Article: EPAs methodology to inform TSCA pre-manufacturing notification decision-making: a critical analysis based on chemicals regulated by consent order Journal: International Journal of Risk Assessment and Management (IJRAM) 2017 Vol.20 No.1/2/3 pp.226 - 239 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. Inderscience Publishers - linking academia, business and industry through research

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.

DOI: 10.1504/IJRAM.2017.082557

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 *

Title: EPAs methodology to inform TSCA pre-manufacturing notification decision-making: a critical analysis based on chemicals regulated by consent order

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