02-20921. National Toxicology Program; Notice of a Meeting of the NTP Board of Scientific Counselors

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors on September 17-18, 2002, at the Radisson Governors Inn, 1-40 at Davis Drive, Exit 280, Research Triangle Park, North Carolina.

The NTP Board of Scientific Counselors (the Board) is composed of scientists from the public and private sector and provides primary scientific oversight to the NTP.

Agenda

The meeting being held on September 17-18, 2002, is open to the public from 8:30 a.m. to adjournment each day with attendance limited only by the space available. Persons needing special assistance should contact the NTP Executive Secretary (contact information below). A draft agenda with tentative schedule is provided below. Primary agenda topics include: (1) A draft format for the NTP brief that will be part of the NTP-CERHR Monograph prepared on each chemical reviewed by the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR); (2) a discussion of the proposed NTP strategy for using genetically altered animals in carcinogen identification, (3) an overview of the NIEHS National Center for Toxicogenomics and its links with the NTP, and (4) recommendations of the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) for substances nominated to the NTP for study. There will also be an update about current NTP testing initiatives, the NTP Board of Scientific Counselors Technical Reports Review Subcommittee meeting on the September 5-6, 2002, and the status of the 10th and 11th Editions of the Report on Carcinogens. The Board will review a concept proposal for the continued use of a contract mechanism to investigate potential genetic toxicity of substances under study by the NTP. Time is allotted during the meeting for the public to present comments to the Board and NTP staff on agenda topics.

NTP-CERHR Monograph

The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) serves as an environmental health resource to the public and to regulatory and health agencies for scientifically based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans are exposed. Additional information about the CERHR is available at http://cerhr.niehs.nih.gov.

As a final step in its evaluation of a chemical, the CERHR will prepare an NTP-CERHR Monograph. The monograph will include an NTP brief, the expert panel's report on the chemical, and all public comments received on the expert panel report. The NTP brief provides the NTP's interpretation of the potential for exposure to the chemical to adversely affect reproduction and/or development in humans. NTP-CERHR monographs will be made publicly available.

As a prototype for the NTP-CERHR Monograph, the CERHR has available the draft NTP-CERHR Monograph on Di-n-butyl Phthalate (DBP) and will request comment from the Board on the proposed format for the NTP brief. The CERHR is interested in obtaining input about the brief's layout and presentation of information, it clarity, and its utility for the public. The draft monograph is available on the NTP-CERHR Web site (http://cerhr.niehs.nih.gov) or by contacting the NTP Executive Secretary.

NTP Draft Strategy for Using Genetically Altered Animals in Carcinogen Identification

The NTP has developed a proposed draft strategy for the routine use of genetically altered animals in carcinogen identification. The NTP is seeking broad external input on this strategy and will present it to the Board for review and comment. This meeting also provides an opportunity for the public to offer comment to the Board and NTP staff on the proposed draft strategy. The draft strategy is available on the NTP Web site (http://ntp-server.niehs.nih.gov,, see What's New, Meeting of the NTP Board of Scientific Counselors) or by contacting the NTP Executive Secretary (contact information below).

Toxicogenomics

With the advent of novel molecular technologies, the NTP is moving into the arena of toxicogenomics, a new scientific field that examines how the entire genome is involved in biological responses of organisms exposed to environmental toxicants. Toxicogenomics studies the effect of toxicants on gene activity and specific proteins produced by genes in response to those toxicants.

In an effort toward centralizing activities in toxicogenomics, the NIEHS/NIH established the National Center for Toxicogenomics (NCT) in September 2000. The NCT's mission is to coordinate a nationwide research effort for the development of a toxicogenomics knowledge base. Additional information about the NCT is available on the NIEHS Web site at http://www.niehs.nih.gov/​nct or by contacting the NTP Executive Secretary (contact information below). The NTP will describe some of its current efforts to incorporate toxicogenomics into its testing strategies through interactions with the NCT.

NTP Testing Program

Overview of Current Initiatives

The NTP seeks to maintain a balanced research and testing program that provides data addressing a wide variety of issues of importance to public health. Currently the NTP is focusing on several areas that have received inadequate attention in the past: for example, photoactive chemicals, contaminants of finished drinking water, endocrine-disrupting agents, and certain occupational exposures. The NTP is addressing potential safety issues associated with herbal medicines, radiofrequency radiation emissions from cellular telephones, hexavalent chromium, and DNA-based therapies. In general, these initiatives are broad-based and include the investigation of various health-related endpoints. Additional information about some current initiatives is available in the NTP Booklet, Current Directions and Evolving Strategies, available on the NTP Web site (http://ntp-server.niehs.nih.gov,, select Publications).

ICCEC Recommendations for Substances Nominated for Future NTP Studies

Information about substances nominated to the NTP for toxicology and carcinogenesis studies and the ICCEC's recommendations was published in the Federal Register on June 12, 2002 (Vol. 67, No. 113, p. 40329-33). This notice is available on the Web (http://ntp-server.niehs.nih.gov/​htdocs/​Liason/​ICCECFinal02JuneFR.html) along with supporting documents for each nomination (http://ntp-server.niehs.nih.gov/​htdocs/​liason/​BkgrSum02June.html) or by contacting the NTP Executive Secretary (contact information below). This meeting provides an additional opportunity for the public to provide comment on these nominations and study recommendations to the Board and NTP staff. Comments submitted to the NTP in response to the June 2002 Federal Register notice are under consideration and do not need to be resubmitted or readdressed.

