Public Citizen v. Young, s. 86-1548
| Decision Date | 23 October 1987 |
| Docket Number | 86-5150,Nos. 86-1548,s. 86-1548 |
| Citation | 831 F.2d 1108 |
| Parties | , 56 USLW 2269, 18 Envtl. L. Rep. 20,173 PUBLIC CITIZEN, et al., Petitioners, v. Dr. Frank YOUNG, Commissioner, Food and Drug Administration, et al., Respondents. Cosmetic, Toiletry and Fragrance Association, Intervenor. PUBLIC CITIZEN, et al., Appellants, v. DEPARTMENT OF HEALTH & HUMAN SERVICES, et al. |
| Court | U.S. Court of Appeals — District of Columbia Circuit |
Appeal from the United States District Court for the District of Columbia (Civil Action No. 85-00209).
William B. Schultz, with whom Katherine A. Meyer and Alan B. Morrison were on the brief for petitioners in No. 86-1548 and appellants in No. 86-5150.
Douglas N. Letter, Appellant Litigation Counsel, Dept. of Justice, with whom Richard K. Willard, Asst. Atty. Gen., Robert L. Cynkar, Deputy Asst. Atty. Gen., Margaret A. Cotter, Asst. Director, Jacqueline H. Eagle, Attorney, Dept. of Justice, Thomas Scarlett, Chief Counsel and Richard E. Geyer, Associate Chief Counsel, Food and Drug Admin. were on the brief for respondents in No. 86-1548.
Robert C. Seldon, Asst. U.S. Atty., with whom Joseph E. diGenova, U.S. Atty., Royce C. Lamberth, R. Craig Lawrence, Asst. U.S. Attys., Thomas Scarlett, Chief Counsel and Richard E. Geyer, Associate Chief Counsel, Food and Drug Admin. were on the brief for federal appellees in No. 86-5150.
John P. McKenna, with whom Daniel R. Thompson was on the brief for appellee, Certified Color Mfrs. Ass'n in No. 86-5150.
Peter Barton Hutt for intervenor in No. 86-1548. Robert M. Sussman, Ellen J. Flannery, and Bruce N. Kuhlik were on the brief for the Cosmetic, Toiletry and Fragrance Ass'n appellee in No. 86-5150 and intervenor in No. 86-1548.
Before RUTH B. GINSBURG and WILLIAMS, Circuit Judges, and HAROLD H. GREENE, * District Judge.
Opinion for the Court filed by Circuit Judge WILLIAMS.
The Color Additive Amendments of 1960, Pub.L. No. 86-618, 74 Stat. 397 (codified at 21 U.S.C. Sec. 376 (1982) ), part of the Food, Drug and Cosmetic Act (the "Act"), establish an elaborate system for regulation of color additives in the interests of safety. A color additive may be used only after the Food and Drug Administration ("FDA") has published a regulation listing the additive for such uses as are safe. Such listing may occur only if the color additive in question satisfies (among other things) the requirements of the applicable "Delaney Clause," Sec. 706(b)(5)(B) of the Act, 21 U.S.C. Sec. 376(b)(5)(B), one of three such clauses in the total system for regulation of color additives, food and animal food and drugs. 1 The Clause prohibits the listing of any color additive "found ... to induce cancer in man or animal."
In No. 86-1548, Public Citizen and certain individuals challenge the decision of the FDA to list two color additives, Orange No. 17 and Red No. 19, based on quantitative risk assessments indicating that the cancer risks presented by these dyes were trivial. This case thus requires us to determine whether the Delaney Clause for color additives is subject to an implicit "de minimis " exception. We conclude, with some reluctance, that the Clause lacks such an exception.
In a second case argued the same day, No. 86-5150, Public Citizen and others challenged the FDA's persistence in giving "provisional" listing to ten color additives, including several found to cause cancer in laboratory animals. The agency has since removed most of the colors at issue from
the provisional list, mooting the case as to these colors. At present, only three of the original colors, Red Nos. 3, 33 and 36, are still provisionally listed. Apart from those rendered moot, we find that these claims are either foreclosed by circuit law or unripe.
The FDA listed Orange No. 17 and Red No. 19 for use in externally applied cosmetics on August 7, 1986. See 21 C.F.R. Secs. 74.1267, 74.2267 (1987) (Orange No. 17); id. Secs. 74.1319, 74.2319 (Red No. 19). In the listing notices, it carefully explained the testing processes for both dyes and praised the processes as "current state-of-the-art toxicological testing." 51 Fed.Reg. 28,331, 28,334 (Aug. 7, 1986) (Orange No. 17); id. at 28,346, 28,349 (Red No. 19). In both notices it specifically rejected industry arguments that the Delaney Clause did not apply because the tests were inappropriate for evaluation of the dyes. 51 Fed.Reg. at 28,342; id. at 28,358-59. It thus concluded that the studies established that the substances caused cancer in the test animals. Id. at 28,334-36, 28,341 (); id. at 28,349-52, 28,357 ().
