05-15539. National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee

AGENCY:

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

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 Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions of ten draft NTP Technical Reports (TR) of rodent toxicology and carcinogenicity studies conducted by the NTP (see Preliminary Agenda below). TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft technical report discussed at the meeting. The TRR Subcommittee deliberations on the draft technical reports will be reported to the NTP Board of Scientific Counselors (NTP Board) at a future date.

DATES:

The TRR Subcommittee meeting will be held on September 27-28, 2005. Written comments should be received by September 13, 2005, to enable review by the TRR Subcommittee and NIEHS/NTP staff prior to the meeting. Individuals wishing to make oral public comments are asked to contact Dr. Barbara Shane (see FOR FURTHER INFORMATION CONTACT below) by September 13, 2005, and if possible, also to send a copy of the statement or talking points at that time. Persons needing special assistance, such as sign language interpretation, or other reasonable accommodation in order to attend, are asked to notify Dr. Shane at least 7 business days prior to the meeting (see FOR FURTHER INFORMATION CONTACT below).

ADDRESSES:

The TRR Subcommittee meeting will be held in the Rodbell Auditorium, Rall Building at the NIEHS, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. A copy of the preliminary agenda, committee roster, and any additional information, when available, will be posted on the NTP Web site (http://ntp.niehs.nih.gov/​ select “Advisory Boards and Committees”) and provided upon request from the NTP (see FOR FURTHER INFORMATION CONTACT below).

FOR FURTHER INFORMATION CONTACT:

Public comments and any other correspondence should be submitted to Dr. Barbara Shane, Executive Secretary for the NTP Board (NTP Liaison and Scientific Review Office, NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; telephone: [phone], fax: [phone]; or e-mail: [e-mail]).

SUPPLEMENTARY INFORMATION:

Background

The primary agenda topic is the peer review of the findings and conclusions of ten draft NTP Technical Reports (TR) of rodent toxicology and carcinogenicity studies conducted by the NTP (see Preliminary Agenda below). Five of the reports are on studies with conventional strains of rats and mice (TR 523, TR 534, TR 535, TR 537, TR 538); four reports are on studies performed in genetically modified models (GMM) including Tg.AC hemizygous and p53 haploinsufficient mice (GMM 5, GMM 6, GMM 10 and GMM 11), and one study is with Crl:SKH-1 hairless mice (TR 524). There will also be a presentation on background seizures in the F344/N rats used by the NTP.

Attendance and Registration

The meeting is scheduled for September 27-28, 2005, from 8:30 a.m. to adjournment and 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 NTP Web site by September 13, 2005, at http://ntp.niehs.nih.gov/​ select “Advisory Boards and Committees” to facilitate access to the NIEHS campus. Please note that a photo ID is required to access the NIEHS campus. The NTP is making plans to videocast the meeting through the Internet at http://www.niehs.nih.gov/​external/​video.htm.

Availability of Meeting Materials

A copy of the preliminary agenda, committee roster, and any additional information, when available, will be posted on the NTP Web site (http://ntp.niehs.nih.gov/​ select “Advisory Boards and Committees”) or may be requested in hardcopy from the NTP (see FOR FURTHER INFORMATION CONTACT above). Following the meeting, summary minutes will be prepared and made available on the NTP Web site.

Request for Comments

Public input at this meeting is invited and time is set aside for the presentation of public comments on any draft technical report. 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. Registration for oral comments will also be available on-site, although time allowed for presentation by on-site 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, if possible, to send a copy of their statement to Dr. Shane (see FOR FURTHER INFORMATION CONTACT above) by September 13, 2005, to enable review by the TRR Subcommittee and NIEHS/NTP staff 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 TRR Subcommittee and NIEHS/NTP staff and to supplement the record. Written comments received in response to this notice will be posted on the NTP website. Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document.

Background Information on the NTP Board of Scientific Counselors

The NTP 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 its centers. Specifically, the NTP 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. The TRR Subcommittee is at standing subcommittee of the NTP Board. NTP Board members are selected from recognized authorities knowledgeable in fields, such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology and neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and minority and female representation on the NTP Board. Its members are invited to serve overlapping terms of up to four years. NTP Board meetings are held annually or biannually.

Dated: July 28, 2005.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

Preliminary Agenda

National Toxicology Program (NTP) Board of Scientific Counselors, Technical Reports Review Subcommittee Meeting, September 27-28, 2005, Rodbell Auditorium, Rall Building, National Institute of Environmental Health Sciences, 111 TW Alexander Drive, Research Triangle Park, NC.

NTP Technical Reports (TR) Scheduled for Review

• TR 524: α- and β-Hydroxy acids (glycolic and salicylic acids, respectively) in combination with solar light (CAS Nos. 79-14-1 and 69-72-7, respectively)

○ Used in many cosmetic formulations for the treatment of skin conditions including acne, ichthyosis, actnic keratosis, warts and psoriasis

• TR 537: Dibromoacetic acid) (CAS No. 631-64-1)

○ Water disinfection by-product

• GMM 11: Dichloroacetic acid (CAS No. 79-43-6)

○ Water disinfection by-product

• GMM 5: Bromodichloromethane (CAS No 75-27-4)

○ Water disinfection by-product

• GMM 6: Sodium bromate (CAS No. 7789-38-0)

○ Water disinfection by-product

• TR 534: Divinylbenzene (high purity) (CAS No. 1321-74-0)

○ Used in production of vinyl polymers

• TR 538: Methyl-isobutyl ketone (CAS No. 108-10-1)

○ Denaturant in rubbing alcohol, solvent for paints, used in industrial extraction processes, dry cleaning preparations and in synthetic reactions

• TR 523: Diisopropylcarbodiimide (CAS No. 693-13-0)

○ Reagent for peptide synthesis, chemical intermediate and used in preparation of coatings

• GMM 10: Diisopropylcarbodiimide (CAS No. 693-13-0)

○ Reagent for peptide synthesis, chemical intermediate and used in preparation of coatings

• TR 535 4-Methylmidazole (822-36-6)

○ Used in manufacture of pharmaceuticals, dyes, agricultural chemicals and rubber

Other Topics

• Background Seizures Observed in F344/N Rats