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Xanthomonas campestris subsp. vesicatoria - Temporary Exemption from Tolerance 8/94

Bacteriophages of Xanthomonas campestris subsp. vesicatoria;

Establishment of Temporary Exemption from Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has established an exemption from the requirement
of a tolerance for bacteriophages isolated from Xanthomonas
campestris subsp. vesicatoria in or on the raw agricultural
commodities tomatoes and peppers. This exemption has been established
by the Agency on its own initiative.

DATES: This temporary exemption expires August 15, 1996.

FOR FURTHER INFORMATION CONTACT: By mail: Steve Robbins, Acting
Product Manager (PM) 21, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 227, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202, (703) 305-6900.

SUPPLEMENTARY INFORMATION: EPA received from AgriPhi, Inc.,
160 North Main, Logan, Utah 84321, an application for an Experimental
Use Permit for proposed field testing of the efficacy of a product
containing bacteriophages isolated from bacterial lesions on
tomato and pepper plants produced by Xanthomonas campestris
subsp. vesicatoria. In order to further the research efforts
of this small company in the development of innovative biological
pest control technology, the Agency has established a temporary
exemption from the requirement for a tolerance of these bacteriophages
in or on the raw agricultural commodities tomatoes and peppers.
This temporary exemption will permit the marketing of the above
raw agricultural commodities when treated in accordance with
the provisions of the Experimental Use Permit 67986-EUP-1 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 establishment of a
temporary tolerance is not necessary to protect the public health.
Public literature citations were referenced which indicate that
bacteriophages are specific to their bacterial host and present
no unique toxicity hazards to humans or wildlife. Research has
been conducted on bacteriophages for the past 80 years with
no documented cases of adverse effects to man or the environment.
Bacteriophages are commonly occurring in nature and would normally
be found on raw agricultural commodities. Therefore, a temporary
tolerance has been established on the condition that the pesticide
be used in accordance with the Experimental Use Permit and with
the following provisions:
   1.  The total amount of the active ingredient to be used
must not exceed the quantity authorized by the Experimental
Use Permit.
   2.  AgriPhi, Inc., 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.
   This temporary exemption from tolerance requirements expires
August 15, 1996. Residues remaining in or on the raw agricultural
commodity after this expiration date will not be considered
actionable if the pesticide is legally applied during the term
of, and in accordance with, the provisions of the experimental
use permit. This tolerance exemption may be revoked if the experimental
use permit is revoked or if any experience with or scientific
data on this biological 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 2 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. 346(j).

List of Subjects

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

   Dated: August 29, 1994.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 94-21867 Filed 9-6-94; 8:45 am]