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Alternative Toxicity Testing Report to Congress
Citation:
Gwinn, M., J. Cowden, J. Lambert, A. Lowit, B. Wetmore, L. Scarano, S. Schappelle, R. Thomas, AND E. Burman. Alternative Toxicity Testing Report to Congress. U.S. Environmental Protection Agency, Washington, DC, 2020. https://doi.org/10.23645/epacomptox.12283958.v4
Impact/Purpose:
This is the U.S. Environmental Protection Agency’s Report to Congress on the EPA’s Alternative Toxicity Testing activities as requested in the House of Representatives Department of the Interior, Environment, and Related Agencies Appropriations Bill. The EPA is providing this report to address the following areas: 1-Progress to date on the research, development, validation, translation, and use of innovative non-animal chemical testing methods; 2-Efforts to coordinate across federal agencies; 3-Future plans on how to continue to implement the toxicity testing vision outlined in the January 2017 National Academies of Science report, ‘Using 21st Century Science to Improve Risk-Related Evaluations’ and 4-Potential barriers and limitations on the use of alternative test methods and how to address them.
Description:
The U.S. Environmental Protection Agency (EPA) develops human health and ecological assessments for large numbers of chemicals. Many of these chemicals have little to no toxicity or exposure information available, and may require toxicity testing and exposure analysis before any determinations can be made as to potential human and environmental risk. However, traditional toxicity testing methods are time-consuming and resource intensive, the use of which may lead to substantial delays in decision making (NRC 2007). The EPA considers the term “alternative scientific approaches” to be equivalent to the new term “new approach methodologies (NAMs)” that has recently been introduced. Since the early 2000s, EPA has made substantial investments to advance NAMs to address this problem, as described in EPA’s FY 2015 Report to Congress on Endocrine Disruptor Research. More recently, on September 10, 2019, EPA released a memorandum prioritizing Agency efforts to reduce animal testing by reducing its requests for, and funding of, mammalian studies by 30 percent by 2025 and eliminating all mammalian study requests and funding by 2035, with any mammalian study requested or funded by EPA after 2035 requiring Administrator approval on a case by case basis. This memorandum supports the continued research, development, validation, and translation of NAMs for risk assessment and regulatory decision-making by the Agency. Working collaboratively with federal partners and other stakeholders, EPA has advanced the research, development, validation, translation and use of alternative scientific approaches to toxicity testing across the Agency. EPA’s research program has generated toxicity information on thousands of chemicals through NAMs including in vitro and in silico, and alternative in vivo assays, moving beyond traditional in vivo based laboratory studies19. Fostering the transition from traditional studies to NAMs allows the Agency’s programs to screen and prioritize chemicals for testing and assessment in a way that conserves resources and reduces the number of laboratory animals used in the testing process. The continued advancement of these methods will require adequate resources for the robust research, development, validation, and translation of non-animal chemical testing methods and their application. This will improve the ability of the Agency and its many partners to characterize toxicity pathways, broaden coverage of chemical classes and biological processes interrogated for potential hazardous effects; inform exposure; adequately capture potential increases in toxicity due to breakdown of the chemical by metabolism in the body; address difficult to test substances, and increase and optimize the validation of efficient testing methods. These activities support key regulatory decision-making, including decisions under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), among others. The views expressed are those of the authors and do not necessarily reflect the view or policy of the US Environmental Protection Agency.
