United States
                    Environment*! Protection
                    Office of Pesticides and Toxic Substances
                    Office of Pesticide Programs (TS-766C)
                    Washington, DC 20460
   &EPA      Pesticide
                    Fact Sheet
                    Name of Chemical: SODIUM FLUOROACETATE  (COMPOUND  ioso)
                   Reason for Issuanpe: CANCELLATION/DENIAL/SUSPENSION/DATA CALL-I
                   Date Issued:  OCTOBER 1988
                   Fact Sheet Number: 174

   Generic Name:   Sodium  Fluoroacetate
   Common Name:
   Trade and  Other  Names:   Compound 1080, Sodium monofluoroacetate,

   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.

   The principle use of  compound 1080 is to control field rodents.
   Thirty  nine rodenticide end-use products are currently author-
   ized 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 Regist-
   rations for 1080  Toxic Collars.  This use will be affected as
   the Agency will require datr-a to support a registration for a
   1080 technical product to  be used only in formulation of live-
   stock protection  collars.

                                -2-                                    <
   Formulation Type:  Compound 1080 rodenticide is formulated into
                      grain baits at 0.2% to 0.11%.  The registra-
                      tion for 1080 water baits was cancelled in


     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 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.

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

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

     4) A data call-in notice [Federal Insecticide, Fungicide, and
        Rodenticide Act section 3(c)(2)(b)3 requiring product
        chemistry data to support a technical grade compound- 1-OBO	
        product to be used only in livestock protection collars
        (USDA, Montama 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.


     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 critial data.  Accord-
ingly, 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 Agricul-
ture (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 sub-
mitted 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 coumpound
      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 108Q 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 Cali-
fornia, 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 noti-
fied 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 qualifica-
tions 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 rescissioin 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 can-
cellation 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 Wildife v. Administrator.