EPAs methodology to inform TSCA pre-manufacturing notification decision-making

a critical analysis based on chemicals regulated by consent order

Robert Borotkanics, Paul Locke

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Regulatory toxicology has emerged as a necessary discipline to ensure chemicals introduced into commerce are safe. The New Chemicals program is a regulatory toxicology program required under the Toxic Substances Control Act (TSCA) where the US Environmental Protection Agency (EPA) evaluates new or significant new uses of existing chemicals. Submitters are not required to include human or environmental effects data, or undertake toxicity testing and so constrain the EPA and the basic data available to make informed decisions. We therefore sought to determine the methodology used by this program to inform regulatory, consent order decisions. We found that the EPA applied analogue analyses, or in silico methods to inform two-thirds of the decisions evaluated. No new tests were carried out. This study’s findings are important for other regulators in the potential adoption of alternative testing methods to inform regulatory decisions going forward.
Original languageEnglish
Pages (from-to)226-239
Number of pages14
JournalInternational Journal of Risk Assessment and Management
Issue number1/2/3
Publication statusPublished - 2017

Bibliographical note

Copyright the Author(s) 2017. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.


  • TSCA new chemicals program
  • alternative test methods
  • tiered testing strategy

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