01-22363. 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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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 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 for Bt 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 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 [phone].

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 [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], 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 the Bt Crops Reassessment relating to the toxicity of Bt 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 the Bacillus 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.