Young v. Community Nutrition Institute, 85-664
| Decision Date | 17 June 1986 |
| Docket Number | No. 85-664,85-664 |
| Citation | 476 U.S. 974,106 S.Ct. 2360,90 L.Ed.2d 959 |
| Parties | Frank YOUNG, Commissioner of Food and Drug Administration, Petitioner v. COMMUNITY NUTRITION INSTITUTE et al |
| Court | U.S. Supreme Court |
The Federal Food, Drug, and Cosmetic Act (Act) provides in 21 U.S.C. § 346 that when the addition of any poisonous or deleterious substance to food is required in the production thereof or cannot be avoided by good manufacturing practice, the Secretary of Health and Human Services "shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health." The Food and Drug Administration (FDA), the Secretary's designee for enforcing the Act, has long interpreted the phrase beginning "to such extent" to modify the word "shall" rather than "the quantity therein or thereon," and therefore views the decision whether to promulgate a § 346 regulation (tolerance level) as a determination to be made by the FDA. Rather than setting a tolerance level for aflatoxin, a potent carcinogen that is unavoidably present in some foods, the FDA set an action level of 20 parts per billion (ppb) (an action level assures food producers that the FDA will not enforce the Act's general adulteration provisions against them if the quantity of the harmful substance in food is less than a specified quantity). But in 1980, the FDA published a notice in the Federal Register that the Act would not be enforced as to a certain harvest of corn to be used for livestock and poultry feed where it contained no more than 100 ppb. Respondents, two public-interest groups and a consumer, brought suit against petitioner Commissioner of Food and Drugs in Federal District Court, alleging that the Act requires the FDA to set a tolerance level for aflatoxin before allowing the shipment of food containing the substance, that in this case the FDA had employed insufficient procedures to set the aflatoxin action level even if a tolerance level was not required, and that the FDA's decision to grant the exemption from the action level violated the Act and the FDA's own regulations. Adopting the FDA's longstanding interpretation of § 346 as giving it discretion whether to promulgate a tolerance level, the District Court, on a motion for summary judgment, ruled that the FDA need not establish a tolerance level for aflatoxin before allowing the shipment of the aflatoxin-tainted corn. The Court of Appeals reversed, holding that the FDA's interpretation of § 346 conflicted with its plain language.
Held: In light of § 346's inherent ambiguity, the FDA's interpretation of the provision is sufficiently rational to preclude a court from substituting its judgment for that of the FDA. The legislative history is equally ambiguous and provides no support for assertions that the FDA's interpretation is insufficiently rational to warrant this Court's deference. Pp. 979-983.
244 U.S.App.D.C. 279, 757 F.2d 354, reversed and remanded.
Paul J. Larkin, Jr., Washington, D.C., for petitioner.
William B. Schultz, Washington, D.C., for respondents.
We granted certiorari in this case to determine whether the Court of Appeals for the District of Columbia Circuit correctly concluded that the Food and Drug Administration's longstanding interpretation of 21 U.S.C. § 346 was in conflict with the plain language of that provision. 474 U.S. 1018, 106 S.Ct. 565, 88 L.Ed.2d 551 (1985). We hold that, in light of the inherent ambiguity of the statutory provision and the reasonableness of the Food and Drug Administration's interpretation thereof, the Court of Appeals erred. We therefore reverse.
The Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act (Act) as the designee of the Secretary of Health and Human Services. 21 U.S.C. § 371(a). See also 21 CFR § 5.10 (1986). The Act seeks to ensure the purity of the Nation's food supply, and accordingly bans "adulterated" food from interstate commerce. 21 U.S.C. § 331(a). Title 21 U.S.C. § 342(a) deems food to be "adulterated"
"(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; or (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than [exceptions not relevant here] ) which is unsafe within the meaning of section 346a(a) of this title. . . ."
As this provision makes clear, food containing a poisonous or deleterious substance in a quantity that ordinarily renders the food injurious to health is adulterated. If the harmful substance in the food is an added substance, then the food is deemed adulterated, even without direct proof that the food may be injurious to health, if the added substance is "unsafe" under 21 U.S.C. § 346.
Section 346 states:
Any quantity of added poisonous or added deleterious substances is therefore "unsafe," unless the substance is required in food production or cannot be avoided by good manufacturing practice. For these latter substances, "the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health." It is this provision that is the heart of the dispute in this case.
The parties do not dispute that, since the enactment of the Act in 1938, the FDA has interpreted this provision to give it the discretion to decide whether to promulgate a § 346 regulation, which is known in the administrative vernacular as a "tolerance level." Tolerance levels are set through a fairly elaborate process, similar to formal rulemaking, with evidentiary hearings. See 21 U.S.C. § 371(e). On some occasions, the FDA has instead set "action levels" through a less formal process. In setting an action level, the FDA essentially assures food producers that it ordinarily will not enforce the general adulteration provisions of the Act against them if the quantity of the harmful added substance in their food is less than the quantity specified by the action level.
The substance at issue in this case is aflatoxin, which is produced by a fungal mold that grows in some foods. Aflatoxin, a potent carcinogen, is indisputedly "poisonous" or "deleterious" under §§ 342 and 346. The parties also agree that, although aflatoxin is naturally and unavoidably present in some foods, it is to be treated as "added" to food under § 346. As a "poisonous or deleterious substance added to any food," then, aflatoxin is a substance falling under the aegis of § 346, and therefore is at least potentially the subject of a tolerance level.
The FDA has not, however, set a § 346 tolerance level for aflatoxin. It has instead established an action level for aflatoxin of 20 parts per billion (ppb). In 1980, however, the FDA stated in a notice published in the Federal Register:
"The agency has determined that it will not recommend regulatory action for violation of the Federal Food, Drug, and Cosmetic Act with respect to the interstate shipment of corn from the 1980 crop harvested in North Carolina, South Carolina, and Virginia and which contains no more than 100 ppb aflatoxin. . . ." 46 Fed.Reg. 7448 (1981).
The notice further specified that such corn was to be used only as feed for mature, nonlactating livestock and mature poultry. Id., at 7447.
In connection with this notice, two public-interest groups and a consumer (respondents here) brought suit against the Commissioner of the FDA (petitioner here) in the United States District Court for the District of Columbia. Respondents alleged that the Act requires the FDA to set a tolerance level for aflatoxin before allowing the shipment in interstate commerce of food containing aflatoxin; that the FDA had employed insufficiently elaborate procedures to set its aflatoxin action level even if a tolerance level was not required; and that the FDA's decision to grant the 1980 exemption from the action level independently violated the Act and the FDA's own regulations.
On a motion for summary judgment, the District Court deferred to the FDA's interpretation of § 346, and therefore ruled that the FDA need not establish a tolerance level for aflatoxin before allowing the shipment of aflatoxin-tainted corn in interstate commerce. The District Court also ruled against respondents on their other claims.
The Court of Appeals reversed the District Court's conclusion as to the proper interpretation of § 346. 244 U.S.App.D.C. 279, 757 F.2d 354 (1985). The Court of Appeals determined that Congress had spoken directly and unambiguously to the precise question at issue:
"The presence of the critical word 'shall' plainly suggests a directive...
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