[Federal Register Volume 66, Number 137 (Tuesday, July 17, 2001)]
[Notices]
[Pages 37227-37229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17906]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00678B; FRL-6793-6]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is currently engaged in a comprehensive reassessment of 
the time-limited registrations for all existing Bacillus thuringiensis 
(Bt) corn and cotton plant-pesticides (also known as plant-incorporated 
protectants). This

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reassessment has been designed to assure that the decisions on the 
renewal and/or extension of these registrations are based on the most 
current scientific data (including recently reviewed non-target impact 
data), and incorporates recommendations made by the FIFRA Scientific 
Advisory Panel (SAP) and any public comments received by the Agency. 
The reassessment process has also been designed to assure maximum 
transparency of the decision-making process. This notice announces the 
opportunity to comment on the implications of the revised risk and 
benefit sections of the reassessment for regulatory decisions affecting 
these Bt products. This notice also announces EPA's plan to make 
available shortly a document discussing potential draft risk mitigation 
and regulatory options for public comment and a request for others to 
submit proposals for regulatory options for consideration. EPA's plans 
to hold a technical briefing for the public on these documents on July 
24, 2001.

DATES: The technical briefing will be held on July 24, 2001, from 
approximately 9 a.m. to 4 p.m.
    Comments, identified by docket control number OPP-00678B, must be 
received on or before August 31, 2001.

ADDRESSES:  The public technical briefing will be held at the Sheraton 
Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA. The 
telephone number for the Sheraton Crystal City Hotel is (703) 486-1111.
    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, and 
Bt 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 these 
Documents and Other Related Documents?

    1. Electronically. You may obtain electronic copies of these 
documents, 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 for Bt plant-pesticides, ecological effects data 
requirements for protein plant-pesticides, allergenicity and health 
effects for protein plant-pesticides, and SAP 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. 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-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

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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

A. Revised Risk and Benefit Sections and Draft Risk Mitigation and 
Regulatory Options Section

    This notice announces the opportunity for public comment on the 
implications of EPA's revised risk and benefit sections of the Bt crops 
reassessment. The risk and benefit sections have been revised based on 
the recent SAP report on the preliminary risk and benefit sections, as 
well as in response to public comment surrounding the regulatory 
decisions affecting these products.
    Although the Agency's conclusions regarding risk to the Monarch 
butterfly are available, the Agency's analysis of Monarch butterfly 
risk is undergoing a CBI substantiation process due to claims of 
confidentiality by the data submitters. The Agency is working on a 
priority basis to resolve this issue.
    The Agency anticipates to release prior to the July 24th technical 
briefing, a document discussing potential risk mitigation and 
regulatory options with questions to be considered by the public. In 
addition, EPA will be holding a briefing for the public on these 
documents on July 24, 2001, from 9 a.m. to 4 p.m. at the Sheraton Hotel 
Crystal City, 1800 Jefferson Davis Highway, Arlington, VA.
    EPA encourages other submissions of potential risk mitigation and 
regulatory options at the public meeting and during the comment period. 
To encourage public participation and dialog, EPA will place all 
comments and proposals in the public docket, and, if possible, will 
also place all comments and proposals on the Biopesticides web site at: 
www.epa.gov/pesticides/biopesticides. In addition, EPA is likely to 
develop additional documents regarding this reassessment and will also 
make these documents available through the public docket and the 
Biopesticides web site.

B. Overall Bt Crops Reassessment

    EPA is currently engaged in a comprehensive reassessment of the 
time-limited registrations for all existing Bt corn and cotton plant-
pesticides. This reassessment has been designed to assure that the 
decisions on the renewal and/or extension of these registrations are 
based on the most current scientific data. Current registrations are 
set to expire September 30, 2001. As part of EPA's reassessment, the 
Agency will decide whether to extend the registrations and, if so, 
whether to include any additional terms and conditions in such 
registrations on issues that could include insect resistance 
management, compliance mechanisms, and the protection of non-target 
organisms among other measures.
    During this reassessment, EPA is committed to conducting an open 
and transparent public process that incorporates sound and current 
science, public involvement, and balanced decision-making. The major 
components of the process and time frames for action are as follows:
    1. Comprehensive risk and benefit assessments. This review 
incorporated consideration of all available scientific information on 
Bt products, including results of recent scientific studies and 
recommendations from various individuals and organizations.
    2. Scientific peer review and public comment. After completing the 
scientific risk assessment, the Agency provided the registrants of the 
products an opportunity to review the risk assessment and suggest 
technical corrections to the Agency. After technical corrections were 
made, EPA released the risk assessments and invited public comment and 
scientific peer review. That release included EPA's regulatory 
assessment and the underlying data, along with registrants' technical 
error correction comments and the corrective actions taken by the 
Agency. All of these materials were placed in the Bt crop reassessment 
docket.
    3. Recommendations from the SAP, National Academy of Sciences, 
public comments, and the Administration-wide review. Since there are 
many organizations providing regulatory and scientific recommendations, 
EPA used the time since the SAP report was issued in March to consider 
and incorporate these recommendations into our revised risk and benefit 
assessments, as appropriate. This included recommendations and comments 
from the public, from the SAP on insect resistance management, and on 
ecological and public health aspects of our regulatory program, along 
with consideration of issues identified from the report released by the 
National Academy of Sciences titled: ``Genetically Modified Pest-
Protected Plants, Science and Regulation'' and from the Administration-
wide review.
    4. Revised risk and benefits assessments and proposed regulatory 
options. EPA has considered all of the public comments and the 
recommendations from the SAP in revising the risk and benefit 
assessments, and in developing elements to be included in risk 
mitigation and the potential options for regulatory decisions. EPA will 
hold a technical briefing to describe the revised scientific 
reassessment and take comments on potential regulatory options.
    5. Final decisions on Bt registrations. This will complete the 
scientific and public process. EPA will continue to take public 
comments for 45 days from publication of this Notice before announcing 
any registration decisions regarding these Bt plant-pesticides for 
future growing seasons on or before September 30, 2001.

List of Subjects

    Environmental protection, Plant-pesticides.


    Dated: July 11, 2001.
Janet L. Andersen.
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. 01-17906 Filed 7-13-01 12:20 pm]
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