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 ordinarily 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 [476 U.S. 974, 975] Appeals reversed, holding that the FDA's interpretation of 346 conflicted with its plain language.
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.
O'CONNOR, J., delivered the opinion of the Court, in which BURGER, C. J., and BRENNAN, WHITE, MARSHALL, BLACKMUN, POWELL, and REHNQUIST, JJ., joined. STEVENS, J., filed a dissenting opinion, post, p. 984.
Paul J. Larkin, Jr., argued the cause for petitioner. With him on the briefs were Solicitor General Fried, Assistant Attorney General Willard, Deputy Solicitor General Geller, Leonard Schaitman, Marleigh D. Dover, and Thomas Scarlett.
William B. Schultz argued the cause for respondents. With him on the brief were Alan B. Morrison and Katherine A. Meyer. *
[ Footnote * ] Briefs of amici curiae urging reversal were filed for the State of South Carolina by Philip C. Olsson, T. Travis Medlock, Attorney General, and Brooks Shealy, Assistant Attorney General; for the American Feed Industry Association by David F. Weeda; for the Grocery Manufacturers of America, Inc., by Peter Barton Hutt; for the National Food Processors Association by H. Edward Dunkelberger, Jr.; and for the National Peanut Council, Inc., by James M. Goldberg.
JUSTICE O'CONNOR delivered the opinion of the Court.
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 (1985). We hold that, in light of the inherent ambiguity of the statutory provision and the reasonableness of the Food [476 U.S. 974, 976] 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"
Section 346 states:
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 [476 U.S. 974, 978] "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:
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 [476 U.S. 974, 979] 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 Court of Appeals considered none of the other issues before the District Court, and therefore only the 346 issue is before this Court.
The FDA's longstanding interpretation of the statute that it administers is that the phrase "to such extent as he finds necessary for the protection of public health" in 346 modifies the word "shall." The FDA therefore interprets the statute to state that the FDA shall promulgate regulations to the extent that it believes the regulations necessary to protect the public health. Whether regulations are necessary to protect the public health is, under this interpretation, a determination to be made by the FDA. [476 U.S. 974, 980]
Respondents, in contrast, argue that the phrase "to such extent" modifies the phrase "the quantity therein or thereon" in 346, not the word "shall." Since respondents therefore view the word "shall" as unqualified, they interpret 346 to require the promulgation of tolerance levels for added, but unavoidable, harmful substances. The FDA under this interpretation of 346 has discretion in setting the particular tolerance level, but not in deciding whether to set a tolerance level at all.
Our analysis must begin with Chevron U.S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). We there stated:
The FDA has therefore advanced an interpretation of an ambiguous statutory provision.
To read 346 as does the FDA is hardly to endorse an absurd result. Like any other administrative agency, the FDA has been delegated broad discretion by Congress in any number of areas. To interpret Congress' statutory language to give the FDA discretion to decide whether tolerance [476 U.S. 974, 982] levels are necessary to protect the public health is therefore sensible.
Nor does any other portion of 346 prohibit the FDA from allowing the shipment of aflatoxin-tainted food without a tolerance level, despite the Court of Appeals' conclusion to the contrary. The Court of Appeals stated:
The legislative history of the Act provides no single view about whether Congress intended 346 to be mandatory or permissive with respect to tolerance levels. Compare, e. g., Confidential House Committee Print 2, on Interstate and Foreign Commerce, 75th Cong., 1st Sess., S. 5, 406(a), reprinted in 5 Legislative History of the Federal Food, Drug, and Cosmetic Act and its Amendments 767, 792 (Dept. of Health, Education, and Welfare 1979) (changing, without explanation, words "is authorized to" to "shall" in relevant provision), with H. R. Rep. No. 2139, 75th Cong., 3d Sess. 6 (1938) (stating that, under the Act, "the establishment of tolerances is authorized") (emphasis added). A clearer indication of Congress' intentions with regard to tolerance levels occurred in 1954, when Congress condemned the cumbersomeness of the tolerance-level procedure as applied to pesticides. Congress fashioned a more streamlined procedure for those and other deliberately added substances. See 21 U.S.C. 346a. But in revisiting 346, Congress did not change the procedures governing unintentionally added substances like aflatoxin. This failure to change the scheme under which the FDA operated is significant, for a "congressional failure to revise or repeal the agency's interpretation is persuasive evidence that the interpretation is the one intended by Congress." NLRB v. Bell Aerospace, Co., 416 U.S. 267, 275 (1974). See FDIC v. Philadelphia Gear Corp., ante, at 437; Zenith Radio Corp. v. United States, 437 U.S. 443, 457 (1978). In sum, although the legislative history is not unambiguous, it certainly is no support for assertions that the FDA's interpretation of 346 is insufficiently rational to warrant our deference.
Finally, we note that our interpretation of 346 does not render that provision superfluous, even in light of Congress' decision to authorize the FDA to "promulgate regulations for the efficient enforcement of [the] Act." 21 U.S.C. 371(a). [476 U.S. 974, 984] Section 346 gives the FDA the authority to choose whatever tolerance level is deemed "necessary for the protection of public health," and food containing a quantity of a required or unavoidable substance less than the tolerance level "shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated." Section 346 thereby creates a specific exception to 342(a)'s general definition of adulterated food as that containing a quantity of a substance that renders the food "ordinarily . . . injurious to health." Simply because the FDA is given the choice between employing the standard of 346 and the standard of 342(a) does not render 346 superfluous.
