On the one year anniversary of major amendments to the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) issued three new “framework” rules on how it plans to prioritize and evaluate risks from new chemicals or new uses of chemicals — offering clearer guidance to manufacturers on how chemicals will be evaluated and regulated.

Here is a brief breakdown of the three rules:

  1. The prioritization rule sets out the first step the EPA will take — determining whether a chemical should be designated as a high priority (e.g., requiring additional study) or low priority, for which immediate study is not required.
  2. The risk evaluation rule outlines how EPA will decide whether a chemical presents an “unreasonable risk of injury to health or the environment.”
  3. The final inventory notification rule requires industry businesses to electronically report chemicals that were manufactured or processed in the United States in the last ten years, so that EPA can focus regulatory decisions on those chemicals that remain active in commerce. Risk evaluations are required for all active chemicals, so inactive ones may be eliminated from the time-consuming risk evaluation process. The TSCA Inventory will be appropriately updated.

In addition to the framework rules, EPA explained the scope of review for the first ten chemicals that will undergo risk evaluation, which we described in a former post.

A clear framework outlining how EPA will evaluate chemicals increases certainty for the manufacturing and chemical processing industries as TSCA still imposes complex requirements. The rules also help define important terms, such as “best available science,” which helps companies plan for the scope of EPA’s review of a given chemical.

EPA is encouraging further company and public involvement as well. For example, when EPA publishes a notice identifying a chemical substance for prioritization, there is a 90-day public comment period that follows. A second 90-day comment period is triggered after EPA publishes its proposed designation of a chemical substance as high or low priority.

EPA Administrator Scott Pruitt commended the new rules as providing “regulatory certainty to American businesses, while protecting human health and the environment.” The American Chemical Council welcomed the framework created by the rules and praised EPA for meeting the deadline required by last year’s amendments.

Under the amended TSCA, EPA has additional obligations beyond promulgating these rules. EPA will release additional documentation relating to the first ten chemicals being evaluated by September 19, 2017, and must complete a minimum of twenty chemical evaluations by 2019. We will share updates on these and other important developments along the way.