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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: November 30, 1999 (Volume 64, Number 229)]
[Notices]
[Page 66913-66915]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no99-85]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-50863; FRL-6396-1]


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

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: This notice announces a receipt from the University of
Maryland, of a notification of intent to conduct small-scale field
testing of a genetically modified Metarhizium strain. The modified
strain contains duplicate Metahizium genes to improve the suppression
of Tricoplusia ni species (cabbage loopers) from infesting cabbage
plants. The Agency had determined that the application may be of
regional and national significance, and may help develop alternatives
to traditional pesticides to protect human health and the environment.
Therefore in accordance with 40 CFR 172.11(a), the Agency is soliciting
comments on this application.
 DATES: Comments, identified by docket control number OPP-50863, must
be received on or before January 14, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-50863 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: Carl Etsitty, Biopesticides, and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: 703-605-0749; fax number: 703-308-7026; e-mail
address: etsitty.carl@epa.gov.
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of pesticide interest to those persons who are or may be
required to conduct small-scale field testing of genetically modified
microbial pesticide under the Federal Food, Drug and Cosmetic Act
(FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Since other entities may also

[[Page 66914]]

be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related ocuments that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' Also, you can go
directly to the Federal Register listings at http://www.epa.gov/
fedrgstr/, to access information about OPP-Docket OPP-50863, or go
directly to Office of Pesticide Programs' web page http://www.epa.gov/
pesticides/ and select Biopesticides, then FR Notice.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-50863. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as Confidential Business Information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-50863 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
    2.  In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-50863. Electronic comments may
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
     2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
     4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
     5. Provide specific examples to illustrate your concerns.
     6. Offer alternative ways to improve the notice or collection
activity.
     7. Make sure to submit your comments by the deadline in this
notice.
     8. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. Background

A. What Action is the Agency Taking?

    The Agency will reviewed and evaluate this Notification and will
make a decision as described in 40 CFR 172.50. Notice of receipt of
this Notification does not imply a decision by the Agency on this
Notification. This small-scale field testing is designed to evaluate
the modified Metarhizium strain, to control Tricoplusia ni species from
infesting cabbage plants. The tested organism, Metarhizium anisopliae,
contains duplicates of a cuticle-degrading protease gene from
Metarhizium anisopliae, under a constitutive Aspergillus nidulans
promoter. A green-fluorescent protein molecular marker is also
incorporated to allow monitoring of the genetic stability and fate.
    The design of the test site is as follows: The plot, located in
Maryland, will consist of a 0.05 hectare (ha) barren area containing a
circular 0.02 ha planting of cabbages designed to allow for efficient
maintenance. There will be monitoring to detect dispersal outside the
confines of the plot of any Metarhizium containing the complete
complemental Metarhizium cuticle-degrading protease gene sequence. A
low-maintenance fallow zone outside the plot will also be monitored. A
0.20 ha² cabbage plant control is included-60 m from the
edge of the barren zone. Background soil samples will be taken prior to
initiation of study; Indigenous

[[Page 66915]]

Metarhizium strains will be analyzed by isozyme, and RAPD analysis to
obtain strain-specific probes for population analysis.
    In accordance with 40 CFR 172.3, the small-scale field test will be
conducted on a cumulative total of no greater than 10 acres of land.
Any food or feed crops will be destroyed.

B. What is the Agency's Authority for Taking this Action?

    The Agency's Authority for reviewing this Notification is described
in 40 CFR 172 Subpart C. This notice of receipt is published in
accordance with 40 CFR 172.11.

List of Subjects

    Environmental protection, Genetically modified organism.

    Dated: November 23, 1999.

Janet L. Anderson,

Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

[FR Doc. 99-31197 Filed 11-29-99; 8:45 am]
BILLING CODE 6560-50-F
Receipt of a Notification to Conduct Small-Scale Field Testing of a Genetically Modified Microbial Pesticide

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