U.S. v. Anderson Seafoods, Inc., 78-1962

• Decision Date: 24 July 1980
• Docket Number: No. 78-1962,78-1962
• Citation: 622 F.2d 157
• Parties: UNITED STATES of America, Plaintiff, v. ANDERSON SEAFOODS, INC. et al., Defendants. ANDERSON SEAFOODS, INC. et al., Plaintiffs-Appellants, v. Patricia Roberts HARRIS, Secretary of Health and Human Services et al., Defendants-Appellees.
• Court: U.S. Court of Appeals — Fifth Circuit

Page 157

622 F.2d 157

UNITED STATES of America, Plaintiff, v. ANDERSON SEAFOODS, INC. et al., Defendants.

ANDERSON SEAFOODS, INC. et al., Plaintiffs-Appellants, v. Patricia Roberts HARRIS, Secretary of Health and Human

Services et al., Defendants-Appellees.

No. 78-1962.

United States Court of Appeals, Fifth Circuit.

July 24, 1980.

Eric M. Blumberg, Stephen D. Terman, Food and Drug Adm., Rockville, Md., Robert Wiggers, John J. Powers, III, App. Section, Antitrust Div., Dept. of Justice, Washington, D. C., for Patricia Roberts Harris.

Robert T. Lasky, Susan A. Elliott, Washington, D. C., for plaintiffs-appellants.

Appeal from the United States District Court for the Northern District of Florida.

Before WISDOM, POLITZ and SAM D. JOHNSON, Circuit Judges.

WISDOM, Circuit Judge:

This appeal poses the question whether mercury in the tissues of swordfish is an "added substance" within the meaning of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a)(1) (1975) (FDA), and is, therefore, subject to regulation under the relaxed standard appropriate to added substances. Only part of that mercury has been added by man.

In April 1977, the United States sought an injunction against Anderson Seafoods, Inc., and its president, Charles F. Anderson, to prevent them from selling swordfish containing more than 0.5 parts per million (ppm) of mercury, which it considered adulterated under the meaning of § 342(a)(1) of the FDA. Anderson responded in May 1977 by seeking a declaratory judgment that fish containing 2.0 ppm of mercury or less are not adulterated. Anderson also sought an injunction against the Food and Drug Administration commensurate with the declaratory judgment. Anderson's suit was certified as a class action, and these suits were consolidated for trial.

The district court denied the injunction that the government sought. In Anderson's suit, the court also denied an injunction, but issued a declaratory judgment that swordfish containing more than 1.0 ppm mercury is adulterated under § 342(a)(1). In doing so, the court determined that mercury is an "added substance" under the Act and rejected Anderson's contention that a level of 2.0 ppm is acceptable. Anderson appealed from the judgment in the class action. The government appealed from the judgment in its enforcement action and cross-appealed in the class action. The government then withdrew its appeal and cross-appeal. This appeal now consists of Anderson's challenge to the way the district court parsed the statute and to the sufficiency of the evidence. We affirm.

I.

Section 342(a)(1) of the Act provides:

A food shall be deemed to be adulterated (a)(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.

21 U.S.C. § 342(a)(1).

The Act does not define "added substance". Whether a substance is added or not is important because of the evidentiary showing that the Food and Drug Administration must make to succeed in an enforcement action. If a substance is deemed "added", then the Agency need show only that it "may render (the food) injurious to health" in order to regulate consumption of the food containing the substance. The "may render" standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer. See United States v. Lexington Mill & Elevator Co., 1914, 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658; Berger v. United States, 8 Cir. 1952, 200 F.2d 818, 821. If, however, a substance is considered "not-added", the Agency must go further, and show that the substance would "ordinarily render (the food) injurious to health", 21 U.S.C. § 342(a)(1), before it can regulate its consumption.

