Document ID: EPA-HQ-ORD-2007-0972-0001
Agency: epa
Document Type: Notice
Title: Draft Scientific and Ethical Approaches for Observational Exposure Studies
Posted Date: 2007-10-04T04:00Z

[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Notices]               
[Page 56757-56758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc07-53]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0972; FRL-8477-8]

 
Draft Scientific and Ethical Approaches for Observational 
Exposure Studies

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) announces 
a 45-day public comment period for the draft document titled, 
``Scientific and Ethical Approaches for Observational Exposure 
Studies.'' This public comment period will overlap an external peer 
review of the draft document by EPA's Human Studies Review Board (HSRB) 
and discussion at their meeting on October 24, 2007. Notice of the HSRB 
meeting was published in the Federal Register on September 27, 2007, at 
72 FR 54908 (Docket ID No. EPA-HQ-ORD-2007-0942) and is posted on the 
EPA HSRB Web site, http://www.epa.gov/osa/ hsrb/.

    The draft document presents ``state-of-the-science'' approaches for 
conducting observational exposure studies based on sound science and 
conforming to the highest ethical standards. These studies, which 
collect information on how people come into contact with chemicals as 
they go about their everyday activities, are critical to EPA's mission 
to protect human health. This document is intended to serve as a 
resource and reference for researchers and is not meant to represent an 
official Agency ``guidance document.''
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. This document has not been formally disseminated by EPA. It 
does not represent and should not be construed to represent any Agency 
policy or determination. EPA will consider any public comments 
submitted in accordance with this notice when revising the document.

DATES: Comments must be received on or before November 19, 2007.

ADDRESSES: The draft document is available primarily via the Internet 
on the National Exposure Research Laboratory's home page under the 
Scientific and Ethical Approaches for Observational Exposure Studies 
link at http://www.epa.gov/nerl/sots. Submit your comments, identified 

by Docket ID No. EPA-HQ-ORD-2007-0972, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 

instructions for submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Fax: 202-566-1753.
     Mail: Docket ID No. EPA-HQ-ORD-2007-0972, Office of 
Research and Development (ORD) Docket, Environmental Protection Agency, 
Mail Code: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Headquarters Docket Center, EPA West 
Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such 
deliveries are only accepted during the Docket's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0972. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information provided, 

unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through http://www.regulations.gov or e-mail. 

The http://www.regulations.gov Web site is an ``anonymous access'' system, 

which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov 

your e-mail address will be automatically captured and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD-ROM you submit. If EPA cannot read 
your comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid

[[Page 56758]]

the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the 
http://www.regulations.gov index. Although listed in the index, some 

information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the EPA Headquarters Docket 

Center, EPA West Building, Room 3334, 1301 Constitution Ave., NW., 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744. Public comments 
received on the document titled, ``Scientific and Ethical Approaches 
for Observational Exposure Studies,'' may be listed under Docket ID No. 
EPA-HQ-ORD-2007-0972 or Docket ID No. EPA-HQ-ORD-2007-0942.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the Office of Research and Development (ORD) Docket; 
telephone: 202-566-1752; facsimile: 202-566-9744; or e-mail: 
ORD.Docket@epa.gov.

    For technical information, contact Roy Fortmann, National Exposure 
Research Laboratory, Environmental Protection Agency, Mail Code E205-
01, 109 T.W. Alexander Dr., Research Triangle Park, NC 27711; telephone 
number: (919) 541-2454; fax number: (919) 541-0239; e-mail address: 
Fortmann.Roy@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    EPA researchers conduct observational exposure studies to 
understand how and the extent to which people come into contact with 
chemicals in their everyday lives. The researchers and their managers 
take the protection of human subjects who participate in these 
observational studies very seriously. EPA wants to ensure that the 
procedures used in their studies meet or exceed the most up-to-date 
scientific and ethical standards. To address this goal, researchers at 
the Agency's National Exposure Research Lab (NERL) have prepared this 
document to identify key scientific and ethical issues and to provide 
information and resources to assist researchers as they plan and 
implement observational exposure studies. This document is not meant to 
represent an official Agency ``guidance document.'' Moreover, it 
recognizes that researchers will work with others--EPA's Human Subjects 
Research Review Official, Institutional Review Board (IRB) members, the 
participants and their community, and other stakeholders--to identify 
and address all of the relevant issues for any specific study to ensure 
that all participants are respected and protected. The draft document 
was developed through recommendations from nationally-recognized 
experts, public comment and external peer review in an open and 
transparent process. As part of this process, the document is being 
submitted to EPA's Human Studies Review Board (HSRB), which was 
established to provide advice, information, and recommendations on 
issues related to scientific and ethical aspects of human subjects 
research.

    Dated: September 26, 2007.
Lawrence W. Reiter,
Director, National Exposure Research Laboratory, Office of Research and 
Development.
[FR Doc. E7-19635 Filed 10-3-07; 8:45 am]

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