1. 52 Fed. Reg. 28331, 28346 (August 7, 1986) (Orange No. 17 & Red No. 19); 52 Fed. Reg. 21302 (June 5, 1987) (Red Nos. 8 & 9); 50 Fed. Reg. 51551 (December 18, 1987) (methylene chloride). The agency may use the de minimis doctrine if it approves FD&C Red No. 3 and D&C Red Nos. 33 & 36, all of which it has concluded are animal carcinogens or probable animal carcinogens.
2.
2. On October 23, 1987, the U.S. Court of Appeals for the District of Columbia Circuit, relying on the plain language of the statute and its legislative history, held that the FDA's “de minimis interpretation of the Delaney Clause of the Color Additive Amendments is contrary to law.” Public Citizen v. Young, supra, 831 F.2d at 1123. On April 18, 1988, the Supreme Court denied the petition for review filed by the Cosmetic, Toiletry and Fragrance Association.
3.
3. 21 U.S.C. § 348(c)(3)(A).
4.
4. 21 U.S.C. §§ 376(b)(5)(B), 360b(d)(1)(H).
5.
5. For example, see Caminetti v. United States, 242 U.S. 470, 485 (1917).
6.
6. The House Committee on Interstate and Foreign Commerce unanimously adopted the Delaney Clause after it had concluded its hearings on the Food Additives Amendment. 104 Cong. Rec. 17414 (1958).
7.
7. Color Additive Hearings on H.R. 7624 Before the House Committee on Interstate and Foreign Commerce, 86th Cong., 2d Sess. 392 (1960) (“1960 Color Additive Hearings”).
14. In Monsanto v. Kennedy, 613 F.2d 947, 955 (1979), the D.C. Circuit judicially modified the definition of “food additive” to exclude “negligible” amounts of indirect additives (such as food packaging) when the FDA finds that the additive “present[s] no public health and safety concerns.” This interpretation of the definition of “food additive” undercuts any argument that the Delaney Clause should be modified in light of modern measuring techniques.
15.
15. As the Court held in Public Citizen v. Young, supra, 833 F.2d at 1117, the legislative history is “perhaps as strong as it is likely to get.”
16.
16. The 1 in 1 million cutoff is discussed at length in numerous Federal Register notices. For example, see 42 Fed. Reg. 10412 (February 22, 1977) and 50 Fed. Reg. 45530 (October 31, 1985).
17.
17. See note 1, supra.
18.
18. Memorandum from Dr. Arthur Hull Hayes, Jr., Commissioner of FDA, to Secretary of HHS, p.3 (March 16, 1983). This memorandum and the memoranda referred to in footnotes 18–20, infra, are in the court record in Public Citizen v. HHS, supra, and Public Citizen v. Young, supra.
19.
19. Memorandum from Dr. Mark Novitch, Acting Commissioner, FDA, to Secretary, HHS (March 30, 1984).
20.
20. Memorandum from Dr. Frank E. Young, Commissioner, FDA, to Secretary, HHS (December 5, 1984).
21.
21. Memorandum to the Commissioner, FDA, from Sanford A. Miller, Director, Center for Food Safety and Applied Nutrition (November 23, 1984).
22.
22. Merrill, R.A., Speech, “Fda's ‘Erasure’ of the Delaney Clause: A Study in Statutory Interpretation” (June 23, 1986) reprinted in 50 A. Food & Drug Officials Q. Bull. 199 (1986); Cooper, R.M., “Stretching Delaney Till It Breaks,” Regulation 11 (Nov./Dec. 1985).
23.
23. The House Committee on Government Operations has issued two reports chastising the FDA for its failure to abide by the command of the Delaney Clause. “HHS' Failure to Enforce the Food, Drug and Cosmetic Act: the Case of Cancer-Causing Color Additives,” H.R. Rep. No. 99–151, 99th Cong., 1st Sess. (1985); “FDA Continues to Permit the Illegal Marketing of Carcinogenic Additives,” 100th Cong., 1st Sess. (1987).
24.
24. The same is true for animal drugs, the other category of substances covered by a Delaney Clause.
25.
25. 42 Fed. Reg. 19,996 (1977).
26.
26. Memorandum to the Commissioner, FDA, at 12, supra note 21.
27.
27. 50 Fed. Reg. 51551, 51555 (December 1, 1985).
28.
28. See pp. XX, supra.
29.
29. Dr. Carney's testimony is contained at 1960 Color Additive Hearings at 265–95.
30.
30. See 44 Fed. Reg. 54852 (September 21, 1984).
31.
31. Herbst, Arthur L., et al. (1971). Adenocarcinoma of the vagina; association of maternal stilbestrol therapy with tumor appearance in young women. N. Engl. J. Med.284, 878.
