United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-94-005
April 1994
v>EPA Reregistration
Eligibility Decision (RED)
Hexadecadienol
Acetates
Recycled/Recyclable
Printed witti SoyfCanoialnX on paper thai
contains at least 50% recycled fiber
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I
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
reregistration eligibility review and decisions on the pesticide chemical case Hexadecadienol
Acetates which includes the active ingredients (Z,E)-7,ll-Hexadecadien-l-yl acetate and
(Z,Z)-7,ll-Hexadecadien-l-yl acetate. The enclosed Reregistration Eligibility Decision
(RED) contains the Agency's evaluation of the data base of these 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
reregistration. The RED includes the data and labeling requirements for products for
reregistration. It may also include requirements for additional data (generic) on the active
ingredients to confirm the risk assessments.
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 Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Tom Myers at (703) 308-8074.
Sincerely yours,
Enclosures
>aniefKT. liarolo, Dire;
Special Review and
Reregistration Division
:or
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (DCI) OR "90-DAY RESPONSE"-If generic data are required
for reregistration, a DCI letter will be enclosed describing such data. If product specific
data are required, another DCI letter will be enclosed listing such requirements. Complete
the two response forms provided with each DCI letter by following the instructions contained
in each DCI. You must submit the response forms for each product and for each DCI
within 90 days of the date you receive the RED; otherwise, your product may be
suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS 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 RED
issuance date (the cover letter 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
reregistration) separately. You may delete uses which the RED says are ineligible for
reregistration. For further labeling guidance, refer 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; 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
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instructions on its back.
e- Certification With Respect to Citation of Data. Complete and sign this
form (EPA form 8570-29) for each product. Cite-all is not a valid option for
reregistration.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE
Comments pertaining to the content of the RED may be submitted to the address
shown hi the Federal Register Notice which announces the availability of this RED.
5 WHERE TO SEND ALL PCI RESPONSES (90-DAY) AND APPLICATIONS
FOR REREGISTRATION (8-MQNTH RESPONSES)
By U.S. Mail;
Document Processing Desk (RED-SRRD-XXXX)* * XXXX = the
Office of Pesticide Programs (H7504C) case code for the
EPA, 401 M St. S.W. RED (see front
Washington, D.C. 20460-0001 cover of RED)
By express:
Document Processing Desk (RED-SRRD-XXXX)*
Office of Pesticide Programs (H7504C)
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 tune extension requests within 60 days. EPA will also try to respond to all
8-month submissions with a final reregistration determination within 14 months after the
RED has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Hexadecadienoi Acetates
LIST D
CASE 4111
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
HEXADECADIENOL ACETATES R.E.D. TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview '. 2
B. Use Profile 2
C. Estimated Usage of Pesticide^ 3
D. Data Requirements 3
E. Regulatory History 3
.HI. SCIENCE ASSESSMENT " 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment ,. 5
a. Acute Toxicityt 5
2. Exposure Assessment 6
a. Dietary Exposure 6
b. Occupational and Residential 6
3. Human Risk Assessment 6
C. Environmental Assessment . 6
1. Environmental Fate 6
a. Environmental Chemistry, Fate and Transport 6
b. Environmental Fate Assessment 7
2. Ecological. Effects 7
a. Ecological Effects Data 7
(1) Terrestrial Data 7
(2) Aquatic Data 8
(3) Non-Targetjtasects Data . 8
b. Ecological Effects Risk Assessment 8
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 9
A. Determination of Eligibility . 9
1. Eligibility Decision . /. '.'.'.'.'.'. 10
2. Eligible and Ineligible Uses 10
t
V. ACTIONS REQUIRED BY REGISTRANTS H
A. Manufacturing-Use Products \ i
1. Additional Generic Data Requirements 11
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2. Labeling Requirements for Manufacturing-Use Products 11
B. End-Use Products 11
1. Additional Product-Specific Data Requirements 11
2. Labeling Requirements for End-Use Products 12
C. Existing Stocks 13
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 Hexadecadienol acetates 29
APPENDIX D. List of Available Related Documents 37
APPENDIX E 41
PR Notice 86-5 43
PR Notice 91-2 63
APPENDIX F. Generic Data Call-In 69
Attachment 1. Chemical Status Sheet - 89
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 93
Attachment 3. Requirements Status and Registrants' Response
Forms Inserts (Form B) plus Instructions . 98
Attachment 4. List of Registrants) sent this DCI (Insert) 105
APPENDIX G. Product Specific Data Call-in 107
Attachment 1. Chemical Status Sheet 123
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 125
Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions 129
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 135
Attachment 5. EPA Acceptance Criteria 139
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice 153
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 155
APPENDIX H. FACT SHEET 165
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HEXADECADIENOL ACETATES R.E.D. TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Eric Maurer
Paul Guillebeau
Environmental Fate and Effects Division
Regina Hirsch
Sharlene R. Matten
E. Brinson Conerly-Perks
Health Effects Division
Roy Sjoblad
J. Thomas McClintock
Al Nielson
Registration Division
JoAnne Hayes
Teung Chin
Willie Nelson
Special Review and Reregistration Division
Tom Myers
Policy and Special Projects Stafi?
Deborah Hartman
Office of Compliance Monitoring:
Beverly Updike
Office of General Counsel:
Kevin Lee
Economic Analysis Branch
Biological Analysis Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Science Analysis Branch
Science Analysis Branch
Occupational and Residential Exposure Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Accelerated Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i.
CAS
CSF
EEC
EP
EPA
FDA
FIFRA
FFDCA
GRAS
HDT
LD
'50
LDIO
LEL
LOEL
MP
MPI
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Generally Recognized As Safe as designated by FDA
Highest Dose Tested
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.
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.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Lowest Observed Effect Level
Manufacturing-Use Product
Maximum Permissible Intake
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
MOE Margin Of Exposure (PAD)
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
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*i The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TGAI Technical Grade Active Ingredient.
TMRC Theoretical Maximum Residue Contribution.
m
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential
human health and environmental risks associated with the pesticidal use of hexadecadienol
acetates hi the United States.
Hexadecadienol acetates are registered as a sex-attractant pheromone of the pink
bollworm (Pectinophora gossvpiella, Saunders), and are applied to growing cotton to disrupt the
male-female mating behavior.
The Agency has determined that the use of hexadecadienol acetates as currently registered
will not cause unreasonable risk to humans or the environment and that this use is eligible for
reregistration. The Agency is requiring additional confirmatory ecological effects studies. A
freshwater fish study with the rainbow trout and a freshwater invertebrate study with Daphnia
magna are required to confirm that the risk to freshwater fish and aquatic invertebrates are
minmal.
Before reregistering the products containing hexadecadienol acetates, 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 for certain registrations.
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. Those products which contain
other active ingredients will be eligible for reregistration only when the other active ingredients
are determined to be eligible for reregistration.
