United States Prevention, Pesticides EPA-738-R-96-003
Environmental Protection And Toxic Substances September 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Starlicide
(3-chloro-p-toluidine
hydrochloride)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide active ingredient 3-chloro-p-
toluidine hydrochloride, or starlicide. The enclosed Reregistration Eligibility Decision (RED)
contains the Agency's evaluation of the data base of these chemicals, its conclusions of the
potential human health and environmental risks of the current product uses, and its decisions
and conditions under which these uses and products will be eligible for reregi strati on. The
RED includes the data and labeling requirements for products for reregi strati on. It may also
include requirements for additional data (generic) on the active ingredients to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the receipt 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
Edward Setren at (703) 308-8166. Address any questions on required generic data to the
Special Review and Reregistration Division representative Mark Wilhite at (703)308-8586.
Sincerely yours,
Lois Rossi, Division 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
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the
receipt of this letter (RED issuance date); otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as
formulation changes, or labeling changes not related to reregi strati on) separately. You may
delete uses which the RED says are ineligible for reregi strati on. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on
Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI)
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
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 reregi strati on determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
3-Chloro-p-toluidine hydrochloride
(Starlicide)
LISTB
CASE 2610
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
STARLICIDE
REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 6
c. Chronic toxicity and Oncogenicity 6
d. Developmental Toxicity 7
e. Mutagenicity 7
2. Exposure Assessment 7
a. Dietary Exposure 7
b. Occupational and Residential 7
3. Risk Assessment 9
a. Dietary 9
b. Occupational and Residential 9
C. Environmental Assessment 9
1. Ecological Toxicity Data 9
a. Toxicity to Terrestrial Animals 9
b. Toxicity to Aquatic Animals 11
c. Toxicity to Plants 12
2. Environmental Fate 12
a. Environmental Fate Assessment 13
b. Environmental Fate and Transport 14
3. Exposure and Risk Characterization 18
a. Ecological Exposure and Risk Characterization 18
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 26
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1. Determination of Eligibility 26
2. Eligibility Decision 27
3. Eligible and Ineligible Uses 27
4. Regulatory Position and Risk Mitigation Measures 27
V. ACTIONS REQUIRED OF REGISTRANTS 30
A. Manufacturing-Use Products 30
1. Additional Generic Data Requirements 30
2. Labeling Requirements for End-Use Products 30
B. End-Use Products 31
1. Additional Product-Specific Data Requirements 31
2. Labeling Requirements for End-Use Products 32
3. Existing Stocks 35
VI. APPENDICES 37
APPENDIX A. Table of Use Patterns Subject to Reregistration 38
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 45
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Starlicide 49
APPENDIX D. Product Specific Data Call-In 56
Attachment 1. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 70
Attachment 2. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 72
Attachment 3. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 80
Attachment 4. List of All Registrants Sent This Data Call-in Notice
(insert) 82
Attachment 5. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 83
APPENDIX E. List of Available Related Documents 89
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STARLICIDE
REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Steve Jarboe
Richard Peacock
Joe Hogue
Environmental Fate and Effects Division
Sharlene Matten
Dana Spatz
Bill Erickson
Health Effects Division
Tom Myers
Felicia Fort
John Leahy
Irving Mauer
Registration Division
Dan Peacock
Bill Jacobs
Mark Perry
Special Review and Reregistration Division
Mark Wilhite
Bruce Sidwell
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Risk Characterization and Analysis Branch
Reregistration Support Chemistry Branch
Occupational and Residential Exposure Branch
Toxicology Branch I
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The D WEL 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
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It i s
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
As required under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended
in 1988, the U.S. Environmental Protection Agency has completed its reregistration eligibility
decision for the pesticide active ingredient starlicide, or 3-chloro-p-toluidine hydrochloride. This
decision includes a comprehensive reassessment of the required target data base and use patterns
of currently registered products. The Agency compared its risk assessment to current science and
regulatory policies. Where appropriate, it has imposed changes to the terms for continued
registration in order to reduce human health and environmental risks.
The Agency has determined that the uses of starlicide as currently labeled on products and
specified in this Reregistration Eligibility Decision document will not cause unreasonable risk to
humans or the environment and these uses are eligible for reregistration. However, the Agency
is requiring new measures and use restrictions to mitigate risks to non-target organisms.
Use Patterns
Starlicide is an avicide used to control ravens, starlings, crows, pigeons, cowbirds,
grackles, blackbirds, magpies, and certain gull species. It is slow-acting and highly toxic to target
species, with death occurring 1-3 days after ingestion. Use sites vary by species but include
livestock and poultry feedlots, buildings and fenced noncrop areas, Federal and State wildlife
refuges and protected areas, gull colonies in coastal areas, and bird staging areas and roosting
sites.
Human Health Assessment
From its review of the target database, the Agency concluded that starlicide is moderately
acutely toxic when administered orally and dermally. It is corrosive to eyes and skin and is a mild
to moderate dermal sensitizer. Although an acute inhalation study was not required, based on its
acute toxicity properties, starlicide is assumed to be highly toxic on an acute inhalation basis.
Starlicide is not a carcinogen and was negative in the three required mutagenicity assays.
Starlicide is not directly applied to food or feed crops or commodities, but is used in some
areas where food or feed crops could be grown. Therefore, for broadcast applications, registrants
will be required to delete such sites and include prohibitions against grazing animals or growing
crops for 365 days on areas treated with starlicide baits. With these changes, no dietary exposure
is expected. Since it is used in relatively small amounts, and all products except one are currently
classified as restricted use, exposure to mixers and applicators is expected to be low.
Environmental Risk Assessment
Starlicide is very highly toxic to birds and freshwater invertebrates, and moderately toxic
to freshwater fish. Starlicide does not hydrolyze, but does photodegrade in water, which, based
on available data, appears to be its primary route of dissipation in the environment. It also binds
IV
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to organic matter in soils. However, the Agency cannot perform a comprehensive environmental
fate assessment for this chemical due to inadequacies associated with the aerobic metabolism and
leaching studies. The Agency is not requiring additional environmental fate data because minimal
environmental impact is expected due to the limited use of this chemical and because it is used as
a bait.
Based on toxicity and exposure estimates, starlicide poses a high acute primary risk to
nonendangered and endangered birds. Acute risk to both endangered aquatic invertebrates and
endangered small mammals also exists.
Risk Mitigation Measures
The Agency is requiring risk reduction measures to mitigate mixer/loader and ecological
risk. These include lowering the application rates on all broadcast applications, which are
currently as high as 0.5 Ib a.i./A, to 0.1 Ib a.i./A, requiring prebaiting to ensure rapid bait
acceptance by target species, and restricting the use of treated baits to at least 50 ft. from bodies
of water. In addition, because of its potential high risk to non-target mammals and birds, the only
remaining starlicide end-use product which is currently classified for general use, is being changed
to restricted use. The Agency is also requiring a respirator for mixers/loaders of packages
containing one pound or more of starlicide concentrate, because of its presumed high acute
inhalation toxicity.
Additional ecological toxicity data to assess risk to freshwater invertebrates or
marine/estuarine species are not required because the prescribed risk mitigation measures will
reduce the likelihood that starlicide or its degradates will be available for runoff.
Before reregistering products containing starlicide, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
within eight months of the issuance of this document. These data include product chemistry for
each registration and acute toxicity testing and efficacy data for public health uses. 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 reregistration" 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 3-chloro-p-toluidine hydrochloride, hereafter referred to as starlicide. The
document consists of six sections. Section I is the introduction. Section II describes starlicide, 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 starlicide. Section V discusses the requirements for its reregistration.
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
Decision:
Common Names:
Starlicide, DRC-1339
Chemical Name:
3-Chloro-p-toluidine hydrochloride
CAS Registry Number: 7745-89-3
OPP Chemical Code: 009901
Empirical Formula:
C7H9C12N
Basic Manufacturer:
B. Use Profile
PM Resources Inc.
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of current uses of Starlicide is in
Appendix A.
Type of Pesticide:
POISON, SINGLE DOSE (Avicide)
Use Sites:
TERRESTRIAL FOOD CROP1
Bird Staging Areas (Including broadcast applications in cut hay fields, grassy
areas, orchards, stubble fields)
Although there are uses currently on Starlicide labels which may result in use in areas where food or feed crops are
grown, these uses must be deleted or modified, as specified in this document. After these uses are removed from
labels, there will no longer be food/feed uses for Starlicide.
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Bird Staging Areas in Rice Growing Areas (Including broadcast applications in
areas under blackbird flight lines near roosts, which are fallow stubble fields,
harvested hay fields, open grassy areas and pastures)
TERRESTRIAL NON-FOOD CROP
Bird Nesting Areas (In coastal nesting areas of certain gulls within predation range
of important nesting colonies of colonial nesting birds)
Bird Roosting or Loafing Areas (Including bridges, buildings, electrical power
stations, electrical towers, flat rooftops, fenced areas, industrial sites)
Bird Staging Areas (Including bare ground noncrop areas, cut hay fields (in bait
dispensers), grassy noncrop areas, near night time roosting sites, orchards
(nonbearing or in bait dispensers), roadsides, roads (unused gravel or dirt), trails,
open areas, rooftops, industrial and commercial structures, stubble fields (in bait
dispensers) and secured parking areas)
Bird Staging Areas in Rice Growing Areas (includes areas under blackbird flight
lines near roosts, which are fallow stubble fields (in bait dispensers), harvested hay
fields (in bait dispensers), open grassy or bare-ground noncrop areas, roadsides,
ungrazed pastures (in bait dispensers) and other noncrop areas
Citrus Fruits (Bait box application only; confined to 5 counties in Texas)
FEEDLOT GROUP (non/food/feed areas only)
Beef cattle , dairy cattle, poultry, livestock and swine feedlots
Fodder/Silage Bags (bags must be unbroken)
Poultry Operations (outside of pens, buildings or range areas)
Rangeland and pastureland areas where birds feed on newborn livestock
(uneaten bait and dead birds must be removed)
Refuges or other areas where pest birds prey upon protected species.