For the reasons set forth, the judgment is reversed, and the case is remanded to the Court of Appeals for the District of Columbia Circuit for further proceedings consistent with this opinion.
The parties agree that aflatoxins are added, unavoidable contaminants of food and as such are governed by the following provision of the Federal Food, Drug, and Cosmetic Act:
The Court's contrary conclusion reflects an absence of judgment and of judging. Before exploring either infirmity, it is worthwhile to summarize the Court's reason for reading the section to authorize, but not require, the promulgation of regulations. First, the Court declares that the qualifying language - "to such extent as he finds necessary for protection of the public health" - is a "dangling participle" that might or might not modify the words "shall promulgate regulations." Ante, at 981. Second, as between the two readings of this "ambiguous statutory provision," ibid., deference dictates that the Commissioner of the Food and Drug Administration (FDA) (to whom enforcement of the Act has been delegated) may take his pick.
The Court's finding of ambiguity is simply untenable. The antecedent of the qualifying language is quite clearly the phrase "limiting the quantity therein or thereon," which immediately precedes it, rather than the word "shall," which appears eight words before it. Thus, the Commissioner is to "limi[t] the quantity [of an added, unavoidable poisonous or deleterious substance] therein or thereon to such extent as he finds necessary for the protection of public health." 1 By instead [476 U.S. 974, 986] reading the section to mean that "the Secretary shall promulgate regulations . . . to such extent as he finds necessary," the Court ignores the import of the words immediately following, which specify the effect of the "limits so fixed" - i. e., fixed by "limiting the quantity [of the poisonous substance] therein or thereon to such extent as he finds necessary for the protection of public health" - which can only mean that the qualification modifies the limits set by regulation rather than the duty to regulate. In addition, the Court's construction, by skipping over the words "limiting the quantity therein or thereon," renders them superfluous and of no operative force or effect. Indeed, the Court renders the very language it construes superfluous, because reading the provision to authorize (rather than mandate) the promulgation of regulations assigns it an office already filled by the general rulemaking authority conferred later in the Food, Drug, and Cosmetic Act. See 21 U.S.C. 371(a). 2 If Congress intended the Secretary to have unbridled authority to proceed with action levels, instead of with formal regulations, there was no need to enact this part of 346 at all. This is plainly a case in which "the intent of Congress is clear [and] the court, as well as the agency, must give effect to the [476 U.S. 974, 987] unambiguously expressed intent of Congress." Chevron U.S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842 -843 (1984). 3 [476 U.S. 974, 988]
The task of interpreting a statute requires more than merely inventing an ambiguity and invoking administrative deference. A statute is not "unclear unless we think there are decent arguments for each of two competing interpretations of it." R. Dworkin, Law's Empire 352 (1986). Thus, to say that the statute is susceptible of two meanings, as does the Court, is not to say that either is acceptable. Furthermore, to say that the Commissioner's interpretation of the statute merits deference, as does the Court, is not to say that the singularly judicial role of marking the boundaries of agency choice is at an end. As Justice Frankfurter reminds us, "[t]he purpose of construction being the ascertainment of meaning, every consideration brought to bear for the solution of that problem must be devoted to that end alone." Frankfurter, Some Reflections on the Reading of Statutes, 47 Colum. L. Rev. 527, 529 (1947). It is not "a ritual to be observed by unimaginative adherence to well-worn professional phrases." Ibid. "Nor can canons of construction save us from the anguish of judgment." Id., at 544. The Court, correctly self-conscious of the limits of the judicial role, employs a reasoning so formulaic that it trivializes the art of judging.
I respectfully dissent.
[ Footnote 2 ] The Court does not deny that the specific language which it construes - the clause providing that "the Secretary shall promulgate regulations" setting tolerance levels - is superfluous under its view of the Act. See ante, at 983-984. It instead emphasizes that a later sentence in 346 which prescribes the legal effect of tolerance-setting regulations remains effective. But since tolerances may be promulgated pursuant to 371(a) as well as 346, the Court's response merely underscores the fact that its construction of the "shall promulgate" clause to authorize rather than to require such rulemaking renders it redundant to the general rulemaking authority conferred by 371(a).
[ Footnote 3 ] Because Congress explicitly required the Commissioner to promulgate regulations for added, unavoidable contaminants, that should be "the end of the matter." Chevron U.S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S., at 842 . The Commissioner's "longstanding" practice to the contrary does not help his legal position. For even if it were true that the Commissioner has from time to time announced an "action level" to advise the industry when he intended to institute enforcement proceedings concerning certain deleterious substances, the fact that the FDA had never actually addressed in any detail the statutory authorization under which it took such action means that its plea for deference should fail for the reasons carefully stated in SEC v. Sloan, 436 U.S. 103, 117 -118 (1978):
The Sloan case also provides an adequate answer to the argument that Congress has revisited the statute from time to time without condemning the FDA's "action level" practice: [476 U.S. 974, 988]