Science Advisory Board Staff Office; Request for Nominations for the Science Advisory Board Formaldehyde Review Panel

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The EPA Science Advisory Board (SAB) Staff Office announces the formation of a new SAB review panel known as the Formaldehyde Review Panel (FRP), and is soliciting nominations for members of the Panel.

DATES:

Nominations should be submitted by May 12, 2004.

FOR FURTHER INFORMATION CONTACT:

Any member of the public requiring further information regarding this Request for Nominations, or a paper nomination form, may contact Dr. Suhair Shallal, Designated Federal Officer (DFO), by telephone/voice mail at (202) 343-9977, via e-mail at shallal.suhair@epa.gov, or at the following address: Suhair Shallal, PhD., Science Advisory Board Staff Office, U.S. Environmental Protection Agency (Mail Code 1400F), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. General information about the SAB can be found in the SAB Web site at: http://www.epa.gov/sab .

SUPPLEMENTARY INFORMATION:

Background: The EPA SAB Staff Office is announcing the formation of a new review panel and soliciting nominations for members of the panel. This panel is being formed to help provide advice to the Agency, as part of the SAB's mission, established by 42 U.S.C. 4365, to provide independent scientific and technical advice, consultation, and recommendations to the EPA Administrator on the technical bases for EPA policies and regulations. The work of this panel is expected to continue until the review is complete. The SAB is a chartered Federal Advisory Committee that reports directly to the Administrator. The FRP will provide advice through the chartered SAB. The FRP will comply with the openness 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 Agency, Science Advisory Board (EPA-SAB-EC-COM-02-010), http://www.epa.gov/sab/pdf/ecm02010.pdf.

EPA's National Center for Environmental Assessment (NCEA) had requested that the SAB conduct a peer review of the set of three toxicological reviews including: formaldehyde, acetaldehyde, and vinyl acetate. All three of these documents were to be reviewed simultaneously. Accordingly, the SAB Staff Office announced in a Federal Register notice dated March 4, 2003 (68 FR10241) the formation of a SAB Review Panel (Formaldehyde, Acetaldehyde, and Vinyl Acetate Toxicological Reviews panel) and sought public nomination of experts to serve on the panel. At this time, NCEA has requested that the SAB conduct a peer review of the Formaldehyde Toxicological Review document first. The Acetaldehyde and Vinyl Acetate Toxicological Reviews will be peer reviewed at a later date. Formaldehyde is listed as a hazardous air pollutants (HAPs) on the Clean Air Act Amendments of 1990 and is associated with significant ambient exposures. The SAB is being asked to conduct this review because of its previous review of the draft formaldehyde risk assessment update (EPA-SAB-EHC-92-021), the precedent setting nature of the assessment using mode of action and biologically based models, and the high priority with respect to programmatic relevance of this document.

The overall charge to the FRP is to review the Formaldehyde Toxicological Review for consistency in application of the Agency's 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 or 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.

SAB Request for Nominations: The SAB Staff Office is requesting nominations of recognized experts with one or more of the following expertise: (a) Inhalation dosimetry modeling (e.g., computational fluid dynamics (CFD) modeling), (b) physiologically based pharmacokinetic (PBPK) modeling, (c) biologically-based dose-response (BBDR) modeling for cancer, (d) epidemiology including exposure reconstruction, (e) biochemistry, (f) inhalation toxicology and respiratory physiology, (g) gastrointestinal tract toxicology and physiology, (h) pathology, (i) carcinogenesis including leukemia, (j) respiratory biology and immunology, (k) toxicology (including, genetic, reproductive, developmental), (l) quantitative risk assessment, and (m) biostatistics and mathematical modeling.

Process and Deadline for Submitting Nominations: Any interested person or organization may nominate qualified individuals to serve as panel members in the areas described above. Nominations should be submitted in electronic format through the Form for Nominating Individuals to Panels of the U.S. Environmental Protection Agency (EPA) Science Advisory Board provided on the SAB Web site. The form can be accessed through a link on the blue navigational bar of the SAB Web site at: http:// www.epa.gov/sab . To be considered, all nominations should include the information requested on that form. Anyone who is unable to access nominations on the SAB Web site can obtain a paper copy of the form by contacting the DFO, as indicated above. The nominating form requests the following: (1) Contact information about the person making the nomination; (2) contact information about the nominee; (3) the disciplinary and specific areas of expertise of the nominee; (4) the nominee's resume; and (5) a general biosketch of the nominee indicating education, expertise, past research, recent service on other advisory committees or with professional associations, and recent grant and/or contract support. Nominations should be submitted in time to arrive no later than May 12, 2004. From the nominees identified by respondents to this notice and through other sources (termed the “Widecast”), the SAB Staff Office will develop a smaller subset (known as the “Short List”) for more detailed consideration. Criteria used by the SAB Staff Office in developing this Short List are given at the end of the following paragraph. The SAB Staff Office will contact individuals who are considered for inclusion in the Short List to determine whether they are willing to serve on the Panel. 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. The Short List also will be available from the DFO listed above. Public comments will be accepted for 14 calendar days on the Short List. During this comment period, the public will be requested to provide information, analysis or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates for the Panel. For the SAB, a balanced 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 members, along with information provided by candidates and information gathered by SAB Staff Office 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 individual nominees 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 panels. Those Short List candidates ultimately chosen to serve on the Panel will be appointed as Special Government Employees (SGEs). Therefore, all Short List candidates will 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 allows Government officials to determine whether there is a statutory conflict between that person's public responsibilities as an SGE 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 SAB Web site at: http://www.epa.gov/sab/pdf/epaform3110-48.pdf.