Sunflowers (Decoy fields)
Target Pests:
Black-billed Magpies, Blackbirds (unspecified), Boat-tailed Crackles, Brewer's
Blackbirds, Brown-headed Cowbirds, Common Crows, Common Crackles,
Common Ravens, Great Black-backed Gulls, Great-tailed Crackles, Herring Gulls,
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Pigeons, Red-wing Blackbirds, Rusty Blackbirds, Ring-billed Gulls, Starlings, Tri-
colored Blackbirds, Yellow-headed Blackbirds and White-necked Ravens.
Types/Formulations Registered:
Technical Grade Active Ingredient
Solid 97.0000%
End Use Product
Bait/Solid 00.1000%
Soluble Concentrate/
Solid 98.0000%
Methods and Rates of Application:
Types of Treatment: Bait application.
Equipment: Aircraft.; Bait box.; By hand.; Glove.; Ground.; Scoop.
Timing: See Appendix A
Use Practice Limitations:
See Appendix A
C. Estimated Usage of Pesticide
Approximately 110 pounds of starlicide active ingredient is applied annually in the
United States. It is applied entirely to non-crop areas for control of bird pests. Starlicide
is applied by treated bait, and treatments are preceded by a non-treated "pre-bait" to
determine the presence of non-target species. Typically, about 85-90 percent of the
applications are ground applications with a broadcast spreader, with nearly all of the rest
being aerial broadcast applications.
D. Regulatory History
The first product containing starlicide was registered in 1967. Currently, there are
15 product registrations; 7 Federal and 8 state.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The physical/chemical characteristics, including the molecular structure, of
starlicide are described below.
NH,+Cl"
Cl
CH3
Molecular weight: 141.6
Starlicide is a granular, gray-colored powder with a mothball-like odor. It has a
melting point of 220-230°C and a density of 0.44 g/mL. Its solubility in water is 91 g/L
at 30°C, vapor pressure is 1.408 x 10'2 Pascals at 25°C and the pH is 2.67. Starlicide is
stable at normal temperatures.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on starlicide is adequate and will support
reregistration eligibility.
a. Acute Toxicity
Acute toxicity studies performed using 95-98% technical grade
starlicide have been submitted and adequately satisfy the Agency's
requirements for reregistration. The table below summarizes the values and
categories for each reviewed study.
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Acute Toxicity Values
Study
Acute Oral LD50 rat
Acute Dermal LD50 rabbit
Acute Inhalation"
Eye Irritation rabbitb
Dermal Irritation rabbitb
Dermal Sensitization guinea pigb
Results
males 350 mg/kg
females 302 mg/kg
> 2000 mg/kg
not required
corrosive
corrosive
mild to moderate sensitizer
Category
II
III
I
I
I
-
MRID No.
41632101
41632102
N/A
41632103
41632104
42201101
An acute inhalation study was not required for starlicide since the technical material is incorporated in small amounts into
various baits. Based on the severely irritating properties observed in the ocular and dermal irritation studies, starlicide has
been placed in toxicity category I for acute inhalation.
This study is a requirement for manufacturing-use and end-use products (40 CFR Section 158). For starlicide data have
been generated on the TGAI and are presented here for informational purposes.
From an acute oral toxicity study with rats, the LD50 was estimated
to be 350 mg/kg for males and 302 mg/kg for females (MRID 41632101).
An acute dermal toxicity study with rabbits estimated the LD50 to be greater
than 2000 mg/kg (MRID 41632102).
Starlicide is considered to be corrosive, both dermally and ocularly,
when administered to rabbits (MRIDs 41632103 and 41632104).
A guinea pig dermal sensitization study conducted by the modified
Buehler method demonstrated that starlicide was a mild to moderate
sensitizer (MRID 42201101).
b. Subchronic Toxicity
Based on the very low volume used and the restricted use nature of
its application, the Agency does not believe the potential exists for
significant exposure of production workers or applicators to starlicide.
Therefore, a subchronic toxicity study is not required.
c. Chronic toxicity and Oncogenicity
While not required due to starlicide's current use patterns, the
Agency thought it noteworthy to mention a study conducted by the National
Cancer Institute. This study conducted with rats and mice indicates that
starlicide is not oncogenic, since the administration of the free base (3-
chloro-p-toluidine) for 78 weeks to rats and mice produced only body
weight depression at 3,629 ppm, the highest dose treated. There were no
other clinical signs or induced tumors noted (MRID 40408814).
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d. Developmental Toxicity
Based on the use characteristics of this active ingredient, the Agency
does not believe the potential exists for repeat oral, dermal or inhalation
exposures to production workers or applicators. Therefore, a
developmental toxicity study is not required.
e. Mutagenicity
An Ames Assay with Salmonella strains TA1535, TA1537,
TA1538, TA98, and TA100 was conducted. Starlicide was negative for
inducing reverse gene mutation at the histidine locus when tested at levels
up to 2,500 /xg/plate with and without metabolic activation (MRID
41605301). Starlicide was also negative for inducing forward mutation at
the HPRT locus of Chinese hamster ovary (CHO) cells exposed in vitro
with and without metabolic activation to cytotoxic/precipitating doses up to
600 /xg/mL (MRID 41605303).
In an in vitro chromosomal aberration test in CHO cells, Starlicide
was positive in a dose-related manner for structural aberrations in S9-
activated cultures when exposed to moderately cytotoxic doses of 250 or
350 /xg/mL. However, Starlicide was negative in the absence of metabolic
activation when exposed to cytotoxic doses up to 350 /xg/mL (MRID
41605302).
2. Exposure Assessment
a. Dietary Exposure
The Agency considers the uses of Starlicide to be non-food.
Therefore, residue chemistry data or tolerances are not required, and a
dietary exposure assessment is not needed. However, for broadcast
applications, the registrants must drop certain sites (orchards and
grasslands) and include a 365 day prohibition on grazing animals and
growing crops on lands treated with Starlicide baits, for the Agency to
consider these uses of Starlicide to be nonfood.
b. Occupational and Residential
Several factors affect occupational exposure. Starlicide concentrate
is a restricted use pesticide to be handled only by (or under the direct
supervision of) certified applicators. One end-use product (EPA Reg. No.
67517-8), containing 0.1% active ingredient intended for use in cattle and
poultry feeding lots, is currently classified for general use, but is now
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being classified as restricted use, as described in this document. Starlicide
concentrate is packaged in one gram, one ounce, and one pound quantities.
The concentrate is dissolved in water or edible oil, and the solution is then
poured over the bait material and allowed to air dry at ambient
temperatures. Egg baits are produced by injecting the solution into eggs
with a hypodermic needle. There are no residential uses registered for
Starlicide.
In addition, approximately 85 to 90% of the applications are ground
applications where 1-2 acres are treated on foot by the applicator with a
broadcast spreader. Nearly all of the remaining percentage is applied
aerially or by using mechanical ground equipment when more than a few
acres are treated. Because Starlicide is relatively unstable, particularly in
sunlight, Starlicide is usually mixed and applied the same day.
An occupational and/or residential exposure assessment is required
for an active ingredient if (1) certain toxicological criteria are triggered and
(2) there is potential exposure to handlers (mixers, loaders, applicators)
during use or to persons entering treated sites after application is complete.
Starlicide and its uses meet these criteria as explained below.
Handler (Mixer/Loader/Applicator) Exposures
The Agency expects that for handlers mixing Starlicide concentrate
from 1 gram and 1 ounce packages, the potential for respiratory exposure
is negligible because the small size of the containers means that a very
small amount of Starlicide is available to result in inhalation exposure by
becoming airborne or through volatilization. However, the Agency is
concerned about potential respiratory exposure to handlers mixing Starlicide
concentrate in the 1 Ib. quantity. This concern is based on Starlicide's
acute inhalation toxicity (category I), its relatively high vapor pressure (1.4
x 10~2 Pa at 25°C), and the potential for greater quantities of the powdered
Starlicide concentrate to become airborne or to volatilize while handling
the 1-pound package, measuring the concentrate, or mixing the powdered
concentrate with water or edible oil under field conditions.
Post-Application Exposure
The Agency has determined that there is potential for only minimal
exposure to persons entering treated sites after application, such as re-
entering poultry and livestock areas where the bait has been applied. While
the toxicity triggers for requiring post-application exposure data are met,
the Agency sees no need to require these data due to the presumed low
level of exposure.
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3. Risk Assessment
a. Dietary
The Agency considers the uses of starlicide to be nonfood, and thus
a dietary risk assessment is not needed.
b. Occupational and Residential
In most cases small volumes of starlicide are handled and exposure
is expected to be minimal. When large volumes are handled, such as
packages containing one pound or more of concentrate, the Agency
believes that there may be a risk of inhalation toxicity to mixers/loaders.
A respirator would minimize inhalation exposure and risk to these workers.
Based on this reasoning, the Agency concludes that a quantified worker risk
assessment is not necessary. Also, for reasons stated above for post
application scenarios, a risk assessment was not conducted.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency has adequate data to characterize the primary toxicity of
starlicide to nontarget terrestrial organisms.
a. Toxicity to Terrestrial Animals
(1) Birds - Acute and Subacute
In order to establish the toxicity of starlicide to birds, the
following tests are required using technical-grade material: an
avian single-dose oral (LD50) study on one species (preferably
mallard or bobwhite quail); two subacute dietary studies (LC50) on
one species of waterfowl (preferably the mallard duck) and one
species of upland game bird (preferably bobwhite quail). These
studies have been conducted and reviewed. The Agency's
conclusions follow.
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Avian Acute Oral Toxicity Findings
Species
Northern Bobwhite Quail
Mallard Duck
% A.I.
97.1
97.1
LD50 (mg/kg)
2.9
105
MRID No.
41760503
41760502
Toxicity Category
very highly toxic
moderately toxic
Avian Subacute Dietary Toxicity Findings
Species
Northern Bobwhite Quail
Mallard Duck
% A.I.
98
98
LC50 (ppm)
14.1
322
MRID No.