IV
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
hi nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all
data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that hi Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" before calling in data
on products and either reregistering products or taking "other appropriate regulatory action."
Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of hexadecadienol acetates. The document consists of six sections. Section I is
the introduction. Section II describes hexadecadienol acetates, 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
hexadecadienol acetates. Section V discusses the reregistration requirements for hexadecadienol
acetates. Finally, Section VI is 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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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Document:
Common Name: Hexadecadienol acetates
Chemical Names: (Z,E)-7,ll-Hexadecadien-l-yl acetate
(Z,Z)-7,11-Hexadecadien-l-yl acetate
CAS Registry Numbers: 52207-99-5 and 53042-79-8
OPP Chemical Codes: 114101 and 114102
Empirical Formula: C18H34O2
Trade and Other Name(s): Gossyplure
Basic Manufacturers: biosys and Mitsubishi International Co.
B. Use Profile
The following is information on the current registered use with an overview of
the use site and application methods. This information is accurate as of December 16,
1993. A detailed table of the use of hexadecadienol acetates is in Appendix A.
For 114101 and 114102:
Type of Pesticide: Biochemical (insect pheromone)
Use Site:
Terrestrial Food/Feed (Cotton)
Target Pest: Pink Bollworm (Pectinophora gossypiella, Saunders)
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Formulation Types Registered: impregnated material
emulsifiable concentrate
water disperable granules (dry flowable)
All of the hexadecadienol acetate formulations are contained, embedded
or impregnated in a solid polymeric matrix or shell.
Method and Rates of Application:
Equipment - solid matrix dispensers (capillary fibers), aerial and ground
sprayers
Method - by hand, aerial and ground broadcast
Impregnated material is applied as 400 or more twist
dispensers/acre. No maximum rate indicated. 400-500 impregnated
stakes per acre.
Microencapsulated formulations are sprayed as tank mix or alone
by air or groimd equipment in water or oil mixtures. Maximum rate is
9 grams/ai/acre/application in an unspecified amount of diluent.
C. Estimated Usage of Pesticide
Hexadecadienol acetates are only registered for use on growing cotton against the
pink bollworm. Approximately 1 % of the cotton crop grown in California is treated with
hexadecadienol acetates. Less than 100 pounds of the active ingredient are applied each
year.
D. Data Requirements
In addition to data requirements imposed to obtain the original registration of this
active ingredient, data were required in the reregistration Phase IV Data Call-In issued
on April 23, 1993. Appendix B includes all generic data requirements identified by the
Agency for the currently registered use needed to support reregistration.
E. Regulatory History
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Pesticide products containing hexadecadienol acetates as active ingredients were
first registered in the United States in 1978. Currently, there are ten products registered
to six companies. These products employ the sex-attractant pheromone of the pink
bollworm which are applied to fields of cotton to disrupt the male-female mating
behavior.
The reregistration case contains four active ingredients. Two of the four are
currently used in registered products. The two registered ingredients are: (Z,E)-7,11-
hexadecadien-1-yl acetate (chemical number 114101) and (Z,Z)-7,ll-hexadecadien-l-yl
acetate (chemical number 114102). The two active ingredients currently not in any
registered products are 7,11-hexadecadienl-yl acetate (chemical number 114103) and
(E,Z)-7,ll-hexadecadien-l-yl acetate (chemical number 128914).
All of the hexadecadienol acetate formulations are contained, embedded or
impregnated in a solid polymeric matrix or shell.
In March of 1994, the Agency published hi the Federal Register, a final rule
exempting from the requirement of a tolerance, residues of arthropod pheromones
resulting from the use of these substances hi retrievably-sized polymeric matrix
dispensers with an annual application limitation of 150 grams active ingredient per acre
for pest control hi or on all raw agricultural commodities.
Presently, the Agency is considering a policy for exempting arthropod
pheromones used hi solid matrix dispensers which would exempt them from regulation
under FIFRA because these uses of pheromones are not considered to pose any greater
risk to human health or the environment than those pheromone active ingredients hi
traps. Therefore, in the future, it is conceivable that all solid matrix formulations of
arthropod with a limitation of 150 g a. i./A/year would be exempt from regulation under
FIFRA.
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The active ingredients, (Z,E) and (Z,Z)-7,11 hexadecadien-1-yl acetates, are
biochemical pesticides which are chemically synthesized hi an 11-step process with the
purity of several intermediate products determined by gas chromatography. The end
product, which contains both isomers (Z,E and Z,Z) is distilled and purity confirmed by
gas chromatography. During the manufacturing process of the technical grade material
several unintentional ingredients (impurities) are synthesized as byproducts. However,
an upper certified limit for each impurity has been established and this limit is not to
exceed 1%. The other minor impurities (less than 0.1%) hi the final product are
structural isomers of the active ingredients and are not expected to contain a toxic
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component or sensitizing agent.
The pheromone solution, containing the technical grade material and inerts, is
then contained, embedded or impregnated in a solid polymeric matrix or shell.
B.
Human Health Assessment
1.
Toxicology Assessment
The toxicological data base on hexadecadienol acetates is adequate and will
support reregistration eligibility.
a. Acute Toxicity
All acute toxicology studies for the technical active ingredient have
been submitted and adequately satisfy the requirements as set forth in 40
CFR 158.690 for food/feed use. The folio whig results from toxicology
studies have been submitted to support the reregistration of the active
ingredient.
STUDY
Acute Oral LD50
Acute Dermal LD50
Acute Inhalation LC50
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Mutagenicity (Ames Assay)
RESULTS
> 5 gm/kg
> 2 gm/kg
> 2.5 mg/1
Slight Irritation*
Slight Erythema
Not a Sensitizer
Not Mutagenic
CATEGORY
IV
III
III
m
IV
N/A
N/A
Mignt iritis and conjunctiva! irritation
Since the potential for nondietary and dietary exposure is
considered negligible, because the active ingredients are contained,
embedded or impregnated in a solid polymeric matrix or shell, the other
standard toxicology and developmental toxicity studies for reregistration
have been waived. Consequently, all toxicology data requirements have
been satisfied.
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2. Exposure Assessment
a. Dietary Exposure
An exemption from the requirments of a tolerance has been
established for residues of the active ingredient as specified in 40 CFR
180.1043, in or on the raw agricultural commodity cottonseed when
applied to cotton from capillary fibers.
This exemption does not includ the microencapsulated material.
b. Occupational and Residential
Based on the fact that the active ingredients are contained,
embedded or impregnated in a solid polymeric matrix or shell, low
exposure and lack of significant toxicological concerns, as demonstrated
in the battery of acute toxicity studies, no exposure data are required.
3. Human Risk Assessment
The potential risks to humans from both nondietary and dietary
routes are considered negligible because the active ingredients are
contained, embedded or impregnated in a solid polymeric matrix or shell,
low exposure and lack of significant toxicological concerns, as
demonstrated in the submitted toxicology studies. Residue data are not
required for the microencapsulated material because the active ingredient
is applied at less than 20 g/ai/acre/application.
