Community Nutrition Institute v. Young, 84-5223

• Decision Date: 26 March 1985
• Docket Number: No. 84-5223,84-5223
• Citation: 244 U.S.App.D.C. 279,757 F.2d 354
• Parties: COMMUNITY NUTRITION INSTITUTE, et al., Appellants, v. Frank YOUNG, Commissioner, Food and Drug Administration.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 354

757 F.2d 354

244 U.S.App.D.C. 279

COMMUNITY NUTRITION INSTITUTE, et al., Appellants, v. Frank YOUNG, Commissioner, Food and Drug Administration.

No. 84-5223.

United States Court of Appeals District of Columbia Circuit.

Argued Jan. 25, 1985.

Decided March 26, 1985.

William B. Schultz, with whom Alan B. Morrison, Washington, D.C., was on the brief, for appellants.

Patricia J. Kenney, Asst. U.S. Atty., Washington, D.C., with whom Joseph E. diGenova, U.S. Atty., Royce C. Lamberth, R. Craig Lawrence, Michael J. Ryan, Asst. U.S. Attys., Washington, D.C., Thomas Scarlett, Chief Counsel, Food and Drug Admin., Stephen D. Terman and Michael M. Landa, Associate Chief Counsel, Food and Drug Admin., Rockville, Md., were on the brief, for appellee.

Philip C. Olsson, Washington, D.C., was on the brief of amicus curiae, the State of S.C., urging affirmance.

Before MIKVA, EDWARDS and STARR, Circuit Judges.

Opinion for the Court filed by Circuit Judge STARR.

STARR, Circuit Judge:

This case presents a challenge to the Food and Drug Administration's regulation of corn adulterated by the presence of aflatoxin. Aflatoxins are by-products of certain common molds that grow on various crops, including corn. The Food and Drug Administration ("FDA" or "agency") permits the shipment of corn containing aflatoxin below an informally adopted "action level." The agency has from time to time granted exemptions to its prescribed action level; moreover, the FDA has permitted blending of adulterated and unadulterated corn to obtain a mixture which the agency believed safe for use as animal feed.

Plaintiffs-appellants, two public interest groups--Community Nutrition Institute and Public Citizen Litigation Group--and an individual consumer (jointly referred to as "CNI"), brought suit in federal district court to require the FDA to adopt, by way of notice-and-comment rulemaking, formal aflatoxin levels or "tolerances," as opposed to informally implemented action levels. ¹ Alternatively, CNI argued that, if action levels rather than formally adopted tolerances were permitted, their adoption or amendment and the grant of any exemptions must be treated as rulemakings subject to the procedural requirements of the Administrative Procedure Act ("APA"), 5 U.S.C. Sec. 553 (1982). Finally, CNI argued that the regulations permitting blending of adulterated and unadulterated corn were contrary to law.

The District Court granted summary judgment in favor of FDA on all three issues. We now reverse with respect to the first issue and hold that, under the plain meaning of the statute, the FDA may not proceed by means of action levels rather than tolerances. By virtue of that disposition, the second issue with respect to the procedures to be employed by the agency in adopting action levels is rendered moot. As to the third issue, the blending of adulterated and unadulterated corn, we vacate that portion of the District Court's judgment and remand for further consideration in light of our holding with respect to the FDA's statutory obligation to promulgate regulations setting forth formal tolerances.

I

Aflatoxins cause liver damage and exhibit carcinogenic properties in animals; evidence also exists suggesting that their ingestion may cause liver cancer in humans. It is thus undisputed that aflatoxin is a "poisonous or deleterious substance" within the meaning of section 402 of the Food, Drug and Cosmetics Act, 21 U.S.C. Sec. 342 (1982) ("the Act"). Furthermore, since aflatoxin is not an inherent constituent of corn, but results from an environmental or agricultural contaminant, ² it must be considered an "added" poisonous or deleterious substance within the meaning of the statute. ³

Since aflatoxin is an "added" substance, it comes within the scope of 21 U.S.C. Sec. 342(a)(2)(A), which provides that "[a] food shall be deemed to be adulterated--... if it bears or contains any added poisonous or added deleterious substance ... which is unsafe within the meaning of section 346 of this title...." Section 346 in turn provides:

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be deemed to be unsafe ...; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe.... While such a regulation is in effect limiting the quantity of such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated.... In determining the quantity of such added substance to be tolerated ... the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided ... and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