The notices then went on to describe two quantitative risk assessments of the dyes, one by the Cosmetic, Toiletry and Fragrance Association ("CTFA," an intervenor here and the industry proponent of both dyes) and one by a special scientific review panel made up of Public Health Service scientists. Such assessments seek to define the extent of health effects of exposures to particular hazards. As described by the National Research Council, they generally involve four steps: (1) hazard identification, or the determination of whether a substance is causally linked to a health effect; (2) dose-response assessment, or determination of the relation between exposure levels and health effects; (3) exposure assessment, or determination of human exposure; and (4) risk characterization, or description of the nature and magnitude of the risk. See National Research Council, Risk Assessment in the Federal Government: Managing the Process 3 (National Academy Press 1983) ("Risk Assessment"). All agree that gaps exist in the available information and that the risk estimator must use assumptions to fill those gaps. See, e.g., Report of the Color Additive Scientific Review Panel (Sept. 1985), Joint Appendix ("J.A.") in No. 86-1548, at 139-40, 167. The choice among possible assumptions is inevitably a matter of policy to some degree. See Risk Assessment at 3. 2
The assessments considered the risk to humans from the substances when used in various cosmetics--lipsticks, face powders and rouges, hair cosmetics, nail products, bathwater products, and wash-off products.
The scientific review panel found the lifetime cancer risks of the substances extremely small: for Orange No. 17, it calculated them as one in 19 billion at worst, and for Red No. 19 one in nine million at worst. The FDA explained that the panel had used conservative assumptions in deriving these figures, and it characterized the risks as "so trivial as to be effectively no risk." It concluded that the two dyes were safe. 51 Fed.Reg. at 28,344, 28,360
The FDA candidly acknowledged that its safety findings represented a departure from past agency practice: "In the past, because the data and information show that D & C Orange No. 17 is a carcinogen when ingested by laboratory animals, FDA in all likelihood would have terminated the provisional listing and denied CTFA's petition for the externally applied uses ... without any further discussion." Id. at 28,341; accord id. at 28,357 (same for Red No. 19). It also acknowledged that "[a] strictly literal application of the Delaney Clause would prohibit FDA from finding [both dyes] safe, and therefore, prohibit FDA from permanently listing [them]...." Id. at 28,341; id. at 28,356. Because the risks presented by these dyes were so small, however, the agency declared that it had "inherent authority" under the de minimis doctrine to list them for use in spite of this language. Id. at 28,341; id. at 28,358. It indicated that as a general matter any risk lower than a one-in-one-million lifetime risk would meet the requirements for a de minimis exception to the Delaney Clause. Id. at 28,344; id. at 28,362.
Assuming that the quantitative risk assessments are accurate, as we do for these purposes, it seems altogether correct to characterize these risks as trivial. For example, CTFA notes that a consumer would run a one-in-a-million lifetime risk of cancer if he or she ate one peanut with the FDA-permitted level of aflatoxins once every 250 days (liver cancer). See J.A. 529, citing FDA Bureau of Foods, Assessment of Estimated Risk Resulting From Aflatoxins in Consumer Peanut Products and Other Food Commodities (1978). Another activity posing a one-in-a-million lifetime risk is spending 1,000 minutes (less than 17 hours) every year in the city of Denver--with its high elevation and cosmic radiation levels--rather than in the District of Columbia. See J.A. 530. Most of us would not regard these as high-risk activities. Those who indulge in them can hardly be thought of as living dangerously. Indeed, they are risks taken without a second thought by persons whose economic position allows them a broad range of choice.
According to the risk assessments here, the riskier dye poses one ninth as much risk as the peanut or Colorado hypothetical; the less risky one poses only one 19,000th as much.
It may help put the one-in-a-million lifetime risk in perspective to compare it with a concedely dangerous activity, in which millions nonetheless engage, cigarette smoking. Each one-in-a-million risk amounts to less than one 200,000th the lifetime risk incurred by the average male smoker. J.A. 536, citing E. Crouch & R. Wilson, "Inter-Risk Comparisons," in J. Rodricks & R. Tardiff, eds., Assessment and Management of Chemical Risks 97, 105, 108 (1984). Thus, a person would have to be exposed to more than 2,000 chemicals bearing the one-in-a-million lifetime risk, at the rates assumed in the risk assessment, in order to reach 100th the risk involved in smoking. To reach that level of risk with chemicals equivalent...
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