United States Prevention, Pesticides EPA 738-R-94-028
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
(Z)-9-Tricosene
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical (Z)-9-tricosene. The
enclosed Eligibility Decision (RED) contains the Agency's evaluation of the data base of this
chemical, 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
ingredient 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,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) 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. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER 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 date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
(Z)-9-TRICOSENE
LISTD
CASE 4112
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
(Z)-9-TRICOSENE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vii
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 5
D. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 7
b. Mutagenicity 7
c. Immune Response 8
d. Subchronic Toxicity 8
2. Exposure Assessment 8
a. Dietary Exposure 8
b. Occupational and Residential 8
3. Human Risk Assessment 8
C. Environmental Assessment 9
1. Environmental Fate 9
a. Environmental Chemistry, Fate and Transport 9
b. Environmental Fate Assessment 9
2. Ecological Effects Data 9
a. Terrestrial Data 9
b. Aquatic Data 12
3. Ecological Effects Risk Assessment 13
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 15
A. Determination of Eligibility 15
1. Eligibility Decision 16
2. Eligible and Ineligible Uses 16
V. ACTIONS REQUIRED BY REGISTRANTS 16
A. Manufacturing-Use Products 16
1. Additional Generic Data Requirements 16
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2. Labeling Requirements for Manufacturing-Use Products 17
B. End-Use Products 17
1. Additional Product-Specific Data Requirements 17
2. Product Modifications for Avian Risk Mitigation 18
3. Labeling Requirements for End-Use Products 18
C. Existing Stocks 18
VI. APPENDICES 19
APPENDIX A. Table of Use Patterns Subject to Reregistration 21
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 31
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of (Z)-9-Tricosene 37
APPENDIX D. List of Available Related Documents 45
APPENDIX E 49
PR Notice 86-5 51
PR Notice 91-2 73
APPENDIX F. Generic Data Call-in 79
Attachment 1. Chemical Status Sheet 97
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 101
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 105
Attachment 4. List of Registrant(s) sent this DCI (Insert) Ill
APPENDIX G. Product Specific Data Call-in 113
Attachment 1. Chemical Status Sheet 127
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 129
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 135
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 139
Attachment 5. EPA Acceptance Criteria 143
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
157
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 159
APPENDIX H. FACT SHEET 169
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(Z)-9-TRICOSENE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Bill Gross Biological Analysis Branch
Steve Jarboe Biological Analysis Branch
John Falkner Economic Analysis Branch
Environmental Fate and Effects Division
Kathy Monk Science Analysis and Coordination Staff
Regina Hirsch Ecological Effects Branch
Robert Pilsucki Environmental Fate and Groundwater Branch
Health Effects Division
Roy Sjoblad Science Analysis Branch
Roger Gardner Science Analysis Branch
Al Nielson Occupational and Residential Exposure Branch
Registration Division
Willie Nelson Insecticide-Rodenticide Branch
JoAnne Hayes Registration Support Branch
Special Review and Reregistration Division
Tom Myers Accelerated Reregistration Branch
Virginia Dietrich Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane
Office of Compliance:
Phyllis Flaherty
Office of General Counsel:
Kevin Lee
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized As Safe as designated by FDA
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
HA Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
jjg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin Of Exposure
MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
iv
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GLOSSARY OF TERMS AND ABBREVIATIONS
N/A
NPDES
NOEL
OP
OPP
PADI
PAM
PHED
PPE
ppb
ppm
PRN
RBC
RED
REI
RfD
RS
TD
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Organophosphate
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Personal Protective Equipment
Parts Per Billion
Parts Per Million
Pesticide Registration Notice
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Toxic Dose. The dose at which a substance produces a toxic effect.
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GLOSSARY OF TERMS AND ABBREVIATIONS
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
VI
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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 (Z)-9-tricosene in
the United States. (Z)-9-tricosene is a biochemical registered as a sex-attractant pheromone
for house and other fly species. The Agency has determined that (Z)-9-tricosene products,
labeled and used as specified in this Reregistration Eligibility Decision Document (RED), will
not cause unreasonable risk to humans or the environment. Therefore, the Agency concludes
that products containing (Z)-9-tricosene for all uses are eligible for reregistration.
The submitted ecological effects studies indicate that (Z)-9-tricosene is highly toxic to
aquatic invertebrates but practically non-toxic to freshwater fish. Risk to aquatic organisms is
expected to be minimal from the uses of products specified in this RED because of low
exposure potential. However, the Agency has concerns about potential risks to avian species.
Birds may have frequent dietary exposure to (Z)-9-tricosene residues from repeated outdoor
broadcast applications of granular product formulations. Studies suggest (Z)-9-tricosene may
cause reproduction effects in mallard ducks at concentrations as low as 2 ppm in their diet.
Expected exposure should not cause acute toxicity effects to birds. To alleviate the avian
reproduction toxicity concern for broadcast products and the accessibility to birds the Agency
is requiring that these products be used only in a manner that would significantly reduce the
exposure potential to birds, such as bait stations.
In addition, the Agency is requiring confirmatory technical chemistry studies to resolve
issues in the method used to quantify the percent active ingredient. Adequate data will resolve
deficiencies in the certification of ingredient limits and also validate the method used to verify
certified limits.
Before reregistering the products containing (Z)-9-tricosene, 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. 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.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" before calling in data
on products and either reregistering products or taking "other appropriate regulatory action."
Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of (Z)-9-tricosene. The document consists of six sections. Section I is the
introduction. Section II describes (Z)-9-tricosene, 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 (Z)-9-tricosene.
Section V discusses the reregistration requirements for (Z)-9-tricosene. 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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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
Common Name:
(Z)-9-tricosene
Chemical Name:
(Z)-9-tricosene
Chemical Family:
Biochemical (pheromone)
CAS Registry Number: 27519-02-4
OPP Chemical Code: 103201
Empirical Formula: C23H
231146
Other Name:
muscalure, muscamone
Basic Manufacturers: Denka International, Farnam Companies Inc., and
Bedoukian Research Inc.
B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of the uses of (Z)-9-tricosene is in
Appendix A.
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For : 103201
Type of Pesticide: Biochemical (insect pheromone)
Use Sites: TERRESTRIAL FOOD + FEED*: Manure, agricultural
crops/soils (unspecified).
TERRESTRIAL NON-FOOD: Agricultural uncultivated areas,
around and outside of feedlots, dairies, stables, broiler houses,
hog houses, livestock barns, kennels, meat and poultry
processing plants; canneries, supermarkets, refuse containers,
refuse solid waste sites (outdoor) dumps, bakeries, restaurants,
walkways in caged layer houses, commissaries, beverage plants,
commercial/institutional/industrial premise/equipment (outdoor)
TERRESTRIAL FOOD*: Cattle feedlots.
TERRESTRIAL NON-FOOD: (Animal kennels/sleeping quarters
(commercial), (agricultural uncultivated areas and recreational
areas), (refuse/solid waste sites (outdoor), (golf course turf)
commercial/institutional/industrial premises/equipment (outdoor).
INDOOR NON-FOOD: Horses, show/race/special/ponies,
rabbits, fur farm equipment and premises, specialized animals,
eating establishments nonfood areas (nonfood contact),
commercial/institutional/industrial premise/equipment.
INDOOR FOOD*: Indoor Agricultural/Farm
structures/buildings and equipment. Rabbits, hog/pig/swine,
calves (meat); poultry (eggs/meat), dairy cattle (lactating or
unspecified), food/grocery/marketing/storage/distribution facility
premise, livestock, food processing plant nonfood handling areas.
OUTDOOR RESIDENTIAL: Ground floors, ledges, window
sills, shelves, litter, garbage, manure, household/domestic
dwellings outdoor premises.
INDOOR RESIDENTIAL: Inside of houses on ceiling or
rafters, incinerators, refuse/solid waste containers, garbage cans.
*Note: The Agency considers all the current uses of (Z)-
9-tricosene as non-food/non-feed uses because the labels have a
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restriction to not place this product directly over exposed food or
food preparation areas and to use this product away from food
and feed areas and out of reach of livestock.
Target Pests: Flies (house flies, stable flies and blow flies)
Formulation Types Registered:
Single Active Ingredient Products:
Manufacturing Use
93.5%, 93.5%, and 99.7%
Single Active Ingredient Products (including bait stations, traps,
sticks, and granulars):
3.57%, 0.076%, and 0.048%
Multiple Active Ingredient Products (including bait stations,
traps, sticks, belts, granulars, and crystals:
0.03% + 1 active ingredient
0.026% + 1 active ingredient
0.025% + 1 active ingredient (4 products)
Method and Rates of Application:
(Z)-9-tricosene may be applied by hand using rubber gloves, cup, or a
scoop. In addition, a rotary hand held duster may be used at some sites.
Application rates are approximately 0.25 lb/500 sq ft. However, all product
labels do not give enough specific information, to determine the exact rates,
especially those labels of products with impregnated formulations.