42671802
42671801
Toxicity Category
very highly toxic
highly toxic
As would be expected given starlicide's pesticidal qualities,
results of the above studies indicate that starlicide is moderately to
very highly toxic to avian species on an acute oral and subacute
dietary basis. The guideline requirements are fulfilled. (MRID
41760502, 41760503, 42671801, 42671802)
(2)
Birds - Chronic
Avian reproduction studies are required when birds may be
exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. Because starlicide
is acutely toxic to birds, chronic exposure is unlikely. Therefore,
avian reproduction testing is not required.
(3)
Mammals
Wild mammal testing is required on a case-by-case basis,
depending on the results of the lower tier studies such as acute and
subacute testing, intended use pattern, and pertinent environmental
fate characteristics. Data from an acute oral LD50 study on rats
(MRID 41632101), previously mentioned in section III.B., suggest
that technical starlicide is moderately toxic to small mammals on an
acute oral basis (LD50 was 350 mg/kg for males and 302 mg/kg for
females).
(4)
Insects
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure. Because starlicide
10
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applications are not likely to result in exposure to honey bees, data
are not required.
Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of a pesticide to freshwater
fish, the minimum data required on the technical grade of the active
ingredient are two acute toxicity studies. One study should use a
cold-water species (preferably the rainbow trout), and the other
should use a warm-water species (preferably the bluegill sunfish).
The results of the 96-hour acute toxicity studies indicate that
starlicide is moderately toxic to cold- and warm-water fish. The
guideline requirements are fulfilled. (MRID 41767501, 41767502)
Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Bluegill sunfish
% A.I.
96.3
96.3
LC50 (ppm)
9.7
10.5
MRID No.
41767502
41767501
Toxicity Category
moderately toxic
moderately toxic
(2)
Freshwater Invertebrates
The minimum testing required to assess the hazard of a
pesticide to freshwater invertebrates is a freshwater aquatic
invertebrate acute toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges.
There is sufficient information to characterize starlicide as
very highly acutely toxic to aquatic invertebrates. The guideline
requirement is fulfilled. (MRID 41783701)
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% A.I.
96.3
EC50 (ppm)
0.07
MRID NO.
41783701
Toxicity Category
very highly toxic
Because starlicide may be transported to water from
application sites, and because the EC50, the exposure at which 50%
of the exposed organisms exhibit the evaluated effect, is less than
1 ppm and the EEC in water is greater than 0.01 of the acute EC50,
11
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data from an aquatic invertebrate life cycle study are generally
required. However, if prebaiting is required to insure rapid
acceptance of treated bait, little toxicant would likely be available
for run-off. Also, a restriction of application of treated baits to at
least 50 feet from water would lessen exposure to aquatic
organisms. Therefore, if prebaiting and distance restrictions are
required for all products, the value of the additional data is
considered to be low.
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms
is required when an end-use product is intended for direct
application to the marine/estuarine environment or is expected to
reach this environment in significant concentrations. Because of the
use site and application methods of the starlicide product registered
for use to control gulls (EPA Reg. No. 56228-17), exposure of
starlicide to marine/estuarine organisms is possible. However,
because of the limited use of this product, the value of the
additional information is considered to be low.
c. Toxicity to Plants
(1) Terrestrial and Aquatic
Terrestrial and aquatic plant testing (seedling emergence and
vegetative vigor) is required for herbicides which have terrestrial
non-food/feed or aquatic non-food (except residential) use patterns
and which have endangered or threatened plant species associated
with the site of application. Because starlicide is not a herbicide,
plant testing is not required.
2. Environmental Fate
The environmental fate data requirements are fulfilled for hydrolysis,
photodegradation in water, and bioaccumulation in fish, but are unfulfilled for
aerobic soil metabolism, unaged leaching-adsorption/desorption and aged leaching
studies. Because of the deficiencies in these key studies, a comprehensive
environmental fate and transport assessment cannot be made at this time. Based on
the available information, a tentative environmental data assessment has been
made. Due to the lack of sound data, the soil metabolism and mobility of starlicide
are not well understood. However, the environmental impact from starlicide is
expected to be minimal because the use is limited and it is applied in bait.
12
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a. Environmental Fate Assessment
Starlicide is highly soluble in water (91 g/L) and has a relatively
high vapor pressure. It has an estimated pKa of 3.9 for protonation of the
amine group; consequently, in soils at pH values >4.8, over 90% of the
Starlicide will be in the free amine form, and in soils below pH 3, the
ammonium ion form of Starlicide will be the major species.
Based on the acceptable studies received to date, Starlicide does not
degrade through hydrolysis in sterile water at pH's 5, 7, or 9, but does
photodegrade in water with a half-life of approximately 16 hours. The
major degradate was identified as 3-hydroxy-p-toluidine (HPT). Starlicide
accumulates only slightly in bluegill sunfish with bioconcentration factors
(BCF's) in the range of 33x to 150x. Therefore, the primary route of
dissipation, based on the acceptable data, is photolysis in water.
Because the loam soil chosen to conduct the aerobic soil metabolism
study was very high in organic matter content (8.2%) and therefore not
representative of all the use sites, the data generated were of limited value.
Starlicide apparently binds to organic matter and in this study, a major
portion was bound almost immediately after treatment.
A similar situation applies to the aged column leaching study, which
was also conducted with the loam soil with an organic matter content of
8.2%. Because binding is often correlated with soil organic matter content,
the use of this high organic soil likely resulted in a limited characterization
of the mobility of aged Starlicide residues. In addition, the study did not
adequately address the mobility of the primary soil degradate, N-acetyl-3-
chloro-4-methylanirine, nor did it address the major degradate found in the
photodegradation in water study, 3-hydroxy-p-toluidine (HPT), and
therefore, did not satisfy the major objective of the data requirement.
Concerning the adsorption/desorption data requirement for parent
Starlicide, only preliminary studies were conducted. Definitive batch
equilibrium studies were not performed. It was reported that equilibrium
("as indicated by a constant value of the concentration of Starlicide in the
supernatant") was not reached in the adsorption phase of the 2-3 day
preliminary experiment. However, based on the kinetics data provided in
the study, the Agency believes that equilibrium was nearly achieved after
approximately 48-72 hours.
13
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b. Environmental Fate and Transport
(1) Degradation
(a) Hydrolysis
Starlicide, (3-chloro-p-toluidine hydrochloride;
purity 98.14%), at 20.94 /xg/mL, did not hydrolyze during
30 days of incubation in aqueous buffer solutions that had
been adjusted to pH 5, 7, and 9 and incubated in the dark at
25 ± 1°C. In the pH 5 solutions, Starlicide averaged 100-
101% of the applied through 139 hours post-treatment,
97.1-98.7% at 331 through 546 hours, and 94.6-96.6% at
643 and 715 hours. In the pH 7 and 9 solutions, Starlicide
averaged 97.9-101 and 98.4-101% of the applied,
respectively, throughout the 30-day incubation period.
During the study, material balances ranged from 93.1 to
103% of the applied. This study fulfills the hydrolysis data
requirement. Starlicide does not degrade in water through
hydrolysis at environmentally significant pH's. (MRID
41760501)
(b) Photodegradation in Water
Starlicide (purity 99.1%), photodegraded with a
half-life of approximately 16 hours in an aqueous buffer
solution (0.001 M phosphate; pH 7) that was continuously
irradiated for 30 hours using a Pyrex glass-filtered, 300-
watt xenon lamp. Starlicide decreased from an average
concentration of 1.07 ppm immediately post-treatment to
0.82 ppm after 6 hours, 0.58 ppm after 12 hours, 0.43 ppm
after 18 hours, and 0.30 ppm after 30 hours of irradiation.
The maximum half-lives of Starlicide in sterile buffer
solution, calculated from the quantum yield, were estimated
to be 6.3 hours under summer sunlight conditions, 16 hours
under fall sunlight, 41 hours under winter sunlight, and 9.2
hours under spring sunlight. Starlicide was stable in the
dark control, averaging 1.07 ppm immediately post-
treatment, 1.01 ppm at 18 hours, and 1.03 ppm at 24 hours.
Ring-labeled [U-14C] Starlicide (radiochemical purity
>98%), at 6.2 ppm, photodegraded with an observed half-
life of > 18 hours in aqueous buffer solutions irradiated
under similar conditions for 18 hours. [14C]Starlicide
14
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decreased from 100% of the applied radioactivity
immediately post-treatment to 80.8-81.1% after 6 hours,
70.4-71.8% after 12 hours, and 57.2% after 18 hours of
irradiation. One [14C]degradate, 3-hydroxy-p-toluidine
(HPT), was identified in the irradiated solution. [14C]HPT
increased from 0% of the applied immediately post-
treatment to 20.4-20.7% after 6 hours, 32.2-35.1% after 12
hours, and 46.8% after 18 hours of irradiation. Material
balances ranged from 100 to 107% of the applied
radioactivity.
This study fulfills the photodegradation in water data
requirement. Starlicide photodegraded with a half-life of
approximately 16 hours in an aqueous buffer solution that
was continuously irradiated for 30 hours using a filtered
xenon lamp. One degradate, 3-hydroxy-p-toluidine (HPT),
was identified. (MRID 42838801)
(2) Mobility
(a) Aerobic Soil Metabolism
The soil chosen for this study was not the
recommended sandy loam or silt loam, but a loam soil high
in organic matter content (8.2%). Starlicide apparently
binds strongly to organic matter and in this study, a major
portion was bound almost immediately after treatment. By
day two, as much as 70.6% of the applied radioactivity was
considered bound. The soil half-life calculated by the
registrant (25.3 hours), is therefore more indicative of soil
binding than starlicide's potential to degrade under aerobic
conditions. This was further demonstrated by a preliminary
study in which the study author, based on the similar half-
lives of Starlicide in nonsterile and sterile (autoclaved) soil,
attributed the "initial rate loss" to the binding of Starlicide
to the soil rather than to degradation resulting from
metabolism of Starlicide. While some degradation did
occur, (i.e., small amounts of N-acetyl-3-chloro-p-toluidine
(ACPTH) were identified through 96 hours and up to 12.8%
of the total radioactivity after 99 days was identified as
14CO2), it was clear that the disappearance of Starlicide was
due primarily to its binding to the soil.
