2016-25930. Request for Nominations of Experts To Augment the Science Advisory Board Chemical Assessment Advisory Committee for the Review of EPA Draft Toxicological Reviews for tert-Butyl Alcohol (tert-butanol) and Ethyl Tertiary Butyl Ether (ETBE)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office requests public nominations of scientific experts to augment the SAB Chemical Assessment Advisory Committee (CAAC) for the peer review of two EPA Draft Toxicological Review: (1) The Toxicological Review of tert-Butyl Alcohol (tert-butanol) and (2) Toxicological Review for Ethyl Tertiary Butyl Ether (ETBE) in Support of Summary Information on the Integrated Risk Information System (IRIS).

DATES:

Nominations should be submitted by November 17, 2016 per the instructions below.

FOR FURTHER INFORMATION:

Any member of the public wishing further information regarding this Notice and Request for Nominations may contact the Designated Federal Officer for the review, as identified below. Nominators unable to submit nominations electronically as described below may contact the Designated Federal Officer for assistance. General information concerning the EPA SAB can be found at the EPA SAB Web site at http://www.epa.gov/​sab.

SUPPLEMENTARY INFORMATION:

Background: The SAB (42 U.S.C. 4365) is a chartered Federal Advisory Committee that provides independent scientific and technical peer review, advice 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. 2) and related regulations. The SAB Chemical Assessment Advisory Committee (CAAC) is a subcommittee of the SAB that provides advice through the chartered SAB regarding assessments of environmental chemicals available on EPA's Integrated Risk Information System (IRIS). The SAB and the CAAC, augmented with additional experts, will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.

The National Center for Environmental Assessment (NCEA) in the EPA's Office of Research and Development (ORD) develops toxicological reviews/assessments for various chemicals for inclusion in the IRIS database. NCEA is developing a draft Toxicological Review of tert-Butyl Alcohol (tert-butanol) and Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE) and has asked the SAB to conduct the peer review of these draft documents. Because tert-butanol is a metabolite of ETBE, the peer reviews will be conducted together. The SAB Staff Office is seeking experts to augment the SAB CAAC for the review of tert- butanol and ETBE.

These two draft EPA documents represent new IRIS assessments of tert-butanol and ETBE. Experimental animal data and other relevant data from studies of the noncancer and cancer effects of tert-butanol and ETBE are evaluated in these assessments. These assessments include an oral reference dose (RfD) and inhalation reference concentration (RfC) for noncancer effects as well as a cancer assessment. The cancer assessments characterize tert-butanol and ETBE as having suggestive evidence of carcinogenic potential to humans and include oral cancer slope factors for both compounds and an inhalation unit risk for ETBE.

Technical Contact for EPA's draft assessments: For information concerning the EPA draft assessments, please contact Gina Perovich, National Center for Environmental Assessment, Office of Research and Development, U.S. EPA, 1200 Pennsylvania Avenue NW., Mail Code 8601P, Washington, DC 20460, phone [phone] or via email at [e-mail].

Request for Nominations: The SAB Staff Office is seeking nominations of nationally and internationally recognized scientists with demonstrated expertise and research on tert-butanol and ETBE to augment the CAAC for the peer review of the tert-butanol and ETBE toxicological reviews. The SAB Staff Office seeks experts in one or more of the following areas, with a particular focus on tert-butanol and ETBE: Toxicology, rat nephrotoxicity, liver toxicity, reproductive toxicity, cancer biology, physiologically-based pharmacokinetic (PBPK) modeling, toxicokinetics, and dose-response modeling of animal data. Questions regarding this review should be directed to Dr. Shaunta Hill, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at [phone], or via email at [e-mail].

Process and Deadline for Submitting Nominations: Any interested person or organization may nominate qualified individuals in the areas of expertise described above for possible service on the augmented CAAC review panel identified in this notice. Nominations should be submitted in electronic format (preferred over hard copy) using the online nomination form under the “Nomination of Experts” category at the bottom of the SAB home page at http://www.epa.gov/​sab. To receive full consideration, nominations should include all of the information requested below.

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 resume or curriculum vitae; 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. Hill as noted above. Nominations should be submitted in time to arrive no later than November 17, 2016. EPA values and welcomes diversity. In an effort to obtain nominations of diverse candidates, EPA encourages nominations of women and men of all racial and ethnic groups.

The EPA SAB Staff Office will acknowledge receipt of nominations. The names and biosketches of qualified nominees identified by respondents to this Federal Register notice, and additional experts identified by the SAB Staff, will be posted in a List of Candidates for the CAAC tert-butanol and ETBE Review Panel on the SAB Web site at http://www.epa.gov/​sab (see links under “Public Input on Membership” at the bottom of the SAB home page). Public comments on the List of Candidates will be accepted for 21 days. The public will be requested to provide relevant information or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates.

For the EPA SAB Staff Office a balanced review panel includes 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. In forming this expert panel, the SAB Staff Office will consider public comments on the List of Candidates, information provided by the candidates themselves, and background information independently gathered by the SAB Staff Office. Selection criteria to be used for panel membership include: (a) Scientific and/or technical expertise, knowledge, and experience (primary factors); (b) availability and willingness to serve; (c) absence of financial conflicts of interest; (d) absence of an appearance of a loss of impartiality; (e) skills working in committees, subcommittees and advisory panels; and, (f) for the panel as a whole, diversity of expertise and scientific points of view.

The SAB Staff Office's evaluation of an absence of financial conflicts of interest will include a review of the “Confidential Financial Disclosure Form for Environmental Protection Agency Special Government Employees” (EPA Form 3110-48). This confidential form allows government officials to determine whether there is a statutory conflict between a person's public responsibilities (which include membership on an EPA federal advisory committee) and private interests and activities, or the appearance of a loss of impartiality, as defined by federal regulation. The form may be viewed and downloaded from the following URL address http://yosemite.epa.gov/​sab/​sabproduct.nsf/​Web/​ethics?​OpenDocument.

The approved policy under which the EPA SAB Office selects members for subcommittees and review panels is described in the following document: Overview of the Panel Formation Process at the Environmental Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is posted on the SAB Web site at http://yosemite.epa.gov/​sab/​sabproduct.nsf/​WebFiles/​OverviewPanelForm/​$File/​ec02010.pdf.

Dated: October 18, 2016.

Khanna Johnston,

Acting Deputy Director, EPA Science Advisory Board Staff Office.