Use Practice Limitations:
Use granules in bait stations or only in places inaccessible to birds. Do
not place strips in areas where birds, pets or children may accidentally come in
contact. Not permitted in food areas of food handling establishments. Do not
use where milk is processed or stored. Keep out of reach of food producing
animals.
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C. 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 August 26, 1993. Appendix B includes all data requirements identified by
the Agency for currently registered uses needed to support reregistration.
D. Regulatory History
Pesticide products containing (Z)-9-tricosene, the sex-attractant pheromone of
the female house fly, as an active ingredient were first registered in the United States in
1975. Currently, there are twelve products registered to nine companies. These
products are used in a number of places where fly control is considered necessary,
including food/feed handling establishments and livestock premises.
The Agency considers the current uses of (Z)-9-tricosene as non-food/non-feed
uses because all labels bearing directions for use in food/feed handling establishments
and livestock premises now carry the restriction to not place product directly over
exposed food or food preparation areas and use away from food and feed areas and out
of reach of livestock.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
(Z)-9-tricosene is a colorless liquid with a molecular weight of 322.62. It has
the structural formula CH3(CH2)12CH = CH(CH2)7CH3. The CAS Number is 27519-02-
04. Trade names for the active ingredient include "muscalure" and "muscamone". (Z)-
9-Tricosene is classified as a biochemical pesticide because, even though chemically
synthesized, it is identical to the sex pheromone of the female house fly Musca
domestica. Also, it is used as an insect attractant with a "non-toxic" mode of action.
The active ingredient is used in other formulations as a fly attractant and products are
applied at sites noted above (Section II.B).
There are certain technical chemistry issues to be resolved which include the
method used to quantify the percent active ingredient. This leads to a deficiency in the
certification of ingredient limits and also to validation of the method used to verify
certified limits.
The product identity is deficient because an E-9 isomer listed as an active
ingredient on the label is not a fly attractant component, and therefore is best
5
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considered as an impurity. Analysis of samples was not completely satisfied because
chromatograms of standards and a standard response curve for TGAI quantification
were not submitted. Because of this deficiency, the data submitted on Certification of
Ingredient Limits needs to be adjusted. The deficiency noted for analysis of samples
above also applies to the validation of analytical methods used to verify certified limits,
where chromatograms for standards of each TGAI component are required to be
submitted. These deficiencies are considered minor to the Agency's ability to assess
the risks associated with the current uses of (Z)-9-tricosene products. These additional
data requirements to correct these deficiencies are considered confirmatory to
accurately characterize the technical chemistry of (Z)-9-tricosene.
B. Human Health Assessment
1. Toxicology Assessment
Acute studies and a developmental toxicity study have been submitted
and adequately satisfy the Agency's requirements for (Z)-9-tricosene as a
biochemical pesticide (40 CFR 158.690), considering its current use patterns.
The table below summarizes the values and categories for the various
toxicology studies:
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STUDY
Acute Oral LD50 - rat
Acute Dermal LD50 - rabbit
Acute Inhalation LC50 rat
Primary Eye Irritation - rabbit1
Primary Dermal Irritation-rabbit1
Dermal Sensitization2 - guinea pig1
Developmental Toxicity - rat
RESULTS
> 5 gm/kg
> 2 gm/kg
> 5.0g/m3
Slight Irritant
Slight Irritant
Moderate Sensitizer
Maternal and
Developmental
NOEL/LOEL
> 5 g/kg/day
CATEGORY
IV
IV
IV
III
IV
N/A
N/A
'Note: Data pertaining to primary eye irritation, primary dermal irritation, and dermal
sensitization are not required to support the reregistration of the TGAI. These data are
presented for informational purposes.
20ne of two studies (MRID no. 42052801) produced moderate sensitization when the
induction phase employed intradermal injection of (Z)-9-tricosene, and the other study
(MRID no. 41783605) showed that (Z)-9-tricosene did not cause dermal sensitization when
applied to the shaved skin during the induction phase of the study.
a. Acute Toxicity
Other than slight eye and dermal irritation effects, and one of
two dermal sensitization studies showing moderate dermal sensitization,
there were no significant treatment-related signs of toxicity. All
hypersensitivity incidents must be reported if they occur.
b. Mutagenicity
Since this compound is not related to a known mutagen or belong
to a class of chemical compounds containing known mutagens, and since
the use is not likely to result in significant human exposure this
requirement is waived.
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c. Immune Response
Due to the lack of significant exposure and lack of significant
acute toxicity concerns under the current use patterns this requirement
is waived.
d. Subchronic Toxicity
Due to the lack of significant exposure and lack of significant
acute toxicity concerns under the current use patterns the 90-day
feeding, dermal, and inhalation studies are waived.
2. Exposure Assessment
a. Dietary Exposure
There are no established tolerances or a tolerance exemption for
(Z)-9-tricosene. All labels bearing directions for use in food/feed
handling establishments and livestock premises carry the restrictions, to
not place directly over exposed food or food preparation areas and to
restrict use away from food and feed areas and out of reach of livestock.
Therefore, these uses as restricted are classified as non-food uses. Thus
there are no dietary exposure concerns for the current uses of (Z)-9-
tricosene.
b. Occupational and Residential
Based on low exposure and lack of significant toxicological
concerns as demonstrated in the mammalian toxicology data base, there
are no exposure concerns and therefore no exposure data are required
for the biochemical (Z)-9-tricosene.
3. Human Risk Assessment
The potential risks to humans from both nondietary and dietary routes
are considered negligible because the active ingredients are embedded or
impregnated in a solid polymeric matrix or shell, there is low exposure and lack
of significant toxicological concerns, as demonstrated in the submitted
toxicology studies.
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C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
The Agency relied on data available in the literature to assess the
environmental fate and transport of (Z)-9-tricosene used as a pesticidal
compound.
b. Environmental Fate Assessment
(Z)-9-tricosene or (cis-9-tricosene), is a twenty-three carbon
straight chain compound with a double bond between the ninth and tenth
carbon atom. It is in the general hydrocarbon family referred to as
alkenes. This family of compounds is relatively more reactive than
saturated hydrocarbons (alkanes) in laboratory reactions. However, in
the environment alkenes would be expected to persist. The solubility of
straight chain alkenes generally tends to decrease as the number of
carbons increases. The major routes of dissipation in the environment
would be expected to be volatilization and microbial mediated
degradation.
2. Ecological Effects Data
a. Terrestrial Data
Mammalian acute toxicity data, described in sections above,
suggest (Z)-9-tricosene has low toxicity to mammalian species that may
come in contact with this pesticide in the environment.
In order to establish the toxicity of (Z)-9-tricosene to birds, the
following tests were required using the technical grade material: one
avian single-dose oral (LD50) study on either a waterfowl species or an
upland game species (preferably the bobwhite quail); and one subacute
dietary (LC50) study on one species of waterfowl or one species of
upland game bird (preferably the bobwhite quail).
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(1) Avian Acute Toxicity
Avian Acute Oral Toxicity Findings
Species
Bobwhite quail
Mallard duck
Mallard duck
%Test
Material
> 98%
> 96%
98.7%
LD50
> 2000 mg/kg
> 4650 mg/kg
> 4640 mg/kg
Conclusions
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
These results demonstrate that (Z)-9-tricosene is practically non-
toxic to birds on an acute oral basis. The requirement for the avian
acute oral LD50 study for (Z)-9-tricosene is fulfilled. (MRID#s 70475;
41785403)
(2) Avian Subacute Dietary Toxicity
Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
Mallard Duck
Bobwhite Quail
Bobwhite Quail
Mallard Duck
%Test
Material
> 98%
98.7%
98.7%
72.9%
72.9%
LC50
> 5000 ppm
> 10,000 ppm
> 10,000 ppm
>4640 ppm
>4640 ppm
Conclusions
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
On a subacute dietary basis, (Z)-9-tricosene is practically non-
toxic to upland game birds and waterfowl. The requirement for the
avian dietary LC50 study is fulfilled. (MRID#s 7036; 7196; 70471,
70472; 41785404)
(3) Avian Reproduction
Avian reproduction studies are required for a pesticide when
birds may be subjected to repeated or continuous exposure. Avian
reproduction studies have been required to support the reregistration of
10
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(Z)-9-tricosene due to the repeated broadcast applications of some
products containing granules and crystals. In this case previously
submitted studies indicate avian reproductive effects at low levels of
concentrations of (Z)-9-tricosene. Five studies have been submitted,
each has been determined to be scientifically credible. However, each
has deficiencies from Agency testing standards.
Avian Reproduction Findings
Species
Mallard Duck
Mallard Duck
Mallard Duck
Bobwhite Quail
Bobwhite Quail
% A.I.
94.7%
TGAI
98.7%
TGAI
98.7%
Reproductive
Impairment
>0.10 ppm
2.0 ppm
20.0 ppm
20.0 ppm*
20.0 ppm*
Note: No effects were noted at the highest dose tested.
