[Federal Register Volume 69, Number 47 (Wednesday, March 10, 2004)]
[Notices]
[Pages 11448-11449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5321]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences (NIEHS); 
National Toxicology Program (NTP); Notice of the Availability of Agency 
Responses to ICCVAM Test Recommendations for the Revised Up-and-Down 
Procedure for Determining Acute Oral Toxicity and In Vitro Methods for 
Assessing Acute Systemic Toxicity

Summary

    The National Toxicology Program Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM) announces the 
availability of Federal agency responses to Interagency Coordinating 
Committee on the Validation of Alternative Methods

[[Page 11449]]

(ICCVAM) test recommendations for: (1) The revised Up-and-Down 
Procedure (UDP) for determining acute oral toxicity and (2) in vitro 
methods for assessing acute systemic toxicity. Pursuant to sections 3 
of the ICCVAM Authorization Act of 2000 [Pub. L. 106-545 (42 U.S.C. 
285l-4)], ICCVAM is required to make final ICCVAM test recommendations 
and the responses from agencies regarding such recommendations 
available to the public.

Availability of Agency Responses

    The agency responses to the ICCVAM test recommendations and other 
current information relevant to these test recommendations are 
available electronically (PDF and HTML formats) on the NICEATM/ICCVAM 
Web site at http://iccvam.niehs.nih.gov. Hard copy versions of these 
responses can be requested by contacting NICEATM at P.O. Box 12233, MD 
EC-17, Research Triangle Park, NC 27709 (mail), 919-541-2384 
(telephone), 919-541-0947 (fax), or [email protected].
    In summary, the Federal agencies agreed that the UDP had been 
adequately validated as a replacement for the conventional LD50 test 
and indicated to the extent applicable, that they will encourage the 
use of in vitro tests for determining starting doses for acute systemic 
toxicity testing.

ICCVAM Recommmendations

    NICEATM announced availability of the ICCVAM recommendations for 
the UDP on February 7, 2002 (Federal Register Vol. 67, No. 26, pages 
5842-5844). ICCVAM recommends based upon the report, The Revised Up-
and-Down Procedure: A Test Method for Determining the Acute Oral 
Toxicity of Chemicals; Results of an Independent Peer Review Evaluation 
Organized by the ICCVAM and NICEATM, NIH Publication No. 02-4501, that 
the UDP be used instead of the conventional LD50 test to determine the 
acute oral toxicity hazard of chemicals for hazard classification and 
labeling purposes.
    NICEATM announced availability of the ICCVAM recommendations for 
the in vitro methods for assessing acute systemic toxicity on September 
28, 2001 (Federal Register Vol. 66, No. 189, pages 49686-49687). ICCVAM 
recommends based upon the reports, Report of the International Workshop 
on In Vitro Methods for Assessing Acute Systemic Toxicity, NIH 
Publication No. 01-4499, and the Guidance Document on Using In Vitro 
Data to Estimate In Vivo Starting Doses for Acute Toxicity, NIH 
Publication No. 01-4500, that the in vitro methods be considered as a 
tool for estimating starting doses for animal tests of acute systemic 
toxicity.

Background Information on ICCVAM and NICEATM

    The NIEHS established the ICCVAM in 1997 to coordinate the 
interagency technical review of new, revised, and alternative test 
methods of interagency interest, and to coordinate cross-agency issues 
relating to the validation, acceptance, and national/international 
harmonization of toxicological testing methods. ICCVAM was established 
as a permanent interagency committee of the NIEHS under the NICEATM on 
December 19, 2000, by the ICCVAM Authorization Act of 2000 (Pub. L. 
106-545, available at http://iccvam.niehs.nih.gov/about/PL106545.pdf). 
The Committee is composed of representatives from fifteen Federal 
regulatory and research agencies that use or generate toxicological 
information. ICCVAM promotes the scientific validation and regulatory 
acceptance of toxicological test methods that will improve agencies' 
ability to accurately assess the safety or hazards of chemicals and 
various types of products, while refining (less pain and distress), 
reducing, and replacing animal use wherever possible. NICEATM 
administers the ICCVAM and provides scientific and operational support 
for ICCVAM and ICCVAM-related activities. NICEATM and ICCVAM work 
collaboratively to evaluate new and improved test methods applicable to 
the needs of Federal agencies. Additional information about ICCVAM and 
NICEATM can be found at the following Web site: http://iccvam.niehs.nih.gov.

    Dated: March 2, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-5321 Filed 3-9-04; 8:45 am]
BILLING CODE 4140-01-P