatment., Early spring., Pressure RTU NA
sprayer.
Bark treatment., Fall., Hand held sprayer. RTU NA
Bark treatment., Fall., Pressure sprayer. RTU NA
Use Group: TERRESTRIAL NON-FOOD CROP
.02813 Ib linear * NS NS
ft
UC * NS NS
.008203 gal *
linear ft
.06571 Ib linear *
ft
.008203 gal * NS
linear ft
NS
UC
NS NS
UC * NS NS
NS
NS
NS NS
NS
NS
NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
Ib tree * NS NS NS NS NS NS
3.969 Ib tree
NS NS
3.969 Ib tree * NS NS
3.969 Ib tree * NS NS
NS
NS
NS
NS NS
NS
NS NS NS
NS NS NS
-------
Date 12/22/94 ) Time 11:38
APPENDIX A ) CASE 4076, [Polybutene resins] Chemical 011402 [Polybutene]
LUIS 1.6 ) Page 2
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES
Bark treatment., Early spring., Hand held RTU NA
sprayer.
Bark treatment., Early spring., Pressure RTU NA
sprayer.
Bark treatment., Fall., Hand held sprayer. RTU NA
Bark treatment., Fall., Pressure sprayer. RTU NA
URBAN AREAS
Strip treatment., When needed., Aerosol can. PRL NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
3.969 Ib tree * NS NS NS NS NS NS
Ib tree * NS NS
NS
NS NS
NS
3.969 Ib tree * NS NS NS NS NS NS
3.969 Ib tree * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
.02813 Ib linear
ft
NS NS
NS
NS NS
NS
Strip treatment., When needed., Caulk gun. RTU NA
Strip treatment., When needed., Knife or RTU NA
spatula.
Strip treatment., When needed., Not on
label.
RTU NA
.008203 gal * NS NS
linear ft
.06571 Ib linear *
ft
.008203 gal
linear ft
NS NS
UC * NS NS
NS
NS NS
RTU NA
WIDE AREA/GENERAL OUTDOOR TREATMENT (PUBLIC HEALTH USE)
Strip treatment., When needed., Aerosol can. PRL NA
UC * NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
.02813 Ib linear
ft
NS NS
NS
NS NS
Strip treatment., When needed., Caulk gun. RTU NA
Strip treatment., When needed., Knife or RTU NA
spatula.
Strip treatment., When needed., Not on RTU NA
label.
UC * NS NS
.008203 gal *
linear ft
.06571 Ib linear *
ft
.008203 gal * NS NS
linear ft
UC * NS NS
-------
Date 12/22/94 ) Time 11:38 APPENDIX A ) CASE 4076, [Polybutene resins] Chemical 011402 [Polybutene] LUIS 1.6 ) Page 3
44444444
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
PRL : PRESSURIZED LIQUID
RTU : LIQUID-READY TO USE
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC Dosage Can Not be Calculated
No Calc
W
V
cwt
nnE-xx
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ". 0001234"
USE LIMITATIONS CODES
CAC : Keep out of lakes, streams, and ponds.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
-------
22
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
23
-------
24
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case 4076 covered by this Reregi strati on Eligibility Decision Document. It
contains generic data requirements that apply to 4076 in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 31 If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
25
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26
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Polybutene
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41779101
41779101
41779101
41779102
41779102
41779102
41779103
41779103
41779103
41779103
41779103
41779103
43133002
41779103
INAPPLICABLE
INAPPLICABLE
INAPPLICABLE
41779103
27
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Data Supporting Guideline Requirements for the Reregistration of Polybutene
REQUIREMENT
USE PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-2A
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
ALL
ALL
ALL
ALL
43076601
43133001
WAIVED
WAIVED
TOXICOLOGY
81-1
81-2
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41772401
41772402
41772403
41772404
41772405
43076602
43076603
43076604
ENVIRONMENTAL FATE
161-1
Hydrolysis
ALL
WAIVED
28
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29
-------
30
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of 4076
-------
32
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregi strati on Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
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 Agency, the Agency 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 Agency has also attempted 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 whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
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 standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of the document.
