Public Citizen v. Foreman

Citation631 F.2d 969
Decision Date31 July 1980
Docket NumberNo. 79-1690,79-1690
PartiesPUBLIC CITIZEN, Claudia Silverman and Sidney M. Wolfe, Appellants, v. Carol Tucker FOREMAN, Assistant Secretary, Department of Agriculture et al.
CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)

Appeal from the United States District Court for the District of Columbia (D.C. Civil Action No. 78-1064).

William B. Schultz, Washington, D. C., with whom Alan B. Morrison, Washington, D. C., was on the brief, for appellants.

Bruce E. Fein, Atty., U. S. Dept. of Justice, Washington, D. C., with whom Barry Grossman, Atty., U. S. Dept. of Justice, Raymond W. Fullerton, Director, Litigation Div., U. S. Dept. of Agriculture, Washington, D. C., and Richard M. Cooper, Chief Counsel, Food and Drug Administration, Rockville, Md., were on the brief, for appellees Foreman et al.

Hershel Shanks and James Bruce Davis, Washington, D. C., were on the brief for appellee National Independent Meat Packers Association.

Alan H. Kaplan, Richard S. Morey and Glenn E. Davis, Washington, D. C., entered appearances for intervenor American Meat Institute.

Before TAMM, ROBB and MIKVA, Circuit Judges.

Opinion for the court filed by Circuit Judge TAMM.

TAMM, Circuit Judge:

In this action Public Citizen, a nonprofit public interest group, and two of its members, seek to bring the nitrites used in bacon within the regulatory ambit of the Food and Drug Administration (FDA). They want a declaratory judgment that nitrites are an "unsafe" food additive within the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392 (1976). Such a declaration would require the FDA to ban the use of nitrites in bacon and other cured meats. United States District Judge Gerhard Gesell denied relief, finding that a prior sanction for the use of nitrites by the United States Department of Agriculture (USDA) exempts nitrites from the provisions of the Food, Drug, and Cosmetic Act. We agree and affirm.

I. STATUTORY BACKGROUND

Both the United States Department of Agriculture and the Food and Drug Administration are charged with ensuring the purity of our food. The USDA enforces the Federal Meat Inspection Act, as amended 21 U.S.C. §§ 601-624 (1976), 1 which prohibits the production or sale of "adulterated" meat. Id. § 610(c). Meat is "adulterated" "if it bears or contains any poisonous or deleterious substance which may render it injurious to health." Id. § 601(m)(1).

The Food and Drug Administration 2 has a different mandate: it regulates food additives. At the beginning of this century, Congress passed the Food and Drugs Act of 1906, ch. 3915, 34 Stat. 768, to regulate poisonous substances added to food. See H.R.Rep. No. 1338, 92d Cong., 2d Sess. 4 (1972). It amended this legislative grant in 1938 to give the FDA authority over all food additives. See Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040. Under the amended statute, the FDA regulates

any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food . . . ) . . . .

21 U.S.C. § 321(s) (1976). Like the USDA, the FDA also enforces a prohibition on the production or sale of any "adulterated" food, which is any food containing an "unsafe" food additive as defined in 21 U.S.C. § 348(a). See id. § 342(a)(2)(C). 3 Until 1958, the burden of proving that a food additive was "unsafe" fell on the government. 4 The Food Additives Amendment of 1958, Pub.L. No. 85-929, 72 Stat. 1784, shifted this burden by creating a presumption that a food additive is "unsafe" until proven otherwise, unless the additive had been exempted from this rule by statute or regulation. 21 U.S.C. § 348(a) (1976).

Under one such statutory exception, the provisions of this regulatory scheme do not apply to "any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter . . . or the Meat Inspection Act (21 U.S.C. §§ 601-624 (1976))." Id. § 321(s)(4). This "grandfather" exemption, called the "prior sanction" provision, relieves the Food and Drug Administration of responsibility for examining food additives already recognized as safe by the federal government. 5

II. FACTUAL BACKGROUND

Nitrites are common chemicals that have been used to cure meats for centuries. 6 The nitrites perform two functions. First, they protect the color and flavor of the cured meat. Without this color fixation, the cured meat would turn a dull grey when cooked. Second, the nitrites inhibit the growth of Clostridium botulinum spores and thus protect against botulism contamination.