In the trial of this case three theories about the meaning of the term "added" emerged. The Food and Drug Administration sponsored the first theory. It argues that an "added substance" is one that is not "inherent". According to FDA regulations:

(c) A "naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An "added poisonous or deleterious substance" is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. §§ 109.3(c), (d) (1977). Under this theory, all the mercury in swordfish is an added substance, because it results not from the creature's bodily processes but from mercury in the environment, whether natural or introduced by man.

Anderson put forward a second theory. A substance, under this theory, is not an added substance unless it is proved to be present as a result of the direct agency of man. Further, only that amount of a substance the lineage of which can be so traced is "added". If some mercury in swordfish occurs naturally, and some is the result of man-made pollution, only that percentage of the mercury in fish proved to result directly from pollution is an added substance.

The district court adopted a third theory. Under the court's theory, if a de minimis amount of the mercury in swordfish is shown to result from industrial pollution, then all of the metal in the fish is treated as an added substance and may be regulated under the statute's "may render injurious" standard. The legislative history and case law, though sparse, persuade us that this is the proper reading of the statute.

The distinction between added and not-added substances comes from the "adulterated food" provisions of the original Food, Drug, and Cosmetic Act of 1906, ch. 3915, 34 Stat. 768. The legislative history shows that "added" meant attributable to acts of man, and "not-added" meant attributable to events of nature. See H.R.Rep.No. 2118, 59th Cong., 1st Sess. 6, 7, 11 (1906) (quoted in United States v. Coca Cola, 1915, 241 U.S. 265, 282-83, 36 S.Ct. 573, 578-79, 60 L.Ed. 995 ("deleterious substances added by man"); 40 Cong.Rec. 1133 (Jan. 16, 1906) ("human action") (remarks by Sen. Heyburn). That the distinction was carried through to the present Act is shown by its legislative history. S.Rep.No. 493, 73rd Cong., 2d Sess. 3 (1934) ("added by man or put there by nature . . . introduced by artifice or (occurring) naturally").

The Supreme Court drew the same distinction in United States v. Coca Cola, 1915, 241 U.S. 265, 36 S.Ct. 573, 60 L.Ed. 995. Construing the "added . . . ingredient" provisions of the 1906 Act, the Court said:

Congress, we think, referred to ingredients artificially introduced; these are described as 'added.' The addition might be made to a natural food product or to a compound . . . we think that it was the intention of Congress that the artificial introduction of ingredients of a poisonous or deleterious character which might render the article injurious to health should cause the prohibition of the statute to attach.

241 U.S. at 284, 36 S.Ct. at 579.

The Food and Drug Administration argues that there need not be any connection between man's acts and the presence of a contaminant for it to be considered an added substance. The Agency points to the rule it recently promulgated interpreting § 342(a)(1), quoted above, which defines an added substance as one which is not "an inherent natural constituent of the food", but is instead the "result of an environmental, agricultural, industrial, or other contamination". 21 C.F.R. §§ 109.3(c), (d) (1977). Under the rule, mercury in swordfish tissue deriving from the mercury naturally dissolved in sea water would be an added substance, as would any substance not produced by or essential for the life processes of the food organism. In light of the legislative history and the Coca Cola case, however, we agree with the district court that the term "added" as used in § 342(a)(1) means artificially introduced, or attributable in some degree to the acts of man. 447 F.Supp. 1151, 1155.

The Food and Drug Administration finds further support for its view in several cases in which the courts refer to not-added substances under the Act as "inherent". In Continental Chemiste Corp. v. Ruckelshaus, 9 Cir. 1972, 461 F.2d 331, 337, and Certified Color Ind. Committee v. Secretary of HEW, 2 Cir. 1956, 236 F.2d 866, 869, however, the courts were not defining the statutory term "added substance". That they referred to not-added substances as being inherent does not mean that all non-inherent substances are added. These cases are consistent with the proposition that some non-inherent substances, present in a food organism but unconnected to man's acts, are not-added substances under the Act. A final case, United States v. An Article of Food Consisting of Cartons of Swordfish, S.D.N.Y., 1975, 395 F.Supp. 1184, reads the...