15
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Starlicide (3-chloro-p-toluidine hydrochloride)
dissipated with a calculated half-life of 25.3 hours in loam
soil that was incubated in the dark at approximately 222C
and 68% of field moisture capacity for 99 days. The only
degradate identified, N-acetyl-3-chloro-p-toluidine
(ACPTH), was at a maximum at one day post-treatment and
exhibited a pattern of dissipation similar to that of Starlicide.
The dissipation of Starlicide could be attributed primarily to
soil binding.
This study does not satisfy the aerobic soil
metabolism data requirement, but does provide supplemental
information. In order to understand the nature and extent of
microbial degradation of Starlicide in soil, an additional
aerobic soil metabolism study with either a sandy loam or
silt loam and an organic matter content of less than 2%
would be needed. (MRID 43284501)
(b) Adsorption/Desorption
The study submitted also does not satisfy the unaged
adsorption/desorption data requirement, but provides
supplemental information. Definitive batch equilibrium
studies were not conducted. It was reported that equilibrium
(as indicated by a constant value of the concentration of
Starlicide in the supernatant) was not reached in the
adsorption phase of the 2-3 day preliminary experiment,
therefore, a definitive experiment was not conducted.
However, based on the kinetics data, the Agency believes
that equilibrium was nearly achieved after approximately
48-72 hours.
Preliminary Kd's, based on the "non-GLP" kinetics
study at a single concentration, were 69, 3.7, 7.0, 3.7, and
8.8 for the loam soil, two sandy loams, a silty clay, and a
clay sediment, respectively.
In order to better assess the mobility of unaged
Starlicide, a soil column leaching study or preferably, a
batch equilibrium study that provides Freundlich Kd's
would be required. (MRID 43284502)
16
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(c) Aged Leaching
This study provides supplemental information
concerning the mobility of aged starlicide in a soil high in
organic matter content. However, the study does not
adequately address the mobility of the major degradates, N-
acetyl-3-chloro-4-methylanirine and 3-hydroxy-p-toluidine
(HPT), and therefore, does not satisfy the major objective
of the data requirement. In addition, the soil chosen for this
study was not representative of all the potential use areas
with respect to percent organic matter. Because binding is
often correlated with soil organic matter content, the use of
this high organic soil likely resulted in a limited
characterization of mobility.
Aged (24 hours) starlicide residues were not mobile
in 45 cm columns of loam soil that were leached with 450-
600 ml of a 0.01 M calcium sulfate solution. Prior to
leaching, each column was topped with loam soil that had
been treated with starlicide (3-chloro-p-toluidine
hydrochloride) and aged under aerobic conditions for 24
hours. In the soil columns, 84.3-95.3% of the applied
radioactivity remained in the upper 6 cm of soil and 1.7-
2.5% was isolated in the column leachates. The degradate
N-acetyl-3-chloro-4-methylaniline was isolated in only the
upper 6 cm of the soil column and amounted to
approximately 1.3% of the applied.
This study does not satisfy the aged leaching data
requirement, but does provide supplemental information.
Additional studies would be required to characterize the
mobility of N-acetyl-3-chloro-4-methylaniline and HPT in
various soils. (MRID 43284503)
(3) Accumulation
(a) Accumulation in Fish
Starlicide residues accumulated only slightly in
bluegill sunfish exposed to starlicide hydrochloride at 0.1
mg/L for 28 days under flow-through conditions. Average
calculated bioconcentration factors were 33x, 150x, and 88x
for edible tissues (muscle), nonedible tissues (carcass and
viscera), and whole fish, respectively. Maximum mean
17
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concentrations of starlicide residues were 3.6 mg/kg in the
edible tissues after 14 days of exposure, 17 mg/kg in the
nonedible tissues after 28 days, and 9.3 mg/kg in the whole
fish after 28 days. One major degradate, N-acetyl-3-chloro-
4-methylaniline, was identified from fish (all tissue
substrates) collected after 28 days of exposure. Depuration
was relatively slow; after 28 days of depuration, 54.3% of
the accumulated [14C]residues were eliminated from the
edible tissues, 64.1% from the nonedible tissues, and 63.4%
from the whole fish.
This study fulfills the fish accumulation data
requirement. Starlicide only slightly accumulates in bluegill
sunfish. Accumulated residues depurate somewhat slowly.
(MRID 43069801)
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RQ) and the Level of
Concern (LOG): The Levels of Concern are criteria used to indicate
potential risk to nontarget organisms. The criteria indicate that a chemical,
when used as directed, has the potential to cause undesirable effects on
nontarget organisms. There are two general categories of LOG (acute and
chronic) for each of the four nontarget faunal groups and one category
(acute) for each of two nontarget floral groups. In order to determine if an
LOG has been exceeded, a risk quotient must be derived and compared to
the LOC's. A risk quotient is calculated by dividing an appropriate
exposure estimate, e.g. the estimated environmental concentration (EEC),
by an appropriate toxicity test effect level, e.g. the LC50. The acute effect
levels typically are:
-EC25 (terrestrial plants),
-EC50 (aquatic plants and invertebrates),
-LC50 (fish and birds), and
-LD50 (birds and mammals)
When the risk quotient is greater than or equal to the LOG for a particular
category, risk to that particular category is presumed to exist. Risk
presumptions are presented along with the corresponding LOC's.
18
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Levels of Concern (LOG) and associated Risk Presumption
Mammals, Birds
IF THE LOG PRESUMPTION
acute RQ _>_ 0.5 High acute risk
acute RQ _>_ 0.2 Risk that may be mitigated
through restricted use
acute RQ _>_ 0.1 Endangered species may be
affected acutely
Fish, Aquatic invertebrates
IF THE LOG PRESUMPTION
acute RQ _>_ 0.5 High acute risk
acute RQ _>_ 0.1 Risk that may be mitigated
through restricted use
acute RQ _>_ 0.05 Endangered species may be
affected acutely
(1) Exposure and Risk to Nontarget Terrestrial Animals
Nontarget birds and mammals may be at risk from either
primary or secondary exposure to starlicide. A primary hazard
occurs if an animal eats treated bait. Secondary hazard occurs if a
predator or scavenger eats a target or nontarget animal that has fed
on treated bait.
(a) Birds
Primary risks: RQs for a broadcast food bait are
based on the number of LD50s applied per square foot and
are determined as follows:
RQ = LD50/ft2 = mg ai/ft2 4- (LD50)(body wt, kg)
where mg ai/ft2 = (Ib ai/acre)(453,590 mg/lb) 4-43,560
ft2/acre
RQs, which are equal to LD50/ft2, for maximum applications
in staging areas (i.e., stubble fields, cut hay fields,
orchards, roadsides, grassy areas, bare ground), sunflower
fields, feedlots, and rooftops and fenced noncrop areas are
tabulated below for four bird species for which body
19
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weights and LD50 values are available. These species are
presumed to represent all bird species that might consume
starlicide-treated bait. Body weights used in the calculations
were obtained from Kenaga (1973) and Dunning (1984).
LD50 values for the mourning dove (3.1 mg/kg) and red-
winged blackbird (2.4 mg/kg) were obtained from
information submitted to the Agency by the
USDA/APHIS/Denver Wildlife Research Center (DWRC)
in 1991 to support starlicide products (EPA Reg. Nos.
56228-10 and -17).
Estimated Risk Quotients (RQs) for birds
Species
(body weight)
Mallard
(1082 g)
Bobwhite quail
(178 g)
Mourning dove
(100 g)
Red-winged blackbird
(53 g)
Application rate
(Ib ai/acre)
0.52
0.1253
0.5
0.125
0.09"
0.055
0.04'
0.5
0.125
0.09
0.05
0.04
0.5
0.125
0.09
0.05
0.04
Est. no.
LD50s/ft2
0.05
0.01
10.1
2.5
1.8
1.0
0.8
16.8
4.2
3.0
1.7
1.3
40.9
10.2
7.4
4.1
3.3
LOC1
HR > 0.5
RU > 0.2
ES > 0.1
'LOCs: HR=high risk; RU = restricted use; ES = endangered species
2staging areas (LA)
'staging areas (IN,KY,TN,TX)
4staging areas; feedlots (concentrate); sunflower fields (ND)
'rooftops and fenced noncrop areas; feedlots (0.1% pellets)
'staging areas (XX)
Based on the number of LD50s/ft2 for the bobwhite quail,
mourning dove, and red-winged blackbird, and because starlicide
is a very highly toxic acute avicide, high acute risk is presumed for
granivorous birds that consume starlicide treated baits. This
20
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presumption of high acute risk to birds is supported by adverse
effects information submitted by the DWRC in 1991, which
indicates that primary poisoning of some nontarget birds is likely
during many starlicide baiting operations. Although RQs cannot be
determined for raptors and avian scavengers that might consume
meat or egg baits, or nontarget species that might eat
bread/margarine baits intended for gulls, acute high risk is
presumed, because such baits are designed to be lethal to target bird
species.
Birds - Secondary Risks: The Agency does not have data
to assess secondary risks to birds, although some indications of risk
can be made from information previously submitted by the DWRC.
The information includes summaries of published and unpublished
laboratory and field studies with starlicide. Studies have included
the metabolism of starlicide in target species, effects of feeding
starlicide killed birds to captive predator or scavenging species, and
carcass searches conducted in conjunction with efficacy field tests.
According to the DWRC, orally ingested starlicide is
absorbed rapidly in the gut and converted into three major
metabolites: N-(3-chloro-4-methylphenyl)acetamide (CAT), 4-
acetylamino-2-chlorobenzoic acid (CPTC), and 4-amino-2-
chlorobenzoic acid (CPTD). CAT is similar in toxicity to
starlicide, whereas CPTC and CPTD have not shown any signs of
toxicity in rats at 4800 mg/kg or in red-winged blackbirds at 316
mg/kg. Target species that ingest starlicide will die after 1-3 days,
with death resulting from a build-up of uric acid. According to
Cunningham et al. (1979), less than 10% of the 3.16-100 mg/kg of
starlicide administered to starlings was retained in the body 30
minutes after treatment. Whole body residues of starlicide or CAT
at death were 1-2 ppm, independent of dosage level or time to
death. Metabolism in mammals is reported to be similar to that in
birds but is slower.
