[Federal Register Volume 59, Number 172 (Wednesday, September 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21867]


[[Page Unknown]]

[Federal Register: September 7, 1994]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[OPP-300357; FRL-4906-6]

 

Bacteriophages of Xanthomonas campestris subsp. vesicatoria; 
Establishment of Temporary Exemption from Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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]
BILLING CODE 6560-50-F