The data indicate that technical (Z)-9-tricosene may impair
reproduction in waterfowl at very low exposures. For bobwhite quail,
an upland game species, there were no reproductive effects at up to 20
ppm, which was the highest dose tested, for technical grade active
ingredient (TGAI) and 98.7% active ingredient. For mallard ducks
adverse reproductive effects were found in two studies. One study
indicates effects to normal hatchlings and 14-day old survivors at 2 ppm
and 20 ppm, respectively; and on viable embryos and live three-week
embryos at 20 ppm. The other study indicates no adverse effects at 2
ppm, however, at 20 ppm there were significant differences from the
control for live 3-week embryos, normal hatchlings, and 14-day old
survivors. The third study available on the mallard duck showed no
effects at 0.10 ppm. These avian reproduction studies were considered
supplemental because they do not include all of the necessary data
required to complete a risk assessment. (MRIDfs 7019; 7038; 70473;
83020; 84455)
11
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These studies, while deficient, suggest (Z)-9-tricosene may
impair reproduction in waterfowl. Avian reproduction studies are
required for a pesticide when birds may be subjected to repeated or
continous exposure to a pesticide. Due to the limitations of these
studies, the Agency would normally require a repeated avian
reproduction study with the mallard duck for products applied by
broadcast applications in order to confirm the reproductive hazard
potential. A repeat study will not be required for products encased in a
solid matrix form or impregnated material (bait stations and strips)
because it is assumed that this type of product will result in minimal
exposure to birds. A repeat study for the broadcast use will not be
required for reasons discussed in Section IV.A.I, Eligibility Decision.
b. Aquatic Data
In order to establish the toxicity of (Z)-9-tricosene to freshwater
fish, the minimum data required on the technical grade of the active
ingredient is one 96-hour acute study.
Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Rainbow trout
Bluegill sunfish
Bluegill sunfish
%Test
Material
(TGAI)
98.7%
72.9%
98.7%
72.9%
Lv>50
> 1000 ppm
> 1000 ppm
> 1000 ppm
> 1000 ppm
Conclusions
Practically
Non-toxic
Practically
Non-toxic
Practically
Non-toxic
Practically
Non-toxic
The data suggest that (Z)-9-tricosene is practically non-toxic to
freshwater fish. However, these data were collected in a static test with
undissolved test material visible and no analytical data were submitted
on actual concentrations in the water. Therefore, the true toxicity of
(Z)-9-tricosene to freshwater fish cannot be determined (MRIDfs 7037;
70470). However, the Agency is not requiring additional data because
the risk potential is considered to be low from the current uses.
12
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(1) Freshwater Invertebrate Toxicity
In order to establish the toxicity of (Z)-9-tricosene to freshwater
invertebrates, the minimum data required on the technical grade of the
active ingredient is a 48-hour acute study. The preferable test organism
is first instar Daphnia magna.
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% Test Material
(TGAI)
98.7%
1^50
l.OSppm
Conclusions
Highly toxic
The data suggest that (Z)-9-tricosene is highly toxic to freshwater
invertebrates. However, these data were collected in a static test with
undissolved test material visible and no analytical data were submitted
on actual concentrations in the water. Therefore, the true toxicity of (Z)-
9-tricosene to freshwater invertebrates cannot be determined (MRIDf
70474). However, the Agency is not requiring a confirmatory study
because the risk potential is considered to be low from the current uses.
3. Ecological Effects Risk Assessment
Terrestrial Organisms
For those products which contain solid matrix forms and
impregnated materials (bait stations and strips) as the end-use product it
is assumed that exposure to terrestrial species will be minimal. The
nature of these products and how they are used do not allow for an
ecological risk assessment to be performed. However, no adverse
effects to terrestrial species are expected with the use of (Z)-9-tricosene
in these products.
For those products formulated as crystals or granules an acute
toxicity risk assessment can be performed with the core acute avian
toxicity data and limited use and application information. From this
information, minimal acute effects can be expected for the granular
formulation for the application rate of 0.25 lb/500 ft2.
To estimate the possible avian reproduction risk from the use of
the granular and crystalline formulations of (Z)-9-tricosene, a more
13
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complete reproduction study would be needed. However, the avian
reproduction studies, described above, suggest reproductive effects can
occur at concentrations as low as 2 ppm in the diet.
For (Z)-9-tricosene in the granular or crystalline broadcast
applications the label rate is 3-4 oz. of product per 500 square foot.
Since there are 28 grams in an ounce this is more or less a gram per
square foot. A square foot would then contain approximately the
amount required to produce effects in a large bird and more than the
amount required to produce effects in a smaller bird. Under these
circumstances, it is assumed the bird will ingest enough product to
produce effects. In order to perform a more complete exposure
assessment for birds the Agency would need to know how attractive the
product is to birds, how often it is applied, how persistent it is, and the
extent of its use.
Aquatic Organisms
For those products which contain solid matrix forms and
impregnated materials (bait stations and strips) as the end-use product it
is assumed that exposure to aquatic organisms will be minimal. The
nature of these products and how they are used do not allow for an
ecological risk assessment to be performed. However, no adverse
effects to aquatic organisms are expected with the use of (Z)-9-tricosene
in these products.
For those products formulated as crystals and granules a
preliminary aquatic organism risk assessment was performed using the
available supplemental acute freshwater toxicity data and limited use and
application information on granular (Z)-9-tricosene. A direct application
model was used to calculate the expected estimated environmental
concentration (EEC) for the granular formulation. Based on this
exposure model, the preliminary risk assessment suggests that adverse
effects to aquatic invertebrates may occur if accidental direct application
occurred. The environmental hazard statement on the label is sufficient
to mitigate this risk. The Agency is not requiring additional data due to
the low risk potential of (Z)-9-tricosene from the current uses.
Endangered Species
For those products formulated as crystals and granules, based on
the current use patterns and amount of active ingredient used, potential
risk of adverse acute effects to avian, aquatic, and mammalian
14
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endangered species would be minimal. However, there could be risk of
reproduction effects to endangered avian species.
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 required the submission of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing (Z)-9-tricosene
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 (Z)-9-tricosene. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregistration eligibility of (Z)-9-
tricosene, and lists the submitted studies that the Agency found acceptable. There are
certain technical chemistry issues to be resolved which include the method used to
quantify the percent active ingredient. This leads to a deficiency in the certification of
ingredient limits, and also to validation of the method used to verify certified limits.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of (Z)-9-tricosene and to determine that (Z)-9-tricosene when used
according to the stipulations in this document should not result in unreasonable adverse
effects to humans and the environment. The Agency therefore finds that all products
containing (Z)-9-tricosene as the active ingredients and if modified to requirements in
this document 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 (Z)-9-tricosene as limited in this
document 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 (Z)-9-tricosene, if new information
comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
15
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1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients (Z)-9-
tricosene, the Agency has sufficient information on the health effects of (Z)-9-
tricosene and on its potential for causing adverse effects in fish and wildlife and
the environment. As described above, the Agency has concerns about avian
reproduction risks for the broadcast application of the crystal and granular
products. The use of these products can result in repeated exposure to avian
species, and two reproduction studies suggest reproductive effects may occur at
levels as low as 2 ppm in the diet of mallard ducks. To mitigate the avian
reproduction risk posed by the broadcast application of (Z)-9-tricosene crystal
and granular products, the registrants are required to change these products and
their method of application to bait stations or make other substantial changes to
significantly reduce the exposure to birds. Registrants are in the process of
changing these formulations and application methods to bait stations to reduce
the exposure to birds. Therefore, the Agency has determined that (Z)-9-
tricosene products, labeled and used as specified in this Reregistration
Eligibility Decision, will not pose unreasonable risks or adverse effects to
humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that the uses of (Z)-9-tricosene as specified
in this RED Document are eligible for reregistration.
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 (Z)-9-tricosene for
the above eligible uses has been reviewed and determined to be substantially
complete. However, there are certain technical chemistry issues to be resolved
which include the method used to quantify the percent active ingredient. This
leads to a deficiency in the certification of ingredient limits, and also to
validation of the method used to verify certified limits.
16
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2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR
Notices, and any applicable policies. The MP labeling must bear the following
statement under Directions for Use:
"Only for formulation into an [ fill in with insecticide, herbicide or the
applicable term which describes the type of pesticide use(s) ]for the following
use (s): [ fill blank only with those uses that are being suppoerted by MP
registrant]."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the
reformulation of the product for a specific use or all additional uses supported
by a formulator or user group:
(a) "This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding the support of such use(s)"
(b) "This product ay be used to formulate products for any additional use(s) not
listed on the MP label if the formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding the support of such use(s)"
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers should
be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
17
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2. Product Modifications for Avian Risk Mitigation
As discussed above, the Agency is requiring registrants of products
formulated as granulars or crystals with directions for broadcast application to
modify their products accordingly to substantially reduce exposure to birds.
This must be accomplished during the existing stocks time frames as stated
below.
3. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10.
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 (Z)-9-
tricosene products bearing old labels/labeling, i.e. labels absent the modifications
specified in this RED document, except as noted below, for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such
products for 50 months from the date of the issuance of this RED. Registrants and
persons other than registrants remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to your products.
