•-              unica Oi Pesticides and Toxic Substances
                      Environmental Protection      Office of Pesticide Programs (TS-766C)
                      Agency              Washington, DC  20460
                                                             540/FS-88-125
     &EPA      Pesticide
                      Fact Sheet
                      Name of Chemical: STRYCHNINE ALKALOID AND SULFATE
                      Reason for Issuance: SUSPENSION and RESCISSION OF SALES
                      Date Issued:       OCTOBER,  1988
                      Fact Sheet Number: 175

1.   DESCRIPTION OF CHEMICAL
               •	'	•—•                   »
    Generic  Name: • Strychnine Alkaloid
    (chemical)     Strychnine Sulfate

    Common Name:   Strychnine

    Trade and
    Other Names:   Nux Vomica

    EPA Shaughnessy Code:  Strychnine Alkaloid  076901-8
                          Strychnine Sulfate   076902-6

    Chemical Abstracts Service (CAS) Number:

        Strychnine Alkaloid 57-24-9
        Strychnine Sulfate  60-41-3

    Pesticide Type:  Vertebrate pesticide.

    U.S. and Foreign Producers:  All manufacturers import  the technical
        material.  Importers include H.  Interdonati,  Inc.; H. R. Harkins,
        Inc.. and Noris Chemical Co.  There are approximately 100
        registrants of end-use products.   The  California  Department of
        Food and Agriculture and California counties  are  registrants
        of  37 end use products.  The U.S. Department  of Agriculture
        has seven strychnine registrations:  6  end use products and a
        technical product which is a repackage of an  importer's product.

    2.  USE PATTERNS AND FORMULATIONS;

       There are 383 products; 194 are registered  for  use  above ground
    and 189  are registered for use below ground.   The  approximately
    200 use  sites include rangelands, pastures,  many crops, forests,
    and below ground application for pocket gophers and moles.
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    Formulation Types;  Strychnine is usually formulated in grain baits
    at  0.2%  to 2.63% but  is also incorporated into a salt  block at 5.79%.

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3. AGENCY ACTION;
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     EPA is taking a number of regulatory actions involving strych-   j
nine registrations and applications for registrations,  since data
required to support the registration of strychnine products has not
been submitted in accordance with Agency requirements.   The Agency
is issuing:

     1.) A notification of rescission of authority to sell or
         distribute intrastate products for (CDFA and numerous
         California counties) which a complete application for
         Federal registration was not submitted prior to July 31,
         1988 in accordance with 40 CFR 152.230.   Further,  regarding
         all strychnine applications which are not associated with
         intrastate products, registration will be withheld pending
         the receipt and acceptance of required data.

     2.) A notice of intent to. suspend all registrations which are
         not in compliance with the submission schedule for data
         and other information (Colorado, Department of Agriculture;
         CDFA and numerous California counties; South Dakota Depart-
         ment of Agriculture; Klamath County,  Oregon; Nevada Depart-
         ment of Agriculture; USDA; and non-governement registrants
         for both end-use and technical grade strychnine products.)

      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 Wildife v.  Administrator.

4. BACKGROUND

     In March 1972, an Executive Order was issued prohibiting the
use of all toxicants, including strychnine, for control of predators
on federal lands or in federal programs.  In the same year, the
Environmental Protection Agency (EPA) cancelled all registrations
of strychnine for predator control.  In addition, in February 1978,
EPA restricted the use of strychnine formulations with concentra-
tions greater than 0.50% to use only by certified applicators.  The
restriction was based on acute oral toxicity, hazards to nontarget
species, and use and accident history.

      In 1976, EPA initiated a Special Review  (formerly Rebuttable
Presumption Against Registration [RPAR]) of the above-ground uses
of strychnine.  The Special Review criteria that were met or exceeded
for above-ground uses are:  1) acute toxicity to mammals and birds;
and 2) significant reduction in populations of nontarget organisms
and fatalities to members of endangered species.

