FRANK YOUNG, COMMISSIONER OF FOOD AND DRUGS, PETITIONER V. COMMUNITY NUTRITION INSTITUTE, ET AL. No. 85-664 In the Supreme Court of the United States October Term, 1985 The Solicitor General, on Behalf of the Commissioner of Food and Drugs, Petitions for a Writ of Certiorari to Review the Judgment of the United States Court of Appeals for the District of Columbia Circuit in this case. Petition for a Writ of Certiorari to the United States Court of Appeals for the District of Columbia Circuit PARTIES TO THE PROCEEDING The petitioner is Frank Young, Commissioner of Food and Drugs. The respondents are the Community Nutrition Institute, Public Citizen, and Linda S. Bardot. TABLE OF CONTENTS Questions Presented Parties to the Proceeding Opinions below Jurisdiction Statutory and regulatory provisions involved Statement Reasons for granting the petition Conclusion Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G OPINIONS BELOW The opinion of the court of appeals (App., infra, 1a-16a) is reported at 757 F.2d 354. The May 1, 1985 order amending the court of appeals' opinion (App., infra, 17a) and the opinion of the district court (App., infra, 21a-34a) are unreported. JURISDICTION The judgment of the court of appeals (App., infra, 35a) was entered on March 26, 1985. A petition for rehearing was denied on May 23, 1985 (App., infra, 18a). By order dated August 13, 1985, Justice Brennan extended the time within which to file a petition for a writ of certiorari to and including October 20, 1985. The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1). STATUTORY AND REGULATORY PROVISIONS INVOLVED Sections 402(a), 406, and 701(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 342(a), 346, and 371(e), and 21 C.F.R. 509.6(b)-(c) are reproduced at App., infra, 36a-40a. QUESTION PRESENTED Whether the Food and Drug Administration is required to regulate unavoidable "added" poisonous or deleterious substances in food by means of formal rulemaking pursuant to 21 U.S.C. 342(a)(2)(A), rather than by case-by-case adjudication pursuant to 21 U.S.C. 342(a)(1). STATEMENT This case concerns the procedures that the Food and Drug Administration (FDA) must employ in regulating the presence in food of any added poisonous or deleterious substance that is required in the production of the food or that cannot be avoided by good manufacturing practice. The specific substance at issue here is "aflatoxin," a carcinogenic mold byproduct that commonly grows on corn and other crops. Since the enactment of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938, the FDA has regulated the amounts of substances like aflatoxin principally by issuing what the FDA terms "action levels." These "action levels" announce the level of the particular substance that the FDA regards as resulting in adulteration under 21 U.S.C. 342(a)(1). In this case, the court of appeals upset this longstanding administrative interpretation of the FDCA and held that the FDA must instead set tolerances by time-consuming and burdensome formal rulemaking procedures. 1. Statutory and Regulatory Scheme. The FDCA, 21 U.S.C. 331, prohibits the shipment in interstate commerce of "adulterated" food. Under 21 U.S.C. 342, a food is deemed to be adulterated if either of two conditions is met. The first, Section 342(a)(1), applies to all poisonous substances, whether inherent in the food or "added" to it, and provides that a food is adulterated if it contains "any poisonous or deleterious substance which may render it injurious to health." The second, Section 342(a)(2)(A), applies only to "added" poisons and states that food is adulterated if it contains any "added poisonous or added deleterious substance * * * which is unsafe within the meaning of" 21 U.S.C. 346. Aflatoxin is regarded as an added poison because it is added by mold, i.e., it is not an inherent constituent of food. Section 346 defines when a food with an added poison is "unsafe" within the meaning of that provision. The first clause of Section 346 provides that any added poison renders the food unsafe unless its presence "is required in the production thereof or cannot be avoided by good manufacturing practice * * *." Since aflatoxin falls within this exception, food containing aflatoxin is not rendered "unsafe" by this clause. Section 346 next addresses the question of when a food to which a required or unavoidable poison, like aflatoxin, has been added is deemed to be unsafe. The statute provides in pertinent part: (W)hen such substance is so required or cannot be so avoided, the Secretary (of Health and Human Services) shall promulgate regulations limiting the quantity therein or thereon to such entent 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 for purposes of the application of (Section 342(a)(2)(A)). For nearly a half-century, the FDA has interpreted these provisions as allowing it to regulate substances such as aflatoxin either by structuring its discretion to bring enforcement actions under Section 342(a)(1) or by issuing formal regulations