18
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VI. APPENDICES
19
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20
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APPENDIX A. Table of Use Patterns Subject to Reregistration
21
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22
-------
Date 08/05/94
Time 09:43
APPENDIX A
CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
LUIS 1.5
Page 1
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
AGRICULTURAL CROPS/SOILS (UNSPECIFIED)
Bait application., When needed., Glove. B/S NA
AGRICULTURAL UNCULTIVATED AREAS
Bait application., When needed., Glove. B/S NA
AGRICULTURAL/FARM STRUCTURES/BUILDINGS AND EQUIPMENT
Attractant treatment., When needed., Not FM/S NA
applicable.
IMPR NA
Bait station., When needed., Not applicable. FM/S NA
CALVES (MEAT)
Insecticidal strip., When needed., Not B/S NA
applicable.
DAIRY CATTLE (LACTATING OR UNSPECIFIED)
Attractant treatment., When needed., Glove. CR NA
Bait station., When needed., Not applicable. FM/S NA
Insecticidal strip., When needed., Not B/S NA
applicable.
Litter and bedding treatment., When needed., CR NA
Glove.
Manure treatment., When needed., Glove. CR NA
FOOD PROCESSING PLANT NON-FOOD HANDLING AREAS
Attractant treatment., When needed., Not FM/S NA
applicable.
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Bait station., When needed., Not applicable. FM/S NA
Use Group: TERRESTRIAL FOOD+FEED CROP
.0045 Ib A * NS NS NS NS AN
Use Group: TERRESTRIAL FOOD+FEED CROP
.0045 Ib A * NS NS
Use Group: INDOOR FOOD
'.400E-07 Ib
sq.ft
NS NS
UC * NS NS
UC * NS NS
Use Group: INDOOR FOOD
UC * NS NS
Use Group: INDOOR FOOD
NS
3.900E-06 Ib * NS
sq.ft
UC * NS NS
UC * NS NS
3.900E-06 Ib * NS NS
sq.ft
3.900E-06 Ib * NS NS
sq.ft
Use Group: INDOOR FOOD
2.400E-07 Ib * NS NS
sq.ft
Use Group: INDOOR FOOD
UC * NS NS
NS
NS
NS
NS
NS
NS AN
NS NS
NS NS
NS 14
NS AN
NS 14
NS AN
NS AN
NS
NS
NS
NS
-------
Date 08/05/94
Time 09:43
APPENDIX A
CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
LUIS 1.5
Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
FOOD/GROCERY/MARKETING/STORAGE/DISTRIBUTION
Attractant treatment., When needed., Glove.
Bait station., When needed., Not applicable.
HOG/PIG/SWINE (MEAT)
Attractant treatment., When needed., Not
applicable .
Bait station., When needed., Not applicable.
Insecticidal strip., When needed., Not
applicable .
LIVESTOCK
Attractant treatment., When needed., Not
applicable .
Bait station., When needed., Not applicable.
Insecticidal strip., When needed., Not
applicable .
MANURE
Manure treatment., When needed., Glove.
POULTRY (EGG/MEAT)
Attractant treatment., When needed., Glove.
Attractant treatment., When needed., Not
applicable .
Bait application., When needed., Package
applicator.
Bait station., When needed., Not applicable.
Bait station., When needed., Not on label.
FACILITY PREMISE Use Group: INDOOR FOOD
CR NA 3.900E-06 Ib * NS NS NS NS AN
FM/S NA
sq.ft
UC * NS
NS NS NS 14
NS A02
NS
Use Group: INDOOR FOOD
FM/S NA
FM/S NA
B/S NA
2.400E-07 Ib * NS
sq.ft
UC * NS
UC * NS
NS NS NS NS
NS NS NS 14
NS NS NS AN
NS
NS
NS
Use Group: INDOOR FOOD
FM/S NA
FM/S NA
B/S NA
2.400E-07 Ib * NS
sq.ft
UC * NS
UC * NS
NS NS NS NS
NS NS NS 14
NS NS NS AN
NS
NS
NS
Use Group: TERRESTRIAL FOOD+FEED CROP
CR NA
3.900E-06 Ib * NS
sq.ft
NS NS NS AN
NS
Use Group: INDOOR FOOD
CR NA
FM/S NA
B/S NA
FM/S NA
B/S NA
3.900E-06 Ib * NS
sq.ft
2.400E-07 Ib * NS
sq.ft
1.250E-07 Ib * NS
sq.ft
UC * NS
1.250E-07 Ib * NS
sq.ft
NS NS NS AN
NS NS NS NS
NS NS NS AN
NS NS NS 14
NS NS NS NS
NS
NS
NS
NS
NS
-------
Date 08/05/94 - Time 09:43
APPENDIX A - CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
LUIS 1.5 - Page 3
SITE Application Type, Application Form(s) Min. Appl .
Timing, Application Equipment - Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POULTRY (EGG/MEAT) (con't)
Insecticidal strip., When needed., Not B/S NA
applicable .
Litter and bedding treatment., When needed., CR NA
Glove .
Manure treatment., When needed., Glove. CR NA
RABBITS (MEAT)
Attractant treatment., When needed., Glove. CR NA
Manure treatment., When needed., Glove. CR NA
NON- FOOD/NON- FEED
AGRICULTURAL UNCULTIVATED AREAS
Attractant treatment., When needed., Glove. CR NA
Attractant treatment., When needed., Not FM/S NA
applicable .
IMPR NA
Bait application., When needed., Package B/S NA
applicator.
Bait station., When needed., Not on label. B/S NA
Insecticidal strip., When needed., Not B/S NA
applicable .
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL)
Attractant treatment., When needed., Glove. CR NA
Attractant treatment., When needed., Not FM/S NA
applicable .
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
UC *
l.OOOE-06 Ib *
sq.ft
3.900E-06 Ib *
sq.ft
Use Group
3.900E-06 Ib *
sq.ft
3.900E-06 Ib *
sq.ft
Use Group
3.900E-06 Ib *
sq.ft
2.400E-07 Ib *
sq.ft
UC *
1.250E-07 Ib *
sq.ft
1.250E-07 Ib *
sq.ft
UC *
Use Group
3.900E-06 Ib *
sq.ft
2.400E-07 Ib *
sq.ft
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
: INDOOR FOOD (con't)
NS NS NS NS AN NS
NS NS NS NS AN NS
NS NS NS NS AN NS
: INDOOR FOOD
NS NS NS NS AN NS
NS NS NS NS AN NS
: TERRESTRIAL NON- FOOD CROP
NS NS NS NS AN NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS AN NS
NS NS NS NS NS NS
NS NS NS NS AN NS
: INDOOR NON- FOOD
NS NS NS NS AN NS
NS NS NS NS NS NS
-------
Date 08/05/94 - Time 09:43
APPENDIX A - CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
LUIS 1.5 - Page 4
SITE Application Type, Application Form(s) Min. Appl .
Timing, Application Equipment - Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL) (con't)
Bait station., When needed., Not applicable. FM/S NA
Insecticidal strip., When needed., Not B/S NA
applicable .
Litter and bedding treatment., When needed., CR NA
Glove .
Manure treatment., When needed., Glove. CR NA
Attractant treatment., When needed., Glove. CR NA
Attractant treatment., When needed., Not FM/S NA
applicable .
Bait application., When needed., Package B/S NA
applicator.
Bait station., When needed., Not on label. B/S NA
Manure treatment., When needed., Glove. CR NA
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP. (INDOOR)
Attractant treatment., When needed., Glove. CR NA
Bait station., When needed., Not applicable. FM/S NA
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (OUTDOOR)
Attractant treatment., When needed., Glove. CR NA
Attractant treatment., When needed., Not FM/S NA
applicable .
Bait application., When needed., Package B/S NA
applicator.
Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min.
Rate (AI Tex. @ Max. Rate unless noted Interv
unless noted Max. /crop /year otherwise) /A] (days)
otherwise) Dose cycle /crop /year
cycle
Use Group: INDOOR NON- FOOD (con't)
UC * NS NS NS NS 14
UC * NS NS NS NS AN
3.900E-06 Ib * NS NS NS NS AN
sq.ft
3.900E-06 Ib * NS NS NS NS AN
sq.ft
Use Group: TERRESTRIAL NON- FOOD CROP
3.900E-06 Ib * NS NS NS NS AN
sq.ft
2.400E-07 Ib * NS NS NS NS NS
sq.ft
1.250E-07 Ib * NS NS NS NS AN
sq.ft
1.250E-07 Ib * NS NS NS NS NS
sq.ft
3.900E-06 Ib * NS NS NS NS AN
sq.ft
Use Group: INDOOR NON- FOOD
3.900E-06 Ib * NS NS NS NS AN
sq.ft
UC * NS NS NS NS 14
Use Group: TERRESTRIAL NON- FOOD CROP
3.900E-06 Ib * NS NS NS NS AN
sq.ft
2.400E-07 Ib * NS NS NS NS NS
sq.ft
1.250E-07 Ib * NS NS NS NS AN
sq.ft
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
-------
Date 08/05/94
Time 09:43
APPENDIX A
CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
LUIS 1.5
Page 5
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (OUTDOOR)
Bait station., When needed., Not on label. B/S NA
Insecticidal strip., When needed., Not
applicable.
