[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Pages 41128-41130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17511]


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ENVIRONMENTAL PROTECTION AGENCY


Science Advisory Board, Request for Nominations, Bioethics 
Advisory Committee (BAC), an ad hoc Committee of the U.S. EPA Science 
Advisory Board

[FRL-7526-1]

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces 
the formation of a new SAB ad hoc Committee, the Bioethics Advisory 
Committee (BAC), and is soliciting nominations for members of the 
Committee.

DATES: Nominations should be submitted in time to arrive by July 31, 
2003.

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, http://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 Mr. Thomas Miller, Designated 
Federal Officer (DFO) as indicated below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing 
further information regarding this Request for Nominations may contact 
Mr. Thomas O. Miller, by telephone/voice mail at (202) 564-4558, or via 
e-mail at

[[Page 41129]]

[email protected], or by mail at: U.S. EPA Science Advisory Board 
Staff Office (1400A), 1200 Pennsylvania Ave., NW., Washington, DC 
20460. General information about the SAB can be found on the SAB Web 
site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:

Summary

    The EPA's SAB Staff Office is announcing the formation of a new ad 
hoc committee to help provide advice, through the SAB Executive 
Committee to the Administrator and other officials in the U.S. 
Environmental Protection Agency, on ethics issues that might arise in a 
number of situations involving the generation and/or use of human and 
animal data. The SAB Staff Office is soliciting nominations to 
establish the members of the new Committee.
    The Board is a chartered Federal Advisory Committee that reports 
directly to the Administrator. This Committee 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 regulations.
    Members of the Bioethics Advisory Committee will help provide 
advice to the Agency through the SAB's Executive Committee. The 
Committee 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 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/pdf/ecm02003.pdf.

Background

    Scientists continue to advance society's ability to understand the 
many factors that are relevant to the evaluation of risks associated 
with environmental contamination and change. The scientific study 
associated with such advances is often accompanied by significant and 
important debate because it raises new or unique questions of ethics. 
Therefore, in addition to the EPA's usual practice of evaluating the 
technical aspects of scientific approaches used to generate data, 
Agency staff and managers also need to consider the ethical 
implications of how data are developed and used in support of EPA's 
mission to protect human health and the environment.
    To assist EPA in its consideration of the ethical implications of 
using various scientific and technical studies in support of its 
mission, the Agency has asked the SAB Staff Office to form an expert 
group to advise senior EPA managers on bioethics issues. Therefore, the 
SAB Staff Office is seeking the public's assistance in identifying and 
nominating experts to serve on a Bioethics Advisory Committee. Specific 
projects have not yet been sent to the SAB for consideration by the 
committee. When specific issues are identified for SAB advice, the 
initiation of SAB advisory actions will be announced in the Federal 
Register. In order to help the public as it considers appropriate 
persons to nominate for this committee, this notice describes the 
Committee's general purview by giving examples of issues that the 
Committee might be asked to consider. Topics might include: (a) Ethical 
issues associated with the use of human data obtained using genomics 
techniques; (b) ethical issues associated with the use of animals to 
develop data for use in EPA evaluations of risk from environmental 
agents; and (c) ethical issues associated with intentional dosing of 
humans to obtain data for use in EPA evaluations of risk from 
environmental agents. Each of these issues is briefly discussed in the 
paragraphs that follow. These examples are not intended to be all 
inclusive and to preclude other types of bioethical issues from being 
raised to the Committee.

(a) Ethical Issues Associated With the Use of Genomics Data

    As used by EPA, the term genomics ``* * * is the study of all the 
genes of a cell, or tissue, at the DNA (genotype), mRNA 
(transcriptome), or protein (proteome) levels'' (Interim Policy on 
Genomics, U.S. EPA Science Policy Council, June 25, 2002). The Interim 
Policy on Genomics acknowledges the potential for genomics information 
to enhance EPA's assessments in support of policy development. The 
interim policy states that ``[g]enomics approaches have the long term 
promise to aid in the understanding of an organism's response to 
stressors and to guide the selection of informative bioindicators for 
monitoring the impact of stressors on human and ecological health. 
Thus, EPA believes that genomics will have an enormous impact on our 
ability to assess risk from exposure to stressors and ultimately 
improve our risk assessments.''
    Although EPA is moving rapidly to take advantage of genomics 
information in support of its mission, the Agency's interim policy 
notes the current limitations in our knowledge, understanding, and use 
of genomics information. As a result, EPA does not consider genomics 
information sufficient, in and of itself, to serve as the sole basis 
for decision-making. To realize the potential for genomics information 
to reduce uncertainties in its assessments, EPA is encouraging 
research, methods development and evaluation, and data collection 
relating to gaps in genomics knowledge. The Agency's interim policy 
finally states that as the Agency ``* * *gains experience in applying 
genomics information and refines its understanding of the use of such 
information, it will develop guidance to explain how genomics data can 
be better utilized in informing decision-making and related ethical, 
legal, and social implications.'' As suggested by the interim policy, 
EPA foresees that it will face a number of ethical issues as its moves 
forward in the development and use of genomics data in support of its 
mission and EPA looks for advice from the SAB in addressing such 
issues.

