[Federal Register Volume 64, Number 179 (Thursday, September 16, 1999)]
[Notices]
[Pages 50297-50298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Meeting of the Advisory Committee on 
Alternative Toxicological Methods

    Pursuant to Section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of 
the National Toxicology Program (NTP) Advisory Committee on Alternative 
Toxicological Methods, U.S. Public Health Service. The meeting will be 
held from 8:45 a.m. to 4:00 p.m. on October 14, 1999 in the Conference 
Center, Building 101, South Campus, NIEHS, 111 Alexander Drive, 
Research Triangle Park, North Carolina, 27709. The meeting will be 
entirely open to the public from 8:45 a.m. to adjournment with 
attendance limited only by space available. Individuals who plan to 
attend and need special assistance, such as sign language 
interpretation or other reasonable accommodations should notify the 
contact person listed below in advance of the meeting.

Background

    Under authority of 42 U.S.C. 217a, Section 222 of the Public Health 
Service Act, as amended, the Department of Health and Human Services 
has established an Advisory Committee on Alternative Toxicological 
Methods. The Committee functions to provide advice on the activities 
and priorities of the National Toxicology Program (NTP) Interagency 
Center for the Evaluation of Alternative Toxicological Methods (Center) 
and the Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM), and to provide advice on ways to foster 
partnership activities and productive interactions among all 
stakeholders. The Advisory Committee is composed of knowledgeable 
representatives drawn from academia, industry, public interest 
organizations, other state and Federal agencies, and the international 
community.
    The National Toxicology Program established the Center and ICCVAM 
to fulfill specific mandates provided to the National Institute of 
Environmental Health Sciences by Public Law 103-43, Section 1301. The 
NIEHS was directed to: (1) Develop and validate toxicological testing 
methods, including alternative methods than can reduce or eliminate the 
use of animals in acute or chronic toxicity testing, (2) establish 
criteria for the validation and regulatory acceptance of alternative 
testing methods, and (3) recommend a process through which 
scientifically validated alternative methods can be accepted for 
regulatory use. Criteria and processes for validation and regulatory 
acceptance were developed in conjunction with 14 other Federal agencies 
and programs with broad input from the public. These are described in 
the document ``Validation and Regulatory Acceptance of Toxicological 
Test Methods: A Report of the Ad Hoc Interagency Coordinating Committee 
on the Validation of Alternative Methods'' NIH publication 97-3981, 
March 1997, which is available on the internet at http://ntp-
server.niehs.nih.gov /htdocs/ICCVAM/ICCVAM/htm, or by request to the 
Center at the address provided below.
    A standing Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) was subsequently established as a 
collaborative effort by NIEHS and 13 other Federal regulatory and 
research agencies and programs. The ICCVAM facilitates cross-agency 
communication and coordination on issues relating to validation, 
acceptance, and national/international harmonization of toxicological 
test methods. The

[[Page 50298]]

ICCVAM works with the Center to carry out the scientific review of 
proposed methods of multi-agency interest, and provides recommendations 
regarding their usefulness to appropriate agencies. The ICCVAM also 
provides a mechanism for interagency communication with stakeholders 
throughout the process of test method development and validation. The 
following Federal regulatory and research agencies and organizations 
are participating in this effort:

Consumer Product Safety Commission
Department of Defense
Department of Energy
Department of Health and Human Services
    Agency for Toxic Substances and Disease Registry
    Food and Drug Administration
    National Institute for Occupational Safety and Health/CDC
    National Institutes of Health
    National Cancer Institute
    National Institute of Environmental Health Sciences
    National Library of Medicine
Department of the Interior
Department of Labor
    Occupational Safety and Health Administration
Department of Transportation
    Research and Special Programs Administration
Environmental Protection Agency

    The Center was established to provide operational support for the 
ICCVAM and to assist Federal Agencies by coordinating and facilitating: 
(1) The interagency review and adoption of toxicological test methods 
of multi-agency interest and (2) the participation and communication 
with other stakeholders throughout the process of test method 
development and validation. The Center organizes, in collaboration with 
ICCVAM, independent scientific peer reviews and workshops for test 
methods of interest to Federal agencies. Peer review panels are 
convened to develop scientific consensus on the usefulness of test 
methods to generate information for specific human health and/or 
ecological risk assessment purposes. Expert workshops are convened to 
evaluate the adequacy of current test methods for assessing specific 
toxicities, to identify areas in need of improved or new methods, to 
evaluate proposed validation studies, and to evaluate the validation 
status of methods. The Center provides an opportunity for partnerships 
with other agencies and organizations to facilitate the development, 
validation, and review of alternative testing methods. The Center and 
ICCVAM seek to promote the scientific validation and regulatory 
acceptance of toxicological test methods that will enhance agencies' 
ability to assess risks and make decisions, and that will refine, 
reduce, and replace animal use whenever possible. The Center Office is 
located at NIEHS and can be contacted by telephone 919-541-3398, fax 
919-541-0947, or email, [email protected].

Tentative Agenda--National Toxicology Program Advisory Committee on 
Alternative Toxicological Methods; October 14, 1999

Building 101, Conference Center, South Campus, National Institute of 
Environmental Health Science (NIEHS), Research Triangle Park, North 
Carolina
8:45-8:55 a.m.
    Call to Order, Introductions--Dr. K. Stitzel, Chair,The Procter & 
Gamble
8:55-9:10 a.m.
    Welcome and NTP Update--Dr. G. Lucier, NIEHS
9:10-9:50 a.m.
    Updates--Dr. W. Stokes, NIEHS
     NTP Center and ICCVAM
     The Corrositex() Peer Review Panel Report (25 
minutes)
    Discussion (15 minutes)
9:50-12:15 p.m.
    Regulatory Agency Processes for Consideration of ICCVAM
    Test Method Recommendations; Acceptance Consideration of the LLNA
     EPA, EPA
     FDA, FDA
     CPSC, CPSC
     OSHA, OSHA

Potential Partnership Opportunities for Center/ICCVAM

 1:15-2:15 p.m.
    Endocrine Disruptor Testing and Screening Methods:
     Update on EPA Standardization and Validation Task Force 
Activities--Dr. T. Maciorowski, EPA
     Update on OECD Endocrine Screening and Testing Validation 
Efforts (30 minutes)--Dr. G. Lucier
     Discussion (30 minutes)
2:30-3:00 p.m.
    Overview of the Multilaboratory Evaluation of in vitro Cytotoxicity 
(MEIC) Test Program (20 Minutes)--Dr. John Harbell, Institute for In 
Vitro Sciences
     Discussion (10 minutes)
3:00-3:30 p.m.
    Potential Use of In Vitro Cytotoxicity Tests to Predict Acute Oral 
Lethality of Science,s Chemicals (20 minutes)--Dr. Rodger Curren, 
Institute for In Vitro
     Discussion (10 minutes)
3:30-4:00 p.m.
    General Discussion (30 minutes)--Dr. K. Stitzel
4:00-4:15 p.m.
    Public Comment
4:15
    Adjourn

    The Executive Secretary's Office, Environmental Toxicology Program, 
P.O. Box 12233, NIEHS, Research Triangle Park, North Carolina 27709, 
telephone (919) 541-3971, FAX (919) 541-0295, will have available an 
agenda with times and a roster of Committee members prior to the 
meeting and summary minutes subsequent to the meeting.

    Dated: September 3, 1999.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 99-24121 Filed 9-15-99; 8:45 am]
BILLING CODE 4140-01-P