United States Prevention, Pesticides EPA 738-R-95-025
Environmental Protection And Toxic Substances September 1995
Agency (7508W)
SEPA Reregistration
Eligibility Decision (RED)
Sodium Fluoroacetate
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
* WASHINGTON, D.C. 20460
OCT I 6 1995
CERTIFIED MAIL
OFFICE OF
PREVENTION. PESTICIDES AND
TOXIC SUBSTANCES
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical sodium fluoroacetate.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of
the data base of this chemical., its conclusions of the potential human health and
environmental risks of the current product's use, and its decisions and conditions under
which this use and products will be eligible for reregistration. The RED includes the data
and labeling requirements for products for reregistration. It may also include requirements
for additional data (generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Frank Rubis at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Leonard Ryan at (703) 308-8067.
Sincerely yours,
Lois Rossi, Director
Special Review
and Reregistration Division
Enclosures
Recycled/Recyclable -Printed with Vegetable Oil Based Inks on 100% Recyded Paper (40% Postconsumer)
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REQUESTS -No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension '
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-022
June 1995
R.E.D. FACTS
Pesticide
Reregistration
Sodium
Fluoroacetate
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration Case 3073, sodium fluoroacetate, also known as compound
1080.
Use Profile
Sodium fluoroacetate is an acute toxicant predacide which is used
against coyotes which prey on sheep and goats. Registered end-use products
are injected into the rubber reservoirs of the Livestock Protection collars,
also referred to as the "toxic collar", which are strapped to the throats of
sheep or goats. Coyotes attempting to kill collared livestock are likely to
puncture the collars and to be fatally poisoned by sodium fluoroacetate as a
result of the attack. When predation is anticipated, up to 20 collars may be
used in fenced pastures up to 100 acres in size; up to 50 collars may be used
in pastures of 101 to 640 acres; and up to 100 collars may be used in
pastures of 641 to 10,000 acres.
Sodium fluoroacetate is a restricted use pesticide which may be used
only by trained, certified applicators and which is only registered for use in
livestock protection collars. Sodium fluoroacetate will retain the restricted
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Regulatory
History
use classification imposed by the Agency in 1978 due to its high acute
toxicity and the need for highly specialized applicator training. The Agency
also has reviewed concerns about the exposure of threatened and endangered
animal species with the United States Fish and Wildlife Service (USFWS).
The March 1993 USFWS final biological opinion on the effects of sodium
fluoroacetate on threatened and endangered species addressed the livestock
protection collar and included jeopardy determinations to the gray wolf and
grizzly bear. Specific areas were identified where the collar could not be
used and such restrictions have been incorporated on the livestock protection
collar labels. No additional use restrictions to further protect threatened and
endangered species are being imposed at this time.
Development and use of sodium fluoroacetate as a predacide and
rodenticide in the U.S. began in the 1940s prior to the 1947 enactment of
the Federal Insecticide, Fungicide, and Rodenticide Act by which
requirements for federal registration of pesticide products were instituted.
In 1964 and again in 1971, the use of poisons to control predatory mammals
were reviewed by selected committees. In 1972 EPA cancelled all
registered predator control uses of sodium fluoroacetate, sodium cyanide,
and strychnine.
In 1977, the U.S. Department of the Interior (USDI) applied for an
Experimental Use Permit (EUP) to investigate the potential risks and
benefits associated with the use of sodium fluoroacetate in "toxic collars"
which would be placed on the necks of sheep and goats. The toxic collar
containing sodium fluoroacetate solution would be positioned around the
animals' throat regions where they would be likely to be ruptured by the
teeth of coyotes that attempted to kill the livestock with species-typical
throat bites.
In 1981, EPA was petitioned by the USDI and livestock interests to
revisit the 1972 predacide cancellation decision with respect to sodium
fluoroacetate. EPA held informal hearings in 1981 and formal
administrative hearings in 1982 resulting in a final decision to permit EPA
to consider applications for registration of sodium fluoroacetate in toxic
collars and single-dose baits.
In 1985, EPA granted a registration to USDI for a toxic collar product
which was transferred in 1986 to the Animal and Plant Health Inspection
Service (APHIS) of the U.S. Department of Agriculture (USDA).
The rodenticide uses of sodium fluoroacetate were cancelled due to
lack of supporting data. In 1989, all "special local needs" registrations
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Human Health
Assessment
issued under § 24(c) of FIFRA were cancelled, and all pending applications
for Federal registration were denied by August 1990.
Toxicity
Sodium fluoroacetate is a sodium salt of fluoroacetic acid which is a
tan colored alkaline powder with a pH of 10.3. It melts at 197-203°C with
decomposition. It is soluble in water, but practically insoluble in all non-
polar solvents. Sodium fluoroacetate is stable in sunlight, at a temperature
of 54°C, and in tin coated metal containers.
The toxicological data base on sodium fluoroacetate is adequate and
will support reregistration eligibility. Sodium fluoroacetate has been placed
in Toxicity Category I, which indicates the highest degree of acute toxicity,
for acute oral toxicity; Toxicity Category II, moderately toxic, for acute
dermal toxicity; Toxicity Category III, slightly toxic, for primary eye
irritant; and Toxicity Category IV, practically non-toxic, for dermal
irritation. The requirements for acute inhalation toxicity and dermal
sensitization studies were waived due to the severe acute toxicity of the
compound.
Sodium fluoroacetate caused dose-related findings in histopathology
and decreased size and weight of testes and epididymides in males in a
subchronic dietary study in rats. In a subchronic study of sodium
fluoroacetate in drinking water of rats, no effects were seen in the kidney or
liver, but testicular atrophy and nonreversible tubular degeneration were
found at the mid-and high-doses. Testicular atrophy with reversible tubular
degeneration was found at the low dose. The metabolism of sodium
fluoroacetate is understood in the mammalian body. It can be absorbed
through the gastrointestinal tract, respiratory tract, or open wounds, but
only slowly through intact skin.
Human Risk Assessment
Because of the specific nature of this registered use, EPA's
primary concern is for the potential risk of acute toxicity. Under the
current limited use pattern, no sodium fluoroacetate exposure to the general
population is expected. Risk of acute toxicity to applicators is mitigated by
the pesticide's use restrictions and its classification as a restricted use
pesticide.
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Environmental
Assessment
Environmental Fate
The Agency has reviewed published literature which suggests that
leaching and metabolism are the major routes of dissipation. However,
undegraded fluoroacetate is considered mobile and consequently has a high
potential to move downward in the soil and reach ground water. While
sodium fluoroacetate has the potential to reach groundwater, the Agency's
Pesticides in Ground Water Database reports no detections for the period
1971 to 1991.
Ecological Effects
The Agency has adequate data to assess the hazard of sodium
fluoroacetate to nontarget organisms. Sodium fluoroacetate is very highly
toxic to the mallard duck, chukar, ring-necked pheasant, widgeon, golden
eagle, black vulture and the black-billed magpie on an acute oral basis.
Substantial chronic exposure to birds is not expected with the use of the
sodium fluoroacetate livestock protection collar. Because the livestock
protection collar is specifically designed to kill a wild mammal (coyote),
wild mammal toxicity testing was required for sodium fluoroacetate.
Sodium fluoroacetate can be classified as very highly toxic to coyotes,
cotton rat, deer mouse, raccoon, opossum and skunk on an acute oral basis.
It is slightly toxic to rainbow trout and practically non-toxic to bluegill
sunfish. Sodium fluoroacetate is practically non-toxic to Daphnia magna, a
freshwater invertebrate. The terrestrial non-food use of sodium
fluoroacetate will not result in substantial exposure to marine and estuarine
organisms, therefore, these data were not required.
Certain nontarget species of birds and mammals, including threatened
and endangered species, may be exposed to sodium fluoroacetate used in
livestock protection collars. Based on a variety of studies that have been
reviewed by the Agency, the principal source of risk is exposure of
scavengers feeding on the head and neck area of dead livestock bearing
sodium fluoroacetate livestock protection collars. Factors that reduce the
risk associated with use of these collars include rapid decomposition of
carcasses, selective feeding of scavengers from wounds on the carcass rather
than contaminated skin surface of the head or neck, and the emetic property
of the chemical. The concerns for risk to wildlife can be addressed by
hazard statements, special use restrictions, and endangered species
protection statements that are required to be placed on the product label.
Additional Data The generic database supporting the reregistration of sodium
Required fluoroacetate for use in livestock protection collars has been determined to
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be substantially complete. No new generic data are being required at this
time.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
Product Labeling
Changes Required
The labels of all registered pesticide products containing sodium
fluoroacetate must comply with EPA's current pesticide labeling
requirements as specified in 40 CFR § 156.10 and other applicable notices.
The statements must also appear on the labels of sodium fluoroacetate end
use products consistent with the USDA/APHIS product's 18 use restrictions.
(See "Use Restrictions" in the RED document for the 18 use restrictions).
In addition, the states may add use restrictions consistent with EPA's
regulatory position and legal decisions regarding predacidal uses of sodium
fluoroacetate, but no requirements may be dropped or mitigated. Any
changes to the use restrictions must be requested through the amendment
process and must be accepted in advance by E.P.A.
Regulatory
Conclusion
For More
Information
The use of registered products containing sodium fluoroacetate will
not pose unreasonable risks or adverse effects to humans or the
environment, provided that these products are used in accordance with the
restrictions on product labeling. Therefore, the current use of these
products is eligible for reregistration. Sodium fluoroacetate products will be
reregistered once the required product-specific data, Confidential Statements
of Formula and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Sodium Fluoroacetate during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and 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.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
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(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Sodium Fluoroacetate RED
document also will be available from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
For more information about EPA's pesticide reregistration program,
the Sodium Fluoroacetate RED, or reregistration of individual products
containing Sodium Fluoroacetate, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard
Time, Monday through Friday.
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REREGISTRATION ELIGIBILITY DECISION
SODIUM FLUOROACETATE
LISTC
CASE 3073
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
SODIUM FLUOROACETATE REREGISTRATION ELIGIBILITY DECISION TEAM
i
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile ......... 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 4
E. Regulatory History 4
m. SCIENCE ASSESSMENT 9
A. Physical Chemistry Assessment 9
B. Human Health Assessment 9
1. Toxicology Assessment 9
a. Acute Toxicity 9
b. Subchronic Toxicity 10
c. Metabolism 10
d. Reference Dose 11
2. Exposure Assessment 11
a. Dietary and Occupational/Residential Exposure 11
3. Risk Characterization 11
a. Toxicological Endpoints ; 11
b. Occupational and Residential 11
C. Environmental Assessment 11
1. Ecological Toxicity Data 11
a. Toxicity to Terrestrial Animals 12
b. Toxicity to Aquatic Animals 14
c. Toxicity to Plants 16
2. Environmental Fate 16
a. Environmental Fate Assessment 16
b. Environmental Fate and Transport 17
c. Water Resources 18
3. Exposure and Risk Characterization 18
a. Ecological Exposure and Risk Characterization 18
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 29
A. Determination of Eligibility 29
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1. Eligibility Decision 30
2. Eligible and Ineligible Uses 30
B. Regulatory Position 30
1. Restricted Use Classification 30
2. Endangered Species Statement 30
V. ACTIONS REQUIRED OF REGISTRANTS 31
A. Manufacturing-Use Products 31
1. Additional Generic Data Requirements 31
2. Labeling Requirements for Manufacturing-Use Products 31
B. End-Use Products 31
1. Additional Product-Specific Data Requirements 31
2. Labeling Requirements for End-Use Products 32
C. Existing Stocks 38
VI. APPENDICES 39
APPENDIX A. Table of Use Patterns Subject to Registration 40
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 47
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Sodium Fluoroacetate 50
APPENDIX D. Product Specific Data Call-in 56
Attachment 1. Chemical Status Sheets 67
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 68
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 72
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 75
Attachment 5. List of All Registrants Sent This Data Call-In (insert)
Notice 77
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 79
APPENDIX E. List of Available Related Documents 86
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SODIUM FLUOROACETATE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Alan Halverson
Gabe Patrick
Environmental Fate and Effects Division
David Farrar
Richard Felthousen
Gail Love
Health Effects Division
Charles Frick
Pat McLaughlin
Winston Dang
Registration Division
Bipin Gandhi
Mark Perry
Bill Jacobs
Dan Peacock
Special Review and Reregistration Division
Leonard Ryan
Kathleen Depukat
Policy and Special Projects Staff
Jean Frane
Office of Compliance:
Mickey Post
Economic Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Toxicology Branch
Occupational and Residential Exposure Branch
Registration Support Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
FOB
GLC
GM
GRAS
HA
HOT
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MOE
MP
MPI
MRID
N/A
NOEC
NPDES
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed; Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No effect concentration
National Pollutant Discharge Elimination System
11
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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'I 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
111
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential human
health and environmental risks associated with the pesticidal use of sodium fluoroacetate in the
United States. Based on its review of the targe database, the Agency has determined that the
currently registered uses will not cause unreasonable risk to humans or the environment and that
these uses are therefore is eligible for reregistration.