33
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c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency 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. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
34
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BIBLIOGRAPHY
MRID
CITATION
41772401 Shapiro, R. (1990) Acute Oral Toxicity in the Rat: Polybutene Resins: Lab
Project Number: T-106. Unpublished study prepared by Product Safety Labs. 15
P-
41772402 Shapiro, R. (1990) Acute Dermal Toxicity in the Rabbit: Polybutene Resin: Lab
Project Number: T-109. Unpublished study prepared by Product Safety Labs. 15
P-
41772403 Shapiro, R. (1990) Primary Eye Irritation Test: Polybutene Resin: Lab Project
Number: T-107. Unpublished study prepared by Product Safety Labs. 21 p.
41772404 Shapiro, R. (1990) Dermal Irritation Test in the Rabbit: Polybutene Resin: Lab
Project Number: T-108. Unpublished study prepared by Product Safety Labs. 16
P-
41772405 Shapiro, R. (1990) Dermal Sensitization Study in the Guinea Pig: Polybutene
Resin: Lab Project Number: T-l 10. Unpublished study prepared by Product
Safety Labs. 24 p.
41779101 Skendzel, J. (1990) Polybutene Resins-Product Identity and Composition. 8 p.
41779102 Skendzel, J. (1991) Polybutene Resins-Analysis and Certification of Product
Ingredients: Unpublished study prepared by Amoco Corp. 7 p.
41779103 Skendzel, J. (1991) Polybutene Resins-Physical and Chemical Characteristics.
Unpublished study prepared by Exxon Chemical Co. & Amoco Chemical Co. 21
P-
43076601 Helsten, B.; Lesar, C. (1993) Polybutene: 14-Day Acute Oral LD50 Study in
Bobwhite Quail: Lab Project Number: 137-003-03. Unpublished study prepared
by Bio-Life Associates, Ltd. 42 p.
43076602 Marshall, M. (1993) Salmonella/Microsome Assay for Bacterial Mutagenicity:
Polybutene: Lab Project Number: 0269-93. Unpublished study prepared by
Stillmeadow, Inc. 25 p.
43076603 Marshall, M. (1993) AS52 Chinese Hamster HGPRT Forward Mutation Assay
with Independent Repeat: Polybutene: Lab Project Number: 0271-93.
Unpublished study prepared by Stillmeadow, Inc. 18 p.
35
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BIBLIOGRAPHY
MRID
CITATION
43076604 Marshall, M. (1993) Mouse Micronucleus Test: Polybutene: Lab Project Number:
0270-93. Unpublished study prepared by Stillmeadow, Inc. 38 p.
43133001 Helsten, B.; Thompson, S. (1994) Polybutene: 9-Day Acute Dietary LC50 Study
in Bobwhite Quail: Final Report: Lab Project Number: 137-001-01. Unpublished
study prepared by Bio-Life Associates, Ltd. 80 p.
43133002 Knaver, J. (1993) Polybutene Resins-Physical and Chemical
Characteristics/Vapor Pressure: Lab Project Number: 93-204. Unpublished study
prepared by Amoco Chemical Co. 7 p.
43382701 Ward, T.; Boeri, R.; Kowalski, P. (1993) Acute Toxicity of Polybutene to the
Daphnid, Daphnia magna: Results of Range Finding Test: Lab Project Number:
58/TA. Unpublished study prepared by T. R. Wilbury Laboratories, Inc. 19 p.
43382702 Ward, T.; Boeri, R.; Kowalski, P. (1993) Acute Toxicity of Polybutene to the
Rainbow Trout, Oncorhynchus mykiss: Results of Range Finding Test: Lab
Project Number: 57/TA. Unpublished study prepared by T. R. Wilbury
Laboratories, Inc. 16 p.
43400801 Ward, T.; Boeri, R. (1993) Acute Toxicity of the Water Accomodated Fractions
(WAFs) of CMA #612 to the Daphnid, Daphnia magna: Lab Project Number:
9178-CMA/ESI-612. Unpublished study prepared by T. R. Wilbury Labs, Inc. 21
P-
43400802 Ward, T.; Boeri, R. (1993) Acute Toxicity of the Water Accomodated Fractions
(WAFs) of CMA #612 to the Fathead Minnow, Pimephales promelas: Lab Project
Number: 9176-CMA/ESI-612. Unpublished study prepared by T. R. Wilbury
Labs, Inc. 21 p.
