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Sodium fluoroacetate (Compound 1080). US EPA Fact Sheet. August 1990


EPA Fact Sheet, August 1990

Sodium fluoroacetate

Name of Chemical: SODIUM FLUOROACETATE (COMPOUND 1080)
Reason for Issuance: CANCELLATION/DENIAL/SUSPENSION/DATA CALL-IN
Date Issued: OCTOBER 1988 (updated 8/9/90)
Fact Sheet Number: 174


1. DESCRIPTION OF CHEMICAL

- Generic Name: Sodium Fluoroacetate, CH2F-COON
- Common Name: 1080
- Trade and Other Names: Compound 1080, Sodium monofluoroacetate, Ratsbane
- EPA Shaughnessy Code: 075003-4
- Chemical Abstracts Service (CAS) Number: 62-74-8
- Pesticide Type: Vertebrate Pesticide
- U.S. Producers: Only one manufacturer, Tull Chemical Company, Inc., sells compound 1080 manufacturing use (technical) product in the United States.


2. USE PATTERNS AND FORMULATIONS

The principle use of compound 1080 is to control field rodents. Thirty nine
rodenticide end-use products are currently authorized for use: 35 with
California counties, 2 with the Colorado Department of Agriculture, and 1
with Klamath County, Oregon. The California and Colorado products have
intrastate registrations. Klamath County has a "special local need"
registration.

Montana, Wyoming, Ranchers Supply of Alpine, Texas, and the U.S. Department
of Agriculture currently have Federal Registrations for 1080 Toxic Collars.
This use will be affected as the Agency will require data to support a
registration for a 1080 technical product to be used only in formulation of
livestock protection collars.


Formulation Type: Compound 1080 rodenticide is formulated into grain baits
at 0.2% to 0.11%. The registration for 1080 water baits was cancelled in
1986.

3. AGENCY ACTION

EPA is taking a number of regulatory actions involving 1080 registrations
and applications for registrations, since data required to support the
registration of 1080 rodenticide products has not been submitted in
accordance with Agency requirements. The Agency is issuing:

- 1. A denial of application for Federal Registration of 1080
intrastate pesticide products effective August 9, 1990 (Federal
Register, 8/9/1990).

- 2) A notice of intent to deny the registration of intrastate products
(20 California counties; Colorado Department of Agriculture) for
which a complete application for Federal registration was
submitted prior to July 31, 1988, in accordance with 40 CFR
152.230.

- 3) A notice of intent to cancel the registration of the one technical
grade compound 1080 product (Tull Chemical Co.).

- 4) A notice of intent to suspend the one end-use federally registered
1080 rodenticides (Klamath County, Oregon).

- 5) A data call-in notice [Federal Insecticide, Fungicide, and
Rodenticide Act section 3(c)(2)(b)] requiring product chemistry
data to support a technical grade compound 1080 product to be
used only in livestock protection collars (USDA, Montana
Department of Livestock, Wyoming Department of Agriculture,
Ranchers Supply Co.).

No actions, other than requests for minimal product chemistry data, are
being taken with respect to the 1080 livestock protection collar
registrations.

4. BACKGROUND

The principal use of compound 1080 is to control field rodents. It was
available for this use in California, Colorado, Nevada, and Oregon because
these states had valid "intrastate" registrations. Other states which had
used 1080 for field rodent control relied on the U.S. Department of the
Interior registration, which was withdrawn following a 1972 Executive
order prohibiting the use of compound 1080 on federal lands. Prior to
1972, 1080 was also used for predator control, principally coyotes.

California uses over 80 percent of the compound 1080 as a field rodenticide
the bulk is used to control ground squirrels. The only Federal Registration
for field rodent use is a "Special Local Needs" registration granted to
Klamath County, Oregon.

On July 31, 1985 the Agency concluded a Special Review on Sodium
Fluoroacetate (1080) with the finding that: 1) use of compound 1080 to
control field rodents may have adverse effects on nontarget wildlife; 2)
these risks could be reduced by modifying the labeling of the products and,
in certain cases, by reducing the concentration of compound 1080 in
rodenticide baits. However, the Agency was unable to determine whether
additional regulatory restrictions were needed due to the lack of critical
data. Accordingly, the Agency conditioned any future use of the 1080
rodenticide on the immediate adoption of certain risk reduction
measures and on the submission of the full complement of data required for
Federal Registration.

