E7-19635. Draft Scientific and Ethical Approaches for Observational Exposure Studies

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public comment period.

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: [e-mail].
• Fax: [phone].
• 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 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 www.regulations.gov or e-mail. The 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 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 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 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 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 [phone]. 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: [phone]; facsimile: 202-566-9744; or e-mail: [e-mail].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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.