The De Minimis Interpretation of the Delaney Clause: Legal and Policy Rationale

1. Vidal Sassoon, Inc. v. Bristol-Myers Company, 661 F.2d 272, 273 (2d Cir. 1981).

2. H. Rep. No. 2284, 85th Cong., 2d Sess. at 4–5 (1958). See 21 C.F.R. § 170.3(i)(1986).

3. See, e.g., FDA, “Listing of D & C Red. No. 8 and D & C Red No. 9 for Use in Ingested Drug and Cosmetic Lip Products and Externally Applied Drugs and Comsetics,” 51 Fed. Reg. 43877 (Dec. 5, 1986); FDA, “Listing of D & C Orange No. 17 for Use in Externally Applied Drugs and Cosmetics” 51 Fed. Reg. 28331 (Aug. 7, 1986); FDA, “Listing of D & C Red No. 19 For Use in Externally Applied Drugs and Cosmetics,” 51 Fed. REg. 28346 (Aug. 7, 1986). FDA has also relied on the de minimis principle in its decision not to revoke the food additive regulation governing residues of methylene chloride in decaffeinated coffee. 50 Fed. Reg. 51551, 51553–58 (Dec. 18, 1985).

4. See, e.g., 51 Fed. Reg. at 43893–96.

5. FDA's application of the de minimis principle to D & C Orange No. 17 and D & C Red No. 19 has been challenged in a Petition for Review filed by Public Citizen in the U.S. Court of Appeals for the District of Columbia Circuit. Public Citizen, et al. v. Young, et al., No. 86–1548 (D.C. Cir., filed October 9, 1986). Oral argument will be heard in March 1987.

6. See, e.g., 51 Fed. Reg. 28331, 28343 (col. 1) (Aug. 7, 1986). FDA's reliance on quantitative risk assessment is not without its detractors but enjoys broad support in the scientific community, and similar reliance is made by other regulatory agencies, especially the Environmental Protection Agency. See 51 Fed. Reg. 33992 (Sept. 24, 1986). The conservative nature of quantitative risk assessment—its tendency to overstate true risk—is well known and thoroughly documented. See NAS/NRC, Risk Assessment in the Federal Government—Managing the Process (National Academy Press, Washington, D.C. 1983); Rodricks & Taylor, “Application of Risk Assessment to Food Safety Decision Making,” 3 Regulatory Toxicology and Pharmacology 275 (1983).

7. 51 Fed. Reg. at 28343.

8. See, e.g., Letter from M.B. Folsom, Secretary, Department of Health, Education and Welfare, to Honorable Oren Harris, Chairman, House Committee on Interstate and Foreign Commerce (July 23, 1957), in “Food Additives,” Hearings Before a Subcommittee of the House Committee on Interstate and Foreign Commerce, 85th Cong., 1st & 2nd Sess. at 38–39 (1957).

9. H. Rep. No. 1761, 86th Cong. 2d Sess. 11–12 (1960).

10. Id.

11. 106 Cong. Rec. 15380-81 (July 1, 1960).

12. See, e.g., 51 Fed. Reg. at 28343 (and references cited therein).

13. Referring to the need for application of the de minimis principle to be consistent with the “legislative design,” the Court in Alabama Power said: In this respect, the principle is a cousin of the doctrine that, notwithstanding the “plain meaning” of a statute, a court must look beyond the words to the purpose of the act where its literal terms lead to “absurd or futile results.” United States v. American Trucking Ass'ns, 310 U.S. 534, 543, 60 S. Ct. 1059, 1063, 84 L. Ed. 1345 (1939); District of Columbia v. Orleans, 132 U.S. App. D.C. 139, 141, 406 F.2d 957, 959 (1968). 636 F.2d at 360, n.89.