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The following starlicide LD50 values to raptors and avian
scavengers have been reported by the DWRC:
Acute Oral Toxicity to Avian Raptors and Scavengers
Species
American crow (Corvus brachyrhynchos)
Barn owl (Tyto alba)
Black-billed magpie (Pica pica)
Common raven (Corvus corax)
Marsh hawk (Circus cyaneus)
Golden eagle (Aquila chrysaetos)
American kestrel (Falco sparverius)
Cooper's hawk (Accipiter cooperii)
LD50 (mg/kg)
1.3
4.2
10
13.3
100
>100
178
562
Laboratory studies with hawks and American kestrels
indicated no adverse effects when they were fed starlings poisoned
with 1% starlicide-treated baits. Two kestrels survived eating 11
and 60 poisoned starlings over 24 and 141 days, respectively. Two
Cooper's hawks ate 191 and 222 starlings with no observable
adverse effects. Three marsh hawks ate 100, 191, and 222 starlings
over 75-104 days and survived with no apparent detrimental effects.
The LD50 values tabulated above suggest, however, that other avian
predators and scavengers (e.g., crows, ravens, owls, magpies) are
acutely more sensitive to starlicide than are hawks and kestrels.
Numerous efficacy field trials have been conducted for
blackbird control in staging areas. Other studies conducted on
blackbirds in feedlots, ravens preying on young livestock, pigeons
on structures, and gulls on islands provide additional information.
Many of these studies reported the nontarget species observed,
including predators and scavengers, their potential exposure to
starlicide, and conducted carcass searches for nontarget species.
DWRC previously submitted the following summarized information
from more than 70 field and operational reports:
Feedlots: From 22 references regarding the use of
starlicide in feedlots, the following birds were observed
feeding on dead or dying birds: great-horned owl, marsh
hawk, red-tailed hawk, short-eared owl, and magpie. The
number of birds involved was not indicated. American
22
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kestrels were reported in the area of one operation but were
not observed feeding on dead or dying birds.
Urban pigeons: From 12 studies, the following species
were observed feeding on dead or dying birds: gull, crow.
Staging areas: From 16 studies, the following observations
were made: owls were in the area of operation, but none
were known to have fed on dead or dying birds.
Livestock depredations: From 22 studies, no predator or
scavenging avian species reported in the area was known to
have been impacted by secondary poisoning.
Gulls on breeding islands: A number of studies conducted
from 1969-73 notes that the only nontarget kill was a crow
that apparently ingested a treated bait. No instances of
scavenger or predatory birds consuming treated gulls were
observed.
The available information on the metabolism of starlicide in
target birds, feeding trials with captive hawks and kestrels, and
observations made in many efficacy field trials indicates that some
avian predators and scavengers will eat poisoned birds. Because
starlicide is slow-acting and intoxicated birds may die some distance
from the treatment site, carcasses from secondary poisoning could
be overlooked during searches for nontarget kills. However, there
are no indications that diurnal birds of prey (hawks, kestrels,
eagles) are at significant risk. Information regarding secondary
risks to more highly sensitive species (e.g., owls, ravens, crows,
magpies) is lacking.
High acute primary risk to non-target bird populations exists
for all registered uses of starlicide. This presumption of risk is
supported by the above risk quotients, as well as the adverse effects
and incident reports submitted to the Agency. Lowering the
maximum application rates and prebaiting would decrease the high
acute risk to non-target birds especially for bird control in "staging
areas".
(b) Mammals
Primary risks: Starlicide baits are most likely
attractive to a variety of rodents and other small mammals
23
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because of the kinds of food (e.g., cracked and whole
grains, raisins, pellets, bread, french fries, meat, eggs) used
to make baits. RQs, based on the number of LD50s/ft2, were
calculated as for birds. They are tabulated below for the
highest application rates used to control birds in staging
areas, where small mammals would be expected to be
present and encounter baits. RQs are calculated for three
rodent species for which toxicity values are available. The
acute oral LD50 value of 330 mg/kg for the laboratory rat
was obtained from data submitted to the Agency to evaluate
potential human hazards from starlicide. LD50 values of 960
mg/kg for the laboratory mouse and 1800 mg/kg for the
deer mouse were obtained from data previously submitted
by theDWRC.
Estimated Risk Quotients (RQs) for small mammals
Species (weight)
Lab. rat (300 g)
Lab. mouse (35 g)
Deer mouse (20 g)
Applicati-on rate (Ib ai/acre)
0.52
0.5
0.1253
0.5
0.125
Est. no. LD50s/ft2
0.05
0.15
0.04
0.14
0.04
LOC1
HR > 0.5
RU > 0.2
ES > 0.1
LOCs:HR=high risk; RU = restricted use;ES = endangered species
staging areas (state of LA)
staging areas (states of IN,KY,TN,TX)
Based on these values, high acute risk to small
mammals is not presumed for applications of starlicide
baits. Risk to endangered small mammals is presumed from
an application of 0.5 Ib ai/acre in staging areas in Louisiana.
Applications of 0.125 Ib ai/acre or less do not exceed any
LOC. Although RQs cannot be determined for egg and
meat baits used to control ravens, crows, and/or magpies on
rangeland, pastureland, or refuges, the Agency presumes
that any carnivorous mammal (e.g., fox, skunk, weasel)
eating such bait is at high risk.
Lowering the maximum application rates and
prebaiting would decrease the high acute risk to small
mammals, especially those exposed to starlicide in bird
control "staging areas".
24
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Secondary risks: Little information on secondary
risks to mammals is available. Coyote and grey fox have
been observed feeding on dead or dying birds, but the fate
of those animals is not known. LD50 values for the coyote
and dog exceed 100 mg/kg, indicating that starlicide is not
highly toxic to canids.
(2) Exposure and Risk to Nontarget Aquatic Animals
Expected Aquatic Concentrations: Peak generic EEC
values in ponded water are tabulated below for various application
rates of starlicide used in staging areas and sunflower fields where
runoff might occur. EEC values are based on the Agency's
Generic Estimated Exposure Concentration (GENEEC) computer
modeling program, and determined by application rate and method,
number of annual applications, the application interval, and the
available environmental fate data (solubility, hydrolysis, soil
aerobic half-life, photolysis). The program estimates runoff from
a 10-hectare field into a 1-hectare, 2-meter deep pond.
Estimated Ponded Residues (ppb)
Application rate (Ib
ai/acre)
0.51
0.125
0.094
0.045
No. applications
5*
22
53
5*
4
Applic-ation
interval
(days)
5*
5*
7
5*
Peak
EEC
(ppb)
28.98
7.24
7.25
5.09
2.32
Fish
RQ
(EEC/LCJ
0.003
0.0007
0.0005
0.0002
Inverte-brate
RQ (EEC/ECJ
0.41
0.10
0.07
0.03
LOC
HR > 0.5
RU > 0.1
ES > 0.05
assumed; not specified on product label
staging areas (LA)
staging areas (TN)
staging areas (IN,KY,TN,TX)
staging areas; sunflower fields (ND)
staging areas (TX)
(a)
Freshwater Fish
As indicated in the tabulations above, freshwater fish
LOCs have not been exceeded for any maximum application
of starlicide bait. Therefore, the Agency presumes no
undue risks to freshwater fish from registered uses of
starlicide.
25
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(b) Freshwater Invertebrates
Based on the RQ values tabulated for freshwater
invertebrates, high acute risk to aquatic invertebrates is not
presumed. However, assuming maximum application rates,
the endangered-species LOG is exceeded for multiple
applications of 0.09 Ib ai/acre or more. Therefore, acute
risk to endangered aquatic invertebrates is presumed. Data
are not currently available to assess chronic risk. However
if prebaiting is required to ensure rapid acceptance of bait,
little toxicant is likely to be available for runoff.
(c) Endangered Species
Applications of starlicide are apt to pose a risk to
endangered/threatened birds and small mammals that would
be attracted to the various food baits registered for control
of pest birds. Endangered aquatic invertebrates may also be
adversely affected if runoff occurs from applications in
staging areas and decoy sunflower fields.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
1. 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
starlicide as an ingredient. 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 starlicide. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility
of starlicide, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to
assess the registered uses of starlicide products and to determine that starlicide, as
labeled and specified in this document, can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products containing starlicide as the active ingredients are
eligible for reregistration. The reregistration of particular products is addressed
in Section V of this document.
26
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The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data, published scientific literature, etc. and the
data identified in Appendix B. Although the Agency has found that all uses of
starlicide 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 starlicide, if new information
comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
2. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
starlicide, the Agency has sufficient information on the health effects of starlicide
and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that starlicide products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore,
the Agency concludes that products containing starlicide for all uses are eligible for
reregistration.
3. Eligible and Ineligible Uses
The Agency has determined that all uses of starlicide are eligible for reregistration.
4. Regulatory Position and Risk Mitigation Measures
The following is a summary of the regulatory positions and rationales for
starlicide. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
a. Restricted Use Classification
Currently, all starlicide products are classified for restricted use
with the exception of one. The restricted use classification is necessary to
address the potential for harm to applicators and because products are
applied to various baits and placed in a variety of areas where exposure to
endangered or other non-target species could occur.
A ready-to-use 0.1% formulation, which is used in unoccupied
cattle and poultry feeding structures, is the only remaining end-use product
currently classified for general use. Because of the potential for adverse
effects to non-target organisms which could result from the use of this
product, the Agency is reclassifying it as restricted use.
27
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(1) Endangered Species Statement
The Agency has concerns about the exposure of threatened
and endangered animal species to starlicide as discussed above in
the science assessment chapter.
Currently, the Agency is developing a program ("The
Endangered Species Protection Program") to identify all pesticides
whose use may cause adverse impacts on endangered and threatened
species and to implement mitigation measures that will eliminate the
adverse impacts. The program would require use modifications or
a generic product label statement, requiring users to consult county-
specific bulletins. These bulletins would provide information about
specific use restrictions to protect endangered and threatened
species in the county. Consultations with the Fish and Wildlife
Service will be necessary to assess risks to newly listed species or
from proposed new uses.
