[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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