[Federal Register: June 19, 2002 (Volume 67, Number 118)]
[Notices]               
[Page 41718-41721]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn02-66]                         

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7233-8]

 
EPA Science Advisory Board; Human Health Research Strategy Review 
Panel; Request for Nominations

ACTION: Notice; request for nominations to serve on the Human Health 
Research Strategy Review Panel (HHRS Review Panel) of the U.S. 
Environmental

[[Page 41719]]

Protection Agency's Science Advisory Board (SAB).

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SUMMARY: The U.S. Environmental Protection Agency's (Agency, EPA) 
Science Advisory Board (SAB) is announcing the formation of a panel to 
review the Agency's Human Health Research Strategy and the solicitation 
of nominations for qualified individuals to serve on this Panel. To 
establish this panel, the SAB is soliciting nominations to augment a 
pool of candidates now composed of its existing Environmental Health 
Committee (EHC) and its Integrated Human Exposure Committee (IHEC). The 
EPA Science Advisory Board was established to provide independent 
scientific and technical advice, consultation, and recommendations to 
the EPA Administrator on the technical bases for EPA regulations. In 
this sense, the Board functions as a technical peer review panel for 
the research strategy.

FOR FURTHER INFORMATION CONTACT: --Additional information on this 
review can be obtained by contacting Mr. Thomas O. Miller, Designated 
Federal Officer, Human Health Research Strategy Review Panel, US EPA 
Science Advisory Board (1400A), Suite 6450CC, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460; telephone/voice mail at (202) 564-4558; fax 
at (202) 501-0582; or via e-mail at miller.tom@epa.gov.
    Nomination information should be submitted via e-mail (preferred) 
to Ms. Diana Pozun, Management Assistant, EPA Science Advisory Board, 
U.S. Environmental Protection Agency (1400A), 1200 Pennsylvania Avenue, 
NW., Washington, DC 20460, telephone (202) 564-4544; FAX (202) 501-
0323, e-mail pozun.diana@epa.gov.
    Additional information concerning the Science Advisory Board, its 
structure, function, and composition, may be found on the SAB Web site 
(http://www.epa.gov/sab) and in the Science Advisory Board FY2001 
Annual Staff Report which is available from the SAB Publications Staff 
at (202) 564-4533, via fax at (202) 501-0256, or on the SAB Web site at 
http://www.epa.gov/sab/annreport01.pdf.
    Nomination Procedures: The approved policy under which the EPA 
Science Advisory Board establishes review panels is described in a 
recent Commentary, 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 Web 
site at www.epa.gov/sab/ecm02003.pdf. Principles discussed in that 
document will govern the establishment of the HHRS Review Panel.
    Any interested person or organization may nominate qualified 
individuals for membership on the HHRS Review Panel. Nominations, 
preferably in electronic format, should be submitted to Ms. Pozun at 
pozun.diana@epa.gov. Anyone unable to submit nominations in electronic 
format should send the information specified below to Ms. Pozun 
(address above) Nominations should arrive no later than July 5, 2002. 
The Agency will not necessarily formally acknowledge or respond to 
nominations.
    Nominations must include the individual's name, occupation, 
position, qualifications to address the issue, and contact information 
(i.e., telephone number, fax number, mailing address, e-mail, and/or 
Web site). To be considered, all nominations must include a current 
biographical sketch (approximately one page in length), CV or resume 
(preferably electronic in MSWord or WordPerfect) providing information 
on the nominee's background, experience, and qualifications for this 
Panel. Detailed information on the nominator is not required, but the 
nominator's name, affiliation, and contact information is requested in 
order to permit the staff to contact the nominators with any questions 
and keep them informed of activities associated with this review. Names 
and affiliations of nominators for individuals on the ``Short List'' 
that the SAB intends to consider further for panel membership, will be 
included in the information made available to the public when the Short 
List is announced.
    To improve the efficiency in processing of nominations the SAB 
requests that nominations be provided in the following manner:
    (1) Send the nomination by e-mail to: pozun.diana@epa.gov
    (2) Use one e-mail per person being nominated
    (3) Please use ``Human Health Research Strategy Nomination'' in the 
subject field, followed by the last name of the candidate you are 
nominating. (For example, ``Human Health Research Strategy Nomination: 
Smith)
    (4) Attach supporting information in MS Word or Wordperfect files 
ending in ``.doc'' or ``.wpd'', respectively
    (5) In a separate file from the biographical sketch, CV or resume, 
please provide the following information in the order shown:
    For the Nominating Individual:
First Name:------------------------------------------------------------
Last Name:-------------------------------------------------------------
Organizational Affiliation and Title:----------------------------------
E-mail Address:--------------------------------------------------------
Mailing Address:-------------------------------------------------------
Work Phone:------------------------------------------------------------
Work Fax:--------------------------------------------------------------
    For the Candidate being nominated:
First Name:------------------------------------------------------------
Last Name:-------------------------------------------------------------
Professional Title:----------------------------------------------------
Department:------------------------------------------------------------
School or Unit:--------------------------------------------------------
University or Organization:--------------------------------------------
Mailing Address:-------------------------------------------------------
Work Phone:------------------------------------------------------------
Fax Work Phone:--------------------------------------------------------
E-mail Address:--------------------------------------------------------
Web site for CV (if one exists):---------------------------------------
    Nominator's Assessment of Expertise:
    The following areas of expertise will be useful in this review. 
Please indicate the areas of expertise the candidate could contribute 
with a short statement explaining why this is the case:
    1. Risk assessment and the application of the Agency's risk 
assessment guidelines;
    2. Exposure measurement/assessment;
    3. Dosimetry/mechanisms of action;
    4. Computational toxicology;
    5. Aggregate and cumulative risk;
    6. Research into various toxicologic endpoints including 
carcinogenicity;
    7. Molecular genetics;
    8. Epidemiology;
    9. Health effects in sensitive and susceptible population groups;
    10. Uncertainty analysis; and
    11. Public health outcomes
    12. Others that nominators might feel to be appropriate
    Evaluation Procedures: The SAB panel formation process, mentioned 
earlier in this notice, is described in an SAB Commentary, EPA Science 
Advisory Board (SAB) Panel Formation Process: Immediate Steps to 
Improve Policies and Procedures: An SAB Commentary (http://www.epa.gov/
sab/ecm02003.pdf). This process guides the activity used by the SAB to 
gather and evaluate nominees and to select a panel having balanced 
membership. At the SAB, a balanced panel is characterized by inclusion 
of 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 
address the charge adequately.
    First, the process solicits nominations to the Panel from SAB 
members and consultants, external outreach to the public, and contact 
with the Agency itself to obtain a broad set of nominees to consider 
for membership. Second, the nominations received are combined and 
entered into a data base termed the ``WIDECAST.'' Third, a smaller 
subset (the ``Short List'') will be identified from

