Last week EPA issued its first regulatory determinations for new chemical substances under the reformed Toxic Substances Control Act (TSCA). The amended section 5 of TSCA requires EPA to make an affirmative safety finding with respect to new chemical substances.  EPA determined that four chemical substances are not likely to present an unreasonable risk.  The four chemicals are fatty alcohols-dimers, trimers, polymers; depolymerized waste plastics; propyl silsesquioxanes, hydrogen-terminated; and organic modified propyl silsesquioxane.

EPA’s initial determinations mark a new era of transparency for EPA’s safety determinations for new chemical substances. Under the old TSCA, EPA was not required to make a safety determination, and chemical substances that were not determined to present an unreasonable risk could be manufactured or imported within 90 days of submission of a premanufacture notice (PMN).  Under the revised TSCA, EPA’s affirmative decision as to whether a new chemical will present an unreasonable risk or not will be publicly available.

The initial determinations shed light on the areas EPA is considering and the standards it is relying on to make its safety determinations for new chemicals. Each of the four safety determinations identifies eight areas of consideration: (1) conditions of use; (2) environmental fate, (3) persistence, (4) bioaccumulation, (5) human health hazard, (6) environmental hazard, (7) potential exposures and (8) potentially exposed or susceptible subpopulations.  Footnotes set out the standards EPA relies on to assess each area.  For example,  the level of persistence is determined based on the half-life of a chemical substance in water or equivalent or analogous data (less than 2 months is considered limited persistence, 2 months to 6 months is considered persistent and greater than 6 months is considered very persistent).

With the limited sample size, it is not clear how EPA will balance the different areas of consideration, but the hazard to human health and the environment likely will be weighed heavily. For example, two of the chemical substances, depolymerized waste plastics and organic modified propyl silsesquioxane, were identified to be very persistent.  Despite them being persistent, EPA determined that there was not a likelihood that the chemical substances presented an unreasonable risk, because they have  low potential for bioaccumulation, low human health hazard and low environmental hazard.  Companies should review the areas of consideration and the standards identified in these initial determinations when preparing PMNs in the future.

Interested parties should also participate in EPA’s on-going regulatory efforts to establish the process for risk assessment and chemical prioritization for existing chemical substances under section 6. On July 26, 2016, EPA announced in the Federal Register, that it would establish two dockets and hold public meetings for the chemical evaluation process on August 9, 2016, and the process of prioritizing chemicals for risk evaluation on August 10, 2016.  EPA’s rulemaking with respect to chemical prioritization and risk assessment likely will impact its risk determinations with respect to new chemical substances.


Mr. Sanders leads Baker & McKenzie’s U.S. environmental litigation practice. He represents both domestic and non-U.S. corporations before federal, state and administrative courts in environmental, class action, mass tort and product liability litigation, government enforcement, permitting and criminal proceedings. He counsels companies with respect to compliance with CERCLA, RCRA, CWA, TSCA, OSHA and state environmental and product regulations. Mr. Sanders advises multi-national and domestic corporations on environmental, health and safety statutory requirements and legal risks with respect to products sold or marketed in the United States, including responding to product liability claims and recalls. He also advises clients on environmental, health & safety risks and liabilities in transactions.