Sodium fluoroacetate (Compound 1080) is an acute toxicant predacide against coyotes
which prey on sheep and goats. Currently registered end-use products are 1 % solutions which are
injected into the rubber reservoirs of Livestock Protection Collars. These collars are strapped to
the throats of sheep or goats. Coyotes attempting to kill collared livestock are likely to puncture
the collars and to be fatally poisoned by sodium fluoroacetate as a result.
Sodium fluoroacetate is highly toxic to warm blooded animals, including humans, when
taken internally. Additionally, sodium fluoroacetate may pose a high acute risk to non-target
birds and mammals that may scavenge the carcasses of predators that are killed from biting the
collared livestock. State-limited registrations for sodium fluoroacetate collars have been issued
in Texas, New Mexico, Wyoming, Montana, and South Dakota. The use of these products are
further limited to only those states which have an EPA-approved certification and training
program, which currently includes only Texas, New Mexico, Wyoming, and Montana. The use
is further restricted within these four states to specific counties when there is potential for adverse
effects to endangered species.
Before reregistering the products containing sodium fluoroacetate, 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. 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.
IV
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed 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 sodium fluoroacetate. The document consists of six sections. Section I is the
introduction. Section II describes sodium fluoroacetate, 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 sodium fluoroacetate.
Section V discusses the reregistration requirements for sodium fluoroacetate Finally, Section VI
is the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name: Sodium Fluoroacetate
Chemical Name: Sodium Monofluoroacetate
Chemical Family: Fluoroacetic Acid
CAS Registry Number: 62-74-8
OPP Chemical Code: 075003
Empirical Formula: F-CH2-C-O2-Na
Trade and Other Names: Compound 1080
Basic Manufacturer: U. S. Department of Agriculture-registrant
Tull Chemical Company, Oxford. AL.-manufacturer
B. Use Profile
Presented below is information on the currently registered uses with an overview
of use sites and application methods. A detailed table of the registered uses of sodium
fluoroacetate is in Ap>pendix A.
For Sodium Fluoroacetate:
Type of Pesticide: Predacide
Mode of action: Stomach poison.
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Use Sites:
Sheep, lambs, kids, goats, dairy goats (lactating or
unspecified), goats (wool/angora animal)
Target Pests:
Product kills coyotes preying on sheep or goats.
Formulation Types
Registered:
Method and Rates of
Application:
Formulation Intermediate - 90% a.i.
Collar: 1% a.i. available. All Collars contain 1.1 oz
of formulated material which is equal to
approximately .00067 Ibs a.i./collar.
When predation is anticipated, collars (one collar per
collared animal) are strapped in place with the
rubber toxicant reservoirs positioned in the throat
regions of sheep or goats in target flocks or herds.
The sodium fluoroacetate solution is released if a
collar reservoir is punctured by an attacking coyote
or by another agent.
Up to 20 collars may be used in fenced pastures up
to 100 acres in size. Up to 50 collars may be used
in pastures of 101 to 640 acres. Up to 100 collars
may be used in pastures of 641 to 10,000 acres.
Use Practice Limitations:
For a complete listing of product limitations, see
Section V, Labeling Requirements for End-use
Products.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
sodium fluoroacetate. These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and site
basis, reflect annual fluctuations in use patterns as well as the variability in using data
from various information sources. Table 1, below, summarizes the amounts of sodium
fluoroacetate used by site.
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Table 1. Estimates of Typical Usage of Sodium Fluoroacetate
Site
Steep - US
MT only
NM only
SD only
TX only
WY only
Goats* US
NM only
TX only
Total - US
Head Available
(000)
$080- 10850
520 - 580
460-510
540 - 590
1710 - 1940
830 - 850
2250 * 2530
80-90
1650 - 1960
11330- 13400
Head Treated
(000)
0>6~0,7
-
.
.
.
-
0.2
-
-
0.8-0.9
Site Treated
(%)
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small tufts of leaves and flowers from long and extensively branched underground stems.
Africans have used extracts of gifblaar (which means "toxic leaf") and related plants as
arrow poisons.
The active substance in gifblaar was extracted as its potassium salt, potassium
fluoroacetate, in 1943 or 1944 (Marais, 1944 cited by Pattison, 1959). By that time,
research already had been undertaken on synthesized fluoroacetic acid and related
compounds.
Synthesis of fluoroacetic acid was reported in 1896 by the Belgian researcher
Swarts (cited by Pattison, 1959). Fluoroacetic acid was patented in Germany in 1930 as
a mothproofing agent. Subsequently, Germans researched a number of related compounds
as potential chemical warfare agents and systemic insecticides. In the mid-to-late 1930s,
Polish military researchers discovered that fluoroacetate compounds are extremely toxic
materials. Much of the research conducted in Nazi-occupied countries prior to the end of
World War II was either lost or very late in being reported publicly. The escape of a
Polish scientist to England brought elements of the knowledge gained in Poland to the
allied side.
Further research took place in England and in the U.S. English scientists
ultimately concluded that "compounds that form fluoroacetic acid by hydrolysis and/or
oxidation are toxic." (Pattison, 1959, p. 19)
In the U.S., research on compounds related to fluoroacetic acid led to several
developments, including the development of sodium fluoroacetate as a rodenticide and
mammalian predacide and fluoroacetamide as a rodenticide. The names 1080 and 1081
for sodium fluoroacetate and fluoroacetamide, respectively, came from the invoice
numbers that these materials were assigned in U.S. Government laboratories (Peacock
1964).
Extensive research on this family of chemicals after World War II led to a general
understanding of the mode of toxic action and the development of analytical methods
which, if not extremely sensitive by present standards, were at least able to detect the use
of compounds related to fluoroacetic acid in certain homicides (Pattison, 1959). However,
the problem of poor recovery of sodium fluoroacetate in or on animal tissues remained
until the mid 1980s (Kimball and Mishelanie, 1993).
U.S. Regulatory History of Sodium Fluoroacetate
Development and use of sodium fluoroacetate as a predacide and rodenticide in the
U.S. began in the 1940s (e.g., Robinson, 1948), prior to the 1947 enactment of the
Federal Insecticide, Fungicide and Rodenticide Act (1947) by which requirements for
Federal registration of pesticide products were instituted. Products containing sodium
fluoroacetate were among those registered shortly after the registration requirement went
-------
into effect. Pattison (1959) reports that the Monsanto Corporation produced about 5 tons
of sodium fluoroacetate in 1948. In 1955, Monsanto's 90% sodium fluoroacetate product
was transferred to lull Chemical Company of Oxford, AL. By the early 1970s, lull
Chemical Company was the only firm legally producing sodium fluoroacetate for pest
control purposes in the U.S. lull's registered product at the time, EPA Registration No.
5217-1, was a 90% sodium fluoroacetate concentrate which was labeled for mixing baits
that could be applied to control a variety of rodents and predatory mammals.
In 1964 and again in 1971, the use of poisons to control predatory mammals were
reviewed by select committees (Leopold, et al 1964; Cain, et al, 1972). Following the
issuance of the "Cain Report", President Nixon issued Executive Order 11643, which
banned the use of poisons to control predators on Federal lands. Shortly thereafter, EPA
issued PR Notice 72-2 which canceled all registered predator control uses of sodium
fluoroacetate, sodium cyanide, and strychnine (Ruckelshaus, 1972). Subsequent to the
cancellation of predacidal uses of sodium fluoroacetate, several parties sought to have such
uses restored.
There was a period of illegal use of sodium fluoroacetate as a predacide in
Wyoming from 1975 to 1977 (Thomas, 1983, p. 22; see also Nissen, 1982, p. 79; and
Johnson, 1978).
In 1977, the U.S. Department of the Interior (USDI) applied for an Experimental
Use Permit (EUP) to investigate the potential risks and benefits associated with the use of
sodium fluoroacetate in "toxic collars" which would be placed on the necks of sheep and
goats. Rubber pouches containing sodium fluoroacetate solution would be positioned
around the animals' throat regions where they would be likely to be ruptured by the teeth
of coyotes that attempted to kill the livestock with species-typical throat bites.
In 1981, EPA was petitioned by the USDI and livestock interests to revisit the 1972
predacide cancellation decision with respect to sodium fluoroacetate. EPA responded by
holding informal hearings on the issue in 1981 and formal, Subpart D administrative
hearings in 1982. The Subpart D hearings considered reinstatement of sodium
fluoroacetate in injected-carcass bait stations and three additional types of applications:
toxic collars, small "single-dose baits" intended to provide enough toxicant to reliably kill
one coyote, and "smear posts." The initial and final decisions (Nissen, 1982; Thomas,
1983) permitted EPA to consider applications for registration of sodium fluoroacetate in
toxic collars and single-dose baits and rejected the carcass baits and smear posts.
On July 18, 1985, EPA granted a registration to USDI for a toxic collar product
(EPA Registration Number 6704-85). By then, the product was called the "Livestock
Protection Collar." In 1986, this product was transferred to the Animal and Plant Health
Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA). Its new
Registration No. became 56228-22. Since 1987, five State-limited registrations have been
issued for Livestock Protection Collars. These products permit use of collars in Montana,
-------
New Mexico, South Dakota, Texas, and Wyoming. However, there is no approved
training and certification program in South Dakota. A concentrate product registered to
APHIS (56228-26) that is limited to use in the manufacture of Livestock Protection Collars
and the six registered livestock collar products mentioned above are the only registered
pesticide products in the U.S. which legally contain sodium fluoroacetate.
In the mid 1980s, USDI and later APHIS obtained EUPs which authorized field
trials with sodium fluoroacetate single-dose baits made of tallow. These baits each
contained 5 mg of active ingredient. However, sodium fluoroacetate was never registered
for this use pattern.
The rodenticidal uses of sodium fluoroacetate were not directly affected by
Executive Order 11643 or by PR Notice 72-2. However, the U.S. Department of the
Interior withdrew its sodium fluoroacetate rodenticide products following the issuance of
Executive Order 11643. At the time, lull's 5217-1 product and dozens of intrastate
registrations for rodenticidal uses of sodium fluoroacetate remained valid. In 1978, EPA
classified all legal uses of sodium fluoroacetate as "Restricted" due to "Acute oral toxicity
hazard to nontarget organisms, use and accident history." (Costle, 1978)
In the mid 1970s, EPA placed the non-predacidal uses of sodium fluoroacetate into
its RPAR ("Rebuttable Presumption Against Registration") process, the forerunner to what
now is called "Special Review." On December 1, 1976, EPA's "Position Document 1"
(PD1) was published (41FR52792, 1976). EPA announced a preliminary decision in the
RPAR in a second document, the PD 2/3, on November 4, 1983 (Barbehenn, et al, 1983).
