## Facts

- Congress amended the Toxic Substances Control Act (TSCA) in 2016 to require EPA to evaluate existing chemicals for “unreasonable risk” under their “conditions of use” and to issue a rule governing the risk-evaluation process.
- EPA issued the Risk Evaluation Rule in 2017 (40 C.F.R. §§ 702.31–702.51), adopting TSCA’s definition of “conditions of use” but stating that each evaluation’s “scope” would include the conditions of use “as determined by the Administrator” that EPA planned to consider.
- The rule also excluded three “legacy activities” from “conditions of use”: (1) legacy uses not tied to ongoing or prospective manufacture/processing/distribution, (2) associated disposals from legacy uses, and (3) legacy disposals that had already occurred.
- Environmental and public-health organizations filed consolidated petitions for review in the Ninth Circuit under TSCA and the Administrative Procedure Act (APA), challenging (a) alleged authorization of use-by-use risk determinations rather than aggregate evaluation, (b) alleged discretion to omit conditions of use from evaluation scope, and (c) the categorical exclusions for legacy activities.

## Issues

1. Whether challenges alleging EPA would evaluate risk on a use-by-use basis (and thus fail to assess aggregate risk across conditions of use) were ripe and supported Article III standing.
2. Whether statements in the rule’s preamble about EPA’s intended discretion regarding conditions of use constituted final agency action reviewable under the APA.
3. Whether the rule’s codified “scope” provisions unlawfully allowed EPA to exclude conditions of use from risk evaluations contrary to TSCA.
4. Whether excluding legacy uses, associated disposals, and legacy disposals from “conditions of use” conflicted with TSCA’s statutory definition.

## Decision

- The court dismissed the “collective evaluation” challenge for lack of Article III jurisdiction because the alleged injury depended on speculative future implementation of the rule.
- The court dismissed challenges aimed at preamble language as nonreviewable because the preamble was not final agency action.
- The court denied the challenge to the codified scope provisions, holding that the regulatory text, read with TSCA, did not grant EPA unlawful discretion to omit conditions of use.
- The court granted the petitions in part by holding unlawful the categorical exclusion of legacy uses and associated disposals because it contradicted TSCA’s plain language.
- The court denied the challenge to the exclusion of legacy disposals, upholding EPA’s decision to exclude disposals that had already occurred.

## Legal Principles

- Article III standing and ripeness require a non-speculative injury; claims premised on uncertain future agency application of a rule may be nonjusticiable.
- Under the APA, only “final agency action” is reviewable; explanatory preamble statements that do not determine rights or obligations or produce legal consequences are not final agency action.
- TSCA’s definition of “conditions of use” includes circumstances under which a chemical is “known, or reasonably foreseen” to be used or disposed of; an agency rule cannot categorically narrow that statutory definition.
- Categorical exclusion of ongoing legacy uses and disposals associated with those uses conflicts with TSCA where those circumstances remain known or reasonably foreseen.
- Exclusion of completed past disposals may be permissible where the agency reasonably treats them as not constituting current “circumstances” of disposal requiring evaluation.

## Conclusion

The Ninth Circuit largely left EPA’s TSCA risk-evaluation framework intact but required EPA to treat legacy uses and their associated disposals as “conditions of use” subject to risk evaluation, while dismissing speculative process-based challenges and upholding both the rule’s scope language and the exclusion of already-completed legacy disposals.


Safer Chemicals, Healthy Families v. U.S. Environmental Protection Agency, 943 F.3d 397 (9th Cir. 2019)