954 F.Supp.2d 965 (2013)

[966] George Andreas Kimbrell, Paige Michele Tomaselli, Center for Food Safety, San Francisco, CA, for Plaintiffs.

Gerald Cooper Kell, US Dept. of Justice, Washington, DC, for Defendant.

ORDER RE CROSS-MOTIONS FOR SUMMARY JUDGMENT

PHYLLIS J. HAMILTON, District Judge.

The parties' cross-motions for summary judgment came on for hearing before this court on March 27, 2013. Plaintiffs appeared by their counsel George Kimbrell, and defendant appeared by her counsel Gerald Kell. Having read the parties' papers and carefully considered their arguments and the relevant legal authority, the court hereby GRANTS plaintiffs' motion and DENIES defendant's motion as follows.

BACKGROUND

This is an action brought by plaintiffs Center for Food Safety and Center for Environmental Health against Margaret Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration ("FDA"), pursuant to the Administrative Procedures Act ("APA"), 5 U.S.C. § 551, et seq. Plaintiffs seek declaratory and injunctive relief regarding the failure of the FDA to promulgate final regulations by mandatory deadlines contained in the FDA Food Safety and Modernization Act of 2010 ("FSMA"), Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified in scattered sections of 21 U.S.C. § 301 et seq., as amended).^[1]

Congress enacted the FSMA — which was signed into law on January 4, 2011 — to modernize food safety laws and regulations by mandating science-based standards and controls; by providing the FDA with greater authority to prevent and address food safety hazards by taking steps to prevent them from occurring; by strengthening the FDA's inspection and enforcement powers; and by improving coordination among federal, state, and foreign food safety agencies. See H.R.Rep. No. 111-234 (2009) at 35-40.^[2] To this end, Congress directed the FDA to promulgate new regulations in seven areas, within 18 months of the effective date of the FSMA.

The seven major food safety regulation areas, and the implementation dates listed in the legislation, are as follows:

(1) regulations with regard to establishing science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventing controls, and documenting implementation of preventive controls, as required by 21 U.S.C. § 350g(n)(1) (regulations to be promulgated "[n]ot later than 18 months after January 4, 2011" — or July 4, 2012);

(2) regulations with regard to (a) activities that constitute on-farm packing or holding of food not raised or consumed on such farm or another under the same ownership for purposes of [967] § 415 of the Food, Drug, and Cosmetic Act; and (b) activities that constitute on-farm manufacturing or processing of food not consumed on that farm or on another farm under common ownership for purposes of § 415, as required by provision that the FDA must clarify activities included as part of definition of "facility," pursuant to 21 U.S.C. § 350d note ("notice of proposed rulemaking" to be published in Federal Register "[n]ot later than 9 months after date of enactment" — or by October 4, 2011 — with final rules to be adopted 9 months after close of comment period);

(3) regulations establishing science-based minimum standards for safe production and harvesting of fruits and vegetables, as required by 21 U.S.C. § 350h (notice of proposed final rulemaking to be published by January 4, 2012, with final regulation to be adopted within one year after close of final comment period);

(4) regulations to protect against intentional adulteration of food subject to FSMA, as required by 21 U.S.C. § 350i(b), in consultation with Secretary of Homeland Security and Secretary of Agriculture (regulations due "[n]ot later than 18 months after January 4, 2011" — or July 4, 2012);

(5) regulations regarding FDA requirement that shippers, carriers by motor vehicle or rail, receivers, and other persons engaged in transportation of food use sanitary transportation practices to ensure that food is not transported under conditions that might render it adulterated, as required by 21 U.S.C. § 350e(b) and note (regulations due by July 4, 2012);

(6) regulations regarding foreign supplier verification program, as required by 21 U.S.C. § 384a(c) (final regulations due by January 4, 2012);

(7) regulations ensuring the neutrality and independence of third-party audits, as required by 21 U.S.C. § 384d(c)(5)(C) (final regulations due by July 4, 2012).

In the complaint, which was filed on August 29, 2012, plaintiffs allege that certain proposed and final regulations have not been issued within the time frame set forth in the FSMA. Plaintiffs seek a judicial declaration that the FDA has violated the FMSA and the APA by failing to issue the regulations by the statutory deadlines, and continues to be in violation of the FMSA and the APA for failing to promulgate the regulations. Plaintiffs also seek an order ordering the FDA to issue the regulations as soon as reasonably possible, according to a court-ordered timeline. In addition, plaintiffs request that the court retain jurisdiction over the case to ensure compliance with the order.

Each side now seeks summary judgment. The issues to be decided are whether the FDA has "unlawfully withheld" or "unreasonably delayed" action in violation of the APA by failing to promulgate the FMSA regulations by the statutory deadlines, and whether the court must grant plaintiffs the relief they seek.

DISCUSSION

A. Legal Standard

A party may move for summary judgment on a "claim or defense" or "part of... a claim or defense." Fed.R.Civ.P. 56(a). Summary judgment is appropriate when there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. Id.

As a general matter, district courts are empowered by the APA to review agency action, and have federal question jurisdiction over such claims pursuant to 28 U.S.C. § 1331. For a court to review agency action pursuant to the APA, there [968] must be "final agency action for which there is no other adequate remedy in a court." 5 U.S.C. § 704. "Agency action" also includes a "failure to act." 5 U.S.C. § 551(13).

In a "failure to act" case, a court can "compel agency action unlawfully withheld or unreasonably delayed." 5 U.S.C. § 706(1). Judicial review is appropriate if the plaintiff makes a showing of "agency recalcitrance ... in the face of clear statutory duty or ... of such a magnitude that it amounts to an abdication of statutory responsibility." ONRC Action v. Bureau of Land Mgmt., 150 F.3d 1132, 1137 (9th Cir.1998) (citation and quotation omitted).

In Norton v. Southern Utah Wilderness Alliance, 542 U.S. 55, 124 S.Ct. 2373, 159 L.Ed.2d 137 (2004), the Supreme Court explained that a "failure to act" within the meaning of the APA is the failure of the agency to issue an "agency rule, order, license, sanction or relief." Id. at 62, 124 S.Ct. 2373. That is, judicial review of a failure to act under § 706(1) "is properly understood to be limited ... to a discrete action" such as "the failure to promulgate a rule or take some decision by a statutory deadline." Id. at 63, 124 S.Ct. 2373.

However, even discrete agency action cannot be compelled under § 706(1) unless that action is "demanded by law." Id. at 65, 124 S.Ct. 2373. Statutory goals that are "mandatory as to the object to be achieved" but leave the agency with "discretion in deciding how to achieve" those goals are insufficient to support a "failure to act" claim because such discretionary actions are not "demanded by law." Id. at 66, 124 S.Ct. 2373.

The sole remedy available under § 706(1) is for the court to "compel agency action," such as by issuing an order requiring the agency to act, without directing the substantive content of the decision. Thus, "a claim under § 706(1) can proceed only where a plaintiff asserts that an agency failed to take a discrete agency action that it is required to take." Id. at 64, 124 S.Ct. 2373.

B. The Parties' Motions

The FDA regulates more than $400 billion worth of domestic and imported food and hundreds of thousands of registered food facilities. Its responsibilities in the food area generally cover almost all domestic and imported food (except for meat, poultry, eggs, tolerance for pesticide residues in food, and requirements for public drinking water). The FDA argues that the regulations that it was directed to promulgate under the FMSA are novel and complex, and the complexity is increased by the need to build a cohesive system of regulatory controls integrating different regions and countries, as well as different food types, and also coordinate with other regulations (such as regulations relating to small businesses) and other federal and state agencies.

The FDA contends that during the period that it has been working on the new regulations, it has also continued to monitor the food industry, and to exercise its preexisting authority regarding food safety under the Federal Food, Drug, and Cosmetic Act (including responding to outbreaks of food-borne illnesses, developing non-FMSA related guidance documents and rulemaking, and overseeing the safety of imported foods as they enter the country).

To carry out this complex and difficult task, the FDA first established an implementation committee, which in turn established six implementation teams, with a number of working groups under those teams. The working groups were assigned the hands-on responsibility for developing [969] the regulations, reports, guidance, and processes required by FMSA.

The FDA asserts that even with this organizational structure specifically directed at the expedited implementation of the FSMA, the aggressive timelines set forth in the statute have proven to be unachievable. In addition, because promulgating the new regulations requires the participation and input of individuals with specific expertise — writers, subject matter experts, regulatory counsel, attorneys, economists, program managers, and operations specialists — and because the FDA employs only a limited number of such individuals (particularly those having the relevant subject matter expertise), the FDA has found it difficult to staff the simultaneous development of such a large number of major rules in the same general subject area.

For this reason, the FDA determined that it needed to prioritize, and decide which regulations to develop first. It initially selected four rules that would be in the "first wave" — Preventive Controls for Human Food; Produce Safety Standards; Foreign Supplier Verification Program; and Preventive Controls for Animal Food. These rules were selected because they are foundational for other rules and offer the most public health benefits. The rules placed in the "second wave" are Intentional Adulteration, Sanitary Transport, and Accredited Third Parties.

The FDA contends that it has been working diligently to develop the required regulations. Briefly, with regard to the "first wave," the FDA submitted draft proposed rules to OMB for review in November and December 2011. According to the FDA, the review process for all four rules is "ongoing." As for the "second wave," the FDA determined with regard to Intentional Adulteration that it would benefit for more information and ideas as to how to implement this novel requirement before engaging in rulemaking, and thus developed a draft Notice of Proposed Rulemaking which is currently undergoing review within the FDA. With regard to Sanitary Transport, the FDA asserts that it has developed draft codified and preamble language, which is currently undergoing review within the FDA. With regard to Accredited Third Parties, the FDA contends that it sent a draft proposed rule to OMB in November 2012, and review remains ongoing.

In addition, after the FDA filed the present motion, it issued two complex and major proposed rules — Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food," and "Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" — which set out extensive new proposals for preventing problems that can cause foodborne illness. The FDA asserts that these proposals are concrete steps taken to implement three of the seven statutory requirements identified in plaintiffs' complaint.

The FDA concedes that FMSA provides specific deadlines for the promulgation of the regulations, but argues that because the issue under the APA is whether it has "unreasonably delayed" in issuing the regulations, the matter that needs to be resolved is the reasonableness of the FDA's administrative timeline. The FDA asserts that it has responded to FMSA by making its implementation a top priority, but still has not been able to complete rules of such magnitude and complexity within the statute's timeframes.

The FDA agrees that these regulations are important to public health and safety, but argues that is just as important that any regulations that are promulgated [970] be carefully developed, given the scope and magnitude of what is called for by the statute. The FDA argues that a particular administrative timetable should be evaluated under the six-factor test set forth in Telecommunications Res. & Action Ctr. v. F.C.C., 750 F.2d 70 (D.C.Cir.1984) ("TRAC").^[3]

In their motion, plaintiffs submit that the FSMA resulted from Congress' recognition of the prevalence and severity of the food-borne illness problem, and argue that it was because of the need to remedy this problem that Congress instructed the FDA to act quickly to promulgate the needed regulations. Plaintiffs contend that without regulations to give it effect, FMSA cannot reduce the dangers to consumers of food-borne illnesses. They contend that because the FDA has not complied with the statutory deadlines set by Congress, the issue under the APA is failure to act.

Plaintiffs disagree with the FDA's argument that the court should apply the TRAC balancing test to this case. They contend that the TRAC test applies only where the issue is whether a delay is unreasonable in the absence of express Congressional deadlines. Here, however, because Congress included mandatory deadlines in the FMSA, plaintiffs argue that the FDA cannot be excused for its per se violation of the law (failing to meet those deadlines).

Plaintiffs contend that the court should grant their motion as a matter of law because the FDA has failed to comply with the mandatory FMSA deadlines. Specifically, plaintiffs seek an order declaring that the FDA has not complied with the deadlines proscribed by FSMA; and compelling the FDA to promulgate and finalize the required regulations by dates certain — including issuing the rules, providing notice and opportunity for comment, and issuing final regulations.

Plaintiffs suggest that the court could either order the parties to stipulate to deadlines; or order the FDA to provide the court with "expedited dates," and then afford plaintiffs an opportunity to oppose the FDA's proposed deadlines. In addition, plaintiffs request that the court retain jurisdiction to ensure that the FDA complies with the court-mandated schedule, and to ensure that the FDA complies with additional upcoming FSMA deadlines.

The court finds that given that the FDA has admittedly failed to comply with the mandatory rulemaking schedule, declaratory relief is proper. As noted above, plaintiffs seek a judicial declaration that the FDA has violated the FMSA and the APA by failing to promulgate the FMSA regulations by the statutory deadlines. The FDA asserts that the court should evaluate this case under the TRAC factors, in order to determine whether it has violated the APA by unreasonably delaying the promulgation of the regulations. However, because the FMSA includes specific deadlines, the failure to comply with those deadlines constitutes a "failure to act" under [971] the APA. See Forest Guardians v. Babbitt, 174 F.3d 1178, 1189-90 (10th Cir. 1999). Moreover, where Congress has specifically provided a deadline for performance by an agency, "no balancing of factors is required or permitted." Biodiversity Legal Found. v. Badgley, 309 F.3d 1166, 1177-78 & n. 11 (9th Cir.2002).^[4]

The question with regard to injunctive relief is less straightforward. Plaintiffs seek an order compelling the FDA to complete the rulemaking process by a date certain. That is, they contend that having found that the FDA has violated the FMSA and the APA by failing to complete the regulations by the statutory deadlines, the court is required to issue an order compelling the FDA to act.

The APA provides that a court "shall" compel unlawfully withheld agency action. See 5 U.S.C. § 706. The question is whether the court has any discretion in this regard. In Forest Guardians, the Tenth Circuit held that where a statute requires action by a date certain, and the plaintiffs proceed under § 706, the courts lack discretion not to grant injunctive relief. Id., 174 F.3d at 1190. However, in In re Barr Labs., Inc., the D.C. Circuit held that courts maintain discretion not to compel agency action even where deadlines are mandatory. Id., 930 F.2d 72, 74 (D.C.Cir.1991).

The Ninth Circuit addressed this issue in Biodiversity, concluding that "a statutory violation does not always lead to the automatic issuance of an injunction." Id., 309 F.3d at 1177. "[W]hen federal statutes are violated, the test for determining if equitable relief is appropriate is whether an injunction is necessary to effectuate the congressional purpose behind the statute." Id. The court looked at the Endangered Species Act (the statute at issue in the case) to determine whether equitable relief was proper, and found that it was, because effectuating Congress' clear intent of protecting endangered species required compelling compliance with the ESA.

Here, the parties are in agreement that the "purpose" of the FMSA is to protect human health by ensuring that the food supply is safe from contaminants. Plaintiffs contend that the regulations are essential to that purpose, and the FDA counters that the issuance of the required regulations on a rushed or hurried basis would not help protect human health and safety. Given that the parties are essentially in agreement as to the purpose of the FMSA, the question becomes whether the court should grant injunctive relief, and if so, what form that relief should take.

Beyond the evident purpose of the FMSA — to ensure the safety of the food supply — Congress also intended that the implementing regulations be promulgated and finalized by a date certain. The dates set for completion of the regulations in the seven areas identified in the complaint have passed. However, that does not mean that the FMSA now should be interpreted as granting the FDA total discretion in deciding when to finalize the regulations. While the FMSA vests the FDA with discretion regarding the substance of the mandated regulations, endless delay does not serve any purpose of the FMSA. At a minimum, it seems clear that by setting deadlines, Congress signaled its intention that the process be closed-ended, rather than open-ended. Thus, the court finds that imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of the FMSA.

[972] Nevertheless, the FDA is correct that the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress. The court issues the following order in the hope that the parties will themselves arrive at a mutually acceptable schedule. It will behoove the parties to attempt to cooperate on this endeavor, as any decision by the court will necessarily be arbitrary.

The parties are hereby ORDERED to meet and confer, and prepare a joint written statement setting forth proposed deadlines, in detail sufficient to form the basis of an injunction. The joint statement shall be submitted no later than May 20, 2013. After reviewing the statement, the court will determine whether any further written submissions would be helpful or necessary.

As for the request for discovery, the only disputed "facts" here relate to the question whether the FDA's delay was unreasonable. Given the ruling that the action is one to compel agency action unlawfully withheld — not to compel agency action unreasonably delayed — and the fact that the court finds the TRAC factors inapplicable to that analysis, the question whether discovery should be permitted falls by the wayside.

CONCLUSION

In accordance with the foregoing, plaintiffs' motion for summary judgment is GRANTED and defendant's motion is DENIED. Plaintiffs' request for declaratory relief is GRANTED, and the court hereby declares that defendant has violated the FMSA and the APA by failing to promulgate the FSMA regulations by the statutory deadlines. Plaintiffs' request for injunctive relief is also GRANTED. The scope of such relief will be determined following the parties' May 20, 2013 submission or such other submissions as deemed warranted.

IT IS SO ORDERED.

[1] The complaint also asserted claims against Jeffrey Zients, Acting Director of the Office of Management and Budget ("OMB"). Those claims were dismissed on January 14, 2013, pursuant to stipulation of the parties.

[2] H.R.Rep. No. 111-234 relates to the Food Safety Enhancement Act, which was passed by the House of Representatives on July 30, 2009. The FSMA, which was passed by the Senate and the House in December 2010, resulted from negotiations regarding the Senate version of the bill.

[3] Under the TRAC test, the court should consider (1) whether the time agencies take to make decisions is governed by a "rule of reason" that governs the analysis; (2) whether Congress provided a timetable in the statute; (3) whether the delays have more or less of an impact on human health and welfare (as opposed to simply having an impact in the area of economic regulation; (4) whether expediting agency action would have an effect on agency actions of a higher or competing priority; (5) the nature and extent of the interests prejudiced by the delay; and (6) whether there is any impropriety "lurking behind agency lassitude" (although such a finding is not essential to a determination that agency action has been unreasonably delayed). See id. at 80; see also cited in Brower v. Evans, 257 F.3d 1058, 1068 (9th Cir.2001).

[4] The court appreciates the FDA's attempt to distinguish Biodiversity, but finds the Ninth Circuit's ruling to be unambiguous and its reasoning unassailable.

488 F.Supp. 230 (1980)

[231] Walter B. Prince, Asst. U. S. Atty., Boston, Mass., for plaintiff.

Robert Y. Murray, Ramsey, Serino & Murray, Patricia G. Curtain, Moulton & Looney, Albert F. Cullen, Jr., Cullen & Wall, Boston, Mass., for defendants.

OPINION

CAFFREY, Chief Judge.

This is an appeal from defendants' convictions for violating § 301(k) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(k). On July 6, 1976 the government filed a seven count information charging New England Grocer Supply Co. (NEGSC) and five individual defendants with causing certain foodstuffs to become adulterated, within the meaning of 21 U.S.C. §§ 342(a)(3) and (4),^[1] while being held for sale after shipment in interstate commerce, in violation of 21 U.S.C. § 331(k).^[2] The defendants waived their right to trial by jury before a district court judge and consented [232] to be tried before a United States magistrate, pursuant to 18 U.S.C. § 3401. After a trial before the magistrate, NEGSC and three of the individual defendants, Julian J. Leavitt, president of NEGSC, Joel A. Leavitt, vice-president of NEGSC, and Julian Schultz, vice-president of NEGSC and general manager of the facility where the foodstuffs became adulterated, were found guilty on all counts of the information.^[3] The corporation was fined $1,000 on each count, Julian Leavitt was fined $250 on each count, and Joel Leavitt and Julian Schultz were both fined $500 on each count.

The scope of review by a district court on appeal from a conviction before a magistrate is "the same as on an appeal from a judgment of a district court to a court of appeals." 18 U.S.C. § 3402; Rule 8(d), Rules of Procedure for the Trial of Minor Offenses Before United States Magistrates. The defendants challenge the conviction below on several grounds.

I

The first ground of appeal relates solely to the defendant Julian Leavitt, president of NEGSC. He contends that he was found guilty by the magistrate solely because he was company president at the time the violations occurred. This was error, defendant argues, because the Supreme Court's decision in United States v. Park, 421 U.S. 658, 95 S.Ct. 1903, 44 L.Ed.2d 489 (1975), requires a finding of negligence or other blameworthiness in order to sustain a conviction for violation of the Food, Drug, and Cosmetic Act.

In Park, the Supreme Court reconsidered and reaffirmed the standard of liability set forth in United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48 (1943), for conviction of a corporate officer under the Act. Dotterweich established two propositions. First, the Act "dispenses with the conventional requirement for criminal conduct — awareness of some wrongdoing." Id. at 281, 64 S.Ct. at 136. Second, the scope of liability includes all those who have "a responsible share in the furtherance of the transaction which the statute outlaws . . .." Id. at 284, 64 S.Ct. at 138. In Park, the Court reaffirmed the first proposition and elaborated somewhat on how the government establishes a "responsible relationship" under Dotterweich.

The Park Court stated that Dotterweich and the cases following it establish that "the Act imposes [on responsible corporate agents] not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur." 421 U.S. at 672, 95 S.Ct. at 1911. The government establishes a prima facie case against corporate officer "when it introduces evidence sufficient to warrant a finding by the trier of the facts that the defendant had, by reasons of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so." Id. at 673-74, 95 S.Ct. at 1912. The Court made it clear however, that a finding of guilty cannot be predicated solely on the defendant's corporate position. Id. at 674-75, 95 S.Ct. at 1912-13.

The defendant in Park was the president and chief executive officer of a national retail food chain. He was charged with the same crime as is the defendant in the instant case, viz., causing foodstuffs being held for sale following shipment in interstate commerce to become adulterated in violation of 21 U.S.C. § 331(k). Park contended as does the defendant here, that the jury instructions allowed the jury to convict him solely on the basis of his corporate position. The Supreme Court did not agree. Viewing the charge in its entirety, the Court was convinced that "the charge did not permit the jury to find guilt solely on the basis of respondent's position in the [233] corporation; rather it fairly advised the jury that to find guilt it must find respondent `had a responsible relation to the situation,' and `by virtue of his position . . . had . . . authority and responsibility' to deal with the situation." Id. at 674, 95 S.Ct. at 1912. The Court was also satisfied from its reading of the trial record that "the jury could not have failed to be aware that the main issue for determination was not respondent's position in the corporate hierarchy, but rather his accountability, because of the responsibility and authority of his position, for the conditions which gave rise to the charges against him." Id. at 675, 95 S.Ct. at 1913.

The defendant in the instant case contends that the magistrate found him guilty solely because of his corporate position as chief executive officer and that this was error since Park requires a finding of negligence or other blameworthiness. Although the defendant makes only one argument with two conjunctive parts, he asserts two separate and distinct grounds for reversal and I will treat them as such. The first ground is that the magistrate erred by convicting him solely on the basis of his corporate position; the second ground is that the magistrate erred by not making a finding of negligence or other blameworthiness.

Reviewing the magistrate's memorandum and findings, I conclude that the magistrate misconstrued the Park decision with regard to defendant Julian Leavitt. Although it appears that the magistrate understood and correctly applied Park's requirement of a "responsible relationship" in finding two other individual defendants guilty, several statements in his opinion convince me that he did not do so in convicting Julian Leavitt. Early in his opinion, the magistrate made the following observation about the Park decision: "Park (President of the corporation `Acme') was individually convicted for violation of the Act by virtue of his position as president." (Opinion at 3) (emphasis added). Later on, the magistrate again noted that Park "stands for the proposition that the head of a corporation can be charged because of his position as a corporate chief." (Opinion at 7) (emphasis added). These two statements demonstrate a basic misinterpretation of Park, since the Supreme Court made it clear that a corporate officer cannot be convicted solely on the basis of his position in the corporate hierarchy. This misunderstanding of Park is reflected in the magistrate's finding that defendant Julian Leavitt was guilty of violating the Act. In his "general discussion" section, the magistrate stated explicitly that the "finding made by this court with respect to Julian was made only on the basis that in Park, the court stated that the position of the President made him liable, responsible and subject to prosecution." (Opinion at 10) (emphasis added). This comment clearly indicates that the magistrate applied the wrong legal standard in convicting Julian Leavitt, finding him guilty solely by reason of his position as president.

To be sure, as the government points out, there are some contrary indications. In his findings of fact, the magistrate found that, beyond a reasonable doubt, "Julian who was President, although active in the operation of the company, had no direct involvement in sanitation problems, except as senior officer with ultimate authority and responsibility for preventing any violations of the Act." (Opinion at 8). This finding could be interpreted as indicating that the magistrate based the defendant's conviction on his "responsible relationship" to the violation rather than on his position as president; this interpretation is, however, negated by the explanation which the magistrate gave for his finding in his "general discussion" section. The government also points to statements made by the magistrate in a section entitled "conclusions." The government appears to rely primarily on the following "conclusion" by the magistrate:

"That Julian, by virtue of office, as one in complete control is guilty within the meaning of the Act as interpreted by Park, supra, in that he possessed the final authority to institute whatever effective programs that were required." (Opinion at 9).

[234] Although the last part of this "conclusion" does comment on the defendant's "authority" to prevent violations of the Act, the "conclusion" as a whole is tainted by the same misinterpretation of the Park decision. And, even if the "conclusion" could be read as a finding on the defendant's responsible relationship with the violations, it would not support a conviction because the magistrate did not make the finding "beyond a reasonable doubt." The government also points to other "conclusions" by the magistrate: that Julian Leavitt "had been consulted with respect to the condition at the warehouse and [was] in direct contact with" defendant Julian Schultz who was general manager and "in complete control"; that Julian Leavitt and other individual defendants could have prevented the violations had they used "higher standards of foresight and vigilance"; and that the defendant Julian Leavitt acknowledged that the "sanitation program was inadequate" at the time of the inspections. Whatever effect these "conclusions" would have in establishing a responsible relationship on the part of Julian Leavitt had the magistrate employed the proper legal standard, I choose not to credit them because of the magistrate's misinterpretation of Park.

Admittedly, looking for guidance in the Park decision is a difficult experience. The line drawn by the Court between a conviction based on corporate position alone and one based on a "responsible relationship" to the violation is a fine one, and arguably no wider than a corporate bylaw. Nevertheless, the Court clearly stated that a conviction under the Act could not be based on corporate position alone and required a finding as to the defendant's responsibility and authority to correct violations of the Act. The magistrate made such a finding with regard to the other individual defendants, but not as to Julian Leavitt. Therefore, his conviction must be reversed.

As noted earlier, defendant's contention that he was convicted solely on the basis of his corporate position was made conjunctively with the contention that the magistrate erred by convicting him without making a finding of negligence or other blame-worthiness. Because this second half of the argument speaks to the same issue raised by the second ground of appeal, I will not consider it separately here.

Thus, the conviction of defendant Julian Leavitt is reversed and his case is remanded to the magistrate for an express finding as to whether the government sustained its burden of proving beyond a reasonable doubt that the defendant bore a responsible relationship to the Food, Drug, and Cosmetic Act violations alleged in the information. If the magistrate determines that defendant did not bear a responsible relationship to the violation, he should enter a judgment of acquittal. If, however, the magistrate finds that the evidence did establish a responsible relationship, he may reinstate the defendant's conviction, but only if reinstatement is warranted after the magistrate makes the findings required by this Court's ruling on defendants' second ground of appeal. In either event, the magistrate is to state the evidentiary basis for his ruling on the responsible relationship issue.

II

The defendants' second ground of appeal is that the convictions of Julian Leavitt, Joel Leavitt, and Julian Schultz must be reversed because the magistrate did not find, beyond a reasonable doubt, that these defendants were not powerless to prevent or correct the violations of the Act. Instead, the defendants argue, the magistrate used a less rigorous, and therefore infirm standard of guilt. To support this contention, the defendants point to the magistrate's comment in his "general discussion" section that the "court is further satisfied that it was not `objectively impossible' to maintain the warehouse in a sanitary condition." (Opinion at 10). This finding is invalid, the defendants posit, because the magistrate did not mention that he was satisfied "beyond a reasonable doubt", a finding they contend is required by Park. It is important to note that the defendants do not challenge the sufficiency of the evidence to make such a finding, just that the magistrate employed an improper legal standard.

[235] The defendants' contentions relate to what is generally referred to as the "impossibility" defense. That defense derives from the following statement by the Court in Park:

"The duty imposed by Congress on responsible corporate agents is, we emphasize, one that requires the highest standard of foresight and vigilance, but the Act, in its criminal aspect, does not require that which is objectively impossible. The theory upon which responsible corporate agents are held criminally accountable for `causing' violations of the Act permits a claim that a defendant was `powerless' to prevent or correct the violation to `be raised defensively at a trial on the merits.' United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 91 [84 S.Ct. 559, 563, 11 L.Ed.2d 536] (1964). If such a claim is made, the defendant has the burden of coming forward with evidence, but this does not alter the Government's ultimate burden of proving beyond a reasonable doubt the defendant's guilt, including his power, in light of the duty imposed by the Act, to prevent or correct the prohibited condition." 421 U.S. at 673, 95 S.Ct. at 1913 (emphasis added).

It is not easy to ascertain from this passage the exact nature and scope of the impossibility defense.

One interpretation of the impossibility defense is that it relates only to the power of the corporate officer, by virtue of his position in the corporation, to correct or prevent violations of the Act. Under this interpretation, the evidence introduced by the defendant at trial to sustain his impossibility defense would serve only to rebut the evidence introduced by the government in establishing its prima facie case. Both sides would direct their proof to the responsible relationship vel non which the defendant bore to the violations of the Act. That this interpretation is what the Court intended is suggested by both the second and third italicized sections above, focusing on the defendant's "power . . . to prevent or correct the prohibited condition." The Supreme Court used much the same terms to define "responsible relationship." Under this interpretation, then, the impossibility defense would not serve as an affirmative defense, but would merely provide corporate officers a defense open to all who are criminally accused, that is, rebuttal of the government's proof.

An alternative interpretation of the impossibility defense is that it is satisfied by evidence that the corporate officer exercised "extraordinary care" and was still unable to prevent the violations. Under this interpretation, the impossibility defense would serve as an affirmative defense, incorporating an objective element — use of extraordinary care — into a strict liability offense. That this interpretation is what the Park Court intended is suggested by the Court's insistence that "the Act, in its criminal aspect, does not require that which is objectively impossible." This interpretation is also suggested by the Court's repeated emphasis that corporate officers must exercise the "highest standard of foresight and vigilance", id. at 672, 673, 95 S.Ct. at 1913, and the "highest standard of care," id. at 676, 95 S.Ct. at 1913. The Park Court's citation to United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 84 S.Ct. 559, 11 L.Ed.2d 536 (1964), is also illuminating. In Wiesenfeld, the Court first suggested the existence of the impossibility defense, stating that "one `who is, by the very nature of his business powerless' to protect against this kind of contamination, however high the standard of care exercised" may raise such defense at trial. Id. at 91, 84 S.Ct. at 563. Wiesenfeld clearly suggests that a corporate officer who exercises extraordinary care and still is unable to prevent violations of the Act will not be held criminally culpable. Finally, further support for this second interpretation of the impossibility defense can also be found in the Court's suggestion that a corporate officer who introduces sufficient evidence of impossibility is entitled, upon request, to a jury instruction that the government is required to prove beyond a reasonable doubt that the defendant was not without the power or capacity to affect the conditions which [236] founded the charges in the information. 421 U.S. at 676-77, 95 S.Ct. at 1913-14. This suggests a separate and distinct burden on the government to disprove an affirmative defense of impossibility, at least once sufficient evidence has been introduced by the defendant to raise that defense.

On balance, although support can also be found for the first interpretation of the impossibility defense in the language of Park, it appears that the second interpretation is the proper one. Moreover, this interpretation appears to be in accord with the two cases which have considered the impossibility defense since Park, United States v. Y. Hata & Co., 535 F.2d 508, 510-12 (9th Cir.), cert. denied, 429 U.S. 828, 97 S.Ct. 87, 50 L.Ed.2d 92 (1976); United States v. Starr, 535 F.2d 512, 515-16 (9th Cir. 1976); cf. United States v. Corbin Farm Service, 444 F.Supp. 510, 536 (E.D.Cal.) (applying impossibility defense to the Migratory Bird Treaty Act, 16 U.S.C. §§ 703 et seq.), aff'd on other grounds, 578 F.2d 259 (9th Cir. 1978), and with legal commentary, Developments in the Law—Corporate Crime: Regulating Corporate Behavior Through Criminal Sanctions, 92 Harv.L.Rev. 1227, 1262-65 & nn. 106 & 107 (1979); O'Keefe, Criminal Liability: Park Update, 32 Food Drug Cosm. L.J. 392, 395 (1977). In light of the severe penalties which may be imposed for a second conviction under the Act, 21 U.S. C.A. § 333,^[4] I am inclined to adopt this more lenient interpretation of the impossibility defense. Rewis v. United States, 401 U.S. 808, 812, 91 S.Ct. 1056, 1059, 28 L.Ed.2d 493 (1971); See United States v. United States Gypsum Co., 438 U.S. 422, 437-38, 442 n.18, 98 S.Ct. 2864, 2873-74, 2876 n.18, 57 L.Ed.2d 854 (1978); Morissette v. United States, 342 U.S. 246, 254 n.14, 256, 72 S.Ct. 240, 245 n.14, 246, 96 L.Ed. 288 (1952).

In sum, the impossibility defense allows the corporate officer to introduce evidence to establish an affirmative defense that he exercised extraordinary care and still could not prevent violations of the Act. The defense is raised when the defendant introduces a sufficient quantum of evidence as to his exercise of "extraordinary care" so as to justify placing an additional burden on the government. At this point, the government must prove beyond a reasonable doubt that the defendant, by the use of extraordinary care, was not without the power or capacity to correct or prevent the violations of the Act.^[5]

Turning to the record of the instant case, I rule that it is impossible to determine whether the magistrate applied the proper legal standard. His comment that the "court is further satisfied that it was not `objectively impossible' to maintain the warehouse in a sanitary condition" can be read either as a finding that the defendant did not introduce sufficient evidence to raise the impossibility defense, or as a finding that, although the defendant introduced sufficient evidence to raise the defense, the government sustained its additional burden to disprove the defense. If the latter, the magistrate's finding is legally deficient because he does not state that the government sustained its burden beyond a reasonable doubt. Because of this uncertainty in the magistrate's finding on the impossibility defense, the convictions of Joel Leavitt and Julian Schultz are also reversed. On remand, the magistrate is to make a finding as to these two defendants whether they introduced sufficient evidence to raise the impossibility defense,^[6] and, if so, whether the government sustained its burden of disproving [237] the defense beyond a reasonable doubt. And, if the magistrate determines on remand that defendant Julian Leavitt bore a responsible relationship with the violations charged in the information, he should also determine whether Julian Leavitt succeeded on his impossibility defense. The magistrate is to make clear the evidentiary basis for his findings.^[7]

III

The defendants' remaining arguments on appeal relate to the denial of their motion to suppress evidence gained during two warrantless administrative inspections of their warehouse. These warrantless inspections, conducted pursuant to the authority granted by 21 U.S.C. § 374,^[8] took place in January and June of 1975; the FDA investigators discovered evidence of rodent infestation and took various product samples for testing.

The defendants first contend that the warrantless inspections violated their Fourth Amendment rights. The defendants raised this argument in their motion to suppress prior to trial. On September 1, 1977, the magistrate ruled that, under the rationale of United States v. Biswell, 406 U.S. 311, 92 S.Ct. 1593, 32 L.Ed.2d 87 (1972), which sanctioned warrantless searches in certain "pervasively regulated" industries, warrants are not required for inspections conducted pursuant to § 374. Nevertheless, the magistrate suppressed the evidence obtained from the June investigation because he found that the focus of the investigation had changed from a routine administrative inspection to a criminal investigation and the defendants had not received Miranda warnings. On interlocutory appeal pursuant to Rule 5 of the Rules of Procedure for the Trial of Minor Offenses Before United States Magistrates this Court agreed with the magistrate's ruling that Biswell applies to inspections under § 374 and therefore that neither a warrant or consent is required, United States v. New England Grocer Supply Co., 442 F.Supp. 47, 48 (D.Mass.1977); however, the Court reversed the magistrate's ruling that Miranda warnings were required during the June inspection. Id. at 49. The defendants now ask this Court to reconsider its previous ruling as to the applicability of Biswell to § 374 inspections, based primarily on the Supreme Court's recent decision in Marshall v. Barlow's, Inc., 436 U.S. 307, 98 S.Ct. 1816, 56 L.Ed.2d 305 (1978).

[238] In Barlow's, the Court held that the warrantless searches authorized by § 8(a) of the Occupational Safety and Health Act, 29 U.S.C. § 657(a), violated the Fourth Amendment. In so doing, however, the Court expressly left intact the exception to the warrant requirement recognized in Biswell and Colonnade Catering Corp. v. United States, 397 U.S. 72 (1970), for closely regulated industries. 436 U.S. at 313, 98 S.Ct. at 1820. In those cases, the Barlow's Court explained, warrantless searches were upheld because a businessman voluntarily entering a closely regulated industry can have "no reasonable expectation of privacy," and "in effect consents to the restrictions placed upon him." Id. Although the Court did not indicate what industries other than firearms (Biswell) and liquor (Colonnade) might fall within the exception to the warrant requirement, it noted that some regulatory statutes "apply only to a single industry, where regulations might already be so pervasive that a Colonnade-Biswell exception to the warrant requirement could apply." Id. at 321, 98 S.Ct. at 1825. The Barlow's Court also stated that the reasonableness of a warrantless search provision in a regulatory statute "will depend on the specific enforcement needs and privacy guarantees of each statute." Id.

After the Court's decision in Biswell and prior to its decision in Barlow's, the weight of authority upheld the constitutionality of the warrantless inspections authorized by § 374. United States v. Acri Wholesale Grocery Co., 409 F.Supp. 529, 533 (S.D.Iowa 1976); United States v. Business Builders, Inc., 354 F.Supp. 141, 143 (N.D.Okl.1973); United States v. Del Campo Baking Mfg. Co., 345 F.Supp. 1371, 1376 (D.Del.1972); contra United States v. Litvin, 353 F.Supp. 1333, 1338 (D.D.C.1973). Contrary to the only other post-Barlow's decision thus far considering the constitutionality of § 374, United States v. Roux Laboratories, Inc., 456 F.Supp. 973, 977 n.2 (M.D.Fla.1978), I do not read Barlow's as requiring a knee-jerk invalidation of the warrantless inspections authorized by § 374. Cf. Marshall v. Nolichuckey Sand Co., 606 F.2d 693, 694-96 (6th Cir. 1979); Marshall v. Stoudt's Ferry Preparation Co., 602 F.2d 589, 592-94 (3rd Cir. 1979), cert. denied, ___ U.S. ___, 100 S.Ct. 665, 62 L.Ed.2d 644 (1980); Marshall v. Donofrio, 465 F.Supp. 838, 841-43 (E.D.Pa. 1978), aff'd, 605 F.2d 1196 (3d Cir. 1979) (post-Barlow's cases holding that the warrantless inspection provision of the Federal Mine Safety and Health Amendments Act of 1977, 30 U.S.C. § 813(a), does not violate the Fourth Amendment). Rather, given the pervasive nature and long history of federal regulation of the food and drug industry, considering that, in contrast to the situation in Barlow's, these regulations apply to a particular industry and not a wide range of business establishments, and mindful of the urgent public health interests that are served by the inspections,^[9] I rule that warrantless inspections pursuant to § 374 are fully consistent with the Fourth Amendment. Therefore, neither a warrant or consent was required to conduct the inspections of defendants' warehouse.

Defendants make several other contentions with regard to the denial of their motion to suppress. First, the defendants argue that the warrantless inspections were invalid because the FDA agents did not secure the defendants' consent. Because of my ruling that the Biswell rationale applies to warrantless inspections conducted pursuant to § 374, I need not consider whether the defendants, in fact, consented to the inspections. The defendants next contend that, even if no warrant or consent was [239] required initially, the warrantless inspections became unreasonable under the Fourth Amendment once the FDA agents had probable cause to suspect violations of the Act. As to this contention, I rule that the FDA agents were not required to suspend the valid warrantless inspections and secure a warrant once they had reason to suspect violations of the Act, so long as the searches were otherwise reasonable in time, manner, and scope as required by § 374.

Defendants' final contention is that the inspections did not comply with § 374, both because the FDA agents did not initiate the inspections by presenting a written notice to the "owner, operator, or agent in charge" and because the inspections were "unreasonable" in time, manner, and scope. As to the first part of this argument, it is relevant that the FDA agent commenced each inspection by asking to see the person most responsible or the person in charge. In January, the agent was directed to David Ginsberg, vice-president of purchasing, whereupon he presented his credentials and issued a notice of inspection to both Mr. Ginsberg and James Kaminsky, the warehouse sanitation officer. In June, the agent presented his credentials and issued a notice of inspection to Peter DeGannaro, the assistant treasurer. I rule that Ginsberg, Kaminsky, and DeGannaro were all "agents" within the meaning of § 374 since they were "responsible representatives of management." See S.Rep.No. 712, 83d Cong., 1st Sess., reprinted in 2 U.S.Code Cong. & Admin.News, pp. 2198, 2203 (1953). The second part of defendants' argument with regard to § 374 is that the inspections were unreasonable in time, manner, and scope and were nothing more than "fishing expeditions." Although both the January and June inspections extended over a period of approximately five days, that period was not unreasonable in light of the very large size of defendants' warehouse. Moreover, in assessing reasonableness it is relevant that the inspections occurred during normal business and apparently did not interfere with the normal course of business. Durovic v. Palmer, 342 F.2d 634, 636 (7th Cir. 1965). Based on these considerations, I rule that the inspections were not unreasonable. In all material respects, the inspections complied with the dictates of § 374.

In sum, the Court rules that the evidence obtained from the January and June inspections was properly admitted at the trial of defendants, and may be considered by the magistrate on remand.

[1] Section 402 of the Act, 21 U.S.C. § 342, provides in relevant part:

"A food shall be deemed to be adulterated —

"(a) . . . (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health . . .."

[2] Section 301 of the Act, 21 U.S.C. § 331, provides in relevant part:

"The following acts and the causing thereof are prohibited:

* * * * * *

"(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded."

[3] Two other individual defendants, Ronald B. Cain, warehouse manager, and James J. Kaminski, warehouse sanitation officer, were originally charged in the information. The charges against Cain were dismissed by the government before trial and Kaminski was acquitted by the magistrate.

[4] Section 303 of the Act, 21 U.S.C. § 333, provides in relevant part:

"(b) Notwithstanding the provisions of subsection (a) of this section, if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both."

[5] Of course, the corporate officer may always introduce evidence that by reason of his corporate position he did not have the power to prevent or correct violations of the Act, and thereby rebut the government's proof on his "responsible relationship" with the violations.

[6] In determining whether the impossibility defense has been properly raised, and if raised, disproved, the magistrate should look to the following cases. United States v. Y. Hata Co., 535 F.2d 508, 510-12 (9th Cir.), cert. denied, 429 U.S. 828, 97 S.Ct. 87, 50 L.Ed.2d 92 (1976); United States v. Starr, 535 F.2d 512, 515-16 (9th Cir. 1976); United States v. Hammond Milling Co., 413 F.2d 608, 612 (5th Cir. 1969), cert. denied, 396 U.S. 1002, 90 S.Ct. 552, 24 L.Ed.2d 494 (1970). See also Kadis v. United States, 373 F.2d 370, 373-74 (1st Cir. 1967); United States v. Jett, 491 F.2d 1078, 1079-80 (1st Cir. 1974) (cases discussing what evidence necessary to raise and rebut the affirmative defense of entrapment). See generally Development in the Law, supra, 92 Harv.L.Rev. at 1265-66.

The narrow scope which the Park Court intended the impossibility defense to have is indicated by the discussion in footnote 19 of the opinion:

"Assuming, arguendo, that it would be objectively impossible for a senior corporate agent to control fully day-to-day conditions in 874 retail outlets, it does not follow that such a corporate agent could not prevent or remedy promptly violations of elementary sanitary conditions in 16 regional warehouses." 421 U.S. at 678, n.19, 95 S.Ct. at 1914.

[7] On September 26, 1979, 125 Cong.Rec. S13452-83, the Senate passed a bill to lower the standard of liability under the Federal Food, Drug, and Cosmetic Act to negligence. Drug Regulation Reform Act of 1979, S.1075, 96th Cong., 1st Sess. § 106 (1979).

[8] Section 704 of the Act, 21 U.S.C. § 374, provides in relevant part:

"(a) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials; containers, and labeling therein."

[9] In this regard, the statement by the court in United States v. Business Builders, Inc., 354 F.Supp. 141 (N.D.Okl.1973), is particularly pertinent:

"It would be an affront to common sense to say that the public interest is not as deeply involved in the regulation of the food industry as it is in the liquor and firearms industries. One need only to call to mind recent cases of deaths occurring from botulism. Modern commerce has devised such an efficient and rapid means of distribution of food products to the consumer that a batch of contaminated food may cause widespread illness and death before the public can be warned and the contaminated products removed from the market." Id. at 143 (footnote omitted).

