[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Proposed Rules]
[Pages 62738-62739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25787]
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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: [email protected].
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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