[Federal Register Volume 66, Number 176 (Tuesday, September 11, 2001)]
[Notices]
[Pages 47218-47219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22757]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-50875B; FRL-6798-1]


Experimental Use Permit; Receipt of Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of an application to amend 524-
EUP-93 from Monsanto Company requesting an experimental use permit 
(EUP) for the plant-pesticide Bacillus thuringiensis Cry3Bb protein and 
the genetic material necessary for its production (Vector ZMIR13L) in 
corn plants. The Agency has determined that the application may be of 
regional and national significance. 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-50875B, must 
be received on or before October 11, 2001.

ADDRESSES: Comments and data 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-50875B in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Mike Mendelsohn, 
Biopesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8715; e-
mail address: [email protected].

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 interest to those persons who are interested in 
agricultural biotechnology or may be required to conduct testing of 
chemical substances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA). Since other entities may also 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 documents 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,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-50875B. The official record 
consists of the documents specifically referenced in this action, 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-50875B 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, 1200 Pennsylvania Ave., NW., 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: [email protected], 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-50875B. 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

[[Page 47219]]

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.
    7. Make sure to submit your comments by the deadline in this 
document.
    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

    Monsanto Company has applied to amend their recently approved EUP 
number 524-EUP-93 amendment/extension in order to allow livestock 
feeding studies and a lifting of the crop destruct provisions. The 
recently approved EUP published in the Federal Register on July 27, 
2001 (66 FR 39163) (FRL-6791-5). A tolerance exemption was established 
for Bacillus thuringiensis Cry3Bb1 protein and the genetic material 
necessary for its production in corn on May 11, 2001. The tolerance 
exemption published in the Federal Register on May 11, 2001 (66 FR 
24061) (FRL-6781-6).

III. What Action is the Agency Taking?

    Following the review of the Monsanto Company application and any 
comments and data received in response to this notice, EPA will decide 
whether to issue or deny the EUP request for this EUP program, and if 
issued, the conditions under which it is to be conducted. Any issuance 
of an EUP will be announced in the Federal Register.

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

    The Agency's authority for taking this action is under 40 CFR part 
172.

List of Subjects

    Environmental protection, Experimental use permits.


    Dated: August 29, 2001.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 01-22757 Filed 9-10-01; 8:45 am]
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