C. Environmental Assessment
1. Environmental Fate
The Agency is relying on data available hi the scientific literature to assess
the environmental fate and transport of hexadecadienol acetates used as a
pesticidal compound.
a. Environmental Chemistry, Fate and Transport
This biochemical has been discussed in the open literature (Henson,
R.D. Environmental Entomology, Vol 6, Environmental Fate of
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Gossvplure). An hydrolysis study revealed that one degradate, 7,11-
hexadecienol, was identified in minimal concentrations. In attempts to
study its rate of photodegradation, the compound was applied to
microscope slides which were placed outdoors for 24 hours.
Volatilization was so rapid that no major degradates were observed,
suggesting that volatilization occurred more rapidly than photodegradation.
b. Environmental Fate Assessment
As is common with pheromones, hexadecadienol acetate is used in
minute quantities. This highly volatile chemical disperses rapidly into the
air when unconfined. Hexadecadienol acetate is applied in
retrievably-sized polymeric matrix dispensers (twist ties and impregnated
stakes) to slow its dispersal into the air. By using these formulations,
hexadecadienol acetate remains effective for up to 20 days. Because there
is no direct application of hexadecadienol acetate to the soil or water, soil
and water contamination are not expected.
Hexadecadienol acetate can also be microencapsulated and applied
to foliage via broadcast, ground- and aerially-applications. These are water
soluble formulations sprayed either as tank mixes or alone as emulsifiable
concentrates or water dispersable granules. By using these formulations,
hexadecadienol acetate remains effective for up to 20 days. Because there
is potential for the microencapsulated material to reach soil or water, soil
or water contamination is possible. However, the microencapsulated
hexadecadienol acetate assumes the vapor state as it is released from
microencapsulation, and would rapidly disperse. Therefore, the amount
which would actually be available in the ecosystem at any given time
would be a small fraction of the amount applied.
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
Technical hexadecadienol is considered to be practically
non-toxic to bobwhite quail with an acute oral LD50 of greater than
2000 mg/kg (MRID#s 42132901 and 42102708). The dietary
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toxicity to bobwhite quail is considered to be practically non-toxic
with a dietary LC50 of greater than 5620 ppm (MRID# 41265801).
(2) Aquatic Data
The toxicity of technical hexadecatiienol acetate to rainbow
trout is tentatively characterized as pratically non-toxic with a 96-
hour LC50 of greater than 120 ppm (MRID# 42132902). The
toxicity of technical hexadecadienol acetate to Daphnia magna is
tentatively characterized as highly toxic with a 48-hour EC50 of
0.70 ppm (MRID# 42092501). Both aquatic studies are considered
to be unacceptable and need to be repeated according to the
guidelines to determine the toxicity and the appropriate
precautionary label information to ensure minimal risk to aquatic
organisms. The presence of an oily film indicates only partial
availability of the test material in solution and requires analytical
verification of the test concentration to be scientifically valid.
The aquatic invertebrate life cycle test is reserved pending
the results of a confirming freshwater invertebrate acute toxicity
test. However, based on the data submitted the ECSO = 0.7 mg/1.
This means that the experimental EC50 < lmg/1 which is the
trigger point for the requirement of an invertebrate life cycle
study. Therefore, if an acceptable acute invertebrate study results
in an EC50 < 1 mg/1 than the aquatic invertebrate life cycle test
may be required.
(3) Non-Target Insects Data
Hexadecadienol acetate is considered to be practically non-
toxic to honey bees (MRID# 237758).
b. Ecological Effects Risk Assessment
A terrestrial risk assessment can be performed with the core acute
avian toxicity data and limited use and application rate information on
hexadecadienol acetate. This risk assessment was based on the
information provided by the emulsifiable concentrate formulation. Aerial
and ground applications of hexadecadienol acetate emulsifiable concentrate
pose the greatest exposure threat to terrestrial organisms.
Hexadecadienol acetate emulsifiable concentrate is applied as a
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sex-attractant pheromone to control the pink bollworm on cotton and
would indirectly contaminate avian food items. The chemical is broadcast
applied as a ground- or aerial-spray. The terrestrial risk assessment with
the emulsifiable concentrate indicates the expected residues would be
below all levels of concern for both non-target and endangered avian
species.
Only a preliminary aquatic organism risk assessment was
performed using the available supplemental acute freshwater toxicity data
and limited use and application information on hexadecadienol acetate.
The available hazard data are not scientifically valid due to inappropriate
test procedures, notably improper solubilization of the test material.
Aerial and ground applications of hexadecadienol acetate emulsifiable
concentrate pose the greatest exposure threat to aquatic organisms.
A direct application model was used to calculate the expected
estimated environmental concentration (EEC) for hexadecadienol acetate
emulsifiable concentrate. Based on this exposure model, the nature of the
chemical (highly volatile), the low application rate, and using the
supplemental acute toxicity data, the preliminary risk assessment suggests
that adverse effects to freshwater organisms would be minimal. However,
to confirm this conclusion, the acute freshwater fish study (72-1) and the
acute freshwater invertebrate study with Daphnia (72-2) need to be
repeated. The presence of an oily film in these two studies suggests
toxicity may actually be higher than indicated in the faulty studies.
Therefore, the test concentration requires analytical verification to be
scientifically valid.
Endangered Species
Based on the current use patterns and amount of active ingredient
used, potential adverse effects to avian and aquatic endangered species
would be minimal. However, data on aquatic fish and invertebrates are
required to confirm this assumption.
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
ingredients are eligible for reregistration. The Agency has previously identified and
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required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing hexadecadienol acetate 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 hexadecadienol
acetate as me sole active ingredient. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility of
hexadecadienol acetates, and lists the submitted studies that the Agency found acceptable.
However, ecological effects data are required to confirm that the risk to both freswater
fish (rainbow trout) and aquatic invertebrates (Daphnia magna) will be minimal.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of hexadecadienol acetates and to determine that hexadecadienol
acetates can be used without resulting in unreasonable adverse effects to humans and the
environment. The Agency therefore finds that all products containing hexadecadienol
acetates as the sole active ingredient 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 and the data identified in Appendix B. Although the
Agency has found that all uses of hexadecadienol acetates 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 hexadecadienol acetates, if new information comes to the Agency's attention
or if the data requirements for registration (or the guidelines for generating such data)
change.
1.
Eligibility Decision
Based on the reviews of the generic data of the four active ingredient
hexadecadienol acetates, the Agency has sufficient information on their potential effects
on human health. The Agency has determined that hexadecadienol acetate products,
labeled and used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore, the
Agency concludes that products containing hexadecadienol acetates for the currently
registered use are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that the currently registered use of
hexadecadienol acetates is eligible for reregistration.
