New NASEM Report Calls for Robust Implementation of New Approach Methods

The National Academies of Sciences, Engineering, and Medicine (NASEM) released a report on building confidence in new approach methods, which acknowledges the increasing scientific support for a transition from animal tests to robust, human relevant, non-animal methods for evaluating the toxicity of chemicals due to concerns over animal welfare, cost, timeliness, and human translatability. The report notes that reliance on animal tests can limit the ability to assess the human health hazards and potential risk of the many chemicals to which we may be exposed. Instead, non-animal methods that can protect humans and predict human health outcomes are being developed, evaluated, and applied.

The NASEM report states that results from toxicity tests on animals should not be solely used to determine the acceptance of data from new methods. Instead, for the assessment of human health effects, new approaches should be assessed for their intrinsic performance characteristics and their “value with respect to protecting human health effects”, including a demonstration that the new method adequately reflects human biology. This recommendation aligns with those outlined in a publication co-authored last year by PETA Science Consortium International, the US Environmental Protection Agency (EPA), the US Consumer Product Safety Commission, and other partners.

The report also recommends a continued reliance on the principles outlined in the 2007 NASEM report, Toxicity Testing in the 21st Century: A Vision and A Strategy, which promotes a paradigm shift away from the use of whole animal testing to a system primarily based on the use of in vitro and in silico methods to protect human health.

The NASEM report, however, missed the opportunity to recommend the assessment of traditional animal tests using the same framework that will be used to build confidence in new approaches. In light of the legal requirement under the EPA’s Toxic Substances Control Act (TSCA) to ensure new approaches are ‘as good as or better’ than the traditional tests they are destined to replace, this was a potentially significant oversight. The report also diverges from TSCA requirements in its recommendation to expand the definition of “new approaches.” TSCA directs the EPA to reduce and replace vertebrate animal use in chemical testing and promote the development of methods that do not require new vertebrate animal tests. Therefore, the definition of ‘new approaches’ should remain as those methods that do not use vertebrate animals.