342 F.2d 634 (1965)

[635] John F. Sembower, Chicago, Ill., for appellant.

Edward V. Hanrahan, U. S. Atty., Chicago, Ill., Thomas W. James, Asst. U. S. Atty., Chicago, Ill., William W. Goodrich, Asst. General Counsel, William R. Pendergast, Attorney, Department of Health, Education, and Welfare, Washington, D. C., for appellees.

Before CASTLE, Acting Chief Judge, DUFFY, SCHNACKENBERG, KNOCH, KILEY, and SWYGERT, Circuit Judges.

SWYGERT, Circuit Judge.

This is an appeal from a judgment dismissing an action against the Secretary of Health, Education and Welfare, his Special Assistant, the District Director of the Food and Drug Administration, and three of the latter's agents and inspectors. Plaintiff sought a mandatory injunction requiring defendants to discontinue their inspections and investigation of plaintiff's manufacture and sale of a drug known as "Krebiozen," a purported treatment for cancer, to surrender a photograph and negatives acquired during an inspection, to produce investigative reports, and to refrain from uttering misleading statements allegedly discrediting plaintiff and his drug.

Upon plaintiff's request for a preliminary injunction, defendants moved for summary judgment and a dismissal of the complaint. The motion for summary judgment was supported by affidavits. Plaintiff filed counteraffidavits. The district court made findings of fact and conclusions of law, then granted the motion for summary judgment and dismissed the action.

Defendants' supporting affidavits showed that the drug Krebiozen had been distributed in interstate commerce by plaintiff. They further showed that although the drug had not been approved under the provisions of section 505 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355, it had been and was being distributed ostensibly for investigational use under section 505(i) of the act and the regulations issued thereunder.

Plaintiff, as early as 1951, had represented to the Food and Drug Administration that Krebiozen was a white powder soluble both in water and mineral oil and distributed in ampule form. Supposedly all of the Krebiozen powder used between 1949 and 1959 had been brought by plaintiff into the United States from Argentina in the late 1940's. Plaintiff represented that this was enough to manufacture approximately 200,000 ampules. Yet investigation revealed that since 1950 plaintiff had purchased approximately 1,500,000 ampules and [636] enough mineral oil to fill them. This precipitated further investigation by the federal authorities.

According to the affidavits in support of the motion for summary judgment plaintiff claimed to have prepared Krebiozen powder from horse blood obtained at the Quaker Oats Company's dog food factory at Rockford, Illinois. Investigation showed that in 1959 and 1960 plaintiff had selected and injected approximately 400 horses with a preparation of actinomyces bovis antigen. Three hundred and fifty-eight horses where slaughtered and then bled. The blood was centrifuged to recover the plasma from which the Krebiozen powder was said to have been made.

On February 19, 1963, plaintiff was informed that the Food and Drug Administration would conduct a further investigation to determine whether Krebiozen was being distributed in accordance with federal law and to review the case histories of patients using the drug. Although plaintiff objected to the further investigation, he did submit records of his patients. The additional investigation was conducted at the dog food plant in Rockford and also at the Promak Laboratories in Chicago, owned by plaintiff and used by him for the preparation of his drug. Plaintiff refused a request to furnish records relating to samples of Krebiozen powder. Thereupon, he was notified that the inspectors wanted to observe the preparation of the next mixture of Krebiozen. They visited the Promak Laboratories on June 5, 1963, but plaintiff was out of town. On Saturday, June 8, 1963, the inspectors again visited his establishment. They found him preparing to label ampules freshly filled with mineral oil and Krebiozen powder. The door to the laboratory was open. Plaintiff's secretary was at work, and at least one sale of Krebiozen was made while the inspectors were present. The inspectors saw several containers with filled ampules. Plaintiff told them that these contained Krebiozen and mineral oil. To demonstrate the method of filling the ampules, plaintiff transferred the mineral oil from a drum to a glass container labeled distilled water. The inspectors took a photograph of the bottle. Later and after considerable difficulty, the inspectors obtained as samples for analysis one hundred ampules filled with Krebiozen powder and the mineral oil solution. They also requested a sample of the Krebiozen powder. Plaintiff told them that it was unavailable. Thereafter the inspectors contacted plaintiff several times to obtain a sample of the powder. Plaintiff promised to supply it but failed to keep his promise. Instead, he filed the instant action.

Plaintiff contends that the inspectors exceeded their statutory authority thereby violating his rights under the fourth amendment to the Constitution. He argues that the constitutional prohibition against unreasonable searches and seizures, applicable in determining the legality of inspections under the Federal Food, Drug, and Cosmetic Act, must be rigidly enforced; and further that the question of reasonableness cannot be answered by a fixed formula but must be resolved according to the facts of each case. Plaintiff cites Davis v. United States, 328 U.S. 582, 66 S.Ct. 1256, 90 L.Ed. 1453 (1946), for the proposition that the time and place of an inspection are important in determining whether it is reasonable. He then relies on the fact that the inspection here was made on a Saturday at a time when he claims his establishment was not open for business. The facts submitted to the district judge showed, however, that the door to plaintiff's establishment was unlocked, his secretary was at work, the manufacturing process was under way, and a sales transaction took place while the inspectors were present.

Section 704 of the act, 21 U.S.C. § 374, specifically authorizes inspections to be conducted "at reasonable times and within reasonable limits and in a reasonable manner." Under the circumstances here present, we hold that the inspection, [637] although conducted on a Saturday, was a reasonable one and that defendants did not interfere with plaintiff's constitutional rights. We think the district judge was justified in concluding that the inspection about which plaintiff complains was conducted at a reasonable time, that reasonable requests were made upon him for data and samples, and that the inspectors "conducted themselves with a view to carrying out their statutory duties."

Plaintiff also contends that the district court erred in granting defendants motion for summary judgment because there were disputed and genuine issues of material facts. He argues that the affidavits submitted by defendants could not be used to determine the facts in issue since contrary assertions were made in affidavits presented by plaintiff. The district court, however, in granting the summary judgment, noted that plaintiff's affidavits are "defective to the extent that [the] affidavits have been offered by persons having no personal knowledge of some of the matters attested." Fed.R.Civ.P. 56(e) provides that affidavits supporting or opposing a motion for summary judgment "shall be made on personal knowledge." In the absence of such legally sufficient affidavits showing the existence of a genuine issue of fact, summary judgment is authorized. Engelhard Indus., Inc. v. Research Instrumental Corp., 324 F.2d 347 (9th Cir. 1963); see also G. D. Searle & Co. v. Chas. Pfizer & Co., Inc., 231 F.2d 316 (7th Cir. 1956). Accordingly, we hold that the district judge properly invoked the rule permitting summary judgment.

Irrespective of the foregoing determinations, there were additional reasons for the dismissal of the action. It was not shown that the photograph taken by the inspectors had been published, nor was there a showing of what use, if any, the Food and Drug Administration intends to make of the photograph in the future. A similar situation was presented in American Dietaids Co., Inc. v. Celebrezze, et al., 317 F.2d 658 (2d Cir. 1963). There the question related to the return of tape recordings made during an investigation. We think the observations of the Second Circuit are peculiarly appropriate to the instant situation: "If a civil or criminal action should be brought and if claimed improper use of the tapes is then attempted, motion to discover or suppress the tapes may be appropriate. * * * The courts are reluctant to decide important constitutional questions at a stage of proceedings when the necessity of their resolution has not been established."

With respect to plaintiff's request for an injunction against further investigations and inspections, plaintiff was not entitled to such relief because, even assuming that the June, 1963 inspection was illegal, there was no showing in the district court of continued or future inspections of such character or the threat thereof. Finally, with respect to plaintiff's requests for other injunctive relief which we have heretofore listed, he has not argued these requests on appeal. He therefore must be held to have abandoned them.

The judgment of dismissal is affirmed.

HASTINGS, Chief Judge, did not participate in the consideration and disposition of this appeal.

SCHNACKENBERG, Circuit Judge (dissenting).

I believe that there should have been a trial rather than disposition by summary judgment.

308 F.3d 785 (2002)

[786] John W. Hoffman (argued), Carr, Korein, Tillery, Kunin, Montroy, Cates & Glass, Belleville, IL, for plaintiffs-appellants.

William F. Conlon, David B. Johnson (argued), Sidley, Austin, Brown & Wood, Chicago, IL, for defendant-appellee.

Before BAUER, MANION, and ROVNER, Circuit Judges.

Rehearing and Suggestion for Rehearing En Banc Denied November 22, 2002.

MANION, Circuit Judge.

Plaintiffs, who are consumers of Tyson chicken, sued in state court alleging that Tyson fraudulently infused its chicken products with water and concealed the deceptive practice from consumers. Tyson removed the lawsuit to federal court. Plaintiffs appeal the district court's denial of their motion to remand to state court and the subsequent dismissal of this case. Because we conclude that the district court lacked the federal question jurisdiction necessary to remove this action from state [787] court, we reverse with instructions to remand this suit to state court.

I.

Tyson Foods, Incorporated ("Tyson") sells chicken throughout the United States. Timothy and Wendy Rogers, and Alan Westfall, ("plaintiffs") consume Tyson chicken. On August 14, 2001, plaintiffs filed a putative class action in the Madison County, Illinois Circuit Court against Tyson, alleging that Tyson violated the Illinois Consumer Fraud and Deceptive Trade Practices Act, 815 ILES § 505/1, et seq., by inflating the weight of chicken carcasses with water during the processing of the chicken, and by concealing this practice from the public. Plaintiffs' first claim was for consumer fraud under the Illinois statute. Plaintiffs' second claim was for unjust enrichment.

Pursuant to 28 U.S.C. § 1441(a), Tyson timely removed this case to the United States District Court for the Southern District of Illinois. In its notice of removal, Tyson alleged that the district court had federal question jurisdiction because the Poultry Products Inspection Act, 21 U.S.C. § 451, et seq. ("PPIA"), triggers the doctrine of complete preemption. Plaintiffs filed a motion to remand, and Tyson filed a motion to dismiss. The district court denied the motion to remand, basing its decision on the PPIA's preemption clause, 21 U.S.C. § 467e. Section 467e declares that "[m]arking, labeling, packaging, or ingredient requirements (or storage or handling requirements found by the Secretary to unduly [sic] interfere with the free flow of poultry products in commerce) in addition to, or different than, those made under this chapter may not be imposed by any State or Territory or the District of Columbia ...." 21 U.S.C. § 467e. The district court reasoned that § 467e "completely preempts [state] marking, labeling, packaging, and ingredient requirements for poultry [and that] [p]laintiffs' claims fall within the scope of the preempted field." The district court then granted Tyson's motion to dismiss, reasoning that the PPIA provides plaintiffs with no basis for relief. On appeal, plaintiffs contend that the district court lacked jurisdiction over this case and therefore erred in denying their motion to remand.

II.

Because the propriety of removing a state action to federal court is a question of federal jurisdiction, we review de novo the denial of a motion to remand to state court. Seinfeld v. Austen, 39 F.3d 761, 763 (7th Cir.1994). Removal of a state civil suit to federal court is proper where "the district courts of the United States have original jurisdiction." 28 U.S.C. § 1441(a). As diversity of citizenship is not alleged, the removal's propriety hinges on whether the district court had federal question jurisdiction. See Seinfeld, 39 F.3d at 763.

Plaintiffs' complaint asserts solely state law claims. Under the well-pleaded complaint doctrine it would thus appear at first blush that the district court lacked subject matter jurisdiction and that the complaint was not removable. See Moran v. Rush Prudential HMO, Inc., 230 F.3d 959, 966 (7th Cir.2000). Tyson argues, and the district court held, however, that removal was justified under the doctrine of complete preemption, which is a corollary to the well-pleaded complaint rule. Rice v. Panchal, 65 F.3d 637, 640 n.2 (7th Cir.1995). Complete, or field, preemption exists where "Congress has so completely preempted a particular area that no room remains for any state regulation and the complaint would be `necessarily federal in character.'" Bastien v. AT&T; Wireless Serv., Inc., 205 F.3d 983, 986 (7th Cir.2000) [788] (quoting Metropolitan Life Ins. Co. v. Taylor, 481 U.S. 58, 63-64, 107 S.Ct. 1542, 95 L.Ed.2d 55 (1987)). We find complete preemption where there is a "congressional intent in the enactment of a federal statute not just to provide a federal defense to a state created cause of action but to grant a defendant the ability to remove the adjudication of the cause of action to a federal court by transforming the state cause of action into a federal cause of action." 14B Charles Alan Wright, Arthur R. Miller, & Edward H. Cooper, Federal Practice and Procedure § 3722.1 (3d ed. 1998 & Supp. 2002) (emphasis added); see also Jass v. Prudential Health Care Plan, Inc., 88 F.3d 1482, 1490 (7th Cir.1996) (reasoning that complete preemption "converts a state law claim into an action arising under federal law") (internal quotation omitted).

In that vein, plaintiffs argue that "`complete preemption' cannot exist here because there is no private right of action under the PPIA" into which either of their state law causes of action could be transformed. Significantly, Tyson concedes that the PPIA does not create a private right of action. Nevertheless, it argues that a private right of action is not a prerequisite to complete preemption. On this dispositive point, precedent compels us to agree with plaintiffs.

As this circuit interprets the law, the "ability to bring suit under [federal law] is an element of `complete preemption.'" Vorhees v. Naper Aero Club, Inc., 272 F.3d 398, 404 (7th Cir.2001) (citing Rice, 65 F.3d at 641). Logically, complete preemption would not be appropriate if a federal remedy did not exist in the alternative. Otherwise, a plaintiff would be forced into federal court with no relief available for "vindicating the same interest." Railway Labor Executives Ass'n v. Pittsburgh & L.E.R.R., 858 F.2d 936, 942 (3d Cir.1988). "Preemption is what wipes out state law, but the foundation for removal is the creation of federal law to replace state law." Rice, 65 F.3d at 641 (quoting Bartholet v. Reishauer A.G. (Zurich), 953 F.2d 1073, 1075 (7th Cir.1992)). Accordingly, "unless the federal law has created a federal remedy — no matter how limited — the federal law, of necessity, will only arise as a defense to a state law action" and will thus not give rise to the federal question jurisdiction underlying complete preemption. Id.; see also McQuerry v. American Med. Sys., Inc., 899 F.Supp. 366, 370 (N.D.Ill.1995) (reasoning that, where there is no federal private right of action, "complaints in such cases do not even arguably raise a federal question and therefore are inappropriate for removal").

Most circuits share our view that the existence of a private right of action under federal law is an antecedent of complete preemption. See Wayne v. DHL Worldwide Express, 294 F.3d 1179, 1184 (9th Cir.2002); Schmeling v. NORDAM, 97 F.3d 1336, 1342 (10th Cir.1996); Strong v. Telectronics Pacing Sys., Inc., 78 F.3d 256, 260 (6th Cir.1996); Hudson Ins. Co. v. American Elec. Corp., 957 F.2d 826, 830 (11th Cir.1992); Aaron v. National Union Fire Ins. Co., 876 F.2d 1157, 1164-65 (5th Cir.1989); Railway Labor Executives Ass'n, 858 F.2d at 942. But cf. Husmann v. Trans World Airlines, Inc., 169 F.3d 1151, 1152-54 (8th Cir.1999) (finding complete preemption without discussing whether there was a replacement federal cause of action); id. at 1154-55 (Morris Sheppard Arnold, J., dissenting) (arguing that the defendant's failure to point to a private right of action in the statute should have been fatal to its argument for complete preemption).

Tyson cites two decisions of this court as standing for the opposite proposition. First, Tyson maintains that, in Bastien v. [789] AT&T; Wireless Serv., Inc., this court "flatly rejected the assertion that a federal remedy must exist for complete preemption." Second, Tyson quotes Lister v. Stark, 890 F.2d 941 (7th Cir.1989) for the proposition that "the availability of a federal remedy is not a prerequisite for federal preemption." Id. at 946. We find both arguments unpersuasive.

In Bastien, the district court held that the Federal Communications Act of 1934, 47 U.S.C. § 332(c)(3)(A) ("FCA"), completely preempted claims regarding mobile-phone rates and market entry, and then granted the defendant's motion to dismiss for failure to state a claim. Bastien, 205 F.3d at 986. The plaintiff only appealed the former ruling, that the FCA effected complete preemption; he did not appeal the dismissal for failure to state a claim. Id. Concluding that Congress intended the FCA completely to preempt the field, we affirmed the district court's decision that the FCA completely preempted the plaintiff's claims; we did not, however, address the question of whether complete preemption could exist where the federal statute provided no private right of action. Id.^[1] Tyson would have us infer that a federal remedy is not a necessary element of complete preemption from the Bastien panel's failure to discuss whether the FCA created a private right of action. For two reasons, we decline Tyson's invitation to read Bastien so broadly.

First, the FCA creates a private cause of action. See 47 U.S.C. § 207; Gilmore v. Southwestern Bell Mobile Sys., 156 F.Supp.2d 916, 922 (N.D.Ill.2001); DeCastro v. AWACS, Inc., 935 F.Supp. 541, 549-50 (D.N.J.1996). The holding of Bastien is therefore not incompatible with the settled rule that a federal remedy is a precondition to the existence of complete preemption.

Second, it would be a mistake to read Bastien for the broad proposition that this Circuit has "flatly rejected the assertion that a federal remedy must exist for complete preemption." Not only did the Bastien panel not "flatly reject" the federal remedy requirement, it did not even address the issue. As discussed above, this court's earlier opinion in Rice specifically held that a private right of action under federal law is an antecedent to complete preemption. This holding was in place before Bastien and the Bastien decision says nothing that alters the holding in Rice. Therefore, Rice remains good law and Bastien does not undermine the rule that a federal private right of action is an element of complete preemption.

Tyson also relies on Lister v. Stark to support its claim that for complete preemption a private right of action is unnecessary. In Lister, we held that the Employee Retirement Income Security Act of 1974, 29 U.S.C. §§ 1001 et seq. ("ERISA"), completely preempted the plaintiff's state law claims, and that the plaintiff failed to state a claim under the civil enforcement provisions of ERISA. Lister, 890 F.2d at 946. Unlike the PPIA, however, ERISA does create a private right of action. See id. at 944 (citing 29 U.S.C. § 1132). It is true that in Lister the plaintiff's claim for breach of an oral contract was not available under ERISA's remedial provisions. Id. at 946. Nevertheless, Lister stands for the unexceptional proposition that complete preemption can exist even where a particular plaintiff seeks a remedy that Congress chose not to provide when it effected complete preemption. [790] "The policy choices reflected in the inclusion of certain remedies and the exclusion of others under the federal scheme would be completely undermined if ERISA-plan participants and beneficiaries were free to obtain remedies under state law that Congress rejected in ERISA." Id. (quoting Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 54, 107 S.Ct. 1549, 95 L.Ed.2d 39 (1987)). A federal cause of action need not provide the same remedies as the preempted state cause of action. "The chance that the `nature of relief' available under federal law might be different from that under state law does not affect the jurisdictional analysis." Schmeling, 97 F.3d at 1343 (discussing Avco v. Aero Lodge No. 735, 390 U.S. 557, 88 S.Ct. 1235, 20 L.Ed.2d 126 (1968)).

Finally, Tyson contends that the PPIA expressly denies plaintiffs' causes of action, and then cites Aaron v. National Union Fire Ins. Co., 876 F.2d at 1165 for the proposition that "express denial of a cause of action may serve the same function as the creation of a federal cause of action" for purposes of complete preemption.

Tyson's argument is without merit. In Aaron, the Fifth Circuit rejected the precise contention that Tyson makes here:

The language from Franchise Tax [Bd. v. Construction Laborers Vacation Trust, 463 U.S. 1, 103 S.Ct. 2841, 77 L.Ed.2d 420 (1983)] quoted above suggests that the express denial of a cause of action may serve the same function as the creation of a federal cause of action.... However, the "express denial" of a cause of action will always be present where federal law preempts state law. Every time federal preemption is asserted as a defense, and the defendant seeks to use that defense as a basis for removal jurisdiction, the defendant can assert that the "express denial" language of Franchise Tax is justified. Something more must therefore be required to create removal jurisdiction if the well-pleaded complaint rule is to have continued vitality, a result clearly indicated by the cases.

Aaron, 876 F.2d at 1165 (emphasis added). We agree with the Fifth Circuit on this point because, as we made clear in Rice, the "something more ... required to create removal jurisdiction" includes a private right of action under the federal statute. We also note that district courts within the Fifth Circuit interpret Aaron as holding that a private right of action is a prerequisite to complete preemption. See, e.g., Sherron v. Private Issue by Discover, 977 F.Supp. 804, 807 (N.D.Miss.1997); City of Laredo v. Texas Mexican Railway Co., 935 F.Supp. 895, 897 (S.D.Tex.1996). Tyson's reliance on Aaron is, accordingly, misplaced.

III.

Tyson does not dispute the fact that the PPIA provides no private right of action, yet complete preemption can only exist where, inter alia, the federal statute provides a private right of action. Therefore, the PPIA does not trigger complete preemption. We accordingly conclude that removal of this action to federal court was improper, and we must reverse and remand this case to the district court with directions to remand the action to state court for lack of federal subject matter jurisdiction. Given the absence of complete preemption, we are obligated to rule in plaintiffs' favor. Clearly, however, this preliminary decision is not the last word on preemption. Although the PPIA provides no private right of action, it and the existing and pending federal regulations maintain wide control over the processing and distribution of poultry products nationally.

[791] Tyson contends that plaintiffs' complaint essentially attacks Tyson for failing to meet labeling requirements that exceed the PPIA's labeling strictures, and that the PPIA preempts state regulation of labeling that exceeds federal requirements. Assuming that Tyson correctly characterizes plaintiffs' complaint, there is certainly precedent for its preemption claims. See National Broiler Council v. Voss, 44 F.3d 740, 743-47 (9th Cir.1994) (holding that the PPIA's preemption clause expressly preempted state labeling requirements in addition to, or different than, federal labeling requirements). National Broiler Council, however, was a case of ordinary, and not complete, preemption. See Hue v. Farmboy Spray Co., Inc., 127 Wash.2d 67, 896 P.2d 682, 691 (1995) (citing National Broiler Council in support of ordinary preemption). Ordinary preemption is an affirmative defense that Tyson may assert in state court; it is not a basis for federal jurisdiction under the complete preemption doctrine. See Smith v. GTE Corp., 236 F.3d 1292, 1313 (11th Cir.2001) (reasoning that "our conclusion that the complete preemption doctrine does not provide a basis for federal jurisdiction in this action does not preclude the parties from" pleading the defense of ordinary preemption in state court). But for the lack of a federal remedy, the federal preemption, although now labeled "ordinary," nevertheless appears to be extensive. Just how extensive this ordinary preemption may be, however, must now be determined in the Illinois state court system.

REVERSED and REMANDED.

[1] Bastien's text does not make it clear whether the plaintiff's failure to appeal the district's court's ruling that he had failed to state a claim led this court to conclude that it did not need to discuss the "no federal remedy" issue.

622 F.2d 157 (1980)

[158] Eric M. Blumberg, Stephen D. Terman, Food and Drug Adm., Rockville, Md., Robert Wiggers, John J. Powers, III, App. Section, Antitrust Div., Dept. of Justice, Washington, D.C., for Patricia Roberts Harris.

Robert T. Lasky, Susan A. Elliott, Washington, D.C., for plaintiffs-appellants.

Before WISDOM, POLITZ and SAM D. JOHNSON, Circuit Judges.

WISDOM, Circuit Judge:

This appeal poses the question whether mercury in the tissues of swordfish is an "added substance" within the meaning of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a)(1) (1975) (FDA), and is, therefore, subject to regulation under the relaxed standard appropriate to added substances. Only part of that mercury has been added by man.

In April 1977, the United States sought an injunction against Anderson Seafoods, Inc., and its president, Charles F. Anderson, to prevent them from selling swordfish containing more than 0.5 parts per million (ppm) of mercury, which it considered adulterated under the meaning of § 342(a)(1) of the FDA. Anderson responded in May 1977 by seeking a declaratory judgment that fish containing 2.0 ppm of mercury or less are not adulterated. Anderson also sought an injunction against the Food and Drug Administration commensurate with the declaratory judgment. Anderson's suit was certified as a class action, and these suits were consolidated for trial.

The district court denied the injunction that the government sought. In Anderson's suit, the court also denied an injunction, but issued a declaratory judgment that [159] swordfish containing more than 1.0 ppm mercury is adulterated under § 342(a)(1). In doing so, the court determined that mercury is an "added substance" under the Act and rejected Anderson's contention that a level of 2.0 ppm is acceptable. Anderson appealed from the judgment in the class action. The government appealed from the judgment in its enforcement action and cross-appealed in the class action. The government then withdrew its appeal and cross-appeal. This appeal now consists of Anderson's challenge to the way the district court parsed the statute and to the sufficiency of the evidence. We affirm.

I.

Section 342(a)(1) of the Act provides:

A food shall be deemed to be adulterated —(a)(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.

21 U.S.C. § 342(a)(1).

The Act does not define "added substance". Whether a substance is added or not is important because of the evidentiary showing that the Food and Drug Administration must make to succeed in an enforcement action. If a substance is deemed "added", then the Agency need show only that it "may render [the food] injurious to health" in order to regulate consumption of the food containing the substance. The "may render" standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer. See United States v. Lexington Mill & Elevator Co., 1914, 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658; Berger v. United States, 8 Cir.1952, 200 F.2d 818, 821. If, however, a substance is considered "not-added", the Agency must go further, and show that the substance would "ordinarily render [the food] injurious to health", 21 U.S.C. § 342(a)(1), before it can regulate its consumption.

In the trial of this case three theories about the meaning of the term "added" emerged. The Food and Drug Administration sponsored the first theory. It argues that an "added substance" is one that is not "inherent". According to FDA regulations:

(c) A "naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An "added poisonous or deleterious substance" is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. §§ 109.3(c), (d) (1977). Under this theory, all the mercury in swordfish is an added substance, because it results not from the creature's bodily processes but from mercury in the environment, whether natural or introduced by man.

Anderson put forward a second theory. A substance, under this theory, is not an added substance unless it is proved to be present as a result of the direct agency of man. Further, only that amount of a substance the lineage of which can be so traced is "added". If some mercury in swordfish occurs naturally, and some is the result of man-made pollution, only that percentage of the mercury in fish proved to result directly from pollution is an added substance.

The district court adopted a third theory. Under the court's theory, if a de minimis amount of the mercury in swordfish is shown to result from industrial pollution, then all of the metal in the fish is treated as an added substance and may be regulated under the statute's "may render injurious" standard. The legislative history and case law, though sparse, persuade us that this is the proper reading of the statute.

[160] The distinction between added and not-added substances comes from the "adulterated food" provisions of the original Food, Drug, and Cosmetic Act of 1906, ch. 3915, 34 Stat. 768. The legislative history shows that "added" meant attributable to acts of man, and "not-added" meant attributable to events of nature. See H.R.Rep.No. 2118, 59th Cong., 1st Sess. 6, 7, 11 (1906) (quoted in United States v. Coca Cola, 1915, 241 U.S. 265, 282-83, 36 S.Ct. 573, 578-79, 60 L.Ed. 995 ("deleterious substances added by man"); 40 Cong.Rec. 1133 (Jan. 16, 1906) ("human action") (remarks by Sen. Heyburn). That the distinction was carried through to the present Act is shown by its legislative history. S.Rep.No. 493, 73rd Cong., 2d Sess. 3 (1934) ("added by man or put there by nature ... introduced by artifice or [occurring] naturally").

The Supreme Court drew the same distinction in United States v. Coca Cola, 1915, 241 U.S. 265, 36 S.Ct. 573, 60 L.Ed. 995. Construing the "added ... ingredient" provisions of the 1906 Act, the Court said:

Congress, we think, referred to ingredients artificially introduced; these are described as `added.' The addition might be made to a natural food product or to a compound ... we think that it was the intention of Congress that the artificial introduction of ingredients of a poisonous or deleterious character which might render the article injurious to health should cause the prohibition of the statute to attach.

241 U.S. at 284, 36 S.Ct. at 579.

The Food and Drug Administration argues that there need not be any connection between man's acts and the presence of a contaminant for it to be considered an added substance. The Agency points to the rule it recently promulgated interpreting § 342(a)(1), quoted above, which defines an added substance as one which is not "an inherent natural constituent of the food", but is instead the "result of an environmental, agricultural, industrial, or other contamination". 21 C.F.R. §§ 109.3(c), (d) (1977). Under the rule, mercury in swordfish tissue deriving from the mercury naturally dissolved in sea water would be an added substance, as would any substance not produced by or essential for the life processes of the food organism. In light of the legislative history and the Coca Cola case, however, we agree with the district court that the term "added" as used in § 342(a)(1) means artificially introduced, or attributable in some degree to the acts of man. 447 F.Supp. 1151, 1155.

The Food and Drug Administration finds further support for its view in several cases in which the courts refer to not-added substances under the Act as "inherent". In Continental Chemiste Corp. v. Ruckelshaus, 9 Cir.1972, 461 F.2d 331, 337, and Certified Color Ind. Committee v. Secretary of HEW, 2 Cir.1956, 236 F.2d 866, 869, however, the courts were not defining the statutory term "added substance". That they referred to not-added substances as being inherent does not mean that all non-inherent substances are added. These cases are consistent with the proposition that some non-inherent substances, present in a food organism but unconnected to man's acts, are not-added substances under the Act. A final case, United States v. An Article of Food Consisting of Cartons of Swordfish, S.D.N.Y., 1975, 395 F.Supp. 1184, reads the Act to mean that any material obtained from the environment is an added substance. As the district court pointed out, "FDA has not urged this rather extreme position upon the court and the ruling, contrary to the legislative history of the Act and the language of the Supreme Court, is not persuasive authority." 447 F.Supp. at 1155.

Determining that man must appear on the stage before a substance is an added one does not determine the size of the role he must play before it is. The dichotomy in § 342(a)(1) is between two clear cases that bracket the present case. The Act considers added things such as lead in coloring agents or caffeine in Coca Cola. It considers not-added things like oxalic acid in rhubarb or caffeine in coffee. The Act did not contemplate, however, the perhaps rare problem of a toxin, part of which occurs [161] "naturally", and part of which results from human acts. The section is designed, of course, to insure the scrutiny of toxins introduced by man. As Senator Heyburn said of the 1906 Act:

Suppose you would say if there is poison in [a food] already it cannot do much harm to put in more. Suppose commercial cupidity should tempt someone to add to the dormant poison that is in a hundred things that we consume everyday, are they to be permitted to do it? This bill says they shall not do it.

40 Cong.Rec. 2758 (1906).

Anderson argues that when a toxin derives in part from man and in part from nature, only that part for which man is responsible may be considered added and so regulated under the "may render injurious" standard. In such a case, however, neither the statute nor FDA regulations suggest that the amount of an added toxic substance be quantified and shown to have a toxic effect of its own if the total amount of the substance in a food is sufficient to render the food potentially hazardous to health. It may be possible—as in this case—to prove that man introduced some percentage of a toxin into a food organism, but difficult or impossible to prove that percentage.

Since the purpose of the "may render injurious" standard was to facilitate regulation of food adulterated by acts of man, we think that it should apply to all of a toxic substance present in a food when any of that substance is shown to have been introduced by man. Anderson argues that this reading of the statute would result "in the anomalous situation where a substance in a food can be 90 percent natural and 10 percent added if the entire substance is considered as added". There is no anomaly, however, in such a situation. The Act's "may render it injurious to health" standard is to be applied to the food, not to the added substance. The food would not be considered adulterated under our view unless the 10 percent increment creates or increases a potentiality of injury to health. If the increment does create or increase such a potentiality, then, because the increment that triggered the potentiality was introduced by man, the Food and Drug Administration ought to be able to regulate it under the standard designed to apply to adulterations of food caused by man. Anderson's argument proves too much. Anderson would argue that if a swordfish contained 0.99 ppm of natural mercury, and 0.99 ppm of mercury from human sources, the fish could be sold although it contained nearly twice as much mercury as the district court found to be a safe level. Such a reading of the statute hardly accords with its "overriding purpose to protect the public health". United States v. Bacto-Unidisk, 1969, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726. The reading we have adopted does accord with this purpose. It may be severe in practice. It may permit the Food and Drug Administration to regulate in some cases where the amount of substance contributed by man—which triggers the potentiality of harm—is minute. But it is the only alternative that fits into the statutory scheme. Congress should amend the statute if our reading produces impracticable results.^[1]

In sum, we hold that where some portion of a toxin present in a food has been introduced by man, the entirety of that substance present in the food will be treated as an added substance and so considered under the "may render injurious to health" standard of the Act.

II.

In addition to its attack on the way the district court parsed the statute, Anderson raises a subsidiary argument. There was insufficient evidence to support the conclusion that man's acts contributed "substantial amounts" of mercury to the tissues of swordfish. And, indeed, the court did not find that the amounts were substantial, but rather that they were unknown and perhaps [162] unquantifiable. Under our reading of the statute, however, the amount of mercury that man contributes need not be "substantial". The FDA need show only that some portion of the mercury is attributable to acts of man, and that the total amount may be injurious to health.

There was sufficient evidence to show that some mercury is attributable to the acts of man. There was evidence that mercury is dumped into rivers and washes onto the continental shelf, where some of it is methylated by bacteria and taken up by plankton. It thereby enters the food chain of swordfish, for the plankton is consumed by small organisms and fish, such as copepods, herring, and hake, which are in turn eaten by larger organisms, and eventually by swordfish, a peak predator. This evidence was enough to trigger the Act's "may render injurious to health" standard.

III.

The district court set 1.0 ppm as the health limit for mercury in swordfish. It noted that the decision was:

based only on the scientific and empirical data accepted into evidence in these cases. It may be that further studies will reveal the decisions here made were based on erroneous or insufficient data.

447 F.Supp. at 1160. We noted above that the government withdrew its appeal and cross-appeal. It is apparently considering new evidence to determine whether its present action level should be reaffirmed or changed. Our decision does not engrave the district court's 1.0 ppm level in administrative stone. While the government may not now prevent the sale of swordfish containing 1.0 ppm or less of mercury, the durability of our order is founded on the evidence the district court accepted.

The order of the district court is AFFIRMED.

[1] For a review of the policy arguments favoring less regulation, see Note, Health Regulation of Naturally Hazardous Foods: The FDA Ban on Swordfish, 85 Harv.L.Rev. 1025 (1972).

674 F.2d 38 (1982)

[39] Joseph A. Artabane, Washington, D. C., with whom Robert T. Lasky and Joseph Ingrisano, Washington, D. C., were on the brief, for appellants.

Eric M. Blumberg, Associate Chief Counsel, Food and Drug Administration, Rockville, Md., with whom Jeffrey B. Springer, Acting Chief Counsel, Food and Drug Administration, Rockville, Md., John J. Powers, III and Daniel J. Conway, Attys., Dept. of Justice, Washington, D. C., were on the brief, for appellees. Charles F. C. Ruff, U. S. Atty., Washington, D. C., at the time the briefs were filed, Kenneth M. Raisler, Patricia J. Kenney and Royce C. Lamberth, Asst. U. S. Attys., Washington, D. C., also entered appearances, for appellees.

Before BAZELON, Senior Circuit Judge, and TAMM and EDWARDS, Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge BAZELON.

BAZELON, Senior Circuit Judge:

We must decide whether the Food and Drug Administration (FDA) acted lawfully in concluding that Indian shrimp contaminated with poisonous bacteria was "adulterated" within the meaning of the Food, [40] Drug and Cosmetic Act (FDCA or Act). The district court answered yes. We affirm.

I.

The Act permits the FDA to prohibit the importation of food that "appears" to be adulterated.^[1] In defining "adulterated," the Act focuses on the origin and dangers of "poisonous or deleterious substance[s]" in the food.^[2] When such substances are "added" to the food, the food is adulterated if the substance "may render it injurious to health."^[3] When, on the other hand, the substance is not added, the food is considered adulterated only if the substance would "ordinarily render it injurious to health."^[4]

Beginning in late 1978, the FDA observed that a significant proportion of shrimp arriving from India contained salmonella. Without proper cooking and storage, food containing that bacteria can cause salmonellosis, a communicable disease that produces a number of serious bodily impairments and sometimes results in death.^[5] After officials of the Indian government acknowledged that insanitary processing facilities were responsible for the high rate of contamination of Indian shrimp, the FDA decided to sample all such shrimp arriving in the United States.^[6]

In the spring of 1979, appellants offered two lots of raw, frozen Indian shrimp for import into the United States. The FDA sampled the shrimp and discovered salmonella in both lots. The importers each received a Notice of Detention and Hearing stating that the lots of shrimp would be refused admission because they "appear[] to contain a poisonous deleterious substance (Salmonella species)."^[7] Appellants were afforded a hearing at which they tried to show that the shipments were not adulterated. After reviewing the evidence offered by the importers, the FDA issued a Notice of Refusal of Admission. The Notice said [41] that the shrimp appeared to be adulterated and ordered the lots destroyed unless they were exported within ninety days. Appellants received permission to retain the shrimp in frozen storage pending the outcome of this litigation.

In their complaint in the district court, appellants contended that the import prohibition (1) was based on an incorrect interpretation of the Act's standard for "adulterated," (2) was unsupported by evidence in the record, and (3) reflected discriminatory treatment of shrimp in comparison to other foods. Based on a review of affidavits, expert testimony, and prior authority,^[8] the district court rejected all three arguments and granted summary judgment in favor of the FDA.

II.

Appellants concede that the two lots of shrimp at issue contain salmonella. The FDA, in turn, acknowledges that salmonella is not "ordinarily injurious" since its dangers can be averted through proper cooking and storage. The only issue before us,^[9] then, is whether the FDA properly concluded that the shrimp met the more relaxed standard of adulteration for "added" substances. Specifically, we must evaluate the FDA's determinations that (A) salmonella was "added" to the Indian shrimp, and (B) that the bacteria "may render" the shrimp unhealthy.^[10]

A. Is salmonella "added" to shrimp?

Appellants argue that this question was conclusively answered in the negative by our decision in American Public Health Association v. Butz ("APHA"), 511 F.2d 331 (D.C.Cir.1974). The plaintiffs in that case contended that inspection labels placed on domestic meat and poultry products by the Secretary of Agriculture were misleading since they failed to warn about the salmonella often found in those products. The court noted that inspection labels could be misleading under the Wholesome Meat Act if salmonella constituted adulteration within the meaning of that statute. Assuming that salmonella "may be inherent in the meat," the court commented: "[W]e think that the presence of salmonella in meat does not constitute adulteration within [the Wholesome Meat Acts'] definition." Id. at 334. Appellants claim this remark amounted to a judicial determination that salmonella does not adulterate food.

The observation in APHA on which appellants rely consists of dictum uttered in a different legal and factual context. The issue presented by that case was whether the inspection labels were misleading, not whether the food was adulterated. In upholding the Secretary, the court relied on its view that consumers understand the importance of proper storage and cooking of meat and poultry as well as its conclusion that Congress did not intend "microscopic examination[s]" of domestic food products by the Department of Agriculture. Id. at [42] 334-35. The court offered no evidentiary support for its additional suggestion that salmonella may not be "added" to meat. Moreover, the court's assumption about the inherent qualities of meat and poultry obviously do not bind the FDA's evaluation of shrimp.^[11] Finally, while the statutes involved in APHA define adulteration in terms similar to the FDCA,^[12] the government enjoys substantially greater discretion in preventing the import of apparently adulterated foods than it does in labelling domestic products.^[13]

Accordingly, we must determine whether the FDA's conclusion that salmonella is an "added" substance in shrimp is consistent with the provisions of the FDCA. The parties urge different interpretations of the word "added." A regulation promulgated by the FDA in 1977 defines the word to include any substance that is not an inherent, natural constituent of the food.^[14] Appellants, on the other hand, argue that "added" describes only those substances which are present due to human intervention. Citing cases that have employed that definition,^[15] appellants contend that the FDA was required to demonstrate that human intervention introduced salmonella to the shrimp at issue here. The district court declined to resolve this definitional dispute. Instead, the court held that the FDA could have deemed the salmonella "added" under either standard.

Appellants' contention that "added" refers only to substances introduced by humans was recently adopted by the Fifth Circuit in United States v. Anderson Seafoods, Inc., 622 F.2d 157 (1980). The court there concluded that the more relaxed standard for adulteration "should apply to all of a toxic substance present in a food when any of that substance is shown to have been introduced by man." Id. at 161. The court further held that a showing of human intervention could be based on general scientific knowledge about the origin of the additive in question. See id. at 162. Anderson Seafoods thus implicitly rejected the notion advanced by appellants here that the FDA must demonstrate human intervention with respect to the particular articles of food it wishes to regulate. We reject the argument explicitly. In light of the FDA's [43] broad authority to prohibit import of any food that "appears" to be adulterated, the agency need not prove that substances present in a particular lot were introduced by man.^[16]

We agree with the district court that the FDA's decision in this case satisfied appellants' definition of "added" as elaborated in Anderson Seafoods. The evidence offered by both parties indicated that salmonella in shrimp can result from human acts and can frequently be attributed to insanitary processing procedures.^[17] The FDA had ample reason to believe that the salmonella frequently observed in Indian shrimp in 1978 and 1979 resulted from insanitary conditions. Representatives of the Indian government acknowledged to the FDA that the salmonella contamination was a result of unclean handling.^[18] And several months before the administrative hearing in this case, FDA officials visited processing facilities in India and determined the nature of conditions there first hand. The district court described what the delegation saw:

[T]he delegation observed unscreened, fly-infested processing areas; inadequate icing of shrimp subjected to temperatures in excess of 90° F.; the placement of porous shrimp-holding pans on heavily-travelled floors; and the use of pitted and cracked work surfaces covered with the residue of fecal matter from previously processed frogs. At a shrimp landing area, FDA officials observed hundreds of people, mostly barefoot and dressed in soiled clothing, milling around the dock where the shrimp were unloaded; poor icing of shrimp; and the use of bamboo baskets, which are virtually impossible to sanitize, to collect shrimp.^[19]

Together with the FDA's understanding of the cause of salmonella in shrimp generally, these observations provided more than enough support for the agency's conclusions that the bacteria had been at least partly introduced by man.

B. Did the FDA show that salmonella "may render" shrimp unhealthy?

Appellants claim the evidence does not support the FDA's determination that salmonella "may render [shrimp] injurious to health." This complaint is groundless. The record indicates that ingestion of even small amounts of the bacteria can cause serious cases of food poisoning in some people.^[20] Appellants do not dispute the medical evidence; indeed, their own expert witness confirmed the danger.^[21] Instead, they rely on (1) the fact that few, if any, cases of salmonellosis traced to shrimp have been reported and (2) their expectation that consumers will properly cook and store the shrimp and thus prevent contraction of the disease.

The FDA offered several reasonable explanations for the low number of reported cases of salmonellosis from shrimp: The [44] sources of information on which appellants rely report only a small proportion of salmonella cases; reporting of "home episodes" is rare; specific cases may often be attributed to the wrong sources; and shrimp products are consumed in much smaller quantities than other foods which may contain salmonella.^[22] These explanations were supported by the record and adopted by the district court.^[23] Accordingly, we agree with the court that the "absence of documentation does not foreclose the [FDA's] discretion to determine that salmonella in shrimp may be injurious to the health of those who consume it."^[24]

Nor are we comforted by appellants' sanguine assurances that consumers will properly cook and store the shrimp. The FDA has authority to ban contaminated articles from import notwithstanding promises that the deleterious condition will be corrected. See United States v. 52 Drums of Maple Syrup, 110 F.2d 914, 915 (2d Cir. 1940). Moreover, there was evidence in the record that many people either do not cook shrimp properly^[25] or, like the patrons of Japanese restaurants, eat it raw.^[26] Under these circumstances, the FDA was well within its authority in concluding that salmonella "may render" shrimp injurious to health.

Affirmed.

[1] Section 801(a) of the Act, 21 U.S.C. § 381(a) (1976) provides in pertinent part:

The Secretary of Treasury shall deliver to the Secretary of Health, Education, and Welfare, upon his request, samples of food ... which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health, Education, and Welfare and have the right to introduce testimony.... If it appears from the examination of such samples or otherwise that ... such article is adulterated ... then such article shall be refused admission ....

[Emphasis added.]

[2] Section 402 of the Act, 21 U.S.C. § 342 (1976) provides:

A food shall be deemed to be adulterated —

(a)(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....

[3] 21 U.S.C. § 342(a)(1) (1976) (emphasis added). See note 2 supra.

[4] 21 U.S.C. § 342(a)(1) (1976) (emphasis added). See note 2 supra.