pursuant to Sections 342(a)(2)(A) and 346. If the FDA elects to proceed under Section 342(a)(1), the government must establish in an enforcement proceeding that the level of the substance present may render the food injurious to health. This is the option that the FDA has used with respect to aflatoxin, and the FDA has adopted an action level to aid the agency in the exercise of its prosecutorial discretion. /1/ In the alternative, FDA may promulgate a Section 346 tolerance. Once a tolerance is in effect, the government in an enforcement proceeding need only establish that the tolerance has been violated; it need not adduce independent evidence that the food may be injurious to health. See 21 U.S.C. 346. The procedures employed in promulgating action levels differ significantly from those required for issuance of tolerances. Action levels are not subject to notice-and-comment rulemaking under the Administrative Procedure Act. However, the FDA does publish a notice in the Federal Register announcing the new level and the availability of all the relevant data, and it invites public comment. 42 Fed. Reg. 52817 (1977). By contrast, 21 U.S.C. 371(e) prescribes a formal and complicated procedure for the issuance of regulations setting tolerances under Section 346. Within 30 days after publication of a final regulation in the Federal Register, any party who may be adversely affected may file objections and request a public hearing. 21 U.S.C. 371(e)(2). The filing of such objections stays the effectiveness of the proposed regulation until the Secretary of Health and Human Services takes final action on the objections. Ibid. If the objections raise genuine and substantial factual issues, the Secretary, after providing further notice in the Federal Register, must conduct a public hearing at which "any interested person may be heard in person or by representative." 21 U.S.C. 371(e)(3). The Secretary must then rule on the objections, setting forth "detailed findings of fact." Ibid. Except in emergencies, the regulation may not take effect until 90 days after the Secretary's decision (ibid.), which is subject to judicial review (21 U.S.C. 371(f)). In determining whether to issue informal action levels or formal tolerances in a particular case, the FDA takes these procedural differences into account. FDA regulations provide for the use of action levels when it is impracticable to set tolerances. See 21 C.F.R. Pt. 109 (human food); 21 C.F.R. Pt. 509 (animal food). For example, action levels rather than tolerances are to be used when changes in the capabilities of good manufacturing practices are expected or when the results of ongoing studies might provide significant new toxicological data or other data that might render a tolerance obsolete. 21 C.F.R. 509.6(b)-(c). 2. Proceedings Below. Respondents (two public interest groups and a consumer) brought this suit in the United States District Court for the District of Columbia to challenge the FDA's regulation of aflatoxin. Respondents contended (1) that the FDA should be compelled to adopt a formal aflatoxin tolerance pursuant to Section 346, as opposed to an informally implemented action level (2) that the action level, in the alternative, should be made subject to notice-and-comment rulemaking, and (3) that certain exemptions to the action level were contrary to law. The district court granted summary judgment in favor of the FDA on all three issues. Recognizing that an agency's interpretation of its statute is entitled to substantial deference, the court found that the FDA's construction of Section 346 was reasonable and that Section 346 "confers discretionary, not mandatory, authority on the agency to establish tolerances." App., infra, 31a-32a (footnote omitted). It also concluded that "action levels" were general statements of policy not requiring notice-and-comment rulemaking and that the exemptions granted were within the agency's discretion. Id. at 32a-34a. The court of appeals reversed, holding that "the FDA may not proceed by means of action levels rather than tolerances" (App., infra, 2a). /2/ In reaching this conclusion, the court relied heavily on its parsing of the second sentence of Section 346, which, as noted, provides that when an added poisonous or deleterious substance is "required" or "cannot be * * * 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. The court refused to accept (App., infra, 6a) the FDA's interpretation of this provision, i.e., that the Secretary is obligated to promulgate formal regulations only "'to such extent as (he) finds necessary for the protection of public health'" and may employ informal action levels in all other circumstances. Instead, the court found (id. at 7a) that it was "clear from the structure of the sentence * * * that the phrase relied upon by the Secretary simply does not modify the pivotal word 'shall'" but, rather, "explains the standard that the Secretary is to employ in setting the tolerance." The court of appeals found additional support for its