     The Special Review was concluded in October 1983, with publi-   (
cation of a Notice of Intent to Cancel  (48 FR 48522).  The Notice

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allowed  continued registration of strychnine for certain above-
ground uses with specific label modifications.  The Notice also
required full cancellation of the uses for the control of prairie
dogs, deer mice, meadow mice, chipmunks, marmots/woodchucks on
rangeland/ pastures and cropland; all rodents and small mammals
(except  ground squirrels, marmots/woodchucks) around rock piles
and  lava outcrops, jackrabbits around airports, and porcupines on
nonagricultural sites.

     The Agency also required label modifications for uses involv-
ing  ground squirrels,  jackrabbits, kangaroo rats, and cotton
rats on  rangeland/pastures and cropland; ground squirrels, marmots/
woodchucks, jackrabbits, and porcupines on nonagricultural sites;
and birds on cropland  and nonagricultural sites.  An administrative
hearing  was convened for the prairie dog, ground squirrel and
meadow mouse uses.

     In  March 1987, the Agency published a Federal Register notice
that withdrew the 1983 Notice of Intent to Cancel product regis-
trations  for control of prairie dogs, meadow mice, and ground
squirrels and allowed  these uses to continue if certain protective
measures were implemented.  This action reflected the terms of the
settlement of the administrative hearing.  The Agency was sued in
1986 in  the U.S. District Court in Minnesota regarding the terms
of the settlement agreement by the Defenders of Wildlife and the
Sierra Club,  who alleged that continued use of strychnine for
above-ground use would result in takings of protected wildlife
under the Endangered Species Act, the Migratory Bird Treaty Act,
and the  Bald and Golden Eagle Protection Act.  The court ordered
EPA to temporarily cancel all registrations of strychnine for
above-ground use to protect nontarget species.  EPA will issue a
Federal  Register notice, currently scheduled for mid-September to
implement the court's  decision.

    The  Special Review also concluded that efficacy/safety data
for ground squirrels should be developed in order to determine
the lowest efficacious dosage.  These data were required through
a Data Call-in (DCI) Notice which was issued in 1984.  The Agency's
current  action with regard to the withdrawal/suspension of strych-
nine registrations relates to a total of three DCI notices which
have been issued:

    1.  The August 1984 Notice requiring ground squirrel efficacy/
       safety data pursuant to the Special Review;

    2.  An October 1986 Notice requiring the submission of residue
       chemistry, toxicology, environmental fate, environmental
       safety and efficacy data for all strychnine products, as

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       well as draft revised labels and data compensation forms;
       and

    3. A December 19P7, DC! Notice requiring the submission of
       four additional environmental fate studies.

    In October 1987, the Agency met with registrants and interest-
ed user groups to explain, among other things, why data were
required and how to generate the data.

    All strychnine registrants were notified by a December 1987
letter that the Agency would extend the data due dates in the DCIs
if the (registrants submitted the following items within 30 days:
1) a commitment to fulfill the data requirements contained in the
three DCI notices; 2) legible draft revised labels, with the use
sites clearly defined; and 3) a Confidential Statement of Formula
(EPA Form 8570-4).  In addition, schedules were established for
progress reports on long-term studies.

     The Agency is taking action against all strychnine products
because of the lack of progress toward completing the long-term
data requirements required in the DCIs, unacceptable qualifica-
tions to the commitments to satisfy data requirements/ and failure
to submit administrative forms.

    The Agency is also taking action with regard to the regis-
trations of compound 1080, which is a vertebrate pesticide used
principally to control field rodents.  The Agency is denying
intrastate product applications for registration, cancelling the
one technical manufacturer's registration, and suspending the
"special local need" registration.  A data call-in requiring
minimal product chemistry data to support the registtation.

These actions are being taken because of the  failure of regis-
trants to satisfactorily respond to DCI requirements concerning
compound 1080.

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