[5] The report of the FDA Salmonella Task Force, introduced in the record by the importers, described some of the effects of salmonellosis:

The syndromes can be a diarrhea, a severe enteritis, a typhoidal picture (fever), septicemia and meningitis. In generalized infections the microorganism may localize in any tissue of the body, producing abscesses, endocarditis, pneumonia and kidney impairment.

Joint Appendix (J.A.) 81. According to one study, there are about 2,000,000 human cases of salmonellosis each year in the United States. The study calls the illness "one of the most important communicable disease problems in the United States today." National Academy of Sciences, An Evaluation of the Salmonella Problem (Report of the U.S. Dept. of Agriculture and the FDA) 6 (1969), reprinted at J.A. 71.

[6] Unless otherwise noted, the facts are undisputed and are taken from the district court's opinion, Seabrook International Foods, Inc. v. Harris, 501 F.Supp. 1086, 1088-89 (D.D.C.1980) ("D.Ct.Op.").

[7] The plaintiffs in the district court included a third importer, Seabrook International Foods, Inc., whose lot of shrimp was seized at about the same time as appellants'. See J.A. 231. Seabrook has voluntarily dismissed its appeal.

[8] In determining the basis for the FDA's actions, the district court relied on affidavits of officials involved in the decisionmaking. The importers did not object to this procedure or to the district court's examination of "the full record before the agency at the time the agency decision was made" in evaluating the informal adjudication at issue. D.Ct.Op. at 1089 n.1. See Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420, 91 S.Ct. 814, 825, 28 L.Ed.2d 136 (1971).

[9] Appellants do not challenge the propriety of the procedures employed by the FDA in reaching its decision. See D.Ct.Op. at 1090.

[10] Appellants also argue that APHA v. Butz, infra, prohibits the FDA from singling out one type of food for regulation. See 511 F.2d at 333. The FDA's action here, they contend, violated that prohibition by focusing only on imported shrimp. As we discuss below, however, APHA concerns the government's authority to label domestic products and not its power to ban foods offered for import. As the district court noted, "foreign products must of necessity be regulated differently from domestic products, because foreign processing facilities cannot be inspected by U.S. authorities." D.Ct.Op. at 1093. The FDA's action was within its long-established authority to treat imported goods differently from domestic ones. Compare 21 U.S.C. § 381(a) (1976), supra note 1, with id. § 334(a)(1) (requiring condemnation proceeding in district court before seizure of domestic foods). See Sugarman v. Forbragd, 405 F.2d 1189 (9th Cir. 1968), cert. denied, 395 U.S. 960, 89 S.Ct. 2103, 23 L.Ed.2d 747 (1969).

[11] The relevant sections of the FDCA clearly contemplate a particularized inquiry into the type of food at issue and the nature and origin of the poisonous substance. See notes 1 & 2 supra. Courts must defer to the expertise of the agency charged with exercising Congress' broad power to bar articles from import. See Sugarman v. Forbragd, 405 F.2d 1189 (9th Cir. 1968), cert. denied, 395 U.S. 960, 89 S.Ct. 2103, 23 L.Ed.2d 747 (1969). See also Board of Trustees of University of Illinois v. United States, 289 U.S. 48, 57, 53 S.Ct. 509, 77 L.Ed. 1025 (1933).

[12] Compare Poultry Products Act § 4, 21 U.S.C. § 453(g)(1) and Wholesome Meat Act § 1, 21 U.S.C. § 601(m)(1) with FDCA § 402, 21 U.S.C. § 342(a).

[13] See note 10 & text accompanying note 1 supra.

[14] The regulations define the relevant phrases in section 402 of the Act as follows:

(c) A "naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An "added poisonous or deleterious substance" is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. § 109.3 (1977). The FDA states that under its "`inherent' test, a substance is `added' to a food if its presence therein is attributable to man or, if the substance is not an inherent, natural constituent of the food." Brief for Appellees at 17 n.13 (emphasis in original). Since we conclude that the FDA has a sufficient basis for determining that salmonella is at least partly "attributable to man," we need not decide whether the agency could apply the more relaxed standard of adulteration to foods which contain dangerous substances due to unusual acts of nature. See p. 43 infra.

[15] E.g., United States v. Coca Cola Co. of Atlanta, 241 U.S. 265, 284, 36 S.Ct. 573, 579, 60 L.Ed. 995 (1916); United States v. Anderson Seafoods, Inc., 622 F.2d 157, 160 (5th Cir. 1980).

[16] See also Sugarman v. Forbragd, 267 F.Supp. 817, 824 (N.D.Cal.1967), aff'd, 405 F.2d 1189 (9th Cir. 1968), cert. denied, 395 U.S. 960, 89 S.Ct. 2103, 23 L.Ed.2d 747 (1969); Church of Scientology of California v. Richardson, 437 F.2d 214, 217 (9th Cir. 1971).

[17] See, e.g., J.A. 40-41 (plaintiffs' expert testifies that salmonella is introduced to shrimp through waters contaminated, for example, by fecal matter; notes that water far from land is not generally contaminated); id. at 75 (National Academy of Sciences publication, supra note 5, states that "[s]almonellae are not known to be indigenous" in seafoods); id. at 175-76 (FDA official testifies that "[s]everal countries routinely export salmonella-free shrimp to the United States" and that "when salmonella[e] are found in seafood, including shrimp, their presence is almost always attributable to insanitary and improper processing procedures"); id. at 251 (defendants' expert states that salmonella does not ordinarily occur in shrimp and is usually caused by "insanitary handling and/or processing practices or harvesting from polluted waters").

[18] J.A. 174.

[19] D.Ct.Op. at 1088.

[20] J.A. 72, 252.

[21] J.A. 91.

[22] See, e.g., J.A. 44, 74, 94, 129.

[23] D.Ct.Op. at 1092.

[24] Id.

[25] E.g., J.A. 73. See also J.A. 79, 95-98.

[26] See J.A. 214-24.

590 F.2d 149 (1979)

[150] Denver L. Rampey, U. S. Atty., Richard E. Nettum, Asst. U. S. Atty., Macon, Ga., Charles H. Johnson, Asst. Chief Counsel for Enforcement, Richard M. Cooper, Chief Counsel, Stuart M. Pape, Associate Chief Counsel for Foods, Food & Drug Administration, Rockville, Md., William D. Coston, Barry Grossman, John H. Shenefield, Asst. Atty. Gen., Dept. of Justice, Washington, D. C., for the U. S.

Harry J. Altman, II, Thomasville, Ga., for defendants-appellees.

Before GEWIN, COLEMAN and GOLDBERG, Circuit Judges.

GOLDBERG, Circuit Judge:

Not often does this Court deal with disputes in which the judgment is easier to pronounce than the name of the matter in controversy, but this is such a case. Our problem involves aflatoxin, a metabolic by-product of the polysyllabic mold aspergillus flavus, but our solution is a by-product of monosyllabic words and logic.

Boston Farm Center, appellee, is a grain distributor in Boston, Georgia. On November 22, 1977, the United States, appellant, applied for an injunction under section 302 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332(a), (the "Act"), seeking to halt the Center's interstate shipment of corn containing more than 20 parts per billion (ppb) of the substance aflatoxin.

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.

[151] 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.

The FDA argues that the court should defer to this action level because it represents the expert, technical judgment of the agency. The government argues in its brief that, "[a]lthough not a regulation, an action level represents the agency's considered judgment as to the level of a contaminant that can be permitted in food without significant risk to public health or to the fitness of food for consumption." In essence, the government implies with such terms as "the agency's considered judgment" that a court should defer to an action level much as it defers to an agency regulation. Indeed, some cases approach this position. See e. g., U. S. v. 484 Bags, More or Less, 423 F.2d 839, 842 (5th Cir. 1970), and Dean Rubber Manufacturing Co. v. U. S., 356 F.2d 161 (8th Cir. 1966). We accept this argument for deference to the agency but only up to a point. The deference principle is less compelling when the agency threshold is a matter of prosecutorial discretion instead of rule-making. Congress requires considerably more fact-finding due process, most especially full notice and comment, in agency rule-making than in agency prosecutorial discretion.^[1] The fuller rule-making due process serves the purposes of accuracy and fairness. When an agency proceeds in non-rule case-by-case adjudication, much of the fact-finding process is shifted to the courts. The purposes of accuracy and fairness require that the courts not slavishly defer to the agency's in house prosecutorial guidelines arrived at without benefit of even minimal due process protections. At the extreme, the deference argument in this context sets up the blocking for an end run by the agency of the procedural checks in the statute for formal rule-making.

Nevertheless, in this circuit we have evolved a policy of considerable deference to agency action levels. Thus, in U. S. v. 484 Bags, More or Less, 423 F.2d 839, 842 (5th Cir. 1970), we wrote: [The District Court]

may accept as a judicial standard the allowable tolerances now permitted by the Secretary, whether published or not. A court may apply a stricter standard than the Secretary and hold a food substance adulterated though within the Secretary's tolerances. Considering the positive command of the statute, the power of the court to allow a greater departure from purity than the administrative tolerances is less certain.

We need not decide in this case "the power of the Court to allow a greater departure from purity than the administrative tolerance" because we find that the facts in this case are so one-sided that any finding of non-adulteration for amounts of aflatoxin between 20 ppb and 100 ppb would be clearly erroneous. Thus, even if the court were to afford no deference whatsoever to the action level set by the agency—that is, even if the court were to make a wholly independent decision as to whether the Boston [152] Farm corn was adulterated—it would still be clearly erroneous on this record to find that amounts of aflatoxin between 20 and 100 ppb do not adulterate corn. Only one expert testified before the lower court on the potential hazardousness of aflatoxin. That expert, Dr. Rodricks, testified that "there is no known level of exposure which can be considered safe, without risk to people." (Transcript, p. 29.) Dr. Rodricks cited numerous studies to support this expert opinion, including one showing the adverse effects of aflatoxin in doses as low as 15 ppb. (Tr. 25, Govt. exhibit 2, paragraph 5(b)). In addition, Dr. Rodricks testified that aflatoxin accumulates in body tissue. Thus, without statistics showing the amount of long term consumption of corn by livestock and by humans, it makes little sense to draw any bright line between doses of aflatoxin which "may" render food injurious to health and doses which are not possibly dangerous.^[2]

Aside from Dr. Rodricks' expert testimony, there was no other evidence in this record on the question of the potential harmfulness of aflatoxin. Appellees presented no evidence on the question and did not elicit from Dr. Rodricks during cross-examination any contradictory evidence on this question. Certainly there is no evidence in the Record to support the Court's assertion that "there is controversy concerning the validity of this determination, it being contended by some that injury to health is not likely unless the content exceeds approximately 400 parts per billion (ppb)."^[3]

As a result, we find the lower court was clearly erroneous in finding that amounts of aflatoxin between 20 and 100 ppb do not render corn adulterated.^[4]

We want to emphasize the limited nature of our ruling today. To an extent the statutory scheme permits the FDA to adopt a relatively ad hoc case-by-case approach to [153] regulating the poisons in our food. The statute does not demand rigid and permanent fixity in the numbers game, mainly because our social policies and scientific knowledge about dangerous food are not themselves steady and static. As scientific research and measurement progress, the digits and integers of thresholds, action levels, and tolerances will necessarily change with them. But, in this case the expert evidence is uncontradicted than 20 ppb of aflatoxin may render corn harmful. Other days and other records may yield other figures, but in this case, with this evidence, only one result is possible. The court must enjoin the corn containing more than 20 ppb of aflatoxin.

We remand to the lower court for it to enter an injunction prohibiting Boston Farms from shipping interstate any corn from the 1977 season containing more than 20 ppb aflatoxin.

REVERSED and REMANDED.

[1] 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).

[2] At best one might make distinctions on the basis of "public interest" policies, but Congress has vested such discretion in the Secretary. 21 U.S.C. § 336.

[3] Appellees argue that the 20 ppb threshold is an arbitrary figure set by the FDA solely because it is the smallest amount of aflatoxin that can be measured. But the Record shows that the FDA kept the level at 20 ppb even after it was able to measure lower amounts. Unrebutted evidence in the Record shows that the FDA could identify aflatoxin at levels of 1-5 ppb as early as 1973, (Govt. Exhibit 2, ¶ 6) and that the agency lowered the level for peanuts to 15 ppb in 1974. 39 Fed.Reg. 42748 (December 6, 1974). Moreover, it is not clear why setting a threshold at the lowest measurable amount of a poison considered dangerous in any amount is improper or irrational.

[4] Two other arguments raised by the parties should be discussed briefly.

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.

179 F.Supp.2d 30 (2001)

[31] [32] [33] Charles S. Kleinberg, United States Attorney's Office, Civil Division, Brooklyn, NY, Allison M. Harnisch, Office of Consumer Litigation, U.S. Dept. of Justice, Washington, DC, for plaintiff.

Russell K. Statman, Plattsburgh, NY, for defendants.

MEMORANDUM AND ORDER

SIFTON, Senior District Judge.

The United States brings this action for injunction against defendants Blue Ribbon Smoked Fish, Inc. ("Blue Ribbon"), Jay A. Suttenberg ("Suttenberg"), Pablo Negron ("Negron"), and Susan Dozortsev ("Dozortsev") (collectively, the "defendants") under 21 U.S.C. § 332(a), the Federal Food, Drug and Cosmetic Act (the "Act" or "FDCA"). Specifically, the United States seeks to enjoin the defendants from violating 21 U.S.C. § 331(a) and (k) by introducing into interstate commerce food (1) that is adulterated within the meaning of the Act or (2) that will become adulterated after shipment.

Defendants Suttenberg, Negron, and Dozortsev (collectively, the "individual defendants") move pursuant to Fed.R.Civ.P. 12(b)(6) to dismiss the complaint against them in their individual capacities. The United States moves pursuant to Fed. R.Civ.P. 56 for summary judgment in its favor, enjoining the defendants from further violations of the FDCA on the ground that there are no material issues in dispute.

For the reasons set forth below, the individual defendants' motion is denied, and the United States' motion is granted.

BACKGROUND

The following facts are taken from the parties' submissions in connection with the present motions and are undisputed except as noted. For the purpose of the individual defendants' motion to dismiss the complaint, I assume the facts alleged in the complaint to be true. I will not consider any matters outside the pleadings submitted by either party and will not treat the individual defendants' motion as one for summary judgment. See Fed.R.Civ.P. 12(b)(6). For the purpose of plaintiff's motion for summary judgment, I assume that all uncontroverted Rule 56.1 factual assertions are not disputed. See Titan Indemnity Co. v. Triborough Bridge & Tunnel Authority, 135 F.3d 831, 835 (2d Cir.1998).

Blue Ribbon, a New York corporation, is engaged in preparing, processing, holding, and distributing a variety of seafood products, including brined fish, hot- and [34] cold-smoked fish products, and seafood salads. It's facility is located at 5901 Foster Avenue, Brooklyn, New York (the "plant"). All three individual defendants work at the plant, are co-owners of Blue Ribbon, and are corporate officers responsible for plant operations. Suttenberg is president and co-owner of Blue Ribbon with ultimate authority over the plant's operations. According to the complaint, his responsibilities include food processing, plant sanitation, product distribution, and implementation of Hazard Analysis Critical Control Point ("HACCP") plans necessary for controlling food safety hazards.^[1] Negron is vice president and co-owner of Blue Ribbon. He was previously Blue Ribbon's president, and as vice president he supervises the day-to-day operations of the plant, which includes overseeing the processing of the seafood, as well as the processes of fish thawing, brining, and smoking. Dozortsev is the secretary and treasurer of Blue Ribbon and a co-owner. Her duties, like those of Negron, include supervising the day-to-day operations of the plant, including overseeing the processing of the seafood, preparing HACCP plans, and monitoring sanitation controls.

Plaintiff alleges that the U.S. Food and Drug Administration ("FDA") and the New York State Department of Agriculture and Markets ("NYSDAM") have documented, throughout the last seven years, insanitary conditions at the facility as well as defendants' failure to establish and implement adequate HACCP plans necessary to control food safety hazards. The FDA and the NYSDAM have documented (1) numerous insanitary conditions at the plant; (2) defendant's failure to implement appropriate HACCP plans; and (3) the presence of Listeria Monocytogenes ("L.monocytogenes"), a bacteria that causes disease, in certain smoked fish products and in the plant environment.

Proper HACCP Plans

Seafood processors are required to establish and implement HACCP plans pursuant to 21 C.F.R. § 123.6(b). HACCP is a management system designed to prevent the occurrence of potential food safety problems. According to FDA regulations, a processor of fish and fishery products is required to assess biological, chemical, and physical hazards at all stages of processing, from production of the raw materials, to procurement and handling, manufacturing, distribution and consumption of the finished products. After assessing the health and safety risks that each particular food presents, the processor must determine necessary steps to control the identified risks. 21 C.F.R. § 123.6(a) & (b). A specific analysis must be done for each fish or fishery product, unless the food safety hazards, critical control points, critical limits, and procedures to be followed are identical for two or more fish products. 21 C.F.R. § 123.6(b)(2). The processor is then required to document these analyses in HACCP plans, as well as keep records to document the monitoring of the actual values and observations obtained when fish processing. 21 C.F.R. § 123.6(c)(7).

During the August 2000 inspection, the FDA found that Blue Ribbon failed to comply with FDA regulations regarding HACCP plans. According to the FDA's Establishment Inspection Report ("EIR"), the inspection team noted that "the firm lacked a written HACCP plan, a process schedule, and process monitoring records for a lot of brined and dried salmon pieces, removed from bones, used to produce a batch of cream cheese & lox." Blue Ribbon [35] recalled this lot of cream cheese and lox^[2] and promised to correct the HACCP deficiencies. In the follow-up inspection of January 2001, the FDA's EIR again noted HACCP deficiencies, stating, in part:

The firm processes cold smoked Nova Salmon with an incomplete written HACCP Plan, incomplete Monitoring Records and Verification Procedures that do not document the accuracy of temperature measuring devices or Salometers used in the brining operation. There is no verification of raw materials (incoming fish) containing levels of microorganisms that will not produce food poisoning or other disease in humans, and the firm operates with inadequate HACCP controls. There is no written HACCP Plans for Nova Salmon Bits (produced from pieces of salmon removed from bones) or smoked Sea Bass.

The EIR detailed the specific deficiencies that the inspection team observed in the HACCP plans. The following problems were identified with the cold smoked Nova salmon HACCP plan: the plan was signed but not dated, as required by 21 C.F.R. 123.6(d); it erroneously listed scombrotoxin formation as a food safety hazard relating to salmon production; there was no critical limit for internal fish temperature; no time was specified for thawing frozen fish; no procedure was included for monitoring brine solution or fish temperature during brining; it was inconsistent with the firm's written procedure for brining;^[3] there was no procedure to check the accuracy of thermometers, salometers, thermostats; and there was inadequate monitoring of critical control points. The EIR also detailed the lack of HACCP plans for Nova salmon bits and noted that this deficiency had been brought to Blue Ribbon's attention during the August 2000 inspection. It was also observed that Blue Ribbon did not have a written HACCP plan for smoked sea bass. These deficiencies were discussed with Suttenberg and Dozortsev.

Defendants do not dispute the FDA findings that the HACCP plans were inadequate or non-existent at the time of these inspections. The defendants maintain that, as of now, Blue Ribbon has implemented an effective HACCP plan, which the company now follows.

Insanitary Plant Conditions

Inspections of the plant were conducted in 1994, 1995, 1996, 1999, 2000, and 2001. According to Jerome G. Woyshner, Director, Investigations Branch, New York District, Northeast Region of the FDA, Department of Health and Human Services ("Woyshner"), the FDA conducted the most recent plant inspection from January 17 to 26, 2001. The January 2001 inspection revealed the following insanitary conditions: old seafood product residue on food contact surfaces; mold in the cooler, freezer, and ceiling of the slicing and packing room; a plastic dividing curtain that touched the floor and came into contact with fish; liquid dripping onto seafood [36] from other seafood stored above; and old dripping product residue on the walls and fan shrouds in the cold smoking/drying room. The inspection found the inadequate cleaning and sanitizing processes, including a failure to adequately sanitize and wash cutting boards, knives, and slicing machine. The inspection also revealed employees touching unclean surfaces and then touching ready-to-eat fish without sanitizing their gloves, wearing street cloths in the processing areas without protective coverings, eating and drinking in the processing areas, inadequate hand washing and sanitizing, and wearing of unrestrained hair and beards. The FDA also found that the plant's construction was not designed to prevent bacterial contamination and filth and that there were inadequate doors or barriers between the slicing and packing room and the garage and toilet, lack of control over foot traffic and product flow to prevent cross-contamination of the finished ready-to-eat product and that surfaces were in disrepair making adequate cleaning impossible.

In August 2000, the FDA conducted two inspections and found insanitary plant conditions. For instance, the ceiling in the processing room was in disrepair and rusted; condensation was dripping from the ceiling into uncovered tanks of brining fish; dried encrusted food residue was observed in processing and packing areas; and used, stained boxes for receiving raw fish were stacked on top of the table in the packing area and on top of a refrigerator. On January 12, 2000, the NYSDAM issued a final determination, based on various inspections and product sampling, revoking Blue Ribbon's food processing establishment license. After subsequent satisfactory testing and sampling by NYSDAM, Blue Ribbon was reissued its license. A joint inspection conducted by the FDA and NYSDAM in October 1999 observed an employee drop a fish on the floor that then continued to be processed, a piece of cardboard and plastic tubing hanging into a brining tank, and the ceiling in disrepair and rusted. Earlier inspections in 1994, 1995, and 1996 found similar insanitary conditions and poor employee practices.^[4]

Defendants do not dispute that the insanitary conditions observed by the FDA existed during the prior seven years of documented inspections. Defendants allege, however, that, since Suttenberg became president of Blue Ribbon on August 24, 2000, conditions at Blue Ribbon have improved. After the January 2001 inspection, Suttenberg wrote to the FDA outlining thirty corrective actions that Blue Ribbon would take to correct the conditions that had been observed. According to Suttenberg, Blue Ribbon has upgraded its physical plant, a wall has been constructed segregating the slicing area, seams in the cold smoking room were sealed and repaired, and the cutting table was replaced with a seamless frame unit. Plant walls were reinforced, and a new thermometer was installed to ensure the accuracy of existing thermostats that monitor fish temperatures. In addition, Suttenberg states that all cooler and freezer doors were painted and are scrubbed daily to keep them clean. Sanitary footpads are [37] placed at all entry points into the plant. Restrooms have been moved, new tile installed, and walls have been constructed to isolate the restrooms from the processing areas. Blue Ribbon has also designated an employee to be responsible for supervising sanitation.

Presence of L. Monocytogenes

During inspections of the plant, the FDA found instances of L. monocytogenes contamination in seafood products and in the plant environment. According to the government, L. monocytogenes is a bacterium that causes the disease listeriosis, and food contaminated with this bacterium is harmful to human health. Listeriosis can be serious and even fatal for high-risk groups such as infants, the elderly, pregnant women, and those with impaired immune systems. The most serious consequence of infections in susceptible individuals is septicemia, a condition in which bacteria enter the bloodstream and multiply, thereby poisoning the bloodstream. Complications in pregnant women include miscarriage, stillbirth, bacteria in the bloodstream of the newborn, and meningitis. In other susceptible children and adults, complications commonly include problems with the central nervous system, pneumonia, endocarditis, localized abscesses, skin lesions, and conjunctivitis. Although listeriosis can be treated with antimicrobial drugs, it can be fatal, and for susceptible individuals who become infected, the mortality rate is between 20 and 30 percent.

In recognition of the health risk associated with listeriosis, the FDA has adopted a "zero-tolerance" policy with regard to L. monocytogenes and has established procedures for fish processors to follow to eliminate and control its presence in food. According to the government's expert, Mary E. Losikoff, FDA Consumer Safety Officer, a processor must test incoming raw materials for the presence of the bacteria, implement and follow strict sanitation measures, conduct environmental monitoring, and implement testing of the finished product. These steps are required particularly in the processing of cold-smoked fish, which are not subjected to heat sufficient to eliminate L. monocytogenes. In addition, as discussed above, a processor must have and follow HACCP plans.

Defendants dispute the seriousness of the risk that small amounts of L. monocytogenes poses to human health. They note that the bacteria does not ordinarily present a risk to healthy individuals, noting that the United Nations Food and Agriculture Organization ("UNFAO") records the incidence of disease associated with the bacteria as of approximately two to ten cases per million people and that epidemiological studies show a 1 in 59 million chance of infection from a 50 gram serving of fish containing 100 bacteria per gram. While L. monocytogenes is frequently found in fish, there have been few instances of listeriosis from fish products. At least one group of researchers has stated that "[l]isteria contaminated fish products should not represent a serious impact on human health."

FDA inspections at the plant revealed the presence of L. monocytogenes in food samples and in the plant environment. During the January 2001 inspection, FDA analysis revealed the bacteria in a sample of Nova salmon bits and in floor drains in a processing area of the plant. During the August 2000 inspection, FDA analysis revealed the presence of L. monocytogenes in a sample of sliced smoked Nova salmon and a sample of cream cheese and lox, as well as on the plant floor near the brining cooler. The NYSDAM inspection at the same time found samples of whitefish salad and smoked baked salmon salad contaminated with L. monocytogenes. On the basis [38] of the FDA and NYSDAM findings in August 2000, Blue Ribbon recalled implicated lots of cream cheese and lox, frozen sliced Nova salmon, frozen deli-cut Nova boards, smoked whitefish salad, and smoked basked salmon salad. During the October 1999 joint inspection by the FDA and NYSDAM, samples of whitefish salad and smoked sable were contaminated with L. monocytogenes, as well as the cleaning room floor. In November 1999, Blue Ribbon recalled fish lots that were found to be contaminated. The FDA and NYSDAM found similarly contaminated food and plant environment samples in September 1999, November 1996, November 1995, and January 1994.

Defendants do not dispute that the FDA and NYSDAM found L. monocytogenes in food samples and in the plant. The defendants dispute that Blue Ribbon caused the contamination and suggest that L. monocytogenes is widely present in the environment, occurs naturally on raw fish, and is a problem faced by every fish processing facility, not just Blue Ribbon. Defendants point to a 1997 FDA study which found that 17.5 percent of cold-smoked fish products sampled nationwide between 1991 and 1995 tested positive for L. monocytogenes. That study found L. monocytogenes in ten of sixteen New York smoked fish processing plants. Other studies and surveys indicate that the FDA study was not an anomaly: a survey of vacuum-packed processed meats in retail stores found 53 percent of samples contaminated with the bacteria; vegetables have been found contaminated with the bacteria; and another study of food samples in the United Kingdom found an incidence rate of 6 percent. One article states that, once bacteria has contaminated the fish, contamination during subsequent processing becomes almost impossible to control, even with stringent sanitation procedures in place. Recalls of contaminated fish are not infrequent, and according to the UNFAO, between 1987 and 1992 there were 970 recalls of ready-to-eat foods from 109 firms in the United States.

In addition to occurring naturally in some raw fish, defendants also argue that it is impossible to prevent the presence of some amount of L. monocytogenes bacteria on cold-smoked fish. Lox, for example, is produced by the cold-smoking process and is not prepared by being subjected to sufficient heat to destroy L. monocytogenes. Rather, smoked salmon subjected to sufficient heat would not be recognized by consumers as lox. In light of this, defendants dispute that the FDA's "zero-tolerance" with respect to L. monocytogenes policy is appropriate. The UNFAO has taken the position that "[a]pplying a strict zero tolerance policy for this organism would effectively put a number of products out of the market, such as pre-cooked shrimp and smoked fish." Many European countries and Canada have set tolerance levels graduated with the health risk posed by the contamination.

Furthermore, defendants dispute that there are ongoing problems of L. monocytogenes contamination at the plant. NYSDAM tested Blue Ribbon samples on April 2, 2001, April 30, 2001, May 10, 2001, June 6, 2001, and August 21, 2001. NYSDAM did not notify the defendants of any contamination.

Proposed Judgment Ordering Permanent Injunction

The United States has proposed terms of a permanent injunction to be entered should it prevail on its motion for summary judgment and defendants are found to have violated Sections 331(a) and 331(k) of the FDCA. First, defendants and all directors, officers, agents, representatives, employees, successors, assigns, attorneys, and any and all persons in active concert [39] with the defendants would be permanently restrained from the processing, preparing, packing, holding, and distributing of food at the plant or at any other locations unless and until certain conditions are met. These conditions include the following:

(1) Defendants must thoroughly clean and sanitize the plant and make certain structural changes to prevent condensation from dripping onto food;

(2) Defendants must select a person, other than an employee of Blue Ribbon, to act as a "Listeria expert" who is qualified to develop a testing program, a Sanitation Standard Operation Procedure ("SSOP"), employee training procedures, and a monitoring protocol, to detect, prevent, and control the introduction and spread of L. monocytogenes in the plant environment and in the raw ingredients and processed food products, especially for food products that will not receive a heat process (like cold smoked fish products);

(3) The United States Food and Drug Administration ("USDA") must approve the raw ingredient testing and treatment program, SSOP, training program, and monitoring program developed by the Listeria expert;

(4) Defendants must, under FDA supervision and by a method detailed by the proposed permanent injunction,^[5] examine all lots of smoked and brined fishery products on hand at the plant for L. monocytogenes;

(5) For any fish or fishery products for which there is no HACCP plan, defendants must conduct a hazard analysis and develop a plan, which is to be approved by the FDA; and

(6) Prior to resuming operations, the FDA must notify defendants in writing that they are in compliance with all requirements set forth by the proposed injunction and 21 C.F.R. Parts 110 and 123.^[6]

Once defendants meet the above conditions and the FDA certifies that the defendants are in compliance with the requirements of 21 C.F.R. Pts. 110 and 123, the plant may resume operations, subject to additional conditions. These conditions require that the defendants implement and maintain a protocol to control the presence of L. monocytogenes. The protocol must include a program for treatment or testing of susceptible raw materials for food products, such as cold-brined or cold-smoked fish that do not receive a heat treatment sufficient to kill the bacteria. Similarly, the protocol must include effective and diligent sanitation procedures, environmental monitoring, and additional controls to monitor the finished product after processing. The FDA will be permitted to inspect the plant, without prior notice to defendants, to ensure continuing compliance with the permanent injunction. Pursuant to the proposed injunction, this inspection authority would be apart from, [40] and in addition to, the FDA's authority to inspect, granted by 21 U.S.C. § 374.

By the terms of the proposed injunction, in the event that the defendants and/or their agents violate Section 331(a) or (k) of the FDCA, defendants shall immediately cease the processing, preparing, packing, holding, and distributing of food. Likewise, defendants must cease production if the FDA notifies them in writing that any article of food at the plant is adulterated, that there appear to be insanitary conditions at the plant, or that the defendants are not in compliance with the terms of the injunction, FDA regulations, or the FDCA. If the FDA deems it necessary, the defendants must also recall all articles of their products, and all costs of such a recall must be borne by the defendants. In the event that the FDA requires defendants to cease production, they may not resume until the FDA certifies that the defendants are in compliance with the terms of the injunction, FDA regulations, and the FDCA.

The proposed injunction provides that all decisions specified shall be vested in the discretion of the FDA and that the decisions will be final, subject only to review by this Court under the arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A). No discovery may be had by either party. The United States as plaintiff shall recover the costs of the present action, including attorneys fees, and the costs of any subsequent action necessary to enforce the terms of the injunction, should it prevail.

DISCUSSION

This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331 and 21 U.S.C. § 332, the latter providing district courts with jurisdiction, for cause shown, to restrain violations of 21 U.S.C. § 331.

Individual Defendants' Motion to Dismiss

The individual defendants assert that the present action against them for an injunction is improper because they are distinct from Blue Ribbon, which is the corporate entity that should be the sole focus of the government's injunction, and because the complaint does not state a claim against them. A motion under Rule 12(b)(6) should be granted only if "`it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.'" Cohen v. Koenig, 25 F.3d 1168, 1172 (2d Cir.1994) (quoting Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). "The court's function on a Rule 12(b)(6) motion is not to weigh the evidence that might be presented at trial but merely to determine whether the complaint itself is legally sufficient." Goldman v. Belden, 754 F.2d 1059, 1067 (2d Cir.1985).

The Supreme Court has established that "the public interest in the purity of its food is so great as to warrant the imposition of the highest standard of care on distributors." United States v. Park, 421 U.S. 658, 671, 95 S.Ct. 1903, 44 L.Ed.2d 489 (1975) (citations and internal quotation marks omitted). Food processing companies, and not consumers, are best positioned to protect public health: "Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless." United States v. Dotterweich, 320 U.S. 277, 285, 64 S.Ct. 134, 88 L.Ed. 48 (1943). The responsibility rests on the corporate entities, as well as its agents, and as such the FDA's statutory authority empowers the government to seek relief [41] against executives, as well as legal entities, in enforcement action. See United States v. Undetermined Quantities of Articles of Drug, 145 F.Supp.2d 692, 694 (D.Md.2001) (citing Park, 421 U.S. at 672, 95 S.Ct. 1903). "[C]orporate agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act bear a `responsible relationship' to, or have a `responsible share' in, violations." Park, 421 U.S. at 672, 95 S.Ct. 1903.

Thus, to state a claim against the individual defendants, the government must allege in the complaint that Suttenberg, Negron, and Dozortsev had responsible relationships to, or responsible shares in, the furtherance of the transactions outlawed by the Act.

According to the complaint, Suttenberg is Blue Ribbon's president with "ultimate authority" and is "in charge of overall operations of Blue Ribbon." Negron is Blue Ribbon's vice president and "manages and supervises day-to-day operations of the firm, including food processing, product thawing, brining, and smoking processes." Dozortsev is secretary and treasurer and "manages and supervises day-to-day operations of the firm, including monitoring food processing, preparing HACCP plans, and monitoring sanitation controls." Assuming the facts of the complaint to be true, the government has set forth facts that establish that corporate officers Suttenberg, Negron, and Dozortsev are responsible for the sanitation of the plant and the safety of the food it produces.

The individual defendants argue that an injunction against corporate officers is unnecessary where there is an injunction against the corporate entity, because agents are generally bound by restrictions placed on the principal. Nevertheless, courts have enjoined corporate officers in civil cases brought under the FDCA, when the corporate entity was likewise enjoined. See United States v. Universal Management Serv. Inc., 191 F.3d 750 759 (6th Cir.1999) (applying Park and Dotterweich to an FDCA injunction case against corporate office due to supervisory and managerial role); cert. denied, 530 U.S. 1274, 120 S.Ct. 2740, 147 L.Ed.2d 1005 (2000); Undetermined Quantities of Articles of Drug, 145 F.Supp.2d at 694 (enjoining company president who had responsible relationship to or responsible share in FDCA violations, despite assertions that he did not personally participate in manufacture, sale, or distribution of adulterated articles); United States v. Sene X Eleemosynary Corp., 479 F.Supp. 970, 976-77 (S.D.Fla. 1979) (individual defendants' positions of authority and responsibility in the operation states a claim under the FDCA against them). While an injunction against corporate official might appear to the individual defendants to be duplicative, the Supreme Court has stated: "The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntary assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them." Park, 421 U.S. at 672, 95 S.Ct. 1903.

The individual defendants' motion to dismiss the complaint against them is denied.

Government's Motion for Summary Judgment

Plaintiff has moved for a summary judgment pursuant to Rule 56(c) of the Federal Rules of Civil Procedure. Summary judgment must be granted if there is no genuine issue as to any material fact and if the moving party is entitled to judgment as a [42] matter of law. See Fed.R.Civ.P. 56(c). The moving party has the burden of demonstrating the absence of any disputed material facts, and the court must resolve all ambiguities and draw all inferences in favor of the party against whom summary judgment is sought. See Thompson v. Gjivoje, 896 F.2d 716, 720 (2d Cir.1990). While the court views the evidence in the light most favorable to the nonmoving party, see O'Brien v. National Gypsum Co., 944 F.2d 69, 72 (2d Cir.1991), "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment."

The FDCA, Section 331 of Title 21 of the United States Code, prohibits:

(a) The introduction or delivery for introduction into interstate commerce of any food ... that is adulterated or misbranded.

(k) [T]he doing of any ... act with respect to [] a food ... while such article is held for sale ... after shipment in interstate commerce and results in such article becoming adulterated or misbranded.

21 U.S.C. § 331(a) & (k). The elements for establishing a violation of either of these provisions are essentially the same: (1) the product in question must be a food; (2) the food must be adulterated; and (3) there must be an interstate commerce nexus. The only difference between subsections (a) and (k) of Section 331 is the timing of the interstate commerce element: Section 331(a) prohibits introducing adulterated food into interstate commerce after processing, while Section 331(k) prohibits adulterating food after its components have traveled in interstate commerce. I address these three violation elements in turn.

Defendant's Products are "Food"

The FDCA defines "food" as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321(f). Under the FDCA, a court may take judicial notice that an article is food where it is common knowledge that the article is used for food. United States v. H.B. Gregory Co., 502 F.2d 700, 704 (7th Cir.1974); United States v. O.F. Bayer & Co., 188 F.2d 555, 557 (2d Cir.1951). Moreover, defendants do not dispute that the fish products it processes and distributes are food.

Nexus to Interstate Commerce

The FDCA defines interstate commerce as "commerce between any State or Territory and any place outside thereof." 21 U.S.C. § 321(b). The FDCA also provides that "[i]n any action to enforce the requirements of [the FDCA] respecting a food ... the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist." 21 U.S.C. § 379a. The government, in addition, has submitted evidence to establish that Blue Ribbon receives raw fish to be processed from Norway, Chile, and the Faroe Islands. Blue Ribbon ships its finished product to retailers in New Jersey and Pennsylvania. Moreover, defendants do not dispute that it is engaged in interstate commerce.

Adulteration of Defendants' Products

It is a violation of the FDCA to move in interstate commerce food that has become adulterated. Food is adulterated as defined by the FDCA:

(1) [i]f 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 [43] under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health[; or]

(4) [i]f it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

21 U.S.C. § 342(a)(1) & (4). According to the United States, defendants' products are adulterated pursuant to this definition on the basis of three alternative grounds. First, plaintiff alleges the food is adulterated as defined by Section 342(a)(4) because defendants had an inadequate HACCP plan for smoked Nova salmon and had no HACCP plans for Nova salmon bits and smoked sea bass. Second, plaintiff alleges that the FDA's and NYSDAM's continued observance of insanitary conditions at the plant, including but not limited to the detection of L. monocytogenes at the plant, demonstrates that defendants' seafood may have become contaminated with filth or otherwise rendered injurious to health pursuant to Section 342(a)(4). Plaintiff alleges a third and independent basis of adulteration pursuant to Section 342(a)(1) due to the presence of L. monocytogenes in defendants' seafood, alleged to be a "poisonous or deleterious substance which may render it injurious to health." Because the absence of a dispute of material facts presented by any one of these allegations will support plaintiff's motion for summary judgment, I will address each basis of adulteration in turn.

1. Lack of an HACCP Plan. The FDA regulations that establish the requirements of the HACCP plan states that the "[f]ailure of a processor to have an implement a HACCP plan that complies with this section whenever a HACCP plan is necessary ... shall render the fish or fishery products of that fishery of that processor adulterated under section [342(a)(4)] of the [FDCA]." 21 C.F.R. § 123.6(g). The government alleges that the HACCP plan deficiencies observed and reported by the FDA during August 2000 and January 2001 allow, as a matter of law, this Court to find Blue Ribbon's food adulterated under the FDCA.

Defendants do not dispute that the FDA has observed, documented, and warned Blue Ribbon and the individual defendants about the problems with the existing HACCP plan for smoked Nova salmon and the problematic lack of HACCP plans for Nova salmon bits and smoked sea bass. Defendants argue, in sum, that Blue Ribbon has in fact "implemented an effective HACCP Plan," which is "effective and followed by Blue Ribbon." Furthermore, defendants complain that "[i]f the Government means to allege that the HACCP Plan is somehow deficient, it has not specified what is wrong with it. Dozortsev, who is HACCP-certified, confirms that it is effective as implemented."

Defendants provide this Court with two HACCP plans, which Dozortsev declares are currently effective. Even a cursory inspection reveals these are the same HACCP plans in effect at Blue Ribbon at the time of the January 2001 inspection and found to be inadequate by the FDA. One plan is labeled cold-smoked fish and one is labeled hot-smoked fish. In handwriting on the former HACCP plan, someone has written "Product: salmon — nova." On the hot smoked fish HACCP plan, unidentified handwriting identifies the plan as operating as to whitefish, chubbs, whiting, trout, winter carp, and butter fish.

As discussed in some detail above, in August 2000, the FDA found Blue Ribbon did not have a HACCP plan for Nova salmon bits, and Blue Ribbon promised to correct this deficiency and implement a written HACCP plan. By January 2001, [44] Blue Ribbon had not implemented a HACCP plan for Nova salmon bits. At the time Dozortsev provided the current HACCP plans to this Court by declaration dated October 12, 2001, there was still no HACCP plan for Nova salmon bits. The FDA also observed, documented, and discussed with defendants the need for an HACCP plan to cover the processing of smoked sea bass. The HACCP plans provided to this Court do not encompass sea bass. Neither was the smoked Nova salmon HACCP plan amended in any way in response to the FDA's January 2001 inspection which revealed a number of critical deficiencies in the current HACCP plan, even though the FDA was assured by Suttenberg that Blue Ribbon promised to correct all HACCP plan violations.^[7] Defendants' claims that they are unaware as to the nature of any HACCP plan deficiencies is both incredible and irrelevant, given the content of the FDA inspection reports from August 2000 and January 2001, defendants' "promise" to undertake the plans' corrections, and the absence of any scienter requirement in the relevant regulations.

Because the defendants' HACCP plans are inadequate and do not comply with the FDA regulations, the food Blue Ribbon processes pursuant to them is adulterated as a matter of law, as defined by Section 342(a)(4) of the FDCA. However, because the scope of an injunction entered against Blue Ribbon to remedy FDCA violations may vary depending on the nature of adulteration of defendants' seafood, I next consider the government's other two bases for asserting adulteration.

2. Insanitary Plant Conditions. The government also contends that defendants' seafood is adulterated under 21 U.S.C. § 342(a)(4) because the undisputed facts show insanitary conditions and practices. A food is deemed adulterated under 21 U.S.C. § 342(a)(4) if "processed under insanitary conditions, whether [the food has] actually ... become dangerous to health or not." United States v. 1250 Cans, Pasteurized Frozen Whole Eggs, 339 F.Supp. 131, 140 (N.D.Ga.1972); see also United States v. Nova Scotia Food Prod. Corp., 568 F.2d 240, 247 (2d Cir.1977) ("[F]ood does not have to be actually contaminated during processing and packing but simply [shown] that `it may have been rendered injurious to health,' § 342(a)(4), by inadequate sanitary conditions of prevention."). To prove adulteration under Section 342(a)(4), the government must show a "reasonable possibility" that, by virtue of the insanitary conditions under which the food is prepared, packed, or held, an article of food may have been rendered filthy or injurious to health. See Berger v. United States, 200 F.2d 818, 821 (8th Cir.1952) ("The condition condemned by the statute ... is one which would with reasonable possibility result in contamination."); United States v. H.B. Gregory, 502 F.2d 700, 704-05 (7th Cir.1974) ("[T]he definitive `reasonable possibility' test [is] now generally accepted in cases involving adulterated food under § 342(a)(4)."). The word "filth," as used in the statute, has [45] been construed to have its usual and ordinary meaning, and is not confined to any scientific or medical definition. See United States v. Swift & Co., 53 F.Supp. 1018 (M.D.Ga.1943).

Some of the insanitary conditions observed during the course of the FDA and NYSDAM inspections since 1994 are detailed above. The defendants do not dispute that these conditions were observed and documented by the FDA and NYSDAM. The government has submitted a large bound volume of inspection reports going back as far as 1994 detailing recurring violations, laboratory results indicating the presence of L. monocytogenes in food products and the plant environment, press releases of Blue Ribbon recalls due to contaminated seafood, letters to Blue Ribbon corporate agents specifying insanitary conditions observed during inspections and warning that a seizure or injunction may result if the conditions are not rectified, and letters of assurances by Blue Ribbon agents that the insanitary conditions would be fixed.

Defendants do not deny that they have been processing seafood under insanitary conditions for the last seven years, but claim that these conditions have been rectified under Suttenberg's relatively new management of the plant presenting an issue of fact for a jury. Defendants' submit that since the January 2001 inspection, NYSDAM has tested Blue Ribbon's products for L. monocytogenes five times, have each time found no trace of the bacteria.