After consideration of responses to the PD2/3, EPA issued its final decisionTiTtne form
of a PD4 document in July of 1985 (Anonymous, 1985). The PD 4 called for retention
of all rodenticidal uses of sodium fluoroacetate that were permitted at that time, but also
imposed significant requirements to modify labels and to supply missing research data.
The PD4 represented a significant change in EPA's regulatory position from that taken in
the PD 2/3 document, which had recommended cancellation or denial of many uses and
modification of all others except those for control of commensal rodents "in and around
buildings and ships" (Barbehenn, et al, 1983).
The data call-in issued with the PD4 sought information on the chemistry, residue
chemistry, environmental fate, toxicology, and ecological effects of sodium fluoroacetate.
The PD4 also dictated that 0.02% was the highest active ingredient strength that could be
used for prairie dog control, where such use was permitted, and for ground squirrel
control within the range of the California condor. EPA gave registrants whose products
were used in such areas the option of developing efficacy data "to establish the lowest
effective concentration" if the 0.02% level did not appear to be effective (Anonymous,
1985). The Agency reserved the right to modify the decisions reached in the PD4.
Tull's product 5217-1 was canceled "by operation of law on February 18, 1986"
(Yost, 1989) because the company did not respond to a November 22, 1985, "Notice of
-------
Intent to Cancel" (Campt, 1985) requiring that an application for amended registration was
submitted within 90 clays of the letter. Later, other parties indicated that they would
provide the data that Tull would not commit to obtain. On November 13, 1986, lull was
granted a registration (5217-2) for a 90% sodium fluoroacetate product that could be used
only as a source of active ingredient for registered sodium fluoroacetate products. Along
with this registration, EPA issued a schedule for supplying missing data pertaining to
lull's new product.
After two deadlines for submitting data for lull's new product (5217-2) passed,
EPA refrained from taking immediate cancellation action. Instead, EPA met with parties
(e.g., end-use registrants, user groups) concerned with the potential loss of a source of
sodium fluoroacetate for controlling rodents. After the various meetings had concluded,
EPA issued revised data call-ins in December 1987 pertaining to 5217-2 and to the
rodenticidal uses of sodium fluoroacetate (Tinsworth, 1987a,b). Due to lack of
appropriate responses toward supplying the data required by the 1985 and 1987 data call-
ins (Campt, 1988), EPA proceeded toward canceling lull's manufacturing use concentrate
(5217-2). The product was canceled on February 21, 1989 (Yost, 1989). Subsequently,
all "special local needs" registrations issued under §24(c) of FIFRA were canceled, and
all pending applications for Federal registration of intrastate products containing sodium
fluoroacetate were denied. These actions were completed by August 9, 1990 (Campt,
1990).
Regulatory Status of Sodium Fluoroacetate
The currently registered uses of sodium fluoroacetate are strictly limited to
livestock protection collars as a predacide in those states which have registrations and EPA
approved certification and training programs. Since all other predacidal uses were canceled
by the Administrator in 1972, as described above in the regulatory history, additional
predacidal uses cannot be granted without observation of the procedures for reconsidering
cancellation decisions set forth in 40 CFR Part 164, Subpart D.
Under the provisions of Subpart D, an application for a new predicidal use of
sodium fluoroacetate would require the submission by an applicant of substantial new
evidence which might have affected the cancellation decision and could not have been
made available to the Administrator during the prior proceeding. In addition, Subpart D
requires that the Administrator conduct a hearing before granting reconsideration of the
1972 cancellation decision.
U.S. Regulatory History of Fluoroacetamide
Fluoroacetamide (Compound 1081) was first registered as a pesticide in the U.S.
in 1972. In 1976, EPA began an RPAR for this compound because of potential hazards
to humans and nontarget animals. In 1978, all uses of fluoroacetamide were classified as
"Restricted" because of "acute oral toxicity" (Costle, 1978) and the absence of a true
8
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antidote. In 1979, label changes were adopted to address the Agency's most critical
concerns by limiting use of the sole registered product to sewers. As a result, the RPAR
process with respect to this chemical was concluded (PD2, Feb. 28, 1980 - 45FR 13189).
Fluoroacetamide ultimately was canceled in 1989 after the registrant of the only product
failed to pay the registration maintenance fee.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Sodium fluoroacetate is a sodium salt of fluoroacetic acid which is a tan colored
alkaline powder with a pH of 10.3. This is probably due to the sodium hydroxide
impurity. It melts at 197-203°C with decomposition. It is soluble in water but practically
insoluble in all non-polar solvents. Sodium fluoroacetate is stable in sunlight, at a
temperature of 54°C, and in tin coated metal containers.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on sodium fluoroacetate is adequate and will
support reregistration eligibility.
a. Acute Toxicity
Table 2. Acute Mammalian Toxicity
TEST
Oral LD50--rat
Dermal LD50«rabbit
Eye irritation-rabbit
Dermal irritationrabbit
HBSULTS
LD50 0.22 mg/kg
LD50 277.1 mg/kg M;
324.2 mg/kg F
slight irritation
not irritating
CATEGORY
I
II
III
IV
An acute oral toxicity study with rats used 90.0% sodium
fluoroacetate. The LD50 was 0.22 mg/kg, which is toxicity category I
(MRID 40016971). An acute oral toxicity study with coyotes used doses
of sodium fluoroacetate diluted with water. The LD50 was 0.12 mg/kg
sodium fluoroacetate, which is toxicity category I (MRID 00065627).
Literature reports have indicated oral LD50s of 0.10 mg/kg for rats, 0.50
mg/kg for mice, 0.066 mg/kg for dogs, and 0.34 mg/kg for rabbits.' The
human oral LD,0 has been reported as 0.714 mg/kg, and the potentially
toxic dose for humans has been stated as 0.5-2.0 me/kg (Sax and Lewis
1989).
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An acute dermal toxicity study with rabbits used technical sodium
fluoroacetate. The LD50 was 277.1 mg/kg for males and 324.2 mg/kg for
females. The animals showed lethargy, diarrhea, and convulsions
preceding death, along with extensive hemorrhage of the thymus and
congestion of the lungs. This is toxicity category II (MRID 152129).
A primary eye irritation study used a 1.0% aqueous solution of
sodium fluoroacetate with rabbits. There was slight irritation and slight
chemosis, which is toxicity category III (MRID 40402603). A primary
dermal irritation study also used a 1.0% aqueous solution on rabbits.
There was only transient slight edema on one rabbit and the compound was
considered not irritating (MRID 40402604).
Requirements for acute inhalation toxicity and dermal sensitization
studies were waived due to the severe acute toxicity of the compound and
the restriction of its use in a livestock protection collar.
b. Subchronic Toxicity
Technical sodium fluoroacetate was administered by gavage for 13
weeks to Crl:CD(SD)Br rats. The doses were 0, 0.05, 0.20, or 0.50
mg/kg/day. The NOEL was 0.05 mg/kg/day. The LOEL was 0.20
mg/kg/day, based on dose-related findings in histopathology
(hypospermatogenesis, fusion bodies, and immature or abnormal sperm)
and decreased size and weight of testes and epididymides in males.
Females had dose-related increases in absolute and relative heart weights
at the mid and high doses (Wolfe, 1988).
In a study with male Sprague Dawley rats, the animals were dosed
with 0, 0.07, 0.19, or 0.71 mg/kg/day of sodium fluoroacetate in their
drinking water for seven days. This was followed by 21 days without the
test compound. A group of rats from each dose level was killed each day
of treatment and on days 3, 7, 14, and 21 after dosing. The testes, kidneys
and liver were examined. Testicular atrophy and nonreversible tubular
degeneration were found at the mid and high dose. Testicular atrophy with
reversible tubular degeneration was found at the low dose. No effects on
liver or kidney were seen. The lowest dose was the LOEL (MRID
40016990).
c. Metabolism
Fluoroacetate in the mammalian body is converted to fluorocitrate.
This compound inhibits the enzyme aconitase, thus blocking the citric acid
cycle. This leads to accumulation of citric acid, which may cause
10
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convulsions and death from cardiac failure or respiratory arrest (Gribble,
Sodium fluoroacetate can be absorbed through the gastrointestinal
tract, respiratory tract, or open wounds, but only slowly through intact skin
(Sax and Lewis, 1989).
d. Reference Dose
The Rft) was determined to be 0.00002 mg/kg/day. This was based
on the 13-week subchronic oral rat study, in which the NOEL was 0.05
mg/kg/day. An uncertainty factor of 3000 was used to account for
mterspecies extrapolation, intraspecies differences, and lack of additional
studies (Ghali, 1994).
2. Exposure Assessment
a. Dietary and Occupational/Residential Exposure
Under the current permitted use pattern there will be no sodium
fluoroacetate exposure to the general population. Based on the use
information, there are no applicator/mixer/loader or post-application
exposure concerns other than following the label restriction for use by
certified personnel only.
3. Risk Characterization
a. lexicological Endpoints
Because of the specific nature of this registered use, the primary
concern is for the potential risk of acute toxicity.
b. Occupational and Residential
There are no uses of sodium fluoroacetate in residential
environments. Based on the use information, potential risk for acute
toxicity to workers exposed to sodium fluoroacetate is not expected.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency has adequate data to assess the hazard of sodium fluoroacetate
to nontarget organisms.
11
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a. Toxicity to Terrestrial Animals
In order to establish the acute and subacute toxicity of sodium
fluoroacetate to birds, the following tests were required using the technical
grade material: one avian single-dose oral LD50 study on one species; the
bobwhite quail (Colinus virginianus) or preferably the mallard duck (Anas
platyrhyncos); two subacute dietary LC50 studies on one species of
waterfowl (preferably the mallard duck) and one species of upland game
bird (preferably the bobwhite quail or the ring-necked pheasant (Phasianus
colchicus).
(1) Birds, Acute and Subacute
Acute oral toxicity
The acute oral LD50 value for the technical grade of sodium
fluoroacetate for avian species has been reported in the literature.
Hudson et al. (1984) reported the acute oral LD50 values for the
ring-necked pheasant, mallard duck and chukar (Alectoris graeca)
to be 6.4 (95% C.I. = 3.85-10.8), 9.1 (95% C.I. = 5.6-14ToTand
3.51 (95% C.I. = 2.58-4.78) mg/kg, respectively. Ward and
Spencer (1947) determined the acute lethal doses for numerous
avian species and reported LD50 values as low as 3.0, 5.0, and 15
mg/kg for the widgeon (Mareca americana), golden eagle (Aquila
chrysaetos), and black vulture (Cartharista urubu), respectively.
Atzert (1971) reported the LD50 for the black-billed magpie (Pica
pica) to be 1 mg/kg. In addition, the USDA conducted a series of
acute oral LD^ tests on the magpie to get toxicity data for a species
that is likely to scavenge the carcasses of coyotes and/or livestock
(Burns and Connolly, 1992). Results of these studies showed that
the acute oral LD50 for the magpie ranged from 1.78 mg/kg to 2.3
mg/kg, depending on temperature and season.
These data indicate that sodium fluoroacetate is very highly
toxic to avian species on an acute oral basis. The guideline
requirements for this test have been satisfied. Table 3, below is a
data summary for the acute toxicity of sodium fluoroacetate to avian
species.
12
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Table 3.
Mallard duck
Chukar
AVIAN ACUTE ORAL TQXICITY DATA
mg/kg
9.1
3.5
Ring-necked Pheasant
Widgeon
Golden eagle
Black vulture
"
Black-billed Magpie
5.0
Table 4.
Species
-
Bobwhite quail
Mallard duck
highly toxic
-
highly toxic
highly toxic
^
highly toxic
highly toxic
highly toxic
highly toxic
Subacute dietary toxicitv
Campbell et al. (1994) reported that the avian dietary LC50
values of sodium fluoroacetate for the mallard duck and bobwhite
quail were 231 (95% C.I. = 150-338) and 486 (95% C I =339-696)
ppm, respectively (MRID #s 43210602; 43210601). Based on these
data, sodium fluoroacetate can be classified as highly toxic to avian
species on a dietary basis. The guideline requirements for a dietary
study have been satisfied. Table 4 is a data summary for the
dietary toxicity of sodium fluoroacetate to avian species.