interpretation in an argument that seems to suggest that much of the nation's food supply is "adulterated" within the meaning of the FDCA. The court interpreted (App., infra, 7a) Section 346 to mean that any food to which an unavoidable poisonous or deleterious substance has been added is adulterated unless "a regulation establishing a tolerance is in effect." The court reasoned (App., infra, 7a): Since the existence of a regulation operates to render the food legally unadulterated, the statute, in our view, plainly requires the establishment by regulation of tolerances before aflatoxin-tainted corn may lawfully be shipped in interstate commerce. The court of appeals advanced no other arguments to buttress its interpretation. It found "little guidance in the legislative history" (App., infra, 9a), and it did not cite any supporting judicial authority, but instead merely attempted to distinguish the cases upon which the FDA relied (id. at 11a-15a). REASONS FOR GRANTING THE PETITION In the production of food, it is often impossible to avoid the presence of small quantities of added substances that may be harmful to human health if taken in sufficient amount. For nearly 50 years, the FDA has regulated the presence of such substances in food principally by issuing informal "action levels" and by enforcing these standards through litigation under Section 342(a)(1) of the FDCA. This informal procedure has allowed the FDA to move quickly in response to health hazards; it has provided flexibility in an area in which the relevant scientific data and the capabilities of good manufacturing processes are subject to frequent changes; and it has permitted the FDA, by limiting burdensome and unproductive formal rulemaking proceedings, to allocate its scarce resources to activities of greater value in safeguarding the public health. The court of appeals' decision, which upsets this settled and successful practice, threatens to squander administrative resources and to impair the FDA's ability to act expeditiously and respond to changed conditions in this important area. The court's reasoning also suggests that much of the nation's food supply is now and will remain "adulterated" within the meaning of the FDCA until formal regulations setting tolerances are issued -- a process that is certain to take years, if not decades, to complete. For these reasons, this case concerns a matter of substantial importance that warrants this Court's review. 1. a. An agency's interpretation of the statute it is charged with administering is "entitled to considerable deference." Chemical Manufacturers Ass'n v. NRDC, No. 83-1013 (Feb. 27, 1985), slip op. 8. "(T)o sustain it, (a court) need not find that it is the only permissible construction that (the agency) might have adopted but only that (the agency's) understanding * * * is a sufficiently rational one to preclude a court from substituting its judgment for that of (the agency)." Id. at 8-9. See also Chevron U.S.A. Inc. v. NRDC, No. 82-1005 (June 25, 1984), slip op. 4-7; United States v. Rutherford, 442 U.S. 544, 553-554 (1979); Train v. NRDC, 421 U.S. 60, 75 (1975). Under this standard, the FDA's interpretation of the relevant provisions of the FDCA should have been sustained. As the court of appeals recognized, the pivotal statutory provision is the second sentence of 21 U.S.C. 346, which provides that when any added poisonous or deleterious substance is "required" in the production of food or "cannot be avoided by good manufacturing practice," the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health * * * In the FDA's view, the phrase "to such extent as he finds necessary for the protection of public health" modifies the verb "shall." Accordingly, the FDA has consistently interpreted this provision to mean that it must promulgate regulations only if it finds that they are necessary for the protection of public health. The court of appeals, by contrast, concluded that the critical phrase "to such extent as he finds necessary for the protection of public health" modifies the participle "limiting." Thus, in the court's view, the FDA must promulgate regulations establishing tolerances for all added poisonous or deleterious substances that cannot practicably be avoided in food production, and these regulations must "limit() the quantity" of such substances "to such extent as (the FDA) finds necessary for the protection of public health." Both interpretations of the statutory language are entirely rational and plausible. Therefore, the statutory language provides no basis for overriding the FDA's longstanding construction of the statute it has been entrusted by Congress with administering, especially in view of the statute's complexity. See Pattern Makers v. NLRB, No. 83-1894 (June 27, 1985), slip op. 19; Chemical Manufacturers Ass'n, slip op. 8. Even if the court of appeals believed that its own interpretation of the statutory language corresponded with the most refined rules regarding the proper placement of modifiers, that alone