[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Page 36533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14897]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9688-7]


Notice of Availability of the Benchmark Dose Technical Guidance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Availability.

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SUMMARY: The U.S. Environmental Protection Agency is announcing the 
availability of Benchmark Dose Technical Guidance (BMD). This document 
was developed as part of an agency-wide guidance development program by 
a technical panel of the EPA's Risk Assessment Forum. Drafts were peer 
reviewed internally by EPA scientists and externally by experts from 
academia, industry, and other federal and state government agencies. 
When appropriate, the EPA intends to use the guidance prospectively in 
conducting risk assessments.

ADDRESSES: The BMD document is available electronically through the 
EPA's Web site at http://www.epa.gov/raf/publications/benchmarkdose.htm.

FOR FURTHER INFORMATION CONTACT: Dr. Michael W. Broder, Risk Assessment 
Forum, Office of the Science Advisor (8105R), U.S. Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; 
on telephone number (202) 564-3393; facsimile number (202) 564-2070; or 
email broder.michael@epa.gov.

SUPPLEMENTARY INFORMATION: In support of its mission to protect human 
health and the environment, the EPA routinely conducts risk assessments 
on chemical agents that may be toxic to humans. A key component of the 
risk assessment process involves evaluating the dose-response 
relationship between exposure to the agent and the observed effect. The 
dose-response assessment is a two-step process: (1) Defining a point of 
departure (POD); and (2) extrapolating from the POD for relevance to 
environmental exposures. Traditionally, the no observed adverse effect 
level (NOAEL) or lowest observed adverse effect level (LOAEL) methods 
were used for establishing the POD for noncancer endpoints. The BMD 
method gained favor within the risk assessment community over time 
because it incorporates and conveys more information than the NOAEL/
LOAEL methods. The EPA conducted workshops and symposia about the 
application of BMD methodology and the development of relevant 
guidance.
    The BMD document focuses on the use of the BMD methodology for 
human health risk assessments. The document discusses computation of 
BMD values and their confidence limits, data requirements, dose-
response assessment, and reporting recommendations that are specific to 
BMD values. Although the EPA has generated its own BMD software (http://www.epa.gov/ncea/BMDS/index.html), this document supports the use of 
other relevant, well-documented software packages.

    Dated: June 6, 2012.
Glenn Paulson,
Science Advisor.
[FR Doc. 2012-14897 Filed 6-18-12; 8:45 am]
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