Defendants' "new management" defense does not present a material issue of fact for a jury with respect to the question of whether defendants' seafood products are adulterated. Whether Blue Ribbon has finally cleaned up its plant does not change the fact that between 1994 and the summer of this year the FDA and the NYSDAM documented critical deficiencies in the plant's conditions and cleanliness, sufficient to establish as a matter of law that there is a reasonable possibility that the food has become filthy or injurious to health. Moreover, while Blue Ribbon may have not tested positive for the presence of L. monocytogenes since the January 2001 inspection, numerous inspections by the NYSDAM since then have revealed continued insanitary conditions at the plant. The March 12, 2001 inspection found a number of violations including: no handwash sign; unshielded light source; soiled fan guards; dust-laden vent cover; an unscreened entrance; an uneven, soiled floor; debris and litter on the floor; a damaged freezer door gasket; the accumulation of dark residues of air curtain to processing room; exposed fish in a freezer; a lack of thermometers in some retail display cases; and improper record-keeping of internal temperatures of processing fish. A subsequent inspection by NYSDAM on April 30, 2001, revealed a "critical deficiency" caused by the improper processing of Nova smoked bits. General deficiencies were also observed, such as: soiled doors; heavy ice accumulation in freezers; employees with no hair restraints; an unscreened entrance; and dead flies and a dead beetle. NYSDAM assessed Blue Ribbon a fine of $300. During a subsequent inspection on June 6, 2001, the day after the United States filed the present complaint, NYSDAM again found both critical and general deficiencies in the plant's operation and environment, including improper fish processing procedures, and insanitary plant conditions, including mouse droppings, cockroaches, live flies, debris, and refuse. Blue Ribbon was assessed a fine of $600. On these facts, as a matter of law, there is a reasonable possibility that Blue Ribbon's food has been "prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby [46] it may have been rendered injurious to health." 21 U.S.C. § 342(a)(4).

3. Presence of L. Monocytogenes. The government argues that Blue Ribbon's seafood is adulterated because L. monocytogenes is a "poisonous or deleterious substance," the presence of which renders the seafood "injurious to health." 21 U.S.C. § 342(a)(1). If L. monocytogenes is an "added substance," according to the FDCA and the FDA's zero-tolerance policy, any trace of it in a food product renders that product adulterated. If L. monocytogenes is not an added substance, defendants' fish are adulterated only if the quantity of the bacteria "ordinarily render[s] it injurious to health." 21 U.S.C. § 342(a)(1) (emphasis added).

Defendants' argue first that L. monocytogenes is not an "added substance" and that, therefore, 21 U.S.C. § 342(a)(1) provides that food is not adulterated if it contains a quantity of L. monocytogenes not ordinarily injurious to health. Defendants argue alternatively that, if L. monocytogenes is an "added substance," the FDA's failure to set a "tolerance level" pursuant to 21 U.S.C. § 346 is a violation of the FDCA.

Added Substance

The FDCA does not define the terms "added substance," but FDA regulations define the relevant terms as follows:

(c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. § 109.3(c) & (d) (italics in original). Defendants argue that L. monocytogenes is not an added substance because it "occurs in seafood naturally in the wild." Defendants cite United States v. 1232 Cases American Beauty Brand Oysters, 43 F.Supp. 749 (W.D.Mo.1942), which held that fish bones and oyster shell fragments, while deleterious, were not artificially added substances. Id. at 750-51. Yet the defendants themselves submit evidence that readily distinguishes the occurrence of L. monocytogenes in fish and the occurrence of fish bones in fish. The UNFAO report submitted by defendants notes that fish are not born with L. monocytogenes but, rather, are contaminated with the bacteria by coming into contact with it in the environment. George W. Bierman, Ph.D., defendants' proposed expert, states that the "[FDA] and the Food Safety Inspection Service of the U.S. Department of Agriculture ("FSIS") have acknowledged that `[b]ecause L. Monocytogenes is widely present in the environment, it would be impossible to prevent animals from coming into contact with the bacteria'" and states that the same is true of raw fish. "Raw fish procured by processors are likely to have come into contact with the organism in the wild," Bierman concludes. L. monocytogenes is, thus, not an inherent natural constituent of fish but, rather, a bacterial organism present in the environment that comes into contact with, and contaminates, some fish. See United States v. Union Cheese Co., 902 F.Supp. 778, 786 (N.D.Ohio 1995) (finding L. monocytogenes not to be an inherent natural constituent of cheese but rather the result of environmental contamination); cf. United States v. An Article of Food Consisting of Cartons of Swordfish, 395 F.Supp. 1184 (S.D.N.Y. [47] 1975) (finding mercury to be an added substance because it does not occur naturally in swordfish).

Even if L. monocytogenes existed naturally in fish, it would still be considered an "added substance" under the FDCA because the spread of the bacteria to other uncontaminated fish is "increased to abnormal levels through mishandling or other intervening acts" and is therefore considered an "added substance" under the FDA regulations. 21 C.F.R. § 109.3(b). Defendants do not dispute but rather advance the argument that L. monocytogenes contamination can be spread by intervening acts of man: "Contamination takes place not only in the wild, but on fishing boats or during filleting, or potentially anywhere else in the chain from ocean to fishing boat to trade to processor to wholesaler to retailer to consumer." Defendants do not dispute the insanitary conditions observed by the FDA and NYSDAM going back as far as 1994. The government's expert, Losikoff, states without dispute that the conditions observed during the January 2001 inspection were such that could result in the cross-contamination of previously uncontaminated fish products, specifically, product residue on food contact surfaces, like the slicer and cutting boards; cutting boards and knives not sanitized before use as specified in the plant's sanitation procedures; cutting boards that were worn from use and gouged with nicks and scrapes making cleaning and sanitizing difficult; cooler and freezer door handles that were caked with residue; and plastic strips used as room-dividing curtains that touched the floor and were then allowed to drag across uncovered processed sea bass as the employee pulled a cart from one room to the next. Other employee practices observed constitute intervening acts increasing the amount of the bacteria in the plant's fish, like employees touching unclean surfaces then handling ready-to-eat fish, the lack of protective clothing over employee street clothes, and bare arms and beards. "Insanitary conditions, which are the intervening acts of humans, are sufficient grounds upon which to conclude that a deleterious substance has been `added.'" Union Cheese Co., 902 F.Supp. at 786; see also Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 43 (D.C.Cir.1982) (affirming similar holding with respect to salmonella in shrimp). Accordingly, I conclude based on the undisputed facts that L. monocytogenes is an added substance under the FDCA.

Injurious to Health

Defendants seek to raise a material and disputed issue of fact as to whether L. monocytogenes is a "poisonous or deleterious substance which may render [food] injurious to health," as required by 21 U.S.C. § 342(a)(1).

Defendants first state that "[t]he bacterium does not ordinarily present a risk to healthy individuals." (Bierman Decl. ¶ 87, 8; FDA, Center for Food Safety and Applied Nutrition, Foodborne Pathogens Microorganisms and Natural Toxins Handbook ("Bad Bug Book")). Defendants further note that "healthy people do not develop listeriosis except in extremely rare cases" and that "epidemiological studies showing a 1 in 59 million chance of infection from a 50 gram serving of fish containing 100 bacteria per gram" focus on the risk of disease to the population at large rather than to susceptible individuals such as the young, old, and pregnant. As to the susceptible population, the FDA's Bad Bug Book also states as of data from 1987 that "there are at least 1600 cases of listeriosis with 415 deaths per year in the U.S." and that "manifestations of listeriosis include septicemia, meningitis (or meningoencephalitis), encephalitis, and intrauterine [48] or cervical infections in pregnant women, which may result in spontaneous abortion ... or stillbirth." An article submitted by defendants states that "[l]isteria monocytogenes causes listeriosis, a disease that can be serious and is often fatal to susceptible individuals.... Accordingly, regulatory agencies in the United States have adopted a zero-tolerance policy towards the incidence of the organism in ready-to-eat food products." M. Eklund et al., U.S. Dept. of Commerce, NOAA, National Marine Fisheries Service, "Incidence and Sources of Listeria monocytogenes in Cold Smokes Fishery Products and Processing Plants," Journal of Food Protection, Vol. 58 (1995). The UNFAO report provided by defendants states that, "[r]ecognizing the potential for fishery products to be a vehicle for large out-breaks of listeriosis, it is prudent to seek appropriate strategies to minimize human exposure to infectious doses of [L. Monocytogenes]." United Nations Food and Agriculture Organization Fisheries Report No. 604. Another article provided by defendants states that "listeriosis is an atypical foodborne disease of major public health concern because of the severity and the nonenteric nature of the disease (meningitis, septicemia, and abortion), a high case-fatality rate (around 20 to 30% of cases), a frequently long incubation time, and a predilection for individuals who have underlying conditions which lead to impairment of T-cell-mediated immunity." J. Rocourt et al., Listeria Monocytogenes, from Food Microbiology Fundamentals and Frontiers (1997). The legal question posed by defendants' arguments is simply whether the substance must be deleterious to the entire population or simply to significant segments of the population such as the old, the young, and pregnant women. To pose the question is to answer it. Because L. monocytogenes is a poisonous or deleterious substance that may render Blue Ribbon's fish products injurious to the health of significant populations of consumers, such products are adulterated within the meaning of Section 342(a)(1) of the FDCA.

Zero-Tolerance Policy

Sections 342(a)(2)(A) and 346 of the FDCA provide that some added poisonous or added deleterious substances in food will not render the food adulterated if the quantity of the offending substance is below a "tolerance level" established by the FDA.^[8] Defendants argue that the FDA's zero-tolerance policy violates the FDCA and that the FDA must promulgate minimum tolerance levels in recognition of the prevalence of L. monocytogenes in smoked fish plants and on cold-smoked fish products. Putting aside the fact that the government need not rely on a finding that the food is adulterated pursuant to Section 342(a)(2)(A), because it can show that the added substance is actually injurious to health and adulterated as per Section 342(a)(1), the defendants' argument is without merit. According to Section 346,^[9] [49] "[a]ny quantity of added poisonous or added deleterious substance is ... "unsafe," unless the substance is required in food production or cannot be avoided by good manufacturing practice." Young, 476 U.S. at 977, 106 S.Ct. 2360 (emphasis in original). "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.'" Id. (citing 21 U.S.C. § 346). Since the enactment of the FDCA 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."" Id. The FDA is not required to promulgate a § 346 regulation to set a tolerance level for L. monocytogenes, and this Court is not permitted to second guess the agency's determination unless its decision is shown to be arbitrary and capricious and in violation of the Administrative Procedure Act, 5 U.S.C. § 706(2)(A) ("APA"), which is not the case here.^[10]See United States v. Royal Baltic Ltd., No. 94-CV-1178 (E.D.N.Y. Oct. 3, 2001) (finding that the FDA has the discretion not to set a tolerance level for L. monocytogenes).

Furthermore, the defendants' own evidence belies the assertion that it would be impossible to produce contamination-free cold-smoked products. Bierman, defendants' expert, points to a number of positive advancements in the smoked fish industry that, if properly implemented, significantly decrease the incidence of L. monocytogenes, specifically, the development and implementation of adequate HACCP plans, strict monitoring of the firm's fish processing procedures and sanitation, and the testing of raw materials before they are allowed to enter and contaminate the plant. It is a matter of undisputed fact that the defendants have failed time and time again to take these necessary precautions.

There is no factual dispute that defendants have violated Section 331(a) and (k) of the FDCA by introducing into interstate commerce food that is adulterated or by causing food to become adulterated after its introduction into interstate commerce.

Jurisdiction to Enter Permanent Injunction

The FDCA expressly authorizes district courts to grant injunctive relief [50] to enforce its provisions. 21 U.S.C. § 332(a).^[11] Where the government is enforcing a statute designed to protect the public interest, it is not required to show irreparable harm to obtain injunctive relief. United States v. Diapulse Corp. of America, 457 F.2d 25, 27-28 (2d Cir.1972); United States v. Schmitt, 734 F.Supp. 1035, 1049 (E.D.N.Y.1990). The statute's enactment constitutes Congress' "implied finding that violations will harm the public and ought, if necessary, be restrained." Diapulse Corp., 457 F.2d at 28 (citing United States v. City and County of San Francisco, 310 U.S. 16, 60 S.Ct. 749, 84 L.Ed. 1050 (1940)). To enjoin future behavior, the government must show that defendants have violated the FDCA and that there is some reasonable likelihood that the violations may recur. See Diapulse Corp., 457 F.2d at 28-29; Schmitt, 734 F.Supp. at 1049. The probability of future violations may be inferred from past unlawful conduct. Commodity Futures Trading Comm'n v. British American Commodity Options Corp., 560 F.2d 135, 144 (2d Cir.1977); United States v. Odessa Union Warehouse Co-op, 833 F.2d 172, 176 (9th Cir.1987).

As established above, the evidence shows that the defendants have violated the FDCA by distributing adulterated seafood on a continued basis throughout the years. Their behavior has persisted despite a series of inspections, warnings from the state and federal government, the temporary revocation of their license by NYSDAM, and a number of monetary fines. Given the extent and numerosity of past warnings to Blue Ribbon and its agents, defendants cannot satisfy the burden to establish that "there is no reasonable expectation that the wrong will be repeated." United States v. W.T. Grant, 345 U.S. 629, 633, 73 S.Ct. 894, 97 L.Ed. 1303 (1953).

The defendants oppose the substance and form of the government's proposed permanent injunction on basically two grounds. First, defendants argue that the effect of the permanent injunction will be to shut down Blue Ribbon, causing its eleven employees, including the three defendants, to lose their jobs. The injunction, however, will not require Blue Ribbon to stop processing fish but, rather, to stop processing fish that is or has become adulterated. The Second Circuit has held that a business may not complain "that the injunction is impermissible because it will put him out of business." Diapulse Corp., 457 F.2d at 29. A business "`can have no vested interest in a business activity found to be illegal.'" Id. (citing United States v. Walsh, 331 U.S. 432, 67 S.Ct. 1283, 91 L.Ed. 1585 (1947)).^[12] Second, defendants argue that the proposed injunction would "empower [the] FDA to micro-manage Blue Ribbon's facility" and that they should not have to pay for FDA inspections to ensure their compliance with the injunction or hire an outside consultant to monitor food safety. These objections to the proposed injunction do not merit an alteration of its terms. These terms of the proposed injunction, including the responsibility for costs and monitoring by outside consultants, have been routinely accepted and imposed by other courts faced with similar proof of FDCA violations. See, e.g., United States v. Syntrax Innovations, Inc., 149 F.Supp.2d 880, 882-891 (E.D.Mo. [51] 2001) (granting government's motion on summary judgment for misbranding in violation of the FDCA and imposing permanent injunction providing for very similar terms); United States v. Union Cheese Co., 902 F.Supp. 778, 787-90 (N.D.Ohio 1995) (granting preliminary injunction against cheese factory due to presence of L. monocytogenes with almost precisely the same terms). I recognize that this Court's equitable powers "should be exercise in harmony with the overall objectives of the legislation," Commodity Futures Trading Comm'n v. Hunt, 591 F.2d 1211, 1219 (7th Cir.1979), and that the FDCA's "overriding purpose [is] to protect the public health." United States v. Article of Drug, Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969). By keeping contaminated fish processed under conditions of filth off consumers' tables, this permanent injunction will serve that important purpose.

CONCLUSION

The individual defendants' motion to dismiss the complaint against them is denied. The government's motion for summary judgment is granted. The government is directed to settle a judgment on notice within thirty days of the date of this decision.

The Clerk is directed to furnish a filed copy of the within to all parties and to the magistrate judge.

SO ORDERED.

[1] In defendants' answer, defendants deny that Suttenberg is responsible for these areas and admit only that Suttenberg is president of Blue Ribbon and that he performs his duties at the plant in Brooklyn.

[2] The press release that announced the product recall stated, in part:

It was revealed during FDA laboratory testing that [the implicated lots] may have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail elderly people, and others with weakened immune systems. Although healthy people may suffer only short-term symptoms, such as high fever, severe headache, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. To date there have been no reported illnesses.

[3] Specifically, the HACCP plan states brining time is four hours, and the firm's written procedures and monitoring records indicate brining time to be six hours.

[4] Based on the January 1994 inspection, the FDA issued a warning letter to Blue Ribbon on March 2, 1994. The warning letter documented insanitary conditions, such as live cockroaches in the customer pickup and loading areas, existence of standing water, dried and encrusted fish on racks and fans, deeply scored cutting boards, the failure of employees to properly wash their hands, whole raw salmon on the floor awaiting processing, and the presence of L. monocytogenes. On March 30, 1994, defendant Negron, as vice president, responded to the warning letter and detailed several corrective actions to be taken.

[5] Specifically, the defendants would be required to select an FDA-approved laboratory to perform the L. monocytogenes testing, and the FDA must receive written reports detailing the laboratory results within two days after the defendants receive the results. The FDA would be authorized to conduct additional analyses and examine food products and raw ingredients as it deems necessary. Any fishery products that contain L. monocytogenes would have to be destroyed or reconditioned under FDA supervision. All FDA expenses relating to supervision, analyses, and examination shall be bourne by the defendants, at rates specified in the proposed permanent injunction.

[6] 21 C.F.R. Pt. 110 details guidelines for "current good manufacturing practice in manufacturing, packing, or holding human food," and 21 C.F.R. Pt. 123 relates to fish and fishery products.

[7] As discussed earlier, the Nova smoked salmon HACCP plan did not comply with FDA regulations and continues not to comply because (1) the plan is signed but not dated as required by 21 C.F.R. 123.6(d), (2) there is no critical limit for internal fish temperature required by 21 C.F.R. § 123.6(c)(4), no time was specified for thawing frozen fish, as required by 21 C.F.R. § 123.6(c)(2)(i), no procedure was included for monitoring brine solution or fish temperature during brining required by 21 C.F.R. § 123.6(c)(4), there was no procedure to check the accuracy of thermometers, Salometers, and thermostats required by 21 C.F.R. § 123.6(c)(4), and there was inadequate monitoring of critical control points, as required by 21 C.F.R. § 123.6(c)(7).

[8] Section 342(a)(2)(A) of the FDCA provides that a food shall be deemed adulterated "if it bears or contains any added poisonous or added deleterious substance (other than [exceptions not relevant here]) that is unsafe within the meaning of section 346 of this title." 21 U.S.C. § 342(a)(2)(A).

[9] Section 346 of the FDCA states in full:

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 for purposes of the application of clause (2)(A) of section 342(a) of this title; 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 for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limiting the quantity of any 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 within the meaning of clause (1) of section 342(a) of this title. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

21 U.S.C. § 346.

[10] The APA provides that an agency action may be overturned only if it is "arbitrary, capricious, and an abuse of discretion, or otherwise not in accordance with the law." 5 U.S.C. § 706(2)(A); Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 375-78, 109 S.Ct. 1851, 104 L.Ed.2d 377 (1989). Although the Court may consider whether the agency has made a clear error of judgment, the Court "is not empowered to substitute its own judgment for that of the agency." Id. at 377, 109 S.Ct. 1851. Moreover, "[a] reviewing court must generally be at its most deferential when the determination is guided by the agency's scientific expertise, unless the agency's views have no basis in fact or are irrational." Henley v. FDA, 77 F.3d 616, 620 (2d Cir.1996). Here, defendants have not demonstrated that the FDA's policy is without basis in fact or is irrational.

[11] Section 332(a) of Title 21 states in full that "[t]he district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown[,] to restrain violations of section 331 of this title."

[12] In addition, it is noted that the government is not seeking a harsher remedy, like criminal penalties, pursuant to 21 U.S.C. § 333, or seizure of defendants' products, pursuant to 21 U.S.C. § 334.

Attorney for the government: Elizabeth H. Trimble.

Attorney for the defendants: James M. Kramon.

Excerpt of Bench Opinion rendered November 28, 1979, from transcript of proceedings.

Before: Herbert F. Murray, District Judge.

THE COURT: The Court would like to proceed to rule on the matter this morning while it is fresh in mind. I do want to thank counsel for their presentations in the matter which have been most thorough. Like counsel often do, I guess, they were a little optimistic in their estimates of how long the case would take, but it is a complicated matter and I can well understand that it takes some time to present, and I am certainly not being critical of counsel because I think it was presented and tried as expeditiously as possible.

I am going to read a bench opinion incorporating my views about it, but in order not to hold the parties in suspense, I will start by giving the ultimate conclusion, and that is that I would have to deny the Motion for Judgment of Acquittal renewed by Mr. Kramon at the close of all the evidence, and I would have to find in favor of the Government and against the Defendants in the case because, in the Court's judgment, the Government has established by proof beyond a reasonable doubt violations of the Act which governs in this case and, basically, therefore, the further remarks that I will make in the matter are really findings of fact and conclusions of law implementing the general finding that I have just announced.

This case involves a criminal prosecution arising under the Federal Food, Drug & Cosmetic Act, 21 U. S. C., Section 301 et seq. The indictment returned on August 7, 1979 charges Baltimore Pizza Crust, Inc., Frank F. Corbi, president of Baltimore Pizza Crust, Inc., and Joseph N. Corbi, treasurer and general manager of Baltimore Pizza Crust, Inc. with two counts of violating 21 U. S. C., Section 331(k). Count One charges that from on or about March 17, 1978 to on or about March 22, 1978, the Defendants held food for sale after shipment in interstate commerce in a building accessible to insects and caused such food to be exposed to contamination by insect filth, which resulted in the food becoming adulterated as defined in 21 U. S. C., Section 342(a)(3) and (a)(4). Count Two is similar to Count One except that Count Two involves the period from on or about December 1, 1977 to on or about December 7, 1977, and Count Two alleges adulteration only as defined in 21 U. S. C., Section 342(a) (4).

The case was tried before the Court, sitting without a jury, on November 26, 27 and 28, 1979, and the Court has heard the final arguments of both sides this morning. For the reasons to be outlined, the Court is convinced beyond a reasonable doubt that the Defendants are guilty of the offenses charged in the indictment.

The facts of the case are not the subject of serious dispute, and the Court makes the following findings with respect to the facts. Defendant Baltimore Pizza Crust, Inc. (the company) is located in Baltimore, Maryland and is engaged in the business of making pizza crust. At the times in question in this case, the company purchased its flour, a major ingredient in pizza crusts, from Seaboard Allied Milling Corporation of Culpepper, Virginia. This flour, which Defendants admit was shipped in interstate commerce, is the food substance that the indictment alleges became adulterated.

The inspection which is the basis of Count Two of the indictment took place on December 6 and 7, 1977 and apparently was a routine periodic inspection of the company by FDA. At trial, Norman Timberlake, one of the two Food and Drug Administration investigators who participated in this inspection, testified that he and his co-investigator collected seventeen subsamples from the interior and exterior of the pizza crust production system. These subsamples were analyzed at an FDA laboratory, and six of the seventeen subsamples were found to contain one or more insects and/or insect larvae. The insects found were flour beetles, silverfish, and cigarette beetles. In addition, Mr. Timberlake testified that he observed at least 25 live insects on top of one of the two bulk flour storage bins, in which flour is stored when it arrives at the plant, and at least 40 insects on top of the other storage bin (Bin #2). The inside of Bin #1 was inspected but the inside of Bin #2 was not because the investigators were told that it was empty and not in use.

Mr. Timberlake learned that the flour which was being processed during his inspection of the plant had been received from Seaboard on December 1, 1977. In discussing the results of the inspection with Defendant Joseph Corbi, Mr. Corbi told him that he thought it was possible that the flour had been received from Seaboard in a contaminated condition. Mr. Timberlake did not conduct an investigation into this allegation, nor did he recommend to anyone at FDA that this possibility should be investigated. Mr. Corbi stated that no one inspected the flour when it arrived at Baltimore Pizza Crust and that it would be too costly to train someone or to hire a specialist to inspect incoming flour.

The findings of the FDA as a result of this investigation were mailed to Defendant Frank Corbi on February 16, 1978. His attention was drawn to the fact that several prior inspections of the company had revealed similar insect infestation problems in the flour handling system, and he was advised that legal action would be considered if the problems were not corrected.

The Court notes that several documents introduced into evidence by the Government (over Defense objection) indicate that the company had been inspected on five previous occasions — twice by the State of Maryland and three times by the Food and Drug Administration. On each of these occasions, active insect infestation was found in the plant and Defendants were notified of the problem.

The inspection which is the basis for Count One of the indictment took place on March 21 to 23, 1978. Troy Williams, one of the two FDA investigators who participated in this inspection, testified that numerous live insects, dead insects, and insect larvae were found in and around the flour handling equipment. The investigators took from Storage Bin #2 a sample of flour which, upon laboratory analysis, was found to contain no evidence of insect contamination. They also took a sample consisting of 47 subsamples from various points of the system, both inside and outside. Twenty-nine of the forty-seven subsamples contained insect filth in the form of live or dead insects, larval cast skins, fragments and webbing. Mr. Williams took a number of photographs of the flour processing area which evidenced conditions that may have contributed to insect infestation.

At several places, significant amounts of static or encrusted flour had built up. This build-up was present on the machinery in the plant, on the ceiling, on ceiling crossbeams, and on at least one light fixture. One photograph shows a crack in the cinderblock wall of the building through which light is entering the building. Another photograph is described as "one of several holes at wall/floor junction apparently in connection with spaces beneath floor or walls." Two other photographs show a hole in one screen of the rotating flour sifter and a tear in another screen. These openings could conceivably let pass through the flour sifter objects, such as insects, which would then become part of the finished product. In fact, two dough balls collected as subsamples near the end of the production system were found to contain insect filth. Another possible means [of] ingress may have been an open, unscreened fan in the ceiling of the production area. This fan was not in use, but Defendant Joseph Corbi indicated that the fan had been installed only recently and would be turned on soon.

Finally, the photographs taken by Mr. Williams show that before the plant commenced operation on the morning of March 22, 1978, the flour processing equipment in many places was still encrusted with dough and flour from the previous day's operations. The inspectors had been told on March 21 that all the machinery was washed at the end of each day.

Mr. Williams testified that in his estimation the temperature in the building was at least 85 degrees Fahrenheit. Mr. Howard Green, a witness for the Defendants, stated that in his experience as an exterminator for over twenty years, higher temperatures result in a decrease in the time necessary for insect larvae to hatch. Thus, it is inferrable that the heat in the Baltimore Pizza Crust building tended to promote the rapid hatching of larvae. In fact, at the conclusion of an FDA inspection in March 1977, Joseph V. Corbi, the son of Defendant Joseph Corbi and the assistant plant manager, was informed by the FDA inspectors that the warmth of the plant was conducive to the incubation of insect larvae.

The Defendant company had an extermination services contract during the periods in question in this case with the Home Exterminating Company of Baltimore. The sanitation program included a "cracks and crevices" program of spraying until approximately early May of 1978. In April 1978, Joseph V. Corbi received from the sales manager of Home Exterminating Company a letter which stated that a substantial increase in the company's pest control program was needed. The letter stated that "After checking your plant (entire building) I found you have great need of Weevil control around your flour bins. This letter was dated eleven days after the completion of the March 1978 FDA inspection. Among the suggestions contained in the letter were the use of a pyrethum fog near the flour bins and the fumigation of the bins "to rid existing Weevil infestation."

Turning to the applicable law, Section 331(k) of 21 U. S. C. states:

"The following acts and the causing thereof are hereby prohibited:

"(k) The … doing of any … act with respect to a food … if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated."

Section 342 defines adulteration as follows:

"A food shall be deemed to be adulterated —

"(a) … (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health…"

As already pointed out, Count One of the indictment charges Defendants with a violation of Section 331(k)in that the flour held by the Defendant company at the time of the March 1978 inspection was adulterated as defined in subsections (a)(3) and (a)(4) of Section 342. Count Two charges a violation of Section 331(k) in that the flour held at the time of the December 1977 inspection was adulterated as defined in Section 342(a) (4).

With respect to Count One, it is clear to the Court beyond a reasonable doubt that the Defendant corporation and the individual Defendants as responsible officers thereof held flour (eventually processed into pizza crust) for sale after shipment in interstate commerce and that the insanitary conditions at the plant may have caused the insect infestation found in the flour and, in fact, did cause at least some of the infestation. The numerous insanitary conditions found by investigator Williams certainly "may have" contributed to the contamination found. Under Section 342(a)(4), the Government need only show that conditions in the plant were such that they "would with reasonable possibility result in contamination." Berger v. United States, 200 F. 2d 818 at 821 (8th Cir. 1952). In the Court's view, the Government has met this burden.

The Court also finds that the Government has proved that the conditions at Baltimore Pizza Crust actually caused adulteration in the flour as defined in Section 342(a)(3).

Under the terms of the statute, an (a)(3) adulteration is proven once the presence of any contamination in food is found, except perhaps a de minimis amount. See United States v. General Foods Corp., 446 F. Supp. 740 at 744 (N. D. N. Y.), aff'd, 591 F. 2d 1332 (2d Cir. 1978).

For example, uncontradicted testimony, in part by one of the Defendants' witnesses, established that the temperature at the plant was such as to facilitate the growth and hatching of insect larvae. Whether or not the larvae were introduced into the plant in the flour when it was shipped from Seaboard, as Defendants contend, the evidence indicates that Defendants maintained a condition that decreased hatching time and, thus, further contributed to the insect infestation found throughout the flour processing system.

Having found that at least on condition at the company actually caused insect infestation, the Court notes that this condition existed at least as far back as March 1977 when it was pointed out to Joseph V. Corbi. The heat problem no doubt existed in December 1977 and, thus, was, in the language of Section 342(a)(4), "an insanitary condition" which "may have" caused contamination of flour in the plant. In addition, in light of the five inspections and the results thereof prior to December 1977, the Court finds beyond a reasonable doubt that the Defendants failed to take adequate precautions against insect infestation and that such failure created an insanitary condition that may have caused contamination. See generally United States v. Park, 421 U. S. 658 at 672 (1975). Thus, the Government, in the Court's judgment, has met its burden of proof with respect to Count Two as well as with respect to Count One.

The Defendant's major contention in this case has been that the insect infestation found by the FDA Inspectors was caused not by Defendants, but by Seaboard Allied Milling Corporation in that the flour shipped by Seaboard allegedly contained insects and larvae. Defendants argue that they cannot be convicted for receiving such flour because they did not initiate the contamination and that the Government has failed to prove that they exacerbated the contamination.

Even if the Government had failed to show that conditions at the Defendants' business may have or actually initiated contamination, which the Court does not believe to be the case, the Court would not view Defendants' argument as meritorious. In United States v. Nova Scotia Food Products Corp., 417 F. Supp. 1364 (E. D. N. Y. 1976), rev'd on other grounds, 568 F. 2d 240 (2d Cir. 1977), the district court was faced with a similar argument. In that case, a processor of smoked whitefish argued that the FDA had no power under Section 342 (a)(4) to promulgate regulations prescribing methods by which fish processors must attempt to eradicate botulism from fish. The processor argued that because th bacteria occurred naturally in the fish in their native habitat and that the processor did not introduce the bacteria into the fish during processing, no "insanitary condition" had been created by the processor.

The court responded to that argument as follows:

"While Section 342(a)(4) may literally seem to deal only with conditions brought about by processing itself, the regulation under review … is specifically addressed to setting processing parameters to prevent the 'outgrowth and toxin formation of C. Botulinum Type E.' Seen in the perspective of (the regulation's) purpose and the purpose of subsection (a)(4), the use of the word 'insanitary' in subdivision (4) of Section 342(a) is, at worst, inelegant, but it is not inadequate to include preparing, packing, or holding conditions which permit a continuance of the outgrowth and toxin formation of the C. Botulinum Type E in the product under process…. It is beside the point that the bacterial infestation here is not one that invades the fish during the processing." 417 F. Supp. at 1369.

Similarly, in the present case, the Court finds it to be irrelevant whether insect infestation of the flour was introduced at Seaboard's facilities in Culpepper, Virginia. Like the court in the case just quoted, this Court believes that the language of subsection (a) (4) is flexible enough to apply to infestation that a defendant permits to continue and grow at its own natural pace, even if the defendant performs no affirmative act to encourage the continuation and growth. If the language of the statute is flexible enough to be so construed, the Court believes that it should be.

As the Supreme Court has stated in United States v. Park at Page 673 of 421 U. S.:

"Congress has seen fit to enforce the accountability of responsible corporate agents dealing with products which may affect the health of consumers by penal sanctions cast in rigorous terms, and the obligation of the court is to give them effect so long as they do not violate the Constitution."

The clear import of Park and other cases is that food and drug legislation should be liberally construed so as to further its important goal — the protection of consumers of food products who cannot protect themselves.

In U. S. v. Dotterweich, 320 U. S. 277, the Supreme Court said, speaking through Mr. Justice Frankfurter:

"The Food and Drugs Act of 1906 was an exertion by Congress of its power to keep impure and adulterated food and drugs out of the channels of commerce. By the Act of 1938, Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience. The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of legislation if it is to be treated as a working instrument of government and not merely as a collection of English words."

Finally, with respect to the liability of the individual Defendants, Joseph N. Corbi and Frank Corbi, the Court finds that the Government has proved that these Defendants had a "responsible relation" to the violations in question and that it is appropriate to find them guilty along with the corporation. As the Supreme Court said in United States v. Wisenfeld Warehouse Co., 376 U. S. 86 at Page 91 (1964):

"Food and drug legislation, concerned as it is with protecting the lives and health of human beings, under circumstances in which they might be unable to protect themselves, often 'dispenses with the conventional requirement for criminal conduct — awareness of some wrongdoing.' In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger." United States v. Balint, 258 U. S. 250 and United States v. Dotterweich, 320 U. S. 277 at 281.

Because of their respective positions at Baltimore Pizza Crust, the individual Defendants clearly stood "in responsible relation to a public danger."

The Court in this regard finally again quotes from the opinion of Mr. Justice Frankfurter speaking about the defendant Dotterweich in that case, who was president of the corporation involved. Mr. Justice Frankfurter said at Page 286 of 64 S. Ct.:

"The offense is committed … by all who … have such a responsible share in the furtherance of the transaction which the statute outlaws, namely, to put into the stream of interstate commerce adulterated or misbranded drugs (or food). Hardship there doubtless may be under a statute which thus penalizes the transaction though consciousness of wrongdoing be totally wanting. Balancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless."

For all of the reasons stated, the Court will enter a judgment order against the Defendants in the case, and I will ask the Government to submit such an order promptly.

MISS TRIMBLE: Yes, we will, Your Honor.

We will also order a presentence report for the two individual Defendants.

THE COURT: Very good. Is there anything further this morning?

MISS TRIMBLE: I don't believe so, Your Honor. They are on personal recognizance and we have no objection to that continuing, Your Honor.

THE COURT: Yes, the Court will continue both Defendants at liberty on their own personal recognizance.

I hereby certify the foregoing is a true and accurate excerpt from transcript of proceedings.

S. M. Lee Schap
Official Court Reporter

476 U.S. 974 (1986)

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

[975] 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.^[1]

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 [976] and Drug Administration's interpretation thereof, the Court of Appeals erred. We therefore reverse.

I

A

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 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 for purposes of the application of clause (2)(A) of section 342(a) of this [977] title; 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 for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect . . . food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated . . . ."

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.

B

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 [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:

"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 [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 presence of the critical word `shall' plainly suggests a directive to the Secretary to establish a tolerance, if a food with an unavoidable . . . deleterious substance is to be considered unadulterated.

.....

"It is . . . clear from the structure of the sentence at issue here that the phrase relied upon by the Secretary simply does not modify the pivotal word `shall.' " Id., at 282, 283, 757 F. 2d, at 357, 358.

After examining the entirety of § 346, the Court of Appeals also concluded that, since tolerance levels make food with added harmful substances unadulterated, tolerance levels were necessary before food could be judged unadulterated. Id., at 283, 757 F. 2d, at 358.

The Court of Appeals considered none of the other issues before the District Court, and therefore only the § 346 issue is before this Court.

II

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.

[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:

"First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter, for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. . . . [A] court may not substitute its own construction of a statutory provision for a reasonable interpretation made by the administrator of an agency." Id., at 842-844.

While we agree with the Court of Appeals that Congress in § 346 was speaking directly to the precise question at issue in this case, we cannot agree with the Court of Appeals that Congress unambiguously expressed its intent through its choice of statutory language. The Court of Appeals' reading of the statute may seem to some to be the more natural interpretation, but the phrasing of § 346 admits of either respondents' or petitioner's reading of the statute. As enemies of [981] the dangling participle well know, the English language does not always force a writer to specify which of two possible objects is the one to which a modifying phrase relates. A Congress more precise or more prescient than the one that enacted § 346 might, if it wished petitioner's position to prevail, have placed "to such extent as he finds necessary for the protection of public health" as an appositive phrase immediately after "shall" rather than as a free-floating phrase after "the quantity therein or thereon." A Congress equally fastidious and foresighted, but intending respondents' position to prevail, might have substituted the phrase "to the quantity" for the phrase "to such extent as." But the Congress that actually enacted § 346 took neither tack. In the absence of such improvements, the wording of § 346 must remain ambiguous.

The FDA has therefore advanced an interpretation of an ambiguous statutory provision.

"This view of the agency charged with administering the statute is entitled to considerable deference; and to sustain it, we need not find that it is the only permissible construction that [the agency] might have adopted but only that [the agency's] understanding of this very `complex statute' is a sufficiently rational one to preclude a court from substituting its judgment for that of [the agency]. Train, Inc. v. NRDC, 421 U. S. 60, 75, 87 (1975) . . . ." Chemical Manufacturers Assn. v. Natural Resources Defense Council, Inc., 470 U. S. 116, 125 (1985).

We find the FDA's interpretation of § 346 to be sufficiently rational to preclude a court from substituting its judgment for that of the FDA.

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 [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:

"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." 244 U. S. App. D. C., at 283, 757 F. 2d, at 358.

The premise of the Court of Appeals is of course correct: the Act does provide that when a tolerance level has been set and a food contains an added harmful substance in a quantity below the tolerance level, the food is legally not adulterated. But one cannot logically draw from this premise, or from the Act, the Court of Appeals' conclusion that food containing substances not subject to a tolerance level must be deemed adulterated. The presence of a certain premise (i. e., tolerance levels) may imply the absence of a particular conclusion (i. e., adulteration) without the absence of the premise implying the presence of the conclusion. For example, the presence of independent and adequate state-law grounds in the decision of a state supreme court means this Court has no jurisdiction over the case, but the absence of independent and adequate state grounds does not mean that this Court necessarily has jurisdiction. The Act is silent on what specifically to do about food containing an unavoidable, harmful, added substance for which there is no tolerance level; we must therefore assume that Congress intended the general provisions of § 342(a) to apply in such a case. Section 342(a) thus remains available to the FDA to prevent the shipment of any food "[i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health." See generally United States v. Lexington Mill & Elevator Co., [983] 232 U. S. 399, 411 (1914) (discussing proper interpretation of the language that became § 342(a)).

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). [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.

Reversed.

JUSTICE STEVENS, dissenting.

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:

"[W]hen 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, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title." 21 U. S. C. § 346 (emphasis added).

To one versed in the English language, the meaning of this provision is readily apparent. The plain language of the section tells us when the Secretary's duty to promulgate regulations arises — "when such substance . . . cannot be so avoided"; it tells us the purpose of the regulations — to establish [985] a tolerance level that will enable manufacturers to know what they can lawfully produce and to enable the public to know what they can safely consume; and it tells us what standard he should employ in drafting them — "to such extent as he finds necessary for the protection of public health." For purposes of deciding this case, the parties' agreement that aflatoxins are substances that "cannot be so avoided" within the meaning of the section triggers the obligation to initiate rulemaking.

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."^[2] By instead [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).^[3] 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 [987] unambiguously expressed intent of Congress." Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-843 (1984).^[4]

[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.

[1] 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.

[2] This interpretation is in accord with the Committee Report on the House bill, which became the Food, Drug, and Cosmetic Act of 1938. The Report states that "[t]he addition of poison to foods is prohibited except where such addition is necessary or cannot be avoided; and in such cases tolerances are provided limiting the amount of added poison to the extent necessary to safeguard the public health." H. R. Rep. No. 2139, 75th Cong., 3d Sess., pt. 1, p. 2 (1938) (emphasis added). By using the present tense, the Report makes clear that the qualifying language is operative when regulations are promulgated — to limit the amount of poison "to the extent necessary to safeguard the public health." The qualifying language thus defines the standard by which tolerances are to be determined and not the occasions on which regulations are to be promulgated.

[3] 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).

[4] 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 Commission next argues that its interpretation of the statute — that the statute authorizes successive suspension orders — has been both consistent and longstanding, dating from 1944. It is thus entitled to great deference. See United States v. National Assn. of Securities Dealers, 422 U. S. 694, 710 (1975); Saxbe v. Bustos, 419 U. S. 65, 74 (1974).

"While this undoubtedly is true as a general principle of law, it is not an argument of sufficient force in this case to overcome the clear contrary indications of the statute itself. In the first place it is not apparent from the record that on any of the occasions when a series of consecutive summary suspension orders was issued the Commission actually addressed in any detail the statutory authorization under which it took that action.

.....

"[S]ince this Court can only speculate as to the Commission's reasons for reaching the conclusion that it did, the mere issuance of consecutive summary suspension orders, without a concomitant exegesis of the statutory authority for doing so, obviously lacks `power to persuade' as to the existence of such authority. [Adamo Wrecking Co. v. United States, 434 U. S. 275, 287-288, n. 5 (1978)]."

As we emphasized in FMC v. Seatrain Lines, Inc., 411 U. S. 726, 745 (1973), "an agency may not bootstrap itself into an area in which it has no jurisdiction by repeatedly violating its statutory mandate." Instead, "our clear duty in such a situation is to reject the administrative interpretation of the statute." SEC v. Sloan, 436 U. S., at 119.

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:

"We are extremely hesitant to presume general congressional awareness of the Commission's construction based only upon a few isolated statements in the thousands of pages of legislative documents. That language in a Committee Report, without additional indication of more widespread congressional awareness, is simply not sufficient to invoke the presumption in a case such as this. For here its invocation would result in a construction of the statute which not only is at odds with the language of the section in question and the pattern of the statute taken as a whole, but also is extremely far reaching in terms of the virtually untrammeled and unreviewable power it would vest in a regulatory agency." Id., at 121.

818 F.2d 943 (1987)

[944] William B. Schultz, with whom Alan B. Morrison and Katherine A. Meyer, Washington, D.C., were on the brief for appellants.

Michael J. Ryan, Asst. U.S. Atty., with whom Joseph E. diGenova, U.S. Atty., Royce C. Lamberth, Craig Lawrence, Asst. U.S. Attys., Washington, D.C., Thomas Scarlett, Chief Counsel, Rockville, Md., and Michael M. Landa, Associate Chief Counsel for Enforcement, Food and Drug Admin., were on the brief for appellee. Patricia J. Kenney, Asst. U.S. Atty., Washington, D.C., Stephen D. Terman, Counsel, Food and Drug Admin., Rockville, Md., Richard K. Willard, Atty. Gen., Leonard Schaitman and John M. Rogers, Attorneys, Dept. of Justice, Washington, D.C., entered appearances for appellee.

[945] Philip C. Olsson, Washington, D.C., was on the brief for amicus curiae in support of appellee, State of South Carolina, urging affirmance of the Dist. Court decision.

Before MIKVA, EDWARDS and STARR, Circuit Judges.

Opinion PER CURIAM.

Opinion concurring in part and dissenting in part filed by Circuit Judge STARR.

PER CURIAM:

This case makes its second appearance before this court. It presents a challenge by a consortium of organizations and private citizens (collectively referred to as CNI) to the Food and Drug Administration's regulation of certain unavoidable contaminants in food, most particularly, aflatoxins in corn.^[1] Pursuant to its statutory mandate to limit the amount of "poisonous or deleterious substances" in food, see 21 U.S.C. § 346, FDA establishes "action levels" informing food producers of the allowable levels of unavoidable contaminants such as aflatoxins. Producers who sell products that are contaminated above the action level, which for aflatoxins in corn is currently set at 20 parts per billion, are subject to enforcement proceedings initiated by FDA.

CNI filed suit in federal district court, launching a three-pronged attack on FDA's action level for aflatoxins in corn: (1) in issuing the action level, FDA failed to comply with the rulemaking requirements of the Food, Drug and Cosmetic Act (FDC Act), see 21 U.S.C. § 346; (2) the action level violated the Administrative Procedure Act because it constitutes a legislative rule issued without the requisite notice-and-comment procedures, see 5 U.S.C. § 553; and (3) FDA's decision to permit adulterated corn to be blended with unadulterated corn to bring the total contamination within the action level violated the FDC Act. The District Court granted summary judgment in favor of FDA on each issue.

In our initial opinion, we confined ourselves to CNI's first argument. We concluded that the FDC Act, by stating that FDA "shall promulgate regulations," 21 U.S.C. § 346, required that FDA issue formal regulations or "tolerances," rather than informal action levels. Having invalidated the action level on this ground, we concluded that CNI's APA argument was thus rendered moot and that the blending issue stood in need of reevaluation on remand. See 757 F.2d 354 (D.C.Cir.1985).

