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Public Citizen v. Young

ELR Citation: 18 ELR 20173
Nos. Nos. 86-1548, -5150, 831 F.2d 1108/(D.C. Cir., 10/23/1987)

The court invalidates the Food and Drug Administration's (FDA's) approval of two color additives under the Federal Food, Drug, and Cosmetic Act (FFDCA) that the FDA concluded have trivial cancer risks, since regulation of color additives under the FFDCA is not subject to a de minimis exception. Assuming that the risk assessments are accurate, the court rules that the de minimis doctrine is not applicable to the regulation of carcinogenic color additives under FFDCA §706(b)(5)(B) (the color additive Delaney Clause). The court first notes that while application of the de minimis doctrine would not necessarily spare agency resources since the risk assessment process involves substantial time and resources, the doctrine would prevent the imposition of a pointless burden on the food dye industry and its customers. The risks associated with the dyes in question may be characterized as acceptable, and application of the de minimis doctrine would therefore be appropriate if the statute allowed it. Moreover, failure to employ the de minimis doctrine may actually subvert the legislative goal of promoting human safety by encouraging manufacturers to produce completely noncarcinogenic, but possibly toxic, color additives. However, despite the desirability of applying the de minimis doctrine here, the court rules that the language of the statute clearly requires rejection of color additives that tend to induce cancer. That the statute gives the agency some discretion concerning the regulation of noncarcinogenic products and no discretion concerning carcinogens indicates that Congress did not intend to permit a de minimis exception for carcinogens. The overall legislative history supports this conclusion, despite a Senate discussion to the effect that the Delaney Clause should be applied in light of the "rule of reason." Congress' rigidity concerning carcinogens is explainable by the nation's alarm about the risks of cancer at the time of the statute's enactment, and the possibility that Congress deemed color additives to be of little social value. No case has ever applied the de minimis doctrine to limit the Delaney Clause in its core application. Analogy to a similar Delaney Clause applicable to food additives is inapposite. Although a rigid interpretation of the food additive clause would wreak havoc with the American diet by banning many common foods that are nevertheless known carcinogens, the food additive clause need not be interpreted as strictly as the color additive clause. The definition of "food additive" in the statute includes an exemption for substances "generally recognized as safe." Also, Congress may not have regarded the social cost of stringent regulation of food additives to be as trivial as that of color additives. And if the plain meaning of the color additive clause proved too strict, Congress would respond by changing it. The court also rules that the FDA's construction of the Delaney Clause to allow the agency to use quantitative risk assessment to determine whether a substance "induces cancer" is contrary to clear congressional intent.

The court next holds that the Secretary's extension of provisional listing for two dyes that had been commercially established color additives prior to the enactment of the statute did not violate the Secretary's statutory mandate. The Secretary found that the extensions were consistent with public health, that evaluations of the dyes were proceeding in good faith, and that they would be completed as soon as reasonably practicable. As to a third dye, the court holds that because the Secretary met these statutory conditions, no argument of "unreasonable delay" could be made. The court also holds that a challenge to the provisional listing of the third dye is not ripe until the agency makes a final determination whether the dye directly causes tumors in animals, because such a determination would preclude permanent listing and thereby, arguably, render provisional listing impermissible.

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

Counsel for Respondents
Douglas N. Letter, Appellant Litigation Counsel
Department of Justice
10th & Constitution Ave. NW, Washington DC 20530
(202) 633-2000

Thomas Scarlett, Richard E. Geyer
Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857
(301) 443-1544

Before: RUTH B. GINSBURG and WILLIAMS, Circuit Judges, and HAROLD H. GREENE,[*] District Judge.