Substances recommended for study:

• Abrasive blasting agents—5 different industrial materials used as alternatives to sand.
• 5-Amino-o-cresol—permanent hair dye ingredient.
• tert-Butyl hydroperoxide—high production volume industrial catalyst.
• Chloramine-T and p-Toluenesulfonamide—active ingredient and metabolite of therapeutant used in aquaculture to control bacterial infections.
• Cobalt metal dust—important industrial material linked to lung problems in workers.
• Ephedrine alkaloid dietary supplements—widely used in herbal dietary supplements with numerous reports of adverse effects.
• Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl)-(Iso-E-Super)—high-production-volume fragrance material.
• Hexafluorosilicic acid and Sodium hexafluorosilicate—primary agents used to fluoridate public drinking water system.
• Ketamine hydrochloride—approved anesthetic drug that causes brain lesions in developing rats.
• Mercury, ((o-carboxyphenyl)thio)ethyl-, sodium salt (Thimerosal)—organomercuryl-based preservative used in vaccines and other biological products.
• Nitrogen trifluoride—cleaning and etching agent in the semiconductor industry.
• Sodium metasilicate—industrial cleaning agent.
• Turpentine—high-production-volume industrial solvent and raw material.
• Welding fumes—variable composition mixture responsible for respiratory and other adverse effects in exposed workers.

Nominations for which no studies are recommended at this time:

• Hexachloro-1,3-butadiene—industrial by-product and persistent environmental contaminant.
• Infrasound—low frequency acoustic energy present at low levels in community and occupational settings.
• Magnesium oxide—high-production-volume chemical with numerous industrial uses.
• Methylolurea—starting material for and impurity in urea-formaldehyde resins.
• 4-Methylquinoline—environmental pollutant structurally related to the rodent carcinogen quinoline.

Public Comment Encouraged

Public input at this meeting is invited and time is set aside for the presentation of public comments on any agenda topic. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Persons registering to make oral comments are asked to provide their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any). Each organization is allowed one time slot per agenda topic. To facilitate planning for the meeting, persons interested in providing formal oral comments are asked to notify Dr. Mary Wolfe, NTP Board Executive Secretary, NIEHS, P.O. Box 12233, MD A3-07, Research Triangle Park, NC 27709; telephone: [phone]; and e-mail: ([e-mail]) by September 10, 2002. Persons registering to make oral comments are asked, if possible, to provide a copy of their statement to the Executive Secretary by September 10th, to enable review by the Board and NTP staff prior to the meeting. Written statements can supplement and may expand the oral presentation. Individuals will also be able to register to give oral public comments on-site at the meeting. However, if registering on-site and reading from written text, please bring 25 copies of the statement for distribution to the Board and NTP staff and to supplement the record.

Persons may also submit written comments in lieu of making oral comments. Written comments should be sent to the Executive Secretary and must be received by September 10th to enable review by the Board and NTP staff prior to the meeting. Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document.

Registration

The NTP Board of Scientific Counselors meeting is open to the public. Attendance at this meeting is limited only by the space available. Due to changes in security policies at the NIEHS, individuals who plan to attend are asked to register with the NTP Executive Secretary (see contact information above). The names of those registered will be given to the NIEHS Security Office in order to gain access to the campus. Persons attending who have not pre-registered may be asked to provide pertinent information about the meeting, i.e., title or host of meeting before gaining access to the campus. All visitors (whether or not you are pre-registered) will need to be prepared to show 2 forms of identification (ID), i.e., driver's license and one of the following: company ID, government ID, or university ID. Also, those planning to attend who need special assistance are asked to notify the NTP Executive Secretary in advance of the meeting (see contact information above).

Additional Information About Meeting

Prior to the meeting, a copy of the agenda and a roster of the Board's members will be available on the NTP Web site at http://ntp-server.niehs.nih.gov and upon request to the Executive Secretary (contact information provided above). Following the meeting, summary minutes will be prepared and available through the NTP Web site and upon request to Central Data Management, NIEHS, P.O. Box 12233, MD E1-02, Research Triangle Park, NC 27709; telephone [phone]; fax [phone]; and email [e-mail].

NTP Board of Scientific Counselors

The Board is a technical advisory body comprised of scientists from the public and private sectors who provide primary scientific oversight to the overall Program and to the NTP Center for the Evaluation of Risks to Human Reproduction. Specifically, the Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the Program for the purposes 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 and neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and minority and female representation on the Board. Its members are invited to serve overlapping terms of up to four years and meetings are held once or twice annually for the Board and its two subcommittees (the Report on Carcinogens Subcommittee and the Technical Reports Review Subcommittee).

Dated: August 12, 2002.

Samuel Wilson,

Deputy Director, National Toxicology Program.

Preliminary Agenda—National Toxicology Program (NTP) Board of Scientific Counselors, September 17-18, 2002

Radisson Governors Inn, 1-40 at Davis Drive, Exit 280, Research Triangle Park, North Carolina

September 17, 2002

8:30 a.m. Welcome and Opening Comments

NTP Update

NTP-CERHR Monograph: Format of Draft NTP Brief

• Public Comments

NTP Draft Strategy for Using Genetically Altered Animals in Carcinogen Identification

• Evaluation of Transgenic Models for Use in Carcinogen Identification
• NTP Draft Strategy
• Agency Comments
• Public Comments

11:30 a.m.—Lunch

1 p.m. —NTP Draft Strategy (continued)

Toxicogenomics

• Overview of the National Center for Toxicogenomics (NCT)
• Links between the NCT and NTP
• Public Comments

5 p.m.—Adjourn

September 18, 2002

8:30 a.m.—Welcome and Introductions

NTP Testing Program

• Overview of Current Initiatives
• Testing Recommendations from the Interagency Committee for Chemical Evaluation
• Public Comments

Concept Review

Update on the NTP Technical Reports Review Subcommittee Meeting

Update on the Report on Carcinogens

Public Comments

Noon—Adjourn