21 U.S.C. Sec. 346 (emphasis added).

Not only is it undisputed that aflatoxin is "poisonous or deleterious" and that it is an "added" substance, but the Secretary also admits facts, see Appellee's Brief at 4, sufficient to conclude that the presence of aflatoxin in food may render such consumables injurious to health. Hence, section 342 would, except for the saving grace of section 346, define any aflatoxin-tainted corn to be adulterated, and such corn would therefore be banned from interstate commerce, see 21 U.S.C. Sec. 331(a). Nonetheless, since it is also undisputed that aflatoxin is unavoidable, occurring as it does in nature, section 346 may still allow for its interstate transportation. The question before us is what, if any, procedures the Secretary or her delegate, the Commissioner of FDA, is required to follow in invoking the savings provisions of section 346.

The principal point of contention between the parties is over the meaning of that portion of the statutory provision, highlighted in the text above, which reads: "[B]ut when such substance ... cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health...." Emphasizing the word "shall," CNI argues that the Secretary is statutorily obligated to issue regulations embodying a tolerance for the substance before the product may lawfully be introduced into interstate commerce. The Commissioner, on the other hand, maintains that this provision merely authorizes FDA to issue tolerances but that the agency may, alternatively, elect to proceed by means of informal action levels indicating the levels of contamination below which the FDA will exercise its enforcement discretion, provided under 21 U.S.C. Sec. 336, ⁴ not to take action. We are thus required to divine the intent of Congress with respect to FDA's authority in this respect under the Act.

II

In questions of statutory construction, our initial inquiry must be, as this court has recently stated, to "determine whether Congress 'has directly spoken to the precise question at issue.' " General Motors Corp. v. Ruckelshaus, 742 F.2d 1561, 1566 (D.C.Cir.1984) (en banc ) (quoting Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., --- U.S. ----, 104 S.Ct. 2778, 2781, 81 L.Ed.2d 694 (1984)). In that process, "reviewing courts ... must not 'rubber-stamp ... administrative decisions that they deem inconsistent with a statutory mandate or that frustrate the congressional policy underlying a statute.' " Bureau of Alcohol, Tobacco and Firearms v. Federal Labor Relations Authority, 464 U.S. 89, 104 S.Ct. 439, 444, 78 L.Ed.2d 195 (1983) (quoting NLRB v. Brown, 380 U.S. 278, 291-92, 85 S.Ct. 980, 988-89 (1965)). See also Chevron, supra, 104 S.Ct. at 2781-82, ("If the intent of Congress is clear ... the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.").

After careful review, we find that Congress has spoken on the issue in question and that the intent of Congress is abundantly clear in requiring the formal issuance of tolerances, rather than permitting agency reliance solely on informal action levels. The interpretation accorded the Act by the FDA flies in the teeth of Congress' clear intent and, under long established principles of administrative law, must therefore be rejected.

A

Our analysis begins, of course, by turning to the language of the statute itself. See, e.g., Consumer Product Safety Comm'n v. GTE Sylvania, 447 U.S. 102, 108, 100 S.Ct. 2051, 2056, 64 L.Ed.2d 766 (1980) ("the starting point for interpreting a statute is the language of the statute itself"); Reiter v. Sonotone Corp., 442 U.S. 330, 337, 99 S.Ct. 2326, 2330, 60 L.Ed.2d 931 (1979) ("our starting point must be the language employed by Congress"); Center for Auto Safety v. Ruckelshaus, 747 F.2d 1, 3 (D.C.Cir.1984) (same, quoting Reiter ). The presence of the critical word "shall" plainly suggests a directive to the Secretary to establish a tolerance, if a food with an unavoidable poisonous or deleterious substance is to be considered unadulterated. The FDA's response to this common-sense reading is to point to the statutory phrase, "to such extent as [the Secretary] finds necessary for the protection of public health." The FDA contends that this phrase modifies the word "shall," and that the agency's decision to proceed by action levels rather than tolerances properly lies within the FDA's broad discretion. Under this view, the Commissioner may simply conclude that establishing a tolerance is not necessary for the protection of public health and, so the FDA argues, the agency may thus proceed by informal action levels.

It is, however, clear from the structure of the sentence at issue here that the phrase relied upon by the...