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Public Citizen v. Bowen

ELR Citation: 18 ELR 20478
Nos. No. 86-1494, 833 F.2d 364/(D.C. Cir., 11/30/1987)

The court holds that the Food and Drug Administration's (FDA's) 1985 notice of proposed rulemaking in which the FDA proposed to continue to allow the use of methylene chloride, a carcinogen, for the decaffeination of coffee is not a final action subject to judicial review. In its notice, the FDA proposed to ban the use of methylene chloride for cosmetic purposes. However, because the agency's quantitative risk assessment indicates that the chemical poses little risk in the decaffeination context, the FDA proposed no change with regard to that use. The court holds that the 1985 notice of proposed rulemaking is not reviewable. Had the FDA's activity on this matter ceased with the issuance of the notice, it might arguably have been a final decision, although the district court would presumably have been the appropriate forum. Even if the FDA had done nothing since issuing the notice, its finality would not be clearcut. There is no pending request that the FDA consider the matter, the notice was of a proposed rather than final rule, and the challenged statement was merely an expression of intent not to do anything. In any event, the FDA's subsequent receipt of new studies and comments on the risks of methylene chloride, and the agency's presently ongoing review of the issue, make it clear that the 1985 notice is not a final agency action. The present activity may produce any of a variety of outcomes. That the FDA has not initiated the delisting process does not mean that there is no current activity. Moreover, the FDA's characterization of the ongoing review as pertaining to methylene chloride's cosmetic uses does not render the 1985 notice a final decision.

Counsel for Petitioners
Katherine A. Meyer, William B. Schultz, Alan B. Morrison
Public Citizen Litigation Group
2000 P St. NW, Washington DC 20036
(202) 785-3704

Counsel for Respondents
Richard K. Willard, Ass't Attorney General
Office of the Attorney General, Rm. 3143
Department of Justice, Washington DC 20530
(202) 633-3301

Before: BUCKLEY and WILLIAMS, Circuit Judges, and AUBREY E. ROBINSON JR.,[*] Chief Judge.