02-15459. 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 Protection Agency's Science Advisory Board (SAB).

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 [phone]; fax at [phone]; or via e-mail at [e-mail].

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 [phone]; FAX [phone], e-mail [e-mail].

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 [phone], via fax at [phone], 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 [e-mail]. 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: [e-mail]

(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 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) 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 [phone]; fax at [phone]; 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.