The Agency plans to publish a description of the Endangered
Species Program in the Federal Register in the future. Because the
Agency is taking this approach for protecting endangered and
threatened species, it is not imposing label modifications at this time
through the RED. Rather, any requirements for product use
modifications will occur in the future under the Endangered Species
Protection Program.
(2) Lower Application Rates
Acute primary risks to birds occurs at all application rates
of starlicide. Decreasing application rates would decrease risks.
However, the Agency is aware that application rates for nationally
registered products were established from numerous efficacy tests
and thus likely could not be decreased for those products without
an unacceptable drop in efficacy.
However, for bird control in "staging areas", for which 8
SLN (special local needs) registrations exist, application rates vary
among states and even between labels within states (i.e., TN, TX).
The proposed maximum application rate on a recently registered
DWRC product (EPA Reg. No. 56228-30) for staging areas is 0.09
Ib ai/acre. The rate in Louisiana (LA930020) is much higher (0.5
Ib ai/acre) for the same use. Rates in TX, KY, and IN (0.125 Ib
ai/acre) also exceed that for the new product. Reducing application
rates of the SLNs to conform to that of the nationwide product
28
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would help reduce risks in those states. Therefore the Agency, after
consultations with USD A, is requiring the application rates for all
product registrations not to exceed 0.1 Ibs a.i./acre, which is the
maximum rate of the Federal product registrations.
(3) Prebaiting
Currently, the various product labels differ somewhat in
their requirements for prebaiting. Some labels require prebaiting,
whereas others only indicate that it "may be necessary". The
Agency believes that prebaiting should be required for all starlicide
products. Prebaiting enables applicators to determine the best
locations and time of day to apply bait and to identify the food base
most acceptable to the target species. Successful prebaiting helps
ensure rapid acceptance of treated bait by the target species,
resulting in less bait being exposed to nontarget birds and mammals
and less potential runoff into water bodies if a rainfall event occurs.
Prebaiting also allows for the identification of at least some
nontarget species, particularly birds, feeding on the prebait,
although nocturnal mammals may be overlooked. If the applicator
determines that a nontarget species problem is likely (e.g., more
than just the occasional nontarget sparrow or two would be
exposed), treated bait should not be applied prior to consultation
with appropriate wildlife authorities.
Other mitigation measures include baiting at another
location where nontarget problems are not likely; baiting at a
different time of day; or switching to a different food base that is
less attractive to the nontarget species present.
(4) Buffer Zone Restriction
Because of the risk posed to aquatic organisms, particularly
aquatic invertebrates, the Agency is requiring that treated starlicide
baits be applied at least 50 feet from water. This "buffer zone" will
lessen the possibility of starlicide residues contaminating nearby
bodies of water where aquatic invertebrates may live.
(5) Personal Protective Equipment Controls for Handlers
Due to its concern for the safety of mixer/loaders of large
quantities of starlicide, the Agency is requiring that, in addition to
29
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the current PPE on starlicide labels (gloves and goggles for
starlicide concentrate products), the requirement for a respiratory
protection device for mixers/loaders be added to the labeling of all
packages containing one pound or more of starlicide concentrate.
The respiratory protection statement shall specify either a respirator
with an organic-vapor-removing cartridge with a prefilter approved
for pesticides (MSHA/NIOSH approval prefix number TC-23C) or
a canister approved for pesticides (MSHA/NIOSH approval prefix
number 14G).
Additional PPE requirements may be imposed by the
Agency at the time of the product reregistration based upon the
acute toxicity of individual products.
(6) Additional Data Requirements
As discussed in the Environmental Assessment portion
(III.C.) of this document, there are deficiencies in information
which do not allow the Agency to do a complete environmental fate
profile for starlicide, as well as assess the risk to non-target
freshwater invertebrates and marine and estuarine organisms.
However, because of the small amount of starlicide used each year
in the United States (approximately 110 Ibs.), the restricted use
classification of starlicide products, required prebaiting, new lower
use rates, and the new requirement of application of baits at a
distance of at least 50 feet from water, the Agency is not requiring
any additional environmental fate or ecotoxicity data at this time.
V. ACTIONS REQUIRED OF 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 starlicide for the
above eligible uses has been reviewed and determined to be complete.
2. Labeling Requirements for End-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
30
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and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into an avicide for use in certain bird
feeding, roosting, staging and nesting areas, livestock feedlots,
rangelands, pasturelands, refuges and decoy sunflower fields. "
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
support of such use(s)."
(b) "This product may 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 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 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.
31
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2. Labeling Requirements for End-Use Products
a. Restricted Use Pesticide Statement
All end-use Starlicide products have been classified as "Restricted".
Therefore, the following text must appear at the top of the Front Panel:
Restricted Use Pesticide
"Due to Acute Hazards to Humans, Nontarget Animals and
Aquatic Invertebrates, and the Need for Highly Specialized
Applicator Training
"For retail sale to and use only by Certified Applicators or
persons under their direct supervision and only for those
uses covered by the Certified Applicators' certification."
"For use only by U.S. Department of Agriculture personnel
trained in bird control or persons under their direct
supervision."
For EPA Reg. No. 67517-8 only, the last sentence may be modified to:
"For use only by personnel specifically trained in bird
control or persons under their direct supervision."
b. Personal Protective Equipment Statement
For end-use products containing 98% active ingredient and packaged in
containers of one (1) pound or more of product, add the following section
to the "Hazards to Humans and Domestic Animals":
"Personal Protective Equipment
Handlers who mix packages containing 1 Ib or more of this
product must wear:
Coveralls over long-sleeved shirt & pants
Water-proof gloves
Chemical-resistant footwear plus socks
Protective eyewear
Respirator with either an organic vapor-removing cartridge
witha prefilter approved for pesticides (MSHA/NIOSH
approval prefix TC-23C) or a canister approved for
pesticides (MSHA/NIOSH approval number TC-14G)"
32
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After the Agency receives the results of the required acute toxicity testing
for the 98% concentrate and 0.1% formulation end-use products, it will
inform the registrants of any additional WPS requirements, such as "Entry
Restrictions" for the 98% or 1% formulas.
c. Skin Sensitization Statement:
Because starlicide is classified as a skin sensitizer, the Agency is requiring
the following statement to be located in the "Hazards to Humans and
Domestic Animals" section of the Precautionary Statements on the labeling
of all end-use products containing starlicide:
"This product may cause skin sensitization reactions in
some people."
d. Use Directions (Food Uses)
Currently, there are several sites on the label that are food use sites.
Therefore, registrants with such sites must do the following:
1. Remove sites such as "fruit trees and grassland" for broadcast
application.
2. For sites such as "cut hay fields" and "stubble fields", add the
following restriction in the use directions:
Do not graze animals or grow crops on treated areas for 365 days.
e. Prebaiting
To insure rapid acceptance of treated baits by target species, prebaiting will
be required for all end-use products unless the registrant provides an
acceptable rationale to the Agency why pre-baiting should be optional or
not required.
f. Buffer Zone
To lessen the risk to aquatic invertebrates, add the following statement to
the "USE RESTRICTIONS" section of the use directions:
33
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Do not apply treated baits within 50 feet of water.
g. Broadcast Rates Above 0.1 Ib/acre
Broadcast rates cannot exceed 0.1 Ib. A.I. per acre. Registrants of
non-complying products must modify their mixing directions so that rates
do not exceed the above figure.
h. Dilution of Treated Baits with Untreated Material
If the label provides for the dilution of treated bait with untreated material,
the registrant must state the minimum, mandatory dilution rate, as follows:
Dilute treated bait with similar untreated material at a rate of at
least 1 part treated material to [insert number] parts untreated
material.
i. Use of Similar Units in Bait Formulas
Currently, calculation of bait concentrations and use rates are overly
difficult because directions for mixing baits are presented inconsistently in
English and Metric units, some of which are by volume and some by
weight. To simplify calculations, insure that each ingredient includes the
amount 1) in English measure and 2) by weight. Other measures may be
used for the convenience of persons mixing baits.
j. Other Labeling Statements Required
The following restrictions must also appear on all starlicide end-use
product labels:
Entry restrictions:
"Keep persons other than authorized handlers, as well as
pets and livestock, away from the bait at all times."
Placement in labeling — Add the entry restriction to the labels of all end-
use products in a section in the Directions For Use with the heading:
"Entry Restrictions:"
34
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Application Restrictions:
"Do not apply this product in a way that will contact
workers or other persons. Only protected handlers may be
in the area during application."
User Safety Requirements:
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions are
provided for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this
product. As soon as possible, wash thoroughly and change
into clean clothing."
3. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregi strati on
Eligibility Decision (RED). Persons other than the registrant may generally
distribute or sell such products for 50 months from the date of the issuance of this
RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and
other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell
starlicide products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such
products for 50 months from the date of the issuance of this RED. Registrants and
persons other than registrants remain obligated to meet pre-existing Agency
imposed label changes and existing stocks requirements applicable to products
they sell or distribute.
35
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36
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VI. APPENDICES
37
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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES2
Bait application., Daytime., Not on
label.
Bait application., When needed.,
Aircraft.
Bait application., When needed., Glove. SC/S
Bait application., When needed., Ground. SC/S
BIRD STAGING AREAS IN RICE GROWING AREAS (Including broadcast applications Use Group: Terrestrial FOOD_FEED CROP
in areas under blackbird flight lines near roosts,
which are fallow stubble fields, harvested hay fields,
open grassy areas and pastures)
NA .49 Ib A * NS NS NS NS NS NS 013 CAT
Geo.013: Apply only in LA in Wards 1 and 3 of Evangeline Parish and a portion of Vermillion Parish.
2
Although there are uses currently on Starlicide labels which may result in use in areas re food or feed crops are grown, these uses must be deleted or modified, as specified in this document. After these uses are removed from the labels, there will
no longer be food/feed uses for this pesticide.
38
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LUIS 2.1 - Page 2
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # 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
BIRD STAGING AREAS IN RICE GROWING AREAS - continued
Bait application., Postemergence., SC/S NA
Ground.