was not a sufficient reason for refusing to defer to the FDA's interpretation. After all, complex regulatory statutes like the FDCA often appear to be written in a language that is all their own, and thus adherence to the highest standards of normal usage is not always a reliable way to divine Congress's intent. b. Not only is the language of Section 342(a)(1) insufficient to support the court of appeals' interpretation, but that interpretation is critically undermined by the overall structure of the statutory scheme. It is a cardinal rule of statutory interpretation that a statute should be construed so as to give effect to all of its provisions. See, e.g., Dickerson v. New Banner Institute, Inc., 460 U.S. 103, 118 (1983). Here, FDA's construction satisfies this canon, while the court of appeals' interpretation makes Section 342(a)(1) superfluous for "added" substances, like aflatoxin, even though Section 342(a)(1) was expressly intended to play a role in the regulation of such substances. /3/ Under Section 346, the addition of a poisonous or deleterious substance automatically renders a food "unsafe" (and thus "adulterated" under Section 342(a)(2)) unless the added substance is "required" or cannot practicably be avoided. Thus, it is undisputed that Section 342(a)(1) is not needed to regulate substances that are not required or are avoidable in food production. This obviously leaves only those added substances that are required or cannot practicably be avoided. As previously noted, FDA's view is that it may regulate the occurrence of these substances either by issuing action levels and bringing suit in appropriate cases under Section 342(a)(1) (in which case the FDA must prove in court that the added substance renders the food "injurious to health") or by promulgating formal regulations under Section 346 (in which case any food exceeding those tolerances is automatically deemed to be unsafe and adulterated). Cf. NLRB v. Bell Aerospace Co., 416 U.S. 267, 294 (1974). This interpretation assigns an important role to both Section 342(a)(1) and Section 342(a)(2). Under the court of appeals' interpretation, however, FDA must issue formal regulations for all such substances. Once such regulations are promulgated, Section 342(a)(1) has no role to play. If a food is "unsafe" under Section 342(a)(2)(A) by virtue of a formal regulation, FDA would have no need to proceed under Section 342(a)(1), which requires proof in court of injury to health. And if a food is deemed to be "safe" under such a regulation, Section 346 expressly provides that the food "shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated" under Section 342(a)(1). /4/ c. The language and structure of the FDCA thus provide substantial support for the FDA's long-settled construction of the statute. Indeed, the FDA's interpretation is entitled to enhanced deference because Congress has specifically noted that interpretation while considering revisions of the FDCA but has done nothing to alter the administrative practice. See Haig v. Agee, 453 U.S. 280, 297-298 (1981); Chemehuevi Tribe of Indians v. FPC, 420 U.S. 395, 410 (1975); NLRB v. Gullett Gin Co., 340 U.S. 361, 366 (1951). Under the FDCA, pesticide residues in food were originally governed by Section 346, but in 1954 Congress enacted a new provision, 21 U.S.C. 346a, to regulate the presence of pesticide residues in raw agricultural products. During the hearings preceding passage of this legislation, both the Commissioner of Food and Drugs and industry representatives called the FDA's position to Congress's attention, /5/ and this interpretation not only was expressly noted by both the House and Senate committees but appears to have played an important part in their thinking. See H.R. Rep. 1385, 83d Cong., 2d Sess. 2, 6-7 (1954); S. Rep. 1635, 83d Cong., 2d Sess. 6 (1954). The House Report observed that while the law "authorizing" the issuance of formal tolerances had been in effect for more than 15 years, "(d)uring all that time control has been exercised through unofficial and informal tolerances." H.R. Rep. 1385, supra, at 2. The Report continued (id. at 2-3) that in 1950 "lengthy public hearings," costing nearly $500,000, had been held for the purposes of establishing official tolerances for pesticide residues in fresh fruits and vegetables but that official tolerances still had not been promulgated due to "the cumbersome, time-consuming, and impracticable procedure prescribed by existing law." To overcome these difficulties, the House committee recommended (id. at 2) "an improved procedure for establishment of of tolerances for pesticide chemicals remaining in or on raw agricultural commodities." The Senate Report (S. Rep. 1635, supra, at 6) made the identical points. Thus, the congressional committees expressly observed that the FDA was relying chiefly on informal rather than formal tolerances, yet they did not suggest that this practice was unlawful or undesirable and did nothing to require its abandonment in favor of exclusive