US EPA Releases Its Draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods

March 19, 2018

The Lautenberg Chemical Safety for the 21^st Century Act (LCSA) amendments to the Toxic Substances Control Act (TSCA) require US EPA to finalize a plan by June 22, 2018 to reduce and eventually eliminate animal testing under TSCA. Following this mandate, US EPA released its “Draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods” (US EPA, 2018) on March 7, 2018. The Draft Plan incorporates input from a public meeting held on November 2, 2017.

The Strategic Plan’s framework relies heavily on “new approach methodologies” (or NAMs) (e.g., in silico, in chemico, and in vitro testing approaches), outlining three principal objectives in that regard: “(1) identifying, developing and integrating NAMs for TSCA decisions; (2) building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and (3) implementing the reliable and relevant NAMs for TSCA decisions” (US EPA, 2018 [emphasis in original]). The Strategic Plan lays out an incremental process, to take place over several years, of adopting and integrating appropriate and fit-for-purpose NAMs for making TSCA decisions (i.e., identifying candidate chemicals for prioritization, completing the prioritization process, and evaluating risks).

NAMs will include methods of evaluating chemical hazards (both human health and environmental), exposure, and environmental fate. The Draft Plan includes a working list of NAMs currently used by US EPA (e.g., computer programs such as Analog Identification Methodology [AIM] and Estimation Programs Interface [EPI Suite^TM]) as well as NAMs that have been accepted by the Organisation for Economic Co-operation and Development (OECD) (e.g., Quantitative Structure-Activity Relationships [QSARs], in vitro skin assays). NAMs that help predict chemical functional uses (and thus possible new exposure pathways), in addition to physiologically based toxicokinetic (PBTK) NAMs that help relate in vitro assay concentrations to in vivo exposure concentrations, are also discussed in the Draft Plan. The Draft Plan also describes weight-of-evidence (WoE) approaches for integrating NAMs for regulatory decision-making (e.g., adverse outcome pathways [AOPs]).

In addition, the Draft Plan establishes criteria for assessing the scientific relevance and reliability of, as well as confidence in, the NAMs. Because many NAMs involve high-throughput test systems and computational data, US EPA acknowledges the importance of educating, training, and collaborating with stakeholders, as well as incorporating quality assurance processes, in its new efforts to apply NAMs in TSCA decision-making. US EPA notes that the rapidly evolving nature of NAMs requires that implementing NAMs for regulatory decision-making be an iterative process that should consider the best available science at any given time.

US EPA will take public comments on the Draft Plan until April 26, 2018 and is holding a public meeting on April 10, 2018 to obtain input on the Draft Plan from interested parties.

Please contact us if you have any questions about how the Strategic Plan may affect your business or if you need help developing and employing alternative test methodologies to evaluate your chemicals under the new TSCA requirements.

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