03-8958. Science Advisory Board, Environmental Health Committee; Notification of an Upcoming Meeting and Final List of Panel Members for the Review of the Supplemental Guidance for Assessing Cancer Susceptibility From Early-life Exposure to ...

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA), Science Advisory Board (SAB), a Federal Advisory Committee, announces: (a) An upcoming meeting (b) and final list of panel members for the Review of the Supplemental Guidance for Assessing Cancer Susceptibility from Early-life Exposure to Carcinogens (SGACS).

DATES:

The face-to-face meeting will take place May 12, 2003 from 1 PM to 5 PM, and May 13 and 14, 2003 from 9 to 5 PM (all times noted are Eastern Daylight Time).

ADDRESS:

The meeting will take place at the Sheraton Crystal City, 1800 Jefferson-Davis Hwy, Arlington, VA 22202

FOR FURTHER INFORMATION CONTACT:

For general information about the meeting, please 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. Notification of Public Meeting: The U.S. Environmental Protection Agency (EPA) Science Advisory Board (SAB) is providing notification of an upcoming meeting and announcing the final membership of the SCAGS panel.

Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the Supplemental Guidance for Assessing Cancer Susceptibility (SGACS) panel of the US EPA Science Advisory Board (SAB) will meet to review the EPA's Office of Research and Development draft document entitled “Supplemental Guidance for Assessing Cancer Susceptibility From Early-Life Exposure to Carcinogens”. This document provides a possible approach for assessing cancer susceptibility from early-life exposure to carcinogens.

The purpose of this meeting is to allow contemporaneous public access to the SGACS review panel's deliberations concerning the above-mentioned draft document. The meeting is open to the public; however, seating is limited and available on a first come basis. The meeting will be held at the times and dates and place specified above. A copy of the draft agenda for the meeting will be posted on the SAB Web site (http://www.epa.gov/​sab) (under the AGENDAS subheading) approximately 10 days before the meeting.

For more information regarding the background on this advising activity, please refer to the Federal Register, 68 FR 10240, published on March 4, 2003 or the SAB Web site at http://www.epa.gov/​sab/​panels/​sgacs.html.

The panel will be charged with responding to the following questions concerning the document to be reviewed.

(a) The Agency seeks the Science Advisory Board's review of the soundness of the Agency's position that the existing scientific information and data support the conclusion that there is greater susceptibility for the development of tumors as a result of exposures in early lifestages as compared with adults to chemicals acting through a mutagenic mode of action. Are there any key studies that the Agency has overlooked in reaching this conclusion?

(b) For chemicals acting through non-mutagenic modes of action, the Agency concludes that a range of approaches needs to be developed over time for addressing cancer risks from childhood exposures. Please comment on the Agency's conclusion that the scientific knowledge and data are insufficient at this time to develop generic guidance on how to address these chemicals and a case-by-case approach is more suitable. Is the SAB aware of any additional data for chemicals acting through non-mutagenic modes of action relevant to possible early lifestage sensitivity?

(c) Assuming that it is appropriate to conclude that there is differential lifestage susceptibility to chemicals acting through a mutagenic mode of action, the Agency's guidance uses a default approach that adjusts cancer slope factors (typically from conventional animal bioassays and/or epidemiologic studies of adult exposure) to address the impact of early-lifestage exposure. Please comment on the appropriateness of this approach.

(d) When considering differential susceptibility, the Agency's guidance separates the potential susceptible period into two age groups, 0-2 years and 2-15 years. These groupings were based on biological considerations rather than exposure considerations. The first grouping, 0-2 years of age, is meant to encompass a period of rapid development and the second grouping, 2-15 years of age, was selected to represent middle adolescence approximately following the period of rapid developmental changes during puberty. Please comment on the appropriateness of these age groupings with respect to susceptible lifestages given the current knowledge.

(e) The Guidance provides a quantitative approach to account for the greater susceptibility of early-life exposure to chemicals that act through a mutagenic mode of action. An adjustment factor of 10 is applied to the cancer slope factor (derived from animal or epidemiology studies) for exposures before 2 years of age, a factor of 3 is applied for ages between 2 and 15 years, and no adjustment after the age of 15. Please comment on the appropriateness of these adjustment factors based on the analysis of available data.

(f) The Agency recognizes that consideration of children's risk is a rapidly developing area and, therefore, the Agency intends to issue future guidance that will further refine the present guidance and possibly address other modes of action as data become available. The Agency welcomes the SAB's recommendations on other modes of action that may be most fruitful to assess in similar future analyses.

(g) The analysis presented in the current Guidance relies on neonatal and early-life exposure studies. Can the SAB recommend how to best incorporate data from transplacental or in utero exposure studies into future analyses?

(h) The Agency welcomes the SAB's recommendations on critical data needs that will facilitate the development of future guidance addressing differential lifestage susceptibility.

Availability of Review Materials: 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. 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].

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) and no more than one hour total. 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 in the opening of this notice 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.

2. Meeting Access: Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Ms. Sandra Friedman ([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.

3. Final List of panel members: 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/​panels/​sgacsrp.html along with the “Panel Selection” document that outlines the issues that were considered in selecting this panel at least 10 days prior to the first meeting, a teleconference scheduled for April 24, 2003 as previously announced in the Federal Register on March 4, 2003 (refer to 68 FR 10240).

Dated: April 7, 2003.

Vanessa T. Vu,

Director, EPA Science Advisory Board.