03-5029. EPA Science Advisory Board, Environmental Health Committee, Notification of an Upcoming Meeting and Request for Information on the Proposed Panel for the Review of the Supplemental Guidance for Assessing Cancer Susceptibility From Early-...

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Request for Information on the Panel and Notification of an Upcoming Meeting.

DATES:

April 24, 2003—Teleconference meeting of the Environmental Health Committee Submissions concerning the proposed panel are due by March 18, 2003.

ADDRESSES:

U.S. EPA Science Advisory Board (1400A), Suite 6450P EPA, 1200 Pennsylvania Avenue, NW, Washington, DC 20460-0001 (zip code for FedEx—20004).

FOR FURTHER INFORMATION CONTACT:

Dr. Suhair Shallal, Designated Federal Officer, by telephone/voice mail at [phone], by fax at [phone]; or via e-mail at [e-mail]. General information concerning the EPA Science Advisory Board can be found on the EPA SAB Web site at: http://www.epa.gov/​sab.

SUPPLEMENTARY INFORMATION:

1. Background on the EPA Science Advisory Board: The U.S. Environmental Protection Agency (EPA or Agency) Science Advisory Board (SAB) is providing notification of an upcoming meeting and requesting information on the proposed SCAGS review panel.

The SAB was established by 42 U.S.C. 4365 to provide independent scientific and technical advice, consultation, and recommendations to the EPA Administrator on the technical basis for Agency positions and regulations. This panel will comply with the provisions of the Federal Advisory Committee Act (FACA) and all appropriate SAB procedural policies. Those selected to serve on the SCAGS review panel will review the draft materials identified in this notice and respond to the appropriate charge questions. Upon completion, the panel's report will be submitted to the SAB executive committee for final approval.

2. Background on this advisory activity: Pursuant to a request by EPA's Office of Research and Development, the SAB will conduct a peer review of the draft document entitled Supplemental Guidance for Assessing Cancer Susceptibility from Early-Life Exposure to Carcinogens. In a separate FR Notice, EPA announced the availability of, and the opportunity to comment on the above mentioned document.

The SAB was selected to lead this review due to its experience in reviewing various documents associated with the EPA's Draft Cancer Guidelines and the relevance of the expertise of its members to this review. In 1996, EPA published for public comment proposed revisions to EPA's 1986 Guidelines for Carcinogen Risk Assessment (61 FR 17960, April 23, 1996). Since the 1996 proposal, EPA's Science Advisory Board (SAB) has conducted three scientific peer reviews. In February 1997, the Science Advisory Board's Environmental Health Committee (SAB EHC) was asked to review the proposed revisions to the Agency's first cancer guidelines issued in 1986 (http://www.epa.gov/​sab/​pdf/​ehc9710.pdf). In January 1999, the EHC met again to consider selected sections of the draft Guidelines that were revised to address recommendations from the public and the earlier SAB review (1997) of the Guideline (http://www.epa.gov/​sab/​pdf/​ec15.pdf). A third meeting took place in July 1999 to provide advice and comment to the EPA on issues related to applying the provisions of EPA's proposed revised Cancer Risk Assessment Guidelines to children (http://www.epa.gov/​sab/​pdf/​ec0016.pdf).

Availability of the Meeting Materials—The materials for this review are available from the Office of Research and Development's National Center for Environmental Assessment, Risk Assessment Forum Web site, located at: http://cfpub.epa.gov/​ncea/​raf/​index.cfm. For questions and information concerning the materials, please contact Dr. William P. Wood, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460; tel. [phone], or e-mail: [e-mail].

3. Meeting via Teleconference of the Environmental Health Committee—April 24, 2003: Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the Environmental Health Committee of the U.S. EPA Science Advisory Board (SAB) will meet on Thursday, April 24, 2003 via teleconference at 3 p.m.-5 p.m. Eastern Standard Time (EST) to begin the review of the EPA's Office of Research and Development draft document entitled, Supplemental Guidance for Assessing Cancer Susceptibility From Early-Life Exposure to Carcinogens (SGACS). This document provides a possible approach for assessing cancer susceptibility from early-life exposure to carcinogens. The purpose of the teleconference is: (a) To discuss the charge and the adequacy of the review materials provided to the SGACS Review Panel; (b) to clarify any questions and issues relating to the charge and the review materials; (c) to discuss specific charge assignments to the SGACS Review Panelists; and (d) to clarify specific points of interest raised by the Panelists in preparation for the face-to-face meeting. All times noted are Eastern Standard Time. The meeting is open to the public, however, seating is limited and available on a first come basis. Important Notice: Documents that are the subject of SAB reviews or consultations are normally available from the originating EPA office and are not available from the SAB Office—information concerning availability of documents generated by the SAB and the relevant Program Office is included above.

