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03/19/82 Continental Seafoods, Inc. v. Richard S. Schweiker

March 19, 1982

CONTINENTAL SEAFOODS, INC., APPELLANTS

v.

RICHARD S. SCHWEIKER, SECRETARY OF HEALTH AND HUMAN SERVICES 1982.CDC.75 DATE DECIDED: MARCH 19, 1982



Before BAZELON, Senior Circuit Judge, and TAMM and EDWARDS, Circuit Judges.

UNITED STATES COURT OF APPEALS, DISTRICT OF COLUMBIA CIRCUIT

Appeal from the United States District Court for the District of Columbia (D.C. Civil Action No. 80-00202).

APPELLATE PANEL:

Opinion for the Court filed by Senior Circuit Judge BAZELON.

DECISION OF THE COURT DELIVERED BY THE HONORABLE JUDGE BAZELON

We must decide whether the Food and Drug Administration acted lawfully in concluding that Indian shrimp contaminated with poisonous bacteria was "adulterated" within the meaning of the Food, Drug and Cosmetic Act (FDCA or Act). The district court answered yes. We affirm. I.

The Act permits the FDA to prohibit the importation of food that "appears" to be adulterated. *fn1 In defining "adulterated," the Act focuses on the origin and dangers of "poisonous or deleterious substance(s)" in the food. *fn2 When such substances are "added" to the food, the food is adulterated if the substance "may render it injurious to health." *fn3 When, on the other hand, the substance is not added, the food is considered adulterated only if the substance would "ordinarily render it injurious to health." *fn4

Beginning in late 1978, the FDA observed that a significant proportion of shrimp arriving from India contained salmonella. Without proper cooking and storage, food containing that bacteria can cause salmonellosis, a communicable disease that produces a number of serious bodily impairments and sometimes results in death. *fn5 After officials of the Indian government acknowledged that insanitary processing facilities were responsible for the high rate of contamination of Indian shrimp, the FDA decided to sample all such shrimp arriving in the United States. *fn6

In the spring of 1979, appellants offered two lots of raw, frozen Indian shrimp for import into the United States. The FDA sampled the shrimp and discovered salmonella in both lots. The importers each received a Notice of Detention and Hearing stating that the lots of shrimp would be refused admission because they "appearto contain a poisonous deleterious substance (Salmonella species)." *fn7 Appellants were afforded a hearing at which they tried to show that the shipments were not adulterated. After reviewing the evidence offered by the importers, the FDA issued a Notice of Refusal of Admission. The Notice said that the shrimp appeared to be adulterated and ordered the lots destroyed unless they were exported within ninety days. Appellants received permission to retain the shrimp in frozen storage pending the outcome of this litigation.

In their complaint in the district court, appellants contended that the import prohibition (1) was based on an incorrect interpretation of the Act's standard for "adulterated," (2) was unsupported by evidence in the record, and (3) reflected discriminatory treatment of shrimp in comparison to other foods. Based on a review of affidavits, expert testimony, and prior authority, *fn8 the district court rejected all three arguments and granted summary judgment in favor of the FDA. II.

Appellants concede that the two lots of shrimp at issue contain salmonella. The FDA, in turn, acknowledges that salmonella is not "ordinarily injurious" since its dangers can be averted through proper cooking and storage. The only issue before us, *fn9 then, is whether the FDA properly concluded that the shrimp met the more relaxed standard of adulteration for "added" substances. Specifically, we must evaluate the FDA's determinations that salmonella was "added" to the Indian shrimp, and that the bacteria "may render" the shrimp unhealthy. *fn10

A. Is salmonella "added" to shrimp?

Appellants argue that this question was conclusively answered in the negative by our decision in American Public Health Association v. Butz , 167 U.S. App. D.C. 93, 511 F.2d 331 (D.C.Cir.1974). The plaintiffs in that case contended that inspection labels placed on domestic meat and poultry products by the Secretary of Agriculture were misleading since they failed to warn about the salmonella often found in those products. The court noted that inspection labels could be misleading under the Wholesome Meat Act if salmonella constituted adulteration within the meaning of that statute. Assuming that salmonella "may be inherent in the meat," the court commented: "e think that the presence of salmonella in meat does not constitute adulteration within (the Wholesome Meat Acts') definition." Id. at 334. Appellants claim this remark amounted to a judicial determination that salmonella does not adulterate food.

The observation in APHA on which appellants rely consists of dictum uttered in a different legal and factual context. The issue presented by that case was whether the inspection labels were misleading, not whether the food was adulterated. In upholding the Secretary, the court relied on its view that consumers understand the importance of proper storage and cooking of meat and poultry as well as its conclusion that Congress did not intend "microscopic examination(s)" of domestic food products by the Department of Agriculture. Id. at 334-35. The court offered no evidentiary support for its additional suggestion that salmonella may not be "added" to meat. Moreover, the court's assumption about the inherent qualities of meat and poultry obviously do not bind the FDA's evaluation of shrimp. *fn11 Finally, while the statutes involved in APHA ...


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