03-5030. 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 [phone], by fax at [phone]; or via e-mail at [e-mail]. 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 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 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: [phone]; via fax at: [phone]; 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.