[Federal Register Volume 61, Number 168 (Wednesday, August 28, 1996)]
[Notices]
[Page 44308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21943]


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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5601-3]


Benchmark Dose Peer Consultation Workshop

AGENCY: U.S. Environmental Protection Agency.

ACTION: Notice of meeting.

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SUMMARY: The EPA's Risk Assessment Forum is organizing a workshop on 
the use of the Benchmark Dose approach in cancer and noncancer risk 
assessments. A panel consisting of experts will discuss general 
principles related to the application of the Benchmark Dose approach as 
discussed in the EPA draft report Benchmark Dose Technical Guidance 
Document (EPA/600/P-96/002A). This draft guidance document is currently 
under development, but is being made available at this stage for a peer 
consultation workshop. Several experts in the areas of toxicology, 
statistics, and mathematical modeling have been asked to review the 
document and provide input at this early stage of development on 
several issues for which there is ongoing discussion within the Agency. 
The workshop will be open to members of the public as observers.

DATES: The meeting will begin on Tuesday, September 10, 1996, at 8:00 
a.m. and end on Wednesday, September 11, 1996, at 3:00 p.m.

ADDRESSES: The meeting will be held at the Holiday Inn Bethesda, 8120 
Wisconsin Avenue, Eastern Research Group, Inc., an EPA contractor, is 
providing logistical support for the workshop. To attend the workshop 
as an observer, contact Eastern Research Group, Inc., Tel: (617) 674-
7474 by September 2, 1996. Space is limited so please register early.

FOR FURTHER INFORMATION CONTACT:
For further information concerning the workshop, please contact Dr. 
Carole Kimmel, U.S. EPA, Office of Research and Development, 401 M 
Street, S.W., Washington, D.C., Telephone (202) 260-7331. To obtain a 
copy of the document, contact ORD Publications, Technology Transfer and 
Support Division, National Risk Management Laboratory, Cincinnati, OH; 
telephone 513-569-7562; fax: 513-569-7566. The document should be 
available on or about August 20, 1996.

SUPPLEMENTARY INFORMATION: The US EPA conducts risk assessments for an 
array of non-cancer health effects as well as for cancer. Historically, 
dose-response analysis has been done very differently, but with the 
recent publication of EPA's Proposed Guidance for Carcinogen Risk 
Assessment (61 FR 17960-18011), the dichotomy between quantitative 
approaches for cancer and noncancer risks will begin to breakdown. The 
EPA is exploring the use of the Benchmark Dose approach as a way of 
modeling effects data in the observable range and determining the point 
of departure that can be used as the basis for linear low-dose 
extrapolation, calculation of a margin of exposure (MOE), or 
application of uncertainty factors for calculating oral reference doses 
(RfDs), inhalation reference concentrations (RfCs), or other exposure 
estimates for human health risk assessment.
    Issues to be discussed at the workshop include: the appropriate 
selection of studies and responses for benchmark dose analysis, use of 
biological significance or limit of detection for selection of the 
benchmark response, model selection and fitting, use of the lower 
confidence limit, and the default decision approach proposed in the 
document.

    Dated: August 16, 1996.
Joseph Alexander,
Acting Assistant Administrator for Research and Development.
[FR Doc. 96-21943 Filed 8-27-96; 8:45 am]
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