Historically, concern over the safety of nitrites usually centered on its toxicity. Nitrites, unlike nitrates, a related chemical compound, are toxic, and consumption of a substantial amount of the compound can be fatal. This concern with the safe use of nitrites led the Department of Agriculture to impose a maximum level of 200 parts per million (ppm) of nitrites in cured meat in 1925. See Kerr, Marsh, Schroeder & Boyer, The Use of Sodium Nitrite in the Curing of Meat, reprinted in Regulation of Food Additives and Medicated Animal Feeds: Hearings Before a Subcomm. of the House Comm. on Government Operations, 92d Cong., 1st Sess. 195-202 (1971).

During the past decade, however, the focus has shifted to nitrites' possible carcinogenic effects on humans. Test results indicate that nitrites in meat combine with secondary and tertiary amines and amides during cooking to form nitrosamines. These substances have caused cancer in laboratory animals, and researchers believe they might have the same effect on humans.

This use of nitrites in bacon causes special concern about nitrosamines. The temperature at which bacon is fried makes it especially susceptible to the formation of nitrosamines. N-nitrosopyrrolidine is the nitrosamine most commonly found in bacon after frying. 43 Fed.Reg. 20992 (1978), reprinted in Joint Appendix (J.A.) at 196.

These questions about nitrites and nitrosamines prompted the USDA to form an Expert Panel on Nitrites, Nitrates, and Nitrosamines to examine the use of nitrites in cured meat products. See id. While the Panel was conducting its investigation, the USDA issued a proposed rule on the use of nitrites in bacon. 40 Fed.Reg. 52614 (1975). 7 As proposed, the rule would prohibit the use of nitrates in bacon 8 and limit the level of nitrites to 125 ppm, with the use of ascorbate or erythorbate being required to block the formation of any nitrosamines. The agency continued to recognize the need for nitrites in bacon to prevent the growth of botulism spores and noted: "To date, no substitute for nitrite has been discovered. No compound or treatment has been found that will produce the characteristic product and that possesses nitrite's antibotulinal properties." Id. at 52615. The Department asked for public comment on the rule.

After a three year study, the Expert Panel reached a conclusion similar to the proposed rule: 120 ppm of sodium nitrite should be permitted in bacon in conjunction with 550 ppm of sodium ascorbate or sodium erythorbate to block nitrosamine formation. Such a combination, the Panel believed, would minimize the risk of botulism while posing little danger of nitrosamine formation.

The final rule adopted by the USDA followed the Expert Panel's recommendations on the use of nitrites and ascorbate or erythorbate in bacon. See 9 C.F.R. § 318.7(b) (1980). 9 The Department believed adoption of the rule would

result in the elimination of nitrosamines at confirmable levels, the reduction in the lowest level at which nitrosamines may be confirmed by laboratory testing, and to the reduction of nitrite to the lowest amount possible while still maintaining the bacon characteristics which are known to satisfy the consumer.

43 Fed.Reg. 20994 (1978), reprinted in J.A. at 198.

III. THIS LITIGATION

Plaintiffs participated in the USDA rulemaking. The agency rejected their argument that the new rule could not be promulgated without prior FDA clearance. 10 Having thus failed at the administrative level, they filed suit in the United States District Court for the District of Columbia seeking a declaratory judgment that the sodium nitrite used in bacon is an "unsafe" food additive under sections 348(a) and 610(c) of title 21, 21 U.S.C. §§ 348(a), 610(c), thus making bacon containing this compound "adulterated" under sections 342(a)(2)(C) and 601(m)(1), 11 id. §§ 342(a)(2)(C), 601(m) (1). The requested declaration would have invalidated the USDA regulation authorizing the use of nitrites in bacon, see 9 C.F.R. § 318.7(b) (1980), and would have required a ban on the sale of cured products containing nitrites until such time as the FDA declares the use of nitrites "safe" under section 348(a)(2), 21 U.S.C. § 348(a)(2).

Plaintiffs acknowledged that the USDA long had permitted the use of nitrites in curing meat. They contended, however, that any prior sanction existed only for nitrites' color fixing qualities. They argued that the present regulation permitting use of nitrites as a preservative is a change in purpose that nullifies this prior sanction. In response, the Government asserted that the prior sanction under section 321(s)(4) of title 21, 21 U.S.C. § 321(s)(4) (1976), existed both for nitrites' color fixing and their preservative qualities.

On cross motions for summary judgment, United States District Judge Gesell ruled for the Government. 12 He agreed with the joint determination of the USDA and the FDA that nitrites qualified for a prior sanction as a preservative. Public Citizen v. Foreman, 471 F.Supp. 586, 591-92 (D.D.C.1979). See Letter from Carol Tucker...

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