2010-9252. National Toxicology Program (NTP); Office of Liaison, Policy and Review Meeting of the NTP Board of Scientific Counselors

AGENCY:

National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health.

ACTION:

Meeting announcement and request for comments.

SUMMARY:

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

DATES:

The BSC meeting will be held on June 21-22, 2010. The deadline for submission of written comments is June 7, 2010, and for pre-registration to attend the meeting, including registering to present oral comments, is June 14, 2010. Persons needing interpreting services in order to attend should contact 301-402-8180 (voice) or 301-435-1908 (TTY). For other accommodations while on the NIEHS campus, contact 919-541-2475 or e-mail [e-mail]. Requests should be made at least 7 business days in advance of the event.

ADDRESSES:

The BSC meeting will be held in the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Public comments on all agenda topics and any other correspondence should be submitted to Dr. Lori White, Designated Federal Officer for the BSC, NTP Office of Liaison, Policy and Review, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709; telephone: [phone]; fax: [phone]; [e-mail]. Courier address: NIEHS, 530 Davis Drive, Room K2136, Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT:

Dr. Lori D. White (telephone: [phone] or [e-mail]).

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

• Report of the NIEHS/NTP Director.
• Report of the NTP Associate Director.
• Center for the Evaluation of Risks to Human Reproduction (CERHR) Proposed Evaluation Concept: Cancer Chemotherapy During Pregnancy.
• Peer Review of Draft Substance Profiles for the 12th Report on Carcinogens (RoC): glass wool fibers, cobalt-tungsten carbide: powders and hard metals, and formaldehyde.
• NTP Testing Program Nomination and Proposed Research Project: Hydroxyurea.

The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting Web site (http://ntp.niehs.nih.gov/​go/​165) or may be requested in hardcopy from the Designated Federal Officer for the BSC (see ADDRESSES above). Updates to the preliminary agenda will also be posted to this site. The draft substance profiles will be available by close of business, April 21, 2010, on the NTP BSC meeting Web site. The draft research concepts for the CERHR evaluation and the NTP Testing Program nomination will be available on the BSC meeting page (http://ntp.niehs.nih.gov/​go/​165) by May 10, 2010.

Following the meeting, summary minutes will be prepared and made available on the BSC meeting Web site.

Attendance and Registration

The meeting is scheduled for June 21-22, 2010, beginning at 8:30 a.m. (Eastern Daylight Time) and continuing to approximately 5:30 p.m. on June 21 and until adjournment on June 22. This meeting is open to the public with attendance limited only by the space available. Individuals who plan to attend are encouraged to register online at the BSC meeting Web site (http://ntp.niehs.nih.gov/​go/​165) by June 14, 2010, to facilitate planning for the meeting. Registered attendees are encouraged to access the meeting website to stay abreast of the most current information regarding the meeting. The NTP is making plans to videocast the meeting through the Internet at http://www.niehs.nih.gov/​news/​video/​live.

Request for Comments

Written comments submitted in response to this notice should be received by June 7, 2010. Comments will be posted on the BSC meeting Web site and persons submitting them will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting written comments should include their name, affiliation (if applicable), phone, e-mail, and sponsoring organization (if any) with the document.

Time will be allotted during the meeting for the public to present oral comments to the BSC on the agenda topics. In addition to in-person oral comments at the meeting at the NIEHS, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The available lines will be open from 8 a.m. until 5:30 p.m. on June 21, and 8 a.m. until adjournment on June 22, although public comments will be received only during the formal public comment periods, which will be indicated on the preliminary agenda. Each organization is allowed one time slot per agenda topic. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes at the discretion of the BSC chair. Persons wishing to present oral comments are encouraged to pre-register on the NTP meeting Web site and indicate whether they will present comments in-person or via the teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Registration for oral comments will also be available on June 21 and June 22, although time allowed for presentation by these registrants may be less than that for pre-registered speakers and will be determined by the number of persons who register at the meeting.

Persons registering to make oral comments are asked to send a copy of their statement to the Designated Federal Officer for the BSC (see ADDRESSES above) by June 14, 2010, to enable review by the BSC prior to the meeting. Written statements can supplement and may expand the oral presentation. If registering on-site and reading from written text, please bring 40 copies of the statement for distribution to the BSC and NTP staff and to supplement the record. Registered speakers using PowerPoint slides with their oral comments should send them to the Designated Federal Officer (see ADDRESSES) by June 14, 2010.

Background Information on CERHR

The NTP established CERHR in 1998 [63 FR 68782]. CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. CERHR follows a formal process for the evaluation of selected substances that includes opportunities for public input. CERHR invites the nomination of substances for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its homepage (http://cerhr.niehs.nih.go v) or by contacting Dr. Kristina Thayer (919-541-5021 or [e-mail]). CERHR selects substances for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. Expert panels conduct scientific evaluations of substances selected by CERHR in public forums. Following these evaluations, CERHR prepares the NTP-CERHR monograph on the substance evaluated. The monograph is transmitted to appropriate Federal and State agencies and made available to the public.

