290 F.3d 377 (D.C. Cir. 2002), 00-1394, General Elec. Co. v. E.P.A.

Docket Nº:00-1394.
Citation:290 F.3d 377
Case Date:May 17, 2002
Court:United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit

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290 F.3d 377 (D.C. Cir. 2002)




No. 00-1394.

United States Court of Appeals, District of Columbia Circuit

May 17, 2002

Argued Dec. 3, 2001.

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On Petition for Review of an Order of the Environmental Protection Agency.

Angus Macbeth argued the cause for petitioner. With him on the briefs were Patricia K. Casano, Christopher L. Bell and Timothy K. Webster.

H. Michael Semler, Attorney, U.S. Department of Justice, argued the cause and filed the briefs for respondent.

Before: GINSBURG, Chief Judge, and RANDOLPH and TATEL, Circuit Judges.

Opinion for the Court filed by Chief Judge GINSBURG.

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

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is a legislative rule such that the court does have jurisdiction 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 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.[*]

That is where the Guidance Document comes in. It "provide[s] an overview of risk assessment techniques, and guidance for reviewing risk assessment documents submitted under the final PCB disposal rule." Guidance Document at 10. Of particular relevance to this case, in the Guidance Document the EPA also explains that an applicant seeking to use an alternative method under § 761.61(c) may take either of two approaches to risk assessment. Id. at 21, 42. First, the applicant may calculate cancer and non-cancer risks separately. Id. To calculate cancer risks the applicant would have to use a cancer potency factor recognized by the EPA. Such cancer potency factors range, depending upon the exposure pathway and upon the composition of the PCB mixture, from .04 to 2.0 (mg/kg/day)-1. Id., Table 9, at 64. To calculate the non-cancer risks a different type of toxicity value—a reference dose, for example—would have to be used, and certain specified non-cancer risks would have to be taken into account. Id. at 21, 42.

The second approach endorsed in the Guidance Document is to use a "total toxicity factor" of 4.0 (mg/kg/day)-1 to account for cancer and non-cancer risks together. Id. In its brief the EPA explains that this approach "provides the applicant an opportunity to reduce the time and expense associated with the risk assessment" because the Agency is willing "to accept this 'default' toxicity value of 4.0 (mg/kg/day)

1 [ ] without requiring further justification."

II. Analysis

GE's primary argument is that the Guidance Document is a legislative rule and therefore should have been promulgated only after public notice and an opportunity for comment. In the alternative it contends that the Guidance Document is

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not supported by substantial evidence. Before considering these arguments about the merits, however, we must determine whether the case is ripe for review and whether we have jurisdiction to hear it.

A. Ripeness

To determine whether a controversy is ripe for judicial review the court must evaluate "the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Abbott Labs. v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 1515, 18 L.Ed.2d 681 (1967). "In determining the fitness of an issue for judicial review we look to see whether the issue is purely legal, whether consideration of the issue would benefit from a more concrete setting, and whether the agency's action is sufficiently final." Clean Air Implementation Project v. EPA, 150 F.3d 1200, 1204 (D.C. Cir. 1998).

Here the EPA argues that "GE's claims satisfy neither aspect of the 'fitness'/'hardship' standard under Abbott Laboratories." Regarding fitness, the EPA argues that (1) GE is asking the court to consider factual questions, such as how the EPA would evaluate an application that did not use either of the approaches to toxicity set out in the Guidance Document; (2) the Guidance Document is not final agency action because the Agency "is currently conducting an assessment of the non-cancer risks of PCBs" and will be modifying the Document "as needed"; (3) "the Court's consideration would be aided by further application of the agency's position to particular facts"; and (4) judicial review is premature because "adjudication may well prove unnecessary."

We think the issues presented are fully fit for review. First, whether the Guidance Document is a legislative rule is largely a legal, not a factual...

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