10
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V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of the eligible use
hexadecadienol acetate has been reviewed and determined to be substantially
complete. However, ecological effects data are required to confirm the
assumption that the risk to both freshwater fish (rainbow trout) and aquatic
invertebrates (Daphnia magna) will be minimal.
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use products that may be contained in an effluent
discharged to the waters of the United States or municipal sewer systems must
bear the following revised effluent discharge labeling statement.
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of
a National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1, 1997 must bear the correct labeling. Refer to PR
Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements
11
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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 instructions hi the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
Based on the supplemental data, the following precautionary statement for
technical hexadecadienol acetate is needed for freshwater invertebrates.
"This product is highly toxic to freshwater invertebrates. Do not apply directly
to water, or to areas where surface water is present or to intertidal areas below
the mean high-water mark. Drift and runoff may be hazardous to aquatic
organisms hi neighboring areas. Do not contaminate water when disposing of
equipment washwater or rinsate"
In addition, each label must include the amount of active ingredient to be
applied per application; maximum number of applications per year and minimum
number of days between each application.
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10.
Any additional" end-use product precautionary labeling and personal
protective equipment will be determined upon submission or citation and review
of acute toxicity studies conducted on the end-use product.
Worker Protection Standard
Any product whose labeling reasonably permits use hi the production of
an agricultural plant on any farm, forest, nursery, or greenhouse must .comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required
by the Worker Protection Standard (WPS), and PR Notice 9311, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
12
-------
with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
otherwise specifically directed in this RED, all statements required by PR Notices
93-7 and 93-11 are to be on the product label exactly as instructed hi those
notices.
After April 21, 1994, except as otherwise provided hi PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by any person.
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 Reregistration 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 hexadecadienol
acetate 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.
13
-------
-------
VI. APPENDICES
15
-------
-------
APPENDIX A. Table of Use Patterns Subject to
Reregistration
17
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
23
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-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Hexadecadienol acetates covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Hexadecadienol
acetates 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 hi 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 3). If the Agency has acceptable data hi 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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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of
Hexadecadienol acetates
29
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-------
GUIDE TO APPENDIX C
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 Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
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.
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.
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
31
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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.
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.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (hi addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1)
(2)
(3)
(4)
Submission date. The date of the earliest known submission appears
immediately following the word "received."
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.
Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
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.
32
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BIBLIOGRAPHY
MRID
CITATION
00083061 Brusick, DJ. (1977) Mutagenicity Evaluation of Gossyplure: LBI Project No.
2683. Final rept. (Unpublished study received Sep 9, 1977 under 36638-1;
prepared by Litton Bionetics, Inc., submitted by Conrel, an Albany
International Co., Needham Heights, Mass.; CDL:096345-K)
00109904 Barker, R. (19??) Is Gossyplure Safe to Honey Bees? (U.S. Dept. of
Agriculture, Science and Education Administration, Carl Hayden Bee Research
Center; unpublished study; CDL:237758-B)
00138848 Shapiro, R. (1983) Ames Mutagenicity Test: Z,Z,Z, E-7, 11-hexadecadienyl
Acetate: Report No. T-3466. (Unpublished study received Jan 19, 1984 under
8730-41; prepared by Product Safety Labs, submitted by Herculite Products,
Inc., New York, NY; CDL:252281-B)
00138849 Wo, C.; Shapiro, R. (1984) Modified Eye Irritation: Z,Z,Z, E-7, 11-
hexadecadienyl Acetate: Rabbits: Report No. T-3479. (Unpublished study
received Jan 19, 1984 under 8730-41; prepared by Product Safety Labs,
submitted by Herculite Products, Inc., New York, NY; CDL:252281-C)
00138851 Costello, B.; Moore, G. (1983) Acute Oral Toxicity - Rats: Disrupt Lure in
Kill PBW Powder: Project No. 83-3858A. (Unpublished study received Jan
19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted by Herculite
Products, Inc., New York, NY; CDL:252281-E)
00138852 Costello, B.; Moore, G. (1983) Acute Dermal Toxicity - Rabbits: Disrupt
Lure in Kill PBW Powder: Project No. 83-3858A. (Unpublished study
received Jan 19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted
by Herculite Products, Inc., New York, NY; CDL:252281-F)
00138853 Costello, B.; Moore, G. (1983) Primary Skin Irritation - Rabbits: Disrupt Lure
in Kill PBW Powder: Project No. 83-3858A. (Unpublished study received Jan
19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted by Herculite
Products, Inc., New York, NY; CDL:252281-G)
00138854 Hershman, R.; Moore, G. (1983) Primary Eye Irritation - Rabbits: Disrupt
Lure hi Kill PBW Powder: Project No. 83-3858A. (Unpublished study
received Jan 19, 1984 under 8730-41; prepared by Bioresearch Inc., submitted
by Herculite Products, Inc., New York, NY; CDL:252281-H)
33
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BIBLIOGRAPHY
MRID
CITATION
00138855 Wo, C.; Shapiro, R. (1983) EPA Acute Oral Toxicity: Gossyplure Powder:
Rats: Report No. T-3450. (Unpublished study received Jan 19, 1984 under
8730-44; prepared by Product Safety Labs, submitted by Herculite Products,
Inc., New York, NY; CDI/.252282-D)
00138856 Wo, C.; Shapiro, R. (1984) Guinea Pig Sensitization (Buehler): Gossyplure
Powder: Report No. T-3480. (Unpublished study received Jan 19, 1984 under
8730-41; prepared by Product Safety labs, submitted by Herculite Products,
Inc., New York, NY; CDL:252281-F)
00146520 Mitsubishi International Corp. (1985) MC 982 (Pink Boll Worm Pheromone
Dispensers): Product Chemistry. Unpublished compilation. 16 p.
00153222 Phillips Chemical Co. (1985) Pesticide Registration Application for Phillips 66
Technical Pheromone Gossyplure: Product Chemistry Data. Unpublished study
24 p.
00157582 Mitsubishi International Corp. (19??) Manufacturing Process: Product
Chemistry for Pink Boll Worm Pheromone. Unpublished compilation. 42 p.
00160402 Mitsubishi International Corp. (1984) Product Chemistry Data of Pink Boll
Worm Pheromone Technical. Unpublished compilation. 12 p.
00160981 Mitsubishi International Corp. (19??) Complete Chemical Description of Pink
Boll Worm Pheromone Technical. Unpublished compilation. 19 p.
40885402 Hart, G. (1988) Acute Oral Toxicity Screen with Microencapsulated
Gossyplure in Albino Rats. Unpublished study prepared by Riker/3M. 11 p.
41265801 Grimes, J.; Jaber, M. (1988) Technical Pheromone Gossyplure: A Dietary
LC50 Study with the Bobwhite: Project No. 251-101. Unpublished study
prepared by Wildlife International Ltd. 17 p.
41476903 Terrill, J. (1989) Acute Inhalation Toxicity Study with Technical Pheromone
Gossyplure in the Rat: Lab Project Number: HLA STUDY No. 652-225.
