[Federal Register Volume 65, Number 224 (Monday, November 20, 2000)]
[Notices]
[Pages 69772-69773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29648]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6904-7]


Draft Benchmark Dose Technical Guidance Document

AGENCY: Environmental Protection Agency.

ACTION: Notice of Peer-Review Workshop and Public Comment Period.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
that Eastern Research Group, Inc. (ERG), an EPA contractor for external 
scientific peer review, will organize, convene, and conduct an external 
peer-review workshop to review the draft document titled: ``Benchmark 
Dose Technical Guidance Document'' (EPA/630/R-00/001). The EPA is also 
announcing a 30-day public comment period for the draft document. The 
document was prepared by an EPA Risk Assessment Forum Technical Panel. 
The Technical Panel will consider the peer-review and public comment 
submissions in finalizing the document.

DATES: The peer-review workshop will begin on Thursday, December 7, 
2000, at 8:30 a.m. and end at 5:00 p.m., then reconvene Friday, 
December 8, 2000, from 8:00 a.m. to 1:00 p.m. Members of the public may 
attend as observers, and there will be a limited time for comments from 
the public. The 30-day public comment period begins November 20, 2000, 
and ends December 20, 2000.

ADDRESSES: The external peer-review workshop will be held at the 
Holiday Inn Capital, 550 C Street SW, Washington DC 20024. To attend 
the workshop register by November 30, 2000 by calling ERG at (781) 674-
7374 or send a facsimile to (781) 674-2906. You may also register on 
the Internet at http://www.erg.com/conferences/index.htm, or by E-mail 
at [email protected]. Space is limited, and reservations will be 
accepted on a first-come, first-served basis. There will be a limited 
time for comments from the public during the workshop. Please let ERG 
know if you wish to make comments.
    The draft ``Benchmark Dose Technical Guidance Document'' is 
available primarily via the Internet at http://www.epa.gov/ncea/
bnchmrk/bmds--peer.htm. A limited number of paper copies are available 
from the Technical Information Staff (8623D), NCEA-W; telephone: 202-
564-3261; facsimile: 202-565-0050. If you are requesting a paper copy, 
please provide your name, mailing address, and the document title, 
draft ``Benchmark Dose Technical Guidance Document.'' Copies are not 
available from ERG. Comments may be mailed to the Technical Information 
Staff (8623D), NCEA-W, U.S. Environmental Protection Agency, 1200 
Pennsylvania Avenue, NW, Washington, DC 20460, or delivered to the 
Technical Information Staff at 808 17th Street, NW, 5th Floor, 
Washington, DC 20006; telephone: 202-564-3261; facsimile: 202-565-0050. 
Comments should be in writing and must be postmarked by December 20, 
2000. Please submit one unbound original with pages numbered 
consecutively, and three copies of the comments. For attachments, 
provide an index, number pages consecutively with the comments, and 
submit an unbound original and three copies. Electronic comments may be 
emailed to: [email protected].
    Please note that all technical comments received in response to 
this notice will be placed in a public record. For that reason, 
commentors should not submit personal information (such as medical data 
or home address), Confidential Business Information, or information 
protected by copyright. Due to limited resources, acknowledgments will 
not be sent.

FOR FURTHER INFORMATION CONTACT: For workshop information, 
registration, and logistics, contact ERG, 110 Hartwell Avenue, 
Lexington, Massachusetts 02173; telephone: (781) 674-7374; facsimile: 
(781) 674-2906.
    For information on the public comment period, contact Marilyn 
Brower, Risk Assessment Forum Staff; telephone: 202-564-3363; 
facsimile: 202-565-0062; or email: [email protected].

SUPPLEMENTARY INFORMATION: The U.S. EPA conducts risk assessments for 
an array of health effects that may result from exposure to 
environmental agents and that require an analysis of the relationship 
between exposure and health-related outcomes. The dose-response 
assessment can be approached as a two-step process, the first being the 
definition of a point of departure (POD) and the second extrapolation 
from the POD to low environmentally-relevant exposure levels. The 
benchmark dose (BMD) approach provides a more quantitative alternative 
to the first step in the dose-response assessment than the current no-
observed-adverse-effect-

[[Page 69773]]

level/lowest-observed-adverse-effect-level (NOAEL/LOAEL) process for 
noncancer health effects and can be applied to determining the POD 
proposed for cancer endpoints (EPA, 1996). As the Agency moves toward 
harmonization of approaches for cancer and noncancer risk assessment, 
the dichotomy between cancer and noncancer health effects is being 
replaced by consideration of mode of action and whether the effects of 
concern are likely to be linear or nonlinear at low doses. Thus, the 
purpose of this document is to provide guidance for the Agency on the 
application of the BMD approach in determining the POD, whether a 
linear or nonlinear low dose extrapolation is used.
    The document addresses a number of issues that must be resolved in 
order to apply the BMD approach for dose-response assessment in a 
consistent manner. These issues include: (1) Determination of 
appropriate studies and endpoints on which to base BMD calculations; 
(2) selection of the benchmark response (BMR) value; (3) choice of the 
model to use in computing the BMD; (4) details surrounding computation 
of the confidence limit for the BMD (BMDL); and (5) reporting 
requirements for BMD and BMDL computation.
    Since the methods for BMD computation require appropriate software, 
another purpose of this document is to provide enough information about 
preferred computational algorithms to allow users to make an informed 
choice in the selection of that software. The document does not 
advocate use of any particular software package, although it is 
recommended that software with well documented algorithms, such as the 
Agency's BMD software (BMDS) package, be used. Nor is this guidance 
intended to document any particular software package, although it will 
present examples for illustrative purposes that use the Agency's BMDS 
package. It is also expected that this guidance will inform the design 
of studies for the computation of BMDs and dose-response analysis, 
though this will not be covered explicitly. The terminology used in the 
document is consistent with the EPA's BMDS. This software is available 
on the Internet at http://www.epa.gov/ncea/bmds.htm.
    The Risk Assessment Forum has been active in promoting research and 
discussion on BMD issues since 1990. In 1993 the Risk Assessment Forum 
sponsored a colloquium on the applications of BMD methods to noncancer 
risk assessment. The focus of this colloquium was to review a Forum 
draft report that outlined the techniques and presented the major 
questions and decisions involved in applying the BMD method. Following 
this a technical panel published a background document on the use of 
BMD in health risk assessment (EPA/630/R-94/007). In the ensuing years 
the Forum sponsored several workshops and symposia on the BMD approach, 
including a 1996 external peer review on an earlier draft of the 
document presently undergoing review. Following this external peer 
review, the Technical Panel will consider reviewers' and public 
comments in finalizing the document.
    This document is intended to be updated as new information becomes 
available that would suggest approaches and default options alternative 
or additional to those indicated here and should not be viewed as 
precluding additional research on modified or alternative approaches 
that will improve quantitative risk assessment.

    Dated: November 9, 2000.
William H. Farland,
Director, National Center for Environmental Assessment.
[FR Doc. 00-29648 Filed 11-17-00; 8:45 am]
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