United States v. Anderson Seafoods, Inc., MCA No. 77-0215

• Citation: 447 F. Supp. 1151
• Decision Date: 08 February 1978
• Docket Number: MCA No. 77-0215,77-0218.
• Court: U.S. District Court — Northern District of Florida
• Parties: UNITED STATES of America, Plaintiff, v. ANDERSON SEAFOODS, INC., a corporation and Charles F. Anderson, an Individual, Defendants. ANDERSON SEAFOODS, INC., a corporation, and Charles F. Anderson, an Individual, Individually and on behalf of all persons similarly situated, Plaintiffs, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education & Welfare, and Donald Kennedy, Commissioner of Food and Drugs, Defendants.

447 F. Supp. 1151

UNITED STATES of America, Plaintiff, v. ANDERSON SEAFOODS, INC., a corporation and Charles F. Anderson, an Individual, Defendants.

ANDERSON SEAFOODS, INC., a corporation, and Charles F. Anderson, an Individual, Individually and on behalf of all persons similarly situated, Plaintiffs, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education & Welfare, and Donald Kennedy, Commissioner of Food and Drugs, Defendants.

MCA Nos. 77-0215, 77-0218.

United States District Court, N. D. Florida, Marianna Division.

February 8, 1978.

COPYRIGHT MATERIAL OMITTED

Nickolas P. Geeker, U. S. Atty., Pensacola, Fla., and Stephen D. Terman, Eric M. Blumberg, Food and Drug Administration, Rockville, Md., for plaintiff, the United States, in MCA No. 77-0215; and for defendants Califano, et al. in MCA No. 77-0218.

Alton O. Paulk, Panama City, Fla., and Robert T. Lasky, Joseph A. Artabane, Susan A. Elliott, Cadwalader, Wickersham & Taft, Washington, D. C., for plaintiffs, Anderson Seafoods, Inc., a corporation, and Charles F. Anderson, an individual, individually and on behalf of all persons similarly situated, in MCA No. 77-0218; and for defendants, Anderson Seafoods, Inc., et al. in MCA 77-0215.

Ronald A. Zumbrun, Raymond M. Momboisee, Pacific Legal Foundation, Sacramento, Cal., and Albert Ferri, Jr., Donald C. Simpson, Pacific Legal Foundation, Washington, D. C., for amicus curiae.

MEMORANDUM DECISION

ARNOW, Chief Judge.

In early 1977, two related claims were filed in this court. On April 26 of that year, the United States brought suit against Anderson Seafoods, Inc., and Charles F. Anderson, its president (the "Enforcement Action"), No. MCA 77-0215. The United States claims that the defendants in that case have distributed fish which are "adulterated" within the meaning of section 402(a)(1) of the Food, Drug and Cosmetic Act ("Act"), 21 U.S.C. § 342(a)(1) (1975) and that they should be enjoined from further violating the Act. On May 11, 1975, Anderson Seafoods, Inc., and Charles F. Anderson filed a complaint for declaratory and injunctive relief on behalf of themselves and all others similarly situated¹ (the "Class Action"), No. MCA 77-0218. These two cases were consolidated and tried jointly because they shared fundamental questions of fact and law. For convenience, the plaintiff in the Enforcement Action and the defendants in the Class Action will be hereafter referred to as "FDA." The plaintiffs in the Class Action and the defendants in the Enforcement Action will be hereafter referred to as "Anderson."

In the Enforcement Action, FDA contends that swordfish distributed by Anderson are adulterated under the Act because they contain more than 0.5 ppm (parts per million) of mercury. In the Class Action, Anderson seeks a declaratory judgment that fish containing more than 0.5 ppm of mercury are not adulterated, even up to the level of 2.0 ppm. Anderson also seeks an injunction against FDA commensurate with the declaratory judgment.²

The Act provides in relevant part that food is deemed adulterated:

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) (1975). FDA presents no real contention that the swordfish in question are "ordinarily" injurious to health. Instead, the agency argues that mercury is an "added substance" in swordfish and that it "may render" the fish injurious. Anderson claims that mercury is not a substance which is added to swordfish and that the fish must be judged by the "ordinarily render . . . injurious" standard.

As the Act provides no definition of "added" or "added substance," the parties have offered interpretations of those terms which, not surprisingly, are quite different. FDA claims that an added substance is one that is not inherent or essential to the organism from which the food is derived. This would mean that nature's own contaminants are added under the Act's meaning. The agency relies on language used in certain court decisions and portions of the legislative history, but places greater emphasis on a very recent regulation in which it defined the statutory term "added substance." Anderson's position is that "added" means directly and proximately attributable to the acts of man. Its argument is based primarily on legislative history and its interpretation of the intent of Congress.

