[Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
[Notices]
[Pages 167-168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34822]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6214-4]


Science Advisory Board; Notification of Public Advisory Committee 
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, notice is hereby given that the Cancer Guidelines Subcommittee of 
the Science Advisory Board Executive Committee will meet on Wednesday, 
January 20 and Thursday, January 21, 1999, beginning no earlier than 
8:30 am and ending no later than 5:30 pm on each day. All times noted 
are Eastern Time. The meeting is open to the public; however, seating 
will be on a first-come basis. The meeting will be held at the Crowne 
Plaza Hotel, 14th & K Streets, N.W., Washington, DC 20005-3411; phone: 
(202) 682-0111. Important Notice: Documents that are the subject of SAB 
reviews are normally available from the originating EPA office and are 
not available from the SAB Office--information concerning availability 
of documents from the relevant Program Office is included below.
    Purpose--The purpose of the meeting is to conduct an advisory on 
the Agency's revisions to its Proposed Guidelines for Carcinogen Risk 
Assessment.
    Background--In February, 1997, the Environmental Health Committee 
(EHC) of the Science Advisory Board met to review the Agency's Proposed 
Guidelines for Carcinogen Risk Assessment which were published in the 
Federal Register on April 23, 1996. During this meeting, the EHC 
responded to specific questions from the EPA's Risk Assessment Forum. 
At that time, the EHC addressed issues that Agency scientists and 
members of the public regarded as particularly important matters of 
science to be addressed to finalize the guidelines. The Environmental 
Health Committee provided its review report to the Agency, Guidelines 
for Cancer Risks Assessment (EPA-SAB-EHC-97-010), in September 1997. 
Since that time, the technical panel has been addressing the SAB 
recommendations in revising the Guidelines.
    Since this meeting is an advisory, the Cancer Guidelines 
Subcommittee does not plan to conduct a full review of the revisions to 
the Proposed Guidelines for Carcinogen Risk Assessment. The Cancer 
Guidelines Subcommittee will provide technical advice on the Agency's 
plans to address the following four topics: (a) changes to the hazard 
descriptors for weight of evidence of human carcinogenic potential; (b) 
a framework for analysis of mode of action data; (c) illustrative 
examples of mode of action framework analysis; and (d) new dose 
response guidance methodologies with illustrative examples for margin 
of exposure analysis. The Cancer Guidelines Subcommittee has been asked 
to respond to the following issues:

1. Hazard Descriptors

    (a) Please comment on the appropriateness and adequacy of the use 
of the narrative summary and the 5 hazard descriptors as a means of 
characterizing human carcinogenic potential.
    (b) Please comment on the adequacy and clarity of the nature of the 
evidence applied to each of the proposed hazard descriptors.

2. Use of Mode of Action Information

    (a) Sections 2.3.5-2.5 have been revised, please comment on the 
clarity and transparency of the guidance.
    (b) Please comment on the proposed key elements and their use in 
supporting a mode of action conclusion via the framework (section 2.5).
    (c) Please evaluate the usefulness of the case studies as 
illustrations of the guidance and framework.

3. Dose Response Analysis--Defining a Point of Departure

    (a) Please comment on the soundness of the scientific rationale 
provided for the standard approach and options for selecting departure 
points.
    (b) Please comment on the adequacy and clarity of the guidance on 
this subject.

4. Dose Response Analysis--Margin of Exposure Analysis

    (a) Please comment on the adequacy and clarity of the guidance 
regarding how to perform a MOE analysis.
    (b) Please comment on the appropriateness of the proposed approach 
and the factors for consideration in determining the appropriate 
magnitude of the MOE. Specifically address the use of factors to 
account for: (1) the nature of the response (i.e., tumors or key events 
selected as the point of departure for extrapolation); (2) steepness of 
the dose response curve; (3) human intraspecies variability, including 
susceptible populations; and (4) interspecies variability.
    For Further Information on the Meeting: Copies of the background 
materials for the advisory are not available from the SAB. The EPA Risk 
Assessment Forum will post the background material by January 8, 1999, 
on its Internet website which is located at www.epa.gov/ncea/raf/
rafpub.htm. Hardcopies of the background material may be requested by 
contacting Dr. William P. Wood, Executive Director, Risk Assessment 
Forum, U.S. EPA (8601-D), 401 M St., S.W., Washington, DC 20460; by 
telephone 202-564-3361; by fax 202-565-0062; or via E-mail at: 
[email protected]. General information about the cancer guidelines 
advisory or technical questions should also be directed to Dr. Wood.
    Members of the public desiring additional information about the 
meeting, including an agenda, should contact Ms. Wanda R. Fields, 
Management Assistant, Science Advisory Board (1400), US EPA, 401 M 
Street, SW, Washington DC 20460, by telephone (202) 260-5510; by fax 
(202)

[[Page 168]]

260-7118; or via E-mail at: [email protected].
    Anyone wishing to make an oral presentation at the meeting must 
contact Ms. Roslyn Edson, Designated Federal Officer, in writing, no 
later than 5 p.m. noon Eastern Time on January 15, 1999, by fax (202) 
260-7118, or via E-mail: [email protected]. The request should 
identify the name of the individual who will make the presentation and 
an outline of the issues to be addressed. At least 35 copies of any 
written comments to the Committee are to be given to Ms. Edson no later 
than the time of the presentation for distribution to the Committee and 
the interested public.

Providing Oral or Written Comments at SAB Meetings

    The Science Advisory Board expects that public statements presented 
at its meetings will not be repetitive of previously submitted oral or 
written statements. In general, each individual or group making an oral 
presentation will be limited to a total time of ten minutes. For 
conference call meetings, opportunities for oral comment will be 
limited to no more than five minutes per speaker and no more than 
fifteen minutes total. Written comments (at least 35 copies) received 
in the SAB Staff Office sufficiently prior to the meeting date, may be 
mailed to the Subcommittee prior to its meeting; comments received too 
close to the meeting date will normally be provided to the Subcommittee 
at its meeting. Written comments may be provided to the Subcommittee up 
until the time of the meeting.
    Information concerning the Science Advisory Board, its structure, 
function, and composition, may be found in The FY1998 Annual Report of 
the Staff Director which is available from the SAB Committee Evaluation 
and Support Staff (CESS) by contacting US EPA, Science Advisory Board 
(1400), Attention: CESS, 401 M Street, SW, Washington, DC 20460 or via 
fax (202) 260-1889. Additional information concerning the SAB can be 
found on the SAB Home Page at: http://www.epa.gov/sab

Meeting Access

    Individuals requiring special accommodation at this meeting, 
including wheelchair access, should contact Ms. Roslyn Edson at 202-
260-3823, via fax at 202-260-7118 or via E-mail at [email protected] 
at least five business days prior to the meeting so that appropriate 
arrangements can be made.

    Dated: December 23, 1998.
Donald G. Barnes,
Staff Director, Science Advisory Board.
[FR Doc. 98-34822 Filed 12-31-98; 8:45 am]
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