Human testing; standards and criteria,

[Federal Register: August 6, 2003 (Volume 68, Number 151)]

[Proposed Rules]

[Page 46535-46536]

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

[DOCID:fr06au03-37]

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.

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: jordan.william@epa.gov. SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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.

   2. 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.

   3. 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.

2. 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.

3. 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]]

4. 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]

   BILLING CODE 6560-50-S