ATOH SU&AdFTE DIETARY TOXICITY DATA
LC3D
486
231
Conclusion
highly toxic
highly toxic
(2) Birds, Chronic
Substantial chronic exposure to birds is not expected with
use of the sodium fluoroacetate livestock protection collar.
(3) Mammals
Wild mammal testing may be required for a pesticide
depending on the results of the lower tier studies such as acute and
subacute testing and on the intended use pattern and pertinent
environmental fate characteristics. Because the livestock protection
13
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Table 5.
collar is specifically designed to kill a wild mammal (coyote), wild
mammal toxicity testing has been required for sodium fluoroacetate.
Ward and Spencer (1947) determined the acute lethal doses
of sodium fluoroacetate for numerous mammalian species and
reported LD50 values as low as 0.1 mg/kg for both the cotton rat
(Sigmodon hispidus) and coyote (Canis latrans). They also reported
that the LD50 for the deer mouse (Peromyces sp.) was 4.0 mg/kg.
Beasom (1982) reported that the LD50 values for the opossum
(Didelphis virginiana) and raccoon (Procyon lotor) were 41.6 and
1.1 mg/kg, respectively. Atzert (1971) reported that the LD50s of
sodium fluoroacetate to the striped skunk (Mephitus mephitus) and
opossum are 1 and 60 mg/kg, respectively. These data indicate that
sodium fluoroacetate can be classified as very highly toxic to
mammals on an acute oral basis. The guideline requirement for the
wild mammal toxicity test has been satisfied. Table 5 is a summary
for the acute toxicity of sodium fluoroacetate to mammals.
MAMMALIAN ACUTE TOXICITY DATA
Species
Coyote
Cotton rat
Deer mouse
Raccoon
Opossum
Skunk
LDjo mg/kg
0.1
0.1
4.0
1.1
41.6
1.0
Conclusions
highly toxic
highly toxic
highly toxic
highly toxic
highly toxic
highly toxic
(4) Insects
Data are not required on toxicity to insects, on the basis of
negligible exposure associated with the sodium fluoroacetate
livestock protection collar.
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 freshwater fish toxicity studies. One study
14
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Table 6.
Table 7.
should use a coldwater species (preferably the rainbow trout), and
the other should use a warmwater species (preferably the bluegill
sunfish). 6
Collins (1993) reported that the 96-hour LC50 values of
technical grade sodium fluoroacetate to the rainbow trout
(Qncorhynchus mykiss) and bluegill sunfish (Lepomis macrochirus)
were 54 mg a.i./l and > 970 mg a.i./l, respectively. When no
substantial mortality occurs at the highest dose evaluated the LC
is reported as greater than that dose. Based on these data, sodium
fluoroacetate can be classified as slightly toxic to coldwater fish
species and practically non-toxic to warm water fish species The
guideline requirements for freshwater fish toxicity tests have been
satisfied (MRID# 42961601, 42961602). Table 6 is a summary for
the toxicity of sodium fluoroacetate to freshwater fish.
FRESHWATER FISH ACUTE TOXICITY DATA
(2) Freshwater Invertebrates
The minimum testing required to assess the toxicity of a
pesticide to freshwater invertebrates is a freshwater aquatic
invertebrate toxicity test, preferably using the first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges
(Chironomus sp.).
Collins (1993) conducted an acute static toxicity test on
daphmds and determined that the 48-hour EC50 of sodium
fluoroacetate was 350 mg a.i./l (MRID# 42961603). Based on
these data, sodium fluoroacetate can be classified as practically non-
toxic to freshwater invertebrates. The guideline requirement for the
freshwater toxicity test has been satisfied. Table 7 is a summary
for the toxicity of sodium fluoroacetate to freshwater invertebrates.
FRESHWATER It^VERTBBRATE TO^IOTY DATA
48-hour EC50 (mg a.i./l)
350
Conclusions
1
practically non-toxic
Daphnia magna
15
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(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 or estuarine environment or is expected to
reach that environment in significant concentrations. The terrestrial
non-food use of sodium fluoroacetate will not result in substantial
exposure to the estuarine environment. Therefore, these data are
not required.
c. Toxicity to Plants
Toxicity data are not required for terrestrial, semiaquatic, or aquatic
plants for sodium fluoroacetate because the chemical is not a herbicide, is
not applied aerially, and there is no other apparent basis for a phytotoxicity
concern.
2. Environmental Fate
The Agency has reviewed all literature submitted on environmental fate
properties, including studies not required for the livestock protection collar use.
No acceptable guideline studies for hydrolysis or other fate properties have been
submitted. Four published articles on environmental fate were submitted by the
Texas Department of Agriculture in support of an emergency exemption, and 13
published or unpublished articles were submitted in 1986 by the State of
California. These articles were found to be lacking significant data and of
uncertain value, and therefore not, acceptable as guideline studies. If any new uses
of sodium fluoroacetate are proposed, acceptable environmental fate studies may
be required.
a. Environmental Fate Assessment
The fate properties of the chemical are characterized to the extent
possible, recognizing the limitations of the available data. The conclusions
are very tentative relative to an evaluation that could be made if guideline
studies were available.
The limited data available suggest that leaching and metabolism are
the major routes of dissipation. However, undegraded fluoroacetate is
considered mobile and consequently has a high potential to move downward
in the soil and reach ground water.
16
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Sodium fluoroacetate appears to degrade primarily by biologically
mediated processes. Sodium fluoroacetate appears first to ionize to sodium
and fluoroacetate with the fluoroacetate portion further degrading by
biologically mediated processes. Microorganisms capable of
denalogenatmg compounds are reported to metabolize fluoroacetate to
fluoride and glycolate faster than other microorganisms. Unvalidated data
suggest that sodium fluoroacetate does not degrade substantially in 27 davs
in sterile soil. 7
Because there are no leaching adsorption-desorption data, mobility
can only be assessed on the basis of solubility in water. Based on solubility
in water, undegraded fluoroacetate may tend to leach However the
potential for leaching may be reduced in some soils by adsorption to
organic matter and clay particles and absorption by plants.
b. Environmental Fate and Transport
(1) Degradation
Hydrolysis (161-1)
Three published articles have been submitted to the Agency
to support the hydrolysis data requirement. These articles were
found to be lacking significant data and of uncertain value and
therefore, not acceptable to fulfill the hydrolysis guideline
requirement. However, the Agency is not requiring a new
hydrolysis study because of the limited amount of sodium
fluoroacetate that is used annually in the livestock protection
collars, as noted Section II.C. (MRID 00061751 40016958
40016959) ' '
Based on one of these published articles the stability of
sodium monofluoroacetate in water and saline was determined for
a period of approximately 6 months. An immediate loss of fluorine
was detected in both the water and saline solutions. A progressive
loss of fluorine was reported in the water solutions. However, the
saline solutions indicated no significant decreases in fluorine content
after the initial loss. The chemical reaction was not further
addressed in the first of the articles by Goldman (MRID 00061751)
However, other articles indicate the following reaction:
XCH2COO- + OH = HOCH2COO- + X-
(where X = F, Cl, or I)
17
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c. Water Resources
(1) Ground Water
For terrestrial uses, the published or unpublished data
indicate that small quantities of sodium fluoroacetate have the
potential to reach groundwater. The Agency's Pesticides in Ground
Water Database reports no detections for the period 1971 to 1991.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
(1) Exposure and Risk to Nontarget Terrestrial Animals
Certain nontarget species of birds and mammals including
endangered and non-endangered species may be exposed by the
following mechanisms:
Primary hazard
Contaminated sheep or goat carcasses with either broken
(punctured) or unbroken collars.
Toxicant spilled on the ground or vegetation when a collar
is punctured.
Secondary hazard
Carcasses of coyotes killed by the sodium fluoroacetate
livestock protection collars and not removed.
Vomitus of poisoned coyotes. (The chemical has emetic
properties)
Based on a variety of studies that have been reviewed by the
Agency, the principal source of risk is exposure of scavengers
feeding on the head and neck area of dead livestock bearing the
sodium fluoroacetate livestock protection collars. The other sources
of exposure identified above are not likely to result in unacceptable
risk. Factors that reduce the risk associated with use of the sodium
fluoroacetate livestock protection collars include rapid
decomposition of carcasses, selective feeding of scavengers from
18
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wounds on the carcass rather than contaminated skin surface of the
head or neck, and the emetic property of the chemical The
concerns for risk to wildlife can be addressed with applicators
following environmental hazard statements, special use restrictions
and endangered species protection statements that are required to be
placed on the label.
The following is a review of information that applies to the
risks to both birds and mammals, which may be exposed by similar
mechanisms.
Risk from exposure to livestock carcasses bearing livestock
protection collars. ~
The information available suggests that the greatest risk to
nontarget species is from exposure to the neck areas of livestock
carcasses bearing the sodium fluoroacetate livestock protection
collars.
Knowlton and Ebbert (1991) used radiolabeled sodium
fluoroacetate as a physiological marker to determine the amount of
toxicant likely to be consumed by a coyote and the amount likely to
occur on the necks of collared goats (Capra sp.) when the coyotes
attacked the goats and punctured the collars that contained 30 ml of
the toxicant. The volume of fluid dispensed from the collar was
19.2 ml on average (range 11.9 to 27.8 ml); the average volume
ingested by the coyote was 1.0 ml (0.1 to 2.9 ml). The average
amount of toxicant contaminating the neck of the goat was 75 mg
(39 to 118 mg). The average amount of toxicant not recovered was
113 mg (0 to 234 mg). Once punctured, the pouches discharged
over 85% of their contents within a short time period. Relatively
little of the toxicant was actually ingested by the coyotes with 6 of
15 coyotes ingesting less than 5 mg when killing the goat.
Savarie etal. 1990 also studied contamination of the necks
of collared lambs (Ovis sp.) killed by coyotes. They found that 12
contaminated sheepskins contained an average of 96 mg sodium
fluoroacetate with a range of 23 to 200 mg.
Comparison of the two studies just cited (Knowlton and
Ebbert, 1991; Savarie etal. 1990) suggests that the amount of
toxicant on the necks of collared livestock is similar for goats and
sheep. The average amount of sodium fluoroacetate released from
the collar was 130 mg in the goat study (Knowlton and Ebert) and
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135 mg for the sheep study (Savarie et al.). The amount not
recovered was 5.6 mg for the goat study and 6.1 mg in the sheep
study.
In the Knowlton and Ebbert study, the average amount of
fluid contaminating the neck of the goat was 7.5 ml (3.9 to 11.8
ml), or about 75 mg toxicant. That level clearly exceeds toxicity
values for numerous birds and mammals that could scavenge the
carcass, which suggests that the primary hazard to the scavengers
is quite high. However, field studies reviewed subsequently suggest
that mortality to scavengers feeding on the carcasses is actually
minor. For example, it has been observed that vultures, magpies,
ravens (Corvus corax), red-tailed hawks (Buteo jamaicensis),
caracaras (Polyborus cheriway), coyotes, and skunks all scavenged
the carcasses of collared livestock killed by coyotes, but none
appeared to have been poisoned (USDA/APHIS, 1991; Connolly,
1980; Littauer, 1983).
Several factors may account for the apparent discrepancy
between the field results and the implications of residue
measurements. First, the typical behavior of scavengers is to feed
at wounds or openings in the carcass or where the skin has been
torn away from the carcass, rather than on the contaminated neck
area. This tendency may greatly reduce the likelihood of exposure
to avian species such as the bald eagle (Haliaeetus leucocephalus)
(USFWS, 1984, 1985). Connolly (1980) simulated exposure to
non-target animals with a series of tests exposing magpies and
domestic dogs (Canis familiaris) to collared livestock killed by
coyotes. Both dogs and magpies fed heavily on the carcass but
neither were poisoned. Connolly further observed that both the
species tended to feed on parts where the coyote had previously fed
rather than on the neck area where the highest contamination is
likely. They concluded that typical feeding behavior of scavengers
confers a degree of protection against accidental poisoning by
livestock collars.
