## Facts

- TSCA § 6(e) generally prohibits manufacturing, processing, distributing, and using PCBs unless EPA determines the activity will not present an unreasonable risk to health or the environment.
- EPA’s PCB regulations allow regulated parties to seek approval for alternative sampling, cleanup, or disposal methods for certain PCB wastes if the alternative will not pose an unreasonable risk.
- The regulations did not specify how applicants must perform risk assessments to support alternative-method requests.
- EPA issued a “PCB Risk Assessment Review Guidance Document” describing risk-assessment techniques and how EPA would review risk assessments submitted under the PCB disposal rules.
- General Electric petitioned for review in the D.C. Circuit under TSCA § 19(a), asserting the guidance functioned as a binding legislative rule adopted without TSCA and APA notice-and-comment procedures.
- EPA argued the petition was not ripe and that the guidance was not a reviewable “rule” under TSCA § 19(a).

## Issues

1. Whether GE’s challenge to the guidance document was ripe for judicial review.
2. Whether the guidance document was a “rule” reviewable under TSCA § 19(a), and specifically whether it was a legislative rule rather than a nonbinding policy statement.
3. If the document was a legislative rule, whether EPA was required to use TSCA and APA notice-and-comment rulemaking and failed to do so.

## Decision

- The court held the case was ripe because the challenge presented a predominantly legal question and the guidance created practical pressure on regulated parties to conform their submissions to avoid rejection.
- The court held the guidance document was a “rule” under TSCA § 19(a) and, in substance, a legislative rule because it governed the evaluation of applications and imposed binding criteria on risk assessments.
- The court held EPA was required to provide prior notice and an opportunity for public comment under TSCA rulemaking procedures and the APA.
- The court vacated the PCB Risk Assessment Review Guidance Document.

## Legal Principles

- A document labeled “guidance” may be treated as a legislative rule if, in operation, it binds regulated parties or agency decisionmakers by setting criteria that govern approvals under existing regulations.
- Courts assess rule status by examining the document’s practical effect, including whether it imposes rights or obligations or merely advises on how the agency may exercise discretion.
- Under the Abbott Laboratories ripeness framework, pre-enforcement review is appropriate when the issue is fit for judicial decision and regulated entities face hardship from practical compulsion to comply.
- Legislative rules must be promulgated through required procedural steps, including notice-and-comment procedures mandated by the APA and applicable statute-specific rulemaking requirements.

## Conclusion

The D.C. Circuit treated EPA’s PCB risk-assessment guidance as a binding legislative rule subject to TSCA and APA notice-and-comment requirements, found the challenge ripe and within TSCA § 19(a) jurisdiction, and vacated the guidance for procedural invalidity.


Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. Cir. 2002)