reliance on formal rulemaking. On the contrary, the committees sharply criticized the formal statutory procedure set out in the FDCA Act and crafted a new, simpler, and speedier method for rectifying the problem caused by the breakdown of the formal procedure in the field of pesticide residues on raw agricultural products. This is powerful evidence that Congress approved the FDA's interpretation of the statutory provisions at issue here. 2. The court of appeals' interpretation of these provisions is inconsistent with that of the Fifth Circuit in United States v. Boston Farm Center, Inc., 590 F.2d 149 (1979), an action to enjoin shipment of grain containing an amount of aflatoxin exceeding the FDA's action level. There, the Fifth Circuit expressly adopted the interpretation of the relevant statutory provisions that the D.C. Circuit rejected in this case. The Fifth Circuit wrote (id. at 151): In implementing the Act, the FDA either may adopt formal regulations, 21 U.S.C. Section 346, or may litigate alleged violations on a case-by-case basis. * * * 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. Holding that the grain at issue was adulterated, the court noted (ibid.) that it had "evolved a policy of considerable deference to agency action levels." See also United States v. Anderson Seafoods, Inc., 447 F.Supp. 1151, 1153 n.2 (N.D. Fla. 1978), aff'd, 622 F.2d 157 (5th Cir. 1980). The D.C. Circuit in the present case distinguished Boston Farm Center (App., infra, 11a-12a) on the ground that it concerned the FDA's authority to enjoin shipment of adulterated grain without issuing a formal tolerance and did not address the FDA's obligation to issue a formal tolerance. This is an exceedingly narrow distinction that cannot camouflage the fact that the two circuits interpret the statutory provisions in ways that are fundamentally irreconcilable. While the D.C. Circuit held (App., infra, 2a) that "the FDA may not proceed by means of action levels rather than tolerances," the Fifth Circuit in Boston Farm Center expressly recognized (590 F.2d at 151) that the FDA had the discretion to follow either either procedure. Moreover, it would be patently inconsistent to hold, as the court below did, that FDA action levels are unlawful substitutes for formal tolerances while at the same time to hold, as the Fifth Circuit did in Boston Farm Center, that the distribution of grain may be enjoined based upon "considerable deference" to the FDA's action level. Surely the distributor in Boston Farm Center, who stood to suffer considerable economic loss, had at least an equal claim to the protection of the formal tolerance procedures as did respondents in this case, whose claim of injury is far more speculative. The court of appeals' interpretation of Section 346 is also inconsistent with the Seventh Circuit's interpretation of 21 U.S.C. 346a(b), which deals with the promulgation of regulations applicable to pesticide residues on raw agricultural products and contains the same critical phrase as Section 346. Section 346a(b) provides in pertinent part (emphasis added): The Administrator (of EPA) shall promulgate regulations establishing tolerances with respect to the use in or on raw agricultural commodities of poisonous or deleterious pesticide chemicals and of pesticide chemicals which are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, to the extent necessary to protect the public health. In United States v. Goodman, 486 F.2d 847, 854 (7th Cir. 1973), the court construed this provision to allow EPA the discretion to decide whether to set a tolerance: The language of Section 346a(b) provides for promulgation of regulations establishing tolerances "to the extent necessary to protect the public health." EPA has determined that a regulation for DDT in raw fish is not necessary at this time. In fact, they have refrained from promulgating such a regulation because DDT levels in the environment are in a state of flux, a state partially induced by their other control activities concerning DDT. This interpretation supports the FDA's understanding of the language in Section 346 and clashes sharply with that of the D.C. Circuit in this case. /6/ To be sure, Boston Farm Center and Goodman did not arise in precisely the same posture as the present case. If there were a significant possibility that such a case might arise in a court of appeals other than the D.C. Circuit, it might be appropriate for this Court to defer review until that occurred. But the likelihood that any circuit other than the D.C. Circuit will confront the legal issue decided below seems remote. Any party seeking to compel the FDA to issue a formal regulation may bring suit in the District of Columbia (see 5 U.S.C. 703), and in view of the decision below such a party is almost certain to make that choice of venue. 