[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Proposed Rules]
[Pages 46535-46536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20154]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[OPP-2003-0132; FRL-7322-3]
RIN: 2070-AD57


Human Testing; Advance Notice of Proposed Rulemaking; Reopening 
of a Comment Period

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Advance notice of proposed rulemaking; reopening of comment 
period.

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SUMMARY:  On May 7, 2003, EPA announced the availability for comment of 
an advance notice of proposed rulemaking (ANPR) discussing EPA's plan 
to conduct rulemaking about criteria and standards EPA would apply in 
deciding the extent to which it will consider or rely on various types 
of research with human subjects to support its actions. The Agency 
received a request to extend the comment period. EPA is hereby 
reopening the comment period, which ended on August 5, 2003. The new 
comment period will end August 20, 2003.

DATES:  Comments, identified by the docket ID number OPP-2003-0132, 
must be received on or before August 20, 2003.

ADDRESSES:  Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION of the May 7, 
2003 Federal Register document.

FOR FURTHER INFORMATION CONTACT:  William L. Jordan, Mail code 7501C, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-1049; fax number: (703) 308-4776; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of particular interest to those who conduct testing of 
substances regulated by EPA. Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0132. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

C. How and to Whom Do I Submit Comments?

    To submit comments, or access the official public docket, please 
follow the detailed instructions as provided in Unit I.C. of the 
SUPPLEMENTARY INFORMATION of the May 7, 2003 Federal Register document. 
If you have questions, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

II. What Action is EPA taking?

    This document reopens the public comment period established in the 
Federal Register of May 7, 2003 (68 FR 24410) (FRL-7302-8). In that 
document, EPA sought comment on its plan to conduct rulemaking about 
criteria and standards the Agency would apply in deciding the extent to 
which it will consider or rely on various types of research with human 
subjects to support its actions. The Agency received a request to 
extend the comment period. EPA is hereby reopening the comment period, 
which ended on August 5, 2003. The new comment period will end August 
20, 2003. The public is strongly encouraged to submit comments as early 
as possible so that EPA may make them available for consideration by a 
committee of the National Academy of Sciences, which is preparing a 
report for EPA on these issues.

III. What is the Agency's Authority for Taking this Action?

    Section 25(a) of FIFRA gives the Administrator authority to 
``prescribe regulations to carry out the purposes of [FIFRA].'' Such a 
rule would implement EPA's authority to require data in support of 
registration of pesticides (see, for example, FIFRA sections 3(c)(1)(F) 
and 3(c)(2)(B)) and to interpret the provision making it unlawful for 
any person ``to use any pesticide in tests on human beings unless such 
human beings (i) are fully informed of the nature and purposes of the 
test and of any physical and mental health consequences which are 
reasonably foreseeable therefrom, and (ii) freely volunteer to 
participate in the test.'' (FIFRA section 12(a)(2)(P)). In addition, 
section 408(e)(1)(C) of the FFDCA authorizes the Administrator to issue 
a regulation establishing ``general procedures and requirements to 
implement this section.''

[[Page 46536]]

IV. Do Any Statutory and Executive Order Reviews Apply to this Action?

    No. This action is not a rulemaking, it merely extends the date by 
which public comments must be submitted to EPA on an ANPR that 
previously published in the Federal Register of May 7, 2003 (68 FR 
24410). For information about the applicability of the regulatory 
assessment requirements to the ANPR, please refer to the discussion in 
Unit III.A. of that document (68 FR 24410).

List of Subjects

    Environmental protection, Human studies.


    Dated: August 1, 2003.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. 03-20154 Filed 8-5-03; 8:45 am]
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