Unpublished study prepared by Hazleton Labs America, Inc. 42 P.
42092501 Graves, W.; Peters, G. (1991) Pink Bollworm Pheromone: A 48-Hour Acute
Toxicity Test with the Cladoceran (Daphnia magna): Final Report: Lab Project
34
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BIBLIOGRAPHY
MRID
CITATION
Number: 322A-101. Unpublished study prepared by Wildlife International
Ltd. 22 p.
42102708 Campbell, S.; Lynn, S. (1991) Acute Oral Toxicity Study of Isomate291
Pheromone in Bobwhite Quail: Lab Project Number: 322-101. Unpublished
study prepared by Wildlife International Ltd. 19 p.
42132901 Campbell, S.; Lynn, S. (1991) Pink Bollworm Pheromone ZZ-7, 11-16AC
50%, 11-6AC 50%: An Acute Oral Toxicity Study with the Northern
Bobwhite: Lab Project Number: 322-101. Unpublished study prepared by
Wildlife International Ltd. 18 p.
42132902 Campbell, S.; Lynn, S. (1991) Pink Bollworm Pheromone: A 96-Hour Static
Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final
Report: Lab Project Number: 322A-103. Unpublished study prepared by
Wildlife International Ltd. 20 p.
35
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APPENDIX D. List of Available Related Documents
37
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The following is a list of available documents related to Hexadecadienol acetates. 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 Hexadecadienol acetates
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. Hexadecadienol acetates 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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APPENDIX E. PR Notices 86-5 and 91-2
41
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PR Notice 86-5
43
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\
o
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
PR NOTICE 86-5
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
Attention:
Subject:
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Persons responsible for Federal registration of
pesticides.
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)(1). This Notice
does not, apply to commeircial, 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
45
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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the _ study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be compatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, _the_screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
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.
46
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- INDEX-
A. Organization of the Submittal Package 3
B. Transmittal Document . 4
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each. Study Volume 6
D. 1 Study Title Page 7
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(1) ) 8
D. 3 Confidential Attachment 8
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1)) 8
D. 5 Good Laboratory Practice Compliance Statement . . 9
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 admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
Text Example
Page Page
17
11
17
12
13
15
14
16
47
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B.
Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP), §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, . . . . of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition_and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (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.
48
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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-! Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a- Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
k- 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 tolereince 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) (1) (A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
49
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of 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
Conf i dent i ality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d) (1) (A) , (B) , or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10 (d) (1) (A) , (B) , or (C)
50
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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.
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).
9; Facts of Publication. If the study is a reprint of a pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
51
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D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d)(1).
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) (1) (A), (B), or (C) . Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(1) 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)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §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 of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
52
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D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E- 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 pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution. Bindings for
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 Conies 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.)
53
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G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
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)(1)(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 phrase "Public Docket Material -
contains no information claimed as confidential".
V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
f a«n«S W. Akvrman
/Acting? Birvctor,
iteg is trait ion 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
54
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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
1234 West Smith Street
Cincinnati, OH 98765
-and-
Jones Chemical Company
5678 Wilson Blvd.
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:.
Company Name:.
Company Contact:
Name
Signature
Name
Phone
55
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
56
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(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:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10 (d) (l)-(A), (B) , or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §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:
Title
Typed Name
Date:
Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide 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) (1) (A), (B) , or (C) , but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
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 con-
nection 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 sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
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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 l. This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE:
PAGE LINE REASON FOR THE DELETION
TIP* Gil "
6
12
100
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE
§10(d) (1) (C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5. This cross reference number is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH(S) :
PAGE
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION FIFRA REFERENCE
2-17 Description of the quality control process §10(d)(1)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7. This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page.
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the 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
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and differs
in the following ways:
1..
2.
3.
Submitter_
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter _^________ -
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ATTACHMENT 7.
FORMAT OF THE SUSMITTAL PACKAGE
LEGEND
Transraittal Document.
Related Administrative Materials
(e.g., Method of Support statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
^^"""" -
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental statement
of Confidentiality Claims,
* When flagging requirements
are finalized.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
61
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PR Notice 91-2
63
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£ ** \
v»'
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 of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the 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
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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
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(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
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 of section 12(a)(1)(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. v
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.
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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, 1997, 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.
\ZC* ~ * £7 - -d-iivC-*
Ann* E. t,irwisay, Director
Registration Division (H-7505
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APPENDIX F. Generic Data Call-In
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GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your produces)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1.
2.
3.
how you will comply with, the requirements set forth in this Notice and its Attachments
1 through 4; or,
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,
why you believe EPA should not require your submission of data hi the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 4).
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 five 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
Section II
Section HI
Section IV
Section V
Section VI
Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This Notice
Consequences Of Failure To Comply With This Notice
Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 -
Attachment 2 -
Attachment 3 -
Attachment 4 -
Data Call-In Chemical Status Sheet
Data Call-in Response Form
Requirements Status And Registrant's Response Form
List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
revaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have produces) containing the subject active ingredients).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The 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
hi this Notice, additional testing may be required.
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 tune frames provided.
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C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel-
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
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)].
D- REGISTRANTS RECEIVING PREVIOUS SECTION 3(cY2)(E~) 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-InCs^. 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
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice 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 hi Section IV-A and IV-
B.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained hi Section III-C. A discussion of options relating to requests for data
waivers is contained hi Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used hi your response to the Agency. These forms are
the Data-Call-in Response Form (Attachment 2) and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-in Response Form must be
submitted as part of every response to this Notice. 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 hi preparing your response, call or write the contact person identified hi
Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
higredient(s) 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 5
on the Data Call-In Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be hi
accordance with the Existing Stocks provisions of this Notice which are contained
hi Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit the Requirements
Status and Registrant's Response Form, a completed application for amendment,
a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-in
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Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source
not connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-In Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with
this Data Call-In Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate proceedings to suspend the registrations
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of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the 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 option 6b and 7 on
the Data Call-In Response Form. If you choose option 6b or 7, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D
of this Notice and are covered by options 8 and 9 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.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), 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 hi this Section. The options are:
1. I will generate and submit data within the specified tune 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),
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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
hi 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 hi conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
hi Section II-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share hi the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory(ies) or individuals
who are or will be conducting the study.
In addition, if the tune frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified hi the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The tune frames in the Requirements Status and Registrant's Response
Form are the tune frames that the Agency is allowing for the submission of
completed study reports or protocols. 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
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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 requirement(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 hi Cost to Develop Data -
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 -
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has hi 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
mat you have made an offer to another registrant (who has an obligation to submit
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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. 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 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:
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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(7) " 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(7), 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 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.
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If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement hi 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 a 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 amy 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
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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 ecological effects studies, the classification generally would be
a rating of "core." 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.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver - Option R nn the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredients) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request hi order to remain qualified
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for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the-active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total, indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredients)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredients), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredients) (following the
parameters in item c above), indirect production costs of product(s)
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containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredients), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in
terms of its benefits, you should provide information on any of the
following factors, as applicable to your produces):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data -Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should riot apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply.
