05-15839. Protections for Test Subjects in Human Research; 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 formalize and clarify EPA's policies on the use of intentional human exposure studies under FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA). The proposed rule would establish stringent ethical protections for human subjects in certain types of research conducted or sponsored by entities other than the Federal government (i.e., “third-parties”). These protections are consistent with requirements currently in place under the Federal Policy for the Protection of Human Subjects of Research (the “Common Rule”), which has been adopted by 17 Federal agencies. The draft proposed rule is not available to the public until after it has been signed by EPA.

ADDRESSES:

EPA has established a docket for this action under Docket identification (ID) number OPP-2005-0219. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/​edocket. Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

William Jordan, Office of Pesticide Programs (7501C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 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 an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 32532)

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 unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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 Access Electronic Copies of this Document and Other Related Information?

In addition to using EDOCKET (http://www.epa.gov/​edocket/​), you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​. A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/​ecfr/​.

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 rule, but 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 26

• Environmental protection
• Human research subjects
• Reporting and recordkeeping requirements

Dated: July 27, 2005.

James Jones,

Director, Office of Pesticide Programs.