Notifications to Secretary of Agriculture:

Federal Register: October 13, 2010 (Volume 75, Number 197)

Proposed Rules

Page 62738-62739

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr13oc10-17

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 26

EPA-HQ-OPP-2010-0785; FRL-8850-2

RIN 2070-AJ76

Revisions to EPA's Rule on Protections for Subjects in Human

Research Involving Pesticides; Notification to the Secretary of

Agriculture

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification to the Secretary of Agriculture.

SUMMARY: This document notifies the public that the Administrator of

EPA has forwarded to the Secretary of Agriculture a draft proposed rule as required by section 25(a) of the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA). As described in the Agency's semi-annual

Regulatory Agenda, the draft proposed rule would amend the portions of

EPA's rules for the protection of human subjects of research that apply to third parties who conduct or support research for pesticides involving intentional exposure of human subjects, and to persons who submit the results of human research for pesticides to EPA. EPA agreed to propose these amendments as a result of a settlement agreement resolving a judicial challenge to the promulgation of these rules in 2006, and is now seeking comments on these draft proposed amendments from the Secretary of Agriculture. The draft proposed amendments would clarify the applicability of the rules to human testing for pesticides submitted to EPA under any statute, would disallow consent by a legally authorized representative of participants in pesticide studies who cannot consent for themselves, and would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based on the recommendations of the National Academy of Sciences and on the

Nuremberg Code.

ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0785. 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 (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Immediate Office of the

Director (7501P), Office of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 305-8401; fax number: (703) 308-4776; e- mail address: sherman.kelly@epa.gov.

SUPPLEMENTARY INFORMATION:

1. 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 U.S.

   Department of Agriculture (USDA) and does not otherwise affect any specific entities. This action may, however, be of particular interest to pesticide registrants (NAICS code 325320) who sponsor or conduct human research for pesticides, and to other entities that sponsor or conduct human research for pesticides (NAICS code 541710). 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.

2. What action is EPA taking?

   Section 25(a)(2) of FIFRA requires the Administrator to provide the

   Secretary of Agriculture with a copy of any proposed regulation 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 the Secretary comments in writing regarding the draft proposed rule within 30-days after receiving it, the Administrator shall include the comments of the Secretary and the

   Administrator's response to those comments in the proposed rule when it is published in the Federal Register. If the Secretary does not comment in writing within 30 days after receiving

   Page 62739

   the draft proposed rule, the Administrator may sign the proposed regulation for publication in the Federal Register anytime after the 30-day period.

3. 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 Secretary of Agriculture. As such, none of the regulatory assessment requirements apply to this document.

   List of Subjects in 40 CFR Part 26

   Environmental protection, Human research, Pesticides.

   Dated: October 4, 2010.

   Steven Bradbury,

   Director, Office of Pesticide Programs.

   FR Doc. 2010-25787 Filed 10-12-10; 8:45 am

   BILLING CODE 6560-50-P