Source: https://law.justia.com/cases/federal/appellate-courts/F2/590/149/224496/
Timestamp: 2019-08-18 11:28:40
Document Index: 94539777

Matched Legal Cases: ['§ 342', '§ 346', '§ 342', '§ 336', '§ 109', '§ 509', '§ 342', '§ 342', '§ 342']

United States of America, Plaintiff-appellant, v. Boston Farm Center, Inc., a Corporation, and James R.gordon, an Individual, Defendants-appellees, 590 F.2d 149 (5th Cir. 1979) :: Justia
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United States of America, Plaintiff-appellant, v. Boston Farm Center, Inc., a Corporation, and James R.gordon, an Individual, Defendants-appellees, 590 F.2d 149 (5th Cir. 1979)
US Court of Appeals for the Fifth Circuit - 590 F.2d 149 (5th Cir. 1979)
Section 301(a) prohibits the interstate shipment of "adulterated" food. Adulterated food is defined as, among other things, food containing "any poisonous or deleterious substance which may render it injurious to health." 21 U.S.C. § 342(a) (1). The lower court issued a preliminary injunction against the Center, but enjoined only the Center's interstate shipment of corn containing more than 100 ppb of aflatoxin. The United States appealed the judgment of the lower court arguing that the injunction threshold should be set at the 20 ppb level it requested.
The 20 ppb level proposed by the Government is the Food and Drug Administration's "action level" for aflatoxin in corn. An action level, to be defined properly, must be explained in the broader context of the FDA's general regulatory scheme. In implementing the Act, the FDA either may adopt formal regulations, 21 U.S.C. § 346, or may litigate alleged violations on a case-by-case basis. Although the Act makes illegal any amount of substance which "may render (food) injurious to health" 21 U.S.C. § 342(a) (1) the FDA is not required to seek to enjoin, prosecute or otherwise litigate "minor violations" of the Act. 21 U.S.C. § 336. To guide its prosecutorial discretion in the bringing of non-rule enforcements of the Act the FDA may establish certain in-house guidelines called action levels. Since 1969 the action level for aflatoxin in corn has been 20 ppb. This means that since 1969 the FDA's internal policy has been to try to prevent the shipment of corn containing more than 20 ppb of aflatoxin, but not of corn containing 20 ppb or less.
For example, FDA regulations state that the agency may take regulatory action "any time after an action level is established and need not await publication of the notice." 21 C.F.R. § 109.4(b) (2). See also 21 C.F.R. § 509.4(b) (2). And see U. S. v. 484 Bags, More or Less, 423 F.2d 839 (5th Cir. 1970) (action level not yet published when litigation initiated)
First, appellees argue that this appeal of an order concerning only corn harvested in 1977 should be dismissed on grounds of mootness. The argument fails on two grounds. There is no evidence in this Record indicating that Boston Farm Center has disposed of all its corn from the 1977 season. And even if Boston Farm had disposed of that corn this case presents a classic example of the controversy that is "capable of repetition, yet evading review" a common exception to the mootness doctrine. Southern Pacific Terminal Co. v. Interstate Commerce Commission, 219 U.S. 498, 515, 31 S. Ct. 279, 55 L. Ed. 310 (1911). See also Roe v. Wade, 410 U.S. 113, 124-125, 93 S. Ct. 705, 35 L. Ed. 2d 147 (1973).
Second, appellants argue that the lower court applied the wrong test in defining "adulterated" food. Specifically, appellants point to the following statement in the Court's opinion: "(C)orn containing an aflatoxin level of less than 100 ppb does not contain a deleterious substance to the degree which Would render it injurious to health and, therefore (is) generally acceptable for interstate shipment." (emphasis added). The government argues that this sentence indicates the court limited its injunction on the basis of a "would render" test instead of the "may render" test established in § 342(a) (1): Food is adulterated if it "contains any poisonous or deleterious substance which May render it injurious to health." (emphasis added) However, we note that earlier in its opinion the lower court twice correctly quoted § 342 and its "may render" test. The later use of the word "would" in a single conclusory sentence does not necessarily mean that the court did not use the correct § 342 test which it explicitly stated twice before a few paragraphs above. In any case, we do not have to decide this question because we hold that, based on the evidence in the record, it would be clearly erroneous to find that corn containing between 20 and 100 ppb aflatoxin is not adulterated. Thus, the lower court must be reversed whether or not it applied the "may render" test.