3. Unless reversed, the court of appeals' decision will have significant adverse practical consequences. In the first place, it will impose a severe administrative burden on the FDA and require the reallocation of scarce resources from activities of far greater value in protecting public health. As Congress has observed, the formal rulemaking procedures set out in 21 U.S.C. 371 are "cumbersome, time-consuming, and impracticable." S.Rep. 1635, supra, at 2; H.R. Rep. 1385, supra, at 2. /7/ Yet the D.C. Circuit's decision would mandate such proceedings for numerous substances. The FDA currently has 21 informal action levels for eight substances that could be regarded as within the scope of Section 346, /8/ and the decision below, at the least, would seem to require that each of these be replaced by a formal tolerance. Moreover, the logic of the court of appeals' decision is not limited to those substances for which an action level has been set but rather extends to all added, unavoidable poisonous or deleterious substances in food. Once formal tolerances are set, they may hamper the FDA's ability to respond quickly to new scientific findings or improvements in manufacturing processes that make it practicable to reduce the level of adulterants. See 21 C.F.R. 509.6(b)(3). If a formal tolerance is in effect, a food that does not exceed the tolerance is automatically deemed to be safe and not adulterated under Sections 342(a)(2) and 346. In addition, Section 346 provides that the food may not then be considered to be adulterated within the meaning of Section 342(a)(1) -- even if the government could prove in court that the food may be "injurious to health." Thus, if a formal tolerance is issued and it is later discovered that the limit is too high, foods that satisfy the formal tolerance but that may in fact be unsafe according to the latest scientific studies will still be considered safe and unadulterated under the FDCA until the lengthy process of issuing a new, lower tolerance can be completed. /9/ Finally, the reasoning of the court of appeals casts a cloud over the legality of much of the nation's food supply. As previously noted, one of the two bases for the decision below was the court's mistaken belief that unless a formal tolerance has been issued any food containing an added, unavoidable poisonous or deleterious substance must be considered to be adulterated. Since much of the food supply now contains such substances (albeit in safe amounts), the obvious implication of the court's reasoning is that this food is "adulterated" within the meaning of 21 U.S.C. 331 and that persons responsible for growing, processing, or distributing it are subject to injunction (21 U.S.C. 332), seizure of the food (21 U.S.C. 334), or even criminal penalties (21 U.S.C. 333). For those potentially affected, it is cold comfort that the court's pronouncement was dictum and that the government would exercise its enforcement discretion in a fair and reasonable manner. See 21 U.S.C. 336; Heckler v. Chaney, No. 83-1878 (Mar. 20, 1985). If the court of appeals' decision is allowed to stand, one of two things must happen. Either there must be a cessation of the production and shipment of all foods containing any amount of any added poisonous or deleterious substance, or all segments of the food industry must act in apparent violation of the FDCA until the lengthy process of of issuing formal tolerances is completed. We assume that the latter course would be followed in the absence of congressional action, but we do not believe that the agency and the food industry should be compelled to operate under such conditions. CONCLUSION The petition for a writ of certiorari should be granted. Respectfully submitted. CHARLES FRIED Acting Solicitor General RICHARD K. WILLARD Acting Assistant Attorney General KENNETH S. GELLER Deputy Solicitor General SAMUEL A. ALITO, JR. Assistant to the Solicitor General LEONARD SCHAITMAN MARLEIGH D. DOVER Attorneys THOMAS SCARLETT Chief Counsel Food and Drug Administration OCTOBER 1985 /1/ Since 1969, the action level for aflatoxin in human food or animal feed has been 20 parts per billion. App., infra, 22a. /2/ Because the court of appeals reversed on this ground, it did not consider respondents' other claims (App., infra, 2a). /3/ Section 342(a)(1) states that "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" (emphasis added). This sentence makes clear that Section 342(a)(1) was meant to govern both added and inherent substances. /4/ Besides its parsing of the second sentence of Section 346, the court of appeals' only ground for its decision was the belief that a food containing a substance such as aflatoxin is adulterated and thus cannot be shipped in interstate commerce unless a regulation establishing a tolerance is in effect. App., infra, 7a. This interpretation of the statute is mistaken. To be sure, if a tolerance has been set, a food containing a substance such as aflatoxin is unsafe and adulterated under Sections 342(a)(2) and 346 unless the tolerance is met. But neither these nor any other provisions of the FDCA provide that a food containing a substance like aflatoxin is unsafe or adulterated if no tolerance is in effect. In that