[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Notices]
[Pages 41254-41255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20604]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-50845; FRL-6021-4]


Receipt of a Notification to Conduct Small-Scale Field Testing of 
a Genetically-Engineered Microbial Pesticide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt from American Cyanamid Company 
of a notification (241-NMP-A) of intent to conduct small-scale field 
testing involving a microorganism, Autographa californica Multiple-
embedded Nuclear Polyhedrosis Virus (AcMNPV). This modified AcMNPV has 
been genetically-engineered to: (1) Express an insect-

[[Page 41255]]

specific pesticidal toxin, TxP-I, from the straw itch mite, Pyemotes 
tritici, and (2) prevent expression of the ecdysteroid UDP-
glucosyltransferase gene. American Cyanamid Company intends to test 
this microbial pesticide on cotton and leafy vegetables to evaluate the 
control of Lepidopteran pests. The Agency has determined that this 
notification may be of regional and national significance. Therefore, 
in accordance with 40 CFR 172.11(a), the Agency is soliciting public 
comments on this notification.

Dates: Written comments must be received on or before September 2, 
1998.

ADDRESSES: By mail, submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: <a href="/cdn-cgi/l/email-protection#8ce3fcfca186e8e3efe7e9f8cce9fcede1ede5e0a2e9fceda2ebe3fa">opp-
<span class="__cf_email__" data-cfemail="167279757d7362567366777b777f7a3873667738717960">[email protected]</span></a>. Follow the instructions under Unit II. of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
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 that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. The public docket is 
available for public inspection in Rm. 119 at the Virginia address 
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays.

FOR FURTHER INFORMATION CONTACT: William R. Schneider, PM 90, 
Biopesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: 9th Floor, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA, (703-308-8683), e-mail: 
<a href="/cdn-cgi/l/email-protection#dfacbcb7b1bab6bbbaadf1a8b6b3b3b6beb29fbaafbeb2beb6b3f1baafbef1b8b0a9"><span class="__cf_email__" data-cfemail="dcafbfb4b2b9b5b8b9aef2abb5b0b0b5bdb19cb9acbdb1bdb5b0f2b9acbdf2bbb3aa">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Notice of receipt of this notification does not imply a decision by 
the Agency on this notification.
    A Notification (241-NMP-A) was received from American Cyanamid 
Company. The proposed small-scale field trial involves the introduction 
of a baculovirus, Autographa californica Multiple-embedded Nuclear 
Polyhedrosis Virus (AcMNPV) which has been genetically-engineered to 
express an insect-specific pesticidal toxin, TxP-I, from the straw itch 
mite, Pyemotes tritici. In addition, the gene for ecdysteroid UDP-
glucosyltransferase (EGT) has been replaced with the same gene 
containing a deletion so that this enzyme will not be produced in the 
infected insect larvae. When insects are infected with the naturally-
occurring (wild-type) virus, EGT prevents the insect from molting, and 
the insect will continue to eat and grow without molting. In contrast, 
an insect infected with the engineered virus, will not eat or molt 
resulting in death 1 to 2 days earlier than seen for the wild-type 
virus.
    American Cyanamid has previously field tested the same baculovirus 
with the same EGT deletion engineered to express a different insect-
specific toxin from a scorpion in 1995, 1996, and 1997. They have 
submitted characterization data for the TxP-I toxin and an oral 
toxicity study in mice in addition to comparative host range studies in 
susceptible and less-susceptible Lepidopteran species. The purpose of 
the proposed testing will be to evaluate the efficacy of the 
baculovirus against lepidopteran pests, including tobacco budworm 
(Heliothis virescens), the cotton bollworm (Helicoverpa zea), the beet 
armyworm (Spodoptera exigua), and the cabbage looper (Trichoplusia ni) 
on cotton and leafy vegetables. The total acreage for all sites will 
not exceed 10 acres per pest and, on completion of the test, the crops 
will be destroyed.
    Following the review of this notification and any comments received 
in response to this notice, EPA may approve the tests, ask for 
additional data, require additional modifications to the test 
protocols, or require EUP applications to be submitted. In accordance 
with 40 CFR 172.50, under no circumstances shall the proposed tests 
proceed until the submitters have received notice from EPA of its 
approval of such tests.

II. Public Record and Electronic Submissions

    The official record for this action, as well as the public version, 
has been established for this action under docket control number ``OPP-
50845'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The 
official rulemaking record is located at the Virginia address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    <a href="/cdn-cgi/l/email-protection#81eef1f1ace5eee2eae4f5c1e4f1e0ece0e8edafe4f1e0afe6eef7"><span class="__cf_email__" data-cfemail="066976762b6269656d6372466376676b676f6a2863766728616970">[email protected]</span></a>


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number ``OPP-50845.'' Electronic comments on this 
action may be filed online at many Federal Depository Libraries.

List of Subjects

    Environmental protection.

    Dated: July 27, 1998.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 98-20604 Filed 7-31-98; 8:45 am]
BILLING CODE 6560-50-F


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