Document ID: EPA-HQ-OPP-2010-0785-0001
Agency: epa
Document Type: Proposed Rule
Title: Notifications to Secretary of Agriculture: Revisions to EPA Rule on Protections for Subjects in Human Research Involving Pesticides
Posted Date: 2010-10-13T04:00Z

[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]                         

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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.

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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:

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 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.

II. 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.

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 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]
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