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 Seneric database supporting the reregistration of sodium
p . j 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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