Seventh Circuit Backs FDA, Sets Low Burden of Proof in Food Adulteration Cases

The chub is a fish that many Americans have never heard of. To many others, however, it is a food; to the fishermen of Lake Michigan, a livelihood; and to the Vita Food Company, purveyors of smoked chub, a business. In the past few years, the level of DDT and dieldrin in Lake Michigan has risen, and so too have residues of the two chemicals in the tissues of the fish caught in the lake's waters.

The presence of DDT and dieldrin in the smoked chub poses several problems for the government agencies charged with protecting public health. First, scientists are unsure how much pesticide humans can ingest safely. The Food and Drug Administration, in the absence of hard data on which to base a tolerance, has established "interim guidelines," also called "action-level guidelines," of 5 parts per million (ppm) of DDT and .3 ppm of dieldrin. In addition, the fishermen and fish processors, unlike farmers, did not cause the pesticide contamination of the product they are selling. To make the fishermen pay the penalty for pollution caused by farmers seems inequitable. It would be still more inequitable, however, to decree that Americans must eat contaminated fish because an inequity would otherwise be worked on the innocent fishermen.

In 1970, the Food and Drug Administration initiated actions against several sellers of Great Lakes fish, raw and processed, that exceeded the interim guideline set for DDT. On August 28 of this year, the Seventh Circuit upheld the government's contention that the pesticide residues present in the fish because of incidental environmental pollution were "food additives" within the meaning of the Federal Food, Drug, and Cosmetic Act.¹ The decision overturned a lower court's ruling that the government must prove that the final food product is itself a potential hazard to health. The Seventh Circuit agreed with the Food and Drug Administration that processed food is adulterated as a matter of law if it contains any food additive not generally recognized to be safe, regardless of whether the finished food product is harmful or harmless.

The FFDCA, as amended in 1958, contains a variety of provisions designed to keep noxious substances from entering the food supply. Different sections of the Act establish varying burdens of proof, depending on the severity of the danger to health involved. Under § 402(a) (1)² of the statute, food is defined as "adulterated" if it [4 ELR 10179] contains any substance which may render it injurious to health. If the substance is not "added," however, its presence is permitted so long as it is in quantities which do not "ordinarily" make the food harmful. Section 402(a) (3)³ extends the definition of adulteration to food which "consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food." In both cases, the focus is on whether the finished food product, rather than the contaminant, is unsafe. In practice, courts have demanded that the government show actual harm to specific individuals. As a result, it has been possible for two courts to reach different conclusions as to the safety of identical merchandise.

Section 402(a) (2) (C)⁴ on the other hand, provides that food is "adulterated" if it contains any "food additive" which is unsafe. "Unsafe" is defined as "not generally recognized … as having been adequately shown through scientific procedures … to be safe."⁵ This standard is clearly much easier for the government to meet, as the hazardousness of the additive itself, rather than that of the finished food product, is as issue.

The statute defines a food additive broadly: "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 …."⁶ However, the law specifically exempts pesticide chemicals on raw agricultural products (fish are considered raw agricultural products) from the class of food additives.⁷ Under the 1954 Amendments to the FFDCA, pesticide chemicals are presumed to be unsafe for use on raw agricultural commodities unless within tolerances issued by the government.⁸ Any affected party can request the EPA Administrator to issue a tolerance, and may attempt to show that it should be set at a particular level. Once a tolerance has been set for the raw agricultural product, processed food made from the raw product may also contain the pesticide, provided that the residue "has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food is not greater than the tolerance prescribed for the raw agricultural commodity."⁹

The Great Lakes fishing and fish processing industry never applied to EPA for tolerances governing DDT and dieldrin, although the high levels of pesticide pollution in the Lakes, especially Lake Michigan, were common knowledge. In United States v. Goodman,¹⁰ decided in 1973, the Seventh Circuit ruled that the EPA Administrator could bring enforcement proceedings against raw Lake Michigan chubs without having first promulgated regulations limiting pesticide levels in fish. The industry was apparently hesitant to request a tolerance, as the scarcity of scientific data on the human health effects of DDT made it difficult to prove that any particular level was appropriate. It waited instead for the government to act.

In the Vita Foods case, the government proceeded on the following reasoning: unless exempted, the pesticides must be considered additives, as they are used with the knowledge that they may find their way into fish; the statute explicitly exempts only pesticides on raw agricultural products from the definition of additives; pesticide chemicals are allowed in processed food only by derivation from the tolerance issued for the raw product; without such a derivative tolerance, the pesticides in the processed food are additives; and therefore, the government need only prove that the chemicals are not generally recognized as safe, without reference to whether the individual jars of fish are edible. The district court rejected this position. Rather than adduce new evidence to show that the processed fish itself was harmful to health, the Food and Drug Administration chose to appeal on the burden of proof issue. All three judges of the Seventh Circuit panel agreed with FDA's reading of the statute. While the court observed that the FDA could have enforced a zero tolerance for the pesticides, it was bound, apparently on estoppel principles, to the interim guidelines set forth in a 1969 press release. It rejected Vita's claim that there is no significant difference between the 5 parts per million tolerated by the FDA and the eight parts per million found in Vita's processed fish. This argument, said the court, should properly be addressed to the EPA Administrator in urging him to set the formal tolerance accordingly.

The FDA is currently preparing interim guidelines, of the type approved in Vita Foods, limiting the levels of mercury in swordfish, aflatoxin in peanuts, lead in evaporated milk, and several other harmful substances. The decision gave judicial approval to what has been the FDA's position for some five years, and as such brings no immediate change in enforcement of the FFDCA. In overturning the lower court's ruling in Vita, however, it eliminates one legal obstruction to the law's full implementation, and establishes precedent for other circuits. The aldrin/dieldrin hearings have brought home the unpleasant reality that massive pesticide use contaminates not merely individual crops, but the soil, air, water, and all living things as well. In the effort to protect the public health against pesticides dispersed throughout the environment, the Food and Drug Administration has won a significant victory.

1. United States v. Ewig, Bros., 4 ELR 20763 (Aug. 28, 1974). The Court of Appeals considered together appeals from two conflicting district court cases. In Ewig Bros., the District Court for the Eastern District of Wisconsin held that the chemicals in one processed fish were food additives. The District Court for the Northern District of Illinois, Eastern Division, ruled in Vita Foods that the pesticides were not food additives. The Seventh Circuit decision affirmed Ewig and reversed Vita.

2. 21 U.S.C. § 342(a) (1).

3. 21 U.S.C. § 342(a) (3).

4. 21 U.S.C. § 342(a) (2) (c).

5. 21 U.S.C. § 348.

6. 21 U.S.C. § 321(s).

7. 21 U.S.C. § 321(s) (1).

8. 21 U.S.C. §§ 342(a) (2) (B), 346.

9. 21 U.S.C. § 342(a) (2) (C).

10. 3 ELR 20817 (7th Cir. 1973).