36
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APPENDIX D. List of Available Related Documents
37
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38
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The following is a list of available documents related to 4076. It's purpose is to provide a
path to more detailed information if it is needed. These accompanying documents are part of the
Administrative Record for 4076 and are included in the EPA's Office of Pesticide Programs
Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. 4076 RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
39
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40
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APPENDIX E. PR Notices 86-5 and 91-2
41
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42
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PR Notice 86-5
43
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44
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tpno1 WASHINGTON, B.C. 20460
July 29,1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
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 §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to be, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 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
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. 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.
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(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
46
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E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative 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).
B. Transmittal Document
The first item in each submittal package must be a transmittal 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 (EUPj, §3(c)(2j(B) data call-in, §6(aj(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 or the studies. Within
these two groups of studies follow the instructions above.
47
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C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. 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 Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range for biorational pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,
151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
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
48
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level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
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
, (B),or(C)
Example
Page 12
Page 13
Page 16
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
(B),or(C)
Only if confidentiality is
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
Page 15
Page 14
D.I. Title Page
A title page is always required for each submitted study, published or unpublished.
The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance (s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
49
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b. Data requirement addressed. Include on the title page the Guideline number (s) of the
specific requirement(s) addressed by the study.
c. Author (s). Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or if it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant facts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(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 §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study 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." 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 associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
50
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D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential 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.
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. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number 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 processing 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 Standard 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 or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
Mark the fourth copy plainly on both its cover and its title page with the phi
"Public Docket Material - contains no information claimed as confidential".
ihrase
V.
For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James 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
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+ Smith Chemical Corporation 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 for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
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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
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
54
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Page 1 of X
(X is the total number of pages in the study)
55
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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
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method, can be approved unless the applicant waives all claims of
confidentiality for the analytical method. These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
• Identify specifically by page and line number (s) each portion of the study for
which you claim confidentiality.
• Cite the reasons why the cited passage qualifies for confidential treatment.
• Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
• Identify the measures taken to guard against undesired disclosure of this
information.
• Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
• Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
• If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
• If you assert that the information in voluntarily submitted, 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.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE. Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph^ 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 FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
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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
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
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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
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 finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
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PR Notice 91-2
61
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62
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91 -2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of Pesticide Program's policy with
respect to the statement of percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
statement on the label must be stated as the nominal concentration of such ingredient(s), as that
term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
II. BACKGROUND
For some time the Agency has accepted two different methods of identifying on the
label what percentage is claimed for the ingredient (s) contained in a pesticide. Some applicants
claimed a percentage which represented a level between the upper and the lower certified
limits. This was referred to as the nominal concentration. Other applicants claimed the lower
limit as the percentage of the ingredient(s) that would be expected to be present in their
product at the end or the product's shelf-life. Unfortunately, this led to a great deal of
confusion among the regulated industry, the regulators, and the consumers as to exactly how
much of a given ingredient was in a given product. The Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in the active ingredient statement
be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended to encompass any such "good
manufacturing practice" variations 40 CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed in connection with a
product's registration, represent the amounts of an ingredient that may legally be present 40
CFR 158.1/5. The lower certified limit is used as the enforceable lower limit for the product
composition according to FIFRA section 12(a)(l)(C), while the nominal concentration
appearing on the label would be the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is
warranted with respect to actual product composition because the nominal concentration would
be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10 (b). In this respect the
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certified limits will be routinely provided by EPA to States for enforcement purposes, since
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes or section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,
elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be fulfilled. Copies of the raw
analytical data must be submitted with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert ingredient, impurities of toxicological
significance (i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set based on representative sampling and chemical analysis (i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40 CFR 156-Labeling
Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must be changed to
nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established, the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
(2) Registrants having products subject to reregistration under FIFRA section 4 (a)
are to comply with the requirements of this Notice when specific products are
called in by the Agency under Phase V of the Reregistration Program.
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(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1557, to comply with this Notice. Such applications should
note "Conversion to Nominal Concentrations on the application form. These
types Or amendments will not be handled as "Fast Track" applications but will
be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Product Specific Data Call-in
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.^iK^- WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
ofyour 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 3, 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 ofyour products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
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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 I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
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).
