[Federal Register Volume 70, Number 66 (Thursday, April 7, 2005)]
[Notices]
[Pages 17817-17818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6641]


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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: [email protected].

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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