2013-20911. Request for Nominations of Experts To Augment the Science Advisory Board Chemical Assessment Advisory Committee for the Review of the EPA's Draft Toxicological Assessments for Ammonia, Trimethylbenzenes and the Evaluation of Inhalation ...

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The EPA Science Advisory Board (SAB) Staff Office requests public nominations of scientific experts to augment the SAB Chemical Assessment Advisory Committee (CAAC) to form three panels for the review of: (1) The EPA's draft Toxicological Review of Ammonia; (2) the EPA's draft Toxicological Review of Trimethylbenzenes; and (3) the EPA's draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide In Support of Summary Information on the Integrated Risk Information System (IRIS).

DATES:

Nominations should be submitted by September 18, 2013 per the instructions below.

FOR FURTHER INFORMATION CONTACT:

Any member of the public wishing further information regarding this Notice and Request for Nominations may contact the appropriate Designated Federal Officer for the specific review, as identified below. Nominators unable to submit nominations electronically as described below may contact the Designated Federal Officers 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, 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. 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 EPA's Integrated Risk Information System (IRIS). NCEA has developed two separate draft IRIS assessments for ammonia and trimethylbenzenes, and a draft evaluation of the inhalation carcinogenicity for ethylene oxide for IRIS. NCEA has asked the SAB to peer review draft documents for ammonia, trimethylbenzenes, and ethylene oxide. The SAB Staff Office is seeking experts to augment the SAB CAAC to form three separate panels to conduct the peer reviews.

(1) NCEA's draft Toxicological Review of Ammonia (August 2013) represents a reassessment of the toxicity of ammonia. The assessment and proposed charge questions may be found at the following URL: http://yosemite.epa.gov/​sab/​sabproduct.nsf/​fedrgstr_​activites/​IRIS%20Ammonia?​OpenDocument. The ammonia assessment currently posted to the IRIS database includes an inhalation reference concentration (RfC, posted in 1991). For the 2013 draft review, NCEA evaluated epidemiological data, experimental animal data, and other relevant data from studies of the noncancer and cancer effects of ammonia. This reassessment includes an inhalation RfC and a qualitative cancer descriptor. The assessment does not include an oral reference dose (RfD) or a quantitative cancer assessment because NCEA considered that adequate information was not available.

(2) NCEA's draft Toxicological Review of Trimethylbenzenes (August 2013) is the first IRIS assessment developed for trimethylbenzenes (TMBs), including 1,2,3-TMB; 1,2,4-TMB; 1,3,5-TMB. The assessment and proposed charge questions may be found at the following URL: http://yosemite.epa.gov/​sab/​sabproduct.nsf/​fedrgstr_​activites/​IRIS%20Trimethylbenzenes?​OpenDocument. NCEA has evaluated experimental animal data and other relevant noncancer data in this assessment. The assessment includes an inhalation RfC, oral RfD, and qualitative cancer descriptor for each isomer. The assessment does not include a quantitative cancer assessment.

(3) NCEA has developed a draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (July 2013 Draft). The draft evaluation and proposed charge questions may be found at the following URL: http://yosemite.epa.gov/​sab/​sabproduct.nsf/​fedrgstr_​activites/​Eto%20Inhalation%20Carcinogenicity?​OpenDocument. This draft evaluation has been revised based on recommendations provided by the SAB in 2007 resulting from their peer review of an earlier version of the carcinogenicity assessment. The SAB report, Review of Office of Research and Development (ORD) draft assessment entitled, “Evaluation of the Carcinogenicity of Ethylene Oxide” (EPA-SAB-08-004), is available at: http://yosemite.epa.gov/​sab/​sabproduct.nsf/​02ad90b136fc21ef85256eba00436459/​5D661BC118B527A3852573B80068C97B/​$File/​EPA-SAB-08-004-unsigned.pdf.

Technical Contact for EPA's draft assessments: For information concerning the EPA draft assessments, please contact Dr. Samantha Jones, 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 to augment the CAAC for three separate review panels.

(1) For the peer review of the EPA's draft Toxicological Review of Ammonia, the SAB Staff Office seeks experts in one or more of the following areas, with a particular focus on ammonia: toxicology of ammonia (and ammonium compounds); epidemiology with experience in respiratory effects (i.e., irritants and measures of lung function); toxicokinetics and the role of endogenous ammonia in maintaining nitrogen homeostasis; and inhalation toxicology. Questions regarding this review should be directed to Dr. Sue Shallal, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at [phone], by fax at [phone], or via email at [e-mail].

(2) For the peer review of the EPA's draft Toxicological Review of Trimethylbenzenes, the SAB seeks experts in one or more of the following areas, particularly with respect to trimethylbenzenes: Developmental neurotoxicity, developmental toxicity, pharmacokinetic modeling, respiratory and inhalation toxicology, hematological toxicology, and carcinogenicity. Questions regarding this review should be directed to Mr. Thomas Carpenter, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at [phone], by fax at [phone], or via email at [e-mail].

(3) For the peer review of the EPA's draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide, the SAB Staff Office is seeking expertise in epidemiology, biostatistics, exposure-response modeling, genotoxicity, cancer biology, and risk assessment. Questions regarding this review may be directed to Mr. Aaron Yeow, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at [phone], by fax 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 any of the augmented CAAC panels identified in this notice.

Nominations should be submitted in electronic format (preferred over hard copy) following the instructions for “Nominating Experts to Advisory Panels and Ad Hoc Committees Being Formed,” http://www.epa.gov/​sab provided on the SAB Web site (see the “Nomination of Experts” link on the blue navigational bar 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. Sue Shallal, Mr. Thomas Carpenter, or Mr. Aaron Yeow, as indicated above in this notice. Nominations should be submitted in time to arrive no later than September 18, 2013. 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 each of the three panels on the SAB Web site at http://www.epa.gov/​sab. Public comments on each 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 these expert panels, the SAB Staff Office will consider public comments on the Lists 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 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 a 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. 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://www.epa.gov/​sab/​pdf/​ec02010.pdf.

Dated: August 19, 2013.

Christopher Zarba,

Acting Director, Science Advisory Board Staff Office.