Protections for Test Subjects in Human Research; Notification to the Secretaries of Agriculture and Health and Human Services, 46448 [05-15839]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Proposed Rules]
[Page 46448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15839]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[OPP-2005-0219; FRL-7728-9]
RIN 2070-AD57


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.

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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  https://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 (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: William Jordan, Office of Pesticide 
Programs (7501C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-1049; 
e-mail address:jordan.william@epa.gov.

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 (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at https://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.
[FR Doc. 05-15839 Filed 8-9-05; 8:45 am]
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