The Supreme Court reversed our decision, ___ U.S. ___, 106 S.Ct. 2360, 90 L.Ed.2d 959, holding that the FDC Act was not so clear as to preclude FDA's interpretation of the statute under which the agency could lawfully proceed by way of action levels. 106 S.Ct. 2360 (1986). Since the Court did not reach the APA or blending issues, it remanded the case to this court for "further proceedings consistent with [its] opinion." Id. at 2366. Thus, with the first issue resolved by the High Court, we must now address the still pending APA and blending issues.

I

Under the APA, agency rules^[2] may be issued only after the familiar notice-and-comment procedures enumerated in the statute are completed. See 5 U.S.C. § 553. It is undisputed that the action level at issue here was promulgated sans those procedures. FDA, however, argues that notice-and-comment requirements do not apply by virtue of subsection (b)(3)(A) of section 553, which carves out an exception for "interpretative rules [and] general statements of policy." According to the [946] FDA, action levels represent nothing more than nonbinding statements of agency enforcement policy. CNI, on the other hand, argues that the action levels restrict enforcement discretion to such a degree as to constitute legislative rules.

The distinction between legislative rules and interpretative rules or policy statements has been described at various times as "tenuous," Chisholm v. FCC, 538 F.2d 349, 393 (D.C.Cir.), cert. denied, 429 U.S. 890, 97 S.Ct. 247, 50 L.Ed.2d 173 (1976), "fuzzy," Pacific Gas & Electric Co. v. FPC, 506 F.2d 33, 38 (D.C.Cir.1974), "blurred," Saunders, Interpretative Rules With Legislative Effect: An Analysis and a Proposal For Public Participation, 1986 Duke L.J. 346, 352, and, perhaps most picturesquely, "enshrouded in considerable smog." Noel v. Chapman, 508 F.2d 1023, 1030 (2d Cir.), cert. denied, 423 U.S. 824, 96 S.Ct. 37, 46 L.Ed.2d 40 (1975), quoted in American Bus Association v. United States, 627 F.2d 525, 529 (D.C. Cir.1980).^[3] As Professor Davis puts it, "the problem is baffling." 2 K. Davis, Administrative Law Treatise 32 (2d ed. 1979). By virtue of Congress' silence with respect to this matter, it has fallen to the courts to discern the line through the painstaking exercise of, hopefully, sound judgment. Guardian Federal Savings & Loan Ass'n v. FSLIC, 589 F.2d 658, 667 (D.C.Cir.1978).

Despite the difficulty of the terrain, prior cases do provide some useful guideposts. In this circuit, we are particularly guided by American Bus. There, in speaking for the court, Judge McGowan identified "two criteria" that courts have used in their efforts to fathom the interpretative/legislative distinction:

First, courts have said that, unless a pronouncement acts prospectively, it is a binding norm. Thus ... a statement of policy may not have a present effect: "a `general statement of policy' is one that does not impose any rights and obligations"....

The second criterion is whether a purported policy statement genuinely leaves the agency and its decisionmakers free to exercise discretion.

627 F.2d at 529 (quoting Texaco v. FPC, 412 F.2d 740, 744 (3d Cir.1969)).^[4]

In conducting our analysis of these two criteria, we consider and give some, albeit "not overwhelming," deference to an agency's characterization of its statement. Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537 (D.C.Cir.1986).^[5] As befits a principled exercise in interpretation, courts are to give far greater weight to the language actually used by the agency; we have, for example, found decisive the choice between the words "will" and "may." Compare American Bus, 627 F.2d at 532 (use of "will" indicates statement is in fact a binding norm) with Guardian Federal, 589 F.2d at 666 (use of "may" indicates statement is a "general statement of policy").

Applying these principles to the case at hand, we are persuaded that the FDA action levels are legislative rules and thus subject to the notice-and-comment requirements of section 553. While FDA [947] now characterizes the action levels as policy statements, see, e.g., Supplemental Brief for Appellee at 7 ("In sum, action levels do not bind courts, food producers or FDA."), a variety of factors, when considered in light of the criteria set out in American Bus, indicate otherwise.

First. The language employed by FDA in creating and describing action levels suggests that those levels both have a present effect and are binding. Specifically, the agency's regulations on action levels explain an action level in the following way:

[A]n action level for an added poisonous or deleterious substance ... may be established to define the level of contamination at which food will be deemed to be adulterated. An action level may prohibit any detectable amount of substance in food.

21 C.F.R. § 109.4 (1986) (emphasis added).^[6] This language, speaking as it does of an action level "defin[ing]" the acceptable level and "prohibit[ing]" substances, clearly reflects an interpretation of action levels as presently binding norms.^[7] This type of mandatory, definitive language is a powerful, even potentially dispositive, factor suggesting that action levels are substantive rules. Cf. Cathedral Bluffs, 796 F.2d at 538. Moreover, the regulations provide that an action level may appropriately be established whenever there exist the same conditions required to establish a formal tolerance, if, in addition, the "appropriateness" of the tolerance may change in the near future because, for example, of technological changes. 21 C.F.R. § 109.6(c); see also id. § 109.6(b) (requirements for establishing a tolerance).^[8]

Second. This view of action levels — as having a present, binding effect — is confirmed by the fact that FDA considers it necessary for food producers to secure exceptions to the action levels. A specific regulatory provision allows FDA to "exempt from regulatory action and permit the marketing of any food that is unlawfully contaminated with a poisonous or deleterious substance" if certain conditions exist. Id. § 109.8(a). This language implies that in the absence of an exemption, food with aflatoxin contamination over the action level is "unlawful." This putatively unlawful status can derive only from the action level, which, again, indicates that the action level is a presently binding norm. If, as the agency would have it, action levels did indeed "not bind courts, food producers or FDA," Supplemental Brief for Appellee at 7, it would scarcely be necessary to require that "exceptions" be obtained.

Third. On several occasions, in authorizing blending of adulterated with unadulterated corn, see infra Part II, the FDA has made statements indicating that action levels establish a binding form. For example, in a telegram to the Commissioner of the South Carolina Department of Agriculture, [948] in which it indicated its approval of a blending plan, the FDA stated that "[a]ny shipments made independent of this plan would, if found to exceed the 20 ppb level, be considered adulterated and subject to condemnation." Joint Appendix (J.A.) at 112 (emphasis added). But we need not resort to informal communications, cf. Ciba-Geigy Corp. v. EPA, 801 F.2d 430 (D.C.Cir.1986), where precision of draftsmanship may understandably be wanting. For, in a formal notice published in the Federal Register of a decision to permit blending and interstate shipment, FDA wrote:

Any food that contains aflatoxin in excess of 20 ppb ... is considered by FDA to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)), and therefore may not be shipped in interstate commerce.

46 Fed.Reg. 7447 (1981) (emphasis added), reprinted in J.A. at 49. Both statements, one informal and the other elaborately formal, indicate that, when judged under the American Bus criteria, action levels constitute substantive rules. The agency's own words strongly suggest that action levels are not musings about what the FDA might do in the future but rather that they set a precise level of aflatoxin contamination that FDA has presently deemed permissible. Action levels inform food producers what this level is; indeed, that is their very purpose.

We are not unmindful that in a suit to enjoin shipment of allegedly contaminated corn, it appears that FDA would be obliged to prove that the corn is "adulterated," within the meaning of the FDC Act, rather than merely prove non-compliance with the action level. See United States v. Boston Farm Center, Inc., 590 F.2d 149, 151 (5th Cir.1979).^[9] The action level thus does not bind food producers in the sense that producers are automatically subject to enforcement proceedings for violating the action level. This factor, accordingly, points in favor of the agency's characterization. But the fact that action levels do not completely bind food producers as would a more classic legislative rule (where the only issue before the court would be if the agency rule were in fact violated) is not determinative of the issue. For here, we are convinced that FDA has bound itself. As FDA conceded at oral argument, it would be daunting indeed to try to convince a court that the agency could appropriately prosecute a producer for shipping corn with less than 20 ppb aflatoxin. And this type of cabining of an agency's prosecutorial discretion can in fact rise to the level of a substantive, legislative rule. Cf. Nader v. CAB, 657 F.2d 453 (D.C.Cir.1981); Guardian Federal, 589 F.2d at 666-67 ("If it appears that a so-called policy statement is in purpose or likely effect one that narrowly limits administrative discretion, it will be taken for what it is — a binding rule of substantive law.") (emphasis added). That is exactly what has happened here.

In sum, consideration of a variety of factors leads us to conclude that the FDA's action levels are not within the section 553(b)(3)(A) exception to notice-and-comment requirements.^[10] Since all agree that [949] those procedures were not followed, the action level at issue here cannot stand.

We pause to observe that nothing in our decision today generally precludes FDA from proceeding by way of informal action levels. The Supreme Court has, of course, decided that such a course is permissible under the FDC Act. Our limited holding is that the current action levels are treated as substantive rules by FDA and, as such, can only be permitted if notice-and-comment procedures are employed. If it so chooses, FDA could proceed by action levels that are pure policy statements. But in order to do so, FDA must avoid giving action levels the kind of substantive significance that it now so plainly attaches to them.

We add one additional caveat. Our holding today in no way indicates that agencies develop written guidelines to aid their exercise of discretion only at the peril of having a court transmogrify those guidelines into binding norms. We recognize that such guidelines have the not inconsiderable benefits of apprising the regulated community of the agency's intentions as well as informing the exercise of discretion by agents and officers in the field. It is beyond question that many such statements are non-binding in nature and would thus be characterized by a court as interpretative rules or policy statements. We are persuaded that courts will appropriately reach an opposite conclusion only where, as here, the agency itself has given its rules substantive effect.

In sum, our holding today is narrow. We conclude that in the circumstances of this case, FDA by virtue of its own course of conduct has chosen to limit its discretion and promulgated action levels which it gives a present, binding effect. Having accorded such substantive significance to action levels, FDA is compelled by the APA to utilize notice-and-comment procedures in promulgating them.

II

The FDA has, on several occasions, granted exemptions to permit the blending of contaminated corn with uncontaminated corn. See, e.g., 43 Fed.Reg. 14,122 (1978), reprinted in J.A. at 41. This blending is typically permitted to help food producers cope with seasonal weather variations which may result in a particular harvest yielding corn with a higher level of aflatoxin. See Supplementary Brief of the State of South Carolina as Amicus Curiae in Support of Appellee at 1-4. In such circumstances, the FDA may permit blending to bring the total level of aflatoxin contamination in the final, blended corn within acceptable levels.

CNI contends that this blending practice causes the final product to be "adulterated" within the meaning of 21 U.S.C. § 342(a)(2)(A). This section reads, in relevant part, as follows:

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, states that

[a]ny poisonous or deleterious substance added to any food, except where such substance ... cannot be avoided ... shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a).

21 U.S.C. § 346. The intentional blending of contaminated corn obviously cannot in reason be considered unavoidable. Surely there can be little doubt that blended corn therefore stands branded as "adulterated" for purposes of the FDC Act; indeed, in its initial brief FDA conceded as much:

The Government does not dispute [CNI's] contention that use of an adulterated feed as an ingredient in another feed causes the finished (blended) feed to be adulterated.

Brief for Appellee at 36. But as FDA goes on to point out, a conclusion that a particular food product is "adulterated," in the abstract, means little other than that FDA [950] could choose to initiate enforcement proceedings. CNI does not, and could not, point to any provision in the FDC Act requiring FDA to initiate enforcement action against every food falling within the Act's definition of "adulterated." Rather, the Act makes clear that these enforcement decisions are vested, as they traditionally are, with the agency. Section 336, for example, expressly recognizes that FDA need not "report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this [Act]." 21 U.S.C. § 336.

Upon analysis, therefore, the gravamen of CNI's complaint is that FDA failed to initiate enforcement proceedings. But as the Supreme Court held in Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), FDA enjoys complete discretion not to employ the enforcement provisions of the FDC Act, and those decisions are not subject to judicial review. As this court recently concluded, the "provisions [of the FDC Act] authorize, but do not compel the FDA to undertake enforcement activity; they `commit complete discretion to the [FDA] to decide how and when they should be exercised.'" Schering Corp. v. Heckler, 779 F.2d 683, 686 (D.C.Cir.1985) (quoting Heckler v. Chaney, 105 S.Ct. at 1658). In light of this principle, CNI's arguments on the blending issue must fall.

III

In conclusion, we find FDA's action levels to be invalid in that they were issued without the requisite notice-and-comment procedures, but we reject CNI's challenge to FDA's disinclination to initiate enforcement action against certain blended corn. Accordingly, the case is remanded to the District Court for further proceedings not inconsistent with this opinion.

It is so ordered.

STARR, Circuit Judge, concurring in part and dissenting in part:

I fully concur in section II of the panel opinion, holding that FDA's decision to permit blending fell within the agency's enforcement discretion. I am also persuaded that the majority's careful treatment of the substantive rules-policy statements distinction is not unfaithful to the teachings of this circuit's more recent precedents. Nonetheless, I am constrained to conclude that the correct rule was that laid down by our court thirteen years ago in Pacific Gas & Electric Co. v. FPC, where we held:

The critical distinction between a substantive rule and a general statement of policy is the different practical effect that these two types of pronouncements have in subsequent administrative proceedings.... A properly adopted substantive rule establishes a standard of conduct which has the force of law.

506 F.2d 33, 38 (D.C.Cir.1974). The Pacific Gas-enunciated factor — whether the pronouncement has the force of law in subsequent proceedings — should be deemed determinative of the issue. Because there is no doubt that the agency pronouncements at issue here have no such effect, I respectfully dissent from section I of the panel opinion.

I

The abiding characteristic of a legislative rule is that it is law. It defines a standard of conduct that regulated individuals or entities ignore at their peril, in the face of possible enforcement action. Significantly, the only issue in any such proceeding is whether the rule applies to the facts at hand. "The underlying policy embodied in the rule is not generally subject to challenge before the agency." Id., at 38.

Before such rules are sanctioned one would think that they should be carefully crafted, with the "underlying polic[ies] embodied in the rule" recognized, openly discussed, and deliberately weighed. To return to basic civics for a moment, statutes passed by Congress have been refined in this manner by the very nature of the legislative process. Bills are considered by committees, hearings are held, debate is conducted, compromises are reached, and votes are taken. And all this is carried on in a bicameral legislative body with the final result presented to the President for [951] his approval or rejection. See INS v. Chadha, 462 U.S. 919, 103 S.Ct. 2764, 77 L.Ed.2d 317 (1983). A statute therefore possesses important attributes justifying placement of the coercive power of the state behind a particular policy framed in accordance with the process ordained at the Founding.

In the modern administrative state, many "laws" emanate not from Congress but from administrative agencies, inasmuch as Congress has seen fit to vest broad rulemaking power in the executive branch, including independent agencies. See Synar v. United States, 626 F.Supp. 1374, 1383-84 (D.D.C.) (three judge court), aff'd, ___ U.S. ___, 106 S.Ct. 3181, 92 L.Ed.2d 583 (1986); K. Davis Administrative Law Treatise § 3.8 (1982 Supp.); cf. Ticor Title Insurance Co. v. FTC, 814 F.2d 731, 732 (D.C.Cir.1987) (dismissing on procedural grounds a challenge to the delegation of law enforcement powers to an independent agency). This rulemaking power is obviously cabined by whatever requirements may exist in the particular statute delegating rulemaking authority, a subject which we treated in our initial decision in this case. See 757 F.2d 354 (D.C.Cir.1985). But Congress has also provided in the APA for certain procedural protections before that which achieves the lofty status of "law" is promulgated by an agency acting in its Congressionally authorized lawmaking capacity. Chief among these protections are the notice-and-comment requirements laid down in the familiar provision of 5 U.S.C. § 553. In a sense, notice-and-comment procedures serve as a Congressionally mandated proxy for the procedures which Congress itself employs in fashioning its "rules," as it were, thereby insuring that agency "rules" are also carefully crafted (with democratic values served by public participation) and developed only after assessment of relevant considerations. It is thus, in theory, important for APA procedures to be followed before an agency pronouncement is deemed a binding legislative rule not merely because the APA says so, but because in saying so the APA is protecting a free people from the danger of coercive state power undergirding pronouncements that lack the essential attributes of deliberativeness present in statutes. Because of the value inhering in such procedures, it is well-established that "`only reluctantly should courts recognize exceptions therefrom.'" American Bus Association v. United States, 627 F.2d 525, 528 (D.C.Cir.1980) (quoting Humana of South Carolina v. Califano, 590 F.2d 1070, 1082 (D.C.Cir.1978)).

Nonetheless, in crafting the APA, Congress directed that courts should recognize certain exceptions to the statute's notice-and-comment requirements. Specifically, Congress recognized that not all agency pronouncements, even those of considerable moment, rise to the dignity of law. Thus, the APA excepts, as the panel opinion recounts, interpretative rules and general statements of policy from the general notice-and-comment requirements. While it is no doubt true, and indeed is frequently recognized, that such agency pronouncements may have a direct effect on the regulated community, and may even be judicially reviewable, see, e.g., AFL-CIO v. Donovan, 757 F.2d 330, 341-43 (D.C.Cir.1985); cf. Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), these pronouncements still lack the dignity of "law." Before that status can be achieved, the agency must run its policies through the notice-and-comment gantlet. Perhaps in part because the agency here has avoided testing its pronouncements in this way, it must in any future proceeding defend and justify its chosen standard in the face of a challenge to that standard. Cf. United States v. Boston Farm Center, Inc., 590 F.2d 149, 151 (5th Cir.1979).

II

The majority is quite correct when it chronicles the difficulty courts have found in attempting to fathom the distinction between legislative or substantive rules on one hand, and interpretative rules or policy statements on the other.^[11] Inasmuch as our [952] decisional law over the last decade avowedly reflects considerable uncertainty in discerning the line between agency pronouncements that are "law" and those that are "policy," see Majority Opinion at 946, it seems advisable to return to the pristine teaching of Pacific Gas. In that case, this court articulated a rule which is clearly preferable to the present muddy state of the law. The wisdom of the Pacific Gas principle is in no small measure found in the fact that the case reflects the "core principles" which I sought briefly to adumbrate in the preceding section of this opinion. As I read the case, Pacific Gas deems as "critical" the effect of the agency pronouncement in future proceedings. This is as it should be, for as I discussed above, it is this element that is the essence of "law." Not only is the Pacific Gas approach therefore the most principled manner in which to draw the legislative-interpretative line (in view of the fact that the determination is whether a pronouncement is "law" or not), but it has the not insignificant practical benefit in an unclear world of providing great clarity where previously there has been "considerable smog." See American Bus, 627 F.2d at 529.

We should reembrace our Pacific Gas test as the determinative factor in analyzing whether a particular pronouncement is legislative or interpretative in nature. If the pronouncement has the force of law in future proceedings, it is a legislative rule. Unless that critical feature is present, however, the agency statement should be considered to be a lower form of pronouncement, a "non-law" as it were, or in APA terms an "interpretative rule" or "general statement of policy." The correct measure of a pronouncement's force in subsequent proceedings is a practical one: must the agency merely show that the pronouncement has been violated or must the agency, if its hand is called, show that the pronouncement itself is justified in light of the underlying statute and the facts.

Application of this test can readily be illustrated by the case at hand.^[12] Action levels offer guidance to the regulated community with respect to what products FDA deems adulterated within the meaning of the FDC Act. But in an enforcement proceeding in which FDA seeks either to impose sanctions for shipment of an adulterated product or to enjoin shipment of an adulterated product, the agency must prove the product is "adulterated." That is, FDA cannot merely show that the product at issue fails to comply with the action level. See Boston Farm Center, 590 F.2d at 151. Rather, FDA must offer scientific or other probative evidence to support its contention that the product is adulterated. Thus, the action level does not have the force of law in the subsequent proceeding. Indeed, it has no "force" at all.

Let me quickly observe that I am not encouraging rebellion and sedition within the circuit. While the law has certainly evolved since Pacific Gas, at no point has this court disavowed that decision.^[13] Quite to the contrary, the leading case since Pacific Gas, American Bus, expressly embraced the earlier decision. See 627 F.2d at [953] 529. Moreover, post-American Bus decisions grappling with the legislative rule-interpretative rule distinction have often emphasized the Pacific Gas factor. Just the other day, for example, Judge Bork, in writing for the court in The National Latino Media Coalition v. FCC, 816 F.2d 785, 788 (D.C.Cir.1987), emphasized that "an interpretative rule does not have the force of law and is not binding upon anyone" in holding that the agency pronouncements at issue there were not legislative rules and thus not subject to the APA's notice-and-comment requirements. To my eye, this represents an application, albeit not explicit, of Pacific Gas. Thus, I view Pacific Gas as not only "good" law, in the sense that it has never been overruled, but can discern in our precedents examples, including very fresh ones, of its being heartily applied. I would therefore urge that the "force of law" factor from Pacific Gas be explicitly recognized anew as the polestar guiding the legislative-interpretative determination. Such a modest step would not only be faithful to fundamental principles informing the nature of legislative rules but would have the happy practical consequence of bringing clarity to a troubled area.

While I thus view this step as warranted, I recognize a potential danger lurking in the embrace of a single-factor, Pacific Gas test. Agencies may yield to temptation and seek to shield their regulations from the scrutiny occasioned by notice-and-comment procedures, choosing instead to cast would-be regulations as interpretative rules. The rule would still, of course, be subject to scrutiny in a subsequent proceeding, but this fact may be of little comfort to prospective commentors, given the deference accorded agency views in any such proceedings. See generally Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). But upon analysis, the danger is more theoretical than real. Indeed, Congress not atypically provides agencies with a direct command to promulgate regulations, cf., e.g., Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 100 S.Ct. 2844, 65 L.Ed.2d 1010 (1980), thereby imposing a duty that would not be satisfied with issuance of an humble interpretative rule. In this case, of course, the Supreme Court has now ruled that FDA is not required by the organic statute to issue formal regulations, but can instead proceed by way of informal action levels. ___ U.S. ___, 106 S.Ct. 2360, 90 L.Ed.2d 959 (1986). But if Congress prefers a traditional model of command to the agencies to issue regulations, it can embrace that model through legislation, informed by the need, reiterated by the Supreme Court in this very case, to avoid dangling participles and other forms of that omnipresent occupational hazard of the draftsman's workshop, ambiguity. But see INS v. Cardoza-Fonseca, ___ U.S. ___, 107 S.Ct. 1207, 94 L.Ed.2d 434 (1987); Board of Governors v. Dimension Financial Corp., 474 U.S. 361, 106 S.Ct. 681, 88 L.Ed.2d 691 (1986). Because Pacific Gas, and the basic principles upon which it stands, points the way to a quite different result than that reached by my colleagues, I am constrained to dissent in part.

[1] Aflatoxins are by-products of certain common molds that grow on various crops, including corn.

[2] The APA defines "rule" as "the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy...." 5 U.S.C. § 551(4). FDA does not dispute that its action levels are indeed "rules." The notice-and-comment requirements of section 553 are thus unquestionably triggered and the only question before us is whether one of the statutory exceptions to notice and comment is applicable.

[3] See also Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 536-37 (D.C.Cir.1986) ("[T]here is no axiom to distinguish between a regulation and general statements of policy.").

[4] The first criterion from American Bus could be read as facially inconsistent with the APA. Specifically, criterion one appears to indicate that interpretative rules must be solely prospective: "[C]ourts have said that, unless a pronouncement acts prospectively, it is a binding norm." 627 F.2d at 529. Since under the APA, interpretative rules can be developed and offered as present indications of the agency's enforcement policy, this "present-is-legislative" reading of American Bus would create a conflict with the statutory definition. In our view, however, criterion one from American Bus is addressed to the binding effect of the agency pronouncement; if a statement has a present-day binding effect, it is legislative. Mere pronouncements of what the agency intends, whether for the present or for the future, which do not have a binding effect, are properly classified as interpretative rules. Thus, it is the binding effect, not the timing, which is the essence of criterion one.

[5] As now-Justice Scalia put it when writing for this court: "[T]here is deference and there is deference — and the degree accorded to the agency on a point such as this is not overwhelming." Cathedral Bluffs, 796 F.2d at 537.

[6] The conditional "may" in this provision refers only to the agency's discretion in deciding whether to establish an action level. It does not suggest that, once established, an action level is non-binding. Rather, with respect to binding effect, the regulation speaks in non-conditional terms.

[7] See also Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (FDA Publication 1980) ("Action levels and tolerances represent limits at or above which FDA will take legal action to remove adulterated products from the market.") (emphasis added), reprinted in Joint Appendix (J.A.) at 76, 77.

[8] The specific action level for aflatoxin in corn was published in the Federal Register. In Cathedral Bluffs, this court indicated that such publication did not necessarily suggest that "the matter published was meant to be a regulation, since the APA requires general statements of policy to be published as well." 796 F.2d at 539 (emphasis in original). Rather, the Cathedral Bluffs court indicated that the "real dividing point between regulations and general statements of policy is publication in the Code of Federal Regulations." Id. This factor, among others, led the court to conclude that the pronouncement at issue there was a general statement of policy. In our case, however, the line cannot be so simply drawn. While the specific action level itself was not published in the Code of Federal Regulations, FDA did publish in the C.F.R. regulations authorizing establishment of action levels which, as noted above, indicate that action levels are to have a binding effect. Thus, we deal with a mixed Federal Register-C.F.R. publication, and accordingly find ourselves unable to divine persuasive indications, one way or another, from what may be called the "publication factor."

[9] Boston Farm Center could be read to indicate that the Fifth Circuit viewed action levels as mere general statements of policy. In reviewing the Government's argument that a court should defer to the action level as positively indicating a violation of the Act, the Boston Farm Center court noted that "[t]he deference principle is less compelling when the agency threshold is a matter of prosecutorial discretion instead of rule-making." 590 F.2d at 149. But see United States v. Ewig Bros., 502 F.2d 715, 725 (7th Cir.1974) (An action level is "meant to operate more like a rule of general applicability than a mere prediction of how the agency would choose to exercise its prosecutorial discretion."), cert. denied, 420 U.S. 945, 95 S.Ct. 1324, 43 L.Ed.2d 423 (1975). We may well prefer the Seventh Circuit's characterization, but neither court was addressing the issue before us: whether action levels are within the interpretative rules/general statements of policy exception to APA notice-and-comment requirements. Thus, these casual characterizations are of limited help in our inquiry.

[10] Our conclusion is buttressed by the Supreme Court's opinion in this case, which could be read to reflect an understanding of the action levels as substantive rules. Specifically, the Court described action levels in the following terms: "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." 106 S.Ct. at 2363. This characterization of the action levels as an agency assurance is consistent with our holding that the action levels are substantive rules subject to notice-and-comment procedures.

[11] In addition, the difficulty can be seen in attempts by courts to quite understandably make sense of this area by seeking simple, easily-applied rules. In Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 539 (D.C.Cir.1986), now-Justice Scalia intimates that "[t]he real dividing point between regulations and general statements of policy is publication in the Code of Federal Regulations." Such an approach would certainly be simple, if arguably inconsistent with the notion that the deference entitled to an agency's own characterizations of its statements is "not overwhelming." Id., at 537. I prefer the Pacific Gas approach, which has a much firmer rooting in the core principles at issue.

[12] I recognize that in many ways, nothing can be "readily" demonstrated by the case at hand; action levels, as the FDA has fashioned them, are a rather curious hybrid. Under a functionalist analysis, this form of agency action comes tantalizingly close to a substantive rule. I find particularly compelling the fact that FDA considers it necessary to grant "exceptions" to its action levels. See 21 C.F.R. § 109.8 (1986). Thus, I must confess in candor that I view the majority's approach not only as faithful to our circuit's more recent pronouncements, but as buttressed by common sanse.

[13] What seems to have taken place as the law has evolved (and arguably become obfuscated) is that the Pacific Gas factor has been consigned to a supporting role, as one aspect of what seems to be a multi-factor test.

241 U.S. 265 (1916)

ERROR TO THE CIRCUIT COURT OF APPEALS FOR THE SIXTH CIRCUIT.

[266] Mr. Assistant Attorney General Underwood, with whom Mr. Elliott Cheatham was on the brief, for the United States.

Mr. Harold Hirsch and Mr. J.B. Sizer, with whom Mr. A.W. Chambliss and Mr. W.D. Thomson were on the brief, for the defendant in error.

[270] MR. JUSTICE HUGHES delivered the opinion of the court.

This is a libel for condemnation under the Food and Drugs Act (June 30, 1906, c. 3915, 34 Stat. 768) of a certain quantity of a food product known as `Coca Cola' transported, for sale, from Atlanta, Georgia, to Chattanooga, Tennessee. It was alleged that the product was adulterated and misbranded. The allegation of adulteration was, in substance, that the product contained an added poisonous or added deleterious ingredient, caffeine, [271] which might render the product injurious to health. It was alleged to be misbranded in that the name `Coca Cola' was a representation of the presence of the substances coca and cola; that the product "contained no coca and little if any cola" and thus was an "imitation" of these substances and was offered for sale under their "distinctive name." We omit other charges which the Government subsequently withdrew. The claimant answered, admitting that the product contained as one of its ingredients "a small portion of caffeine," but denying that it was either and `added' ingredient, or a poisonous or a deleterious ingredient which might make the product injurious. It was also denied that there were substances known as coca and cola "under their own distinctive names," and it was averred that the product did contain "certain elements or substances derived from coca leaves and cola nuts." The answer also set forth, in substance, that `Coca Cola' was the `distinctive name' of the product under which it had been known and sold for more than twenty years as an article of food, with other averments negativing adulteration and misbranding under the provisions of the Act.

Jury trial was demanded, and voluminous testimony was taken. The District Judge directed a verdict for the claimant (191 Fed. Rep. 431), and judgment entered accordingly was affirmed on writ of error by the Circuit Court of Appeals (215 Fed. Rep. 535). And the Government now prosecutes this writ.

First. As to `adulteration.' The claimant, in its summary of the testimony, states that the article in question "is a syrup manufactured by the claimant . . . and sold and used as a base for soft drinks both at soda fountains and in bottles. The evidence shows that the article contains sugar, water, caffeine, glycerine, lime juice and other flavoring matters. As used by the consumer, about one ounce of this syrup is taken in a glass mixed with [272] about seven ounces of carbonated water, so that the consumer gets in an eight ounce glass or bottle of the beverage, about 1.21 grains of caffeine." It is said that in the year 1886 a pharmacist in Atlanta "compounded a syrup by a secret formula, which he called `Coca-Cola Syrup and Extract'"; that the claimant acquired "the formula, name, label and good will for the product" in 1892, and then registered "a trade-mark for the syrup consisting of the name Coca Cola" and has since manufactured and sold the syrup under that name. The proportion of caffeine was slightly diminished in the preparation of the article for bottling purposes. The claimant again registered the name `Coca Cola' as a trade-mark in 1905, averring that the mark had been "in actual use as a trade-mark of the applicant for more than ten years next preceding the passage of the act of February 20, 1905," and that it was believed such use had been exclusive. It is further stated that in manufacturing in accordance with the formula "certain extracts from the leaves of the Coca shrub and the nut kernels of the Cola tree were used for the purpose of obtaining a flavor" and that "the ingredient containing these extracts," with cocaine eliminated, is designated as "Merchandise No. 5." It appears that in the manufacturing process water and sugar are boiled to make a syrup; there are four meltings; in the second or third the caffeine is put in; after the meltings the syrup is conveyed to a cooling tank and then to a mixing tank where the other ingredients are introduced and the final combination is effected; and from the mixing tank the finished product is drawn off into barrels for shipment.

The questions with respect to the charge of `adulteration' are (1) whether the caffeine in the article was an added ingredient within the meaning of the Act (§ 7, subd. Fifth) and, if so, (2) whether it was a poisonous or deleterious ingredient which might render the article injurious to health. The decisive ruling in the courts below resulted [273] from a negative answer to the first question. Both the District Judge and the Circuit Court of Appeals assumed for the purpose of the decision that as to the second question there was a conflict of evidence which would require its submission to the jury. (191 Fed. Rep. 433; 215 Fed. Rep. 540.) But it was concluded, as the claimant contended, that the caffeine — even if it could be found by the jury to have the alleged effect — could not be deemed to be an `added ingredient' for the reason that the article was a compound, known and sold under its own distinctive name, of which the caffeine was a usual and normal constituent. The Government challenges this ruling and the construction of the statute upon which it depends; and the extreme importance of the question thus presented with respect to the application of the Act to articles of food sold under trade names is at once apparent. The Government insists that the fact that a formula has been made up and followed and a distinctive name adopted do not suffice to take an article from the reach of the statute; that the standard by which the combination in such a case is to be judged is not necessarily the combination itself; that a poisonous or deleterious ingredient with the stated injurious effect may still be an added ingredient in the statutory sense, although it is covered by the formula and made a constituent of the article sold.

The term `food' as used in the statute includes "all articles used for food, drink, confectionery, or condiment . . . whether simple, mixed, or compound" (§ 6). An article of `food' is to be deemed to be `adulterated' if it contain "any added poisonous or other added deleterious ingredient which may render such article injurious to health." (Sec. 7, subd. Fifth.^[1]) With this [274] section is to be read the proviso in § 8, to the effect that "an article of food which does not contain any added poisonous or deleterious ingredients shall not be deemed to be adulterated or misbranded" in the case of "mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names," if the distinctive name of another article is not used or imitated and the name on the label or brand is accompanied with a statement of the place of production. And § 8 concludes with a further proviso that nothing in the Act shall be construed "as requiring or compelling proprietors or manufacturers of proprietary foods which [275] contain no unwholesome added ingredient to disclose their trade formulas, except in so far as the provisions of this Act may require to secure freedom from adulteration or misbranding."^[2]

[276] In support of the ruling below, emphasis is placed upon the general purpose of the Act which it is said was to prevent deception, rather than to protect the public health by prohibiting traffic in articles which might be determined to be deleterious. But a description of the purpose of the statute would be inadequate which failed to take account of the design to protect the public from lurking dangers caused by the introduction of harmful ingredients, or which assumed that this end was sought to be achieved by simply requiring certain disclosures. The statute is entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors," etc. In the case of confectionery, we find that it is to be deemed to be adulterated if it contains certain specified substances "or other ingredient deleterious or detrimental to health." So, under § 7, subdivision Sixth, there may be adulteration of food in case the article consists in whole or in part of "any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter." In United States v. Lexington Mills Co., 232 U.S. 399, 409, it was said that "the statute upon its face shows that the primary purpose of Congress was to prevent injury to the public health by the sale and transportation [277] in interstate commerce of misbranded and adulterated foods. The legislation, as against misbranding, intended to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was and not upon misrepresentations as to character and quality. As against adulteration, the statute was intended to protect the public health from possible injury by adding to articles of food consumption poisonous and deleterious substances which might render such articles injurious to the health of consumers." See also United States v. Antikamnia Co., 231 U.S. 654, 665; H.R. Report, No. 2118, 59th Cong., 1st Sess., 6-9. It is true that in executing these purposes Congress has limited its prohibitions (Savage v. Jones, 225 U.S. 501, 529, 532) and has specifically defined what shall constitute adulteration or misbranding; but in determining the scope of specific provisions the purpose to protect the public health, as an important aim of the statute, must not be ignored.

Reading the provisions here in question in the light of the context, we observe:

(a) That the term `adulteration' is used in a special sense. For example, the product of a diseased animal may not be adulterated in the ordinary or strict meaning of the word but by reason of its being that product the article is adulterated within the meaning of the Act. The statute with respect to `adulteration' and `misbranding' has its own glossary. We cannot, therefore, assume that simply because a prepared `food' has its formula and distinctive name, it is not, as such, `adulterated.' In the case of confectionery, it is plain that the article may be `adulterated' although it is made in strict accordance with some formula and bears a fanciful trade name, if in fact it contains an `ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound or narcotic drug.' And the context clearly indicates that [278] with respect to articles of food the ordinary meaning of `adulteration' cannot be regarded as controlling.

(b) The provision in § 7, subdivision Fifth, assumes that the substance which renders the article injurious, and the introduction of which causes `adulteration,' is an ingredient of the article. It must be an `added' ingredient; but it is still an ingredient. Component parts, or constituents, of the article which is the subject of the described traffic are thus not excluded but are included in the definition. The article referred to in subdivision Fifth is the article sought to be made an article of commerce, — the article which `contains' the ingredient.

(c) `Adulteration' is not to be confused with `misbranding.' The fact that the provisions as to the latter require a statement of certain substances if contained in an article of food, in order to avoid `misbranding' does not limit the explicit provisions of § 7 as to adulteration. Both provisions are operative. Had it been the intention of Congress to confine its definition of adulteration to the introduction of the particular substances specified in the section as to misbranding, it cannot be doubted that this would have been stated, but Congress gave a broader description of ingredients in defining `adulteration.' It is `any' added poisonous or `other added deleterious ingredient,' provided it `may render such article injurious to health.'

(d) Proprietary foods, sold under distinctive names, are within the purview of the provision. Not only is `food' defined as including articles used for food or drink `whether simple, mixed or compound,' but the intention to include `proprietary foods' sold under distinctive names is manifest from the provisos in § 8 which the claimant invokes. `Mixtures or compounds' which satisfy the first paragraph of the proviso are not only `articles of food,' but are to enjoy the stated immunity only in case they do "not contain any added poisonous or deleterious [279] ingredients." By the concluding clause of § 8, it is provided that nothing in the Act shall be construed to require manufacturers of `proprietary foods' to disclose `their trade formulas' except in so far as the provisions of the Act `may require to secure freedom from adulteration or misbranding,' and the immunity is conditioned upon the fact that such foods `contain no unwholesome added ingredient.' Thus the statute contemplates that mixtures or compounds manufactured by those having trade formulas, and bearing distinctive names, may nevertheless contain `added ingredients' which are poisonous or deleterious and may make the article injurious, and, if so, the article is not taken out of the condemnation of § 7, subdivision Fifth.

(e) Again, articles of food including `proprietary foods' which fall within this condemnation are not saved because they were already on the market when the statute was passed. The Act makes no such distinction; and it is to be observed that the proviso of § 8 explicitly refers to `mixtures or compounds which may be now or from time to time hereafter known as articles of food.' Nor does the length of the period covered by the traffic, or its extent, affect the question if the article is in fact adulterated within the meaning of the Act.

Having these considerations in mind we deem it to be clear that, whatever difficulties there may be in construing the provision, the claimant's argument proves far too much. We are not now dealing with the question whether the caffeine did, or might, render the article in question injurious; that is a separate inquiry. The fundamental contention of the claimant, as we have seen, is that a constituent of a food product having a distinctive name cannot be an `added' ingredient. In such case, the standard is said to be the food product itself which the name designates. It must be, it is urged, this `finished product' that is `adulterated.' In that view, there would [280] seem to be no escape from the conclusion that however poisonous or deleterious the introduced ingredient might be, and however injurious its effect, if it be made a constituent of a product having its own distinctive name it is not within the provision. If this were so, the statute would be reduced to an absurdity. Manufacturers would be free, for example, to put arsenic or strychnine or other poisonous or deleterious ingredients with an unquestioned injurious effect into compound articles of food, provided the compound were made according to formula and sold under some fanciful name which would be distinctive. When challenged upon the ground that the poison was an `added' ingredient, the answer would be that without it the so-called food product would not be the product described by the name. Further, if an article purporting to be an ordinary food product sold under its ordinary name were condemned because of some added deleterious ingredient, it would be difficult to see why the same result could not be attained with impunity by composing a formula and giving a distinctive name to the article with the criticized substance as a component part. We think that an analysis of the statute shows such a construction of the provision to be inadmissible. Certain incongruities may follow from any definition of the word `added,' but we cannot conclude that it was the intention of Congress to afford immunity by the simple choice of a formula and a name. It does not seem to us to be a reasonable construction that in the case of `proprietary foods' manufactured under secret formulas Congress was simply concerned with additions to what such formulas might embrace. Undoubtedly, it was not desired needlessly to embarrass manufacturers of `proprietary foods' sold under distinctive names, but it was not the purpose of the Act to protect articles of this sort regardless of their character. Only such food products as contain `no unwholesome added ingredient' are within the saving clause and [281] in using the words quoted we are satisfied that Congress did not make the proprietary article its own standard.

Equally extreme and inadmissible is the suggestion that where a `proprietary food' would not be the same without the harmful ingredient, to eliminate the latter would constitute an `adulteration' under § 7, subdivision Third, by the abstraction of a `valuable constituent.' In that subdivision Congress evidently refers to articles of food which normally are not within the condemnation of the Act. Congress certainly did not intend that a poisonous or deleterious ingredient which made a proprietary food an enemy to the public health should be treated as a `valuable constituent,' or to induce the continued use of such injurious ingredients by making their elimination an adulteration subject to the penalties of the statute.

It is apparent, however, that Congress in using the word `added' had some distinction in view. In the Senate bill (for which the measure as adopted was a substitute) there was a separate clause relating to `liquors,' providing that the article should be deemed to be adulterated if it contained "any added ingredient of a poisonous or deleterious character"; while in the case of food (which was defined as excluding liquors) the article was to be deemed to be `adulterated' if it contained "any added poisonous or other ingredient which may render such article injurious to human health." Cong. Rec., 59th Cong., 1st Sess., Vol. 40, p. 897. In explaining the provision as to `liquors,' Senator Heyburn, the chairman of the Senate Committee having the bill in charge, stated to the Senate (Id., p. 2647): "The word `added,' after very mature consideration by your committee, was adopted because of the fact that there is to be found in nature's products as she produces them, poisonous substances to be determined by analysis. Nature has so combined them that they are not a danger or an evil — that is, so long as they are left in [282] the chemical connection in which nature has organized them; but when they are extracted by the artificial processes of chemistry they become a poison. You can extract poison from grain or its products and when it is extracted it is a deadly poison; but if you leave that poison as nature embodied it in the original substances it is not a dangerous poison or an active agency of poison at all. — So, in order to avoid the threat that those who produce a perfectly legitimate article from a natural product might be held liable because the product contained nature's poison it was thought sufficient to provide against the adding of any new substance that was in itself a poison, and thus emphasizing the evils of existing conditions in nature's product. That is the reason the word `added' is in the bill. Fusel oil is a poison. If you extract it, it becomes a single active agency of destruction, but allow it to remain in the combination where nature has placed it, and, while it is nominally a poison, it is a harmless one, or comparatively so." For the Senate bill, the House of Representatives substituted a measure which had the particular provisions now under consideration in substantially the same form in which they were finally enacted into law. (Section 7, subd. Fifth; § 8, subd. Fourth, provisos.) And the Committee of the House of Representatives in reporting this substituted measure said (H.R. Report, No. 2118, 59th Cong., 1st Sess., pp. 6, 7, 11): "The purpose of the pending measure is not to compel people to consume particular kinds of foods. It is not to compel manufacturers to produce particular kinds or grades of foods. One of the principal objects of the bill is to prohibit in the manufacture of foods intended for interstate commerce the addition of foreign substances poisonous or deleterious to health. The bill does not relate to any natural constituents of food products which are placed in the foods by nature itself. It is well known that in many kinds of foods in their natural state some quantity of poisonous [283] or deleterious ingredients exist. How far these substances may be deleterious to health when the food articles containing them are consumed may be a subject of dispute between the scientists, but the bill reported does not in any way consider that question. If, however, poisonous or deleterious substances are added by man to the food product, then the bill declares the article to be adulterated and forbids interstate traffic."

This statement throws light upon the intention of Congress. Illustrations are given to show possible incongruous results of the test, but they do not outweigh this deliberate declaration of purpose; nor do we find in the subsequent legislative history of the substituted measure containing the provision any opposing statement as to the significance of the phrase. It must also be noted that some of the Illustrations which are given lose their force when it is remembered that the statutory ban (§ 7, subd. Fifth) by its explicit terms only applies where the added ingredient may render the article injurious to health. See United States v. Lexington Mills Co., 232 U.S. 399, supra. It is urged, that whatever may be said of natural food products, or simple food products, to which some addition is made, a `proprietary food' must necessarily be `something else than the simple or natural article'; that it is an `artificial preparation.' It is insisted that every ingredient in such a compound cannot be deemed to be an `added' ingredient. But this argument, and the others that are advanced, do not compel the adoption of the asserted alternative as to the saving efficacy of the formula. Nor can we accept the view that the word `added' should be taken as referring to the quantity of the ingredient used. It is added ingredient which the statute describes, not added quantity of the ingredient, although of course quantity may be highly important in determining whether the ingredient may render the article harmful, and experience in the use of ordinary articles of [284] food may be of greatest value in dealing with such questions of fact.

