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AcMNPV - Receipt of a Notification to Conduct Small-Scale Field Testing 7/98

[Federal Register: August 3, 1998 (Volume 63, Number 148)]
[Page 41254-41255]
From the Federal Register Online via GPO Access []



[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.


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,

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: opp- 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.

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:


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
    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:

    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]