[Federal Register: April 7, 2005 (Volume 70, Number 66)]
[Notices]
[Page 17817-17818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap05-134]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7895-1]
Notice of Availability of the Document Entitled Supplemental
Guidance for Assessing Susceptibility From Early-Life Exposure to
Carcinogens
AGENCY: U.S. Environmental Protection Agency (EPA).
ACTION: Notice of availability of final document.
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SUMMARY: This Notice announces the availability of the final document
entitled Supplemental Guidance for Assessing Susceptibility from Early-
Life Exposure to Carcinogens, hereafter referred to as Supplemental
Guidance.
DATES: The Supplemental Guidance is available for use by EPA risk
assessors as of March 29, 2005.
ADDRESSES: The Supplemental Guidance document is available
electronically through the EPA Web site at http://www.epa.gov/cancerguidelines.
A limited number of paper and CDROM copies will be
available from the EPA's National Service Center for Environmental
Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone:
(800) 490-9198 or (513) 489-8190; facsimile: (513) 489-8695. Please
provide your name, mailing address, the title and the EPA number of the
requested publication (EPA/630/R-03/003F). Additionally, copies of the
Supplemental Guidance will be available for inspection at EPA
headquarters and regional libraries, through the U.S. Government
Depository Library program.
FOR FURTHER INFORMATION CONTACT: Dr. William P. Wood, Risk Assessment
Forum, National Center for Environmental Assessment (8601D), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone: (202) 564-3361; facsimile: (202) 565-
0062; or e-mail: risk.forum@epa.gov.
SUPPLEMENTARY INFORMATION:
Background
In another notice in today's Federal Register, EPA has announced
the availability of final Guidelines for Carcinogen Risk Assessment
(EPA/630/P-03/001F), hereafter referred to as the Guidelines. The
background and scope of the Guidelines are explained in that notice.
The Guidelines explicitly call for
[[Page 17818]]
consideration of possible sensitive subpopulations and/or lifestages
(such as childhood). The consideration of childhood risks in the final
Guidelines has been augmented by the development of the Supplemental
Guidance document announced in this Notice. The Supplemental Guidance
is issued separately from the Guidelines so that it may be more easily
updated in a timely manner given the expected rapid evolution of
scientific understanding about the effects of early-life exposures.
A draft of the Supplemental Guidance was subjected to public
comment and was peer reviewed by the Agency's Science Advisory Board
(SAB) in May 2003. In response to one of the SAB's recommendations EPA
developed additional analyses of the available data. This analysis is
included in the Supplemental Guidance and has been accepted for
publication in the National Institute of Environmental Health Sciences
journal, Environmental Health Perspectives. A separate peer review of
the analysis also was conducted earlier in 2005.
Scope of the Supplement
The Supplemental Guidance recommends consideration of all studies
on the effects of early-life exposures. For the common case where there
are no early-life studies on a potential carcinogen, the Guidelines
suggest consideration of the carcinogen's mode of action. The
Supplemental Guidance addresses a number of issues pertaining to cancer
risks associated with early-life exposures generally, but provides
specific guidance on suggested actions only for carcinogens acting
through a mutagenic mode of action. The Supplemental Guidance addresses
carcinogens with a mutagenic mode of action because the currently
available early-life studies are generally for carcinogens with a
mutagenic mode of action. This Supplemental Guidance recommends for
such agents, a default approach using estimates from chronic studies
(i.e., cancer slope factors) with appropriate modifications to address
the potential for differential risk of early-lifestage exposure. As new
research leads to more conclusive evidence, EPA intends to update this
Supplemental Guidance to address other modes of action. The Agency
expects to produce additional guidance documents for other modes of
action, as data from new research and toxicity testing indicate it is
warranted. EPA intends to focus its research, and work collaboratively
with its federal partners, to improve understanding of the implications
of early life exposure to carcinogens.
EPA intends to use, to the extent practicable and consistent with
Agency statutes and regulations, the best available science in its risk
assessments and regulatory actions, and this Supplemental Guidance is
not intended to provide any substantive or procedural obstacle in
achieving that goal. Therefore, the Supplemental Guidance has no
binding effect on EPA or on any regulated entity. EPA expects its risk
assessments to reflect emerging science even if the Supplemental
Guidance has not been updated to reflect it. EPA intends to use the
approaches in the Supplemental Guidance to develop risk assessments,
when EPA has determined the approaches are suitable and appropriate.
Thus, EPA is not establishing any substantive, binding ``rules'' under
the Administrative Procedure Act or any other law in publishing this
Supplemental Guidance, but is issuing the Supplemental Guidance as a
non-binding statement of policy.
Dated: March 29, 2005.
Stephen L. Johnson,
Acting Administrator.
[FR Doc. 05-6641 Filed 4-6-05; 8:45 am]
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