Congress, we think, referred to ingredients artificially introduced; these it described as `added.' The addition might be made to a natural food product or to a compound. If the ingredient thus introduced was of the character and had the effect described, it was to make no difference whether the resulting mixture or combination was or was not called by a new name or did or did not constitute a proprietary food. It is said that the preparation might be `entirely new.' But Congress might well suppose that novelty would probably be sought by the use of such ingredients, and that this would constitute a means of deception and a menace to health from which the public should be protected. It may also have been supposed that, ordinarily, familiar food bases would be used for this purpose. But, however, the compound purporting to be an article of food might be made up, we think that it was the intention of Congress that the artificial introduction of ingredients of a poisonous or deleterious character which might render the article injurious to health should cause the prohibition of the statute to attach.

In the present case, the article belongs to a familiar group; it is a syrup. It was originally called `Coca Cola Syrup and Extract.' It is produced by melting sugar, — the analysis showing that 52.64 per cent. of the product is sugar and 42.63 per cent. is water. Into the syrup thus formed by boiling the sugar, there are introduced coloring, flavoring, and other ingredients, in order to give the syrup a distinctive character. The caffeine, as has been said, is introduced in the second or third `melting.' We see no escape from the conclusion that it is an `added' ingredient within the meaning of the statute.

Upon the remaining question whether the caffeine was a poisonous or deleterious ingredient which might render the article injurious to health, there was a decided conflict [285] of competent evidence. The Government's experts gave testimony to the effect that it was, and the claimant introduced evidence to show the contrary. It is sufficient to say that the question was plainly one of fact which was for the consideration of the jury. See 443 Cans of Egg Product,) 226 U.S. 172, 183.

Second. As to `misbranding.' In the second count it was charged that the expression `Coca Cola' represented the presence in the product of the substances coca and cola and that it contained "no coca and little if any cola." So far as `cola' was concerned, the charge was vague and indefinite and this seems to have been conceded by the Government at the beginning of the trial. With respect to `coca,' there was evidence on the part of the Government tending to show that there was nothing in the product obtained from the leaves of the coca plant, while on behalf of the claimant it was testified that the material called `Merchandise No. 5' (one of the ingredients) was obtained from both coca leaves and cola nuts. It was assumed on the motion for a peremptory instruction that there might be a disputed question of fact as to whether the use of the word `coca' is to be regarded "intrinsically and originally" as stating or suggesting the presence of "some material element or quality" derived from coca leaves, and it was also assumed that the evidence might be deemed to be conflicting with respect to the question whether the product actually contained anything so derived. 191 Fed. Rep. pp. 438, 439. But these issues of fact were considered not to be material. On this branch of the case, the claimant succeeded upon the ground that its article was within the protection of the proviso in § 8 as one known `under its own distinctive name.' 215 Fed. Rep. p. 544.

Section 8 (ante, p. 275), in its Fourth specification as to `food,' provides that the article shall be deemed to be `misbranded' "if the package containing it or its label shall [286] bear any statement, design, or device regarding the ingredients or the substances contained therein, which . . . shall be false or misleading in any particular." Then follows the proviso in question that an article not containing any added poisonous or deleterious ingredients "shall not be deemed to be . . . misbranded" in the case of "mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article," if the name is accompanied with a statement of the place where the article has been produced.^[3]

A distinctive name is a name that distinguishes. It may be a name in common use as a generic name, e.g., [287] coffee, flour, etc. Where there is a trade description of this sort by which a product of a given kind is distinctively known to the public, it matters not that the name had originally a different significance. Thus, soda-water is a familiar trade description of an article which now, as is well known, rarely contains soda in any form. Such a name is not be deemed either `misleading' or `false,' as it is in fact distinctive. But unless the name is truly distinctive, the immunity cannot be enjoyed; it does not extend to a case where an article is offered for sale `under the distinctive name of another article.' Thus, that which is not coffee, or is an imitation of coffee, cannot be sold as coffee; and it would not be protected by being called "X's Coffee." Similarly, that which is not lemon extract could not obtain immunity by being sold under the name of "Y's Lemon Extract." The name so used is not `distinctive' as it does not appropriately distinguish the product; it is an effort to trade under the name of an article of a different sort. So, with respect to `mixtures or compounds,' we think that the term `another article' in the proviso embraces different compounds from the compound in question. The aim of the statute is to prevent deception, and that which appropriately describes a different compound cannot secure protection as a `distinctive name.'

A `distinctive name' may also, of course, be purely arbitrary or fanciful and thus, being the trade description of the particular thing, may satisfy the statute, provided the name has not already been appropriated for something else so that its use would tend to deceive.

If, in the present case, the article had been named `Coca' and it were found that the name was actually descriptive in the sense that it fairly implied that the article was derived from the leaves of the coca plant, it could not be said that this was `its own distinctive name' if in fact it contained nothing so derived. The [288] name, if thus descriptive, would import a different product from the one to which it was actually affixed. And, in the case supposed, the name would not become the `distinctive name' of a product without any coca ingredient unless in popular acceptation it came to be regarded as identifying a product known to be of that character. It would follow that the mere sale of the product under the name `Coca,' and the fact that this was used as a trade designation of the product, would not suffice to show that it had ceased to have its original significance if it did not appear that it had become known to the public that the article contained nothing derived from coca. Until such knowledge could be attributed to the public the name would naturally continue to be descriptive in the original sense. Nor would it be controlling that at the time of the adoption of the name the coca plant was known only to foreigners and scientists, for if the name had appropriate reference to that plant and to substances derived therefrom, its use would primarily be taken in that sense by those who did know or who took pains to inform themselves of its meaning. Mere ignorance on the part of others as to the nature of the composition would not change the descriptive character of the designation. The same conclusion would be reached if the single name `Cola' had been used as the name of the product, and it were found that in fact the name imported that the product was obtained from the cola nut. The name would not be the distinctive name of a product not so derived until in usage it achieved that secondary significance.

We are thus brought to the question whether if the names coca and cola were respectively descriptive, as the Government contends, a combination of the two names constituted a `distinctive name' within the protection of the proviso in case either of the described ingredients was absent. It is said that `coca' indicates one [289] article, and `cola' another, but that the two names together did not constitute the distinctive name of any other substance or combination of substances. The contention leads far. To take the illustration suggested in argument, it would permit a manufacturer, who could not use the name chocolate to describe that which was not chocolate, or vanilla to describe that which was not vanilla, to designate a mixture as `Chocolate-Vanilla,' although it was destitute of either or both, provided the combined name had not been previously used. We think that the contention misses the point of the proviso. A mixture or compound may have a name descriptive of its ingredients or an arbitrary name. The latter (if not already appropriated) being arbitrary, designates the particular product. Names, however, which are merely descriptive of ingredients are not primarily distinctive names save as they appropriately describe the compound with such ingredients. To call the compound by a name descriptive of ingredients which are not present is not to give it `its own distinctive name' — which distinguishes it from other compounds — but to give it the name of a different compound. That, in our judgment, is not protected by the proviso, unless the name has achieved a secondary significance as descriptive of a product known to be destitute of the ingredients indicated by its primary meaning.

In the present case we are of opinion that it could not be said as matter of law that the name was not primarily descriptive of a compound with coca and cola ingredients, as charged. Nor is there basis for the conclusion that the designation had attained a secondary meaning as the name of a compound from which either coca or cola ingredients were known to be absent; the claimant has always insisted, and now insists, that its product contains both. But if the name was found to be descriptive, as charged, there was clearly a conflict of evidence with respect to the presence of any coca ingredient. We conclude [290] that the court erred in directing a verdict on the second count.

The judgment is reversed and the cause is remanded for further proceedings in conformity with this opinion.

It is so ordered.

MR. JUSTICE McREYNOLDS took no part in the consideration or decision of this case.

[1] Section 7, with respect to `confectionery' and `food' is as follows:

"Sec. 7. That for the purposes of this Act an article shall be deemed to be adulterated:

. . .

"In the case of confectionery:

"If it contains terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound or narcotic drug.

"In the case of food:

"First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength.

"Second. If any substance has been substituted wholly or in part for the article.

"Third. If any valuable constituent of the article has been wholly or in part abstracted.

"Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed.

"Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this Act shall be construed as applying only when said products are ready for consumption.

"Sixth. If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter."

[2] Section 8 provides:

"Sec. 8. That the term `misbranded,' as used herein, shall apply to all drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, . . .

"That for the purposes of this Act an article shall also be deemed to be misbranded:

* * * * * * * *

"In the case of food:

"First. If it be an imitation of or offered for sale under the distinctive name of another article.

"Second. If it be labeled or branded so as to deceive or mislead the purchaser, or purport to be a foreign product when not so, or if the contents of the package as originally put up shall have been removed in whole or in part and other contents shall have been placed in such package, or if it fail to bear a statement on the label of the quantity or proportion of any morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any of such substances contained therein.

"Third. If in package form, and the contents are stated in terms of weight or measure, they are not plainly and correctly stated on the outside of the package.

"Fourth. If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or the substances contained therein, which statement, design, or device shall be false or misleading in any particular: Provided, That an article of food which does not contain any added poisonous or deleterious ingredients shall not be deemed to be adulterated or misbranded in the following cases:

"First. In the case of mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with a statement of the place where said article has been manufactured or produced.

"Second. In the case of articles labeled, branded, or tagged so as to plainly indicate that they are compounds, imitations, or blends, and the word `compound,' `imitation,' or `blend,' as the case may be, is plainly stated on the package in which it is offered for sale: Provided, That the term blend as used herein shall be construed to mean a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only: And provided further, That nothing in this Act shall be construed as requiring or compelling proprietors or manufacturers of proprietary foods which contain no unwholesome added ingredient to disclose their trade formulas, except in so far as the provisions of this Act may require to secure freedom from adulteration or misbranding."

[3] Among the departmental regulations (adopted in October, 1906, pursuant to § 3, for the enforcement of the Act) is Regulation 20 with respect to `distinctive names' under § 8, as follows:

"(a) A `distinctive name' is a trade, arbitrary, or fancy name which clearly distinguishes a food product, mixture, or compound from any other food product, mixture, or compound.

"(b) A distinctive name shall not be one representing any single constituent of a mixture or compound.

"(c) A distinctive name shall not misrepresent any property or quality of a mixture or compound.

"(d) A distinctive name shall give no false indication of origin, character, or place of manufacture, nor lead the purchaser to suppose that it is any other food or drug product."

Regulation 27 is as follows:

"(a) The terms `mixtures' and `compounds' are interchangeable and indicate the results of putting together two or more food products.

"(b) These mixtures or compounds shall not be imitations of other articles, whether simple, mixt, or compound, or offered for sale under the name of other articles. They shall bear a distinctive name and the name of the place where the mixture or compound has been manufactured or produced.

"(c) If the name of the place be one which is found in different States, Territories, or countries, the name of the State, Territory, or country, as well as the name of the place, must be stated."

232 U.S. 399 (1914)

CERTIORARI TO THE CIRCUIT COURT OF APPEALS FOR THE EIGHTH CIRCUIT.

[400] Mr. Attorney General McReynolds, with whom Mr. Francis G. Caffey was on the brief, for the United States.

Mr. Edward P. Smith and Mr. Bruce S. Elliott, with whom Mr. Edward L. Scarritt, Mr. C.J. Smyth and Mr. W.C. Scarritt were on the brief, for respondent.

[404] MR. JUSTICE DAY delivered the opinion of the court.

The petitioner, the United States of America, proceeding under § 10 of the Food and Drugs Act (June 30, 1906, c. 3915, 34 Stat. 768, 771), by libel filed in the District Court of the United States for the Western District of Missouri, sought to seize and condemn 625 sacks of flour in the possession of one Terry, which had been shipped from Lexington, Nebraska, to Castle, Missouri, and which remained in original, unbroken packages. The judgment of the District Court, upon verdict, in favor of the Government, was reversed by the Circuit Court of Appeals for the Eighth Circuit (202 Fed. Rep. 615), and this writ of certiorari is to review the judgment of that court.

[405] The amended libel charged that the flour had been treated by the "Alsop Process," so called, by which nitrogen peroxide gas, generated by electricity, was mixed with atmospheric air and the mixture then brought in contact with the flour, and that it was thereby adulterated under the fourth and fifth subdivisions of § 7 of the act, namely, (1) in that the flour had been mixed, colored and stained in a manner whereby damage and inferiority were concealed and the flour given the appearance of a better grade of flour than it really was, and (2) in that the flour had been caused to contain added poisonous or other added deleterious ingredients, to-wit, nitrites or nitrite reacting material, nitrogen peroxide, nitrous acid, nitric acid and other poisonous and deleterious substances which might render the flour injurious to health. The libel also charged that the flour was adulterated under the first subdivision of § 7, and was misbranded; but the Government does not urge these features of the case here. The verdict was broad enough to cover the charge under the first subdivision of § 7, but in the view we take of the case as to the instruction of the court under subdivision 5 it need not be noticed.

The Lexington Mill & Elevator Company, the respondent herein, appeared, claiming the flour, and answered the libel, admitting that the flour had been treated by the Alsop Process, but denying that it had been adulterated and attacking the constitutionality of the act.

A special verdict to the effect that the flour was adulterated was returned and judgment of condemnation entered. The case was taken to the Circuit Court of Appeals upon writ of error. The respondent contended that, among other errors, the instructions of the trial court as to adulteration were erroneous and that the act was unconstitutional. The Circuit Court of Appeals held that the testimony was insufficient to show that by the [406] bleaching process the flour was so colored as to conceal inferiority and was thereby adulterated, within the provisions of subdivision 4. That court also held — and this holding gives rise to the principal controversy here — that the trial court erred in instructing the jury that the addition of a poisonous substance, in any quantity, would adulterate the article, for the reason that "the possibility of injury to health due to the added ingredient and in the quantity in which it is added, is plainly made an essential element of the prohibition." It did not pass upon the constitutionality of the act, in view of its rulings on the act's construction.

The case requires a construction of the Food and Drugs Act. Parts of the statute pertinent to this case are:

"SEC. 7. (34 Stat. 769.) That for the purposes of this act an article shall be deemed to be adulterated: . . .

"In the case of food:

"First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength. . . .

"Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed.

"Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health. . . .

* * * * * * * *

"SEC. 10. (34 Stat. 771.) That any article of food, drug, or liquor that is adulterated or misbranded within the meaning of this act, and is being transported from one State, Territory, district, or insular possession to another for sale, or, having been transported, remains unloaded, unsold, or in original unbroken packages, . . . shall be liable to be proceeded against in any district court of the United States within the district where the same is found, and seized for confiscation by a process of libel for [407] condemnation. And if such article is condemned as being adulterated or misbranded, or of a poisonous or deleterious character, within the meaning of this act, the same shall be disposed of by destruction or sale, as the said court may direct."

Without reciting the testimony in detail it is enough to say that for the Government it tended to show that the added poisonous substances introduced into the flour by the Alsop Process, in the proportion of 1.8 parts per million, calculated as nitrogen, may be injurious to the health of those who use the flour in bread and other forms of food. On the other hand, the testimony for the respondent tended to show that the process does not add to the flour any poisonous or deleterious ingredients which can in any manner render it injurious to the health of a consumer. On these conflicting proofs the trial court was required to submit the case to the jury. That court, after stating the claims of the parties, the Government insisting that the flour was adulterated and should be condemned if it contained any added poisonous or other added deleterious ingredient of a kind or character which was capable of rendering such article injurious to health; the respondent contending that the flour should not be condemned unless the added substances were present in such quantity that the flour would be thereby rendered injurious to health, gave certain instructions to the jury. Part of the charge, excepted to by the respondent, reads:

"The fact that poisonous substances are to be found in the bodies of human beings, in the air, in potable water, and in articles of food, such as ham, bacon, fruits, certain vegetables, and other articles, does not justify the adding of the same or other poisonous substances to articles of food, such as flour, because the statute condemns the adding of poisonous substances. Therefore the court charges you that the Government need not prove that this flour or food-stuffs made by the use of it would injure [408] the health of any consumer. It is the character — not the quantity — of the added substance, if any, which is to determine this case."

On the other hand the respondent insisted that the law is, and requested the court to charge the jury:

"That the burden is upon the prosecution to prove the truth of the charge in the libel, that by the treatment of the flour in question by the said Alsop Process it has been caused to contain added poisonous or other added deleterious ingredients, to-wit, nitrites or nitrite reacting material, which may render said flour injurious to health.

"And in this connection you are further instructed that it is incumbent upon the Government to prove that any such added poisonous or other added deleterious ingredients, if any contained in said flour, are of such a character and contained in the flour seized in such quantities, conditions and amounts as may render said flour injurious to health, and unless you find that all of such facts are so proven you cannot find against the claimant or condemn the flour in question under that charge in the libel, and if you fail to so find your verdict upon that count or charge in the libel must be in favor of the claimant or defendant.

* * * * * * * *

"The law does not prohibit the adding of nitrites or nitrite reacting material to flour, and a jury cannot find for the Government or against the claimant, even if it be shown that nitrites or nitrite reacting material was added to the flour in question, unless they believe from a preponderance of the evidence that such addition, if any, rendered said flour injurious to the health of those who might consume the bread or other foods made from said flour."

It is evident from the charge given and requests refused that the trial court regarded the addition to the flour of any poisonous ingredient as an offense within this statute, no [409] matter how small the quantity, and whether the flour might or might not injure the health of the consumer. At least such is the purport of the part of the charge above given, and if not correct, it was clearly misleading, notwithstanding other parts of the charge seem to recognize that in order to prove adulteration it is necessary to show that the flour may be injurious to health. The testimony shows that the effect of the Alsop Process is to bleach or whiten the flour and thus make it more marketable. If the testimony introduced on the part of the respondent was believed by the jury they must necessarily have found that the added ingredient, nitrites of a poisonous character, did not have the effect to make the consumption of the flour by any possibility injurious to the health of the consumer.

The statute upon its face shows, that the primary purpose of Congress was to prevent injury to the public health by the sale and transportation in interstate commerce of misbranded and adulterated foods. The legislation, as against misbranding, intended to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was and not upon misrepresentations as to character and quality. As against adulteration, the statute was intended to protect the public health from possible injury by adding to articles of food consumption poisonous and deleterious substances which might render such articles injurious to the health of consumers. If this purpose has been effected by plain and unambiguous language, and the act is within the power of Congress, the only duty of the courts is to give it effect according to its terms. This principle has been frequently recognized in this court. Lake County v. Rollins, 130 U.S. 662, 670:

"Where a law is expressed in plain and unambiguous terms, whether those terms are general or limited, the legislature should be intended to mean what they have [410] plainly expressed, and consequently no room is left for construction."

Hamilton v. Rathbone, 175 U.S. 414, 421:

"The cases are so numerous in this court to the effect that the province of construction lies wholly within the domain of ambiguity, that an extended review of them is quite unnecessary."

Furthermore all the words used in the statute should be given their proper signification and effect; Washington Market Co. v. Hoffman, 101 U.S. 112, 115:

"We are not at liberty," said Mr. Justice Strong, "to construe any statute so as to deny effect to any part of its language. It is a cardinal rule of statutory construction that significance and effect shall, if possible, be accorded to every word. As early as in Bacon's Abridgment, sec. 2, it was said that `a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word, shall be superfluous, void, or insignificant.' This rule has been repeated innumerable times."

Applying these well-known principles in considering this statute, we find that the fifth subdivision of § 7 provides that food shall be deemed to be adulterated: "If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health." The instruction of the trial court permitted this statute to be read without the final and qualifying words, concerning the effect of the article upon health. If Congress had so intended the provision would have stopped with the condemnation of food which contained any added poisonous or other added deleterious ingredient. In other words, the first and familiar consideration is that, if Congress had intended to enact the statute in that form, it would have done so by choice of apt words to express that intent. It did not do so, but only condemned food containing an added poisonous or other added deleterious ingredient when such addition might render the article of food injurious [411] to the health. Congress has here, in this statute, with its penalties and forfeitures definitely outlined its inhibition against a particular class of adulteration.

It is not required that the article of food containing added poisonous or other added deleterious ingredients must affect the public health, and it is not incumbent upon the Government in order to make out a case to establish that fact. The act has placed upon the Government the burden of establishing, in order to secure a verdict of condemnation under this statute, that the added poisonous or deleterious substances must be such as may render such article injurious to health. The word "may" is here used in its ordinary and usual signification, there being nothing to show the intention of Congress to affix to it any other meaning. It is, says Webster, "an auxiliary verb, qualifying the meaning of another verb, by expressing ability, . . ., contingency or liability, or possibility or probability." In thus describing the offense Congress doubtless took into consideration that flour may be used in many ways, in bread, cake, gravy, broth, etc. It may be consumed, when prepared as a food, by the strong and the weak, the old and the young, the well and the sick; and it is intended that if any flour, because of any added poisonous or other deleterious ingredient, may possibly injure the health of any of these, it shall come within the ban of the statute. If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such flour, though having a small addition of poisonous or deleterious ingredients, may not be condemned under the act. This is the plain meaning of the words and in our view needs no additional support by reference to reports and debates, although it may be said in passing that the meaning which we have given to the statute was well expressed by Mr. Heyburn, chairman of the committee having it in charge upon the floor of the Senate (Congressional Record, vol. 40, pt. 2, p. 1131):

[412] "As to the use of the term `poisonous,' let me state that everything which contains poison is not poison. It depends on the quantity and the combination. A very large majority of the things consumed by the human family contain, under analysis, some kind of poison, but it depends upon the combination, the chemical relation which it bears to the body in which it exists as to whether or not it is dangerous to take into the human system."

And such is the view of the English courts construing a similar statute. The English statute provides (§ 3, of the Sale of Food and Drugs Act, 1875):

"No person shall mix, color, . . . or order or permit any other person to mix, color, . . . any article of food with any ingredient or material so as to render the article injurious to health."

That section was construed in Hull v. Horsnell, 68 J.P. 591, which involved preserved peas, the color of which had been retained by the addition of sulphate of copper, charged to be a poisonous substance and injurious to health. There was a conviction in the lower court. Lord Alverstone, C.J., in reversing and remitting the case on appeal, said:

"In my opinion, if the justices convicted the appellant of an offence under § 3 of the Sale of Food and Drugs Act, 1875, on the ground that the ingredient mixed with the article of food was injurious to health, — that the sulphate of copper was injurious to health, and not on the ground that the peas by reason of the addition of sulphate of copper were rendered injurious to health, the conviction is clearly wrong. To constitute an offence under the latter part of § 3 the article of food sold must, by the addition of an ingredient, be rendered injurious to health. All the circumstances must be examined to see whether the article of food has been rendered injurious to health."

We reach the conclusion that the Circuit Court of Appeals did not err in reversing the judgment of the District [413] Court for error in its charge with reference to subdivision five of § 7.

The Circuit Court of Appeals reached the conclusion that there was no substantial proof to warrant the conviction under the fourth subdivision of § 7, that the flour was mixed, colored and stained in a manner whereby damage and inferiority was concealed. As the case is to be retried to a jury, we say nothing upon this point.

As to the objection on constitutional grounds, it is not contended that the statute as construed by the Circuit Court of Appeals and this court is unconstitutional.

It follows that the judgment of the Circuit Court of Appeals reversing the judgment of the District Court must be affirmed, and the case remanded to the District Court for a new trial.

Affirmed.

831 F.2d 1108 (1987)

[1109] William B. Schultz, with whom Katherine A. Meyer and Alan B. Morrison were on the brief for petitioners in No. 86-1548 and appellants in No. 86-5150.

Douglas N. Letter, Appellant Litigation Counsel, Dept. of Justice, with whom Richard K. Willard, Asst. Atty. Gen., Robert L. Cynkar, Deputy Asst. Atty. Gen., Margaret A. Cotter, Asst. Director, Jacqueline H. Eagle, Attorney, Dept. of Justice, Thomas Scarlett, Chief Counsel and Richard E. Geyer, Associate Chief Counsel, Food and Drug Admin. were on the brief for respondents in No. 86-1548.

Robert C. Seldon, Asst. U.S. Atty., with whom Joseph E. diGenova, U.S. Atty., Royce C. Lamberth, R. Craig Lawrence, Asst. U.S. Attys., Thomas Scarlett, Chief Counsel and Richard E. Geyer, Associate Chief Counsel, Food and Drug Admin. were on the brief for federal appellees in No. 86-5150.

John P. McKenna, with whom Daniel R. Thompson was on the brief for appellee, Certified Color Mfrs. Ass'n in No. 86-5150.

Peter Barton Hutt for intervenor in No. 86-1548. Robert M. Sussman, Ellen J. Flannery, and Bruce N. Kuhlik were on the brief for the Cosmetic, Toiletry and Fragrance Ass'n appellee in No. 86-5150 and intervenor in No. 86-1548.

Before RUTH B. GINSBURG and WILLIAMS, Circuit Judges, and HAROLD H. GREENE,^[1] District Judge.

Petition for Review of an Order of the Food and Drug Administration

Opinion for the Court filed by Circuit Judge WILLIAMS.

WILLIAMS, Circuit Judge:

The Color Additive Amendments of 1960, Pub.L. No. 86-618, 74 Stat. 397 (codified at 21 U.S.C. § 376 (1982)), part of the Food, Drug and Cosmetic Act (the "Act"), establish an elaborate system for regulation of color additives in the interests of safety. A color additive may be used only after the Food and Drug Administration ("FDA") has published a regulation listing the additive for such uses as are safe. Such listing may occur only if the color additive in question satisfies (among other things) the requirements of the applicable "Delaney Clause," § 706(b)(5)(B) of the Act, 21 U.S.C. § 376(b)(5)(B), one of three such clauses in the total system for regulation of color additives, food and animal food and drugs.^[2] The Clause prohibits the listing of any color additive "found ... to induce cancer in man or animal."

In No. 86-1548, Public Citizen and certain individuals challenge the decision of the FDA to list two color additives, Orange No. 17 and Red No. 19, based on quantitative risk assessments indicating that the cancer risks presented by these dyes were trivial. This case thus requires us to determine whether the Delaney Clause for color additives is subject to an implicit "de minimis" exception. We conclude, with some reluctance, that the Clause lacks such an exception.

In a second case argued the same day, No. 86-5150, Public Citizen and others challenged the FDA's persistence in giving "provisional" listing to ten color additives, including several found to cause cancer in laboratory animals. The agency has since removed most of the colors at issue from [1110] the provisional list, mooting the case as to these colors. At present, only three of the original colors, Red Nos. 3, 33 and 36, are still provisionally listed. Apart from those rendered moot, we find that these claims are either foreclosed by circuit law or unripe.

I. THE DELANEY CLAUSE AND "DE MINIMIS" EXCEPTIONS

A. Factual Background

The FDA listed Orange No. 17 and Red No. 19 for use in externally applied cosmetics on August 7, 1986. See 21 C.F.R. §§ 74.1267, 74.2267 (1987) (Orange No. 17); id. §§ 74.1319, 74.2319 (Red No. 19). In the listing notices, it carefully explained the testing processes for both dyes and praised the processes as "current state-of-the-art toxicological testing." 51 Fed.Reg. 28,331, 28,334 (Aug. 7, 1986) (Orange No. 17); id. at 28,346, 28,349 (Red No. 19). In both notices it specifically rejected industry arguments that the Delaney Clause did not apply because the tests were inappropriate for evaluation of the dyes. 51 Fed.Reg. at 28,342; id. at 28,358-59. It thus concluded that the studies established that the substances caused cancer in the test animals. Id. at 28,334-36, 28,341 (Orange No. 17 "induces cancer when tested in laboratory animals"); id. at 28,349-52, 28,357 (Red No. 19 "induces cancer when tested in laboratory animals").

The notices then went on to describe two quantitative risk assessments of the dyes, one by the Cosmetic, Toiletry and Fragrance Association ("CTFA," an intervenor here and the industry proponent of both dyes) and one by a special scientific review panel made up of Public Health Service scientists. Such assessments seek to define the extent of health effects of exposures to particular hazards. As described by the National Research Council, they generally involve four steps: (1) hazard identification, or the determination of whether a substance is causally linked to a health effect; (2) dose-response assessment, or determination of the relation between exposure levels and health effects; (3) exposure assessment, or determination of human exposure; and (4) risk characterization, or description of the nature and magnitude of the risk. See National Research Council, Risk Assessment in the Federal Government: Managing the Process 3 (National Academy Press 1983) ("Risk Assessment"). All agree that gaps exist in the available information and that the risk estimator must use assumptions to fill those gaps. See, e.g., Report of the Color Additive Scientific Review Panel (Sept. 1985), Joint Appendix ("J.A.") in No. 86-1548, at 139-40, 167. The choice among possible assumptions is inevitably a matter of policy to some degree. See Risk Assessment at 3.^[3]

The assessments considered the risk to humans from the substances when used in various cosmetics — lipsticks, face powders and rouges, hair cosmetics, nail products, bathwater products, and wash-off products. [1111] The scientific review panel found the lifetime cancer risks of the substances extremely small: for Orange No. 17, it calculated them as one in 19 billion at worst, and for Red No. 19 one in nine million at worst. The FDA explained that the panel had used conservative assumptions in deriving these figures, and it characterized the risks as "so trivial as to be effectively no risk." It concluded that the two dyes were safe. 51 Fed.Reg. at 28,344, 28,360.

The FDA candidly acknowledged that its safety findings represented a departure from past agency practice: "In the past, because the data and information show that D & C Orange No. 17 is a carcinogen when ingested by laboratory animals, FDA in all likelihood would have terminated the provisional listing and denied CTFA's petition for the externally applied uses ... without any further discussion." Id. at 28,341; accord id. at 28,357 (same for Red No. 19). It also acknowledged that "[a] strictly literal application of the Delaney Clause would prohibit FDA from finding [both dyes] safe, and therefore, prohibit FDA from permanently listing [them]...." Id. at 28,341; id. at 28,356. Because the risks presented by these dyes were so small, however, the agency declared that it had "inherent authority" under the de minimis doctrine to list them for use in spite of this language. Id. at 28,341; id. at 28,358. It indicated that as a general matter any risk lower than a one-in-one-million lifetime risk would meet the requirements for a de minimis exception to the Delaney Clause. Id. at 28,344; id. at 28,362.

Assuming that the quantitative risk assessments are accurate, as we do for these purposes, it seems altogether correct to characterize these risks as trivial. For example, CTFA notes that a consumer would run a one-in-a-million lifetime risk of cancer if he or she ate one peanut with the FDA-permitted level of aflatoxins once every 250 days (liver cancer). See J.A. 529, citing FDA Bureau of Foods, Assessment of Estimated Risk Resulting From Aflatoxins in Consumer Peanut Products and Other Food Commodities (1978). Another activity posing a one-in-a-million lifetime risk is spending 1,000 minutes (less than 17 hours) every year in the city of Denver — with its high elevation and cosmic radiation levels — rather than in the District of Columbia. See J.A. 530. Most of us would not regard these as high-risk activities. Those who indulge in them can hardly be thought of as living dangerously. Indeed, they are risks taken without a second thought by persons whose economic position allows them a broad range of choice.

According to the risk assessments here, the riskier dye poses one ninth as much risk as the peanut or Colorado hypothetical; the less risky one poses only one 19,000th as much.

It may help put the one-in-a-million lifetime risk in perspective to compare it with a concedely dangerous activity, in which millions nonetheless engage, cigarette smoking. Each one-in-a-million risk amounts to less than one 200,000th the lifetime risk incurred by the average male smoker. J.A. 536, citing E. Crouch & R. Wilson, "Inter-Risk Comparisons," in J. Rodricks & R. Tardiff, eds., Assessment and Management of Chemical Risks 97, 105, 108 (1984). Thus, a person would have to be exposed to more than 2,000 chemicals bearing the one-in-a-million lifetime risk, at the rates assumed in the risk assessment, in order to reach 100th the risk involved in smoking. To reach that level of risk with chemicals equivalent to the less risky dye (Orange No. 17), he would have to be exposed to more than 40 million such chemicals.

B. Plain Language and the de Minimis Doctrine

The Delaney Clause of the Color Additive Amendments provides as follows:

a color additive ... (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the [1112] Secretary to induce cancer in man or animal....^[4]

21 U.S.C. § 376(b)(5)(B).

The natural — almost inescapable — reading of this language is that if the Secretary finds the additive to "induce" cancer in animals, he must deny listing. Here, of course, the agency made precisely the finding that Orange No. 17 and Red No. 19 "induce[] cancer when tested in laboratory animals." (Below we address later agency pronouncements appearing to back away from these statements.)

The setting of the clause supports this strict reading. Adjacent to it is a section governing safety generally and directing the FDA to consider a variety of factors, including probable exposure, cumulative effects, and detection difficulties. 21 U.S.C. § 376(b)(5)(A). The contract in approach seems to us significant. For all safety hazards other than carcinogens, Congress made safety the issue, and authorized the agency to pursue a multifaceted inquiry in arriving at an evaluation. For carcinogens, however, it framed the issue in the simple form, "If A [finding that cancer is induced in man or animals], then B [no listing]." There is language inviting administrative discretion, but it relates only to the process leading to the finding of carcinogenicity: "appropriate" tests or "other relevant exposure," and the agency's "evaluation" of such data. Once the finding is made, the dye "shall be deemed unsafe, and shall not be listed." 21 U.S.C. § 367(b)(5)(B).

Courts (and agencies) are not, of course, helpless slaves to literalism. One escape hatch, invoked by the government and CTFA here, is the de minimis doctrine, shorthand for de minimis non curat lex ("the law does not concern itself with trifles"). The doctrine — articulated in recent times in a series of decisions by Judge Leventhal — serves a number of purposes. One is to spare agency resources for more important matters. See Alabama Power Co. v. Costle, 636 F.2d 323, 360 (D.C.Cir.1979). But that is a goal of dubious relevance here. The finding of trivial risk necessarily followed not only the elaborate animal testing, but also the quantitative risk assessment process itself; indeed, application of the doctrine required additional expenditure of agency resources.

More relevant is the concept that "notwithstanding the `plain meaning' of a statute, a court must look beyond the words to the purpose of the act where its literal terms lead to `absurd or futile results.'" Alabama Power, 636 F.2d at 360 n. 89 (quoting United States v. American Trucking Ass'ns, 310 U.S. 534, 543, 60 S.Ct. 1059, 1063, 84 L.Ed. 1345 (1939)). Imposition of pointless burdens on regulated entities is obviously to be avoided if possible, see Alabama Power, 636 F.2d at 360-61, especially as burdens on them almost invariably entail losses for their customers: here, obviously, loss of access to the colors made possible by a broad range of dyes.

We have employed the concept in construing the Clean Air Act's mandate to the Environmental Protection Agency to set standards providing "an ample margin of safety to protect the public health," 42 U.S.C. § 7412(b)(1) (1982). That does not, we said, require limits assuring a "riskfree" environment. Rather, the agency must decide "what risks are acceptable in the world in which we live" and set limits accordingly. See Natural Resources Defense Council, Inc. v. EPA, 824 F.2d 1146, 1164-65 (D.C.Cir.1987) (citing Industrial Union Dep't, AFL-CIO v. American Petroleum Inst., 448 U.S. 607, 642, 100 S.Ct. 2844, 2864, 65 L.Ed.2d 1010 (1980). Assuming as always the validity of the risk assessments, we believe that the risks posed by the two dyes would have to be characterized as "acceptable." Accordingly, if the statute were to permit a de minimis exception, this would appear to be a case for its application.^[5]

[1113] Moreover, failure to employ a de minimis doctrine may lead to regulation that not only is "absurd or futile" in some general cost-benefit sense but also is directly contrary to the primary legislative goal. See id. at 360 (de minimis doctrine a "tool to be used in implementing the legislative design"). In a certain sense, precisely that may be the effect here. The primary goal of the Act is human safety, but literal application of the Delaney Clause may in some instances increase risk. No one contends that the Color Additive Amendments impose a zero-risk standard for non-carcinogenic substances; if they did, the number of dyes passing muster might prove miniscule. As a result, makers of drugs and cosmetics who are barred from using a carcinogenic dye carrying a one-in-20-million lifetime risk may use instead a noncarcinogenic, but toxic, dye carrying, say, a one-in-10-million lifetime risk. The substitution appears to be a clear loss for safety.

Judge Leventhal articulated the standard for application of de minimis as virtually a presumption in its favor: "Unless Congress has been extraordinarily rigid, there is likely a basis for an implication of de minimis authority to provide [an] exemption when the burdens of regulation yield a gain of trivial or no value." Alabama Power, 636 F.2d at 360-61. But the doctrine obviously is not available to thwart a statutory command; it must be interpreted with a view to "implementing the legislative design." Id. at 360. Nor is an agency to apply it on a finding merely that regulatory costs exceed regulatory benefits. Id. at 361.

Here, we cannot find that exemption of exceedingly small (but measurable) risks tends to implement the legislative design of the color additive Delaney Clause. The language itself is rigid; the context — an alternative design admitting administrative discretion for all risks other than carcinogens — tends to confirm that rigidity. Below we consider first the legislative history; rather than offering any hint of softening, this only strengthens the inference. Second, we consider a number of factors that make Congress's apparent decision at least a comprehensible policy choice.

1. Legislative History

The Delaney Clause arose in the House bill and was, indeed, what principally distinguished the House from the Senate bill. The House included it in H.R. 7624, 106 Cong.Rec. 14,353-56, and the Senate accepted the language without debate, 106 Cong. Rec. 15,133 (1960). The House committee gave considerable attention to the degree of discretion permitted under the provision. The discussion points powerfully against any de minimis exception, and is not contradicted either by consideration on the House floor or by a post-enactment colloquy in the Senate.

House Committee. The House Report on the Color Additive Amendments is the most detailed evidence as to Congress's intentions on this issue. H.R.Rep. No. 1761, 86th Cong., 2d Sess. (1960), U.S.Code Cong. & Admin.News p. 2887 (hereinafter the "House Report"). In discussing the Clause, the report first explains the source of concern: "[T]oday cancer is second only to heart disease as a cause of death among the American people. Every year, approximately 250,000 people die of cancer in this country. Approximately 450,000 new cases of cancer are discovered each year." Id. at 11, U.S.Code Cong. & Admin.News 1960, p. 2893. The report reflects intense congressional concern over cancer risks from manmade substances.^[6]

The report acknowledged the "many unknowns about cancer," but highlighted certain areas of general agreement: "Laboratory experiments have shown that a number of substances when added to the diet of test animals have produced cancers of various kinds in the test animals. It is this fact — namely, that small quantities of certain materials over a period of time will cause abnormal cell growth in animals — that gave rise to the Delaney anticancer clause...." Id. The report quoted at [1114] length from the hearing testimony of Arthur S. Flemming, Secretary of Health, Education, and Welfare (the parent agency of the FDA and the predecessor of Health and Human Services). The Secretary took a very strong line on the absence of a basis for finding "threshold" levels below which carcinogens would not be dangerous:

We have no basis for asking Congress to give us discretion to establish a safe tolerance for a substance which definitely has been shown to produce cancer when added to the diet of test animals. We simply have no basis on which such discretion could be exercised because no one can tell us with any assurance at all how to establish a safe dose of any cancer-producing substance.

Id. at 13, U.S.Code Cong. & Admin.News 1960, p. 2894.^[7]

Secretary Flemming also developed the theme that, with many cancer risks inescapably present in the environment, it made sense to remove unnecessary ones:

Unless and until there is a sound scientific basis for the establishment of tolerances for carcinogens, I believe the Government has a duty to make clear — in law as well as in administrative policy — that it will do everything possible to put persons in a position where they will not unnecessarily be adding residues of carcinogens to their diet.

The population is inadvertently exposed to certain carcinogens.... In view of these facts, it becomes all the more imperative to protect the public from deliberate introduction of additional carcinogenic materials into the human environment.

. . . . .

It is clear that if we include in our diet substances that induce cancer when included in the diet of test animals, we are taking a risk. In light of the rising number of cases of cancer, why should we take that risk?

Id. at 12-13, U.S.Code Cong. & Admin.News 1960, p. 2894.

Before adopting Flemming's no-threshold premise the House committee heard many witnesses on the opposite side of the debate,^[8] and its Report acknowledges their contentions. Id. at 13 (witnesses stated that it was "possible to establish safe tolerance levels"). It also notes that some took the position that the ban should "apply only to colors that induce cancer when ingested in an amount and under conditions reasonably related to their intended use." [1115] Id.^[9] Similarly, it notes support for making carcinogenicity simply one of the factors for the Secretary to consider in determining safety. Id.^[10] Finally, it mentions a position taken by some scientific witnesses strikingly similar to that taken by FDA here. These experts suggested that, in spite of the difficulties in designing and evaluating tests for carcinogenicity, the Secretary "should have the authority to decide that a minute amount of a cancer-producing chemical may be added to man's food after a group of scientists consider all the facts and conclude that the quantity to be tolerated is probably without hazard." Id. at 13-14, U.S.Code Cong. & Admin.News 1960, p. 2895.^[11]

The committee rejected all these positions on the grounds that they would "weaken the present anticancer clause." Id. at 13. The report responded to them with another quote from Secretary Flemming's hearing testimony, reflecting the view that agency discretion should cease once "a substance has been shown to produce cancer when added to the diet of test animals":

The rallying point against the anticancer provision is the catch phrase that it takes away the scientists's [sic] right to exercise judgment. The issue thus made is a false one, because the clause allows the exercise of all the judgment that can safely be exercised on the basis of our present knowledge.... It allows the Department and its scientific people full discretion and judgment in deciding whether a substance has been shown to produce cancer when added to the diet of test animals. But once this decision is made, the limits of judgment have been reached and there is no reliable basis on which discretion could be exercised in determining a safe threshold dose for the established carcinogen.

Id. at 14, U.S.Code Cong. & Admin.News 1960, pp. 2895-96.

Beyond this delineation of the intended scope of discretion, the House Report also addressed the possibility that its scientific premise — the absence of a threshold — might prove false. Its evident solution was that Congress, not the FDA, should examine the evidence and find a solution. The House Report at 12, U.S.Code Cong. & Admin.News 1960, p. 2894 quotes Secretary Flemming to precisely this effect:

Whenever a sound scientific basis is developed for the establishment of tolerances for carcinogens, we will request the Congress to give us that authority. We believe, however, that the issue is so important that the elected representatives of the people should have the opportunity of examining the evidence and determining whether or not the authority should be granted.

See also Color Additives Hearings at 34 (administration statement that "if additional scientific evidence indicates that further [1116] relaxation of the Delaney amendment is desirable, it will of course be proposed").

The government and CFTA note that exempting substances shown by quantitative risk assessment to carry only trivial risks rests on a quite different foundation from establishing threshold levels below which no cancer is thought to occur. We agree that the two are distinguishable, but do not find the distinctions between them to cut in favor of a de minimis exception. If it is correct to read the statute as barring tolerances based on an assumed threshold, it follows a fortiori that the agency must ban color additives with real but negligible cancer risks.

House floor. In the House debate, little of substance occurred. Congressman Delaney contended that the anticancer provision was essential "if the public health is to be adequately protected," 106 Cong. Rec. at 14,350, and asserted in conclusory terms the inability to establish a safe dose or tolerance, id. Congressman Rogers, describing the anticancer clause (which he supported), observed that "[t]he `safe for use' principle does not apply to situations where carcinogenicity is at issue." Id. at 14,371. One participant, Congressman Allen, expressed the view that the anticancer clause was "unnecessary and restrictive," and that the "decision on safety [should] be determined by the Secretary of Health, Education and Welfare rather than ... determined by law." Id. at 14,351. Accordingly, he urged passage of the Senate bill instead. Although Congressman Allen's view of the bill was negative, his interpretation seems to accord with that of its proponents: a ban follows automatically from a finding of carcinogenicity in man or animal.

Post-enactment Senate colloquy. The inferences of rigidity supported by the above remarks are drawn slightly in question — but ultimately, we think, not much — by an exchange that occurred the day after the Senate took final action on the final version of the Act. Senator Javits politely complained about the Senate's acting on this legislation in his absence. He secured unanimous consent for including in the Record the conclusions of a then-recent Report of the Panel on Food Additives of the President's Advisory Committee (the "Kistiakowsky Report"). He characterized the Report as stating that "authority such as that conferred by the amendment [the Report was addressed to the food additive Delaney Clause] should be used and applied within the `rule of reason.'" 106 Cong. Rec. at 15,381. After Senators Dirksen and Hill assented to this proposition, Javits agreed to lay on the table a motion to reconsider the vote of the previous day. Id.

Appellees interpret the rule-of-reason colloquy as squarely supporting their de minimis approach, but in fact it is ambiguous. The Kistiakowsky Report defined "rule of reason" by a quotation from Rathbun v. United States, 355 U.S. 107, 109, 78 S.Ct. 161, 162, 2 L.Ed.2d 134 (1957): "Every statute must be interpreted in the light of reason and common understanding to reach the results intended by the legislature." The proposition accords exactly with the way in which Judge Leventhal formulated the test for application of the de minimis doctrine: would the doctrine "implement[] the legislative design"? Alabama Power, 636 F.2d at 360. But that is the question, not the answer. Thus the exchange invoking the rule of reason appears to do no more than exhort us to pursue the inquiry we've been pursuing.