The Agency's current action on compound 1080 registrations relates to the
failure of registrants to satisfactorily respond to two DCI Notices. In
November, 1985, a Notice Requiring Submission of Full Applications for
Federal Registration for all intrastate products was sent to states with
intrastate registrations (40 CFR 162.17). A DCI Notice was also issued to
California, Colorado and Nevada requiring the submission of data to support
compound 1080 Federal Registrations. Similar DCIs were also issued to Tull
Chemical Co., Inc. and Klamath County. Tull Chemical Co. declined to
submit data, but the California Department of Food and Agriculture (CDFA)
agreed to provide the data for the company.

Prior to issuing the November 1985 DCI, the Agency met with registrants and
interested user groups to explain, among other things, why data were
required and how to generate the data.

Thirty six applications for Federal Registrations were submitted by CDFA,
and two were submitted by the Colorado Department of Food and Agriculture.
The Nevada Department of Agriculture failed to submit Federal Registration
applications for its three intrastate products.

In December 1986, the Agency received data from CDFA and the Colorado
Department of Agriculture to support the compound 1080 rodenticide use for
California, Colorado, Klamath County, and for the technical 1080
registration for Tull Chemical Co., Inc. However, upon review of the data,
the Agency determined that the submissions by California and Colorado are
unsatisfactory for the following reasons:

1. Inadequate safety data to determine hazards to nontarget
fish, birds, and mammals

2. Lack of specific directions for 1080 use to enable the
Agency to determine the food/feed sites for which compound
1080 is/has been used so applicable data requirements can be
determined, and

3. No validated analytical method with detection limits low
enough to determine concentrations of compound 1080 at the
level of concern.

A second public meeting was held in October 1987 where the Agency again
explained why the data were required and clarified procedures for data
development.

On December 15, 1987 another DCI Notice was issued to California, Colorado,
Tull Chemical Co., Inc., and Klamath County. This Notice required the
submission of four additional environmental fate studies.

On December 17, 1987 the compound 1080 registrants were notified that the
Agency would extend the data due dates in the 1985 DCI Notice if the
registrants submitted the following items within 30 days: 1) a commitment
to fulfill the data requirements, 2) legible draft revised labels, with the
use of sites clearly defined; and 3) A Confidential Statement of Formula
(EPA Form 8570-4). In addition, progress reports were required for many
long-term studies required by the DCI.

Additional data were submitted by CDFA in May 1988, to support compound
1080 use in California, Colorado, Klamath County, and the technical
registration for Tull Chemical Co., Inc. Upon Agency review, the data were
again found to be unsatisfactory. When CDFA also requested waivers of many
of the data requirements, the Agency denied the request.

The Agency is taking action against all rodenticide compound 1080
registrations because of the lack of progress toward completing the DCI
long-term data requirements, failure to submit the DCI short-term
requirements by the due dates, unacceptable qualifications to the
commitments to satisfy data requirements, and failure to submit
administrative forms.

The Agency is requiring the four compound 1080 toxic collar registrants to
register a compound 1080 manufacturing-use product (technical) to be used
only in the formulation of livestock protection collars. The data required
to support this registration will involve only product chemistry requirements.

The Agency also will be taking action with regard to the registrations of
strychnine products, another vertebrate control pesticide. The Agency is
issuing a rescission of the authority to sell or distribute intrastate
products, and initiating a process to suspend the remaining strychnine
registrations until all data required by three Data Call-In Notices are
submitted to the Agency and, upon Agency review, are found to be
acceptable. (These actions against strychnine are independent of the
temporary cancellation action required by the April 11, 1988 order of the
United States District Court for the District of Minnesota in the case of Defenders of Wildlife v. Administrator.

For more information relative to pesticides and their use, please contact
the PMEP staff at:
5123 Comstock Hall
Cornell University
Ithaca, New York 14853-0901
(607)-255-1866
Last Modified:
05/14/1999