[[Page 41720]]

this larger group of nominees for more detailed consideration. The 
Short List includes the names of candidates, a short biographical 
sketch of each candidate, and the names of those who nominated the 
person. Fourth, the Short List is posted on the SAB Web site 
(www.epa.gov/sab), and public comments accepted on the individual's 
expertise, conflict-of-interest, questions on any perceived lack of 
impartiality of the person (as defined by federal regulation), as well 
as on the overall balance of technical views represented on the Panel.
    Finally, the Panel members are selected by considering public 
reaction to the Short List candidates, information provided by 
candidates, and information on the background of each candidate which 
is gathered independently by SAB Staff. Criteria used in the evaluating 
of individual panelists include: (a) Expertise, knowledge, and 
experience (primary factors); (b) scientific credibility and 
impartiality; (c) skills working in committees and advisory panels; and 
(d) availability.
    Panel members will be asked to attend at least one public face-to-
face meeting and, probably, several public telephone conference call 
meetings over the anticipated 3-month course of the activity. The 
Executive Committee (EC) of the SAB will review the Panel's report in a 
public meeting and reach a judgment about its transmittal to the 
Administrator.
    Background: The mission of the U.S. Environmental Protection Agency 
(EPA) is to protect public health and safeguard the natural 
environment. Risk assessment is an integral part of this mission in 
that it identifies and characterizes environmentally related human 
health problems. The Human Health Research Strategy document presents a 
conceptual framework for future human health research by EPA's Office 
of Research and Development (ORD). The Agency's research strategy 
outlines a core research effort to provide broader, more fundamental 
information that will improve understanding of problem-driven health 
risk issues encountered by the EPA's Program and Regional Offices. The 
document focuses on broad themes and general approaches. Implementation 
of an integrated research program on human health is described in 
greater detail in ORD's Multiyear Plan on Human Health Research which 
identifies the specific performance goals and the measures needed to 
achieve those goals over a 5 to 10 year period.
    ORD's strategic research directions for Human Health include (1) 
research to improve the scientific foundation of human health risk 
assessment; and (2) research to enable evaluation of public health 
outcomes from environmental risk management decisions.
    1. Research to Improve the Scientific Foundation of Human Health 
Risk Assessment. ORD's human health risk assessment program assumes 
that major uncertainties in risk assessment can be reduced by 
understanding and elucidating the fundamental determinants of exposure 
and dose and the basic biological changes that follow exposure to 
pollutants and which result in a toxic response. This research will 
provide the scientific knowledge and principles to improve the risk 
assessment for all human health endpoints, aggregate and cumulative 
risk, and risk to susceptible populations.
    One component of this forward looking research focuses on 
Harmonizing Risk Assessment Approaches. This research addresses the 
differing approaches for the assessment of risk from cancer and 
noncancer health endpoints. The intent of this research is to develop a 
common set of principles and guidelines for drawing inferences about 
risk based on mechanistic information. Specific research objectives 
include: (i) The development of emerging technologies or methods to 
study mode or mechanism of action; (ii) provision of a framework for 
defining mode or mechanism of action; (iii) development of a basis for 
comparing risk across all health endpoints using mechanistic 
information; (iv) developing principles for the use of mechanistic data 
to select the most appropriate risk assessment model; and (v) 
development of principles for the use of mechanistic data to reduce or 
replace uncertainty factors in risk assessments, especially for inter- 
and intraspecies extrapolation.
    Research on Aggregate and Cumulative Risk reflects the reality that 
humans are exposed to mixtures of pollutants from multiple sources. 
This research will provide the scientific support for decisions 
concerning exposure to a pollutant by multiple routes of exposure or to 
multiple pollutants having a similar mode of action. ORD will also 
develop approaches to study how people and communities are affected 
following exposure to multiple pollutants that may interact with other 
environmental stressors. Specific research objectives include: (i) 
Determining the best and most cost-effective ways to measure human 
exposures in all relevant media; (ii) developing exposure models and 
methods suitable for the EPA and the public to assess aggregate and 
cumulative risk; and (iii) providing the scientific basis to predict 
the interactive effects of pollutants in mixtures and the most 
appropriate approaches for combining effects and risks from pollutant 
mixtures.
    Research on Susceptible and Highly-Exposed Subpopulations will 
focus on developing a scientific understanding of the biological basis 
for differing responsiveness of subpopulations within the general 
population. Specific research objectives include the following: (i) 
Identifying the key factors that contribute to variability in human 
exposure; (ii) improving the accuracy of dose estimation in the general 
population; (iii) identifying the biological basis underlying 
differential responsiveness of sensitive subpopulations of humans to 
pollutant exposure; and (iv) determining how exposure, dose and effect 
information can be incorporated into risk assessment methods to account 
for interindividual variability.
    2. Research to Enable Evaluation of Public Health Outcomes from 
Risk Management Actions.
    Generally, the EPA has not prepared retrospective evaluations to 
determine if the intended public health protection benefits were 
realized once an EPA decision had been in place for a period of time. 
With the advent of the Government Performance and Results Act (GPRA) 
and calls for the EPA to stress and demonstrate outcome-oriented goals 
and measures of success, research is needed to enable evaluation of 
actual public health outcomes from risk management actions. Estimating 
public health benefits of EPA regulatory decisions and rule making, or 
in a more general sense evaluating public health outcomes from risk 
management actions, will involve a number of disciplines grounded in 
both the physical and social sciences, and increasingly must take into 
account the economic and behavioral aspects of human decision-making.
    The long term goal of ORD's research on public health outcomes is 
to provide the scientific understanding and tools for use in evaluating 
the effectiveness of public health outcomes resulting from risk 
management actions. Research will focus on identifying, discovering, or 
developing the most effective methods and models; determining how they 
can be integrated into a decision-making framework to assist Federal, 
State, and local decision-makers in evaluating changes in public health 
as a result of risk management actions; and developing a framework to 
quantify such changes accurately. Specific research objectives include: 
(i)

