E6-3339. Human Studies Review Board; Notice of Public Meeting and Proposed Candidates for Membership to the Board

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The U.S. Environmental Protection Agency's (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and ethical reviews of human subjects research. In addition, OSA is soliciting public comment on its proposed list of candidates for membership to the HSRB.

DATES:

The public meeting will be held April 4-6, 2006 from 8:30 a.m. to approximately 5 p.m., eastern time.

Location: Holiday Inn Rosslyn at Key Bridge, 1900 North Fort Myer Drive, Arlington, VA 22209. The telephone number for the Holiday Inn Rosslyn at Key Bridge is 703-807-2000.

Requests to Present Oral Comments and Special Accommodations: To submit requests for special accommodation arrangements or requests to present oral comments, notify the DFO listed under FOR FURTHER INFORMATION CONTACT. To ensure proper receipt by EPA, your request must identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line on the first page of your response. Additional information concerning the submission of requests to present oral comments and submission of written comments is provided in Unit I.E.

FOR FURTHER INFORMATION CONTACT:

Any member of the public who wishes further information should contact Paul I. Lewis, Designated Federal Official (DFO), EPA, Office of the Science Advisor, (8105), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax: [phone]; e-mail addresses: [e-mail].

ADDRESSES:

Submit your written comments, identified by Docket ID No. EPA-HQ-ORD-2006-018, by one of the following methods: http://www.regulations.gov: Follow the on-line instructions for submitting comments.

E-mail: [e-mail].

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-2006-0187. 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 comments to Docket ID No. EPA-HQ-ORD-2006-0187. EPA's policy is that all comments 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 comment 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 comment. If you send an e-mail comment directly to EPA, without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

I. Public Meeting

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 studies 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) or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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/​. A frequently updated electronic version of the Code of Federal Regulations (CFR) is available at http://www.gpoaccess.gov/​ecfr/​.

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 [phone], and the telephone number for the ORD Docket is [phone].

EPA's position paper, charge/questions to the HSRB, HSRB composition and the meeting agenda will be available by mid March 2006. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, from the regulations.gov Web site and the HSRB Internet Home Page at http://www.epa.gov/​osa/​hsrb/​.

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

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

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. Provide specific examples to illustrate your concerns.

5. 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.

E. How May I Participate in This Meeting?

You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line on the first page of your request.

1. Oral comments. Oral comments presented at the meetings should not be repetitive of previously submitted oral or written comments. Although requests to present oral comments are accepted until the date of the meeting (unless otherwise stated), to the extent that time permits, interested persons may be permitted by the Chair of the HSRB to present oral comments at the meeting. Each individual or group wishing to make brief oral comments to the HSRB is strongly advised to submit their request (preferably via email) to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon, eastern time, March 29, 2006, in order to be included on the meeting agenda. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment (e.g., overhead projector, 35 mm projector, chalkboard). Oral comments before the HSRB are limited to approximately 5 minutes unless prior arrangements have been made. In addition, each speaker should bring 30 copies of his or her comments and presentation slides for distribution to the HSRB at the meeting.

2. Written comments. Although written comments will be accepted until the date of the meeting (unless otherwise stated), the Agency strongly encourages that written comments be submitted, using the instructions in Unit 1.C. no later than noon, eastern time, March 29, 2006 to provide the HSRB the time necessary to consider and review the written comments. It is requested that persons submitting comments directly to the docket also notify the DFO listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the extent of written comments for consideration by the HSRB.

3. Seating at the meeting. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access and assistance for the hearing impaired, should contact the DFO at least 10 business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT so that appropriate arrangements can be made.

F. Background

At the inaugural meeting of the HSRB, EPA will provide a broad overview of the Agency's approach to the assessment of the potential risk to human health from the use of pesticides and how EPA uses data from human studies in such risk assessments. The Agency will then present to the HSRB its scientific and ethics reviews of approximately two dozen completed human studies concerning the following pesticide active ingredients: aldicarb, amitraz, azinphos-methyl, dichlorovos (DDVP), ethephon, methomyl, oxamyl, and sodium cyanide. The studies being reviewed at this meeting will include both studies on which the Agency proposes to rely in actions under the pesticide laws and studies that the Agency has decided not to use in its risk assessments, either for ethical or scientific reasons. The Agency will ask the HSRB to advise the Agency on a range of scientific issues and on how the studies should be assessed against the provisions in sections 26.1701-26.1704 of EPA's final human studies rule.

II. Proposed Candidates for Membership to the Board

On January 3, 2006, the EPA, OSA announced a request for nominations of qualified individuals to serve on the HSRB (Federal Register 71 116). Per the Federal Register notice, the OSA requested nominees who are nationally-recognized experts in one or more of the following disciplines:

(a) Biostatistics. Expertise in statistical design and analysis of human subjects research studies.

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

(c) Bioethics. Expertise in the ethics of research on human subjects; research ethics.

(d) Human health risk assessment.

EPA carefully considered the qualifications of nominees who agreed to be further considered and has identified candidates from whom EPA expects to select members to serve on the HSRB. EPA now invites comments from members of the public for relevant information or other documentation that the OSA should consider in the selection of HSRB members. The names of the candidates, together with a short biographical description of their qualifications, appear on the Agency's Web site at http://www.epa.gov/​osa/​hsrb/​. Please e-mail your comments no later than noon, eastern time, March 14, 2006, listed under FOR FURTHER INFORMATION CONTACT.

Any information furnished by the public in response to this Web site posting will be combined with information already provided by the candidates, and gathered independently by the OSA. Prior to final selection of HSRB members, the combined information will be reviewed and evaluated for any possible financial conflict of interest or a possible appearance of a lack of impartiality. The information will also be used to ensure appropriate balance and breadth of expertise needed to address the charge to the Board. The EPA Science Advisor will make the final decision concerning who will serve on the HSRB.

Dated: March 2, 2006.

George Gray,

EPA Science Advisor.