[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Notices]
[Pages 23131-23132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10651]



[[Page 23131]]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7490-2]


Science Advisory Board, Computational Toxicology Framework 
Consultative Panel; Request for Nominations for Expertise

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 (202) 564-6488, or via e-
mail at [email protected]. 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:

    [sbull] Develop improved linages across the source-to-outcome 
paradigm. Understanding those linkages will decrease uncertainties in 
assessing risk to human health and the environment.
    [sbull] 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.
    [sbull] 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;

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    (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.
[FR Doc. 03-10651 Filed 4-29-03; 8:45 am]
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