2011-5997. Pesticides; Data Requirements for Plant-Incorporated Protectants (PIPs) and Certain Exemptions for PIPs; Notification to the Secretaries of Agriculture and Health and Human Services

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notification to the Secretaries of Agriculture and Health and Human Services.

SUMMARY:

This document notifies the public that the Administrator of EPA has forwarded to the Secretaries of Agriculture and Health and Human Services a draft proposed rule under sections 21 and 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The draft proposed rule will propose codifying data requirements that specifically address the registration data needs of plant-incorporated protectants (PIPs). These data requirements are intended to provide EPA with data and other information necessary for the registration of a PIP or the issuance of an experimental use permit for a PIP. Also, EPA will propose to exempt cisgenic PIPs from registration to encourage research and development of useful biotechnology and reduce the number of PIPs seeking registration. Cisgenic PIPs are formed when genetic material is transferred, using bioengineering technology, between plants that could transfer the genetic material naturally.

DATES:

Comments must be received on or before April 15, 2011.

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0499. All documents in the docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov,, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Rose Kyprianou, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

This action is directed to the public in general. It simply announces the submission of a draft proposed rule to the United States Department of Agriculture (USDA) and does not otherwise affect any specific entities. This action may, however, be of particular interest to those persons who produce or register plant-incorporated protectants (PIPs) under FIFRA or may seek a tolerance or tolerance exemption for a PIP under the Federal Food, Drug, and Cosmetic Act (FFDCA). This action may also be of interest to those persons involved in biotechnology research or development of PIPs. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. What action is EPA taking?

Section 25(a)(2) of FIFRA provides that the Administrator must provide the Secretary of Agriculture with a copy of any draft proposed rule at least 60 days before signing it for publication in the Federal Register. Similarly, section 21(b) of FIFRA provides that the Administrator must provide the Secretary of Health and Human Services with a copy of any draft proposed rule pertaining to a public health pesticide at least 60 days before signing it for publication in the Federal Register. The draft proposed rule is not available to the public until after it has been signed by EPA. If either Secretary comments in writing regarding the draft proposed rule within 30 days after receiving it, the Administrator shall include in the proposed rule when published in the Federal Register the comments of the Secretary and the Administrator's response to those comments. If neither Secretary comments in writing within 30 days after receiving the draft proposed rule, the Administrator may sign the proposed regulation for publication in the Federal Register anytime after the 30-day period.

III. Do any Statutory and Executive Order reviews apply to this notification?

No. This document is not a proposed rule, it is merely a notification of submission to the Secretaries of Agriculture and Health and Human Services. As such, none of the regulatory assessment requirements apply to this document.

List of Subjects

40 CFR Part 152

• Environmental protection
• Administrative practice and procedure
• Pesticides and pests
• Reporting and recordkeeping requirements

40 CFR Part 158

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

40 CFR Part 174

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Plant-incorporated protectants
• Reporting and recordkeeping requirements

Dated: March 4, 2011.

Steven Bradbury,

Director, Office of Pesticide Programs.