Environmental Protection Agency (EPA).
The U.S. Environmental Protection Agency (EPA or Agency) Science Advisory Board (SAB or the Board) Staff Office is soliciting nominations of nationally recognized scientists for consideration of membership on an SAB Panel to provide advice on EPA's reassessment of the health risks from dioxin and related compounds.
Nominations should be submitted by November 5, 2008 per the instructions below.Start Further Info
FOR FURTHER INFORMATION CONTACT:
For information regarding this Request for Nominations please contact Dr. Thomas Armitage, Designated Federal Officer (DFO), EPA Science Advisory Board Staff, at email@example.com or (202) 343-9995. General information concerning the SAB can be found on the SAB Web site at http://www.epa.gov/sab. Any inquiry regarding EPA's dioxin reassessment activity should be directed to Dr. Peter W. Preuss, Director, EPA National Center for Environmental Assessment at firstname.lastname@example.org or (703) 347-8600. In addition, updated communication materials have been developed that provide further information on dioxin and EPA's dioxin reassessment activity. These materials are available on EPA's Web site at http://www.epa.gov/ncea under Headlines and also at http://www.cfsan.fda.gov/lrd/dioxinqa.html.End Further Info End Preamble Start Supplemental Information
Background: The SAB (42 U.S.C. 4365) is a chartered Federal Advisory Committee that provides independent scientific and technical peer review, advice, consultation, and recommendations to the EPA Administrator on the technical basis for EPA actions. As a Federal Advisory Committee, the SAB conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. C) and related regulations. Generally, SAB meetings are announced in the Federal Register, conducted in public view, and provide opportunities for public input during deliberations. Additional information about the SAB and its committees can be obtained on the SAB Web site at: http://www.epa.gov/sab.
In 1991, EPA announced that it would conduct a scientific reassessment of the potential health risks of exposure to dioxin and related compounds. The SAB provided independent peer review and advice on EPA's dioxin reassessment. The SAB first reviewed the draft dioxin reassessment in 1995 and the document was revised to address SAB comments. In 2000, the SAB reviewed the integrated summary, risk characterization, and other information on toxic equivalency of dioxin-like compounds. Reports of the findings and recommendations of these SAB reviews are available on the SAB Web site at http://www.epa.gov/sab (see reports EPA-SAB-EC-95-021 and EPA-SAB-EC-01-006).
In 2003, EPA produced an external review draft of the multi-year comprehensive reassessment of dioxin exposure and human health effects (http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=87843). This dioxin reassessment document, titled Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds, consisted of three parts: (1) A scientific review of information relating to sources and exposures to TCDD and other dioxins in the environment; (2) detailed reviews of scientific information on the health effects of TCDD, other dioxins, and dioxin-like compounds; and (3) an integrated summary and risk characterization for TCDD and related compounds.
In 2004, EPA asked the National Research Council of the National Academy of Sciences (NAS) to review the 2003 dioxin reassessment document. The NAS was charged with reviewing “EPA's modeling assumptions (including those associated with dose-response curve and points-of-departure dose ranges and associated likelihood estimates identified for human health outcomes); EPA's quantitative uncertainty analysis; and EPA's selection of studies as a basis for its assessments and gaps in scientific knowledge.” The NAS was also charged with addressing two points of controversy: (1) The scientific evidence for classifying dioxin as a human carcinogen, and (2) the validity of the nonthreshold low-dose linear dose-response model and the cancer slope factor calculated through the use of this model. In addition, EPA asked the NAS to comment on the usefulness of toxic equivalency factors (TEFs) and uncertainties associated with their use in risk assessment, as well as the uncertainty associated with EPA's approach to analysis of food sampling and human dietary intake data, taking into consideration the Institute of Medicine's report Dioxin and Dioxin-like Compounds in the Food Supply: Strategies to Decrease Exposure. In 2006, the NAS published its review titled Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment. The NAS identified three areas that required substantial improvement to support a scientifically robust risk characterization. These three areas were: (1) Justification of approaches to dose-response modeling for cancer and non-cancer endpoints, (2) transparency and clarity in selection of key data sets for analysis, and (3) transparency, thoroughness, and clarity in quantitative uncertainty analysis. The NAS provided EPA with recommendations to address their key concerns. The full NAS report, including recommendations, is available Start Printed Page 61115at http://books.nap.edu/catalog.php?record_id=11688.
EPA is now beginning to prepare a response to the NAS review of the dioxin reassessment. The Agency has requested that the SAB form an expert panel to provide independent advice regarding the draft technical plan, the revised draft, and the final draft of the EPA response to the recommendations of the NAS.
Expertise Sought: The SAB Staff Office requests nominations of recognized experts with specific experience and knowledge of dioxin in one or more of the following areas: (a) Epidemiology; (b) toxicology (with expertise in cancer, reproductive toxicology, developmental toxicology, immunotoxicology, dosimetry, toxicokinetics, mechanisms of action, or mixtures); (c) endocrinology; (d) lipid metabolism; (e) cardiovascular mechanisms of pathology; (f) risk assessment (with expertise in statistics, quantitative uncertainty analysis, or dose-response modeling); and (g) exposure assessment (with expertise in bioavailability, weathering, or effects of partitioning in environmental media).
How to Submit Nominations: Any interested person or organization may nominate qualified individuals to be considered for appointment on this SAB Panel. Candidates may also nominate themselves. Nominations should be submitted in electronic format (which is preferred over hard copy) following the instructions for “Nominating Experts to Advisory Panels and Ad Hoc Committees Being Formed” provided on the SAB Web site. The form can be accessed through the “Nomination of Experts” link on the blue navigational bar on the SAB Web site at http://www.epa.gov/sab. To receive full consideration, nominations should include all of the information requested.
EPA's SAB Staff Office 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 curriculum vita; sources of recent grant and/or contract support; and a biographical sketch of the nominee indicating current position, educational background, research activities, and recent service on other national advisory committees or national professional organizations.
Persons having questions about the nomination procedures, or who are unable to submit nominations through the SAB Web site, should contact Dr. Thomas Armitage, DFO, at the contact information provided above in this notice. Non-electronic submissions must follow the same format and contain the same information as the electronic.
The SAB Staff Office will acknowledge receipt of the nomination and inform nominees of the panel for which they have been nominated. From the nominees identified by respondents to this Federal Register notice (termed the “Widecast”) and other sources, the SAB Staff Office will develop a smaller subset (known as the “Short List”) for more detailed consideration. 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 on the Short List will be accepted for 21 calendar days. During this comment period, the public will be requested to provide information, analysis, or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates for the Panel.
For the SAB, a balanced 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 SAB Staff independently concerning 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 evaluation of an individual Panel 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.
Prospective candidates will 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 (which include 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. Ethics information, including EPA Form 3110-48, is available on the SAB Web site at http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument.Start Signature
Dated: October 6, 2008.
Anthony F. Maciorowski,
Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. E8-24417 Filed 10-14-08; 8:45 am]
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