[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Notices]
[Pages 46457-46458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22363]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-00678C; FRL-6801-7]


Opportunity to Comment on Implications of Revised Bt Crops 
Reassessment for Regulatory Decisions Affecting These Products, and on 
Potential Elements of Regulatory Options; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is currently engaged in a comprehensive reassessment of 
the time-limited registrations for all existing Bacillus thuringiensis 
(Bt) corn and cotton plant-incorporated protectants. This notice 
announces the Agency's intent to provide additional time to comment on 
the implications of the revised risk and benefit sections of the 
reassessment, the draft Potential Risk Mitigation and Regulatory 
Options paper, and the regulatory decisions affecting Bacillus 
thuringiensis Cry1F protein and the genetic material necessary for its 
production (plasmid insert PHI8999) in corn plants.

DATES: Comments, identified by docket control number OPP-00678B, must 
be received on or before September 10, 2001.

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-00678B in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: 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; fax number: 
(703) 308-7026; 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 
be of particular interest to manufacturers, producers, distributors, 
users, and other persons interested in the registrations listed below. 
This action may also be of interest to other persons who have an 
interest in the registration and/or the use of Bt corn, Bt cotton, 
andBt potato plant-pesticides regulated under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). 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 (including copies of 
EPA's fact sheets on each registered Bt plant-pesticide, workshop 
proceedings on resistance management, EPA technical papers on 
regulation of agricultural biotechnology including resistance 
management forBt plant-pesticides, ecological effects data requirements 
for protein plant-pesticides, allergenicity and health effects for 
protein plant-pesticides, and Scientific Advisory Panel reports from 
EPA's Biopesticide Internet Home Page at http://www.epa.gov/pesticides/biopesticides and from EPA's SAP Home Page at http://www.epa.gov/scipoly/sap). 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.'' 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-00678B. Additionally, the 
Bt Corn Cry1F registrations have official records under docket control 
numbers OPP-30494 and OPP-30120. 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

[[Page 46458]]

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-00678B 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-00678B. 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 and Explanation of Actions Being Taken

    In the July 17, 2001 Federal Register (66 FR 37227) (FRL-6793-6), 
the Agency announced the July 24, 2001 Technical Briefing and an 
opportunity to comment on the Bt Crops reassessment. EPA asked that 
comments be submitted by August 30, 2001. In the August 10, 2001 
Federal Register (66 FR 42220) (FRL-6791-4), the Agency announced the 
registration of the Cry1F corn plant-incorporated protectant and the 
opening of a public docket containing the record on which EPA based 
this registration.
    Several members of the public have asked for additional time to 
submit comments in response to the July 17 Notice. In addition, some 
members of the public have asked for additional time to comment on the 
Cry1F product and have asked that it be considered separately from the 
other products covered by the Bt Crops Reassessment. Although the 
notice of registration and materials in the public docket for Cry1F 
state that the Cry1F product would be reevaluated on the same schedule 
as other Bt corn products and that relevant decisions in the Bt Crops 
Reassessment would be applied to that registration, this information 
was not noted in the FR Notice. Thus, this notice clarifies that the 
Cry1F product is included within the scope of the Bt Crops 
Reassessment. Further, in light of all of the circumstances, this 
Notice also announces the Agency's decision to provide additional time 
to comment for all Bt corn and cotton products with expiring 
registrations.
    Several members of the public have also asked in a letter dated 
July 23, 2001, for an extension because a portion of the data base for 
theBt Crops Reassessment relating to the toxicity ofBt corn pollen to 
Monarch butterflies is not publicly available. While these data are 
still subject to a confidentiality claim that prevents public release 
at this time, EPA has arranged to allow the public to inspect these 
data in EPA reading rooms, provided that any person inspecting the data 
first signs a Confidentiality Agreement. See www.epa.gov/pesticides/biopesticides for more information.
    In summary, the Agency is extending until September 10, 2001, the 
period for comment on the implications of the revised risk and benefit 
sections of the reassessment, the draft Potential Risk Mitigation and 
Regulatory Options paper, and the regulatory decisions on theBacillus 
thuringiensis Cry1F protein and the genetic material necessary for its 
production (plasmid insert PHI8999) in corn plants.

List of Subjects

    Environmental protection, Plant-pesticides.


    Dated: August 30, 2001.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. 01-22363 Filed 8-31-01 12:21 pm]
BILLING CODE 6560-50-S