The legislative history supports Anderson's position. The distinction between added and non-added substances was established in the "adulterated food" provisions of the original Food, Drug and Cosmetic Act of 1906, ch. 3915, 34 Stat. 768 (current version at 21 U.S.C. § 342(a)(1) (1975)).³ The history of that version of the Act identifies the distinction as that between acts of man and acts of nature. H.R.Rep.No.2118, 59th Cong., 1st Sess. 6, 7, 11 (1906) (quoted in United States v. Coca Cola, 241 U.S. 265, 282-83, 36 S.Ct. 573, 60 L.Ed. 995 (1915)) ("deleterious substances added by man"); 40 Cong.Rec. 1133 (Jan. 16, 1906) ("human action") (remarks by Sen. Heyburn). The same distinction was also made in the legislative history of the present version of the Act. 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 made the same distinction in construing the "added . . . ingredient" provisions of the 1906 Act. United States v. Coca Cola Co., 241 U.S. 265, 36 S.Ct. 573, 60 L.Ed. 995 (1915). Quoting legislative history including H.R.Rep. 2118, supra, the court stated:

Congress, we think, referred to ingredients artificially introduced; these it 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 (emphasis added).

FDA cites three cases subsequent to this decision which it contends support the agency interpretation. Two of the cases are circuit court decisions in which the courts use the word "inherent" when speaking of non-added substances under the Act. Continental Chemiste Corp. v. Rukelshaus, 461 F.2d 331, 337 (9th Cir. 1972); Certified Color Ind. Committee v. Secretary of HEW, 236 F.2d 866, 869 (2d Cir. 1956). The meaning of "added" was not an issue before either court, and neither court cited the Coca Cola decision. Moreover, the use of the word "inherent" is not necessarily inconsistent with the concept that non-added substances result from natural forces unaffected by the acts of man. The third case upon which FDA relies, again in which Coca Cola was not cited, stands for the proposition that any material obtained from the environment is an added substance. United States v. An Article of Food Consisting of Cartons of Swordfish, 395 F.Supp. 1184 (S.D.N.Y.1975). FDA has not urged this rather extreme position upon the court and the ruling, contrary to the legislative history of the Act and the language of the Supreme Court, is not persuasive authority.

FDA argues that its recently promulgated rule interpreting section 342(a)(1) is entitled to great deference. The rule in effect defines an added substance as one which is not "an inherent natural constituent of the food," but is rather the "result of environmental, agricultural, industrial, or other contamination."⁴ 42 Fed.Reg. 52819 (1977) (to be codified at 21 C.F.R. § 109.3(c), (d)). Even the greatest of deference, however, would not require or permit a court to accept an interpretation contrary both to the legislative history and the language of the Supreme Court. The term "added" as used in section 342(a)(1) means artificially introduced, or attributable to the acts or intervention of man.

A preponderance of the evidence shows that some unquantified portion of the mercury in swordfish is attributable to the acts of man. Though Anderson claims that no mercury in swordfish can be attributed to artificial sources, its evidence on this matter consists largely of studies showing that man's mercury pollution may have had no substantial effect on the total level of mercury in several species of fish, including swordfish. The conclusion that man has not significantly affected the total level of mercury in swordfish, even if accepted, does not prove that man by his pollution has not achieved a share of that total. The evidence presented shows that the food supply is the primary if not the sole source of mercury in swordfish and that in the estuaries and shelf areas man contributes about two-thirds of the mercury found in the upper six to eight inches of sediment, which serves as the beginning of the swordfish's food chain. It is clear from the evidence that some portion of the mercury finding its way into swordfish comes from man's contribution to the food chain. That portion is an added substance under the Act.

A food is not adulterated within the meaning of the statute unless the added substance "may render it injurious to health." The word "may" connotes a reasonable possibility. It does not mean that a food may be prohibited absent absolute certainty that no one under the most extreme circumstances could be harmed. Nothing in the Act or legislative history suggests that Congress intended to proscribe a food simply because it was physically possible for one to consume enough of it to harm oneself. The Supreme Court has taken notice that a person could be harmed by ingesting a certain level of table salt, or even water. Flemming v. Florida Citrus Exchange, 358 U.S. 153, 163, 79 S.Ct. 160, 3 L.Ed.2d 188 (1958).

There is ample...