Bait application., When needed.,
Aircraft.
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/FEED
BEEF CATTLE FEEDLOTS (Non-food/feed areas only)
Bait application., Early morning., Bait SC/S
box.
2.377E-04 Ib bird
2.377E-04 Ib bird
NS NS NS NS 013 C20, C92, CAG, CEA,
GE3
Geo.013: For coastal breeding areas or colonies within predation radius of important
nesting areas or colonies of protected birds.
NS 013
* 10 NS NS
Geo.013: See above
Use Group: TERRESTRIAL NON-FOOD CROP
39
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Time 13:43 APPENDIX A - CASE 2610, [Starlicide (*)] Chemical 009901 [3-Chloro-p-toluidine hydrochloride] LUIS 2.1 - 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)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/FEED USES
BIRD ROOSTING OR LOAFING AREAS -continued SC/S
SC/S
Bait application., When needed., Scoop. SC/S
BIRD STAGING AREAS (Including bare ground noncrop areas, cut hay Use Group: TERRESTRIAL NON-FOOD CROP
fields (in bait dispensers), grassy noncrop areas,
near night time roosting sites, nonbearing orchards,
orchards (in bait dispensers), roadsides, roads
(unused gravel or dirt), trails, open areas, rooftops,
industrial and commercial structures, stubble fields (in
bait dispensers) and other noncrop areas)
* NS NS NS
SC/S
SC/S
Bait application., When needed., Glove. SC/S
SC/S NA .002178 Ib IK
sq.ft
SC/S
Bait application., When needed., Ground. SC/S
40
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LUIS 2.1 - Page 4
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # 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/FEED USES
BIRD STAGING AREAS IN RICE GROWING AREAS (Including broadcast applications Use Group: TERRESTRIAL NON_FOOD
in areas under blackbird flight lines near roosts, which
are follow stubble fields (in bait dispensers), harvested
hay fields (in bait dispensers), open grassy areas or
bare-ground noncrop areas, roadsides, ungrazed pastures
(in bait dispensers) and other noncrop areas.
Bait application., Postemergence.,
Aircraft.
Bait application., When needed.,
Aircraft.
Bait application., When needed., Ground. SC/S
CITRUS FRUITS (Bait box application only)
Bait application., Daytime., Bait box. SC/S
.245 Ib A
2 NS NS
2 NS NS NS NS NS TX
Use Group: TERRESTRIAL NON-FOOD CROP
NS NS NS NS NS NS 013
DAIRY CATTLE FEEDLOTS (nonfood-feed areas)
Bait application., Early morning., Bait SC/S
box.
Use Group: TERRESTRIAL NON-FOOD
UC * NS NS NS
NS NS
NS
LIVESTOCK FEEDLOTS (in areas not accessable to livestock)
Bait application., Early morning., Bait B/S NA
box.
Bait application., Early morning., By B/S NA
hand.
1.296E-04 Ib *
sq.ft
6.482E-04 Ib Ik
sq.ft
41
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LUIS 2.1 - Page 5
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # 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/FEED USES
POULTRY FEEDLOTS (nonfood-feed areas)
POULTRY OPERATIONS (outside of pens, buildings or range areas)
Bait application., Early morning., By B/S NA
hand.
Bait application., Early morning., Bait B/S NA
box.
RANGELAND PASTURELAND AREAS WHERE BIRDS FEED ON NEWBORN LIVESTOCK
(uneaten bait and dead birds must be removed)
NS
Use Group: TERRESTRIAL NON-FOOD CROP
.05 Ib A * NS NS NS NS NS
NS
Use Group: TERRESTRIAL NON-FOOD CROP
6.482E-04 Ib IK
sq.ft
REFUGES OR OTHER AREAS WHERE PEST BIRDS PREY UPON PROTECTED SPECIES
SWINE FEEDLOTS (nonfood-feed areas)
Bait application., Early morning., Bait SC/S
box.
6.482E-04 Ib IK *
sq.ft
1.296E-04 Ib * NS
sq.ft
NS
NS
SUNFLOWER (Decoy Fields)
Bait application., When needed., Glove. SC/S
Use Group: TERRESTRIAL FOOD+FEED CROP
.0882 Ib A * NS NS NS NS 7 NS ND
42
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APPENDIX A
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless
noted otherwise)
Max. Appl. Rate (AI unless
noted otherwise)
Soil Tex. Max. Dose
Max. # Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days)
PRO Report Date
Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
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"
Maximum dose applied to a site over a single crop cycle or year. System calculated.
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
B/S : BAIT/SOLID
SC/S : SOLUBLE CONCENTRATE/SOLID
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
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
Keep out of lakes, streams, ponds, tidal marshes, and estuaries.
Keep out of lakes, streams, and ponds.
Do not apply where runoff is likely to occur.
day (s) pregrazing interval.
Do not graze or feed forage.
Do not use for food or feed.
day (s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS, DAYS, ETC.) DESCRIBED IN THE LIMITATION.
43
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GEOGRAPHIC CODES
013 : Other
IL : Illinois
44
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Starlicide covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Starlicide in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 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.
45
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Starlicide
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-17
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
Storage stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
43708001
43437301
43708001
43708001
43708001
43708001
41609301
41609301
41609301
41609301
WAIVED
41609301
41609301
42114501
41609301
42225702
42225703
41609301
43437301
46
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Data Supporting Guideline Requirements for the Reregistration of Starlicide
REQUIREMENT
USE PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1A
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
ABC
ABC
ABC
ABC
ABC
ABC
41760502, 41760503
42671802
42671801
41767501
417667502
41783701
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
41632101
41632102
WAIVED
41632103
41632104
42201101
41605301
41605302
41605302
OCCUPATIONAL EXPOSURE
No occupational exposure data were required.
47
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Data Supporting Guideline Requirements for the Reregistration of Starlicide
REQUIREMENT USE PATTERN CITATION(S)
ENVIRONMENTAL FATE
161-1 Hydrolysis ABC 41760501
161-2 Photodegradation - Water ABC 42838801
162-1 Aerobic Soil Metabolism ABC 43284501
163-1 Leaching/Adsorption/Desorption ABC 43284502, 43284503
165-4 Bioaccumulation in Fish ABC 43069801
48
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the 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.
49
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b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
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.
50
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BIBLIOGRAPHY
MRID
CITATION
Cunningham, D.J., E.W. Schafer, Jr., and L.K. McConnell. (1979) Starlicide
and DRC-2698 Residues in Starlings: Preliminary Evaluation of their Effects on
Secondary Hazard Potential. Proc. Bird Control Seminar 8:31-37.
Dunning, J.B., Jr. (1984) Body Weights of 686 species of North American Birds.
Western Bird Banding Association, Monograph No. 1. Cave Creek, AZ: Eldon
Publishing.
Kenaga, E.E. (1973) Factors to be Considered in the Evaluation of the Toxicity
of Pesticides to Birds in their Environment. Pages 166-181 in Environmental
Quality and Safety: Global Aspects of Chemistry, Toxicology, and Technology
as Applied to the Environment. Academic Press, NY.
41605301 Stankowski, L. (1990) Ames/Salmonella Plate Incorporation Assay
(3-Chloro-p-toluidine HCL): Lab Project No: PH 301-DW-001-90. Unpublished
study prepared by Pharkom Research International, Inc. 69 p.
41605302 SanSebastian, J. (1990) In vitro Chromosome Aberration Analysis in Chinese
Hamster Ovary (CHO) Cells (3-Cl-p-toluidine HCL): Lab Project Number: PH
320-DW-001-90. Unpublished study prepared by Pharmakon Research
International, Inc. 150 p.
41605303 Stankowski, L. (1990) CHO/HPRT Mammalian Cell Forward Gene Mutation
Assay (3-Cl-p-toluidine HCL): Lab Project No: PH 314-DW-001-90. Unpublished
study prepared by Pharmakon Research International, Inc. 103 p.
41609301 Ferder, T.; Fickerson, C. (1990) Product Chemistry Data: Purina Starlicide
Technical Contains 97% (3-Chloro-p-toluidine hydrochloride). Unpublished study
prepared by Purina Mills Inc. 162 P.
41632101 Cerven, D. (1990) Single Dose Oral Toxicity in Rats/LD 50 in Rats:
3-Chloro-p-toluidine HCL Final Report: Lab Project No: MB 90-9968 A:
QA-124. Unpublished study prepared by MB Research Laboratories, Inc., in
cooperation with Denver Wildlife Research Center. 86 p.
41632102 Cerven, D. (1990) Acute Dermal Toxicity in Rabbits/LD 50 in Rabbits :
3-Chloro-p-toluidine HCL: Final Report: Lab Project Number: MB 90-9968 B:
QA-125. Unpublished study prepared by MB Research Laboratories, Inc., in
cooperation with Denver Wildlife Research Center. 59 p.
51
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BIBLIOGRAPHY
MRID
CITATION
41632103 Cerven, D. (1990) Primary Dermal Irritation in Albino Rabbits:
3-chloro-p-toluidine HCL: Final Report: Lab Project No. MB 90-9968 C:
QA-127. Unpublished study prepared by MB Research Laboratories, Inc., in
cooperation with Denver Wildlife Research Center. 54 p.
41632104 Cerven, D. (1990) Primary Eye Irritation/Corrosion in Rabbits:
3-chloro-p-toluidine HCL: Final Report: Lab Project Number: MB 90-9968 D:
QA-126. Unpublished study prepared by MB Research Laboratories, Inc., in
cooperation with Denver Wildlife Research Center. 72 p.
41760501 Kimball, B.; Greiner, S.; Mishalanie, E. (1990) Enviromental Fate Study:
Hydrolysis of 3-Chloro-p-toluidine Hydrochloride: Lab Project Number: QA-144.
Unpublished study prepared by Denver Widelife Research Center. 124 p.
41760502 Fletcher, D.; Pedersen, C. (1990) Compound 1339: 21-Day Acute Oral LD50
Study in Mallard Ducks: Lab Project Number: 89 DD 71. Unpublished study
prepared by Bio-Life Associates, Ltd. 148 p.