Secondly, toxicity data suggest that birds likely to scavenge,
particularly raptors, tend to be less sensitive to sodium fluoroacetate
than mammals, especially canids (Haegele etal., 1984; Ward and
Spencer, 1947 and Atzert, 1971). Also, emesis has been observed
as an early symptom of sodium fluoroacetate poisoning (Ward and
Spencer, 1947) and may cause certain raptors to discontinue feeding
before lethal amounts are absorbed (Dana, 1971). The emetic
property of sodium fluoroacetate is likely to reduce exposure to
20
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raptors scavenging on livestock, and probably will also make the
raptors less likely to continue feeding on them.
Another factor that can greatly influence the primary hazard,
especially in warm weather, is that livestock carcasses decompose
rapidly under field conditions, rendering them unpalatable to many
avian and mammalian species (Burns et al., 1984 and Connollv
1980). y'
Risk from lost or spilled toxicant
Knowlton and Ebbert (1991) found that the average volume
of fluid not recovered was 11.3 (0-23.4) ml or approximately 113
mg sodium fluoroacetate, which is nearly 33% of the total amount
in the 30 ml collar. It is believed that most of the fluid not
recovered is spilled on the ground. The available fate information
consists largely of studies that were not found to be acceptable.
Nevertheless the available information on fate properties suggests
that sodium fluoroacetate tends to be absorbed rapidly to organic
material and tends to degrade rapidly in soil. The Agency believes
that there is no substantial hazard to non-target organisms from the
sodium fluoroacetate that spills on the ground as a result of the
collar being punctured by an attacking coyote.
Risk from consumption of tissue, stomach contents, or vomitus of
coyotes killed by the sodium fluoroacetate livestock protection
collars
Connolly (1980) evaluated sodium fluoroacetate residues in
muscle of captive coyotes that received known oral doses. At a
known oral dose of 5.0 mg the concentration in muscle was
determined to be 0.10 ppm while the 10 mg dose resulted in a
concentration of 0.19 ppm. Based on this relationship a coyote that
ingests an average of 1 ml fluid (10 mg toxicant) will have muscle
tissue residues of 0.19 ppm sodium fluoroacetate. The highest
sodium fluoroacetate residue level found in muscle tissue was 0 93
ppm.
Residues in coyotes that have killed sheep wearing the 30 ml
collar have been determined by Burns et al. (1984). Those authors
report average concentrations of 0.15 ppm in muscle, 0.5 ppm in
stomach contents, and 0.35 ppm in vomitus. The highest residue
found occurred in the stomach contents and was 2.3 ppm.
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Knowlton and Ebbert (1991) analyzed muscle tissue from 10
coyotes that were killed as a result of puncturing collars. Residues
were detected in the muscle of all the coyotes. The concentration
in muscle tissue was 0.089 ppm (range of 0.05 to 0.280 ppm); the
mean±SE sodium fluoroacetate lost from 12 collars was 92 ±56 mg
(range 3 to 183 mg).
Table 9 below gives estimates of the amount of muscle
tissue, stomach contents, or vomitus, from coyotes killed with the
30 ml sodium fluoroacetate livestock protection collar that would
have to be consumed in order for a scavenger to ingest an LD50
(Burns et al., 1984). These data suggest that secondary hazard to
to animals that may feed on a contaminated coyote carcass is
ordinarily not substantial (Burns et al., 1984; Connolly, 1980;
Knowlton and Ebbert, 1991). However, it is likely that carcasses
will occasionally contain enough sodium fluoroacetate to kill a
scavenger. The results below represent average exposures. The data
suggest substantial variation from one carcass to the next. This
qualification has to be considered when interpreting statements in
the following assessments related to muscle tissue, vomitus, and
stomach contents.
Table 9.
Approximate aroouafc of timu? from coyotes JdJled %i& tb* 30 ml sodium &ioioa
-------
weights, respectively, to obtain an LD50 dose from muscle tissue
Even a coyote, the most sensitive species tested, would have to eat
approximately 67% of its body weight to get an LD50 dose.
Stomach Contents
Black vulture, golden eagle, and black-billed magpie would
have to consume 30x, 10x and 2x their body weight
respectively, to obtain an LD50 dose from stomach contents'
Because of the higher concentrations in stomach contents, species
that feed primarily on the viscera may be at greater risk than those
that feed primarily on muscle.
Vomitus
Clinical observations suggest that sodium fluoroacetate is
emetic especially to canids which have ingested more than an LD,n
[Ward and Spencer, 1947 and Texas A&M University System
(TAMUS), 19831. Observations of coyote behavior made during
the TAMUS study also found that some coyotes would cache the
vomitus, which may further reduce exposure to animals that would
otherwise eat it. Connolly (1980) reported that concentrations in
vomitus of four poisoned coyotes ranged from below the detection
limit (0.1 ppm) to 0.72 ppm. The average concentration in vomitus
from five coyotes that attacked sheep wearing the 30 ml collar has
been reported to be 0.35 ppm (USDA/APHIS, Unpublished Report
1986). These levels may be toxic to certain species that are very
sensitive to sodium fluoroacetate; however, the Agency considers
it unlikely that sufficiently large amounts of vomitus would be
available or found by non-target animals under field conditions to
exceed the Agency's risk criteria. For example, the coyote would
have to consume about 29% of its body weight to obtain a LD
equivalent from vomitus. The skunk would have to consume 280%
of its body weight.
Burns et al. (1986) also studied residues in coyotes killed
with single drop baits (SDBs) treated at 5 mg/bait. They found
average concentrations of 0.29 ppm for muscle, 0.30 ppm for small
intestine, and 0.31 ppm for stomach. They concluded that these
values were consistent with those found in the 30 ml sodium
fluoroacetate livestock protection collars study conducted by
Connolly (1980). They also conducted a series of feeding tests to
determine if there was any potential for secondary hazard to non-
target animals that fed on coyotes poisoned by the SDBs. All of the
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removed tissue except the gastrointestinal tract was fed to 3 dogs
(Canis familiaris), 3 coyotes, 4 striped skunks and 15 magpies for
periods ranging from 14 to 35 days. The total amount of
contaminated tissue consumed, and expressed as percent of body
weight averaged 67% for dogs, 152% for coyotes, 117% for skunks
and 371 % for the magpies. None of the test species exhibited any
signs of sodium fluoroacetate poisoning or had any detectable
sodium fluoroacetate residues in there tissues. Again, these data
indicate that even if non-target species feed on carcasses of coyotes
killed by the collar, it is highly unlikely that they will ingest
sufficient quantities of contaminated tissue to result in a secondary
hazard.
Finally, the U.S. Fish and Wildlife Service was required to
evaluate secondary hazard to non-target organisms resulting from
use of the 30 ml sodium fluoroacetate livestock protection collars.
To simulate secondary poisoning, coyotes were administered doses
of 4 mg, 100 mg, and 400 mg of sodium fluoroacetate. Upon
death, all the coyotes were skinned and eviscerated and all muscle
tissue was removed from the skeletons. All the tissue except the
gastrointestinal tract was ground up and fed to stripped skunks,
raccoons and opossums. The results indicated that only the
carcasses of animals that had received more than 200 mg of sodium
fluoroacetate would be expected to place scavengers at risk and that
the only species of scavengers that would be expected to be at risk
would be those with relatively low tolerance for the chemical
(TAMUS, 1983). The dosages that caused observable effects
greatly exceeded those administered to the coyote by the sodium
fluoroacetate livestock protection collars, indicating that mortality
to non-target animals is unlikely from operational use of the collar.
Total Collar Use
In addition to the residue information, it is important to
consider how many collars will typically be used in coyote control
operations. Based on the results of field studies conducted in
various states, it appears that the numbers of collars used and the
amounts of sodium fluoroacetate actually lost to the environment
are both quite low. For example, in the study conducted in New
Mexico only 23 of 330 of the collars (or 7%) were ever punctured.
Of those 23 collars only 5 (or 22%) were punctured by coyotes
(Littauer, 1991). The remaining 18 collars were punctured from
vegetation or unknown causes.
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During three years of monitoring in Wyoming, Montana,
Texas, and New Mexico only 294 out of 2257 collars (13%) were
punctured and had their contents released. Assuming that each
collar was completely emptied, the amount of sodium fluoroacetate
released to the environment would be 88.2 grams, or an average of
29.4 grams/year over the four state area where the collars were
used. What is even more significant is that only 108 of the 294
collars punctured, or 36.7%, were punctured by coyotes. The total
amount of sodium fluoroacetate released from collars punctured by
coyote attacks (assuming that each collar was emptied) was 32.4
grams or an average of only 10.8 grams/year over the four state
area. Nearly as many collars (80 collars or 4%) were punctured
from vegetation and unknown causes as from coyote attacks.
Field Studies
From 1978 to 1980, the U.S. Fish and Wildlife Service
conducted field research in various states to assess primary and
secondary hazards from the use of the sodium fluoroacetate
livestock protection collars (Connolly, 1980). It was found that the
primary scavenger of collared goats that were killed by coyotes in
Texas were turkey vultures (Cartharista aura) and black vultures,
while red-tailed hawks, caracaras and ravens infrequently scavenged
kills. No scavenging by mammals was observed. In Montana and
Idaho, black-billed magpie was the species observed most
frequently as a scavenger of sheep killed by coyote. Scavenging by
ravens was observed infrequently. In addition the following
summary is given for primarly poisoning:
"In summary, coyote-killed collared livestock were known
to have been scavenged by turkey vultures, black vultures, magpies,
ravens, red-tailed hawks, caracaras, a skunk and a coyote during
the present studies. No scavenger was known or believed to have
been poisoned. Scavengers ignored the collars and fed instead upon
the viscera and muscle that has been exposed by the killer coyote."
Field observations of secondary poisoning studies, conducted
in Texas and Montana showed that turkey vultures were the only
scavengers of dead coyotes although numerous other scavengers
such as golden eagles, ravens, magpies, skunks and other potential
scavengers were abundant in the area.
From 1981 to 1983, the New Mexico Department of
Agriculture conducted an experimental field program evaluating the
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efficacy and safety of the toxic collar. A total of 330 collars were
used over approximately 1,000 days. Twelve collared lambs were
attacked, but only 5 collars were actually punctured by predators.
A total of 18 collars were accidentally punctured while 21 collars
were lost. Three predators were found dead, two coyote and one
bobcat (Lynx rufus). The only non-target animal believed to have
been poisoned during the study was a skunk. The results of this
study suggest that exposure of non-target species by feeding on the
coyote carcass or the neck area of the collared livestock was low
and did not result in any significant adverse effects (Littauer, 1983).
As part of the registration requirements, the USDA/APHIS
was required to submit information on hazard to non-target species
resulting from the use of the 30 ml sodium fluoroacetate livestock
protection collars, collected as a result of use of the device in
Montana, Wyoming, New Mexico, South Dakota and Texas
(USDA/APHIS, 1991). The major findings from the actual use of
the collar during 1988, 1989 and 1990 as well as a report on the
field and laboratory research conducted from 1978 to 1980 are as
follows:
The contents of a small portion (13%) of the collars placed
on livestock were actually released into the environment.
The total amount of sodium fluoroacetate involved in the
release, assuming that each collar was completely emptied,
was 88.2 grams. This is an average of 29.4 grams/year
over the four state area where the collars were used. (No
collars were used in South Dakota.)
There were no reports of deaths of non-target animals
associated with the use of the sodium fluoroacetate livestock
protection collars during this period.
Only limited scavenging occurred on coyote carcasses.
Scavenging was reported by caracara and two species of
vulture.
