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U.S. regulatory agencies are charged to protect human and animal health and the environment. To do this, agencies must determine the hazards presented by substances such as pesticides, consumer products, and workplace chemicals. Testing these substances provides information about possible hazards and enables informed decisions about responsible use, storage, and disposal.
Many currently accepted test methods use laboratory animals. Alternative test methods are methods that replace animal use with non-animal test systems or lower species, reduce the number of animals required for a specific test procedure, or refine animal use to enhance animal well-being and lessen or avoid pain and distress. Collectively, the principles of replacement, reduction, or refinement of animal use for scientific research or product safety testing are referred to as the 3Rs. More recently, the term new approach methodologies has been adopted as a broadly descriptive reference to any non-animal technology, methodology, approach, or combination of these that can be used to provide information on chemical hazard and risk assessment.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to
establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid safety testing methods that protect human and animal health and the environment while reducing, refining, and replacing animal tests and ensuring human safety and product effectiveness.
The ICCVAM Authorization Act states that the purposes of ICCVAM are to:
ICCVAM is a permanent interagency committee of the NIEHS under the NTP Interagency Center for the Evaluation of Alternative Methods (NICEATM).
In 2016, the National Institute of Standards and Technology (NIST) joined ICCVAM. This was the first time ICCVAM expanded its membership to include a new member agency since its inception in 2000. NIST, which is part of the U.S. Department of Commerce, had been interacting with ICCVAM since 2015. The agency submitted an official request to join ICCVAM in January 2016, which was approved in February by NIEHS Director Linda Birnbaum, Ph.D.
NIST participation provides ICCVAM with interest and experience in the study of process controls, measurement artifacts, and interlaboratory testing. This will particularly benefit ICCVAM in the development of validation studies to assess the appropriateness of new test methods for specific purposes. Specifically, NIST has experience with cell-based and small model organism assays, which are becoming increasingly important as alternatives for traditional animal tests. NIST also brings to ICCVAM additional expertise in experimental design and statistical analysis.
The ICCVAM Authorization Act established the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Director of NIEHS, NICEATM, and ICCVAM about NICEATM and ICCVAM activities.
SACATM, which is directed by its charter to meet at least once each fiscal year, met in September 2016 and September 2017.