2010-16169. Declaration of Prion as a Pest under FIFRA and Amendment of EPA's Regulatory Definition of Pests to Include Prion; 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 rule proposes to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion product”) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain EPA approval before it can be distributed or sold in the United States. This draft proposed rule would codify the Agency's current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in EPA's regulations. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion products under FIFRA. Regulating prion products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective.

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0427. 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:

Jeff Kempter, Antimicrobials Division (7510P), 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:

• Producers of pesticide products (NAICS 32532).
• Producers of antimicrobial pesticides (NAICS 32561).
• Veterinary testing laboratories (NAICS 541940).
• Medical pathology laboratories (NAICS 621511).
• Taxidermists, independent (NAICS 711510).
• Surgeons (NAICS 621111).
• Dental surgeons (NAICS 621210).

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 the Secretary does not comment 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 in 40 CFR Part 152

• Environmental protection
• Antimicrobial pesticides
• Pests

Dated: June 24, 2010.

Steven Bradbury,

Director, Office of Pesticide Programs.