41760503 Fletcher, D.; Pedersen, C. (1990) Compound 1339: 21-Day Acute Oral LD50
Study in Bobwhite Quail: Lab Project Number: 89 QD 135. Unpublished study
prepared by Bio-Life Associates, Ltd. 176 p.
41767501 Bowman, J. (1991) Acute Toxicity of DRC-1339 To Bluegill (Lepomis
macrochirus): Lab Project Number: 38319: QA-141. Unpublished study prepared
by Analytical Bio-Chemistry Labs., Inc. 105 p.
41767502 Bowman, J. (1991) Acute Toxicity of DRC-1339 to Rainbow Trout Oncoryhnchus
mykiss): Lab Project Number: 38318: QA-140. Unpublished study prepared by
Analytical Bio-Chemistry Labs., Inc. 110 p.
41783701 Blasberg, J.; Herzog, D. (1991) Acute Toxicity of DRC 1339 to Daphnia magna:
Lab Project Number: 38320: 139. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 98 p.
42114501 Bicking, M. (1991) Determination of Vapor Pressure in Test Substance Starlicide:
Lab Project Number: 26/90-PUR.2. Unpublished study prepared by Twin City
Testing Corp., and Univ. of Leeds. 29 p.
52
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BIBLIOGRAPHY
MRID
CITATION
42196301 Glahn, J. (1990) Preliminary Investigation of DRC-1339 Baiting to Reduce
Blackbird Damage to Sprouting Rice in Vermillion Parish, Louisiana.
Unpublished study prepared by Denver Wildlife Research Center. 8 p.
42196302 Glahn, J. (1988) Evaluation of Potential Baiting Procedures to Reduce
Great-Tailed Grackle Damage to Citrus in Southern Texas. Unpublished study
prepared by Denver Wildlife Research Center. 10 p.
42196303 Cummings, J.; Glahn, J.; Wilson, E. (1992) Efficacy and Nontarget Hazards of
DRC-1339 Treated Rice Baits Used to Reduce Roosting Populations of
Depredating Blackbirds in Louisiana: Lab Project Number: QA-171. Unpublished
study prepared by Denver Wildlife Research Center. 136 p.
42201101 Cerven, D. (1992) Delayed Contact Dermal Sensitization Test: Buehler Method:
Lab Project Number: MB 91-987: DWRC QA-205. Unpublished study prepared
by MB Research Labs., Inc. 62 p.
42256401 Ferder, T. (1991) Product Chemistry Data: [Starlicide Technical]. Unpublished
study prepared by Purina Mills, Inc. 12 p.
42671801 Pedersen, C.; Lesar, C. (1993) Compound DRC-1339 98% Concentrate
(Starlicide): 12-Day Acute Dietary LC50 Study in Mallard Ducklings: Lab Project
Number: 90 DC 151. Unpublished study prepared by Bio-Life Associates, Ltd.
220 p.
42671802 Pedersen, C.; Lesar, C. (1993) Compound DRC-1339 98% Concentrate
(Starlicide): 12-Day Acute Dietary LC50 Study in Bobwhite Quail: Lab Project
Number: 90 QC 155. Unpublished study prepared by Bio-Life Associates, Ltd.
214 p.
42830601 Yao, D.; Mill, T. (1993) Aquatic Photolysis Study of 3-Chloro-p-Toluidine
Hydrochloride: Lab Project Number: 3743-20: QA-268. Unpublished study
prepared by SRI International Chemistry Lab. 64 p.
42838801 Yao, D.; Mill, T. (1993) Aquatic Photolysis Study of 3-Chloro-p-Toluidine
Hydrochloride: Lab Project Number: 3743-20: QA-268. Unpublished study
prepared by SRI International Chemistry Lab. 64 p.
53
-------
BIBLIOGRAPHY
MRID
CITATION
43069801 Schocken, M. (1993) Starlicide (3-chloro-p-toluidine hydrochloride,
CPTH)-Bioconcentration and Elimination of (carbon 14) Residues by Bluegill
Sunfish (Lepomis macrochirus): Amended Final Report: Lab Project Number:
3743-50: 287.1192.6105.140: 93-7-4855. Springborn Labs, Inc. 112 p.
43069802 Collins, M. (1993) STARLICIDE (3-chloro-p-toluidine hydrochloride,
CPTH)—Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) under static
renewal conditions: Lab Project Number: 93-3-4659: 287.1192.6104.100:
3743-40-SA. Unpublished study prepared by Springborn Laboratories, Inc. 62 p.
43284500 Purina Mills, Inc. (1994) Submission of Environmental Fate Data in Support of
the Reregistration of 3-Chloro-p-Toluidine Hydrochloride. Transmittal of 3
Studies.
43284501 Spanggord, R.; Gordon, G. (1994) Aerobic Soil Metabolism Study of
3-Chloro-p-Toluidine Hydrochloride: Lab Project Number: 3743-N003-93:
QA-270. Unpublished study prepared by SRI International. 73 p.
43284502 Irwin, K.; Podoll, R. (1994) Sorption and Desorption Study of
3-Chloro-p-Toluidine Hydrochloride: Lab Project Number: 3743-N005-93:
QA-271. Unpublished study prepared by SRI International. 75 p.
43284503 Irwin, K.; Podoll, R. (1994) Aged Leaching Study of 3-Chloro-p-Toluidine
Hydrochloride: Lab Project Number: 3743-N004-93: QA-362. Unpublished study
prepared by SRI International. 70 p.
43342701 Cummings, J.; Pochop, P.; Garrison, M.; et al. (1994) Laboratory Studies with
Compound DRC-1339 in Feral Pigeons: Lab Project Number: QA-280.
Unpublished study prepared by Denver Wildlife Research Center. 134 p.
43437300 Purina Mills, Inc. (1994) Submission of product chemistry data in support of
reregistration for Starlicide Technical. Transmittal of 1 study.
43437301 Rose, J. (1994) Guidelines 61-1, 61-2 and 61-3 (Product Chemistry): Starlicide
Technical: Lab Project Number: PURINA/STARLICIDE. Unpublished study
prepared by Purina Mills, Inc. 175 p.
43708001 Rose, J. (1995) Characterization of Technical Starlicide: Lab Project Number:
FM-PC-73. Unpublished study prepared by PM Resources, Inc. 192 p.
54
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BIBLIOGRAPHY
MRID CITATION
43712101 Cummings, J.; Wilson, E.; Primus, T.; et al. (1994) Compound DRC-1339
Concentrate—Staging Areas: Comparison of DRC-1339 Baiting Techniques to
Reduce Depredating Blackbirds, Their Associated Nontarget Hazards and
Residues: Lab Project Number: QA-371. Unpublished study prepared by
USDA/APHIS, Denver Wildlife Research Center. 197 p.
92170999 US Dept Of Agriculture, Aphis & Adc (1990) Reregistration Phase 3 Response:
Chloro-p-toluidine hydrochloride. Correspondence and Supporting Material.
55
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$
_ ° UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
%j"
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
of your product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; 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 of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 1 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).
56
-------
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-in Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms, and the Confidential Statement of
Formula 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.
57
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II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
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).
58
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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 of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-In Response Form 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
5 on the Data Call-In Response Form. If you choose this option, this is the only form that you
are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed 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 low 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 III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
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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).
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
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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(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 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
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available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
you must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
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.
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Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information 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.
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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;
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
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:
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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.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
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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(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
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 Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms, and the Confidential Statement of
Formula Form
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STARLICIDE PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing starlicide.
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 reregi strati on of starlicide.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2)
the Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements Status and
Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), (6)
a list of registrants receiving this DCI (Attachment 6) and the Cost Share and Data Compensation
Forms in replying to this starlicide Product Specific Data Call-In. Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for starlicide are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded
that additional data on starlicide 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
reregi strati on of all eligible starlicide products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Edward Setren at (703) 308-8166.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Edward Setren
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Starlicide
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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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REMOVE THIS PAGE AND INSERT PART A OF THE PRODUCT SPECIFIC DCI
HERE
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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, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only 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 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. 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
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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 "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
73
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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 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
74
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have already voluntarily canceled this product. For these cases, please supply
all relevant details so that EPA can ensure that its records are correct.
75
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REMOVE THIS PAGE AND INSERT PART B PAGE 1 OF THE PSDCI
76
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REMOVE THIS PAGE AND INSERT PART B PAGE 2 OF THE PSDCI
77
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REMOVE THIS PAGE AND INSERT PART B PAGE 3 OF THE PSDCI
78
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REMOVE THIS PAGE AND INSERT PART B PAGE 1 OF THE PSDCI
79
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EPA'S BATCHING OF STARLICIDE PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing starlicide as the
active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products
within a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwith-standing the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the
Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so.
If a registrant supplies the data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant
depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
80
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Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should
know that choosing not to participate in a batch does not preclude other registrants in the batch
from citing his/her studies and offering to cost share (Option 3) those studies.
Sixteen products were found which contain starlicide as the active ingredient. The
products have been placed into one batch in accordance with the active and inert ingredients,
type of formulation and current labeling. Table 1 identifies the products in the batch and the
"no batch" product.
Table 1
No
Batch
Batch
1
EPA Reg. No.
67517-8
56228-10
56228-17
56228-28
56228-29
56228-30
67517-7
IL89000600
IN90000300
KY89000300
LA93002000
ND92000100
TN89000500
TN94000600
TX89000100
TX94001200
% Active Ingredient
0.1
98.0
98.0
98.0
98.0
98.0
97.0
98.0
98.0
98.0
98.0
98.0
98.0
98.0
98.0
98.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
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Attachment 4. List of All Registrants Sent This Data Call-In Notice (insert)
82
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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.
83
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84
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Signature of A
00
85
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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 Maine
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
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
86
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87
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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. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
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 compensation 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 FIFRA 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, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
88
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The following is a list of available documents for Starlicide that my further assist you in
responding to this Reregistration Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregistration Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Edward Setren at (703)-308-8166.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the Fact Sheet for Starlicide.
The following documents are part of the Administrative Record for Starlicide and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed
on the Chemical Status Sheet.
1.Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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