Background Information on the Report on Carcinogens

The RoC is a public information document prepared for the U.S. Congress by the NTP in response to Section 301(b)(4) of the Public Health Service Act, as amended. The intent of the document is to provide a listing of agents, substances, mixtures, or exposure circumstances that are either known or reasonably anticipated to cause cancer in humans and to which a significant number of people in the United States are exposed. The NTP is following a multi-step scientific review process with multiple opportunities for public input for preparation of the 12th RoC (http://ntp.niehs.nih.gov/​go/​29353) that was announced in the Federal Register on April 16, 2007 (72 FR 18999). On several occasions, the NTP has published notices announcing candidate substances under consideration for review for the 12th RoC (69 FR 28940, 69 FR 62276, 70 FR 60548, 72 FR 26394). Publication of the RoC is intended to occur every two years (42 U.S.C. 301(b)(4)); however, in 2007, the NTP initiated a revised and extended review process for the 12th RoC (72 FR 18999). Although the NTP initially planned to review a larger set of candidate substances, in light of the time and resources required to carry out the review process, the NTP has now defined the set of eight candidate substances for the 12th RoC. The three draft substance profiles being peer-reviewed at this BSC meeting are the second and last set of candidate substances that the NTP intends to review for the 12th RoC. The draft substance profiles for the first set of five candidate substances for the 12th RoC were peer reviewed by the BSC at a meeting on February 24, 2009 (http://ntp.niehs.nih.gov/​go/​9741). Information about the review of candidate substances for the 12th RoC, including public comments and background documents, is available on the RoC Web site (http://ntp.niehs.nih.gov/​go/​10091) or from the RoC Center Director, Dr. Ruth Lunn (919-316-4637 or [e-mail]). The remaining candidate substances initially identified for possible review for the 12th RoC may be considered for the 13th RoC.

Background Information on NTP Testing Program Nominations and Proposed Research Projects

The NTP actively seeks to identify and select for study chemicals and other substances for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal, open nomination and selection process. Substances considered appropriate for study generally fall into two broad, yet overlapping categories: (1) Substances judged to have high concern as possible public health hazards based on the extent of human exposure and/or suspicion of toxicity and (2) substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g., by facilitating cross-species extrapolation or evaluating dose-response relationships. Nominations are subject to a multi-step, formal process of review before selections for testing are made and toxicological studies are designed and implemented. The nomination review and selection process is accomplished through the participation of representatives from the NIEHS, other Federal agencies represented on the Interagency Committee for Chemical Evaluation and Coordination (ICCEC)—the NTP Federal interagency review committee for NTP study nominations, the BSC, the NTP Executive Committee—the NTP federal interagency policy body, and the public. The nomination review and selection process is described in further detail on the NTP Web site (http://ntp.niehs.nih.gov/​,, select “Nominations to the Testing Program”).

Background documents for each nomination are available on the NTP Web site http://ntp.niehs.nih.gov/​go/​nom. The NTP invites interested parties to submit written comments, provide supplementary information, or present oral comments at the BSC meeting on the nominated substances and preliminary study recommendations (see “Request for Comments” below). The NTP welcomes toxicology study information from completed, ongoing, or anticipated studies, as well as information on current U.S. production levels, use or consumption patterns, human exposure, environmental occurrence, or public health concerns for any of the nominated substances. The NTP is interested in identifying appropriate animal and non-animal experimental models for mechanistic-based research, including genetically modified rodents and high-throughput in vitro test methods, and as such, solicits comments regarding the use of specific in vivo and in vitro experimental approaches to address questions relevant to the nominated substances and issues under consideration. Although the deadline for submission of written comments to be considered at the BSC meeting is June 7, 2010 (see “Request for Comments” above), the NTP welcomes comments or additional information on these study nominations at any time.

To facilitate review of the proposed research project by the BSC and the public, NTP staff developed a draft research concept document for the nomination recommended for study. A research concept is a brief document outlining the nomination or study rationale, and the significance, study approach, and expected outcome of a proposed research program tailored for each nomination. The purpose of a research concept is to outline the general elements of a program of study that would address the specific issues that prompted the nomination and the preliminary study recommendations. A research concept may also encompass larger public health issues or topics in toxicology that could be appropriately addressed through studies on the nominated substance(s). Draft research concept will be available on the BSC meeting page (http://ntp.niehs.nih.gov/​go/​165) by May 10, 2010.

Background Information on the NTP Board of Scientific Counselors

The BSC is a technical advisory body comprised of scientists from the public and private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. Members serve overlapping terms of up to four years. The BSC usually meets biannually.

Dated: April 13, 2010.

John R. Bucher,

Associate Director, National Toxicology Program.