Not a Lexis Advance subscriber? Try it out for free.


United States Court of Appeals for the District of Columbia Circuit

December 3, 2001, Argued ; May 17, 2002, Decided

No. 00-1394


 [*378]  On Petition for Review of an Order of the Environmental Protection Agency.

GINSBURG, Chief Judge: General Electric Co. petitions for review of the "PCB Risk Assessment Review Guidance Document" issued by the Environmental Protection Agency. The parties dispute (1) whether this case is ripe for review; (2) whether the Document is a "rule" within the meaning of § 19(a) of the Toxic Substances Control Act (TSCA), and hence whether the court has jurisdiction to review its promulgation; and (3) whether the Agency should have followed the procedures required for rulemaking in the TSCA and in the Administrative Procedure Act when it promulgated the Document. We conclude that the case is ripe for review, and that the Guidance Document  [*379]  is a legislative rule such that the court does have jurisdiction [**2]  to entertain GE's petition and the Document should not have been issued without prior notice and an opportunity for public comment.

I. Background

The TSCA prohibits the manufacture, processing, distribution, and use (other than in a "totally enclosed manner") of polychlorinated biphenyls (PCBs) unless the EPA determines that the activity will not result in an "unreasonable risk of injury to health or the environment." 15 U.S.C. § 2605(e)(2) & (3). The Guidance Document governs the application of two regulations promulgated by the EPA under the TSCA to provide respectively for the cleanup and disposal of PCB remediation waste and for the disposal of PCB bulk product waste. See 40 C.F.R. §§ 761.61 ("cleanup and disposal options for PCB remediation waste"), 761.62 (how "PCB bulk product waste shall be disposed").

Under subsection (c) of each regulation a party may apply for permission to use a method other than one of the generic methods set out in the regulations for sampling, cleaning up, or disposing of PCB remediation waste, or for sampling or disposing of PCB bulk product waste. The EPA will approve applications under these [**3]  subsections if the alternative method proposed does "not pose an unreasonable risk of injury to health or the environment." Id. The regulations do not, however, tell applicants how to conduct the necessary risk assessment. 1

Read The Full CaseNot a Lexis Advance subscriber? Try it out for free.

Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.

290 F.3d 377 *; 2002 U.S. App. LEXIS 9507 **; 351 U.S. App. D.C. 291; 32 ELR 20672; 54 ERC (BNA) 1385


Disposition: Petition for review granted. Guidance Document vacated.


binding, toxicity, non-cancer, risk assessment, legislative rule, cancer, promulgated, regulations, risks, calculate, argues, agency's action, disposal, parties, cleanup, merits, notice, judicial review, ripe for review, force of law, obligations, rulemaking, endpoints, hardship, purport

Administrative Law, Judicial Review, Reviewability, Ripeness, Civil Procedure, Justiciability, Ripeness, Tests for Ripeness, General Overview, Factual Determinations, Reviewable Agency Action, Governments, Legislation, Statute of Limitations, Time Limitations, Environmental Law, Hazardous Wastes & Toxic Substances, Toxic Substances, Jurisdiction & Venue, Agency Rulemaking, Informal Rulemaking, Negotiated Rulemaking, Agency Adjudication, Informal Agency Action