Livestock carcasses were scavenged by vultures, magpies,
ravens, red-tailed hawks, caracaras, skunks and coyotes, but
none of these non-target species were known to have been
poisoned as a result.
» Scavenger species tended to feed mainly on viscera and
muscle of hind quarters.
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Of the 13% of the collars that had their contents released
during the time period (or 294 collars), only 5% (108
collars) were punctured by coyotes.
(a) Birds
The chemical is very highly toxic to birds on an
acute oral basis. Certain bird species may be exposed,
primarily as a result of scavenging the carcasses of livestock
bearing the sodium fluoroacetate livestock protection
collars. The risks are discussed in detail above, generically
for nontarget avian scavengers and nontarget mammalian
scavengers. The concerns for risk to wildlife can be
addressed with the environmental hazard statements, special
use restrictions, and endangered species protection
statements, that are required to be placed on the label.
(b) Mammals
The chemical is very highly toxic to mammals on an
acute oral basis. Certain species may be exposed, primarily
as a result of scavenging the carcasses of livestock bearing
the sodium fluoroacetate livestock protection collars. The
risks are discussed in detail above, generically for nontarget
avian scavengers and nontarget mammalian scavengers.
The concerns for risk to wildlife can be addressed with
environmental hazard statements, special use restrictions,
and endangered species protection statements, that are
required to be placed on the label.
(c) Insects
Substantial exposure of nontarget insects is not
anticipated from the use of the sodium fluoroacetate
livestock protection collars.
(2) Exposure and Risk to Nontarget Aquatic Animals
Based on low toxicity to aquatic animals and low exposure
associated with use of the sodium fluoroacetate livestock protection
collars, the Agency finds that use of the collar is not likely to result
in unacceptable risk. Sodium fluoroacetate is practically non-toxic
to warmwater fish species and aquatic invertebrates, and only
27
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slightly toxic to coldwater fish species. The Agency does not have
reports of detections in surface or ground water.
(3) Exposure and Risk to Nontarget Plants
Evaluation of exposure and risk is not required for
terrestrial, semiaquatic, or aquatic plants because sodium
fluoroacetate is not a herbicide and is not applied aerially, and there
is no other apparent basis for a phytotoxicity concern.
(4) Endangered Species
On March 21, 1985, the Agency requested formal Section
7 consultation relative to the United States Department of Interior's
application to register compound sodium fluoroacetate livestock
protection collar. On June 14, 1985, the U. S. Fish and Wildlife
Service - Office of Endangered Species (USFWS-OES) responded
and concluded that the use of the sodium fluoroacetate collar with
proposed use directions and restrictions posed no jeopardy to the
bald eagle, San Joaquin kit fox, black-footed ferret (Mustela
nigripes), and gray wolf (Canis lupus), but was likely to jeopardize
the continued existence of the grizzly bear (Ursus arctos horribilus),
Rocky Mountain wolf (Canis lupus irremotus) and California
condor (Gymnogys californianus) (USFWS, 1985). The USFWS-
OES provided specific state and county recommendations for
avoiding adverse effects to the non-jeopardy species as well as
reasonable and prudent alternatives for precluding jeopardy to the
three species in jeopardy from the use pattern. Based on these
recommendations, the Agency developed specific endangered
species label precautions and use restrictions for the 30 ml collar.
These use restrictions have been included in a Technical Bulletin
that accompanies the labeling.
In 1987, as a result of informal consultation with field
operations personnel from the USFWS, the Agency became aware
that additional precautions, specifically addressing the use of the
sodium fluoroacetate livestock protection collars in Texas, were
required to protect the ocelot (Felis pardalis) and jaguarundi (Felis
yagouarundi cacomitei) (USFWS, 1986). The additional use
precautions were reviewed by the Agency and included in the
Technical Bulletin.
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In March 1993 the USFWS issued a final biological opinion
on the effects of 16 vertebrate control agents on threatened and
endangered species. This opinion specifically addressed the
livestock protection collar and included jeopardy determinations to
the gray wolf and grizzly bear. It did not conclude jeopardy
determinations to any other species. The USFWS identified specific
areas where the collar could not be used and concluded that
implementation of such a restriction would preclude jeopardy to
both the graph wolf and the grizzly and that no incidental take
would occur from the use of the collar. Such restrictions have been
incorporated on the livestock protection collar labels.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing sodium fluoroacetate active ingredients. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing sodium fluoroacetate.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of sodium fluoroacetate, 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 sodium fluoroacetate and to determine that sodium fluoroacetate can be
used without resulting in unreasonable adverse effects to humans and the environment.
The Agency, therefore, finds that all products containing sodium fluoroacetate as the
active ingredients are eligible for reregistration. The reregistration of particular products
is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all currently registered uses of sodium
fluoroacetate 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 sodium fluoroacetate if new information
comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
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As described in the Regulatory History and Status section of this document (Section
H.E.), and in 40 CFR Part 164, Subpart D, new predicidal uses for sodium fluoroacetate
cannot be granted without submission by the applicant of new evidence which was not
available and which could have impacted the outcome of the decision in 1972 by the
Administrator to cancel the predicidal uses, and without a hearing involving all interested
parties.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient sodium
fluoroacetate, the Agency has sufficient information on the health effects of sodium
fluoroacetate and on its potential for causing adverse effects in fish and wildlife
and the environment.
The Agency has determined that sodium fluoroacetate 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 sodium fluoroacetate registered for the
sole remaining use are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that the single currently registered use of
sodium fluoroacetate is eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for sodium
fluoroacetate. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Restricted Use Classification
Sodium fluoroacetate, which is only registered for use in livestock
protection collars, will retain the restricted use classification imposed by the
Agency in 1978 due to its high acute toxicity and the need for highly specialized
applicator training.
2. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
animal species to sodium fluoroacetate as discussed above in the science assessment
chapter.
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At this time no farther measures are necessary for protection of endangered
species. Should the use of sodium fluoroacetate change or the Agency becomes
aware of new information that would warrant new concerns, the Agency will take
additional action as necessary.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data and labeling 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 sodium fluoroacetate
for the above eligible use has been reviewed and determined to be substantially
complete.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"For use only for reformulating into sodium fluoroacetate solutions for use only
in Federally-registered livestock protection collars".
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
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2. Labeling Requirements for End-Use Products
The use of sodium fluoroacetate in the animal protection collar is currently
registered in five states (Montana, New Mexico, South Dakota, Texas, and
Wyoming).
The following list of use restrictions for sodium fluoroacetate represents the
USDA/APHIS product.
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other applicable
notices.
USE RESTRICTIONS
1. Use of livestock protection (LP) collars shall conform to all applicable
Federal, State, and local regulations.
2. LP Collars shall be sold or transferred only by registrants or their agents
and only to certified Livestock Protection Collar applicators. Collars may
be used only by specifically certified Livestock Protection Collar
applicators or by persons under their direct supervision. l
The certified applicator is directly responsible for assuring that all use
restrictions are met. The certified applicator will decide, in accordance
with label directions, when and under what circumstances collars will be
used. The certified applicator will either apply collars or be physically
present where collars are applied by a noncertified person. However, a
noncertified person who has received adequate instructions from the
certified applicator may store collars, check collars in the field, remove
collars, repair or dispose of damaged collars in accordance with use
restrictions, retrieve collars laying in the field and properly dispose of
contaminated material and animal carcasses.
3. Certification of applicators shall be performed by appropriate regulatory
agencies. Prior to certification, each applicator shall receive training which
will include, but need not be limited to:
(a) Training in safe handling and attachment of LP collars.
1 "Direct Supervision," as described in this restriction, conforms to the requirements
established under 40 CFR 171.6.
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(b) Trainig in disposal of punctured or leaking LP collars, and
contaminated animal remains, vegetation, soil, and clothing.
(c) Instructions for practical treatment of 1080 poisoning in humans
and domestic animals.
(d) Instructions on record keeping.
4. Registrants or their agents shall keep records of all collars sold or
transferred at their address of record. Records shall include the name,
address, state where Livestock Protection Collar certification was issued,'
certification number of each recipient, and dates and numbers of collars
sold or transferred.
5. Each applicator shall keep records dealing with the use of LP Collars and
the results of such use. Records shall be maintained in accordance with
appropriate State or Federal regulations but for not less than two years
following disposal or loss of collar. Such records shall include, but need
not be limited to:
(a) The number of LP collars attached on livestock.
(b) The pasture(s) where LP collared livestock were placed.
(c) The dates of each attachment, inspection, and removal
(d) The number and locations of livestock found with ruptured or
punctured LP collars and the apparent cause of the damage.
(e) The number, dates, and approximate location of LP collars lost.
(f) The species, locations, and dates of all suspected poisonings of
humans, domestic animals or non-target wild animals resulting from
LP collar use.
6. Any suspected poisoning of threatened or endangered species must be
reported immediately (within three days) to the Environmental Protection
Agency, as will each suspected poisoning of humans, domestic animals or
non-target wild animals. The person to contact at the Environmental
Protection Agency is Robert A. Forrest (PM-14), Registration Division
(7505C), 401 M Street, SW, Washington, DC 20460.
7. Only the registrant or collar manufacturer is authorized to fill LP collars
with 1080 solution. Certified applicators are not authorized to fill LP
collars. Compound 1080 solution may not be removed from collars and
used for any other purpose.
33
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8. LP Collars shall only be used to take coyotes within fenced pastures2 no
larger than 2,560 acres (4 square miles). But where average annual
precipitation does not exceed 20 inches and vegetation is sparse, consisting
only of short to mid-height grasses and scattered shrubs, collars may be
used in pastures up to a maximum of 10,000 acres (16 square miles) in
size.
In no case shall the applicator place LP collared livestock in pastures where
compliance with other Use Restrictions, such as monitoring, is impossible; in
fenced pastures larger than 10,000 acres; or in unfenced, open range.
9. LP Collars shall be used only where losses of sheep or goats due to
predation by coyotes are occurring or, based upon prior experience, where
coyote predation can reasonably be expected to occur.
10. Where LP collars are in use, each logical point of access (for example,
roads, gates, and trails) shall be conspicuously posted with a bilingual
(English/Spanish or other second language appropriate for the region)
warning sign not less than 8" X 10" in size. Signs shall be inspected weekly
to ensure their continued presence and legibility and will be removed when
collars are removed. The signs will have a minimum type size for
"DANGER-POISON" of 24 point (1/4 inches), with remaining text at least
18 point (3/16 inches).
11. All LP collared livestock must be checked at least once every seven days
and collars adjusted if needed.
If any LP collared animal is not accounted for in two consecutive checks,
an intensive search for it must be made.
In addition, if more than three LP collared animals are not accounted for
during any one check, an intensive search for these animals is required.
If more than nine (9) LP collars are unaccounted for during any 60 day
period, remove all collars from animals and terminate their use. Do not
resume use until adequate steps have been taken to prevent further,
excessive loss of collars.
Fenced pastures include all grazing land that is enclosed by livestock fencing. This includes
wire or other man-made fences such as rock walls, and natural barriers such as escarpments,
lakes, and large rivers that will prevent the escape of livestock.
34
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12. Damaged, punctured, or leaking LP collars shall be removed from the field
for repair or proper disposal. Damaged collars shall be placed individually
in leakproof containers while awaiting repair or proper disposal
Authorized collar repairs are limited to minor repairs of straps and
fastenings. Leaking or punctured collars must be properly disposed.
13. Dispose of 1080 wastes (punctured, leaking, or otherwise unrepairable LP
collars; contaminated leather clothing, animal remains, wool, hair
vegetation, water, and soil) under three feet of soil, at a safe location!
preferably on property owned or managed by the applicator and at least 1/2
mile from human habitations and water supplies. No more than 10 collars
may be buried in any one hole. If buried in a trench, each group of 10
collars must be at least 10 feet apart.
Incineration may be used instead of burial for disposal in the field
(preferably on property owned or managed by the applicator) at least 1/2
mile from human habitation and water supplies. Place collars and waste
(listed above) in an incinerator or refuse hole, saturate with diesel fuel, and
ignite. Attend the burn until the contaminated material is completely
consumed.