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Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-in(s), 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. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy or the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-In Response Form in Attachment 2). Please note that
the company's authorized representative is required to sign the first page of the Data Call-In
Response Form and Requirements Status and Registrant's Response Form (if this form is
required) and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person (s) identified in Attachment 1.
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1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation or your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-
In Response Form, indicating your election of this option. Voluntary cancellation is item number
b on the Data Calf-In Response Form. If you choose this option, this is the only form that you
are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response .Form. Deletion of a use(s) and the iow volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section 111-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
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 item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
1) I will generate and submit data within the specified time frame (Developing Data)
2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
3) I have made offers to cost-share (Offers to Cost Share)
4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1 Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
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The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing tor 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, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of producing
the data upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c) (2) (B) (iii) and must not qualify this offer. The other registrant
must also inform EPA of its election of an option to develop and submit the data required by this
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Notice by submitting a Data Call-in Response Form and a Requirements Status and Registrant's
Response Form committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
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158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
you must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of~how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number (s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or ' core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete Justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in
force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3 (c) (2) (B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
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.
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8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEP TABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals, dose and effect levels to be
tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
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the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 3D day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment Z and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person (s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review and
Reregistration Division
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Attachments
1 - Data Call-in Chemical Status Sheet
2 - Froduct-Speciric Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - FFA Grouping or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
5 - FFA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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POLYBUTENE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing polybutene.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
polybutene. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Polybutene Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for polybutene are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on polybutene are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible polybutene products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of polybutene, please contact
Mark Wilhite at (703)'308-8586.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Jean Holmes at (703)308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Jean Holmes
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 4076
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 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 now listed under 40 CFR 158.155 through
158.180, SubpartC.
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 pertain 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 me 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 pertainingto the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and 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 required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
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"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 also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-in Notice (Section 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. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 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 guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
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 Documents 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.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this 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 required data; if the required study is not
submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed "
Certification of offer to Cost Share in the Development Data" form. I am including
a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the require data; if the
required study is not submitted on 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.
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4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-in Notice (Section 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.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing itudy). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit
a revised "Requirements Status chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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EPA'S BATCHING OF 6 PRODUCTS 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 products containing Polybutene resin polymers (Code
01140z) as the active ingredient, the Agency has batched products which can be considered similar
for purposes 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.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological 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. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In (DCI) 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 z), 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 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.
Six products were found which contain Polybutene resin polymers (Code 011402) as the
active ingredient. Three of the products have been placed in a single batch in accordance with the
active and inert ingredients, type of formulation and current labeling. Table 1 identifies the products
in each batch. The remaining product are dissimilar enough, with respect to percent active
ingredient, inert ingredients and type of formulation, to preclude meaningful batching. Table 2
identifies these products.
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Table 1
Batch
1
EPA Reg. No.
1621-17
8254-1
8254-4
% Active Ingredient
97.0%
90.0%
80.0%
Formulation
Type
Repellant
adhesive
Repellant
adhesive
Repellant
adhesive
Table 2 (Unbatched products)
EPA REG#
1621-16
8254-3
55943-1
% Active Ingred.
42.8%
49.0%
93.5%
Formulation Type
Aerosol
Aerosol
Repellant adhesive
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Attachment 5. EPA Acceptance Criteria
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 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 lexicologically 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
ortoxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the parameters
that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which may
be present at > 0.1% or was found at > 0.1% by product analyses and (2) certain lexicologically significant impurities
(see #3).
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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 > pa 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 now the limits were determined.
8. _ Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant impurities
at <0. 1% along with explanation of how limit determined.
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 py FDA) are fully described.
10. _ Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
101
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as " garlic-like, characteristic of aromatic compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported 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 lbs/ft3 or Ibs/gallon.]
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
102
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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
103
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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/grqup.
3.^ Dosing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
104
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 . _ Identify material tested (technical, end-use product, etc).
2 _ At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. _ Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.JL 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
mgestion.
11. _ Individual observations at least once a day.
12. _ Observation period to last at least 14 days.
13. _ Individual body weights.
14. _ Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
105
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81-3 Acute Inhalation Toxic ity 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 mhalable size for man (aerodynamic diameter 15 (jm 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).
1 1 . _ Individual observations at least once a day.