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Establishing the linkage between sources, environmental concentrations, 
exposure, adverse effects or disease, and effectiveness so that a 
change in a human health outcomes subsequent to a risk management 
action can be determined by measuring or modeling any one of these 
linked steps; and (ii) improving methods and models by which others can 
measure or model changes in public health outcomes following various 
risk management actions.
    Charge: The current Charge that the Agency is asking the SAB to 
implement in this review follows. The final Charge may change some as a 
result of ongoing discussions between the Agency and the Panel. Updates 
will be posted on the SAB Web site: www.epa.gov/sab.
    ORD is requesting a review by the SAB of the Human Health Research 
Strategy, including the following points:
    a. Does the document establish the appropriate direction and 
research areas (i.e., aggregate-cumulative risk, harmonization, 
susceptible subpopulations, effectiveness of public health outcomes) 
for a long-term, core research program on human health risk assessment?
    b. Will the research that is described reduce uncertainty in the 
risk assessment process?
    c. For the research areas selected, does the strategy provide a 
clear framework for a multi-disciplinary research program?
    d. Does the strategy provide a logical approach for framing 
research to evaluate the impact of risk management decisions on human 
health?
    Review Document Availability--The EPA research strategy for human 
health is documented in the Human Health Research Strategy, U.S. EPA 
Office of Research and Development, Internal Review Draft, May 2002. 
Those members of the public who wish to view the Agency draft document 
as they consider who might be appropriate to nominate for this panel 
should obtain or read it on the EPA ORD NHEERL Web site at www.epa.gov/
nheerl/humanhealth. The public may also contact Dr. Hugh Tilson, 
National Health and Environmental Effects Research Laboratory by voice 
telephone at (919) 541-4607; fax at (919) 685-3252; or mail at Dr. Hugh 
Tilson, Associate Laboratory Director, NHEERL, Mail Code B30502, 
Research Triangle Park, NC 27711.

    Dated: June 11, 2002.
A. Robert Flaak,
Acting Deputy Director, EPA Science Advisory Board.
[FR Doc. 02-15459 Filed 6-19-02; 8:45 am]
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