Alternatively, contact your State Pesticide or Environmental Control
Agency or the Hazardous Waste representative at the nearest EPA Regional
Office for guidance in disposing of wastes at approved hazardous waste
disposal facilities.
When snow or frozen ground make on-site disposal impractical, up to one
cubic foot of wastes may be stored in a leak-proof container in a dry
locked place for 90 days.
Metal Container: Triple rinse contaminated and uncontaminated containers
with water. Puncture and dispose of contaminated container and rinsate as
above.
Plastic Container: Triple rinse with water. Then puncture and dispose of
container and rinsate as above.
14. All persons authorized to possess and use LP Collars shall store them under
lock and key in a dry place away from food, feed, domestic animals, and
corrosive chemicals and in outbuildings, or in outdoor storage areas
attached to, but separate from human living quarters.
35
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15. Provisions for the protection of endangered species:
The LP Collar may not be used in the following areas due to potential
adverse effects to endangered species (California condor).
STATE
California
COUNTIES
Fresno, Kern, Kings, Los Angeles, Monterey, San
Luis Obispo, Santa Barbara, Tulare, and Ventura
The LP collar may not be used in the following areas without written approval
from the nearest U.S. Fish and Wildlife Service Office (FWS, Endangered Species
Specialists). If FWS or the user determines that the use of collars may adversely
impact an endangered species (San Joquin kit fox, black-footed ferret, Northern
Rocky Mountain wolf, or Grizzly bear) in the specific areas requested, collars
may not be used in these areas. Written approval must be obtained annually.
State
Counties or Area
NEAREST FWS
OFFICE/
PHONE
California Alameda, Contra Costa,
Merced, San Joaquin,
Santa Clara, and Satnislaus
Idaho Bonner, Boise (north of
State Highway 21),
Boundry, Clearwater,
Custer (north of local road
running from Sun Valley to
Chilly and a corresponding
line northeast from Chilly
to Patterson), Fremont,
Idaho, Lemhi, Shosshone,
and Valley
Michigan Keweenaw (Isle Royal) and
entire Upper Peninsula
Sacramento, CA
916-978-4866
Boise, ID
208-334-1931
Twin Cities, MN
612-725-3276
36
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State
Counties or Area
NEAREST FWS
OFFICE/
PHONE
Minnesota Aitkin, Becker, Beltrami, Twin Cities, MN
Carlton, Cass, Clearwater, 612-725-3276
Cook, Crow Wing,
Hubbard, Itasca, Kittson,
Koochiching, Lake, Lake
of the Woods, Mahnomen,
Marshall, Pennington, Pine
Roseau, and St. Louis
Montana Beaverhead, Carbon, Helena, MT
Flathead, Gallatin, Glacier, 406-449-5322
Lake, Lewis and Clark,
Lincoln, Madison,
Missoula, Park, Pondera,
Powell, Sanders,
Stillwater, Sweet Grass,
and Teton
Washington Pend Orielle, Okanogan,
(National Park and Forrest
Land), Skagit, and
Whatcom
Wisconsin Douglas, Florence,
Lincoln, Oneida, and Price
Wyoming Fremont, Park, and Teton
and Yellowstone National
Parks
16.
Boise, ID
208-334-1931
Twin Cities, MN
612-725-3276
Helena, MT
406-449-5322
The number of LP collars used shall be the minimum necessary for
effective livestock protection. For pastures of the following size classes, do
not use more collars than the number indicated.
Size (acres)
up to 100
101 to 640
641 to 10,000
Number of Collars
20
50
100
37
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17. Each applicator will have a one-ounce bottle of syrup of ipecac (to induce
vomiting in case of accidental poisoning) available when attaching,
inspecting, removing, or disposing of LP collars.
18. No contaminated animal will be used for food or feed.
In addition, for State-limited products, additional use restrictions consistent with
EPA's regulatory position and legal decisions regarding predacidal uses of sodium
fluoroacetate may be added. The organization of restrictions may be altered so as to
maintain consistency with applicable State and Federal laws and regulations but no
requirements may be dropped or mitigated. Any changes to the use restrictions must be
requested through the amendment process and must be accepted by the U.S.
Environmental Protection Agency before they may be incorporated into the labeling of
product released for shipment in the U.S.
Unless the Agency specifically indicates otherwise, the current accepted labeling
for registered 1080 Livestock Protection Collar products remains acceptable.
The registrants should submit 5 copies of their last accepted labeling (all 3
componets thereof) with their 8-months responses. The Agency will then review the
documents to determine whether any changes are needed.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Registration 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 sodium
fluoroacetate products bearing old labels/labeling, i.e., labels absent the modifications
specified in this RED document, except as noted below, for 26 months from the date of
issuance of this RED. Registrants and persons other than the registrants remain obligated
to meet preexisting Agency imposed label changes and existing stocks requirements
applicable to your products.
38
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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 SODIUM FLUOROACETATE covered by this Reregistration
Eligibility Decision Document. It contains generic data requirements that apply to SODIUM
FLUOROACETATE 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 m 4U UhK Fart 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.
47
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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.
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,
50
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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.
51
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BIBLIOGRAPHY
MRID CITATION
Beasom, S. L., (1982). Report on-Efficacy of the 1080 toxic collarsas a predator
damage control method (July 1, 1982 -September 30,1982). Texas A & M
University, College Station, Texas.
Burns R. J., Connolly, G. E. and Okuno, I. (1986). Secondary toxicity of coyotes
killed by 1080 single-dose baits. Denver Wildlife Research Center, USDA/APHIS.
Proc. 12th Vertebrate Pest Conf, San Diego, California. p324-329.
Burns, R.J. and G.E. Connolly 1992. Toxicity of Compound 1080 to Magpies
and the Relationship of Dose Rates to Residues Recovered. USDA, Denver
Wildlife Research Center. Proc. 15th Vertebrate Pest Conf., Newport Beach, Ca.
p403 (6).
Dana, R. H. 1971. Vertebrate pest control in California. Unpublished mimeo. rep.
California Dept. of Agriculture. 14 pp.
Ghali, G. 1994. RfD/Peer Review Report of Sodium Fluoroacetate. U.S. EPA
memorandum.
Gribble, G. 1973. Fluoroacetate Toxicity. J. Chem. Educ. 50:460-2.
Hegdal, P. L., T.A. Gatz, K. A. Fagerstone, J.F. Glahn and G. H.Matschke.
(1979). Hazards to wildlife associated with 1080 baiting for California ground
squirrels.
Hilton, H. W., Q.H. Yuen, and N.S. Nomura. 1969. Absorption of
monofluoroacetate-2C ion and its translocation in sugarcane. J.Agric. Food Chem
17:131-134.
Hudson, R. K., R. K. Tucker, and M. A. Haegele, 1984. Handbook of toxicity
of pesticides to wildlife, 2nd edition. U.S. Dept. oflnterior, Fish and Wildlife
Service, Resource Publication 153, Washington, D.C. 90 pp.
Knowlton, F.F., and S.M. Ebbert. 1991. Develop physiologic markersto identify
coyotes that kill sheep or goats (Unpublished report to the EPA - QA-090)
USDA/APHIS, Denver Wildlife Research Center, Denver, Colorado. 27 pp.
Sax, N. I., and Lewis, R. J. SR, (1989) Dangerous Properties of Industrial
Materials, 7th Ed. Van Nostrand Reinhold,
TAMUS (Texas A&M University System). 1983. Efficacy of the 1080 toxic collar
as a predator damage control method. Final report tothe U.S. Fish and Wildlife
Service for Cooperative Research Project No. 14-16-0009-81-934, September 1,
1980-June 30, 1983. Department of Wildlife and Fisheries Sciences, Texas
Agricultural Experiment Station. Data report submitted to the Environmental
Protection Agency to support modification of the Texas A&M University System,
College Station, TX. 134pp.
52
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BIBLIOGRAPHY
MRID
CITATION
USDA/APHIS, 1986. Unpublished Report entitled: Residues of sodium
fluoroacetate (1080) in coyotes and on the necks of sheep due to the use of large
(60 ml) compound 1080 livestock protection collars. Denver Wildlife Research
Center, Denver, Colorado. A data report to support the registration of the 60 ml
collar. Laboratory and Pen Studies. September 1985-January 1986. 10 pp.
USDA/APHIS, 1991. Correspondence from P. Joseph, summarizing the
information on the use of the Compound 1080 Livestock Protection Collar durine
FY-1988, 1989, and 1990 in five western states.
USFWS, 1984. Formal Section 7 Biological Opinion regarding 1 year extension
of experimental use permit for the 1080 toxic collar in Idaho, Montana and Texas
(6704-EUP-14). (FWS/OES EPA-84-3) 5 pp.
USFWS, 1985. Formal Section 7 Biological Opinion on the 1080 livestock
protection collar. Region 6 (6-RO-85-001) 18 pp.
USFWS, 1986. Letter from Allan J. Mueller, Acting Field Supervisor Division of
Ecological Services, Houston, Texas to Roger Mulder, Regulatory Division, Texas
Department of Agriculture, regarding endangered species use restrictions for
Texas.
Ward, J. C. and D.A. Spencer. 1947. Notes on the pharmacology ofsodium
fluoroacetate-compound 1080. Journal of the American Pharmaceutical
Association. 36(2): 59-62.
Wolfe, G. 1988. Subchronic Toxicity Study in Rats with Sodium Fluoroacetate
Study No. HLA-2399-118. Unpublished study conducted by Hazleton.
00061746
00061750
00065627
Atzert, S.P. (1971) A Review of Sodium monofluoroacetate (Compound 1080):
Its Properties, Toxicology, and Use in Predator and Rodent Control. By U.S. Fish
and Wildlife Service, Div. of Wildlife Services. Washington, D.C.: U.S. FWS.
(Special scientific report-wildlife no. 146; available from: Superintendent of
Documents, U.S. Government Printing Office, Washington, D.C. 20402-
published study; CDL:229637-B)
David, W.A.L.; Gardiner, B.O.C. (1966) Persistence of Fluoroacetate and
fluoroacetamide in soil. Nature 209(5030): 1367-1368. (Also in unpublished
submission received Apr 21, 1977 under 35978-2; submitted by Wyoming, Dept
of Agriculture, cheyenne, Wyo.; CDL: 229637-F)
Connolly, G., comp. (1980) Use of Compound 1080 in Livestock Neck Collars to
Kill Depredating Coyotes. (U.S. Fish and Wildlife Service, Denver Wildlife
Research Center; unpublished study including published data; CDL:243665-A)
53
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BIBLIOGRAPHY
MRID
CITATION
00144405 Burns, R.; Connolly, G.; Meeker, D.; et al. (1984) Efficacy and Hazards of
Compound 1080 in Toxic Collars: Laboratory and Pen Studies, April 1980 July
1984. Unpublished compilation prepared by US Fish and Wildlife Service,
Denver Wildlife Research Center. 53 p.
00243665 USDI Fish and Wildlife. 1980. Acute Oral Toxicity Study with Coyotes.
40016958 Goldman, P.; Milne, G. (1966) Carbon-fluorine bond cleavage. II. Studies on the
mechanism of the defluorination of fluoroacetate. Journal of Biological Chemistry
241(23):5557-5559.
40016959 Harrison, B.; Bransford, A.; MaNamara, B. (1951) Deterioration of sodium
monofluoroacetate in water and saline solutions. Federation Proceed. Pharm. and
Experimental Therapeutics 10:306-307.
Kelly, M. (1965) Isolation of bacteria able to metabolize fluoroacetate or
fluoroacetamide. Nature 208(5012):809-810.
Lien, B.; Cole, A.; Walker, J. (1979) Effect of sodium fluoroacetate ("compound
1080") on the soil microflora. Soil Biol. Biochem. 11:13-18.
