[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13557]


[[Page Unknown]]

[Federal Register: June 3, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-50784; FRL-4778-7]

 

Issuance of an Amendment/Extension of an Experimental Use Permit 
for a Transgenic Plant Pesticide

AGENCY: Environmental Protection Agency

ACTION: Notice.

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SUMMARY: On April 5, 1994, EPA issued an amendment/extension for 
Experimental Use Permit (524-EUP-73) to Monsanto Company to conduct 
field testing of a transgenic plant pesticide. The first EUP on this 
organism was issued April 10, 1992. The Agency has determined that this 
may be of national or regional significance. Therefore, in accordance 
with 40 CFR 172.11(a), the Agency is soliciting public comments on this 
application.

Dates: Written comments must be received on or before July 5, 1994.

ADDRESSES: Comments in triplicate, must bear the docket control number 
OPP-50784 and be submitted to: Public Docket and Freedom of Information 
Section, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person bring comments to: Rm. 246, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA.
    Information submitted in any comment(s) concerning this notice may 
be claimed confidential by marking any part or all of that information 
as ``Confidential Business Information'' (CBI). Information so marked, 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2. A copy of the comment(s) that does not contain CBI must 
be submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice to 
the submitter. Information on the proposed test and all written 
comments will be available for public inspection in Rm. 246 at the 
Virginia address given above, from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Phil Hutton, Product Manager 
(PM) 18, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Rm. 213, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA (703-305-7690).

SUPPLEMENTARY INFORMATION: The Monsanto Company experimental use 
program proposes to assess the effectiveness of six different versions 
of delta-endotoxin when expressed in several varieties of cotton and to 
introduce the delta-endotoxin genes into other cotton cultivars. An 
extension of the experimental use permit was granted May 18, 1993. An 
additional amendment was granted December 1993, for the purposes of 
adding two sites in Puerto Rico. The purpose of this amendment/
extension is to conduct an additional 12 experiments on 120 sites in 15 
states (four additional states to include Florida, Maryland, Missouri, 
and Virginia) and the territory of Puerto Rico. Total transgenic B.t.k. 
cotton plantings at all sites combined will not exceed 1,665 acres. 
Cotton lines for the additional sites contain the plasmid vectors PV-
GHBKO3, PV-GHBKO4, and PV-GHBKO7.
    EPA's scientific staff has evaluated the potential for adverse 
effects on nontarget species and the environment as a result of this 
EUP amendment. According to Monsanto, the B.t.k. delta-endotoxin is 
expected to occur in roots, stems, leaves, bolls and seeds of the 
cotton plant; the NPT II marker enzyme is expected to occur in stems 
and seeds. Neither protein was detected by Monsanto in the pollen, 
nectar or lint of the genetically-engineered cotton plants. The Agency 
does not foresee any human health risks or effects resulting from the 
proposed field tests because there will be minimal human exposure.
    Several microbial pesticides containing nonengineered B.t.k. 
proteins have been registered over the last few years for which 
extensive avian, aquatic, and beneficial insect testing has failed to 
demonstrate any significant toxicity to these nontarget organisms. 
Monsanto, however, is using a truncated form of delta-endotoxin in 
three of its seven genetically-engineered cotton plants; it is possible 
that the truncated forms of B.t.k. proteins may affect a greater range 
of organisms than the full-length, nonengineered B.t.k. proteins 
present in wettable powder or oil flowable microbial pesticide 
formulations. This is not a concern, however, due to the limited 
exposure for nontarget organisms with the EUP amendment.
    Because the field tests will be conducted in areas of the States 
where no known population of endangered lepidopteran species exist, no 
risk is expected as a result of the additional sites. In addition, 
because of the low exposure due the limited acreage and duration of the 
EUP, EPA feels that there will not be a situation warranting a formal 
review under the Endangered Species Act for any endangered mammals, 
birds, invertebrates, plants, or aquatic species.
    Comments on this EUP amendment should be submitted by July 5, 1994.

Lists of Subjects

    Environmental protection.

    Dated: May 18, 1994.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 94-13557 Filed 6-2-94; 8:45 am]
BILLING CODE 6560-50-F