[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, iccvam@niehs.nih.gov.
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