You must also submit the current label(s) of your produces) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
produces), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for vour productCsX you
must choose a method of meeting the requirements of this Notice within the time
frame provided bv this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
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IV- CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
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.
2.
3.
4.
7.
8.
Failure to respond as required by this Notice within 90 days of your
receipt of this Notice.
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.
Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
Failure to submit on the required schedule acceptable data as required by
this Notice.
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).
Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section III-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
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: or,
b. fulfill the commitment to develop and submit the data as required
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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
hi the specified tune frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
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.
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 Federal Insecticide, Fungicide, and
Rodenticide Act.
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The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency 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(s) 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 hi the Agency granting any additional tune 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 hi 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 mformation 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 mformation regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the mformation
to the Agency. Registrants must notify the Agency of any factual mformation 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.
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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 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 Call-in Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified hi
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 (QCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Daniel M. Barolo,
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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Hexadecadienol acetates DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Hexadecadienol acetates.
This Generic 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
Hexadecadienol acetates. This attachment is to be used hi conjunction with (1) the Generic Data
Call-In Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this
DCI (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share
and Data Compensation Forms in replying to this Hexadecadienol acetates Generic Data Callln
(Attachment F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Hexadecadienol acetates are contained hi the Requirements Status and Registrant's Response.
Attachment C. The Agency has concluded that additional product chemistry data on
Hexadecadienol acetates are needed. These data are needed to fully complete the reregistration
of all eligible Hexadecadienol acetates products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Tom Myers at (703) 308-8074.
All responses to this Notice for the generic data requirements should be submitted to:
Tom Myers, Chemical Review Manager
ARE
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Hexadecadienol acetates
91
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
93
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed
by the registrant as appropriate Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503.
INSTRUCTIONS
Item 1.
Item 2.
Item 3.
Item 4.
Item 5.
This item identifies your company name, number and address.
This item identifies the ease number, ease name, EPA chemical number
and chemical name.
This item identifies the date and type of data call-in.
This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be
covered by this data call-in but that is not listed by the Agency hi Item 4.
You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate hi Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
95
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-in Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of mat active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this
item for all products listed on this form If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of
the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated hi
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item To. Check this item if this call-in is a data call-in for an end use product
(EUP) as indicated hi Item 3 and if your product is an end use product for
which you agree to supply product-specific data. Attach the Requirements
Status and Registrant's Response Form that indicates how you will satisfy
those requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used hi your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
96
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Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
97
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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
98
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all
other items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to Chief, Information Policy Branch
PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460^
and to the Office of Management and Budget, Paperwork Reduction Project 2070-010?'
Washington, D.C. 20503.
INSTRUCTIONS
Item 1.
Item 2.
Item 3.
Item 4.
Item 5.
This item identifies your company name, number, and address.
This item identifies the case number, case name, EPA chemical number and
chemical name.
This item identifies the date and type of data call-in.
This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-in Notice, govern the conduct of the required studies.
This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
99
-------
Item 6.
submitted in connection with the study. As noted in Section III of the Data
Call-in Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and
Registrant's Response Form.
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
Terrestrial food
Terrestrial feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP *
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
100
-------
TEP/MET
TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
MET
IMP
DEGR
*See: guideline comment
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient
and Metabolites
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
Degradates
Item 8.
Item 9.
This item identifies the time frame allowed for submission of the study or
protocol identified in item 2. The tune frame runs from the date of your receipt
of the Data Call-In Notice.
Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-In Notice contains a fuller description of each of these options.
1.
2.
3.
(Developing Data) I will conduct a new study and submit it within the
time frames specified in item 8 above. 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 and that I will provide the protocol and progress
reports required hi item 5 above.
(Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to sharing hi the cost of developing data as outlined in the Data
Call-In Notice.
(Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of
Data" that describes this offer/agreement. By indicating that I have
chosen this option, I certify that I will comply with all the requirements
pertaining to making an offer to share hi the cost of developing data as
outlined hi the Data Call-In Notice.
101
-------
Item 10.
4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-in
Notice and I have attached the needed supporting information along with
this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described in the Data Call-in Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other
things, all information required to support the request. I understand that,
unless modified by the Agency in writing, the data requirement as stated
in the Notice governs.
This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
102
-------
Item 11.
Item 12.
Enter the date of signature.
Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
103
-------
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
105
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APPENDIX G. Product Specific Data Call-in
107
-------
-------
DATA CALL-IN NOTICE
CERTIFIED MATT.
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 She** to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section III below. Your response must state-
1.
2.
3.
How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
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 '
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 produces) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 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).
109
-------
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 IH- 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 Reresistration
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 H. DATA REQUIRED BY THIS NOTICE
H-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
110
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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).
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)].
n-D- REGISTRANTS RECEIVING PREVIOUS SECTION 3fc₯2₯B^ NOTTrFS
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into with me 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 IH. COMPLIANCE WTTH RFQUIREMFNTS OF THIS NOTTPF
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.
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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 HI-C. A discussion of options relating to
requests for data waivers is contained in Section ffi-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 of the Requirements Status and Registrant's Response Form must
be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form hi 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.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-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 hi Section IH-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 low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3- Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and 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.
HI-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)
(2)
(3)
(4)
(5)
(6)
I will generate and submit- data within the specified time frame (Developing Data)
I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
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 hi conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports The noted
deadlines run from the date of the receipt of this 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 registrations).
If you cannot submit the data/reports to the Agency hi the time required by this Notice and
intend to seek additional time to meet the requirements^), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
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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 hi 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 then- differences through binding arbitration.
Option 3. Offer to Share hi 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(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has hi good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrants) 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 hi 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 hi 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
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develop and submit the data required by this 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 hi
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(3) " '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
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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 Registration 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 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.
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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.
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 hi 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
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
TV-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:
Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
1.
2.
3.
4.
5.
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.
Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
Failure to submit on the required schedule acceptable data as required by this Notice.
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 m-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share hi 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
nn 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
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9.
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
!V-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
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 produces) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act You
must also explain why an "existing stocks" provision is necessary, including a statement of the
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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 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of 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 RESPONSF.S 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 Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 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.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
M. Barolo,
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
7 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of Fjid-Use Products for Meeting
T* _ . ff *. .gi
Acute Toxicology Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Date Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
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HEXADECADIENOL ACETATES DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Hexadecadienol acetates.
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
Hexadecadienol acetates. This attachment is to be used hi 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 Hexadecadienol
acetates 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 Hexadecadienol
acetates are contained hi the Requirements Status and Registrant's Response. Attachment 3.
The Agency has concluded that additional data on Hexadecadienol acetates are needed for
specific products. These data are required to be submitted to the Agency within the tune frame
listed. These data are needed to fully complete the reregistration of all eligible Hexadecadienol
acetates products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Hexadecadienol acetates,
please contact Tom Myers at (703) 308-8074.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 308-8184.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Frank Rubis
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: Hexadecadienol acetates
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
125
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4.