12. _ Observation period to last at least 14 days.
1 3 . _ Individual body weights.
14. _ Gross necropsy on all animals.
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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 > 1 1 . 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 parti culate substance.
6. _ Solid or granular test material ground to a fine dust.
7. _ Eyes not washed for at least 24 hours.
8. _ Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9*_ _ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
107
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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 apH of <2 or>11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held 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).
1 l.f. Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
108
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof<2or>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.JL Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
109
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110
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
111
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112
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Attachment 7. Cost Share Data Compensation Forms, Confidential Statement of
Formula Form and Instructions
113
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114
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116
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products must
be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the
trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10 and
must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will volumes
be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
117
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118
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
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 Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company'
Name and Title (Please
s Authorized Representative
Dale
Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580. which is obsolete
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120
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United States Environmental Protection Agency ,-TGD
Washington, DC 20460 <>
CERTIFICATION WITH RESPECT TO -^ ^
DATA COMPENSATION REQUIREMENTS *H PRQ^
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodentipide 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.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay cpmpensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FlFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wi
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
with regard to the registration or
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
121
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122
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APPENDIX G. FACT SHEET
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124
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-008
January 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Polybutene
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregi strati on
case 4076, polybutene.
Polybutene is a non-drying, sticky polymer which is registered for use
as a bird and squirrel repellent. When birds land on treated objects or
surfaces, they dislike the unpleasant sticky sensation and usually do not
return. Polybutene's sticky quality therefore is the source of the repellent
action of pesticide products containing this active ingredient.
Polybutene products may be used outdoors or indoors, on buildings or
adjacent structures (for example, on girders, beams, ledges, windowsills,
gutters, trees, shrubs, and vines) where birds land or roost. Formulations
include a gel which is applied as a bead strip to surfaces with a ready-to-use
tube or caulking gun, and a liquid concentrate which is applied with a paint
brush or sprayed on using a hand or pressure sprayer.
Use practice limitations include prohibitions against applying the
product to surfaces where small protected bird species may become
entrapped, or where people walk or stand; and against applying the product in
wet, damp, or freezing conditions.
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Regulatory
History
Polybutene has been registered in the U.S. since 1960 as an insect
control agent, since 1963 as a bird repellent, and since 1967 as a tree squirrel
repellent. The insect repellent uses were deregulated because their mode of
action is more to trap than to repel insects. A Data Call-In notice issued in
July 1993 required only minimal studies to complete the database for
reregi strati on. Currently, six polybutene pesticide products are registered.
Human Health
Assessment
Toxicity
Polybutene generally is of relatively low acute toxicity. It has been
placed in Toxicity Categories III and IV respectively for acute dermal and
oral effects (these are the lowest of four categories, indicating the lowest
degree of acute toxicity). Polybutene is not irritating to the skin (Toxicity
Category IV), but is irritating to the eyes and has been placed in Toxicity
Category II for eye irritation effects.
Polybutene is not mutagenic in studies available at this time. Additional
information is required on an Ames study to upgrade it to an acceptable level.
Dietary Exposure
Dietary exposure to polybutene is not expected since no food-related
uses are registered.
Occupational and Residential Exposure
The potential for exposure to workers (mixers, loaders and applicators)
is low when using polybutene products in accordance with label instructions.
The potential for post-application exposure is minimal, based on polybutene's
use patterns.
Human Risk Assessment
Polybutene generally is of low acute toxicity but causes eye irritation
(Toxicity Category II). No other toxicological endpoints are of concern for
workers or homeowners exposed to polybutene.
No food-related uses are registered so dietary exposure is not of
concern. Worker exposure is low when products are used in accordance with
approved labeling. Risk to workers and homeowners from exposure to
polybutene is expected to be negligible.
Environmental
Assessment
Environmental Fate
Polybutene is a highly stable polymeric substance which is resistant to
physical or chemical change due to aging or temperature. The Agency
imposed no environmental fate data requirements for reregi strati on of
polybutene because of its physical properties and use patterns. The hydrolysis
data requirement was waived based on the limited environmental exposure
that results from its use.
Ecological Effects
Because of its properties and use patterns, honey bees, small mammals,
aquatic organisms, and other wildlife are not likely to ingest or otherwise be
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exposed to significant amounts of polybutene. Many of the studies usually
required for reregi strati on therefore have been waived.