situation, Sections 342(a)(2) and 346 are silent. Section 342(a)(1) is then the governing provision, and the food is considered to be adulterated only if it can be shown to be "injurious to health." /5/ The FDA Commissioner, Charles W. Crawford, stated (Federal Food Drug, and Cosmetic Act: Hearing on H.R. 4277 Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 83d Cong., 1st Sess. 121 (1953): We have given out so-called informal tolerances on a great many of these things, we have freely given that out and if their schedules bring those spray residues within those informal tolerances there is no basis under the law for us to proceed because if we proceed on the other provision of section 402(2) U.S.C. 342) -- that is 402(a)(1) (21 U.S.C. 342(a)(1)), we have to assume the burden of proving that the quantity of the spray residue present in this particular commodity here in and of itself may injure the health of consumers and we would not give a tentative tolerance at a figure where there was any likelihood of our being able to make a case of that kind. The National Canners Association wrote to both the House and Senate committees to express its understanding that Section 408 (21 U.S.C. 346a) would apply only to raw agricultural products. The Association's letter to the House committee stated (Federal Food, Drug, and Cosmetic Act: Hearing on H.R. 7125 Before the House Comm. on Interstate and Foreign Commerce, 83d Cong., 2d Sess. 31 (1954) (emphasis added)): It is the understanding of the National Canners Association that after passage of this bill processed foods will be in exactly the same position as before in that tolerances for pesticide residues with respect to processed foods may be established under section 406 (21 U.S.C. 346) of the Act; that in the event the Secretary acts to establish a tolerance for residues on processed foods under section 406 actions for adulteration will be taken under section 402(a)(2) but if the Secretary has not acted under 406 any action for adulteration because of excessive pesticide residue in the processed food will still be taken under section 402(a)(1) (21 U.S.C. 342(a)(1)). This understanding of the canning industry is, we are advised, shared by Dr. Miller (i.e., Representative Miller, the sponsor of the House bill), by the FDA, and by all others interested in this legislation. See also Residues of Pesticide Chemicals: Hearing on S. 2868 and H.R. 7125 Before the Subcomm. on Health of the Senate Comm. on Labor and Public Welfare, 83d Cong., 2d Sess. 93 (1954) (NCA letter to the Senate committee chairman to the same effect). /6/ While the language of Sections 346 and 346a is similar in the respect noted above, the overall scheme for regulating pesticide chemicals in or on agricultural commodities differs significantly from the statutory scheme governing other added, deleterious or poisonous substances. Accordingly, we do not believe that the decision of the court of appeals applies to action levels for pesticides. /7/ This is graphically illustrated by the adoption of formal tolerances for polychlorinated biphenyls (PCBs) in paper materials used in packaging foods. In March 1972, the FDA proposed to establish formal tolerances for PCBs in food and paper food-packaging materials. 37 Fed. Reg. 5705. In July 1973, the FDA published a final rule based on the proposal. 38 Fed. Reg. 18096. At the request of several paper industry firms a public hearing was granted. 40 Fed. Reg. 11563 (1973). Subsequently, the FDA's Bureau of Foods and the industry parties reached a proposed settlement agreement, which was submitted for the Commissioner's approval in November 1978. After further proceedings, a revised settlement agreement was announced in the Federal Register in August 1983. 48 Fed. Reg. 37020. Thus, the promulgation of a formal tolerance -- where there was an objection but no full trial-type hearing -- took more than a decade to complete. /8/ FDA action levels to which Section 346 could apply are: aflatoxin, cadmium, crotolaria seeds, mercury, nitrosodimethylamine (NDMA), paralytic shellfish toxin, polybrominated biphenyls (PBBs), and plychlorinated biphenyls (PCBs). /9/ This, too, is illustrated by the FDA's experience with the formal PCB tolerances. Based on newly obtained toxicological data, the FDA in April 1977 proposed to lower the existing tolerance for residues of PCBs in fish, shellfish, and several other classes of food. 42 Fed. Reg. 14487. The final rule was promulgated in 1979. 44 Fed. Reg. 38330. At the request of a fishing industry trade association, a hearing was held in May 1981, and the FDA issued its decision in March 1982. 47 Fed. Reg. 10079. After the agency invited the submission of other relevant materials (ibid.), the final decision was issued in May 1984. 49 Fed. Reg. 21514. Accordingly, the entire process of lowering the tolerance for PCBs in fish and shellfish took seven years, although a comparable amendment of an action level probably could have been effected in a relatively brief period. APPENDIX