Environmental Protection Agency (EPA).
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 Start Printed Page 37228reassessment 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.
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.
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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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@example.com, 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 Start Printed Page 37229information 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.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
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]
BILLING CODE 6560-50-S