Comments on EPA's Alternative Test Method Strategic Plan

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Under the amended Toxic Substances and Control Act, Congress directed EPA to develop a Strategic Plan “to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures” (see section 4(h)(2)(A)).  The first version of the Strategic Plan is due within two years of the bill’s enactment (by June 22,2018).  The strategic planning process is to be iterative, with reports to Congress every five years, and is intended to serve as a roadmap for the integration of health-protective uses of alternative test methods (ATMs) in Agency decision-making. 

In December 2017, EPA held a public meeting to obtain input on draft considerations for its strategic planning process.  The draft considerations outlined a timeline and process for developing a strategic plan that needs to be consistent with the statutory requirements for using complementary testing methods that are reliable, relevant, and are of equal or better scientific quality to existing methods to protect the health of vulnerable populations (including pregnant women, children, and workers) and ecosystems.

In our comments to the Agency on designing a Strategic Plan that is both protective and responsive to the requirements outlined in the amended TSCA , NRDC recommended that the first iteration of the plan focus on building confidence in ATMs to provide health protective information, increasing the knowledge base necessary to increase the relevance of new testing methods (knowledge development), and identifying the types of problems that can be solved with emerging tools (problem formulation). 

We also recommended that:

  1. The process of integrating ATMs into decision-making be incremental, iterative, and transparent.
  2. The timeline and associated objectives outlined in the Strategic Plan must represent realistic expectations and should extend beyond a five-year time frame.
  3. Recommended timelines and uses of ATMs should be consistent with their capacity to accurately and adequately assess hazard, risk, or exposure potential – particularly for vulnerable populations.
  4. ATMs and strategies must be proven to be reliable, relevant, and able to provide information of equivalent or better scientific reliability and quality prior to being included on a list of acceptable tools to aide decision making.
  5. Emerging tools involving the use of vertebrate animals (e.g., zebrafish, transgenic whole animals, and genetically diverse mammalian systems) should be included in the Strategic Plan.

The multistage process for the development and implementation of ATMs under the amended TSCA gives the Agency a powerful opportunity to build upon the potential of new and emerging methods to provide added health protections to human and ecological populations.  This process must be deliberate and thoughtful, however, and should not exceed or outpace the ability of ATMs to provide equivalent or better information for purposes of assessing chemicals. Testing methods that leverage and combine the strengths of various tools – including mammalian, non-mammalian, in vitro, in silico, epidemiologic, and other methods – can increase the speed, accuracy, relevance, and reliability of testing large numbers of chemicals for adverse outcomes, ensuring the health of populations for generations to come.  The overzealous deployment of tests that may underestimate or completely miss toxicity or exposure (high false negative rate), however, would result in risk evaluations and determinations that are not consistent with the requirements of the revised TSCA, and will fail to protect public health and the environment.