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Draft Benchmark Dose Technical Guidance Document
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: November 20, 2000 (Volume 65, Number 224)]
[Notices]
[Page 69772-69773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no00-72]
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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 confmail@erg.com. 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: nceadc.comment@epa.gov.
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: brower.marilyn@epa.gov.
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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