The meeting will begin on April 24, 2003 at 3 p.m. EST and adjourn no later than 5 p.m. EST that day. The meeting will be held at EPA Headquarters, Washington, DC, Ariel Rios North, room 6013. For further information concerning this meeting, please contact the individuals listed at the beginning of this Federal Register notice. A copy of the draft agenda for the meeting will be posted on the SAB Web site (www.epa.gov/​sab) (under the AGENDAS subheading) approximately 10 days before the meeting. Information concerning a subsequent face to face meeting will be forthcoming in a separate Federal Register notice.

Providing Oral or Written Comments at SAB Meetings—It is the policy of the EPA Science Advisory Board (SAB) to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA SAB expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements. Oral Comments: In general, each individual or group requesting an oral presentation at a face-to-face meeting will be limited to a total time of ten minutes (unless otherwise indicated). For teleconference meetings, opportunities for oral comment will usually be limited to no more than three minutes per speaker and no more than fifteen minutes total. Interested parties should contact the DFO at least one week prior to the meeting in order to be placed on the public speaker list for the meeting. Speakers may attend the meeting and provide comment up to the meeting time. Speakers should bring at least 35 copies of their comments and presentation slides for distribution to the reviewers and public at the meeting. Written Comments: Although the SAB accepts written comments until the date of the meeting (unless otherwise stated), written comments should be received in the SAB Staff Office at least one week prior to the meeting date so that the comments may be made available to the review panel for their consideration. Comments should be supplied to the DFO at the address/contact information noted below in the following formats: one hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat, WordPerfect, Word, or Rich Text files (in IBM-PC/Windows 95/98 format). Those providing written comments and who attend the meeting are also asked to bring 35 copies of their comments for public distribution. Should comment be provided at the meeting and not in advance of the meeting, they should be in-hand to the DFO up to and immediately following the meeting. The SAB allows a grace period of 48 hours after adjournment of the public meeting to provide written comments supporting any verbal comments stated at the public meeting to be made a part of the public record.

Meeting Access—Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Ms. Zisa Lubarov-Walton ([e-mail]) or by telephone/voice mail at [phone] at least five business days prior to the meeting date so that appropriate arrangements can be made.

4. Solicitation of information on the Proposed Review Panel: To provide the Agency with meaningful input, we have determined that the following expertise is needed for the review: toxicology including carcinogenicity; biostatistics; epidemiology; pediatrics; radiation biology; risk assessment and the application of the Agency's risk assessment guidelines. As requested by EPA's ORD, the EPA Science Advisory Board's Environmental Health Committee, a standing committee of the Board, will conduct this review. The SAB EHC will be augmented with members from the SAB Radiation Advisory Committee, the FIFRA Science Advisory Panel (SAP) and the Children's Health Protection Advisory Council (CHPAC) to form the SGACS review Panel. By including members of the three EPA advisory bodies in the review of this document, the requesting office hopes to benefit from their unique expertise in children's risk assessment and to receive a peer review report which reflects the views of these bodies on the charge questions in an expedited manner. Therefore, we are not soliciting additional experts for this review.

The SAB Staff Office will post the names and biosketches for members of the review Panel on the SAB Web site at: http://www.epa.gov/​sab. The public has the opportunity to provide information, analysis or other documentation relevant to the membership of the panel before the SAB Staff Office makes a final decision. Information, analysis or documentation must be received by the Designated Federal Officer (DFO) no later than March 18, 2003. Please see the address/contact information noted above. The complete SAB process for panel formation described in the Overview of the Panel Formation Process at the Environmental Protection Agency Science Advisory Board, which can found on the SAB's Web site at: http://www.epa.gov/​sab/​pdf/​ec02010.pdf.

For the EPA SAB, a balanced review panel (i.e., committee, subcommittee, or panel) is characterized by inclusion of candidates who possess the necessary domains of knowledge, the relevant scientific perspectives (which, among other factors, can be influenced by work history and affiliation), and the collective breadth of experience to adequately address the charge. Information provided by the public will be considered in the selection of the panel, along with information provided by candidates and information gathered by EPA SAB Staff independently on the background of each candidate (e.g., financial disclosure information and computer searches to evaluate a nominee's prior involvement with the topic under review). Specific criteria to be used in evaluating an individual subcommittee member include: (a) Scientific and/or technical expertise, knowledge, and experience (primary factors); (b) availability and willingness to serve; (c) absence of financial conflicts of interest; (d) scientific credibility and impartiality; and (e) ability to work constructively and effectively in committees.

Dated: February 26, 2003.

Robert Flaak,

Acting Deputy Director, EPA Science Advisory Board.