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General Electric Co. v. Environmental Protection Agency

Court of Appeals for the D.C. Circuit
290 F.3d 377, 351 U.S. App. D.C. 291 (2002)
ELI5:

Rule of Law:

An agency document that uses mandatory language and is applied in a binding manner, imposing obligations on regulated parties and constraining the agency's own discretion, qualifies as a legislative rule that must be promulgated through notice-and-comment rulemaking.


Facts:

  • The Toxic Substances Control Act (TSCA) regulates the cleanup of polychlorinated biphenyls (PCBs).
  • EPA regulations under TSCA allow parties to apply for permission to use alternative cleanup methods if they can demonstrate the method poses no 'unreasonable risk of injury to health or the environment.'
  • The EPA issued a 'PCB Risk Assessment Review Guidance Document' to provide instructions on how applicants should conduct this risk assessment.
  • The Guidance Document mandates that applicants must use one of two prescribed methods to assess risk.
  • The first method requires separate calculations for cancer and non-cancer risks, and states that applicants 'must, at a minimum' account for a specific list of non-cancer health risks.
  • The second method allows an applicant to use a pre-set 'total toxicity factor' of 4.0 (mg/kg/day)-1, which the document implies the EPA will accept without further justification.

Procedural Posture:

  • The Environmental Protection Agency (EPA) issued the 'PCB Risk Assessment Review Guidance Document' without a notice-and-comment period.
  • General Electric Co. (GE) filed a petition for judicial review of the Guidance Document directly with the United States Court of Appeals for the District of Columbia Circuit.
  • GE, as the petitioner, argued that the document was a legislative rule that was invalidly promulgated.
  • The EPA, as the respondent, argued that the court lacked jurisdiction because the document was not a 'rule' and that the case was not ripe for review.

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Issue:

Is the Environmental Protection Agency's 'PCB Risk Assessment Review Guidance Document' a legislative rule that must be promulgated through the notice-and-comment procedures required by the Administrative Procedure Act and the Toxic Substances Control Act?


Opinions:

Majority - Chief Judge Ginsburg

Yes, the Guidance Document is a legislative rule that must be promulgated through notice-and-comment procedures. An agency action is a legislative rule if it has the 'force of law,' which is determined by whether it imposes rights and obligations or genuinely leaves the agency free to exercise discretion. Here, the Guidance Document is binding on its face because it uses mandatory language, such as 'must,' which commands applicants to use one of two prescribed approaches and details specific endpoints that 'must' be addressed. This language makes clear to applicants that the agency will not consider other approaches. Furthermore, the document binds the EPA itself by creating a 'safe harbor'—it strongly implies the agency will automatically accept applications using the 4.0 total toxicity factor, thus constraining the agency's discretion. Because the document has a binding effect on both applicants and the agency, it is a legislative rule, and its promulgation without notice and comment violated the APA and TSCA.



Analysis:

This decision significantly clarifies the distinction between non-binding agency guidance and binding legislative rules. It establishes that an agency cannot evade the procedural requirements of notice-and-comment rulemaking simply by labeling a document as 'guidance.' The court's focus on the practical, binding effect of the document's mandatory language and its creation of a 'safe harbor' provides a clear standard for regulated parties to challenge such agency actions. This precedent strengthens the role of public participation under the APA by ensuring that agencies cannot impose substantive, binding norms without first soliciting public input.

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