Since 1970, it has become increasingly clear that it would be impossible to ban all food substances that have been found to induce cancer in man or animals, and indeed that it would be impossible to survive on a diet that did not include such substances. Among the food substances that have been found to be animal carcinogens are the following: Essential nutrients, including vitamin Raw agricultural commodities, including Substances added through food process- Inherent constituents of raw agricul- Naturally occurring environmental These substances and others, as well as the scientific support for findings of carcinogenicity, are discussed in the Joint Appendix at pages 591-631. Under FDA's comprehensive definition of "food additive" under the FD&C Act, virtually all of these substances could be considered food additives subject to the Delaney Clause. 38/ As just one example, any food that either is washed with water or has water added to it -- which encompasses virtually all food -- could be considered to contain as food additives the numerous carcinogens identified in drinking water (see J.A. 606-610). Thus, in the absence of a de minimis policy under the Delaney Clause, virtually the entire food supply would be jeopardized. None of this could have been foreseen when the Delaney Clause was enacted in 1958. 39/ Congress plainly did not intend the absurd result of jeopardizing the nation's food supply through the combination of scientific advances and an unyielding, unscientific interpretation of the Delaney Clause, and the statute should not be interpreted to require that result: "All laws should receive a sensible contruc- 38/ Under FDA's definition, the term "food additive" encompasses an almost unlimited number of food substances, including substances that are intentionally incorporated into food, substances used to process food, substances that migrate into food from containers or the environment, and raw agricultural commodities that are processed in any way. See 21 C.F.R. S 170.3. 39/ See R. Scheuplein, et al., supra, at 564 ("Congress did not foresee the widespread presence of trace amounts of carcinogens in food, the possibility that common food substances might themselves be shown to contain carcinogens or the occurrence in humans of carcinogens as essential nutrients or an outcome of normal metabolism."); see also J.A. 545-555. as These principles apply with special force to the FD&C Act, which "is to be treated as a working instrument of government and not merely as a collection of English words." United States v. Dotterweich, 320 U.S. 277, 280 (1943). 2. 40/ The De Minimis Policy Is Consistent With and the Logical Outgrowth of FDA's Historical Regulation of Carcinogens In view of the developments described above, FDA has been required to adopt an organic interpretation of the general safety clauses and the Delaney Clause in order to pursue the statutory purpose of protecting the public without imposing wholly disproportionate and unintended regulatory burdens on society. A review of the history of regulatory toxicology as applied by FDA to carcinogens demonstrates that the agency consistently has relied on the same standard under both the general safety provisions and the Delaney Clause. As scientific techniques have advanced, FDA has become more sophisicated in its application of the safety clauses and the Delaney Clause to carcinogens. The de minimis policy represents the agency's most recent step in this gradual process, which has its roots in administrative practice even before the Delaney Clause was enacted. From 1958 to the present, FDA has never ultimately banned a substance under the Delaney Clause where, as here, the risk has been shown to be de 40/ See also, e.g., American Tobacco Co. v. Patterson, 456 U.S. 63, 71 (1982) ("Statutes should be interpreted to avoid unreasonable results whenever possible."); Consumers Union v. Heimann, 589 F.2d 531, 534 (D.C. Cir. 1978) (court should "look beyond the plain meaning of a statute" where there is "a significant change in circumstances since enactment, or when a literal reading leads to an unreasonable result"); In re Grand Jury Subpoena of Persico, 522 F.2d 41, 64-65 (2d Cir. 1975). minimis. 41/ a. Pre-1958 decisions FDA's standard rule for determining the safe level of a noncarcinogenic substance has been the same from at least the 1940s to the present. That rule provides: "A substance proposed for use in foods should See also 21 C.F.R. § 170.22 (1986). While appropriate for noncarcinogens, this 100-to-1 no-observed-effect-level (NOEL) approach has never been used by the agency for animal or human carcinogens, either before or after adoption of the Delaney Clause. 42/ Instead, under the general safety standard of section 402(a)(1), the agency prior to 1958 refused to permit animal carcinogens in food because of the risk to humans. For example, in 1950 the agency stated that the artificial sweeteners dulcin and P-4000 41/ Even assuming that former FDA Commissioners might have reached contrary conclusions on the adoption of the de minimis policy, current FDA Commissioner Young had the responsibility to re-evaluate the situation and form his own conclusions, which are owed deference by the Court. See, e.g., Motor Vehicle Manufacturers Ass'n v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29, 42 (1983). Petitioners' argument that FDA was overruled by its parent, the Department of Health and Human Services, is rebutted in CTFA's brief in the provisional listing case, No. 86-5150, at pages 37-40. 42/ CTFA has calculated that the no observed effect level for the carcinogenic risk of the two color additives in this case, based on the Panel's 90th percentile exposure estimates, would be 420 million to one for D&C Orange No. 17 and 65,000 to one for D&C Red No. 19. are "poisonous substances which have no place in food." 15 Fed. Reg. 321 (1950). This finding was based in large part on tests showing that the substances produced liver tumors in 43/ rats. Similarly, in 1954 the agency stated that any food containing coumarin would be regarded as adulterated under the general safety clause, again because of a finding of animal carcinogenicity. 19 Fed. Reg. 1239 (1954); Delaney Clause Study at 51, Appropriations Hearings at 214. Thus, prior to enactment of the Delaney Clause, the agency interpreted the general safety provisions of the FD&C Act to establish precisely the ban on carcinogenic risks to humans as the Delaney Clause itself later embodied. In view of the comparatively crude toxicological tools then available, and the potency of the carcinogens known at the time, it is not surprising that no attempt was made at the time to quantify the risk to humans presented by animal carcinogens. Rather, the assumption, based on then-current science, was that animal carcinogens were unsafe for humans. b. 1958-1973 decisions Following enactment of the Delaney Clause in 1958, the agency continued to interpret the general safety clauses to bar the use of animal carcinogens just as was required by the Delaney Clause. As in the earlier era, the state of toxicology did not permit assessment of human risks. 43/ See Study of the Delaney Clause and Other Anticancer Clauses 51 (hereinafter cited as Delaney Clause Study], reprinted in Agriculture-Environmental, and Consumer Protection Appropriations for 1975: Hearings Before a Subcomm. of the House Comm. on Appropriations, 93d Cong., 2d Sess., Part 8, at 214 (1974) (hereinafter cited as Appropriations Hearings). This study includes a comprehensive review of the regulation of carcinogens in the food supply. |