Polybutene is practically nontoxic to birds on an acute oral and a
subacute dietary basis. It also is practically nontoxic to small mammals on an
acute basis.
Attempts to conduct acute toxicity studies with the rainbow trout and
Daphnia magna were thwarted by the test material, which was insoluble and
formed a surface slick in the test vessel, resulting in unacceptably low levels
of dissolved oxygen. After all appropriate means of increasing the solubility
of polybutene were exhausted, EPA waived the requirements for freshwater
fish and aquatic invertebrate toxicity studies.
Ecological Effects Risk Assessment
Based on the nature of polybutene, toxic exposure to birds is not likely.
However, birds whose feathers contact the sticky material may become
temporarily entrapped, or their feathers may become coated with gel. When
such incidents occur they can be fatal, but usually involve only one or several
birds at a time. Risk to many nontarget, small birds probably is alleviated by
the fact that polybutene products are used primarily in/on urban commercial
and industrial buildings where small birds protected by the Federal Migratory
Bird Treaty Act are unlikely to be found.
EPA is concerned that the liquid formulation of polybutene poses some
risks to small nontarget bird species. The liquid product can be sprayed to the
point of runoff on trees, shrubs, bushes, vines, etc., where a variety of small,
legally protected bird species could be present. The Agency's concern is
lessened somewhat, however, because the liquid formulation generally is
available to and applied by commercial applicators.
EPA does not anticipate any undue risks to wild mammals or aquatic
animals from use of polybutene. Due to polybutene's nature and consistency,
mammals are unlikely to consume this material. Because polybutene is
insoluble, contamination of water bodies is not expected to occur.
In the future, when EPA implements the Endangered Species Protection
Program, the use of polybutene may be limited to protect endangered and
threatened species. However, these limitations have not yet been defined.
Risk MitiqatJOn EPA is requiring the following risk mitigation measures for polybutene,
as discussed earlier:
Because of the Agency's concern for potential harm to non-target birds,
especially small birds covered by the Federal Migratory Bird Protection
Treaty Act, a warning statement clarifying this risk is required to appear on
polybutene labels.
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Additional Data
Required
Product Labeling
Changes Required
EPA considered classifying the polybutene liquid product as a
Restricted Use Pesticide, to be applied only by trained, certified applicators.
However, this product already is sold through commercial channels and
generally is not available to retail customers and homeowners. It is sold only
in one gallon units and generally is applied using equipment that is not used
by homeowners. The Agency decided, therefore, that adding a Restricted Use
Pesticide classification would have little impact on reducing risk to non-target
species.
The generic data base supporting polybutene is substantially complete.
Additional information is required only to upgrade a mutagenicity study.
EPA also is requiring product-specific data including product chemistry and
acute toxicity studies, revised Confidential Statements of Formula (CSFs),
and revised labeling for reregi strati on.
All polybutene end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Environmental Hazards - All polybutene products must bear the following
statement in the Environmental Hazards section of the label:
"Small birds may become fatally entrapped by this tacky repellent. To
reduce hazards to legally protected species, and to avoid noncompliance
with the Federal Migratory Bird Treaty Act, follow all instructions in
the Directions For Use."
Worker Protection - All currently registered products containing polybutene
are outside the scope of the Worker Protection Standard for Agricultural
Pesticides (WPS). The personal protective equipment required for products
that contain polybutene will be determined by the toxicity of the end-use
product.
The Agency is requiring the following statement on the label of the
liquid formulation product:
"Do not apply liquid products in a way that will contact workers or
other persons, either directly or through drift. Only protected handlers
may be in the area during application."
Regulatory
Conclusion
Currently registered pesticide products containing the active ingredient
polybutene, labeled and used as specified in the RED document, will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregi strati on. Products
containing polybutene will be reregistered once the required product specific
data, revised Confidential Statements of Formula, and revised labeling are
received and accepted by EPA.
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For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for polybutene during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using WWW
(World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-
489-8190, fax 513-489-8695.
Following the comment period, the polybutene RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program, the
polybutene RED, or reregi strati on of individual products containing
polybutene, please contact the Special Review and Reregi strati on Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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