[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 10242]]
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
[[Page 10243]]
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]
BILLING CODE 6560-50-P