Item 5.
Item 6.
Already completed by EPA.
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).
Not applicable since this form calls hi 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 reregistration 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.
For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
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 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.
Item 7a.
Item 7b.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
129
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3.
Item 4.
Item 5.
Item 6.
Item 7.
Item 8.
Item 9.
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.
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, Subpart c.
The study title associated with the guideline reference number is identified.
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.
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.
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.
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 toxiciry 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).
131
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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 HI-C.l.) apply as well.
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 ffl-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 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)
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
132
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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.
133
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
135
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EPA'S DECISION ON BATCHING PRODUCTS CONTAINING HEXADECADIENOL ACETATE FOR PURPOSES OF 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 the active ingredient hexadecadienol acetate, the Agency considered batching products This
process involves grouping similar products for purposes of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent 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 l'abelin« etc)
Note that the Agency is not describing batched products as "substantially similar" since some products within a batch may^ot be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the preceding paragraph Acute
toxicity data on individual products has frequently been found to be incomplete. Notwithstanding the batching process the Agency
reserves the right to require, at any time, acute toxicity data for an individual 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 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 cited the
registrant must clearly identify the material tested by its 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
Notice and its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and
submitted to the Agency within 90 days of receipt. The first form, "Data Call-in Response", asks whether the registrant will meet the
data requirements for each product. The second form, "Requirements Status and Registrant's Response", lists the product specific data
required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies the data to support a batch of
products, he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4)
Upgrading an Existing Study (Option 5), or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must
choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does
not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3)
those studies.
Table I lists the batched products. (The notations beside the active percentages indicate the different isomers of the active
present in the formulation.)
Table I.
Table 1: Batched Hexadecadienol Acetate Products
Batch
No.
1
EPA Reg. No.
====
50675-2
67250-2
% of Hexadecadienol Acetate
49.8 (Z,Z)
47.2 (Z,E)
49.2 (Z,Z)
43.5 (Z,E)
Formulation Type
liquid
liquid
137
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Table II lists the products which could not be batched. For the purposes of acute toxicity batching, these products were not
considered similar, or their similarity could not be determined with the information available. The registrants of these products
are responsible for meeting the acute toxicity data requirements specified in the data matrix for end-use products.
Table II.
Table II: Non-Batched Products
EPA Reg. No.
10350-25
36638-12
36638-1
50675-5
53871-1
56336-1
67250-3
67250-4
% of Hexadecadienol Acetate
10.0 (Z,Z)
10.0 (Z,E)
10.0 (Z,Z)
10.0 (Z,E)
3.8 (Z,E)
3.8 (Z,Z)
43.0 (Z,Z)
. 44.0 (Z,E)
0.316 (Z,Z)
0.316 (Z,E)
40.4 (Z,Z)
40.4 (Z,E)
63 (Z,E) & (Z,Z)
48.8
Formulation Type
microencapsulated
liquid
microencapsulated
liquid
impregnated fibers
dispenser tube
microencapsulated
liquid
water dispersable solid
granules
solid beads
solid stakes
138
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Attachment 5. EPA Acceptance Criteria
139
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity arid Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
141
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
j, _ 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%.
44 _ Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Registry Number
' for each active ingredient and, if available, for each intentionally-added inert.
6 _ Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
_ EPA Registration Number if registered;
for other beginning materials, the following:
_ Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
- Technical specifications or data sheets by which manufacturer or supplier describes composition, properties or
toxicity.
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
03).
142
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62 Analysis and Certification of Product Ingredients
_
3.
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the information
1H Items 0, /, 3X1G o.
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 %. r
Degree of accountability or closure _>_ ca 98%.
Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the case of products
containing dinitroamlines or containing secondary or tertiary amines/alkanolamines plus nitrites- polyhalogenated
dibenzodioxms and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored samples must be analyzed ]
Complete and detailed description of each step in analytical method used to analyze above samples.
Statement of precision and accuracy of analytical method used to analyze above samples.
Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient
Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with explanation
of how the limits were determined.
Upper certified limit proposed for each impurity present at >. 0.1 % and for certain toxicologically significant impurities
at <0.1 % along with explanation of how limit determined.
Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt from
requirement of tolerance or if generally recognized as safe by FDA) are fully described.
Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy
4.
5."
6."
7.
9.
10.
143
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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 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 77J50)
~~"~~~ Data supporting reported value provided
144
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63-12
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
145
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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
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
! Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4.* Vehicle control if other than water.
5- Doses tested, sufficient to determine a toxiciry 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.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Docs 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.
g.* 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).
g/ 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
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2."
3.
13.
14.
. Identify material tested (technical, end-use product, etc).
' S?T ^f3 Ti' 5 SOHd ThiCh ^ PI'°dUCe a siSnificant vaP°r ^ard based on toxicity and expected use or contains
particles of mhalable size for man (aerodynamic diameter 15 /an or less).
At least 5 young adult rats/sex/group.
Dosing, at least 4 hours by inhalation.
Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content
Chamber temperature, 22° C (+2°), relative humidity 40-60%.
Monitor rate of air flow.
Monitor actual concentrations of test material in breathing zone.
Monitor aerodynamic particle size for aerosols.
._ Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable substance).
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Docs 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 J>_11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal. .
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
g. 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.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1- Identify material tested (technical, end-use product, etc).
2- Study not required if material is corrosive or has a pH of <2 or JM1.5.
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).
11.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
-------
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
pH of <2 or Ml.5.
3. One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described hi 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.
152
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
153
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Attachment 7. Cost Share Data Compensation Forms, Confidential Statement of
Formula Form and Instructions
155
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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.
d.
e.
f.
g-
h.
i.
j-
k.
1.
m.
n.
The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
All applicable information which is on the product specific data submission must
also be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
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.
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).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
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.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
159
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/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
s^rs?18 instajctjr- srrc.hing existing data s°urces- 9atherfn9a«m*wS»
complet.ng and reviewingi the collection of information. Send comments regarding the burden estimate
^^S^^JSSSS^^S"0 ST f°r redUCing this bu?den'to Chief« 'nformaono
Branch, PM-223. US. 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. Fung,c,de 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
wSngto e"ter into sucn an agreement. That offer was irrevocable and included an
s d nnt r "JTT dfCISi°Tnhunder section 3{c)(2}(B)(iK) of FIFRA if final agreement on all
terms could not be reached otherw.se. This offer was made to the following firm(s) on the following
Name of Firm(s)
Date of Offer
Certification;
I certify that 1 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 Sng y fatee or
misleading statement may be punishable by fine or imprisonment or both under applkS law
Signature of Company's Authorized Representative
Name and Title (Please Type or Print)
Dale
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, whieh is obsolete
161
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&EPA
i"«^
United States EnvJronmantal Prouetlon Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
F«m Afftmv*
OH* N*. 2070-0X07
2070-0057
CxplfM 3-31-96
.