B/S NA
EATING ESTABLISHMENTS NON-FOOD AREAS (NONFOOD CONTACT)
Attractant treatment., When needed., Glove. CR NA
FUR FARM EQUIPMENT/PREMISES
Attractant treatment., When needed., Not FM/S NA
applicable.
GOLF COURSE TURF
Bait application., When needed., Glove. B/S NA
HORSES (SHOW/RACE/SPECIAL/PONIES)
Attractant treatment., When needed., Not FM/S NA
applicable.
Bait station., When needed., Not applicable. FM/S NA
Insecticidal strip., When needed., Not B/S NA
applicable.
HOUSEHOLD/DOMESTIC DWELLINGS
Attractant treatment., When needed., Not IMPR NA
applicable.
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Attractant treatment., When needed., Not IMPR NA
applicable.
Bait station., When needed., Not applicable. FM/S NA
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Attractant treatment., When needed., Glove. CR NA
(con' Use Group: TERRESTRIAL NON-FOOD CROP (con't)
NS NS NS NS NS NS
1.250E-07 Ib
sq.ft
UC * NS
NS
NS
NS AN
Use Group: INDOOR NON-FOOD
3.900E-06 Ib * NS NS NS NS AN
sq.ft
Use Group: INDOOR NON-FOOD
2.400E-07 Ib * NS NS NS NS NS
sq.ft
Use Group: TERRESTRIAL NON-FOOD CROP
.0045 Ib A * NS NS NS NS AN
Use Group: INDOOR NON-FOOD
NS NS NS
'.400E-07 Ib * NS NS
sq.ft
UC * NS NS
UC * NS NS
NS NS 14
NS NS AN
3.900E-06 Ib
sq.ft
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
UC * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
NS NS NS
NS
NS
NS
-------
Date 08/05/94 - Time 09:43
APPENDIX A - CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
LUIS 1.5 - Page 6
SITE Application Type, Application Form(s) Min. Appl .
Timing, Application Equipment - Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES (con't)
Attractant treatment., When needed., Not IMPR NA
applicable .
Perimeter treatment., When needed., Glove. B/S NA
INCINERATORS
Attractant treatment., When needed., Glove. CR NA
RABBITS
Attractant treatment., When needed., Glove. CR NA
Manure treatment., When needed., Glove. CR NA
RECREATIONAL AREAS
Attractant treatment., When needed., Glove. CR NA
REFUSE/SOLID WASTE CONTAINERS (GARBAGE CANS)
Bait station., When needed., Not applicable. FM/S NA
REFUSE/SOLID WASTE SITES (OUTDOOR)
Attractant treatment., When needed., Glove. CR NA
Attractant treatment., When needed., Hand CR NA
held duster.
Bait application., When needed., Package B/S NA
applicator.
Bait station., When needed., Not on label. B/S NA
Insecticidal strip., When needed., Not B/S NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
UC *
.0045 Ib A *
Use Group
3.900E-06 Ib *
sq.ft
Use Group
3.900E-06 Ib *
sq.ft
3.900E-06 Ib *
sq.ft
Use Group
3.900E-06 Ib *
sq.ft
Use Group
UC *
Use Group
3.900E-06 Ib *
sq.ft
6.500E-07 Ib *
sq.ft
1.250E-07 Ib *
sq.ft
1.250E-07 Ib *
sq.ft
UC *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
: OUTDOOR RESIDENTIAL (con't)
NS NS NS NS NS NS
NS NS NS NS AN NS AZ
: INDOOR RESIDENTIAL
NS NS NS NS AN NS
: INDOOR NON- FOOD
NS NS NS NS AN NS
NS NS NS NS AN NS
: TERRESTRIAL NON- FOOD CROP
NS NS NS NS AN NS
: INDOOR RESIDENTIAL
NS NS NS NS 14 NS
: TERRESTRIAL NON- FOOD CROP
NS NS NS NS AN NS
NS NS NS NS AN NS
NS NS NS NS AN NS
NS NS NS NS NS NS
NS NS NS NS AN NS
applicable.
SPECIALIZED ANIMALS
Use Group: INDOOR NON-FOOD
-------
Date 08/05/94
Time 09:43
APPENDIX A
CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene]
Page 7
SITE Application Type, Application
Timing, Application Equipment
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALIZED ANIMALS (con't)
Attractant treatment., When needed., Glove. CR NA
Litter and bedding treatment., When needed., CR NA
Glove .
Manure treatment., When needed., Glove. CR NA
NOT SPECIFIED
Use Group: INDOOR NON- FOOD (con't)
3.900E-06
sq.
3.900E-06
sq.
3.900E-06
sq.
Ib * NS NS
ft
Ib * NS NS
ft
Ib * NS NS
ft
NS NS AN NS
NS NS AN NS
NS NS AN NS
EATING ESTABLISHMENTS
Bait station., When needed., Not applicable. FM/S NA
SITE NOT SPECIFIED
Attractant treatment., When needed., Not IMPR NA
applicable.
Use Group: INDOOR FOOD+INDOOR NON-FOOD
UC * NS NS NS NS 14
Use Group: USE GROUP FOR SITE 00000
UC * NS NS NS NS 30
Bait station., When needed., Not applicable. FM/S NA
UC * NS NS
NS NS 7
-------
Date 08/05/94 - Time 09:43 APPENDIX A - CASE 4112, [Muscalure (*)] Chemical 103201 [(Z)-9-Tricosene] LUIS 1.5 - Page
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
B/S : BAIT/SOLID
CR : CRYSTALLINE
FM/S : FORM NOT IDENTIFIED/SOLID
IMPR : IMPREGNATED MATERIAL
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
A02 : Inedible product area.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
AZ : Arizona
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
31
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32
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case (Z)-9-Tricosene covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to (Z)-9-Tricosene in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
33
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34
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of (Z)-9-Tricosene
REQUIREMENT
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
151B-10 Chemical Identity
151B-11 Start. Mat. & Mnfg. Process
151 B-12 Formation of Impurities
151B-13 Preliminary Analysis
151 B-15 Certification of limits
151 B-16 Analytical Method
151B-17a Color
151B-17b Physical State
151B-17c Odor
151B-17d Melting Point
151B-17e Boiling Point
151B-17f Density
151B-17g Solubility
151B-17h Vapor Pressure
151B-17J Stability
ECOLOGICAL EFFECTS
154B-6 Acute Avian Oral - Quail
154B-6 Acute Avian Oral - Duck
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
40883001; additional data required
40883001
40883001
40883002; additional data required
40883002; additional data required
40883002; additional data required
40883003
40883003
40883003
40883003
40883003
40883003
40883003
40883003
40883003
41785403
70475
35
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Data Supporting Guideline Requirements for the Reregistration of (Z)-9-Tricosene
REQUIREMENT
154B-7a Avian Dietary - Quail
154B-7b Avian Dietary - Duck
7 1-4 A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
154B-8a Fish Toxicity - Rainbow Trout
154B-8b Fish Toxicity - Bluegill Sunfish
154B-9 Invertebrate Toxicity
TOXICOLOGY
152B-10 Acute Oral Toxicity - Rat
152B-11 Acute Dermal Toxicity - Rabbit
152B-12 Acute Inhalation Toxicity - Rat
152B-13 Primary Eye Irritation - Rabbit
152B-14 Primary Dermal Irritation - Rabbit
152B-15 Dermal Sensitization - Guinea Pig
152B-23 Developmental Toxicity - Rat
OCCUPATIONAL/RESIDENTIAL EXPOSURE
Requirements Waived
ENVIRONMENTAL FATE
Requirements Waived
USE
PATTERN
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CMO
CITATION(S)
7196, 70471, 41785404
7036, 70472
70473, 84455
7019, 7038, 83020
7037, 70470
7037, 70470
70474
41783601, 42077301
41783602, 42077302
42176701, 42052802
41783603, 41785401
41783604, 41785402
41783605, 42052801
00093993
36
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of (Z)-9-Tricosene
37
-------
38
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the 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.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
39
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as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
40
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BIBLIOGRAPHY
MRID
CITATION
TOXICOLOGY REFERENCES FOR Z-9-TRICOSENE RED
00007019 Fink, R. (1975) Final Report: One-Generation Reproduction Study-Mallard
Duck: Project No. 100-105. (Unpublished study received Apr 20, 1977 under
2724-274; prepared by Truslow Farms, Inc. in cooperation with Maryland,
Dept. of Agriculture, Div. of Inspection and Regulation for Thuron Industries,
Inc., submitted by Zoecon Industries, Inc., Dallas, Tex.; CDL:229393-A)
00007036 Truslow, J.U. (1973) Final Report: Eight-Day Dietary LC50 Mallard Ducks:
Muscamone Fly Attractant: Project No. 100-100. (Unpublished study received
Oct 14, 1977 under 2724-274; prepared by Truslow Farms, Inc. for Thuron
Industries, Inc., submitted by Zoecon Industries, Inc., Dallas, Tex.;
CDL:232017-G)
00007037 Sleight, B.H., III (1973) Bioassay Report submitted to Zoecon Corporation,
Palo Alto, California: Acute Toxicity of Muscamone(TM) to Bluegill (Lepomis
