03-10651. Science Advisory Board, Computational Toxicology Framework Consultative Panel; Request for Nominations for Expertise

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) announces the formation of a new “Computational Toxicology Framework (CTF) Consultative Panel” and is soliciting nominations for members of the panel.

DATES:

Nominations should be submitted by May 21, 2003. The consultation of the panel is planned for the summer of 2003 (tentatively mid-July) in Chicago, IL.

ADDRESSES:

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 Web site. The form can be accessed through a link on the blue navigational bar on the SAB Web site, www.epa.gov/​sab. To be considered, all nominations must include the information required on that form. Anyone who is unable to submit nominations via this form may contact Dr. James N. Rowe, Designated Federal Officer (DFO) as indicated below.

FOR FURTHER INFORMATION CONTACT:

Any member of the public wishing further information regarding this Request for Nomination may contact Dr. James N. Rowe, by telephone/voice mail at [phone], or via e-mail at [e-mail]. General information about the SAB can be found in the SAB Web site at http://www.epa.gov/​sab.

SUPPLEMENTARY INFORMATION:

Summary: The U.S. Environmental Protection Agency (EPA or Agency) Science Advisory Board is requesting nominations of expertise for a review panel to evaluate the EPA's Office of Research and Development framework for the development of an initiative in Computational Toxicology. (Computational Toxicology is defined as the application of models from computational and mathematical biology and computational chemistry for prediction and understanding mechanisms.)

This Panel is being formed to provide advice to the Agency as part of the EPA SAB 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 positions and regulations.

This project is intended as a consultation on the direction of the CTF; the background for the effort and the charge to the Panel is described below. The Board is a chartered Federal Advisory Committee, which reports directly to the Administrator.

Members of the Panel will provide advice to the Agency, through the SAB's Executive Committee. The Panel will comply with the provisions of FACA and all appropriate procedural policies, including the SAB process for panel formation described in the EPA Science Advisory Board (SAB) Panel Formation Process: Immediate Steps to Improve Policies and Procedures—An SAB Commentary (EPA-SAB-EC-COM-002-003), http://www.epa.gov/​sab/​ecm02003.pdf.

Background: The EPA's Office of Research and Development is seeking SAB advice in development of a Framework for the Use of Computational Toxicology in Risk Assessment. Computational toxicology involves the application of various mathematical and computer models for prediction and the understanding of mechanisms. The Computational Toxicology Initiative is a technology-based, hypothesis-driven effort to increase the soundness of risk assessment decisions within the Agency, while building the capacity to prioritize, screen and evaluate significantly greater numbers of chemicals by enhancing the predictive understanding of toxicities. Success will be measured by the ability to improve assessments relative to the traditional means that have been utilized to understand modes of action and to characterize adverse outcomes, and by classifying chemicals by their potential to influence molecular and biochemical pathways of concern.

ORD has found it useful to envision the risk assessment paradigm as a continuum of events leading from environmental release to adverse effect. Between those two events are a whole cascade of events that lead from one measurable event to the next. ORD's research program focuses on learning more about the processes that lead from exposure to adverse outcome. ORD will use new techniques in computational toxicology (bioinformatics, mathematical biology, computational chemistry), toxicogenomics technology (genomics, proteomics, metabonomics) and systems biology to improve the understanding of the linkages between the processes in the continuum.

The overall goal of ORD's research initiative on Computational Toxicololgy is to use the biology and computing to provide EPA with the tools to improve quantitative risk assessments and reduce uncertainties in the source to adverse outcome continuum. To meet this goal, ORD has identified three strategic objectives for the Computational Toxicology Initiative:

• Develop improved linages across the source-to-outcome paradigm. Understanding those linkages will decrease uncertainties in assessing risk to human health and the environment.
• Develop strategies for prioritizing chemicals for subsequent screening and testing. The current approach requires extensive resources for screening and testing chemicals and an approach must be developed to determine which chemicals or classes of chemicals in the universe or chemicals should be screened and tested first.
• Develop better methods and predictive models for quantitative risk assessment.

Tentative Charge to the Panel: The charge is for a consultation by the Panel to review the Computational Toxicology Framework being developed by ORD and advise on appropriate research directions and roles. A “consultation” is one of several types of formal interactions between the Agency and the Science Advisory Board. The purpose of the consultation is to conduct an early discussion between the Agency and the SAB to help articulate important issues in the development of the project. The meeting is public and consists of briefings and discussions. In some cases a partial document, or an early draft is available to serve as a basis for discussions. A charge is often defined but is less focused than that used in a formal peer review. No consensus advice is sought and no report is generated by the SAB.

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 discussions to be addressed by the Consultative Panel for the Computational Toxicology Framework:

(a) Comparative genomics/proteomics/metabonomics;

(b) Mixtures;

(c) Quantitative structure-activity relationships;

(d) Systems biology;

(e) Endocrine disruptors;

(f) Computational biology/bioinformatics;

(g) Risk assessment;

(h) Mathematical biology;

(i) Pharmacokinetics/metabolism of toxicants: PBPK/BBDR

(j) Exposure; and

(k) Fate and transport;

Process and Deadline for Submitting Nominations: Any interested persons or organization may nominate qualified individuals to add expertise to the Panel in the above areas. 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 Web site. The form can be accessed through a link on the blue navigation bar on the SAB Web site, www.epa.gov/​sab. To be considered, all nominations must include the information required on that form.

Anyone who is unable to submit nominations using this form, and any questions concerning any aspects of the nomination process may contact Dr. James Rowe as indicated above in this Federal Register notice. Nominations should be submitted in time to arrive no later than May 21, 2003.

The EPA Science Advisory Board 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 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 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 one public conference call meeting over the anticipated course of the consultative activity.

Dated: April 22, 2003.

Vanessa T. Vu,

Director, EPA Science Advisory Board Staff Office.