01-20774. Plant-Incorporated Protectants (Formerly Plant-Pesticides), Supplemental Proposal; Extension of Comment Period

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Supplemental proposal; Extension of comment period.

SUMMARY:

EPA in response to request from the public is extending an existing comment period for a supplemental proposal appearing in the Federal Register on July 19, 2001. EPA issued the July 19, 2001 supplemental proposal to solicit additional comment on the exemptions it proposed in 1994 for plant-incorporated protectants. Specifically, EPA solicits comment on two alternative regulatory approaches to plant-incorporated protectants derived from plants sexually compatible with the recipient plant and on proposed exemptions for plant-incorporated protectants that act by primarily affecting the plant or are based on viral coat proteins. EPA is also providing notice that it has placed the report issued by the National Academy of Sciences (NAS) entitled Genetically Modified Plants: Science and Regulation in the dockets for the rulemakings relating to certain proposals on plant-incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The Agency anticipates this extension will result in more in-depth, detailed and thus more constructive comment.

DATES:

Comments, identified by the docket control number OPP-300370C, must be received on or before September 19, 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-300370C in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Phillip Hutton, 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?-

You may be potentially affected by this action if you are a person or company involved with agricultural biotechnology that may develop and market plant-incorporated protectants. Potentially affected categories and entities may include, but are not limited to:

Categories	NAICS codes	Examples of potentially affected entities
Pesticide manufacturers	32532	Establishments primarily engaged in the formulation and preparation of agricultural and household pest control chemicals
Seed companies	111	Establishments primarily engaged in growing crops, plants, vines, or trees and their seeds
Colleges, universities, and professional schools	611310	Establishment of higher learning which are engaged in development and marketing of plant-incorporated protectants
Establishments involved in research and development in the life sciences	54171	Establishments primarily engaged in conducting research in the physical, engineering, or life sciences, such as agriculture and biotechnology

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This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. The North American Industrial Classification System (NAICS) codes are provided to assist you and others in determining whether or not this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the provisions in 40 CFR part 174. If you have 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 that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. On the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” 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/​.

To access information about plant-incorporated protectants and the supplemental proposal, go directly to the Home Page for the Office of Science Policy and Coordination at http://www.epa.gov/​scipoly/​ and select “What's New.”-

2. In person. The Agency has established an official record for this action under docket control number OPP-300370C. 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?-

As described in Unit I. of the supplemental proposal published in the Federal Register of July 19, 2001 (66 FR 37855) (FRL-6760-4), you may submit your comments through the mail, in person, or electronically. Please follow the instructions that are provided in the supplemental proposal. Do not submit any information electronically that you consider to be CBI. To ensure proper receipt by EPA, be sure to identify docket control number OPP-300370C in the subject line on the first page of your response.

II. Background

A. What Action is EPA Taking? -

EPA in response to public comment is extending the comment period for a supplemental proposal appearing in the Federal Register on July 19, 2001. EPA issued the July 19, 2001 supplemental proposal to solicit additional comment on the exemptions it proposed in 1994 for plant-incorporated protectants. EPA solicits comment on two alternative regulatory approaches to plant-incorporated protectants derived from plants sexually compatible with the recipient plant and on proposed exemptions for plant-incorporated protectants that act by primarily affecting the plant or are based on viral coat proteins. EPA is also providing notice that it has placed the NAS report in the dockets for the rulemakings relating to certain proposals on plant-incorporated protectants under FIFRA and FFDCA. With the July 19, 2001 supplemental proposal, EPA reopened the comment period for these particular 1994 proposals to allow the public an opportunity to comment on the information, analyses, and conclusions in the NAS report.

B. What is the Agency's Authority for Taking this Action?-

EPA takes this action under the authority of FIFRA section 3 and section 25(a) and (b) (7 U.S.C. 136a and 136w(a) and (b)) and FFDCA section 346a and 371.

III. Do Any Regulatory Assessment Requirements Apply to this Action?-

No. This action is not a rulemaking, it merely extends the date by which public comments must be submitted to EPA on a supplemental proposal that previously published in the Federal Register of July 19, 2001 (66 FR 37855) (FRL-6760-4). For information about the applicability of the regulatory assessment requirements to that supplemental proposal, which published in the Federal Register, please refer to the discussion in Unit VIII. of that document.

List of Subjects in 40 CFR Part 174

• Environmental protection
• Agricultural commodities
• Pesticides and pests
• Plants

Dated: August 13, 2001.

Stephen L. Johnson,

Assistant Administrator for Prevention, Pesticides and Toxic Substances.