[Federal Register Volume 65, Number 54 (Monday, March 20, 2000)]
[Notices]
[Pages 14966-14967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6936]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6563-5]


Workshop on Information Needs To Address Children's Cancer Risk

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: The EPA's Office of Research and Development and the National 
Institutes of Health's National Institute of Environmental Health 
Sciences (NIEHS) are co-sponsoring a workshop entitled, ``Information 
Needs to Address Children's Cancer Risk.'' The main focus of the 
workshop is to discuss children's cancer risk assessment and related 
data needs to address issues that have arisen during public review of 
the Agency's 1999 Draft Revised Guidelines for Carcinogen Risk 
Assessment. These issues include: characterizing the ideal data set to 
adequately address children's cancer risk, and proposed approaches to 
using available data in the absence of the ideal data set. Invited 
participants represent the pediatric, toxicologic, and risk assessment 
communities and are leaders in the area of human health testing, 
research, and assessment.

DATES: The workshop will begin on Thursday, March 30, 2000, at 7:00 
p.m. and end on Friday, March 31, 2000, at 4:30 p.m. There will be 
space available for observers on a first-come, first-served basis.

[[Page 14967]]


ADDRESSES: The meeting will be held at the Holiday Inn Arlington at 
Ballston, 4610 North Fairfax Drive, Arlington, Virginia, 22203, Tel: 
(703) 243-9800. As seating capacity is limited, please contact Eastern 
Research Group, Inc., Tel: (781) 674-7374, Fax: (781) 674-2906 by 
Monday, March 27, 2000, to attend the workshop as an observer.

FOR FURTHER INFORMATION CONTACT: For technical inquires, contact Linda 
C. Tuxen (Mail Code 8601D), U.S. EPA, Ariel Rios Building, 1200 
Pennsylvania Avenue, N.W., Washington D.C. 20460, Tel: (202) 564-3332, 
Fax: (202) 565-0090, and E-Mail: [email protected]. Inquiries 
concerning the workshop should be directed to Eastern Research Group, 
Inc. Copies of background materials will be made available to observers 
upon request from Eastern Research Group, Inc., Tel: (781) 674-7374. 
Copies of background materials will also be available at the workshop.

SUPPLEMENTARY INFORMATION: The purpose of the workshop is focused and 
derives from issues discussed in the EPA's 1999 Draft Revised 
Guidelines for Carcinogen Risk Assessment. First, participants will 
consider the content of the ideal data set to adequately address 
children's cancer risk. The workshop participants will focus on data 
needed for assessing the impact of childhood (including in utero) 
exposures to carcinogens and the issues related to hazard 
identification and dose-response analyses. The participants will 
address not only induction of childhood cancer, but also increased 
risks of cancer during adulthood resulting from childhood exposure. As 
part of this discussion, the participants also will be asked to 
consider how current protocols might be redesigned to better answer 
questions related to children's cancer risk and what additional types 
of data might be brought to bear on children's cancer risk assessment. 
This would include information that is currently collected as well as 
data sets using new approaches. In addition, the workshop participants 
will be asked to discuss the question, What are the elements of a 
``cogent biological rationale,'' as presented in the draft revised 
cancer guidelines, for addressing modes-of-action for children's 
cancer? Further, participants will address whether and how such a 
rationale can be made, which is sufficiently health-protective of 
children, based on the kinds of data that are typically collected by 
and available to Federal and state health science agencies at the 
present time. These might include data on cancer mode-of-action, 
comparative pharmacokinetics and pharmacodynamics in adults and 
children, rate and pattern of exposure in adults and children, etc. The 
background for these discussions is the reality that chemical-specific 
data are often lacking to specifically address children's cancer risk 
from environmental chemical exposures. As a consequence, the assessment 
of children's risk is currently addressed by evaluations of traditional 
cancer bioassays in mature animals using sensitive responders, 
comparative biochemistry and physiology between adults and developing 
animals and humans, and public-health-protective default positions in 
the absence of child-specific data. It is expected that workshop 
discussions will be valuable to the general risk assessment community, 
will provide input to Federal testing strategies for the future, and 
will inform the public dialogue around children's health issues as they 
are addressed in the EPA's draft revised cancer guidelines.
    The workshop format will be an evening session on Thursday at which 
the key participants will set the stage for the discussion to follow at 
the Friday full-day session. The evening session will include an 
overview of the contents of and current issues coming out of the EPA's 
1999 Draft Revised Guidelines for Cancer Risk Assessment regarding 
assessment of children's cancer risk, and a discussion of the questions 
to be addressed in detail at the Friday session. A summary report of 
the perspectives and views coming out of this workshop will be 
published in the peer-reviewed, scientific literature.

    Dated: March 15, 2000.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 00-6936 Filed 3-17-00; 8:45 am]
BILLING CODE 6560-50-P