Environmental Protection Agency (EPA).
Notice.
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).
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).
The meeting will take place at the Sheraton Crystal City, 1800 Jefferson-Davis Hwy, Arlington, VA 22202
For general information about the meeting, please contact Dr. Suhair Shallal, Designated Federal Officer, by telephone/voice mail at (202) 564–4566, by fax at (202) 501–0582; or via e-mail at
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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 (
For more information regarding the background on this advising activity, please refer to the
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
(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.
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