Title: EPAs methodology to inform TSCA pre-manufacturing notification decision-making: a critical analysis based on chemicals regulated by consent order
Authors: Robert Borotkanics; Paul Locke
Addresses: Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe, St. Baltimore, Maryland, 21205, USA; Faculty of Medicine and Health Sciences, Macquarie University, Australia ' Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe, St. Baltimore, Maryland, 21205, USA
Abstract: 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.
Keywords: Toxic Substances Control Act; TSCA New Chemicals program; alternative test methods; tiered testing strategy; EPA; US Environmental Protection Agency; pre-manufacturing notification decision making; chemicals regulation; consent order; regulatory toxicology; safe chemicals; chemical safety; USA; United States.
International Journal of Risk Assessment and Management, 2017 Vol.20 No.1/2/3, pp.226 - 239
Received: 18 Jan 2016
Accepted: 19 Jan 2016
Published online: 01 Mar 2017 *