macrochirus) and Rainbow Trout (Salmo gairdneri). (Unpublished study
received Oct 14, 1977 under 2724-274; prepared by Bionomics, Inc., submitted
by Zoecon Industries, Inc., Dallas, Tex.; CDL:232017-H)
00007038 Fink, R. (1974) Final Report: One-Generation Reproduction Study-Mallard
Ducks: Technical Muscamone: Project No. 100-104. (Unpublished study
including analytical report, received Oct 14, 1977 under 2724-274; prepared by
Truslow Farms, Inc. in cooperation with Maryland Dept. of Agriculture for
Thuron Industries, Inc., submitted by Zoecon Industries, Inc., Dallas, Tex.;
CDL:232017-I)
00007196 Fink, R. (1973) Final Report: Eight-Day Dietary LC50 Bobwhite Quail:
Technical Muscamone: Project No. 100-102. (Unpublished study received Oct
14, 1977 under 2724-274; prepared by Truslow Farms, Inc. for Thuron
Industries, Inc., submitted by Zoecon Industries, Inc., Dallas, Tex.;
CDL:232017-F)
00070470 Bentley, R.E. (1974) Acute Toxicity of Muscalure to Bluegill (Leponis
macrochirus) and Rainbow Trout (Salmo gairdneri). (Unpublished study
received Nov 7, 1977 under 270-129; prepared by Bionomics, EG & G
Environmental Consultants, submitted by Farnam Cos., Inc., Phoenix, Ariz.;
CDL:232388-B)
41
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BIBLIOGRAPHY
MRID
CITATION
00070471 Fink, R. (1975) Final Report: Eight-day Dietary LC50 Bobwhite Quail: Project
No. 127-101. (Unpublished study received Nov 7, 1977 under 270-129;
prepared by Truslow Farms, Inc., submitted by Farnam Cos., Inc., Phoenix,
Ariz.; CDL:232388-C)
00070472 Fink, R. (1975) Final Report: Eight-day Dietary LC50 Mallard Ducks: Project
No. 127-102. (Unpublished study received Nov 7, 1977 under 270-129;
prepared by Truslow Farms, Inc., submitted by Farnam Cos., Inc., Phoenix,
Ariz.; CDL:232388-D)
00070473 Fink, R. (1975) Final Report: One-generation Reproduction Study Bobwhite
Quail: Project No. 127-103. (Unpublished study received Nov 7, 1977 under
270-129; prepared by Truslow Farms, Inc., submitted by Farnam Cos., Inc.,
Phoenix, Ariz.;CDL:232388-F)
00070474 LeBlanc, G.A. (1976) Acute Toxicity of Muscalure to Daphnia magna.
(Unpublished study received Nov 7, 1977 under 270-129; prepared by EG & G,
Bionomics, submitted by Farnam Cos., Inc., Phoenix, Ariz.; CDL:232388-G)
00070475 Fink, R. (1976) Final Report: Acute Oral LD50 Mallard Duck: Project No.
127-105. (Unpublished study received Nov 7, 1977 under 270-129; prepared by
Truslow Farms, Inc., submitted by Farnam Cos., Inc., Phoenix, Ariz.;
CDL:232388-H)
00083020 Fink, R. (1975) Final Report: One-generation Reproduction Study - Mallard
Duck: Project No. 127-104. (Unpublished study received Nov 7, 1977 under
270-129; prepared by Truslow Farms,Inc., submitted by Farnam Cos., Inc.,
Phoenix, Ariz.; CDL:232388-E)
00084455 Fink, R. (1974) Final Report: One-generation Reproduction Study - Bobwhite
Quail: Project No. 100-103. (Unpublished study received Jul 24, 1974 under
2724-227; prepared by Truslow Farms, Inc., submitted by Zoecon Industries,
Inc., Dallas, Tex.; CDL:229080-A)
00093993 Beliles, R.P.; Makris, S.L. (1978) Teratology Study in Rats: Z-9-Tricosene
Technical: LBI Project No. 20876. Final rept. (Un-published study received
Nov 14, 1979 under 2724-274; prepared by Litton Bionetics, Inc., submitted by
Zoecon Industries, Inc., Dallas, Tex.; CDL:246674-A)
42
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BIBLIOGRAPHY
MRID
CITATION
40883001 Jovanovich, A. (1988) Product Chemistry: Product Identity and Composition:
Application To Register Technical Muscalure (9-tricosene): A Biochemical
Attractant for Control of House Flies. Unpublished compilation prepared by
Technology Services Group, Inc. 33 p.
40883002 Jovanovich, A. (1988) Product Chemistry: Analysis and Certification of
Ingredients: Application To Register Technical Muscalure (9-tricosene): A
Biochemical Attractant for Control of House Flies. Unpublished compilation
prepared by Technology Services Group, Inc. 38 p.
40883003 Jovanovich, A. (1988) Product Chemistry: Physical and Chemical
Characteristics: Application To Register Technical Muscalure (9-tricosene): A
Biochemical Attractant for Control of House Flies. Unpublished study prepared
by Technology Services Group, Inc. 7 p.
41783601 Robbins, G. (1990) Tricosene-Acute Oral Toxicity in Rats: Lab Project
Number: F2085. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 19 p.
41783602 Robbins, G. (1990) Tricosene—Acute Dermal Absorption: Lab Project Number:
B2085. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc.
23 p.
41783603 Robbins, G. (1990) Tricosene—Primary Eye Irritation in Rabbits: Lab Project
Number: D2085. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 18 p.
41783604 Robbins, G. (1990) Tricosene—Primary Dermal Irritation in Rabbits: Lab
Project Number: E2085. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 13 p.
41783605 Robins, G. R. (1990) Tricosene - Guinea Pig Sensitization Study: Project
Number F2085. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc.
41785401 Daamen, P. (1990) Acute Eye Irritation/Corrosion Study with Muscalure in the
Rabbit: Lab Project Number: 2/91 M/RR-4. Unpublished study prepared by
Technology Services Group, Inc. 29 p.
43
-------
BIBLIOGRAPHY
MRID
CITATION
41785402 Daamen, P. (1990) Primary Skin Irritation/Corrosion Study with Muscalure in
the Rabbit: Lab Project Number: 2/91 M/RR-5. Unpublished study prepared
by Technology Services Group, Inc. 22 p.
41785403 Coenen, T. (1990) Acute Oral Toxicity of Muscalure in Bobwhite Quail: Lab
Project Number: 2-91 M/RR-6. Unpublished study prepared by Technology
Services Group, Inc. 29 p.
41785404 Coenen, T. (1990) 5-Day Dietary Toxicity Study of Muscalure in Bobwhite
Quail: Lab Project Number: 2/91 M/RR-7. Unpublished study prepared by
Technology Services Group, Inc. 45 p.
42052801 Deamen, P.A.M. (1991) Contact Hypersensitivity to Muscalure in Guinea
Pigs: Lab Project Number: 051637. Unpublished study prepared by RCC
NOTOX B.V. Hertogenbosch, The Netherlands.
42052802 Arts, I. (1991) Acute (4-Hour) Inhalation Toxicity Study of Muscalure in Rats:
Lab Project Number: V 91.375. Unpublished study prepared by TNO
Nutrition and Food Research. 28 p.
42077301 Riebeek, W. (1990) Acute Oral Toxicity of the Compound Muscalure in Rats:
Lab Project Number: 2/91 M/RR-2. Unpublished study prepared by
Technology Services Group, Inc. 19 p.
42077302 Riebeek, W. (1990) Acute Dermal Toxicity of the Compound Muscalure in
Rats: Lab Project Number: 2-91 M/RR-3. Unpublished study prepared by
Technology Services Group, Inc. 20 p.
42176701 Robbins, G. (1990) Acute Inhalation Study in Rats: [Tricosene]: Lab Project
Number: C2085. Unpublished study prepared by CSE, Inc. 31 p.
44
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APPENDIX D. List of Available Related Documents
45
-------
46
-------
The following is a list of available documents related to (Z)-9-Tricosene. 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 (Z)-9-Tricosene 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. (Z)-9-Tricosene 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
47
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48
-------
APPENDIX E. PR Notices 86-5 and 91-2
49
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50
-------
PR Notice 86-5
51
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52
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tpno1 WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of pesticides.
Subject: Standard format for data submitted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental Protection Agency (EPA) in a
standard format. This Notice also provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
requirements for granting or maintaining pesticide registrations, experimental use permits,
tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
are defined in FIFRA §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to be, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice.
OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8 14
D. 5 Good Laboratory Practice Compliance Statement 9 16
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E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then be bound separately.