(b) Use of Animals to Develop Data for Use in EPA Evaluations of Risk 
From Environmental Agents

    Concern has been voiced about EPA's heavy reliance on animal 
testing protocols to generate test data that is needed to support 
Agency decision-making. EPA is conducting research that will help it to 
reduce, refine, and replace animal test protocols that now guide the 
development of such data. EPA is developing the science that will help 
it to more selectively apply these test protocols. EPA also works with 
national and international groups [e.g., the Organisation for Economic 
Cooperation and Development (OECD) and the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM)] in this 
regard.
    Notwithstanding EPA's current research into approaches that will 
allow the reduction, refinement, and replacement of certain animal test 
protocols, ethical issues will continue to be raised over the animal-
based test systems to support decision-making. The Bioethics Advisory 
Committee can provide a venue where the Administrator can ask for 
consultations and advisory reviews of this important issue.

(c) Intentional Dosing of Humans To Obtain Data To Be Used in EPA 
Evaluations of Risk From Environmental Agents

    This issue involves the use of data obtained from intentionally 
dosing

[[Page 41130]]

humans with agents that might be found in or released to the 
environment under different situations. The intent of these studies is 
to obtain data that can be used in evaluating the human health effects 
associated with such agents. These studies are often conducted by third 
parties (not the government itself) and can be used to support 
decision-making conducted pursuant to a variety of EPA legislative 
mandates. The SAB might be asked to advise on specific issues that 
arise in association with the use of such studies.

Request for Nominations

Background

    The EPA SAB Staff Office requests nominations of individuals who 
are regarded as national level experts in the issues described in this 
notice. In soliciting these nominations, the SAB recognizes that in 
questions of ethical development and use of scientific information, 
relevant issues and expertise come from many disciplines and not just 
those disciplines associated with human health and environmental risk 
assessment. Examples of areas of expertise that reflect domains of 
knowledge possessed by individuals who have commonly been involved in 
the consideration of bioethics issues include at least the following: 
medicine in many specialties, human toxicology and pharmacology; 
ecology; risk assessment; statistics; clinical and epidemiology 
studies; genetics; occupational and public health; human subjects 
protection; ethics; religious studies; sociology; public policy; tribal 
health; health policy; law; psychology; technology studies; and animal 
welfare.

Process and Deadline for Submitting Nominations

    Any interested person or organization may nominate qualified 
individuals for the Committee who have expertise as discussed above.
    The nominating form requests contact information about the person 
making the nomination; contact information about the nominee; the 
disciplinary and specific areas of expertise of the nominee; the 
nominee's resume; and 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.
    Anyone who is unable to submit nominations through the SAB Web site 
or has any question concerning any aspect of the nomination process may 
contact Mr. Thomas O. Miller as indicated above in this FR notice. 
Nominations should be submitted in time to arrive no later than July 
31, 2003.
    The EPA Science Advisory Board Staff Office will acknowledge 
receipt of nominations. From the nominees identified by respondents to 
this Federal Register 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 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 on the Short List to 
determine whether they are willing to serve on the Committee. 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 Mr. Miller at the 
address listed above. 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 on 
nominees that the SAB Staff should consider in evaluating candidates 
for the Committee.
    For the EPA SAB, a balanced committee 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 
Committee members, along with information provided by candidates and 
information gathered by the EPA 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 
and statements on the topic under review). Specific criteria to be used 
in evaluating an individual committee 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.
    Those Short List candidates ultimately chosen to serve on the 
Committee will be appointed as Special Government Employees. Therefore, 
all 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 allows Government officials to determine whether there is a 
statutory conflict between that person's public responsibilities as a 
Special Government Employee and private interests and activities, or 
the appearance of a lack of impartiality, as defined by Federal 
regulation. The blank form may be viewed and downloaded from the 
following URL address: http://www.epa.gov/sab/pdf/epaform3110-48.pdf. 
Committee members will likely be asked to attend two to three public 
meetings and public conferences per year over the anticipated course of 
the advisory activity.

    Dated: July 2, 2003.
Vanessa T. Vu,
Director, EPA Science Advisory Board Staff Office.
[FR Doc. 03-17511 Filed 7-9-03; 8:45 am]
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