On 22nd June 2016, President Obama signed the Frank R Lautenburg Chemical Safety for the 21st Century Act which brings about major reform to the 1976 Toxic Substances Control Act (TSCA). Many of the responsibilities for controlling this process lies in the hands of the US Environmental Protection Agency (EPA) and the deadlines for implementing the changes are quite strict. This has led to the EPA issuing a roadmap of major activities on which they will focus during the first year of implementation.
The roadmap includes a series of immediate actions, framework actions, early mandatory actions and later mandatory actions which scope out important aspects such as reviewing and meeting deadlines for pre-manufacture notices (PMNs), significant new use notices (SNUNs) and confidential business information claims, defining rules for chemical risk assessment, devising a TSCA inventory of existing chemicals and publishing an alternative testing methods strategy.
The alternative testing strategy is an important point as the new Act strongly focuses on a reduction of testing in vertebrate animals. It defines;
Section 4 (3): STATEMENT OF NEED – ‘explain the basis for any decision that requires the use of vertebrate animals’.
Section 4 (9h1): REDUCTION OF TESTING ON VERTEBRATES – ‘The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures’
Section 4 (9h2) IMPLEMENTATION OF ALTERNATIVE TESTING METHODS –‘ To promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals.’
Within the first year implementation plan, the Act specifies a deadline of mid-June 2018 for publishing an Alternative Testing Methods Strategy by the EPA. This strategy is expected to include approaches such as computational methods, high-throughput screening methods, testing of categories of chemical substances, tiered testing methods, in vitro studies, systems biology, new or revised methods identified by validation bodies such as the Interagency Coordinating Committee on the Validation of Alternative Methods and the Organization for Economic Co-operation and Development as well as recommendations by industry consortia. This strategy is likely to follow many of the methods currently employed within the European REACH regulations.