Submitters sometimes provide additional materials that are intended to clarify,
emphasize, or otherwise comment to help Product Managers and reviewers better understand
the submittal.
- If such materials relate to one study, they should be included as an appendix to that
study.
- If such materials relate to more than one study (as for example a summary of all
studies in a discipline) or to the submittal in general, they must be included in the
submittal package as a separate study (with title page and statement of confidentiality
claims).
B. Transmittal Document
The first item in each submittal package must be a transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted--i.e., a registration application, petition, experimental
use permit (EUPj, §3(c)(2j(B) data call-in, §6(aj(2) submittal, or a special review; the
transmittal date; and a list of all individual studies included in the package in the order of their
appearance, showing (usually by Guideline reference number) the data requirement(s)
addressed by each one. The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be included in the transmittal
document as well, if it is known to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data submittal package supporting a
registration application should be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data submittal package supporting a
petition for tolerance or an application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and an application for a
registration or an EUP, list the petition studies first, then the balance or the studies. Within
these two groups of studies follow the instructions above.
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C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range for biorational pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,
151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
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151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely
broad in scope; studies addressing residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
, (B),or(C)
Example
Page 12
Page 13
Page 16
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
(B),or(C)
Only if confidentiality is
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
Page 15
Page 14
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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 it it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant tacts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
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D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachment
must be associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list of the points to address in such a statement is included in Attachment 4
on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims must be signed and dated
and must include the typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory work subject to GLP
requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
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microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies Required - All submittal packages except those associated with a
Registration Standard or Special Review (See Part G below) must be provided In three
complete, identical copies. (The proposed regulations specified two copies; three are now
being required to expedite and reduce the cost of processing data into the OPP Pesticide
Document Management System and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard or Special Review
must be provided in four copies, from one of which all material claimed as CBI has been
excised. This fourth copy will become part of the public docket for the RS or SR case. If no
claims of confidentiality are made for the study, the fourth copy should be identical to the
other three. When portions of a study submitted in support or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
Mark the fourth copy plainly on both its cover and its title page with the phi
"Public Docket Material - contains no information claimed as confidential".
ihrase
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V. For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+ Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+ Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official:
Signature Name
Company Name
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
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Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method, can be approved unless the applicant waives all claims of
confidentiality for the analytical method. These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
• Identify specifically by page and line number (s) each portion of the study for
which you claim confidentiality.
• Cite the reasons why the cited passage qualifies for confidential treatment.
• Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
• Identify the measures taken to guard against undesired disclosure of this
information.
• Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
• Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
• If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
• If you assert that the information in voluntarily submitted, indicate whether you
believe disclosure of this information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PARAGRAPH(S) :
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process § 1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10 (d) (1) (A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
• Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
:—"]' _. :""; . Supplemental Statement
i...-r--''' i of Confidentiality Claims
• " * When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
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72
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PR Notice 91-2
73
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91 -2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of Pesticide Program's policy with
respect to the statement of percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
statement on the label must be stated as the nominal concentration of such ingredient(s), as that
term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
II. BACKGROUND
For some time the Agency has accepted two different methods of identifying on the
label what percentage is claimed for the ingredient (s) contained in a pesticide. Some applicants
claimed a percentage which represented a level between the upper and the lower certified
limits. This was referred to as the nominal concentration. Other applicants claimed the lower
limit as the percentage of the ingredient(s) that would be expected to be present in their
product at the end or the product's shelf-life. Unfortunately, this led to a great deal of
confusion among the regulated industry, the regulators, and the consumers as to exactly how
much of a given ingredient was in a given product. The Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in the active ingredient statement
be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended to encompass any such "good
manufacturing practice" variations 40 CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed in connection with a
product's registration, represent the amounts of an ingredient that may legally be present 40
CFR 158.1/5. The lower certified limit is used as the enforceable lower limit for the product
composition according to FIFRA section 12(a)(l)(C), while the nominal concentration
appearing on the label would be the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is
warranted with respect to actual product composition because the nominal concentration would
be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10 (b). In this respect the
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certified limits will be routinely provided by EPA to States for enforcement purposes, since
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes or section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,
elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be fulfilled. Copies of the raw
analytical data must be submitted with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert ingredient, impurities of toxicological
significance (i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set based on representative sampling and chemical analysis (i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40 CFR 156-Labeling
Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must be changed to
nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established, the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
(2) Registrants having products subject to reregistration under FIFRA section 4 (a)
are to comply with the requirements of this Notice when specific products are
called in by the Agency under Phase V of the Reregistration Program.
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(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1557, to comply with this Notice. Such applications should
note "Conversion to Nominal Concentrations on the application form. These
types Or amendments will not be handled as "Fast Track" applications but will
be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Generic Data Call-in
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/ WASHINGTON. D.C. 20460
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 product(s)
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. how you will comply with the requirements set forth in this Notice and its Attachments 1
through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 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).
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:
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Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - 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 reevaluation
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 product(s)
containing the subject active ingredient(s).
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
in 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 time frames provided.
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 s 15o. Normally,
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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(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-In(s), or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their
affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
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 in Section IV-A and IV-B.
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 in Section III-C. A discussion of options relating to requests for data
waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (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 Noticed 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 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 (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 b
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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 in
accordance with the Existing Stocks provisions of this Notice which are contained
in 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
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
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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 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 Caii-ln Response Form, it 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 '(), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first
six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below
with information in parentheses to guide registrants to additional instructions provided in
this Section. The options are:
1. I will generate and submit data within the specified time frame (Developing
Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously to
the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1, Developing Data —
If you choose to develop the required data it must be in conformance with
Agency deadlines and with other Agency requirements as referenced herein and in
the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
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Pesticide Assessment Guidelines (PAG), and be in 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
in 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 or 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 in the cost of developing that study. A 90-day progress report must be
submitted for all studies. This 9T)-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 time 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 in 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 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 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
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 in 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
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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
It you have made an otter to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration^), although you do not comply with the
data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of
a product of a registrant who has in good faith sought and continues to seek to
enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer. To qualify for this option,
you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data.
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
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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.
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 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 a study is in the Agency's files, you need
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only cite it along with the notification. If not in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data submitted
and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally
without any time extension. Deficient, but upgradeable studies will normally be
classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing
study you must satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated
as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as 'core-guideline" or ' core minimum.'
For 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.
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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^) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Eorm. Section 3(cj (2) (A) of FIFKA 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 ingredient(s) 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 in order to remain qualified
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 ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient (s), 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.
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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 ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
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
ingredient(s), 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 product(s):
(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 FofrrT This option may be used if you believe that a
particular data requirement should not 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 product(s) 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
product(s), 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 your product(s), you
must choose a method of meeting the requirements of this Notice within the time
frame provided by 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. Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing studies
or offers, arrangements, or arbitration on the sharing of costs or the
formation of Task Forces, failure to comply with the terms of an agreement
or arbitration concerning joint data development or failure to comply with
any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the
cost of developing data and provided proof of the registrant's receipt of
such offer, or failure of a registrant on whom you rely for a generic data
exemption either to:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-in Response Form and a Requirements Status
and Registrant's Response Form; of,
b. fulfill the commitment to develop and submit the data as required
by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
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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 or 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.
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 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.
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Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due
unless you demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3 year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person 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, ana should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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(Z)-9-TRICOSENE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing (Z)-9-Tricosene.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point or contact tor inquiries pertaining to the reregistration of (Z)-9-
Tricosene. This attachment is to be used in 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 (Z)-9-Tricosene 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 (Z)-9-
Tricosene are contained in the Requirements Status and Registrant's Response, Attachment C.
The Agency has concluded that additional product chemistry data on (Zj-9-Tricosene are needed.
These data are needed to fully complete the reregistration of all eligible (Z)-9-Tricosene 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-o074.
All responses to this Notice for the generic data requirements should be submitted to:
Tom Myers, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: (Zj-9-Tricosene
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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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. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered
by this data call-in but that is not listed by the Agency in Item 4. You must
bring any such apparent omission to the Agency's attention within the
period required for submission of this response form.
Item 5. 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 in 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.
Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-in Notice), and
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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 in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in 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 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is 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 in your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
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.
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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
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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 or 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 2070-0107, Washington, D.C.
20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the 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.
Item 5. 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
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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.
0.
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_*
TEP/MET
TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
MET
IMP
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
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
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DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
Item 9. 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. (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 in
item 5 above.
2. (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 in the cost of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop datajointly. 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 in the cost of developing data as outlined in the
Data Call-in Notice.
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.
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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.
Item 10. 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.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
in
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APPENDIX G. Product Specific Data Call-in
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.^iK^- WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
ofyour product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all ofyour products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
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
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Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
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
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complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-in(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy or the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-In Response Form in Attachment 2). Please note that
the company's authorized representative is required to sign the first page of the Data Call-In
Response Form and Requirements Status and Registrant's Response Form (if this form is
required) and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person (s) identified in Attachment 1.
