[Federal Register Volume 68, Number 42 (Tuesday, March 4, 2003)]
[Notices]
[Pages 10241-10243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5030]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7457-5]


Science Advisory Board, Environmental Health Subcommittee; 
Request for Nominations for Additional Expertise for the Formaldehyde/
Acetaldehyde/Vinyl Acetate Toxicological Reviews (FAVATR) Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Request for nominations.

DATES: All nominations are due by March 25, 2003.

ADDRESSES: U.S. EPA Science Advisory Board (1400A), Suite 6450P EPA, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001 (zip code for 
FedEx--20004)

FOR FURTHER INFORMATION CONTACT: Dr. Suhair Shallal, Designated Federal 
Officer, by telephone/voice mail at (202) 564-4566, by fax at (202) 
501-0582; or via e-mail at [email protected]. General information 
concerning the EPA Science Advisory Board can be found on the EPA SAB 
Web site at: http//www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    1. Background on the EPA Science Advisory Board: The U.S. 
Environmental Protection Agency (EPA or Agency) Science Advisory Board 
(SAB) is requesting nominations to add expertise to the Environmental 
Health Committee.
    The SAB was established by 42 U.S.C. 4365 to provide independent 
scientific and technical advice, consultation, and recommendations to 
the EPA Administrator on the technical basis for Agency positions and 
regulations. This panel will comply with the provisions of the Federal 
Advisory Committee Act (FACA) and all appropriate SAB procedural 
policies, including the SAB process for panel formation described in 
the Overview of the Panel Formation Process at the Environmental 
Protection