Indeed, although the Kistiakowsky Report itself points out some possible consequences of "a literal interpretation" of the food additive Delaney Clause, see Color Additives Hearings at 396-97, and states that in its interpretation the FDA "must employ the `rule of reason'" as defined in Rathbun, id. at 398, it also acknowledges that clause may prevent the agency from "exercis[ing] discretion consistent with the recommendations of this report," id. Thus a commitment to the "rule of reason" in this context hardly carries an inexorable implication that the color additive Delaney Clause grants the FDA the discretion it now claims.

Taken as a whole, the remarks do not seem strong enough to undermine the inference [1117] we have drawn that the clause was to operate automatically once the FDA squeezed the scientific trigger. This is so even without regard to the usual hazards of post-enactment legislative history, which ordinarily lead to its being disregarded altogether. See Regional Rail Reorganization Act Cases, 419 U.S. 102, 132, 95 S.Ct. 335, 352, 42 L.Ed.2d 320 (1974) ("post-passage remarks of legislators, however explicit, cannot serve to change the legislative intent of Congress expressed before the Act's passage").

2. Possible Explanations for an Absolute Rule

Like all legislative history, this is hardly conclusive. But short of an explicit declaration in the statute barring use of a de minimis exception, this is perhaps as strong as it is likely to get. Facing the explicit claim that the Clause was "extraordinarily rigid," a claim well supported by the Clause's language in contrast with the bill's grants of discretion elsewhere, Congress persevered.

Moreover, our reading of the legislative history suggests some possible explanations for Congress's apparent rigidity. One is that Congress, and the nation in general (at least as perceived by Congress), appear to have been truly alarmed about the risks of cancer. House Report at 11; Color Additive Hearings at 327 (statement of Rep. Oren Harris, Chairman); id. at 491 (statement of Dr. Zavon) (Delaney Clause "tends to highlight the current hysteria regarding cancer"). This concern resulted in a close focus on substances increasing cancer threats and a willingness to take extreme steps to lessen even small risks.^[12] Congress hoped to reduce the incidence of cancer by banning carcinogenic dyes, and may also have hoped to lessen public fears by demonstrating strong resolve.^[13]

A second possible explanation for Congress's failure to authorize greater administrative discretion is that it perceived color additives as lacking any great value. For example, Congressman Delaney remarked, "Some food additives serve a useful purpose.... However, color additives provide no nutrient value. They have no value at all, except so-called eye appeal." Color Additives Hearings at 108. Representative Sullivan said, "we like the bright and light [lipstick] shades but if they cannot safely be produced, then we prefer to do without these particular shades." Id. at 114. And Representative King: "The colors which go into our foods and cosmetics are in no way essential to the public interest or the national security.... [C]onsumers will easily get along without [carcinogenic colors]." Id. at 246-47.

It is true that the legislation as a whole implicitly recognizes that color additives are of value, since one of its purposes was to allow tolerances for certain dyes — harmful but not carcinogenic — that would have been banned under the former law. See House Report at 8-9; S.Rep. No. 795, 86th Cong., 1st Sess. 1-2 (1959). There was also testimony pointing out that in some uses color additives advance health: they can help identify medications and prevent misapplications where a patient must take several. See Color Additives Hearings at 255 (statement of representative of Pharmaceutical Manufacturers Association). Nevertheless, there is evidence that Congress thought the public could get along without carcinogenic colors, especially in view of the existence of safer substitutes. Thus the legislators may have estimated the costs of an overly protective rule as trivial.

So far as we can determine, no one drew the legislators' attention to the way in which the Delaney Clause, interacting with the flexible standard for determining safety [1118] of non-carcinogens, might cause manufacturers to substitute more dangerous toxic chemicals for less dangerous carcinogens. See discussion at [10] supra. But the obviously more stringent standard for carcinogens may rest on a view that cancer deaths are in some way more to be feared than others.

Finally, as we have already noted, the House committee (or its amanuenses) considered the possibility that its no-threshold assumption might prove false and contemplated a solution: renewed consideration by Congress.

Considering these circumstances — great concern over a specific health risk, the apparently low cost of protection, and the possibility of remedying any mistakes — Congress's enactment of an absolute rule seems less surprising.

C. Special Arguments for Application of de Minimis

Apart from their contentions on legislative history, the FDA and CTFA assert two grounds for a de minimis exception: an analysis of two cases applying de minimis concepts in the food and drug regulation context, and contentions that, because of scientific advances since enactment, the disallowance of de minimis authority would have preposterous results in related areas of food and drug law. (We treat an argument based on a new interpretation of the statutory language separately in section I-D.) We are, ultimately, not persuaded.

1. De minimis cases

Monsanto Co. v. Kennedy, 613 F.2d 947 (D.C.Cir.1979) (Leventhal, J.), considered whether acrylonitrile in beverage containers was a "food additive" within the meaning of the Food, Drug and Cosmetic Act's definition of that term:

any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food ... if such substance is not generally recognized ... to be safe under the conditions of its intended use ...

Section 201(s), Food, Drug and Cosmetic Act, 21 U.S.C. § 321(s) (1982).

By operation of the second law of thermodynamics, any substance, obviously including acrylonitrile, will migrate in minute amounts from a bottle into a beverage within the bottle. Questions had been raised about its safety. The court found the FDA's decision to ban its use insufficiently well considered. In remanding the case for reconsideration, the court emphasized the FDA Commissioner's discretion to exclude a chemical from the statutory definition of food additives if "the level of migration into food ... is so negligible as to present no public health or safety concerns." Id. at 955.

The opinion makes no suggestion that anyone supposed acrylonitrile to be carcinogenic, or that the Delaney Clause governing food additives, 21 U.S.C. § 348(c)(3)(A), was in any way implicated. Thus the case cannot support a view that the food additive Delaney Clause (or, obviously, the color additive one) admits of a de minimis exception.^[14]

Scott v. Food and Drug Administration, 728 F.2d 322 (6th Cir.1984) (per curiam), involves the color additive Delaney Clause, but is nonetheless distinguishable. Petitioner challenged the FDA's listing of Green No. 5, on the grounds that it contained a chemical impurity in minute quantities that had been found to cause cancer in test animals. The dye as a whole, however, had been found not to induce cancer in test animals. See 47 Fed.Reg. 49,628, 49,629 (1984). The Sixth Circuit upheld the FDA's decision that the Delaney Clause of the Color Additive Amendments did not apply. The court cited Monsanto in support of upholding the FDA's view that it had discretion "to find that low-level migration into food of substances in indirect additives is so insignificant as to present no [1119] public health or safety concerns." Id. at 325 (quoting the FDA's statement of its own discretion) (emphasis added).

We must evaluate Scott in light of the possibility that the carcinogenic impurity in question acted as an "initiating agent" or was a "complete carcinogen," see note 6 supra, and, accordingly, would be subject to no threshold. If so, it would seem that if the impurity itself were carcinogenic, so would be any substance to which it was added.

Application of a de minimis exception for constituents of a color additive, however, seems to us materially different from use of such a doctrine for the color additive itself. As the Scott court noted, the FDA's action was completely consistent with the plain language of the statute, as there was no finding that the dye caused cancer in animals. 728 F.2d at 325. Here, as we have observed, application of a de minimis exception requires putting a gloss on the statute qualifying its literal terms.

Monsanto and Scott demonstrate that the de minimis doctrine is alive and well in the food and drug context, even on the periphery of the Delaney Clauses. But no case has applied it to limit the apparent meaning of any of those Clauses in their core operation.

2. Scientific Advance and the Implications for Food Additive Regulation

The CTFA also argues that in a number of respects scientific advance has rendered obsolete any inference of congressional insistence on rigidity. CTFA notes that while in 1958 (date of enactment of the food additive Delaney Clause) there were only four known human carcinogens, by 1978 there were 37 substances known to produce cancer in humans and over 500 in animals. They identify an impressive array of food ingredients now found to be animal carcinogens and that appear in a large number of food products. These include many items normally viewed as essential ingredients in a healthy diet, such as vitamins C and D, calcium, protein, and amino acids. If the color additive Delaney Clause has no de minimis exception, it follows (they suggest) that the food additive one must be equally rigid. The upshot would be to deny the American people access to a healthy food supply.

As a historical matter, the argument is overdrawn: the House committee was clearly on notice that certain common foods and nutrients were suspected carcinogens.^[15]

Beyond that, it is not clear that an interpretation of the food additive Delaney Clause identical with our interpretation of the color additive clause would entail the feared consequences. The food additive definition contains an exception for substances "generally recognized" as safe (known as the "GRAS" exception),^[16] an exception that has no parallel in the color additive definition, 21 U.S.C. § 321(t)(1). That definition may permit a de minimis [1120] exception at a stage that logically precedes the FDA's ever reaching the food additive Delaney Clause. Indeed, Monsanto so holds — though, as we have noted, in a case not trenching upon the food additive Delaney Clause. Moreover, the GRAS exception itself builds in special protection for substances used in food prior to January 1, 1958, which may be shown to be safe "through either scientific procedures or experience based on common use in food." Indeed, the Kistiakowsky Report, filed with the House committee, stated that the grandfathering provision of the food additives Delaney Clause "considerably narrows [its] effect ... on industry and the public." See Color Additives Hearings at 395.

The relationship of the GRAS exception and the food additive Delaney Clause clearly poses a problem: if the food additive definition allows the FDA to classify as GRAS substances carrying trivial risks (as Monsanto and our recent decision in Natural Resources Defense Council v. EPA seem to suggest), but the food additive Delaney Clause is absolute, then Congress has adopted inconsistent provisions. Cf. Color Additives Hearings at 313 (representative of Pharmaceutical Manufacturers Association testifies that Secretary Flemming will propose legislation to delete the grandfathering provision from the food additives definition because of inconsistency with the food additives Delaney Clause). On the other hand, if (1) the GRAS exception does not encompass substances with trivial carcinogenic effect (especially if its special provision for substances used before 1958 does not do so for long-established substances), and (2) the food additive Delaney Clause is as rigid as we find the color additive clause to be, conceivably the consequences identified by the CTFA, or some of them, may follow. All these are difficult questions, but they are neither before us nor is their answer foreordained by our decision here.

Moreover, we deal here only with the color additive Delaney Clause, not the one for food additives. Although the clauses have almost identical wording, the context is clearly different. Without having canvassed the legislative history of the food additive Delaney Clause, we may safely say that its proponents could not have regarded as trivial the social cost of banning those parts of the American diet that CTFA argues are at risk.

Finally, even a court decision construing the food additive provisions to require a ban on dietary essentials would not, in fact, bring about such a ban. As Secretary Flemming noted, in words selected by the House Report for quotation, the FDA could bring critical new discoveries to Congress's attention. If the present law would lead to the consequences predicted, we suppose that the FDA would do so, and that Congress would respond.

D. The Meaning of "[I]nduce Cancer"

After Public Citizen initiated the litigation in No. 86-5150, the FDA published a notice embellishing the preamble to its initial safety determinations. 52 Fed.Reg. at 5081 (Orange No. 17); id. at 5083 (Red No. 19). These notices effectively apply quantitative risk assessment at the stage of determining whether a substance "induce[s] cancer in man or animal." They assert that even where a substance does cause cancer in animals in the conventional sense of the term, the FDA may find that it does not "induce cancer in man or animal" within the meaning of 21 U.S.C. § 376(b)(5)(B). It is not crystal clear whether such a negative finding would flow simply from a quantitative risk assessment finding the risk to be trivial for humans under conditions of intended use, or whether it would require a projection back to the laboratory animals: i.e., an assessment that the risk would be trivial for animals exposed to the substance in quantities proportional to the exposure hypothesized for human risk assessment purposes. (Perhaps the distinction is without a difference.) In any event, the notices argued:

The words "induce cancer in man or animal" as used in the Delaney Clause are terms of art intended to convey a regulatory judgment that is something more than a scientific observation that an additive is carcinogenic in laboratory animals. [1121] To limit this judgment to such a simple observation would be to arbitrarily exclude from FDA's consideration developing sophisticated testing and analytical methodologies, leaving FDA with only the most primitive techniques for its use in this important endeavor to protect public health. Certainly the language of the Delaney Clause itself cannot be read to mandate such a counterproductive limit on FDA's discharge of its responsibilities.

Id. at 5082; id. at 5084.

The notices acknowledged that the words "to induce cancer" had not been "rigorously and unambiguously" so limited in the previous notices. Id. at 5082; id. at 5084. This is a considerable understatement. The original determinations were quite unambiguous in concluding that the colors induced cancer in animals in valid tests; the explanations went to some trouble to rebut industry arguments to the contrary. Despite these arguments, FDA concluded that the tests demonstrated that the dyes were responsible for increases in animal tumors.

The plain language of the Delaney Clause covers all animals exposed to color additives, including laboratory animals exposed to high doses. It would be surprising if it did not. High-dose exposures are standard testing procedure, today just as in 1960; such high doses are justified to offset practical limitations on such tests: compared to expected exposure of millions of humans over long periods, the time periods are short and the animals few.^[17] Many references in the legislative history reflect awareness of reliance on animal testing,^[18] and at least the more sophisticated participants must have been aware that this meant high-dose testing. A few so specified.^[19]

All this indicates to us that Congress did not intend the FDA to be able to take a finding that a substance causes only trivial risk in humans and work back from that to a finding that the substance does not "induce cancer in ... animals." This is simply the basic question — is the operation of the clause automatic once the FDA makes a finding of carcinogenicity in animals? — in a new guise. The only new argument offered in the notices is that, without the new [1122] interpretation, only "primitive techniques" could be used. In fact, of course, the agency is clearly free to incorporate the latest breakthroughs in animal testing; indeed, here it touted the most recent animal tests as "state of the art." The limitation on techniques is only that the agency may not, once a color additive is found to induce cancer in test animals in the conventional sense of the term, undercut the statutory consequence. As we find the FDA's construction "contrary to clear congressional intent," Chevron U.S.A. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843 n. 9, 104 S.Ct. 2778, 2781 n. 9, 81 L.Ed.2d 694 (1984), we need not defer to it.

* * *

In sum, we hold that the Delaney Clause of the Color Additive Amendments does not contain an implicit de minimis exception for carcinogenic dyes with trivial risks to humans. We based this decision on our understanding that Congress adopted an "extraordinarily rigid" position, denying the FDA authority to list a dye once it found it to "induce cancer in ... animals" in the conventional sense of the term. We believe that, in the color additive context, Congress intended that if this rule produced unexpected or undesirable consequences, the agency should come to it for relief. That moment may well have arrived, but we cannot provide the desired escape.

II. PROVISIONAL LISTING

The regulatory scheme of the Color Additive Amendments included grandfathering provisions for commercially established color additives. Pub.L. 86-618, tit. II, § 203, 74 Stat. 404 (uncodified provisions appearing at 21 U.S.C. § 376 note (1982)). These allowed provisional listing of established dyes pending testing for a two-and-a-half year period. They empowered the Secretary to extend the listing

"for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive...."

Id. § 203(a)(2).

The process of completing these scientific investigations is only now being completed. When the litigation in No. 86-5150 began, ten color additives were on the provisional list. Public Citizen v. Department of Health and Human Services, No. 85-1573 (D.D.C. Feb. 13, 1986). Today, only three — Red No. 3, Red No. 33, and Red No. 36 — remain.

Public Citizen petitioned for a ban on the provisionally listed colors; when the petition was denied, it sued in the court below. The court granted summary judgment for the FDA (and other appellees supporting provisional listing).

In McIlwain v. Hayes, 690 F.2d 1041 (D.C.Cir.1982), this court set forth the guidelines governing challenges to the speediness of the Secretary's evaluations of provisionally listed dyes. The McIlwain court determined that agency discretion to postpone the expiration of provisional listings was limited only as follows: "Such postponements must be consistent with the public health, and the Commissioner must judge that the scientific investigations are going forward in good faith and will be completed as soon as reasonably practicable." Id. at 1047. The majority acknowledged that it was doubtful that Congress foresaw the advances in testing technology that occasioned the delays, but saw no reason to depart from the statute's plain language. Id.

McIlwain controls here. The FDA has found that the postponements for further evaluation of Red No. 3, Red No. 33, and Red No. 36 are consistent with the public health, that evaluations are going forward in good faith, and that they will be completed as soon as reasonably practicable. The agency carefully explained in its Federal Register notices and response to the rulemaking petition that extra time was needed for review of completed tests and in some cases the conduct of additional tests; a special scientific review panel was involved [1123] in this, and on completion of its work the agency would have to review its report. See 50 Fed.Reg. 35,783-84, 35,786-89 (1985); 51 Fed.Reg. 31,323 (1986) (extension for Red No. 3 until Nov. 3, 1986); J.A. in No. 86-5150 at 387-421 (FDA Commissioner's response to Public Citizen's petition requesting ban). Announcing its most recent extension of Red No. 3, the agency explained that more time was needed "[b]ecause of the complexity of the scientific issues being considered." 51 Fed.Reg. at 39,856 (extension until Nov. 3, 1987). The most recent extensions for Red No. 33 and Red No. 36 announced that these reviews were essentially complete and the agency intended to list these dyes permanently, but that further time was necessary for the agency to prepare adequate explanations of its decisions. 52 Fed.Reg. 33,573 (1987) (extending provisional status until November 3, 1987); see also id. at 15,945 (extension for same dyes until July 6, 1987), id. at 6,323 (extension until May 4, 1987). Although McIlwain dealt specifically with delays caused by the need for further testing, its logic applies with equal force where further evaluation of completed tests is required. To the extent that Public Citizen's complaint rests on the length of time already taken and anticipated for review of these dyes, it is foreclosed by McIlwain.^[20] Public Citizen's allegations of bad faith were not properly raised below, and in any event amount to no more than speculation.

Public Citizen also argues that provisional listing is permissible only when permanent listing is a reasonable possibility — an outcome precluded under this opinion if the outcome from the animal studies is positive. But this has not yet happened and may never happen. Neither Red No. 33 nor Red No. 36 has been found to induce cancer in humans or animals.

The situation is slightly less clear with regard to Red No. 3. The Commissioner explained, in denying Public Citizen's petition, that further evaluation was necessary to determine whether a carcinogenic effect observed in animal testing was caused by a secondary mechanism. J.A. in No. 86-5150, at 407-10. There was, to be sure, evidence linking a statistically significant increase in tumors to the dye, but the chain of causation has yet to be established. There was a possibility, the Commission explained, that the dye might have effected the rats' thyroid glands, with that effect in turn causing the tumors. Id. If this were established, then a no-effect level in rats might be established. Id.; see also 50 Fed.Reg. at 35,786-87. Until the agency arrives at a final decision as to this question, the question of the Delaney Clause's application is not ripe. We therefore express no opinion as to the applicability of the provision in this secondary-effect situation, and decline to disturb the judgment of the District Court.

CONCLUSION

In sum, we hold that the agency's de minimis interpretation of the Delaney Clause of the Color Additive Amendments is contrary to law. The listing decisions for Orange No. 17 and Red No. 19 based on that interpretation must therefore be corrected. As for the colors still on the provisional list, we affirm the judgment of the court below in No. 85-5150, in view of McIlwain and the lack of a finding of carcinogenicity in the dyes at issue.

So ordered.

[1] Of the United States District Court for the District of Columbia, sitting by designation pursuant to 28 U.S.C. § 292(a).

[2] The other clauses relate to food additives, 21 U.S.C. § 348(c)(3)(A), and to animal drugs, id. § 306b(d)(1)(H). All clauses prohibit carcinogens. The clauses differ slightly in language, more materially in statutory context and legislative history.

[3] Agencies have used quantitative risk assessments in a variety of regulatory contexts. For example, the Occupational Safety and Health Administration is under a mandate to establish standards "reasonably necessary or appropriate to provide safe or healthful ... places of employment," 29 U.S.C. § 652(8) (1982), which was construed in Industrial Union Dep't v. American Petroleum Institute, 448 U.S. 607, 639-40, 100 S.Ct. 2844, 2862-63, 65 L.Ed.2d 1010 (1980), to call for promulgation of standards only where appropriate to remedy a "significant risk of material health impairment." In fulfillment of this mandate, OSHA used quantitative risk assessment in promulgating a rule on exposure limits to airborne inorganic arsenic. 48 Fed.Reg. 1864 (1983). See also Environmental Protection Agency, "Guidelines for Carcinogen Risk Assessment," 51 Fed.Reg. 33,992 (1986). The FDA itself has used the technique in evaluating safety where the Delaney Clause did not apply. See 47 Fed.Reg. 14,138 (1982) (Green No. 6). See also Cooper, Stretching Delaney Till It Breaks, Regulation 11 (Nov./Dec. 1985) (describing FDA's increasing confidence in quantitative risk assessment); Nichols and Zeckhauser, The Perils of Prudence: How Conservative Risk Assessments Distort Regulation, Regulation 13 (Nov./Dec. 1986) ("Quantitative risk assessment is an increasingly important tool in regulatory decisions involving health and safety."). FDA has also used the technique in the face of the Delaney Clause in approving a carcinogenic food additive, methylene chloride. 50 Fed. Reg. 51,551 (1985). A challenge to the methylene chloride determination is currently pending before this court. Public Citizen v. Bowen, No. 86-1494.

[4] This quotation omits subsection (i), which concerns uses involving ingestion; none of the uses here at issue concerns such a use.

[5] We do not, of course, purport to decide the appropriate dividing point between de minimis and other risks. FDA's proposed one-in-one-million dividing point has been used by EPA to distinguish acceptable and unacceptable risks. 49 Fed.Reg. 46,294 (1984) (general guidelines); 51 Fed.Reg. 1602, 1635 (1986) (hazardous wastes). FDA has used the same break point to determine whether the general safety clause of the Act applies. 47 Fed.Reg. 14,138 (1982).

[6] For other indicia of congressional anxiety, see infra p. 1117 and nn. 11-12.

[7] In fact the existence of a threshold for chemical carcinogens, below which their use would have no ill effect, appears to depend on whether one is speaking of an "initiating" agent, a "promoting" agent, or a "complete carcinogen." (The latter both initiates and promotes.) Both activities are necessary for the production of tumors. Both the theory of the operation of initiating agents and the empirical data support the belief that for them no threshold applies. Equally, the theory and data as to promoting agents support the view that there is a "no-effect" threshold level. See H. Pitot, "Principles of Cancer Biology: Chemical Carcinogenesis," 1 Cancer: Principles and Practice of Oncology 79-99 (V. DeVita, S. Hellman, & S. Rosenberg, 2d eds. 1985).

[8] See Color Additives: Hearings Before the House Comm. on Interstate and Foreign Commerce, 86th Cong., 2d Sess. 115-18 (1960) [hereinafter Color Additives Hearings] (testimony of representative of the Toilet Goods Association) (arguing that risk from ingestion of lipstick colors did not justify absolute prohibition and proposing amendment specifying that tests should be "appropriate" to proposed uses of additive for which listing was sought); id. at 224 (paper submitted by Edward J. Matson of Abbott Laboratories) ("One thing already accepted by most experts in the field is that there truly is a threshold dose of a carcinogen, below which cancer is not produced in animals ... [W]e cannot yet predict the threshold dose in man from knowledge of the threshold dose in experimental animals."); id. at 237-38 (representative of Manufacturing Chemists Association) ("there is lack of agreement among scientists as to whether a safe level can be set for all carcinogens"); id. at 260-61 (statement of representative of Pharmaceutical Manufacturers) ("when you consider conditions reasonably related to the intended use, I understand there is adequate scientific knowledge as to whether [an additive] could be used safely or not"); id. at 318 (representative of Pharmaceutical Manufacturers Association) (arguing that "as a practical matter, no-effect levels of carcinogens must be recognized" because "[w]e cannot dispense with the many common foods which are implicated in carcinogenicity").

[9] For testimony advocating such a position, see Color Additives Hearings at 118, 224, 313; see also id. at 396 (Report of the Panel on Food Additives of the President's Scientific Advisory Committee) [hereinafter "Kistiakowsky Report"] ("dietary levels of carcinogenic agents exist at which the probability of cancer induction in animals is near zero").

[10] Several industry representatives and other experts testified that the Delaney Clause was too inflexible as written and should be modified to permit greater administrative discretion. See Color Additives Hearings at 140-42 (testimony of representative of the Certified Color Industry Committee) (characterizing the provision as "an unwise, absolute rigid standard" and as lacking "any flexibility for future action" and proposing language to make carcinogenicity one of the factors considered in the general safety determination); id. at 237-38 (representative of Manufacturing Chemists Association) (arguing that requiring "the Secretary to return to Congress when a scientific breakthrough occurs injects inflexibility...." and anticipating problems such inflexibility could cause); id. at 266 (vice president of Eli Lilly & Co.) ("The main objection to the Delaney amendment is its rigidity."); cf. id. at 397 (Kistiakowsky Report states that "the panel believes that the probability of cancer induction from a particular carcinogen in minute doses may be eventually assessed by weighing scientific evidence as it becomes available").

[11] See Color Additives Hearings at 429 (statement of Dr. Charles J. Kensler); see also id. at 468 (statement of Dr. William J. Darby) (favoring omission of Delaney Clause as long as there is "a law providing this adequate protection combined with ample provision for scientific review and judgment, plus publication of the basis of decisions").

[12] See Color Additives Hearings at 341 (testimony of representative of Consumers Union) ("we are faced with an epidemic, an epidemic of cancer, a chronic disease, and ... all measures that will protect the public health should be taken, even at the cost of discomfort or sacrifice, financial sacrifice, to some segments of industry.").

[13] Color Additive Hearings at 327 (statement of Rep. Harris) (noting that "almost everyone[] is so conscious of cancer as a dread disease" and hypothesizing that throwing out the Delaney Clause "would create so much fear in the mind of the American people" that they might react against industry).

[14] As we note below, the operation of the food additive Delaney Clause raises complex issues distinct from those of this appeal.

[15] See Color Additives Hearings at 270 (statement of vice-president of Eli Lilly) (noting substances implicated in carcinogenicity in animals, including coffee, tea, milk, cream, cocoa, claret, caffeine, whiskey, sulfonamides, fat, cholesterol, vitamins, eggs, sugars, and others); id. at 318, 328 (testimony of Representative of Pharmaceutical Manufacturers' Association) ("so many of our common foods do contain carcinogens"); id. at 337-38 (testimony of representative of Consumers' Union) ("the fact that weak carcinogens are present in natural foods is no justification" for tolerances for carcinogenic additives); id. at 342 (statement of Rep. Nelson) ("we have been told that, for example, hens' eggs, milk, beef, soybeans, corn, lettuce alfalfa, have certain factors in them that create cancer"); id. at 397 (Kistiakowsky Report) ("In foodstuffs, as they occur in nature, one finds traces of chemicals which in larger amounts are generally accepted as carcinogenic...."); id. at 427 (Rep. Flynt) (asking witness whether it was "substantially true that nearly every element of food known at the present time if either injected or ingested in large quantities is capable of producing cancer first or toxicity secondly?").

[16] The pertinent part of 21 U.S.C. § 321(s) excepts a substance

generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use....

[17] See, e.g., Office of Science and Technology Policy, "Chemical Carcinogens; Review of the Science and Its Associated Principles," 49 Fed.Reg. 21,594, 21,598 (1984) ("It is appropriate to use test doses that generally exceed human exposure levels in order to overcome the inherent insensitivity of the traditional design of the long-term animal test.").

[18] See House Report at 11 (explaining the Delaney Clause's foundation in experiments showing that "a number of substances when added to the diet of test animals have produced cancers of various kinds in the test animals"); Color Additives Hearings at 46-47, 50-55 (summary of National Cancer Institute study describing animal testing techniques and describing uncertainties in predicting human responses from animal tests); id. at 74 (testimony of Secretary of HEW Flemming) ("anticancer clause constitutes sound public policy in view of the fact that no one knows how much or how little of a substance will induce cancer when added to the diet of man if it has been demonstrated that it will induce cancer when added to the diet of a test animal"); id. at 396 (Kistiakowsky Report) ("Definition of induced cancer in animals.... The criteria for defining whether or not a `cancer' has been induced in experimental animals are varied."); id. at 424 (remark of Rep. Dingell); id. at 514 (testimony of Sec. Flemming) ("where those tests show that a substance will induce cancer when included in the diet of a test animal, ... it will be banned."); 106 Cong. Rec. 14,350 (1960) (remarks of Rep. Delaney) ("a number of these dyes have been shown to induce cancer in experimental animals, and are strongly suspected as being able to induce cancer in man."); id at 14,372 (remarks of Rep. Rogers) ("the point was made by scientific experts that many substances when administered to laboratory animals in certain quantities and under certain conditions are capable of inducing cancer.").

[19] See 106 Cong.Rec. 14,372 (remarks of Rep. Kyl) (expressing reservations about Delaney Clause and stating "[t]he prohibition is based on the assumption that a substance which increases the incidence of cancer when included in the diet of animals at any dose may increase the incidence of cancer in man."); Color Additive Hearings at 396 (Kistiakowsky Report) (notes that food additive Delaney Clause prohibition "is based on the assumption that a substance which increases the incidence of cancer when included in the diet of animals at any dose level may increase the incidence of cancer when included in the diet of man even when present in amounts detectable only by the most sensitive analytical techniques.").

[20] We also find Public Citizen's claim that action on Red No. 3 has been "unreasonably delayed" under 5 U.S.C. § 706(1) to be without merit. Unreasonable delay must be determined in the statutory context. Public Citizen Health Research v. Commissioner, Food & Drug Administration, 740 F.2d 21, 35 (D.C.Cir.1984). As McIlwain suggested, the statutory scheme for grandfathering color additives allows the time necessary for careful testing and also for careful review of data.

613 F.2d 947 (1979)

[948] [949] [950] John H. Pickering, Washington, D. C., with whom Jerome H. Heckman, William T. Lake and Michael S. Schooler, Washington, D. C., were on the brief, for petitioner in No. 77-2023.

Joel E. Hoffman, Washington, D. C., with whom Gloria Phraes Stewart, Washington, D. C., was on the brief, for petitioner in No. 77-2032.

Edward B. Williams, Washington, D. C., with whom John F. Jones, Cleveland, Ohio, George Meader and Daniel S. Orci, Jr., Washington, D. C., were on the brief, for petitioner in No. 77-2026.

Jerome H. Heckman, Washington, D. C., with whom John B. Dubeck and John S. Eldred, Washington, D. C., were on the brief, for petitioner in No. 77-2024.

Richard M. Cooper, Chief Counsel, Food and Drug Administration, Rockville, Md., with whom Charles R. McConachie, J. Patrick Glynn, Attys., Dept. of Justice, and Thomas Scarlett, Attys., Food and Drug Administration, Washington, D. C., were on the brief, for respondents.

Marcia J. Cleveland, New York City, was on the brief, for amicus curiae, Natural Resources Defense Council, Inc. urging affirmance.

Eugene I. Lambert, Allan J. Topol and Richard F. Kingham, Washington, D. C., were on the brief, for amicus curiae, American Can Co. et al., urging that the Commission's order to be set aside with directions to reinstate the regulations.

Malcolm D. MacArthur, Washington, D. C., was on the brief, for amicus curiae, National Flexible Packaging Ass'n urging Commissioner's order to be vacated and set aside.

Ronald A. Zumbrun, Robert K. Best, Raymond M. Momboisse, Sacramento, Cal., Albert Ferri, Jr. and Donald C. Simpson were on the brief, for Amicus Curiae, Pacific Legal Foundation, Washington, D.C., urging the order be reversed and vacated.

Before BAZELON, Senior Circuit Judge, and LEVENTHAL and ROBINSON, Circuit Judges.

Opinion for the Court filed by Circuit Judge LEVENTHAL.

LEVENTHAL, Circuit Judge:

This case arises on a petition for review of a Final Decision and Order of the Commissioner of Food and Drugs^[1] in which he ruled that a substance used to fabricate unbreakable beverage containers, acrylonitrile copolymer, is a "food additive" within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (the Act).^[2] He further concluded that the data of record failed to provide the demonstration of safety established by section 409(c)(3)(A) of the Act as a precedent to FDA approval for [951] use of any "food additive."^[3] The Commissioner's Final Order amended the pertinent FDA regulations to provide: "Acrylonitrile copolymers [of the type identified in the regulations] are not authorized to be used to fabricate beverage containers."^[4]

For the reasons set forth below, the decision of the Commissioner is affirmed in part, and in part is remanded to provide the opportunity for reconsideration.

I.

The FDA determination that acrylonitrile copolymers used in beverage containers are "food additives" within the statute is based on the finding that such containers invariably retain a residual level of acrylonitrile monomer that has failed to polymerize completely during the manufacturing process and that will migrate from the wall of the container into the beverage under the conditions of intended use. Although the administrative proceedings focused on beverage containers with a residual acrylonitrile monomer (RAN) level equal to or greater than 3.3 parts per million (ppm), the Commissioner made findings and conclusions applicable to all beverage containers manufactured with acrylonitrile, and the Final Order prohibited manufacture of such containers irrespective of their RAN levels.^[5]

FDA began to focus on acrylonitrile copolymer beverage containers in 1974, when the duPont Company submitted test results on a container fabricated from a somewhat different substance which alerted FDA to the possibility of significant migration from acrylonitrile containers. Subsequently, the Commissioner determined that, because of this putative migration, acrylonitrile copolymer was a "food additive" within the statute, and, on February 12, 1975, he published a regulation prescribing the conditions under which the chemical might be used safely in beverage containers: RAN levels in the wall of the container were limited to 80 parts per million (ppm), and acceptable migration of acrylonitrile monomer into the food was set at 300 ppb (parts per billion).^[6]

Two years later, FDA issued test results indicating that acrylonitrile caused adverse [952] affects in laboratory animals. The Commissioner announced that he would lower the acceptable migration threshold for nonbeverage containers to 50 ppb, and would withdraw approval entirely for acrylonitrile beverage containers, on the assumption that no such container could satisfy the 50 ppb migration limitation.^[7] Upon judicial review, this court held FDA's suspension of its food additive regulation without a hearing to be invalid. The court stayed the administrative action on March 18, 1977^[8] and ordered that the required hearing be completed within 60 days. Monsanto Co. v. Gardner (No. 77-1245, 3/18/77). Subsequently, on a joint motion of the parties, the time limitation was extended by 120 days.

At the administrative hearing, petitioners introduced results from tests on a newly developed acrylonitrile beverage container having a RAN level of approximately 3.3 ppm. Tests on the container, employing a detection method sensitive to 10 ppb, detected no migration of acrylonitrile monomer. Nevertheless, the administrative law judge found that acrylonitrile copolymer was a "food additive," since migration had been detected from beverage containers composed of the same chemical compounds, though with higher RAN levels than those present in the "new" container.^[9] The Final Order prohibited manufacture of beverage containers containing acrylonitrile copolymer irrespective of their RAN levels.^[10]

II.

This case brings into court the second law of thermodynamics, which C. P. Snow used as a paradigm of technical information well understood by all scientists and practically no persons of the culture of humanism and letters.^[11] That law leads to a scientifically indisputable prediction that there will be some migration of any two substances which come in contact. The Commissioner's Final Decision, which upheld the ALJ's determination, is unclear on whether and to what extent reliance was placed on this "diffusion principle" rather than on a meaningful projection from reliable data. At one point in the Final Decision the Commissioner stated: "the migration of any amount of a substance is sufficient to make it a food additive"^[12] — a passage evocative of the diffusion principle. Elsewhere, the Commissioner stated that he was able to make a finding of migration based on a projection from actual data — on the assumption that a roughly linear relationship (as a function of time and temperature) existed between the RAN levels in a container and the concentration of acrylonitrile that would migrate into a test fluid. On this premise, though migration from the 3.3 ppm RAN container was itself below the threshold of detectability (10 ppb), it could be projected from the testing data obtained from containers with higher RAN levels.^[13]

This was a troublesome aspect of the case. As it was presented to us, the Commissioner had made a projection of migration from 3.3 ppm RAN containers without the support of any actual data showing that migration had occurred from such containers. One of petitioners' experts put it that the relationship might not be linear at very low RAN levels; but this was dismissed by the Commissioner as "speculative."^[14] One [953] could not say that the expert's contention of no migration from very low RAN containers was improbable as a concept of physical chemistry, but it was put to us that the validity of this contention could neither be demonstrated nor refuted for 3.3 ppm RAN containers because, under the conditions of intended use, migration was projected to occur in amounts below the threshold of detectability.

Our own study showed the possibility of using experimental data to check the FDA's projection analysis. The FDA revealed that a projection of migration from low RAN containers had in fact been made for test conditions of prolonged duration and above-normal temperature. Under such conditions migration was projected in concentrations greater than 10 ppb, the threshold of detectability at the time of the Final Decision.^[15] Therefore, this court requested post-argument memoranda from the parties on whether tests had been performed, or would be feasible, to confirm by actual data the hypothesis that migration occurs from containers with a RAN level of 3.3 ppm.

The responses to our inquiry have revealed the probable existence of data unavailable to counsel during the administrative proceedings that bear importantly upon the assumptions made by the Commissioner in reaching his findings and conclusions. This discovery buttressed our earlier conclusion that the Commissioner did not have sufficient support for his decision to apply the "food additive" definition in this case.

In light of the inadequacy of the agency's inquiry and in light of our view that the Commissioner has a greater measure of discretion in applying the statutory definitions of "food additive" than he appears to have thought, we remand this proceeding for further consideration.

III

The proceedings at hand are dramatic testimony to the rapid advance of scientific knowledge in our society. At the time of the administrative proceedings, the lowest concentration of acrylonitrile in a test fluid that could be detected with an acceptable degree of confidence was 10 ppb. There are now analytical techniques available that can detect acrylonitrile concentration of 0.1 ppb, an improvement of two orders of magnitude.^[16] Thus, on the issue of migration of acrylonitrile monomer it is now possible to generate "hard" data previously unobtainable.

In his post-argument testimony, Monsanto's expert claims, on the basis of such "hard" data, that the hypothesis which the Commissioner labeled as "speculative" may accurately describe the migration characteristics of containers with very low RAN levels, to wit, that in such containers the acrylonitrile monomer is so firmly affixed within the structure of the copolymer that no migration will occur under the conditions of intended use.^[17] If these assertions can be demonstrated to the satisfaction of the Commissioner, a modification of the current regulation is a likely corollary. The actual issuance of a regulation approving the production of a beverage container with an acceptable RAN level would presumably require both a container that had been developed^[18] and the appropriate petition. However, [954] the Commissioner would have latitude to issue a statement of policy based upon the results of the proceeding or remand that would specify what in his review was an acceptable RAN level. This would serve a technology-forcing objective.^[19]

FDA opposes petitioners' post-argument motion for remand, asserting that the proffered new evidence will not affect the Commissioner's order insofar as that order precludes manufacture of beverage containers with RAN levels equal to or greater than 3.3 ppm — the type of container already tested. FDA points out that the material submitted in response to this court's inquiry affirmatively supports the validity of the Commissioner's findings and conclusions.^[20] FDA contends that a petition for modification of the regulation, or a similar procedure, would be the appropriate vehicle for presentation of any new evidence indicating that migration ceases when RAN levels fall below a certain threshold.

As a general rule, courts defer to administrative agency orders closing the record and terminating proceedings. The rule has applicability in cases involving scientific matters notwithstanding the possibility that advances and experiments will yield new material data. Indeed, the importance of finality as a matter of administrative necessity may be magnified by the possibility — indeed probability — of advance in at least some areas. Procedures for rehearing or modifying orders are generally available to provide appropriate relief from any hardships or other harm.^[21]

The general rule of finality applies in the usual case because the courts trust the administrator's ability to make a reasoned judgment that sufficient evidence has been submitted, that adequate time has been provided for rebuttal, and that the record should be closed. However, in this instance, the closing of the record did not reflect unfettered administrative judgment: FDA conducted these administrative proceedings under a time constraint dictated by an order of this court.

The Court is also concerned that the Commissioner may have reached his determination in the belief that he was constrained to apply the strictly literal terms of the statute irrespective of the public health and safety considerations. As we discuss below, there is latitude inherent in the statutory scheme to avoid literal application of the statutory definition of "food additive" in those de minimis situations that, in the informed judgment of the Commissioner, clearly present no public health or safety concerns.

In the usual case, the general doctrine of necessity and finality serves the public interest in immediate protection of the consuming public. But in this case production of acrylonitrile beverage containers was deferred voluntarily even when this court issued a stay of the FDA order, and in any event it is now prohibited pending further proceedings.

Finally, we are concerned that the record reflects a momentum toward a precipitate determination. Several factors bear on our judgment. One is the text of the decision, with its lack of precision as to basis. Another is the fact that the beverage container evaluated by the Commissioner was characterized by a migration level well below the agency's initial limit. It was offered by [955] petitioners in the hearing as available as a result of ongoing technology, but the time constraint imposed by judicial mandate prevented the agency from scheduling the kind of administrative consideration that would ordinarily have been provided.

IV

Pretermitting various issues that should await conclusion of the remand proceedings, we turn to certain other important questions that are presented by the record, that have been fully briefed and argued, and that are ripe for resolution.^[22]

The statute requires a demonstration of safety precedent to FDA approval of any "food additive."^[23] The statutory definition of "food additive" which triggers that requirement contains a two part test. First, the component element of the definition states that the intended use of the substance must be reasonably expected to result in its becoming a component of any food.^[24] Second, the safety element of the definition states that the substance must be not "generally recognized [as] safe under the conditions of its intended use."^[25]

Petitioners are concerned that the Commissioner has determined, or will determine, that the component element of the definition may be satisfied solely by that application of the second law of thermodynamics called the diffusion principle: any two substances that are in contact will tend to diffuse into each other at a rate that will be determined as a function of time, temperature, and the nature of the substances. Congress did not intend that the component requirement of a "food additive" would be satisfied by a mere recitation of the diffusion principle, a mere finding of any contact whatever with food. Petitioner's contention on this point is sound.

For the component element of the definition to be satisfied, Congress must have intended the Commissioner to determine with a fair degree of confidence that a substance migrates into food in more than insignificant amounts. We do not suggest that the substance must be toxicologically significant; that aspect is subsumed by the safety element of the definition. Nor is it necessary that the level of migration be significant with reference to the threshold of direct detectability, so long as its presence in food can be predicted on the basis of a meaningful projection from reliable data. Congress has granted to the Commissioner a limited but important area of discretion. Although as a matter of theory the statutory net might sweep within the term "food additive" a single molecule of any substance that finds its way into food, the Commissioner is not required to determine that the component element of the definition has been satisfied by such an exiguous showing. The Commissioner has latitude under particular circumstances to find migration "insignificant" even giving full weight to the public health and welfare concerns that must inform his discretion.

Thus, the Commissioner may determine based on the evidence before him that the level of migration into food of a particular chemical is so negligible as to present no public health or safety concerns, even to assure a wide margin of safety. This authority derives from the administrative discretion, inherent in the statutory scheme, to deal appropriately with de minimis situations.^[26] However, if the Commissioner [956] declines to define a substance as a "food additive," though it comes within the strictly literal terms of the statutory definition, he must state the reasons for exercising this limited exemption authority. In context, a decision to apply the literal terms of the statute, requires nothing more than a finding that the elements of the "food additive" definition have been satisfied.^[27]

In the case at hand, the Commissioner made specific rulings that the component element of the definition was satisfied with respect to acrylonitrile beverage containers having an RAN level of 3.3 ppm or more. These rulings were premised on a projection, based on an extrapolation from reliable data, of migration of acrylonitrile monomer in then-undetectable amounts. In light of the supplementary submission made in response to the post-argument inquiry of this court, we find that the determination can be made for the 3.3 ppm RAN containers with an appropriate degree of confidence, and with the support of the required quantum of evidence.^[28]

Turning to the safety element of the definition, the Commissioner determined that the scientific community had insufficient experience with acrylonitrile to form a judgment as to safety. Based on this lack of opinion, the Commissioner made a finding that acrylonitrile was not generally recognized as safe within the meaning of the statute. The Commissioner acted within his discretion in making such a finding, but we note that the underlying premise may be affected, perhaps weakened, perhaps strengthened, with time and greater experience with acrylonitrile.^[29] This finding on the safety element will be open to reexamination on remand at the discretion of the Commissioner. He would have latitude to consider whether acrylonitrile is generally recognized as safe at concentrations below a certain threshold, even though he has determined for higher concentrations that in the view of the scientific community acrylonitrile is not generally recognized as safe.

V

Petitioners also made a claim of discriminatory treatment — that the Commissioner is applying policies in the petitioners' case that have not been applied in other similar circumstances. However, there is no claim that the Commissioner was motivated by discriminatory intention to bring the petitioners before the agency and to focus on their product. Petitioners came before the agency in the ordinary course. Once the Commissioner undertook scrutiny, he shifted the lens of his microscope to a higher power — but that is no ground for objection, so long as the final action remains within the legitimate scope of discretion.