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
b on the Data Calf-In Response Form. If you choose this option, this is the only form that you
are required to complete.
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If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response Form. Deletion of a use(s) and the iow volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section 111-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
1) I will generate and submit data within the specified time frame (Developing Data)
2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
3) I have made offers to cost-share (Offers to Cost Share)
4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1 Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
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 registration(s).
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If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of producing
the data upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c) (2) (B) (iii) and must not qualify this offer. The other registrant
must also inform EPA of its election of an option to develop and submit the data required by this
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
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well as that of the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
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 you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
you must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of~how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number (s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or ' core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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.
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III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete Justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in
force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3 (c) (2) (B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
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a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEP TABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals, dose and effect levels to be
tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
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.
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If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 3D day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 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.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review and
Reregistration Division
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Attachments
1 - Data Call-in Chemical Status Sheet
2 - Froduct-Speciric Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EFA Grouping or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
5 - FFA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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(Z)-9-TRICOSENE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing (Z)-9-Tricosene.
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 (Z)-9-
Tricosene. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this (Z)-9-Tricosene 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 (Z)-9-Tricosene are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on (Z)-9-Tricosene are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible (Z)-9-Tricosene products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of (Z)-9-Tricosene, 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.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Wanda Daughtry
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: (Z)-9-Tricosene
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in me Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertainingto the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
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"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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136
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed "
Certification of offer to Cost Share in the Development Data" form. I am including
a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the require data; if the
required study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-in Notice (Section III-
C.l.) apply as well.
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4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing itudy). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit
a revised "Requirements Status chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
139
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140
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EPA'S DECISION ON BATCHING PRODUCTS CONTAINING MUSCALURE 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 muscalure 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 labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since some
products within a batch may not be considered chemically similar or nave 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.
m 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 ne/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),
Suomitting 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. Ftowever, 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.
Ta
lie I lists 7 hatches
Batch
No.
1
2
EPA Reg. No.
270-112
7319-5
52991-4
270-255
2724-274
2724-296
53871-3
AZ90000700
% of Muscalure
& other Active Ingredients
93.48
99.7
93.46
0.025
l.OOMethomyl
0.025
l.OOMethomyl
0.025
l.OOMethomyl
0.025
l.OOMethomyl
0.025
l.OOMethomyl
Formulation Type
liquid
liquid
liquid
bait
bait
bait tray
bait
bait
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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
EPA Reg. No.
1203-69
34473-2
11715-210
11715-214
64296-1
% of Methomyl
& other Active Ingredients
0.026
1.127 Methomyl
3.57
0.048
0.076
0.03
1.19 Metarhizium anisopliae
Formulation Type
crystalline
impregnated material
granules
impregnated material
impregnated material
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Attachment 5. EPA Acceptance Criteria
143
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144
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SUBDIVISION D
Guideline Study Tide
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each intentionally-
added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at > 0.1% by weight and for
certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at < 071%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Registry
Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition, properties
or toxicity.
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 (seeT3).
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all
impurities present at > 0.1%.
2. Degree of accountability or closure _>_ ca 98%.
3. Analyses conducted for certain trace"toxic impurities at lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at _>_ 0.1% and for certain lexicologically significant
impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt from
requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic compounds"
Observed at room temperature
63-5 Melting Point
Reported in ° C
Any observed decomposition reported
63-6 Boiling Point
Reported in ° C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with reference
to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure too
low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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SUBDIVISION F
Guideline Study Tide
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?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.r Dosing, single oral may be administered over 24 hrs.
4.*^ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.~ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with 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. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
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 > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One ofthe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6.~ Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
155
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156
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
157
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158
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Attachment 7. Cost Share Data Compensation Forms, Confidential Statement
of Formula Form and Instructions
159
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160
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162
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
163
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164
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Dale
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
165
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166
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. SencTcomments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodentipide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay cpmpensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FlFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wi
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
with regard to the registration or
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
167
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168
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APPENDIX H. FACT SHEET
169
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170
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-F-94-025
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
(Z)-9-Tricosene
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for 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 document for
reregistration case 4112, (Z)-9-tricosene.
(Z)-9-tricosene is the sex-attractant pheromone of the female housefly.
This biochemical pesticide is used in a number of places where fly control is
necessary including food/feed handling establishments, livestock premises
and residential areas. However, these are considered non-food/feed uses
because label restrictions prohibit use near food and feed. (Z)-9-tricosene is
formulated as an impregnated material or pest strip, as well as a granular
and crystal. Products are applied by hand, using rubber gloves or a cup or
scoop.
Use restrictions for products containing (Z)-9-tricosene include: use
granules and crystals in bait stations or only in places inaccessible to birds;
strips containing the chemical may not be placed in areas where birds, pets
or children can accidentally come in contact; products are not permitted in
food areas of food handling establishments, or where milk is processed or
stored; and products must be kept out of reach of food producing animals.
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Regulatory Pesticide products containing (Z)-9-tricosene were first registered in
History the United States in 1975. Currently, there are twelve products registered,
several also containing other pesticide active ingredients.
Human Health
Assessment
Physical Chemistry
(Z)-9-tricosene is classified as a biochemical pesticide because even
though it is chemically synthesized, it is identical to the sex pheromone of
the female house fly Musca domestica.
There are certain technical chemistry issues to be resolved, including
the method used to quantify the percent active ingredient. This leads to a
deficiency in the Certification of Ingredient Limits and also the validation of
the method used to verify certified limits. These deficiencies are considered
minor to the Agency's ability to assess the risks associated with the current
uses of (Z)-9-tricosene products. However, the Agency is requiring
confirmatory data to correct these deficiencies and accurately characterize
the technical chemistry of the (Z)-9-tricosene.
Toxicity
Other than slight eye and dermal irritation effects, and possibly
moderate dermal sensitization, (Z)-9-tricosene showed no significant signs
of acute toxicity. Because of its use patterns, no further toxicology studies
are required.
Dietary Exposure
There are no established tolerances or tolerance exemptions for (Z)-9-
tricosene. All labels bearing directions for use in food or feed handling
establishments must carry restrictions to keep products containing this
chemical away from food and feed areas and out of reach of livestock.
These uses are classified as non-food uses and thus, there are no dietary
exposure concerns.
Occupational and Residential Exposure
Based on the registered uses of products containing (Z)-9-tricosene,
there are no worker or residential exposure concerns.
Human Risk Assessment
The potential risks to humans from both non-dietary and dietary routes
are considered negligible. Because the active ingredients are impregnated or
embedded in a solid polymeric matrix shell, there is low potential for
exposure and there are no toxicological concerns.
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Environmental
Assessment
Environmental Fate
The major routes of dissipation in the environment for (Z)-9-tricosene
are volatilization and microbial mediated degradation.
Ecological Effects
(Z)-9-tricosene has low toxicity to mammalian species that may come
in contact with this pesticide in the environment. The chemical is
practically non-toxic to birds or freshwater fish on an acute oral basis. On a
subacute dietary basis, it is practically non-toxic to upland game birds and
waterfowl.
(Z)-9-tricosene is very highly toxic, even in low doses, to waterfowl
for reproductive effects and is also highly toxic to freshwater invertebrates.
Additional Data
Required
Product Labeling
Changes Required
Ecological Effects Risk Assessment
For products which contain impregnated materials and solid matrix
forms (bait stations and strips), it is assumed that exposure to terrestrial and
aquatic species will be minimal. For products formulated as crystals or
granules, minimal acute effects to terrestrial species can be expected.
Effects to aquatic invertebrates may occur if direct application of the
chemical accidentally occurs.
Endangered Species
Based on the current use pattern for products formulated as crystals
and granules, the potential risk of adverse acute effects to avian, aquatic and
mammalian endangered species would be minimal. However, there could
be a risk of reproductive effects to endangered avian species.
EPA is requiring confirmatory generic product chemistry data on the
method used to quantify the percent of the active ingredient. Product-
specific data including product chemistry, revised Confidential Statements of
Formula (CSFs) and revised product labeling also are required for
reregistration of products containing (Z)-9-tricosene.
The labels of all registered end use products containing (Z)-9-tricosene
must comply with EPA's current labeling requirements, and with the
following:
Avian Risk Mitigation: To mitigate the avian reproduction toxicity
concern for broadcast products and the accessibility to birds, the Agency is
requiring registrants to modify their products in a manner that would
significantly reduce the exposure potential to birds, such as bait stations.
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Regulatory
Conclusion
For More
Information
The use of registered products containing (Z)-9-tricosene will not pose
unreasonable risks or adverse effects to humans or the environment,
provided that these products are used in accordance with the restrictions on
product labeling. Therefore, all uses of these products are eligible for
reregistration. Products containing (Z)-9-tricosene will be reregistered once
required confirmatory generic data, product-specific data, Confidential
Statements of Formula and revised labeling are received and accepted by
EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for (Z)-9-tricosene 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 (Z)-9-tricosene 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 (Z)-9-tricosene RED, or reregistration of individual products containing
(Z)-9-tricosene, 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, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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