Request for Nominations for a Human Studies Review Board

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The U.S. Environmental Protection Agency (EPA or Agency) Office of the Science Advisor (OSA) is soliciting nominations of qualified individuals to serve on a proposed Human Studies Review Board (HSRB). The Agency anticipates establishment of such a board to provide advice and recommendations on issues related to the scientific and ethical review of human subjects research. EPA was directed to establish such a Board pursuant to the 2006 EPA Appropriations Act and included such a Board in a proposed rule for protection of subjects in human research. See: “Department of Interior, Environment, and Related Agencies Appropriations Act, 2006”, Public Law No. 109-54 and “Protections for Subjects in Human Research: Proposed Rule,” 70 FR 53,838; September 12, 2005.

DATES:

Nominations should be submitted to EPA no later than February 2, 2006.

ADDRESSES:

Submit your nominations (“comments”), identified by Docket ID No. EPA-HQ-ORD-2005-0553, by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: ORD.Docket@epa.gov.
• Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
• Hand Delivery: EPA Docket Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-ORD-2005-0553. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed information.

Instructions: Direct your nominations to Docket ID No. EPA-HQ-ORD-2005-0553. EPA's policy is that all nominations received will be included in the public docket without change and may be made available online at http://www.regulations.gov , including any personal information provided, unless the nomination includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your nomination. If you send an e-mail nomination directly to EPA, without going through http://www.regulations.gov , your e-mail address will be automatically captured and included as part of the nomination that is placed in the public docket and made available on the Internet. If you submit a nomination electronically, EPA recommends that you include your name and other contact information in the body of your nomination and with any disk or CD-ROM you submit. If EPA cannot read your nomination due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider it. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the ORD Docket is (202) 566-1752.

FOR FURTHER INFORMATION CONTACT:

Paul I. Lewis, Office of the Science Advisor, Mail Code 8105R, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-8381 fax number: (202) 564-2070, e-mail: lewis.paul@epa.gov, or William Sette, Office of the Science Advisor, Mail Code 8105R, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-0693, fax number: (202) 564-2070, e-mail: sette.william@epa.gov.

I. General Information

A. Does This Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to persons who conduct or assess human research on substances regulated by EPA or to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Food Quality Protection Act of 1996 (FQPA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other Related Information?

In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr/.

C. What Should I Consider as I Prepare My Nomination for EPA?

You may find the following suggestions helpful for preparing your nomination:

1. Providing as much supporting information as possible about the nominee, including contact information.

2. Make sure to submit your nomination by the deadline in this document.

3. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date and Federal Register citation.

SUPPLEMENTARY INFORMATION:

Background

On August 2, 2005, the President signed into law the Department of Interior, Environment, and Related Agencies Appropriations Act, 2006, Public Law 109-54 (Appropriations Act), which provides appropriated funds for the Environmental Protection Agency and other Federal departments and agencies. Section 201 of the Appropriations Act includes the following provision:

None of the funds made available by this Act may be used by the Administrator of the Environmental Protection Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. The Administrator shall allow for a period of not less than 90 days for public comment on the Agency's proposed rule before issuing a final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board. The final rule shall be issued no later than 180 days after enactment of this Act.

Consistent with the express Congressional directive, on September 12, 2005 (70 FR 53838), EPA published a Notice of Proposed Rulemaking (NPRM) regarding protections for subjects in human research and the establishment of the Human Studies Review Board (HSRB or Board).

Concurrent with this rulemaking process, EPA is reevaluating older registered pesticides with a goal of meeting the August 2006 deadline for completing the reregistration of pesticide active ingredients with food uses and the reassessment of tolerances mandated by section 408(q) of the FFDCA, as amended by the 1996 Food Quality Protection Act (FQPA) [Pub. L. 104-70]. In addition, EPA has received applications for registration or amended registration of pesticide products. Under the provisions of the Pesticide Registration Improvement Act (PRIA), EPA has deadlines by which it must make a decision whether to approve new applications for pesticide registrations or amendments to registrations.

EPA expects to issue the final rule in early 2006 after considering all public comments provided to the Agency. However, once the rule is finalized, there will be limited time between the establishment of the HSRB and the mandatory completion dates for tolerance reassessment and PRIA deadlines. Therefore, the Agency is initiating the actions necessary to enable a HSRB to begin reviewing completed human research that would be relevant to pending reregistration, tolerance reassessment and new registration decisions, and in accordance with the provisions of the final rule. The first step toward establishing a HSRB is to solicit nominations for qualified individuals to serve on the HSRB for a review of intentional dosing human studies.

Process and Deadline for Submitting Nominations

Any interested person or organization may nominate qualified individuals to be considered as prospective candidates for the HSRB. Additional avenues and resources may be utilized in the solicitation of nominees to encourage a broad pool of expertise. Nominees should be experts who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the ethical and/or scientific issues that may be considered by the HSRB. Nominees are requested who are nationally recognized experts in one or more of the following areas:

Biostatistics: expertise in statistical design and analysis of human subjects research studies.

Human toxicology: Expertise in pharmacokinetic and toxicokinetic studies, clinical trials, toxicology of cholinesterase inhibitors, and other classes of environmental substances.

Bioethics: Expertise in the ethics of research on human subjects; research ethics.

Human health risk assessment

To be considered, all nominations should include: a current curriculum vitae (C.V.) which provides the nominee's background, qualifications, relevant research experience and publications; and a brief biographical sketch (“biosketch”). The biosketch should be no longer than one page and should contain the following information for the nominee:

(a) Current professional affiliations and positions held;

(b) Area(s) of expertise, and research activities and publications relevant to the HSRB;

(c) Leadership positions in national associations or professional publications or other significant distinctions;

(d) Educational background, especially advanced degrees, including when and from which institutions these were granted.

The credentials of nominees received in reply to this notice will be compared to the specific expertise sought for the HSRB. Qualified nominees who agree to be further considered will be included in a smaller subset (known as the “Short List”). This subset will be posted on the OSA Web site http://www.epa.gov/osa/index.htm and will include, for each candidate, the nominee's name and their biosketch. Public comments will be accepted for 14 calendar days on the Short List. During this comment period, the public will be requested to provide relevant information or other documentation on nominees that OSA should consider in evaluating the candidates. Board members will be selected from the Short List.

The selection of experts to serve on the HSRB will be based on the function of the Board and the expertise needed. No interested candidates shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency (except the EPA). Other factors that will be considered during the selection process include availability of the potential Board member to fully participate in the Board's reviews, absence of any conflicts of interest, impartiality, independence with respect to the matters under review, and public comments to the Short List. Though financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on the HSRB. Numerous qualified candidates may be identified. Therefore, selection decisions involve carefully weighing a number of factors including, but not limited to, the candidates' areas of expertise and professional qualifications, and responses to the Short List in achieving an overall balance of different perspectives on the Board.

If a prospective candidate for service on the HSRB is considered, the candidate is subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. As such, the HSRB candidate is required to submit a Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency (EPA Form 3110-48 [5-02]) which shall fully disclose, among other financial interests, the candidate's employment, stocks, and bonds, and where applicable, sources of research support. The EPA will evaluate the candidate's financial disclosure form to assess that there are no financial conflicts of interest, no appearance of lack of impartiality, and no prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on the HSRB.

Those who are selected from the pool of prospective candidates will be asked to attend public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes. The Agency will consider all nominations of prospective candidates for this meeting that are received on or before February 2, 2006. However, final selection of members is a discretionary function of the Agency. Nominations should be submitted by one of the methods listed under ADDRESSES.