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By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).

The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA.  EPA describes alternative test methods and strategies as different descriptors that have a common goal.  The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard.  The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints. 

Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM).  The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”

A much more detailed summary and analysis of this important issue is available in our memorandum.