Tonomura, K.; Futai, F.; Tanabe, O., et al. (1965) Defluorination of
monofluoroacetate by bacteria. Part I. Isolation of bacteria and their activity of
defluorination. Agr. Biol. Chem. 29(2): 124-128.
40016966 Walker, J.; Lien, B. (1981) Metabolism of fluoroacetate by a soil Pseudomonas
sp. and Fusarium solani. Soil. Biol. Biochem. 13: 231-235.
40016967 Corr, P.; Martire, P. (1971) Leaching by rain of sodium fluoroacetate ("1080")
from baits used for rabbit control. Austral. J. Exp. Agric. and Animal Husb.
ll(Jun):287-28l.
40016969 Peters, J. (1974) Environmental Contamination, Toxicology, and Residues of
Compound 1080 (Sodium Fluoroacetate) in Relation to Aerial Control Programmes
in Protection Forests: A Synopsis. Unpublished study prepared by New Zealand
Forest Service. 6 p.
40016970 Staples, E. (1968) The reduction of the sodium monofluoroacetate ("1080")
content of carrot baits of various thickness by weathering. N.Z. Jour. Agric. Res.
ll(2):319-329.
40016971 Dieke, S.; Richter, C. (1946) Comparative assays of rodenticides on wild norway
rats: I. Toxicity. Reprint No. 2708, Public Health Reports 61(19):672-679.
40016990 Sullivan, J.; Smith, F.; Carman, R. (1979) Effects of fluoroacetate on the testis
of the rat. Reprod. Pert. 56:201-207.
54
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BIBLIOGRAPHY
MRID
CITATION
40402603
40402604
41514901
42961601
42961602
42961603
43210601
43210602
Cerven, D. (1987) Primary Eye Irritation/Corrosion in Albino Rabbits: Sodium
Monofluoroacetate Compound 1080-1% (...) Poison: Lab. Proj. ID MB 87-8886
D. Unpublished study prepared by MB Research Laboratories, Inc. lip.
Cerven, D. (1987) Primary Dermal Irritation in Albino Rabbits: Sodium
Monofluoroacetate Compound 1080-1% (...) Poison: Lab. Proj. ID MB 87-8886
C. Unpublished study prepared by MB Research Laboratories, Inc. 10 p.
Savarie, P.; Burns, R.; Zemlicka, D. (1990) Sodium Fluoroacetate (Compound
1080) Contamination on the Necks of Lambs with Livestock Protection Collars
(LPCs) that are killed by Coyotes: Lab Project Number: QA-65. Unpublished
study prepared by USDA-APHIS-S&T, Denver Wildlife Research Center. 227 p.
Collins, M. (1993) Sodium Fluoroacetate-Acute Toxicity to Bluegill Sunfish
(Lepomis macrochirus) Under Static Renewal Conditions: Lab Project Number
13014.0293.6100.100: DWRC QA-294: 93-7-4847. Unpublished study prepared
by Springborn Labs, Inc. 65 p.
Collins, M. (1993) Sodium Fluoroacetate-Acute Toxicity to Rainbow Trout
(Oncorhynchus mykiss) Under Static Conditions: Lab Project Number
13014.0293.6101.103: QA-295: 93-8-4885. Unpublished study prepared by
Springborn Labs, Inc. 68 p.
Collins, M. (1993) Sodium Fluoroacetate-Acute Toxicity to Daphnids (Daphnia
magna) Under Static Conditions: Lab Project Number: 13014.0293.6102.110-
DWRC QA-296: 93-7-4844. Unpublished study prepared by Springborn Labs, Inc.
70 p.
Campbell, S.; Beavers, J.; Grimes, J. (1994) Sodium Fluoroacetate: A Dietary
LC50 Study with the Northern Bobwhite: Lab Project Number: 247-101B-
QA-297: 94-021. Unpublished study prepared by Wildlife International Ltd 27
P-
Campbell, S.; Beavers, J.; Grimes, J. (1994) Sodium Fluoroacetate: A Dietary
LC50 Study with the Mallard: Lab Project Number: 247-102B: 94-021: QA-298
Unpublished study prepared by Wildlife International Ltd. 26 p.
55
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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 A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of y9ur products subject to this Notice in Attachment 2, Data Call-in Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
Tnis Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
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Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - rrociuct-speclfic Data Call-in Response Form
3 - Kequirements status and Registrant's Response Form
4 - zrA mtcning"or ana- use rroaucts tor Meeting Acute Toxicology Data
Kequirements tor Keregistration ~ -
5 - List ot Registrants Receiving This Notice
6 - Cost Share and Data Compensation horms, and Product Specific Data Report
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and Devaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II- A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required .
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided. ~ - * -
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.
,XT J!?ese ^P4 Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
/^r^^^ aPProved ty 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
OhLD 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
57
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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-ln(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 CNOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
or (c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of options
relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
Attachment 2 and Attachment 3. The Data Call-in Response Form must be submitted as part
of every response to this Notice. In addition, one copy or the Requirements Status and
Registrant's Response Form must be submitted for each product listed on the Data Call-In
Response horm 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
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completed Data Call-in Response Form, indicating your election of this option. Voluntary
cancellation is item number 3 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 avaiiaoie to satisfy trie product specific data requirements ot 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
Lall-In Response horm. Deletion ot a use(s) and the low volume/minor use option are not
valid options tor fulfilling product specific data requirements.
3 Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in section lll-U or 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
5oth forms as well as any otner mtormation/data pertaining to the option chosen to address the
data requirement.
HI-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If yoa 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) F
(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
confprmance witn Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-
5.
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The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing tor the submission of completed study reports. The
noted deadlines run from the date of the receipt of this Notice by the registrant. If the data are
not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose
this option tor 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 chooseTo 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 etticacy 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
60
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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
Fo.rm. an,d 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 vour
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4 Submitting an Existing Study -- If you choose to submit an existing study in
response to mis 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
mis Notice. Do not use this option if you are submitting data to upgrade a study. (See Option
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
Pan 160. As stated in 40 CFR 160.3(j) " 'raw data1 means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data 'Raw
data may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
(r°m 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
61
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c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the
study clearly meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding acceptable protocols. If
you wish to submit the study, you must, in addition to certifying that the
purposes of the PAG are met by the study, clearly articulate the rationale why
you believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the PAG
and that necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If 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 rationalefof how the
deficiencies have been remedied or corrected and why the study should be rated as acceptable
to EPA. Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6, Citing Existing Studies If you choose to cite a study that has been
previously submitted to fcPA, 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
62
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toxicology studies generally will have been classified as "core-guideline" or "core minimum "
hor all other disciplines the classification would be "acceptable." With respect to any studies
tor 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. y
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 tor product
cnemistry, acute toxicity and etticacy (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
!° miUoAby a.registrant to comply with the requirements of this Data Call-in Notice, pursuant
to HhRA 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. r
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.
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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:
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
64
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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.
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
AUVfcKSb 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
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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 horm (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be
submitted to the contact person(s) identified in Attachment 1. If the voluntary cancellation or
generic data exemption option is chosen, only the Data Call-In Response Form need be
submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
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 - fcFA Batching ot bnd-Use Products tor Meeting Acute Toxicology Data
Requirements lor Reregistration
5 - List of Registrants ReceivingThis Notice
6 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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SODIUM FLUOROACETATE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing sodium fluoroacetate. F um,iw
. .. This. Generic Data Call-in Chemical Status Sheet, contains an overview of data required
£T iiASD???%'?A0^111^ C0mact ror m(luines Pertaining to the reregistration of SODIUM
£ iff *T ,ix TE;, Thls attachment is to be used in conjunction with (1) the Generic Data
Call-In Notice, (2) the Generic Data Call-In Respnse Form (Attachment 2), (3) the Requirements
Status and Registrant s Form (Attachment 5), (4) a list of registrants receiving this DCI
(Attachment 4) (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data
Lompnsation Forms in replying to this sodium fluoroacetate Generic Data Call In (Attachment
r). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
~ me additional data requirements needed to complete the generic database for sodium
fluoroacetate are contained in the Requirements Status and Registrant's Response. Attachment C
The Agency has concluded that additional product chemistry data on sodium tluoroacetate are
fluoroacet d ^ ****** l° ^ complete the ^registration of all eligible sodium
INQUIRIES AND RESPONSES TO THIS NOTICE
u,- 1J 7?u !l?ve.Tany Questions regarding the generic data requirements and procedures
established by this Notice, please contact Leonard Ryan at (703) 308-8067.
All responses to this Notice for the generic data requirements should be submitted to:
Leonard Ryan, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: SODIUM FLUOROACETATE
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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.
68
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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 Registration 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 Requirements11
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
that this option is available only for acute toxicity or certain efficacy data and only
if EPA indicates in an attachment to this Notice that my product is similar enough
to another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
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
3.
I understand that this option is a^
69
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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 ffl-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. 1.) and will meet the
attached acceptance criteria (for acute tpxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I have
indicated this choice. By the specified due date, I will also submit a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) to show what data compensation option I have chosen. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this
option outlined Option 5 in the Data Call-in Notice (Section III-C. 1.) 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).
70
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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 have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
71
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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. Tnis number must be used in the transmittal document for any data submissions
in response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data, the
required studies only pertain to products which have the use sites and/ or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-in Notice.
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing). I am submitting a copy of this agreement. I
understand that this option is available on for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this notice that my product is similar.
Enough to another product to qualify for this option. I certify that another party
in the agreement is committing to submit or provide the required data; if the
required study is not submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost
Share). I understand that this option is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an attachment to this Data Call-In Notice
that my product is similar enough to another product to qualify for this option. I
am submitting evidence that I have made an offer to another registrant (who has
an obligation to submit data) to share in the cost of that data. I am also submitting
72
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a completed " Certification of offer to Cost Share in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
require data; if the required study is not submitted on time, my product may be
subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product,
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose this
option if I am citing my own data. In either case, I will provide the MRID or
Accession number (s) number (s) for the cited data on a "Product Specific Data
Report" form or in a similar format. If I cite another registratrant's data, I will
submit a completed "Certification With Respect To Data Compensation
Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request.
If the Agency approves my waiver request, I will not be require to supply the data
pursuant to Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
chosen. I also understand that the deadline for submission of data as specified by
the original data cal-in notice will not change.
73
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Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
74
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EPA'S BATCHING OF SODIUM FLUOROACETATE 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 sodium fluoroacetate
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. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery or 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
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.
Seven products were found which contain sodium fluoroacetate as the active ingredient.
The products have been placed into one batch and a "no batch" category in accordance with
75
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the active and inert ingredients, type of formulation and current labeling. Table 1 identifies the
products in the batch. Table 2 lists the product which has been placed in the "no batch"
category.
Table 1
Batch
l
EPA Reg. No,
13808-7
35975-4
35978-8
39508-2
46779-1
56228-22
% Active lagrediea*
1.0
1.0
1.0
1.0
1.0
1.0
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
The following table lists a product that was either considered not to be similar or the
Agency lacked sufficient information for decision making and were not placed in any batch.
The registrant of this product is responsible for meeting the acute toxicity data requirements
separately.
Table 2 (No Batch)
EPA Reg, No.
56228-26
% Active Ingredient
90.0
Formulation Type
Solid
76
-------
Attachment 5. List of All Registrants Sent This Data
Cair-ln (insert) Notice 6
77
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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.
79
-------
80
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81
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82
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?/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
207MK157
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460: and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company (Number
F.PA 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 Rodenticlde 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):
Nam* of Flrm(a)
Oat* of Offer
Certification:
I certify that 1 am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company' a Authorized Rapr*aantatlv*
Dat*
Nama and Tit la (Picas* Typ* or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which i* obsolete
83
-------
84
-------
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)
:PA Form 8570-31 (4-96)
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The following is a list of available documents related to sodium fluoroacetate. It's purpose
is to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Sodium fluoroacetate and are included in the EPA's
Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Sodium fluoroacetate RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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