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Agency Science Advisory Board, which can found on the SAB's Web site 
at: http://www.epa.gov/sab/pdf/ec02010.pdf. Those selected to serve on 
the FAVATR panel will review the draft materials identified in this 
notice and respond to the charge questions provided below. Upon 
completion, the panel's report will be submitted to the SAB executive 
committee for final approval.
    2. Background on this Advisory Activity: The Agency has requested 
that the SAB conduct a peer review of the set of three toxicological 
reviews including: formaldehyde, acetaldehyde, and vinyl acetate. The 
SAB has been asked to conduct this review because of their previous 
review of the draft formaldehyde risk assessment update (EPA-SAB-EHC-
92-021), the precedent setting nature of the assessments using mode of 
action and biologically based models, and the high priority with 
respect to programmatic relevance of these documents.
    Formaldehyde, acetaldehyde, and vinyl acetate are all listed as 
hazardous air pollutants (HAPs) on the Clean Air Act Amendments of 1990 
and each is associated with significant ambient exposures. These 
assessments are required for each to support major regulatory 
initiatives and methods for program offices. Because of these 
priorities, all three have been listed for development of toxicological 
reviews to be included on the Integrated Risk Information System 
(IRIS).
    An overview of the documents to be reviewed can be found on the 
EPA's National Center for Environmental Assessment website (http://cfpub.epa.gov/ncea/). The final draft toxicological review for each 
chemical (Acetaldehyde, Formaldehyde and Vinyl Acetate) will be 
released in May 2003.
    3. Tentative Charge to the FAVATR Review Panel. The overall charge 
to the FAVATR review panel is to review the set of three (3) IRIS 
toxicological reviews for consistency in application of the proposed 
revised cancer guidelines and principles of mode-of-action modeling, 
with special emphasis on: (a) Weight-of-the-evidence issues to identify 
key events; (b) the use of pharmacokinetic and pharmacodynamic data; 
(c) motivation for dose surrogate and effect measures; (d) model 
structures for interspecies dosimetric adjustment; (e) model structures 
for dose-response analysis; (f) data-derived uncertainty factors for 
interspecies and intrahuman variability; and (g) leveraging of data on 
critical health effects and model structure sharing between routes and 
across chemically-related compounds to help inform alignment of the 
estimates.
    4. SAB Request for Nominations: The EPA SAB is requesting 
nominations of individuals who are recognized, national-level experts 
in one or more of the following disciplines necessary to contribute to 
the charge questions to be addressed by the FAVATR review panel: (a) 
Inhalation dosimetry modeling (e.g., computational fluid dynamics (CFD) 
modeling), (b) physiologically based pharmacokinetic (PBPK) modeling, 
(c), (d) biologically-based dose-response (BBDR) modeling for cancer, 
(e) epidemiology, (f) biochemistry, (g) inhalation toxicology and 
respiratory physiology, (h) gastrointestinal tract toxicology and 
physiology, (i) pathology, (j) carcinogenesis, (k) respiratory biology 
and immunology, (l) toxicology (including, genetic, reproductive, 
developmental), (m) quantitative risk assessment, (n) biostatistics and 
mathematical modeling.
    5. Process and Deadline for Submitting Nominations: Any interested 
person or organization may nominate qualified individuals to add 
expertise in the above areas for the FAVATR review panel. Nominations 
should be submitted in electronic format through the Form for 
Nominating Individuals to Panels of the EPA Science Advisory Board 
provided on the SAB website. The form can be accessed through a link on 
the blue navigational bar on the SAB website, www.epa.gov/sab. To be 
considered, all nominations must include the information required on 
that form.
    Anyone who is unable to submit nominations in electronic format may 
contact Dr. Suhair Shallal at the mailing address given at the end of 
this notice. Nominations should be submitted in time to arrive no later 
than March 25, 2003. Any questions concerning either this process or 
any other aspects notice should be directed to Dr. Shallal.
    The EPA Science Advisory Board Staff Office will acknowledge 
receipt of the nomination and inform nominators of the panel selected. 
From the nominees identified by respondents to this Federal Register 
notice (termed the ``Widecast''), SAB Staff will develop a smaller 
subset (known as the ``Short List'') for more detailed consideration. 
Criteria used by the SAB Staff in developing this Short List are given 
at the end of the following paragraph. The Short List will be posted on 
the SAB Web site at: http://www.epa.gov/sab, and will include, for each 
candidate, the nominee's name and their biosketch. Public comments will 
be accepted for 21 calendar days on the Short List. During this comment 
period, the public will be requested to provide information, analysis 
or other documentation that the SAB Staff should consider in evaluating 
candidates for the specific expertise to add to the FAVATR review 
panel.
    For the EPA SAB, a balanced review panel (i.e., committee, 
subcommittee, or panel) is characterized by inclusion of candidates who 
possess the necessary domains of knowledge, the relevant scientific 
perspectives (which, among other factors, can be influenced by work 
history and affiliation), and the collective breadth of experience to 
adequately address the charge. Public responses to the Short List 
candidates will be considered in the selection of the panel, along with 
information provided by candidates and information gathered by EPA SAB 
Staff independently on the background of each candidate (e.g., 
financial disclosure information and computer searches to evaluate a 
nominee's prior involvement with the topic under review). Specific 
criteria to be used in evaluating an individual subcommittee member 
include: (a) Scientific and/or technical expertise, knowledge, and 
experience (primary factors); (b) absence of financial conflicts of 
interest; (c) scientific credibility and impartiality; (d) availability 
and willingness to serve; and (e) ability to work constructively and 
effectively in committees.
    Short List candidates will also be required to fill-out the 
``Confidential Financial Disclosure Form for Special Government 
Employees Serving on Federal Advisory Committees at the U.S. 
Environmental Protection Agency'' (EPA Form 3110-48). This confidential 
form, which is submitted by EPA SAB Members and Consultants, allows 
Government officials to determine whether there is a statutory conflict 
between that person's public responsibilities (which includes 
membership on an EPA Federal advisory committee) and private interests 
and activities, or the appearance of a lack of impartiality, as defined 
by Federal regulation. The form may be viewed and downloaded from the 
following URL address: http://www.epa.gov/sab/pdf/epaform3110-48.pdf. 
Subcommittee members will likely be asked to attend at least one public 
face-to-face meeting and several public conference call meetings over 
the anticipated course of the advisory activity.
    The approved policy under which the EPA SAB selects review panels 
is described in a recent SAB document, EPA Science Advisory Board (SAB) 
Panel Formation Process: Immediate Steps to Improve Policies and

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Procedures--An SAB Commentary (EPA-SAB-EC-COM-002-003), which can be 
found on the SAB's Web site at: http://www.epa.gov/sab/pdf/ecm02003.pdf.
    Additional information concerning the EPA Science Advisory Board, 
including its structure, function, and composition, may be found on the 
EPA SAB Web site at: http://www.epa.gov/sab; and in the EPA Science 
Advisory Board FY2001 Annual Staff Report, which is available from the 
EPA SAB Publications Staff at phone: (202) 564-4533; via fax at: (202) 
501-0256; or on the SAB Web site at: http://www.epa.gov/sab/annreport01.pdf.

    Dated: February 26, 2003.
A. Robert Flaak,
Acting Deputy Director, EPA Science Advisory Board.
[FR Doc. 03-5030 Filed 3-3-03; 8:45 am]
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