Pleas* fill In blanks btlow.
ICartifythat
"
II Jheeonpaniw who hav* submitted tht studies Gsted
snwts. or MOM on th» attached -Requirements Status w
Signature
Nam« «i4 Tilto (PIMM TyM «r MM)
Signature
£
Nam* and TItte (PIMM Typ. or Print)
EPA Form M70-J1 (440)
163
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APPENDIX H. FACT SHEET
165
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-005
April 1994
&EPA R.E.D. FACTS
Hexadecadienol
Acetates
Pesticide All pesticides sold or distributed in the United States must be
Reregistration registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, 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 reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED for hexadecadienol
acetates, including the active ingredients (Z,E)-7,ll-Hexadecadien-l-yl
acetate and (Z,Z)-7,ll-Hexadecadien-l-yl acetate, which are marketed
under the trade name Gossyplure.
Use Profile
Hexadecadienol acetates are sex-attractant pheromones of the pink
boHworm, Pectinophora gossypiella. Saunders, registered only for use on
growing cotton to disrupt the male-female mating behavior. They are used
in small quaintities-less than 100 pounds of the active ingredients are
applied each year, and only about 1 % of the California cotton crop is
treated with these biochemical pesticides.
Some products of this pheromone are applied in retrievably-sized
polymeric matrix dispensers (twist ties and impregnated stakes). There are
also end-use products which are microencapsulated and applied to foliage
via broadcast, ground- and aerially-applications. These are water soluble
167
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Regulatory
History
fbimulations sprayed as either tank mixes or alone as emulsifiable
concentrates or water dispersable granules.
Hexadecadienol acetates were first registered as pesticides in the U.S.
i*1 1978- Currently, 10 products are registered by six companies. The
reregistration case contains four active ingredients, however two are not in
any registered products.
The hexadecadienol acetate formulations classified as solid matrix
dispensers soon may be exempted from regulation as pesticides because
they pose little risk to human health or the environment.
Human Health
Assessment
Environmental
Assessment
Toxicity
Hexadecadienol acetates generally are of low acute toxicity. They
are placed in Tbxicity Category IV, indicating the lowest level of acute
toxicity, for acute oral and primary dermal effects. For acute dermal,
acute inhalation and primary eye irritation effects, hexadecadienol acetates
are placed in Toxicity Category ffl. Since the potential for human
exposure to these pesticides is considered negligible, all other standard
toxicology studies are waived.
Dietary Exposure
Hexadecadienol acetates may be present in the diet at low levels, but
these residues are considered to be negligible and are not believed to pose
human health risks. An exemption from the requirement of a tolerance has
been established for residues of the active ingredient in or on the raw
agricultural commodity cottonseed when applied to cotton from capillary
fibers (see 40 CFR 180.1043). This exemption does not include the
microencapsulated active ingredient.
Occupational and Residential Exposure
Since hexadecadienol acetates are contained, embedded or
impregnated in a solid polymeric matrix or shell, cause little exposure, and
do not pose significant lexicological concerns, no exposure data are
required.
Human Risk Assessment
Based on their application methods, insignificant dietary and non-
dietary exposure and relatively low toxicity, the hexadecadienol acetates'
potential risks to humans are considered negligible.
Environmental Fate
Hexadecadienol acetates are highly volatile and rapidly disperse into
air. They are used in minute quantities in impregnated materials (stakes or
twist ties) or as microencapsulated material which is applied to foliage via
broadcast, ground- and aerially-applications. Because there is potential for
168
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the microencapsulated material to reach soil or water, soil or water
contamination is possible. However, since the microencapsulated
hexadecadienol acetate assumes the vapor state as it is released and rapidly
disperses, the amount which would actually be available in the ecosystem
at any given time would be a small fraction of the amount applied.
Ecological Effects
Technical hexadecadienol is practically non-toxic to bobwhite quail,
rainbow trout and honey bees. It is tentatively characterized as highly
toxic to freshwater invertebrates. However, two aquatic studies are
considered unacceptable and must be repeated as confirmatory data.
Ecological Effects Risk Assessment
Hexadecadienol acetate emulsifiable concentrate residues on treated
food and forage items are expected to be below all levels of concern for
both non-target and endangered avian species. A model used to calculate
the expected environmental concentration (EEC) of hexadecadienol acetate
emulsifiable concentrate in water indicates that adverse effects to aquatic
species would be unlikely. Because it is highly volatile and is used in very
small amounts, EPA believes that the risk to freshwater aquatic organisms
will be minimal. However, the Agency is requiring acute toxicity data on
both freshwater fish and aquatic invertebrates to confirm this assumption.
Additional Data
The generic data base for hexadecadienol acetates is substantially
Required complete. However, EPA is requiring additional ecological effects studies
as confirmatory data. The Agency also is requiring product specific data
including product chemistry and acute toxicity studies, revised Confidential
Statements of Formula (CSFs) and revised labeling for reiegistration of
pesticide products containing hexadecadienol acetates.
Product Labeling
Changes Required
All hexadecadienol acetate end-use products must comply with EPA's
current pesticide product labeling requirements. In addition:
Protection of Freshwater Invertebrates - All end-use products must bear
the following precautionary statement:
"This product is highly toxic to freshwater invertebrates. Do not
apply directly to water, or to areas where surface water is present or
to intertidal areas below the mean high-water mark. Drift and runoff
may be hazardous to aquatic organisms in neighboring areas. Do not
contaminate water when disposing of equipment washwater or
rinsate."
Application Rates - Product labels must include the amount of active
ingredient to be applied per application, the maximum number of
applications per year, and the minimum number of days between each
application.
169
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Worker Protection Standard (WPS) - Any product whose labeling
permits use in the production of an agricultural plant on any agricultural
establishment (farm, forest, nursery or greenhouse) must comply with the
labeling requirements of EPA's Worker Protection Standard (WPS). See
PR Notice 93-7, "Labeling Revisions Required by the Worker Protection
Standard (WPS)," and PR Notice 93-11, "Supplemental Guidance for PR
Notice 93-7." Unless specifically directed in the RED, all statements
required by the WPS and reflected in these two PR Notices must be
included on product labeling.
Regulatory
Conclusion
The use of currently registered pesticide products containing
hexadecadienol acetates in accordance with approved labeling will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all currently registered products are eligible for reregistration.
These products will be reregistered once the required confirmatory generic
data, product specific data, revised Confidential Statements of Formula and
revised labeling are received and accepted by EPA.
For More
information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for hexadecadienol acetates 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.
Following the comment period, the hexadecadienol acetates RED
document 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 reregistration program,
the hexadecadienol acetates RED, or reregistration of individual products
containing hexadecadienol acetates, please contact the Special Review and
Reregistration 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, from 8:00 am to 6:00 pm Central
Time, Monday through Friday.
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