[Federal Register Volume 68, Number 70 (Friday, April 11, 2003)]
[Notices]
[Pages 17803-17804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8958]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL -7482-5 ]


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 Carcinogens (SGACS)

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 (202) 564-4566, by fax at (202) 501-0582; or 
via e-mail at [email protected]. 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

[[Page 17804]]

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. (202) 
564-3361, or e-mail: [email protected].
    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 ([email protected]) or by 
telephone/voice mail at (202) 564-2526 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.
[FR Doc. 03-8958 Filed 4-10-03; 8:45 am]
BILLING CODE 6560-50-P