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Bacillus thuringiensis CryIA(b) Delta-Endotoxin - Tolerance Requirement Exemption 4/97

ENVIRONMENTAL PROTECTION AGENCY
[PP 5G4495 and 6E4709/T695; FRL 5382-5]
Monsanto Agricultural Company; Establishment of Exemptions from
Requirement of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA has established exemptions from the requirement of
tolerances for the combined residues of the plant pesticide Bacillus
thuringiensis CryIA(b) delta-endotoxin and the genetic material
necessary for its production and for the plant pesticide inert
ingredient CP4 EPSPS protein and its regulatory regions in or on
certain raw agricultural commodities.

DATES: These temporary exemptions from the requirement of tolerances
expire April 25, 1997.

FOR FURTHER INFORMATION CONTACT: By mail: Michael Mendelsohn,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. Crystal
Station, 5th Fl., 2800 Crystal Drive, Arlington, VA, (703) 308-8712; e-
mail: mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Monsanto Agricultural Company, 700
Chesterfield Parkway North, St. Louis, MO 63198, has requested in
pesticide petitions (PP) 5G4495 and 6E4709 the establishment of
exemptions from the requirement of tolerances in or on certain raw
agricultural commodities as follows:
    1. Pesticide petition (PP) 5G4495 has established an exemption from
the requirement of a tolerance for the combined residues of the plant
pesticide Bacillus thuringiensis CryIA(b) delta-endotoxin and the
genetic material necessary for its production in corn, when used as a
plant pesticide in all raw agricultural commodities of field corn,
sweet corn, and popcorn.
    2. Pesticide petition (PP) 6E4709 has established an exemption from
the requirement of a tolerance for the combined residues of the plant
pesticide inert ingredient CP4 EPSPS protein and the genetic material
necessary for its production in corn when used as a plant pesticide
inert ingredient in all raw agricultural commodities of field corn,
sweet corn, and popcorn.
    These temporary exemptions from the requirement of tolerances will
permit the marketing of the above raw agricultural commodities when
treated in accordance with the provisions of experimental use permit
524-EUP-82, which is being issued under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended (Pub. L. 95-396, 92
Stat. 819; 7 U.S.C. 136).
    The scientific data reported and other relevant material were
evaluated, and it was determined that exemptions from the requirement
of tolerances will protect the public health. Therefore, the temporary
exemptions from the requirement of tolerances have been established on
the condition that the pesticides be used in accordance with the
experimental use permit and with the following provisions:
    1. The total amount of the active ingredients to be use must not
exceed the quantity authorized by the experimental use permit.
    2. Monsanto Agricultural Company must immediately notify the EPA of
any findings from the experimental use that have a bearing on safety.
The company must also keep records of production, distribution, and
performance and on request make the records available to any authorized
officer or employee of the EPA or the Food and Drug Administration.
    These temporary exemptions from the requirement of tolerances
expire April 25, 1997. Residues remaining in or on all raw agricultural
commodities after this expiration date will not be considered
actionable if the pesticides are legally applied during the term of,
and in accordance with, the provisions of the experimental use permit
and temporary exemptions from the requirement of tolerances. These
temporary exemptions from the requirement of tolerances may be revoked
if the experimental use permit is revoked or if any experience with or
scientific data on this pesticide indicate that such revocation is
necessary to protect the public health.
    The Office of Management and Budget has exempted this notice from
the requirement of section 3 of Executive Order 12866.
    Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).

    Authority: 21 U.S.C. 346a(j).

List of Subjects

    Environmental protection, Administative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 18, 1996.

Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

[FR Doc. 96-19456; Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F