US: Ninth Circuit Court of Appeals Issues Decision on Risk Evaluation Rule Challenge

On November 14, 2019 the 9th Circuit Court of Appeals issued a decision on multiple challenges to the 2017 Risk Evaluation Rule promulgated by US EPA in accordance with the 2016 updates of the Toxic Substances Control Act (TSCA). In its decision, the 9th Circuit found that the petitioners challenging the rule were not able to prove that their case was ripe in order to bring a complaint with regards to their argument that TSCA required EPA to analyze collective risks and all circumstances of a chemical’s use. However, the court did find that EPA should consider legacy activities when determining risks from a chemical’s “conditions of use” under TSCA. As a result of this decision, EPA must now modify the rule in accordance with this decision or attempt to appeal to the US Supreme Court.

The Risk Evaluation Rule, promulgated in 2017, codified the 2016 TSCA updates’s mandate requiring EPA to perform a full-scale re-evaluation of the risks of chemicals in commerce in the United States. The TSCA updates required EPA to determine which chemicals should be given high priority status in order to be reviewed first versus low priority chemicals. The updates also required EPA to first perform risk evaluations on ten specific chemicals. In the Risk Evaluation Rule, EPA developed a method for assessing risks in accordance with the updates. The Risk Evaluation Rule states, “As part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of uses [sic] within the scope of the risk evaluation, either in a single decision document or in multiple decision documents.” Then the rule provides three categories of uses that are excluded from the definition of conditions of use: (1) “circumstances associated with activities that do not reflect ongoing or prospective manufacturing, processing, or distribution,” which the Agency calls “legacy uses”; (2) “disposals from such uses,” which the Agency calls “associated disposal”; and (3) “disposals that have already occurred,” which the Agency calls “legacy disposal.”

In this decision, the 9th Circuit sided with EPA on the majority of its arguments, but found that legacy activities should not be excluded from the definition of conditions of use and should be analyzed during risk evaluations.


Ninth Circuit Court of Appeals Issues Decision on Risk Evaluation Rule Challenge, Safer Chemicals, Health Families v. US EPA, (9th Cir. Nov. 14, 2019).