E6-2899. EPA Science Advisory Board Staff Office; Request for Nominations of Experts for the Ethylene Oxide Review Panel

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Requesting the nomination of experts for the Science Advisory Board (SAB) Ethylene Oxide Review Panel.

DATES:

Nominations should be submitted by March 22, 2006, per instructions below.

FOR FURTHER INFORMATION CONTACT:

Any member of the public wishing further information regarding this Request for Nominations may contact Dr. Sue Shallal, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at [phone]; by fax at [phone]; or via e-mail at [e-mail]. General information concerning the EPA Science Advisory Board can be found on the EPA SAB Web site at: http://www.epa.gov/​sab.

SUPPLEMENTARY INFORMATION:

 

Background: EPA last published a health assessment of the potential carcinogenicity of ethylene oxide (EtO) in 1985 (U.S. EPA, 1985). EPA's Office of Research and Development (ORD) has now completed a review of the more recent database on the carcinogenicity of EtO, pertinent data from the 1985 assessment, and several reviews and assessments issued by other organizations. EtO is manufactured from ethylene and used primarily as a chemical intermediate in the manufacture of ethylene glycol. It is also used as a sterilizing agent for medical equipment and as a fumigating agent for spices. ORD's draft assessment focuses on lifetime cancer risk from inhalation exposure. The assessment broadly supports activities authorized in the 1990 Clean Air Act and is of particular interest to EPA's Office of Air and Radiation. However, this review also should be applicable to the needs of all program Offices and Regions in evaluating the carcinogenicity of EtO. ORD has requested that the Science Advisory Board (SAB) review its draft assessment entitled “Evaluation of the Carcinogenicity of Ethylene Oxide”.

The EPA Science Advisory Board (SAB) was established by 42 U.S.C. 4365 to provide independent scientific and technical advice, consultation and recommendations to the EPA Administrator on the technical basis for Agency positions and regulations. The SAB review panel, conducting the review of the Agency's evaluation of the carcinogenicity of ethylene oxide, will consist of members of the chartered SAB, SAB Committee members and other experts as determined to be necessary. This panel will comply with the provisions of the Federal Advisory Committee Act (FACA) and all appropriate SAB procedural policies. Upon completion, the panel's report will be submitted to the chartered SAB for final approval for transmittal to the EPA Administrator. The SAB Ethylene Oxide Review Panel is being asked to comment on the scientific soundness of this carcinogenicity assessment.

Availability of the Review Materials: The EPA draft document to be reviewed by the SAB Panel will be made available by the Office of Research and Development. For questions and information concerning the review materials, please contact Dr. Henry Kahn, at [phone], or [e-mail].

Request for Nominations: The SAB Staff Office is requesting nominations of recognized experts with one or more of the following areas of expertise, especially with respect to the potential human carcinogenic effects of ethylene oxide: Respiratory/pulmonary physiology and exposure; epidemiology; toxicology, including genetic toxicology and mechanisms of action for carcinogenicity; metabolism; pharmacokinetics and modeling; dose-response assessment; risk assessment and statistical evaluation of epidemiological and toxicological data.

Process and Deadline for Submitting Nominations: Any interested person or organization may nominate qualified individuals to serve on the SAB Panel(s). Nominations should be submitted in electronic format through the SAB Web site at the following URL: http://www.epa.gov/​sab; or directly via the Form for Nominating Individuals to Panels of the EPA Science Advisory Board link found at URL: http://www.epa.gov/​sab/​panels/​paneltopics.html. To be considered, nominations must include all of the information required on the associated forms. Anyone who is unable to submit nominations using this form, and who has any questions concerning any aspects of the nomination process may contact the DFO, as indicated above in this notice. Nominations should be submitted in time to arrive no later than March 22, 2006.

The EPA SAB Staff Office will acknowledge receipt of the nomination. From the nominees identified by respondents to this notice (termed the “Widecast”), the SAB Staff Office will develop a smaller subset (known as the “Short List”) for more detailed consideration. Criteria used by the SAB Staff in developing this Short List are given at the end of the following paragraph. The Short List will be posted for public comment on the SAB Web site at: http://www.epa.gov/​sab. The Short List will include each nominee's name and a short biographical description of expertise and professional experiences. During this comment period, the public may provide relevant information on nominees that the SAB Staff Office should consider in evaluating candidates for the Panel.

For the EPA SAB Staff Office, a balanced subcommittee or 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 independently-gathered by the SAB Staff Office on the background of each candidate. Specific criteria to be used in evaluating an individual nominee 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 lack of impartiality; and (e) skills working in committees, subcommittees and advisory panels; and, for the Panel as a whole, (f) diversity of, and balance among, scientific expertise and viewpoints.

Prospective candidates will also 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 includes 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://www.epa.gov/​sab/​sge_​course/​pdf_​sge/​epaform3110_​48.pdf. The process by which the EPA SAB Office forms 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: February 23, 2006.

Anthony F. Maciorowski,

Associate Director for Science, EPA Science Advisory Board Staff Office.