2024-20970. Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2022-2023; Availability of Report

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Department of Health and Human Services

National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2022-2023.

ADDRESSES:

The report is available at https://ntp.niehs.nih.gov/​go/​2023iccvamreport.

FOR FURTHER INFORMATION CONTACT:

Dr. Nicole Kleinstreuer, Director, National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), email: [e-mail], telephone: [phone].

SUPPLEMENTARY INFORMATION:

Background: The ICCVAM Authorization Act of 2000 established ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences (NIEHS) under NICEATM. ICCVAM's mission is to facilitate development, validation, and regulatory acceptance of new and revised regulatory test methods that reduce, refine, or replace the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment.

A provision of the ICCVAM Authorization Act states that ICCVAM shall prepare “reports to be made available to the public on its progress under this Act.” The twelfth progress report describing ICCVAM activities and accomplishments from January 2022 through December 2023 is now available.

Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

• Development of an updated document on “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies,” by the ICCVAM Validation Workgroup. This document describes an approach to validation of new approach methodologies (NAMs) that reflects modern toxicity testing, placing less emphasis on replacement of in vivo tests with a single alternative method and more emphasis on integrating results from multiple in vitro and in chemico assays and in silico approaches.
• Publication of articles describing U.S. and international information needs and testing requirements for nanomaterials, ecotoxicity, and acute systemic toxicity. An ICCVAM workgroup also published an award-winning article describing federal agency application of in vitro to in vivo extrapolation.
• Curation and publication of a human skin sensitization database. ( print page 75550) ICCVAM agencies and NICEATM collaborated with the German Federal Institute of Risk Assessment to compile the largest existing database of human reference data for skin sensitization.
• Broadening applicability of defined approaches for skin sensitization. Following international acceptance of defined approaches to skin sensitization, ICCVAM agency scientists evaluated use of defined approaches to characterizing sensitization potential of agrochemical formulations and isothiazolinones, a type of preservative used in consumer products.
• Establishment of an ICCVAM workgroup to provide expertise in identifying and evaluating NAMs to predict toxicity of per- and polyfluoroalkyl substances (PFAS).
• Development, updates, and training on web tools and data resources for chemical exploration and toxicity prediction. The report describes tools provided by NIEHS, the U.S. Environmental Protection Agency, and others, as well as training that has been provided to support their use.

Availability of Report: The report is available at https://ntp.niehs.nih.gov/​go/​2023iccvamreport. Links to this report and all past ICCVAM annual and biennial reports are available at http://ntp.niehs.nih.gov/​go/​iccvam-bien.

Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 18 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine animal use.

The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l -3) establishes ICCVAM as a permanent interagency committee of NIEHS and provides the authority for ICCVAM involvement in activities relevant to the development of alternative test methods. Additional information about ICCVAM can be found at https://ntp.niehs.nih.gov/​go/​iccvam.

NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about NICEATM can be found at https://ntp.niehs.nih.gov/​go/​niceatm.

Dated: September 10, 2024.

Richard P. Woychik,

Director, National Institute of Environmental Health Sciences and National Toxicology Program, National Institutes of Health.