The decision of the Commissioner is affirmed in part, and in part is remanded to provide the opportunity for reconsideration.

So ordered.

[1] Acrylonitrile Copolymers Used to Fabricate Beverage Containers, Final Decision, 42 Fed.Reg. 48528-48544 (1977); J.A. at 1-17.

[2] Id., Conclusion of Law ¶ 15, 42 Fed.Reg. at 48543; J.A. at 16. Section 201(s) of the Act, 21 U.S.C. § 321(s) (1976) provides:

(s) The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include —

(1) a pesticide chemical in or on a raw agricultural commodity; or

(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or

(3) a color additive; or

(4) any substance used in accordance with a sanction or approval granted prior to September 6, 1953, pursuant to this chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 601 et seq.]; or

(5) a new animal drug.

[3] Final Decision, note 1 supra, Conclusions of Law ¶ 16, 42 Fed.Reg. at 48543; J.A. at 16. Section 409(c), 21 U.S.C. § 348(c) (1976), provides in part:

(c) Approval or denial of petition; time for issuance of orders; evaluation of data; factors

(1) The Secretary shall —

(A) by order establish a regulation (whether or not in accord with that proposed by the petitioner) prescribing, with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or in which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and shall notify the petitioner of such order and the reasons for such action; or

(B) by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.

(2) The order required by paragraph (1)(A) or (B) of this subsection shall be issued within ninety days after the date of filing of the petition except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition.

(3) No such regulation shall issue if a fair evaluation of the data before the Secretary —

(A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe: . . .

[4] Final Decision, note 1 supra, Final Order, 42 Fed.Reg. at 48543-44; J.A. 16-17. The provisions of the Order have been incorporated into FDA regulations at 21 C.F.R. §§ 177.1020(f), 177.1030(f), 177.1040(e), 177.1050(g) and 177.1480(d) (1978).

[5] See e. g., 21 C.F.R. § 177.1040(c) (1978). This is the regulation under which petitioner Monsanto manufactures its acrylonitrile beverage container. Petitioner Vistron's container is manufactured under 21 C.F.R. § 177.1480 (1978).

[6] 40 Fed.Reg. 6489 (1975); J.A. at 22.

[7] 42 Fed.Reg. 13540 (1977); J.A. at 139.

[8] Monsanto Br. at 17 states that there has been no use of the court's stay to continue manufacture.

[9] Acrylonitrile Copolymers Used To Fabricate Beverage Containers, Initial Decision 35 (August 4, 1977); J.A. at 186.

[10] See, e. g., 21 C.F.R. § 177.1040(c) (1978). This is the regulation under which petitioner Monsanto manufactures its acrylonitrile beverage container. Petitioner Vistron's container is manufactured under 21 C.F.R. § 277.1480 (1978).

[11] See C. P. Snow, The Two Cultures and the Scientific Revolution (1959).

[12] Final Decision, note 1 supra, 42 Fed.Reg. at 48534; J.A. at 7. Id., 42 Fed.Reg. at 48532-33; J.A. at 5-6.

[13] Id., 42 Fed.Reg. at 48529-48530; J.A. at 2-3.

[14] The suggestion was made in the prepared testimony of Monsanto's expert witness, Mr. Morris Salame. J.A. at 457-58. The Commissioner dismissed the hypothesis as "speculative" in his response to the exceptions of the parties. Final Decision, note 1 supra, part C(2)(a)(i), 42 Fed.Reg. at 48530-31; J.A. at 3-4.

[15] The chart showed the following projections of migration from a beverage container with a RAN level of 3.7 ppm:

          at 150° F for 30 days   — 26 ppb;
          at 120° F for 180 days  — 27 ppb;
          at 120° F for 90 days   — 14 ppb.

J.A. at 794.

[16] Memorandum of Monsanto Company In Support of Motion For Remand Under Section 409(g)(4) at 4.

[17] Affidavit of Morris Salame, accompanying Monsanto Memorandum, note 16 supra, at ¶¶ 9, 10.

[18] The Act does not contemplate promulgation of food additive regulations for hypothetical food additives. 21 U.S.C. §§ 321(s) & 348(c) (1976). The Commissioner must base his decision on a container actually existing and actually before him in the remand proceeding or any subsequent proceeding.

[19] The submission by Monsanto is that no migration can be expected to occur from containers with RAN levels lower than 0.1 ppm. Salame Affidavit, note 16 supra, at ¶ 10. There is a further indication that the manufacture of beverage containers with RAN levels of less than 0.1 ppm is technologically feasible. Monsanto Memorandum, note 15 supra, at 7.

[20] In view of the new data generated in response to the Court's inquiry, petitioners no longer contest that migration does occur from Monsanto's "Cycle-Safe" container (RAN level of 3.3 ppm) under the conditions of its intended use. See Salame Affidavit, note 16 supra; Monsanto Memorandum, note 15 supra, at 11.

[21] See Investment Co. Institute v. Federal Reserve System, 179 U.S.App.D.C. 311, 322, 551 F.2d 1270, 1281 (1977).

[22] The issues fully ripe for decision at this time include questions of statutory interpretation that will be pertinent to the proceeding on remand.

[23] See § 409(c)(3)(A), quoted in note 3, supra.

[24] See note 2 supra.

[25] Id.

[26] See, e. g., FPC v. Texaco, Inc., 417 U.S. 380, 399, 94 S.Ct. 2315, 41 L.Ed.2d 141 (1974); Volkswagenwerk, A. G. v. FMC, 390 U.S. 261, 276-77, 88 S.Ct. 929, 19 L.Ed.2d 1090 (1968); United Glass & Ceramic Workers v. Marshall, 189 U.S.App.D.C. 240, 242, 584 F.2d 398, 400 (1978); Marine Space Enclosures, Inc. v. FMC, 137 U.S.App.D.C. 9, 16, 420 F.2d 577, 584 (1969). Cf. Ingraham v. Wright, 430 U.S. 651, 674, 97 S.Ct. 1401, 51 L.Ed.2d 711 (1977). Sniadach v. Family Finance Corp., 395 U.S. 337, 342, 89 S.Ct. 1820, 23 L.Ed.2d 349 (1969) (Harlan, J., concurring).

[27] Absent a showing of bad faith or other extraordinary circumstances, a court will not consider meritorious the claim that the Commissioner has abused his discretion in declining to exercise his exemption authority for de minimis situations. This is an area of decision by its nature committed to the informed discretion of the Commissioner.

[28] See note 20 supra. On judicial review, the court must be satisfied that the Order of the Commissioner is based "upon a fair evaluation of the entire record." 21 U.S.C. § 348(f)(2), (g)(3) (1976). The Commissioner applied the "component" part too automatically, and in the future must support his decision with more than a conclusory reference to the diffusion principle of the second law of thermodynamics.

[29] Like the "component" element of the definition, the "safety" element may at times call for more rigorous examination. Thus, the Commissioner has discretion in determining when the statute applies to a given substance, but substances that do fall within its term should be so identified.

116 F.Supp.2d 166 (2000)

[167] [168] [169] Joseph Mendelson, III, Andree C. Kimbrell, Washington, DC, for plaintiffs.

Mark E. Nagle, Meredith Manning, U.S. Atty's Office, Washington, DC, Andrew E. Clark, U.S. Dept. of Justice, Washington, DC, for defendants.

MEMORANDUM OPINION

KOLLAR-KOTELLY, District Judge.

Technological advances have dramatically increased our ability to manipulate our environment, including the foods we consume. One of these advances, recombinant deoxyribonucleic acid (rDNA) technology, has enabled scientists to alter the genetic composition of organisms by mixing genes on the cellular and molecular level in order to create new breeds of plants for human and animal consumption. See Pls.' Statement of Material Facts Not in Dispute ¶¶ 1-3 ["Pls.' Stmt."]; Defs.' Statement of Material Facts Not in Dispute ¶¶ 6-7 ["Defs.' Stmt."]. These new breeds may be designed to repel pests, retain their freshness for a longer period of time, or contain more intense flavor and/or nutritional value. See Pls.' Stmt. ¶¶ 5-6; Defs.' Stmt. ¶ 8. Much controversy has attended such developments in biotechnology, and in particular the production, sale, and trade of genetically modified organisms and foods. The above-captioned lawsuit represents one articulation of this controversy.

[170] Among Plaintiffs, some fear that these new breeds of genetically modified food could contain unexpected toxins or allergens, and others believe that their religion forbids consumption of foods produced through rDNA technology. See Pls.' Cross Mot. for Summ.J. ["Pls.' Mot. Summ.J."], Ex. 2 (Fagan Aff.); Ex. 3 (Lacey Aff.); Ex. 4 (Regal Aff.); Ex. 5 (Speck Aff.), Ex. 6 (Jaworowsky Aff.), Ex. 7 (Kedala Aff.). Plaintiffs, a coalition of groups and individuals including scientists and religious leaders concerned about genetically altered foods, have brought this action to protest the Food and Drug Administration's ("FDA") policy on such foods in general, and in particular on various genetically modified foods that already have entered the marketplace. The parties have filed cross-motions for summary judgment on plaintiffs' multiple claims. Upon careful consideration of the parties' briefs and the entire record, the Court shall grant Defendants' motion as to all counts of Plaintiffs' Complaint.

I. BACKGROUND

On May 29, 1992, the FDA published a "Statement of Policy: Foods Derived From New Plant Varieties" (Statement of Policy). See 57 Fed.Reg. 22,984; Pls.' Stmt. ¶ 16; Defs.' Stmt. ¶ 14. In the Statement of Policy, FDA announced that the agency would presume that foods produced through the rDNA process were "generally recognized as safe" (GRAS) under the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 321(s), and therefore not subject to regulation as food additives. See 57 Fed.Reg. 22,989-91. While FDA recommended that food producers consult with it before marketing rDNA-produced foods, the agency did not mandate such consultation. See id. at 22,991. In addition, FDA reserved the right to regulate any particular rDNA-developed food that FDA believed was unsafe on a case-by-case basis, just as FDA would regulate unsafe foods produced through conventional means. See id. at 22,990.

The Statement of Policy also indicated that rDNA modification was not a "material fact" under the FDCA, 21 U.S.C. § 321(n), and that therefore labeling of rDNA-produced foods was not necessarily required. See id. at 22,991. FDA did not engage in a formal notice-and-comment process on the Statement of Policy, nor did it prepare an Environmental Impact Statement or Environmental Assessment. See id. at 23,004-05; Pls.' Stmt. ¶ 23. At least thirty-six foods, genetically altered through rDNA technology, have been marketed since the Statement of Policy was issued. See Pls.' Stmt. ¶ 30; Defs.' Stmt. ¶ 21.

Plaintiffs filed a Complaint in this Court challenging the FDA's policy on six different grounds: (1) the Statement was not properly subjected to notice-and-comment procedures; (2) the FDA did not comply with the National Environmental Protection Act (NEPA) by compiling an Environmental Assessment or Environmental Impact Statement; (3) the FDA's presumption that rDNA-developed foods are GRAS and therefore do not require food additive petitions under 21 U.S.C. § 321(s) is arbitrary and capricious; (4) the FDA's decision not to require labeling for rDNA-developed foods is arbitrary and capricious; (5) the FDA's decision not to regulate or require labeling for rDNA-developed foods violates the Free Exercise Clause; and (6) the FDA's decision not to regulate or require labeling for rDNA-developed foods violates the Religious Freedom Restoration Act. See Pls.' Second Am.Compl. ¶¶ 129-159. Plaintiffs have also challenged on the third and fourth grounds each of FDA's specific decisions not to regulate 36 individual rDNA-produced products. See id. ¶¶ 160-696. The parties have filed cross-motions for summary judgment on all of Plaintiff's claims.

II. DISCUSSION

A litigant is entitled to summary judgment when "there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). Summary judgment is [171] only warranted where "the record, viewed in the light most favorable to the nonmoving party, reveals that there is no genuine issue as to any material fact." Aka v. Washington Hosp. Ctr., 156 F.3d 1284, 1288 (D.C.Cir.1998) (en banc).

A. Subject Matter Jurisdiction

Defendants contend that Court lacks jurisdiction to hear plaintiffs' claims. See Defs.' Mot. to Dismiss, or Alternatively for Summ.J. at 15-17 ("Defs.' Mot. Summ.J."). Although Defendants have not presented this argument as a threshold to the Court's consideration of the entire case, raising it instead after developing several other arguments, the Court must treat it as such. See, e.g., Steel Co. v. Citizens for Better Env't, 523 U.S. 83, 9495, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998) ("The requirement that jurisdiction be established as a threshold matter springs from the nature and limits of the judicial power of the United States and is inflexible and without exception") (internal citation omitted). In particular, Defendants argue that the Statement of Policy functioned as a way for the agency to "set its own enforcement agenda," and therefore, that this enforcement action belongs to agency discretion by Congressional mandate and is not subject to judicial review. See Defs.' Mot.Summ.J. at 13. Although the Supreme Court held that individual enforcement decisions are not subject to judicial review in Heckler v. Chaney, 470 U.S. 821, 831, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), Defendants' attempt to extend this holding to agency decisions not to enforce against a whole class has not been accepted by this Circuit. See Shell Oil Co. v. EPA, 950 F.2d 741, 764 (D.C.Cir.1991).

The Chaney Court reasoned that courts reviewing agency action "need a meaningful standard against which to judge the agency's exercise of discretion." Chaney, 470 U.S. at 830, 105 S.Ct. 1649. Individual agency decisions not to enforce a statute "involve a complicated balancing of a number of factors," and courts do not have a meaningful standard with which to evaluate the agency's balancing. Id. at 831, 105 S.Ct. 1649. Therefore, these decisions are "committed to agency discretion by law" and are not subject to judicial review. 5 U.S.C. § 701(a)(2). The Court noted that an agency's enforcement discretion may be limited when Congress has "set[ ] substantive priorities, or ... otherwise circumscrib[ed] an agency's power to discriminate among issues or cases it will pursue." Id. at 833, 105 S.Ct. 1649. When determining if an agency action is reviewable, courts looks to "whether the applicable statutes and regulations are drawn so that a court would have a meaningful standard against which to judge the agency's exercise of discretion." Nat'l Fed'n of Fed. Employees v. United States, 905 F.2d 400, 405 (D.C.Cir.1990); C C Distrib., Inc. v. United States, 883 F.2d 146, 153 (D.C.Cir.1989).

This Circuit has recognized a distinction between agency decisions not to regulate an entire class of conduct, which are essentially policy choices, and individual nonenforcement decisions. See Shell Oil Co., 950 F.2d at 764. When an agency has employed a formal procedure, such as notice and comment rulemaking, to announce a major policy decision not to regulate certain conduct, courts can use this procedure as "a focal point for judicial review." Nat'l Treasury Employees Union v. Horner, 854 F.2d 490, 496 (D.C.Cir. 1988). In the instant case, even without actual notice and comment procedures, the FDA's formal publication of the Statement of Policy provides a focal point for this Court's review of the agency's action. Moreover, this Court has a meaningful standard against which to judge the Statement of Policy. Congress's passage of the various statutes on which Plaintiffs rely here—the Administrative Procedure Act, the Federal Food Drug and Cosmetic Act, the National Environmental Protection Act, and the Religious Freedom Restoration Act—has limited the FDA's enforcement discretion. Although the Court may not review FDA's policy-laden individual enforcement decisions, the Court has jurisdiction to review whether or not FDA's [172] Statement of Policy comports with Congressional directives.

B. Notice and Comment

Plaintiffs argue that the Statement of Policy should be set aside because it was not subjected to notice and comment proceedings, as required under the Administrative Procedure Act ("APA"), 5 U.S.C. § 553. See Pls.' Mot.Summ.J. at 9. While conceding that the Statement of Policy did not undergo a formal notice and comment process, Defendants maintain that the Statement of Policy is a policy statement or an interpretive rule not subject to notice and comment requirements.^[1]See Defs.' Opp'n to Pls.' Mot.Summ.J. ["Defs.' Opp'n"] at 2; see also 5 U.S.C. § 553(b)(3)(A) (1994) (exempting from notice and comment interpretive rules and general statements of policy). Plaintiffs contend instead that the Statement of Policy is a substantive rule, and that therefore it was improperly exempted from a formal notice and comment process. See Pls.' Mot.Summ.J. at 13.

A substantive rule, which must undergo a formal notice-and-comment process, is a rule that "implement[s]" a statute and has "the force and effect of law." Chrysler Corp. v. Brown, 441 U.S. 281, 302 n. 31, 99 S.Ct. 1705, 60 L.Ed.2d 208 (1979). Policy statements, on the other hand, are "statements issued by an agency to advise the public prospectively of the manner in which the agency proposes to exercise a discretionary power." Id. Although the distinction between these categories is not entirely clear,^[2] in American Bus. Ass'n v. United States, 627 F.2d 525 (D.C.Cir.1980), the Court of Appeals articulated a two-part test for determining when an agency action is a policy statement. Policy statements (1) must not impose any new rights or obligations, and (2) must "genuinely leave the agency and its decision-makers free to exercise discretion." Id. at 529. In weighing these criteria, "the ultimate issue is the agency's intent to be bound." Public Citizen v. United States Nuclear Regulatory Comm'n, 940 F.2d 679, 682 (D.C.Cir.1991). An agency's own characterization of its statement deserves some weight, but it is not dispositive. See Truckers United for Safety v. Fed'l Highway Admin., 1998 WL 151182 (D.C.Cir. 1998). Rather, courts will look to the actual language of the statement. See Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537-38 (D.C.Cir.1986).

By its very name, the Statement of Policy announces itself as a policy statement. More importantly, the plain language of the Statement suggests that it does not have a binding effect. For example, the Statement does not declare that transferred genetic material will be considered GRAS; rather, it announces that "such material is presumed to be GRAS." 57 Fed.Reg. 22989 (emphasis added). This presumption of safety is rebuttable, because FDA will "require food additive petitions in cases where safety questions exist sufficient to warrant formal premarket review by FDA to ensure public health protection." Id. at 22990. Rebuttable presumptions leave an agency free to exercise its discretion and may therefore properly be announced in policy statements. See Panhandle Producers v. Econ. Regulatory Admin., 822 F.2d 1105, 1110 (D.C.Cir. 1987); Mada-Luna v. Fitzpatrick, 813 F.2d 1006, 1013 (9th Cir.1987) ("To the [173] extent that the directive merely provides guidance to agency officials in exercising their discretionary powers while preserving their flexibility and their opportunity to make individualized determination[s], it constitutes a general statement of policy"); accord Ryder Truck Lines, Inc. v. United States, 716 F.2d 1369, 1377 (11th Cir.1983) ("As long as the agency remains free to consider the individual facts in the various cases that arise, then the agency action in question has not established a binding norm.")

In response to the argument that the Policy Statement vests broad discretion with the agency, Plaintiffs contend that the FDA's application of the Statement has given it a "practical effect" that has effectively bound the agency's discretion, as evidenced by the thirty-six genetically engineered foods that are currently on the market and not regulated by the FDA. See Pls.' Reply to Defs.' Opp'n ["Pls.' Reply"] at 8-9. Although courts will look to the "agency's actual applications" to determine the nature of an agency statement, such an inquiry occurs "[w]here the language and context of a statement are inconclusive." Public Citizen, 940 F.2d at 682. Here, the plain language of the Statement clearly indicates that it is a policy statement that merely creates a presumption and does not ultimately bind the agency's discretion. See Brock, 796 F.2d at 537. Given this unambiguous language, this Court need not consider the agency's application of the Statement to determine the Statement's meaning.^[3]

Even if, as Plaintiffs argue, FDA has previously used notice-and-comment procedures to determine GRAS status, in the instant case FDA has not determined GRAS status but has rather announced a GRAS presumption. See Pls.' Mot. Summ.J. at 9; Panhandle Producers, 822 F.2d at 1110 ("This court and others have consistently stated that an agency may announce presumptions through policy statements rather than notice-and-comment rulemaking."). The Statement of Policy creates a rebuttable presumption of GRAS that does not constrain the FDA's ability to exercise its discretion. See Panhandle Producers, 822 F.2d at 1110 ("Presumptions, so long as rebuttable, leave such freedom [to exercise the agency's discretion]."). Because the Statement is a policy statement merely announcing a GRAS presumption, the omission of formal notice-and-comment procedures does not violate the Administrative Procedure Act.

C. NEPA

Plaintiffs have also alleged that FDA violated the National Environmental Protection Act (NEPA), 42 U.S.C. § 4321 et seq., by not performing an Environmental Assessment (EA) or an Environmental Impact Statement (EIS) in conjunction with the Statement of Policy. See Pl.'s Mot.Summ.J. at 20. NEPA requires "all agencies of the Federal Government ... [to] include in every recommendation or report on proposals for legislation and other major Federal actions significantly affecting the quality of the human environment, a detailed statement ... on the [174] environmental impact of the proposed action." 42 U.S.C. § 4332(2)(c)(i).

"Major federal action," as defined in the Code of Federal Regulations, includes actions such as "[a]doption of official policy ... [a]doption of formal plans ... [a]doption of programs ... [and][a]pproval of specific projects." 40 C.F.R. § 1508.18(b)(1-4). For major federal actions, agencies must either prepare an EIS examining the environmental impact of the proposed action, prepare an EA determining whether or not to prepare an EIS, or claim that the action falls within a Categorical Exclusion, "a category of actions which do not individually or cumulatively have a significant effect on the human environment." 40 C.F.R. § 1508.4 (1999). If the agency is not engaging in a major federal action, NEPA requirements do not apply. See Macht v. Skinner, 916 F.2d 13, 16 (D.C.Cir.1990); see also 42 U.S.C. § 4332(2)(c) (requiring compliance only for "proposals for legislation and other major federal actions").

In the Statement of Policy, FDA announces that "the activities [FDA] may undertake with respect to foods from new plant varieties ... will [not] constitute agency action under NEPA." 57 Fed.Reg. 23005. FDA's determination that the Statement is not a major federal action is essentially an interpretation of the meaning of "major federal action" in 42 U.S.C. § 4332(2)(c) and 40 C.F.R. § 1508.18. Agencies enjoy wide discretion in interpreting regulations, and the agency's interpretation will be upheld unless it is arbitrary and capricious. See United States v. Larionoff, 431 U.S. 864, 872, 97 S.Ct. 2150, 53 L.Ed.2d 48 (1977); Nat'l Trust for Historic Preservation v. Dole, 828 F.2d 776, 782 (D.C.Cir.1987).

The FDA's determination that the Statement was not a major federal action comports with the holdings of this Circuit, and is therefore neither arbitrary nor capricious. While declaring a rebuttable presumption that foods produced through rDNA technology are GRAS, the FDA has neither made a final determination that any particular food will be allowed into the environment, nor taken any particular regulatory actions that could affect the environment. In order to trigger the NEPA requirement of an EIS, the agency must be prepared to undertake an "`irreversible and irretrievable commitment of resources' to an action that will affect the environment." Wyoming Outdoor Council v. U.S. Forest Service, 165 F.3d 43, 49 (D.C.Cir. 1999) (quoting Mobil Oil Corp. v. FTC, 562 F.2d 170, 173 (2d Cir.1977)). Because the FDA's presumption does not bind its decision-making authority, it has neither taken nor prepared to take the irreversible action that is necessary to require preparation of an EIS under Wyoming Outdoor Council. See id. Evidencing this nonbinding effect is the FDA's 1993 decision to open the labeling issue for further discussion, requesting additional public comment on the possible implementation of a general labeling requirement. 58 Fed. Reg. 25,837 (1993).

Moreover, agency decisions that maintain the substantive status quo do not constitute major federal actions under NEPA. See Fund for Animals, Inc. v. Thomas, 127 F.3d 80, 84 (D.C.Cir.1997); Committee for Auto Responsibility v. Solomon, 603 F.2d 992, 1002-03 (D.C.Cir. 1979). Defendants maintain correctly that their actions have not altered the status quo because "rDNA modified foods ... were regulated no differently before the publication of the Policy Statement than they are now." Def.'s Mot.Summ.J. at 44. Because the announcement of a rebuttable presumption of GRAS does not affect the substantive regulatory status quo, it is not a major federal action. See Fund for Animals, 127 F.3d at 84.

The Statement of Policy is not only reversible and consistent with the status quo ante; it is also not properly an "agency action." The core of Plaintiff's NEPA claim is that FDA has failed to regulate rDNA-modified foods, and that this failure to act engenders environmental consequences. But NEPA applies only to agency actions, "even if inaction has environmental [175] consequences." Defenders Wildlife v. Andrus, 627 F.2d 1238, 1243 (D.C.Cir.1980). The Defenders of Wildlife court reasoned that Congress did not intend for agencies to perform environmental studies when the agencies were not acting. See id. at 1244. In certain cases, agencies may take action by authorizing private action, but in such cases the government still must undertake some overt act, such as issuing a permit or affirming a substance as GRAS. See id.

In the instant case, FDA has not taken an overt action, but instead has merely announced a presumption that certain foods do not require special regulation. This presumption against regulation does not constitute an overt action, and is therefore not subject to NEPA requirements. See Cross-Sound Ferry Services, Inc. v. ICC, 934 F.2d 327, 334 (D.C.Cir.1991) (upholding I.C.C. finding that "a conclusion that regulation is not necessary is not a federal action, but is simply a determination not to take action," 6 I.C.C.2d 228, 246 (1989)), abrogated on other grounds by Steel Co. v. Citizens for a Better Environment, 523 U.S. 83, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998).

In sum, because FDA's Statement of Policy is reversible, maintains the substantive status quo, and takes no overt action, the Statement of Policy does not constitute a major federal action under NEPA.^[4] FDA was not required to compile an Environmental Assessment or an Environmental Impact Statement in conjunction with the Statement of Policy, and therefore its failure to do so does not violate NEPA.^[5]

D. GRAS Presumption

In their challenge to the FDA's Statement of Policy, Plaintiffs further claim that the Statement of Policy's presumption that rDNA-engineered foods are GRAS violates the GRAS requirements of the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 321(s), and is therefore arbitrary and capricious. See Pls.' Mot.Summ.J. at 27; see also 5 U.S.C. § 706(2)(A). The FDCA provides that any substance which may "becom[e] a component or otherwise affect[ ] the characteristics of any food" shall be deemed a food additive. See 21 U.S.C. § 321(s). A producer of a food additive must submit a food additive petition to FDA for approval unless FDA determines that the additive is "generally recognized [by qualified experts] ... as having been adequately shown through scientific procedures ... to be safe under the conditions of its intended use."^[6]Id.

[176] In the Statement of Policy, FDA indicated that, under § 321(s),

it is the intended or expected introduction of a substance into food that makes the substance potentially subject to food additive regulation. Thus, in the case of foods derived from new plant varieties, it is the transferred genetic material and the intended expression product or products that could be subject to food additive regulation, if such material or expression products are not GRAS.

57 Fed.Reg. at 22,990. Accordingly, FDA reasoned that the only substances added to rDNA engineered foods are nucleic acid proteins, generally recognized as not only safe but also necessary for survival. See id. ("Nucleic acids are present in the cells of every living organism, including every plant and animal used for food by humans or animals, and do not raise a safety concern as a component of food"). Therefore, FDA concluded that rDNA engineered foods should be presumed to be GRAS unless evidence arises to the contrary. See id. at 22,991 ("Ultimately, it is the food producer who is responsible for assuring safety."); see also Defs.' Mot.Summ.J. at 18-20. The Statement of Policy does acknowledge, however, that certain genetically modified substances might trigger application of the food additives petitioning process. In that vein, FDA recognized that "the intended expression product in a food could be a protein, carbohydrate, fat or oil, or other substance that differs significantly in structure, function, or composition from substances found currently in food. Such substances may not be GRAS and may require regulation as a food additive." Id. at 22,990.

This Court's evaluation of the FDA's interpretation of § 321(s) is framed by Chevron, U.S.A. v. Natural Resources Defense Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Since "`statutory interpretation begins with the language of the statute itself,'" Butler v. West, 164 F.3d 634, 639 (D.C.Cir.1999) (quoting Pennsylvania Dep't of Pub. Welfare v. Davenport, 495 U.S. 552, 557-58, 110 S.Ct. 2126, 109 L.Ed.2d 588 (1990)), as a general matter the Court first must determine whether Congress has spoken directly to the issue at hand, a line of analysis that has become known as Chevron step one. If, using "traditional tools of statutory construction," Natural Resources Defense Council, Inc. v. Browner, 57 F.3d 1122, 1125 (D.C.Cir.1995), the Court answers this inquiry in the affirmative, then "that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress." Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778.

But Chevron review also concerns itself with the extent and application of agency discretion in interpreting the statute at issue. In other words, "a reviewing court's inquiry under Chevron is rooted in statutory analysis and is focused on discerning the boundaries of Congress' delegation of authority to the agency." Arent v. Shalala, 70 F.3d 610, 615 (D.C.Cir.1995). To resolve the issue, "the question for the reviewing court is whether the agency's construction of the statute is faithful to its plain meaning, or, if the statute has no plain meaning, whether the agency's interpretation `is based on a permissible construction of the statute."' Id. (quoting Chevron, 467 U.S. at 843, 104 S.Ct. 2778). If this interpretation is "reasonable and consistent with the statutory scheme and legislative history." Cleveland v. United States Nuclear Regulatory Comm'n, 68 F.3d 1361, 1367 (D.C.Cir.1995), then the Court must defer to the agency. This inquiry into the agency's interpretation constitutes Chevron step two. See id.

[177] When Congress passed the Food Additives Amendment in 1958, it obviously could not account for the late twentieth-century technologies that would permit the genetic modification of food. The "object and policy" of the food additive amendments, Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1067 (D.C.Cir.1998), is to "require the processor who wants to add a new and unproven additive to accept the responsibility ... of first proving it to be safe for ingestion by human beings." S.Rep. No. 85-2422, at 2 (1958). The plain language of § 321(s) fosters a broad reading of "food additive" and includes "any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and ... any source of radiation intended for any such use." § 321(s).

Nonetheless, the statute exempts from regulation as additives substances that are "generally recognized ... to be safe under the conditions of its intended use. . . ." § 321(s). Plaintiffs have not disputed FDA's claim that nucleic acid proteins are generally recognized to be safe. See Pls.' Resp. to Defs.' Stmt. ¶ 1. Plaintiffs have argued, however, that significant disagreement exists among scientific experts as to whether or not nucleic acid proteins are generally recognized to be safe when they are used to alter organisms genetically. Having examined the record in this case, the Court cannot say that FDA's decision to accord genetically modified foods a presumption of GRAS status is arbitrary and capricious. "The rationale for deference is particularly strong when the [agency] is evaluating scientific data within its technical expertise." International Fabricare Institute v. U.S.E.P.A., 972 F.2d 384, 389 (D.C.Cir.1992). "[I]n an area characterized by scientific and technological uncertainty[,] ... this court must proceed with particular caution, avoiding all temptation to direct the agency in a choice between rational alternatives."

Environmental Defense Fund, Inc. v. Costle, 578 F.2d 337, 339 (D.C.Cir.1978).

To be generally recognized as safe, a substance must meet two criteria: (1) it must have technical evidence of safety, usually in published scientific studies, and (2) this technical evidence must be generally known and accepted in the scientific community. See 21 C.F.R. § 170.30(a-b); 62 Fed.Reg. 18940. Although unanimity among scientists is not required, "a severe conflict among experts ... precludes a finding of general recognition." 62 Fed.Reg. at 18939. Plaintiffs have produced several documents showing significant disagreements among scientific experts.^[7] However, this Court's review is confined to the record before the agency at the time it made its decision. IMS, P.C. v. Alvarez, 129 F.3d 618, 623 (D.C.Cir.1997); Walter O. Boswell Mem'l Hosp. v. Heckler, 749 F.2d 788, 792 (D.C.Cir.1984) ("If a court is to review an agency's record fairly, it should have before it neither more nor less information than did the agency when it made its decision."). Therefore, the affidavits submitted by Plaintiffs that are not part of the administrative record will not be considered.

Nonetheless, Plaintiffs, pointing to the critical comments of lower-level FDA officials insist that even the administrative record reveals a lack of general recognition of safety among qualified experts. See Pl's Mot. at 35. However, lower-level [178] comments on a regulation "do[ ] not invalidate the agency's subsequent application and interpretation of its own regulation." San Luis Obispo Mothers for Peace v. U.S. Nuclear Regulatory Comm'n, 789 F.2d 26, 33 (D.C.Cir.1986). Moreover, pointing to a 44,000 page record, the FDA notes that Plaintiffs have chosen to highlight a selected few comments of FDA employees, which were ultimately addressed in the agency's final Policy Statement. As a result, Plaintiffs have failed to convince the Court that the GRAS presumption is inconsistent with the statutory requirements.

E. Labeling

Plaintiffs have also challenged the Statement of Policy's failure to require labeling for genetically engineered foods, for which FDA relied on the presumption that most genetically modified food ingredients would be GRAS. See Pl.'s Mot. at 39. Plaintiffs claim that FDA should have considered the widespread consumer interest in having genetically engineered foods labeled, as well as the special concerns of religious groups and persons with allergies in having these foods labeled. See Pl.'s Mot. at 51-54.

The FDCA, 21 U.S.C. § 321(n), grants the FDA limited authority to require labeling. In general, foods shall be deemed misbranded if their labeling "fails to reveal facts ... material with respect to consequences which may result from the use of the article to which the labeling ... relates under the conditions of use prescribed in the labeling ... or under such conditions of use as are customary or usual." 21 U.S.C. § 321(n). Plaintiffs challenge the FDA's interpretation of the term "material." Thus, the question is again one of statutory interpretation. As is apparent from the statutory language, Congress has not squarely addressed whether materiality pertains only to safety concerns or whether it also includes consumer interest. Accordingly, interpretation of the § 321(n)'s broad language is left to the agency. Cf. Community Nutrition Inst. v. Block, 749 F.2d 50, 54 (D.C.Cir.1984) ("[T]he relatively unspecific nature of the labeling standard which Congress has prescribed ... suggests that this is an area in which courts must give great deference to the Secretary [of Agriculture]'s judgments.").

Because Congress has not spoken directly to the issue, this Court must determine whether the agency's interpretation of the statute is reasonable. See Chevron, 467 U.S. at 864, 104 S.Ct. 2778. Agency interpretations receive substantial deference, particularly when the agency is interpreting a statute that it is charged with administering. See Rust v. Sullivan, 500 U.S. 173, 184, 111 S.Ct. 1759, 114 L.Ed.2d 233 (1991). Even if the agency's interpretation is not "the best or most natural by grammatical or other standards," if the interpretation is reasonable, then it is entitled to deference. Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 702, 111 S.Ct. 2524, 115 L.Ed.2d 604 (1991).

The FDA takes the position that no "material change," under § 321(n), has occurred in the rDNA derived foods at issue here. Absent unique risks to consumer health^[8] or uniform changes to food derived [179] through rDNA technology, the FDA does not read § 321(n) to authorize an agency imposed food labeling requirement. More specifically irksome to the Plaintiffs, the FDA does not read § 321(n) to authorize labeling requirements solely because of consumer demand. The FDA's exclusion of consumer interest from the factors which determine whether a change is "material" constitutes a reasonable interpretation of the statute. Moreover, it is doubtful whether the FDA would even have the power under the FDCA to require labeling in a situation where the sole justification for such a requirement is consumer demand. See Stauber v. Shalala, 895 F.Supp. 1178, 1193 (W.D.Wis.1995) ("In the absence of evidence of a material difference between [milk from cows treated with a synthetic hormone] and ordinary milk, the use of consumer demand as the rationale for labeling would violate the Food, Drug, and Cosmetic Act.").

Plaintiffs fail to understand the limitation on the FDA's power to consider consumer demand when making labeling decisions because they fail to recognize that the determination that a product differs materially from the type of product it purports to be is a factual predicate to the requirement of labeling. Only once materiality has been established may the FDA consider consumer opinion to determine whether a label is required to disclose a material fact. Thus, "if there is a [material] difference, and consumers would likely want to know about the difference, then labeling is appropriate. If, however, the product does not differ in any significant way from what it purports to be, then it would be misbranding to label the product as different, even if consumers misperceived the product as different." Id. The FDA has already determined that, in general, rDNA modification does not "materially" alter foods, and as discussed in Section II.E, supra, this determination is entitled to deference.^[9] Given these facts, the FDA lacks a basis upon which it can legally mandate labeling, regardless of the level of consumer demand.

Plaintiffs also contend that the process^[10] of genetic modification is a "material fact" under § 321(n) which mandates special labeling, implying that there are new risks posed to the consumer. However, the FDA has determined that foods produced through rDNA techniques do not "present any different or greater safety concern than foods developed by traditional plant breeding," and concluded that labeling was not warranted. 57 Fed.Reg. at 22991. That determination, unless irrational, is entitled to deference. See Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 702, 111 S.Ct. 2524, 115 L.Ed.2d 604 (1991). Accordingly, there is little basis upon which this Court could find that the FDA's interpretation of § 321(n) is arbitrary and capricious.

F. Free Exercise

Plaintiffs have argued that the Statement of Policy unconstitutionally violates their right to free exercise of religion by allowing unlabeled genetically engineered foods on the market. Under the Supreme Court's decision in Employment Division v. Smith, 494 U.S. 872, 110 S.Ct. 1595, 108 L.Ed.2d 876 (1990), however, neutral laws of general applicability do not violate the Free Exercise Clause, even if the laws incidentally burden religion. See id. at 878. Because it is not disputed that [180] the Statement of Policy is neutral and generally applicable, Plaintiffs Free Exercise Claim must fail. See Pls.' Mot. at 64 (conceding that the Statement of Policy is neutral and generally applicable).^[11]

G. Religious Freedom Restoration Act

Plaintiffs also claim that the Statement of Policy burdens their religion in violation of the Religious Freedom Restoration Act (RFRA), 42 U.S.C. § 2000bb-2000bb-4. See Pls.' Mot. at 58. Congress enacted RFRA in reaction to the Employment Division v. Smith decision in order to "restore the compelling interest test" for Free Exercise issues. § 2000bb(b). RFRA's definition of the compelling interest test provides that "Government shall not substantially burden a person's exercise of religion even if the burden results from a rule of general applicability ... [unless the rule is] (1) in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest." § 2000bb-1(a-b). This test is not to be "construed more stringently or more leniently than it was prior to Smith." H.R.Rep. No. 103-88, at 7 (1993).

Although the Supreme Court has overruled the portions of RFRA applicable to the state governments on the grounds that Congress exceeded its authority under the Fourteenth Amendment, see City of Boerne v. Flores, 521 U.S. 507, 536, 117 S.Ct. 2157, 138 L.Ed.2d 624 (1997), its holding does not affect RFRA's applicability to the federal government. Cf. Alaska Airlines v. Brock, 480 U.S. 678, 684, 107 S.Ct. 1476, 94 L.Ed.2d 661 (1987) ("A court should refrain from invalidating more of the statute than is necessary ..."). Before Boerne, this Circuit held that Congress had the authority to enact RFRA as to federal law. See EEOC v. Catholic Univ. of Am., 83 F.3d 455, 470 (D.C.Cir. 1996). While this Circuit has not squarely addressed the constitutionality of RFRA as applied to the federal government since Boerne, several decisions in this and other circuits support the continuing validity of Catholic University's holding that RFRA applies to the federal government. See Alamo v. Clay, 137 F.3d 1366, 1368 (D.C.Cir.1998) (assuming without deciding that RFRA applies to the federal government); In re Young, 141 F.3d 854, 863 (8th Cir.1998), cert. denied, 525 U.S. 811, 119 S.Ct. 43, 142 L.Ed.2d 34 (1998) (holding the portion of RFRA applicable to federal law constitutional); see also Branch Ministries v. Rossotti, 40 F.Supp.2d 15, 24 n. 6 (D.D.C.1999) (applying RFRA after federal government conceded RFRA's constitutionality as applied to it.)

Defendants concede that RFRA applies to the FDA. See Def.'s Mot. at 42. Assuming arguendo that Plaintiffs' meet the RFRA requirement that their beliefs are sincerely held and can demonstrate an "honest conviction" desiring to avoid genetically engineered foods, see Thomas v. Review Board, Indiana Employment Sec. Div., 450 U.S. 707, 715-16, 101 S.Ct. 1425, 67 L.Ed.2d 624 (1981), Plaintiffs still must establish that Defendants have substantially burdened Plaintiffs' religion. See 42 U.S.C. § 2000bb-1(b). A substantial burden does not arise merely because "the government refuses to conduct its own affairs in ways that comport with the religious beliefs of particular citizens." See Bowen v. Roy 476 U.S. 693, 699, 106 S.Ct. 2147, 90 L.Ed.2d 735 (1986). The Free Exercise Clause (as interpreted before Smith and incorporated into RFRA) does not require the government to take action to further the practice of individuals' religion. See id. Indeed, were the government to take such action, it might bring itself precariously close to violating the First Amendment's Establishment Clause.

Arguing that the government does have some obligation to facilitate the practice of religion, Plaintiffs point to several cases involving prisoners, in which the government [181] was required to provide nutritional information and alternative diets for inmates whose religious beliefs required dietary restrictions. See Pl.'s Reply at 44; Barnett v. Rodgers, 410 F.2d 995, 999 (D.C.Cir.1969) (rejecting the government's contention that Muslim inmates could practice their religion by simply not eating foods they found objectionable and held that the government was required to disclose the pork content of meals and make at least one pork-free meal a day available). However, the prisoner cases cited by the Plaintiffs are inapposite to the issue before this Court. In this case, the Plaintiffs' liberty is not restricted and they are free to choose their food and may obtain their food from the source of their choosing.

Still, Plaintiffs argue that in the absence of labeling they are unable to know whether the foods they consume are genetically engineered or not. See Pls.' Reply at 44-45. While the Court recognizes the potential inconvenience the lack of labeling presents for Plaintiffs, Defendant's decision to mandate labeling of genetically modified foods does not "substantially" burden Plaintiffs' religious beliefs. Furthermore, given that the FDA functions under statutory power granted by Congress and cannot exceed that power, Plaintiffs' argument on this point is probably better directed at Congress, than at the Defendant or this Court.^[12] The Policy Statement does not place "substantial pressure" on any of the Plaintiffs, nor does it force them to abandon their religious beliefs or practices. See Branch Ministries v. Rossotti, 40 F.Supp.2d 15 (D.D.C.1999) (citing Thomas v. Review Bd. of Indiana Employment Sec. Div., 450 U.S. 707, 718, 101 S.Ct. 1425, 67 L.Ed.2d 624 (1981) and Sherbert v. Verner, 374 U.S. 398, 404, 83 S.Ct. 1790, 10 L.Ed.2d 965 (1963)). Accordingly, Plaintiffs are not entitled to relief under *** RFRA.

CONCLUSION

For the foregoing reasons, the Court determines that Defendant's 1992 Policy Statement did not violate the Administrative Procedures Act, the National Environmental Policy Act, or the procedures mandated by the FDCA and FDA regulations. Furthermore, Defendant was not arbitrary and capricious in its finding that genetically modified foods need not be labeled because they do not differ "materially" from non-modified foods under 21 U.S.C. § 321(n). Finally, the Court finds that Defendant's Policy Statement does not violate the First Amendment Free Exercise Clause or RFRA, 42 U.S.C. § 2000bb-1(b). Hence, the Court denies Plaintiffs' motion for summary judgment and grants Defendant's motion for same. An appropriate order accompanies this memorandum opinion.

[1] Because the Court finds that the Statement is a policy statement, it does not reach the question of whether the Statement could be viewed alternatively as an interpretive rule. See Syncor Int'l Corp. v. Shalala, 127 F.3d 90, 94-95 (D.C.Cir.1997) (suggesting that an agency statement cannot be both an interpretive rule and a policy statement). "An agency policy statement does not seek to impose or elaborate or interpret a legal norm. It merely represents an agency position with respect to how it will treat—typically enforce—the governing legal norm." Id. at 94.

[2] See Community Nutrition Inst. v. Young, 818 F.2d 943, 946 (D.C.Cir.1987) ("The distinction between legislative rules and interpretive rules or policy statements has been described at various times as `tenuous,' `fuzzy,' `blurred,' and perhaps most picturesquely, `enshrouded in considerable smog.'") (citations omitted).

[3] Moreover, were the Court to consider the agency's application, Plaintiff has not shown that the agency has treated the Statement as binding. The FDA has used a food additive petition process to declare one genetically engineered food to be safe, and it has labeled two others to account for their differences from traditionally engineered foods. See 21 C.F.R. §§ 173.170, 573.130 (recognizing as safe the food additive aminoglycoside 3'-phospotransferase II, the additive used to genetically modify the Flavr Savr tomato); AR at 37832-33; 37836; 39947-48. Plaintiffs argue that the food additive petition for aminoglycoside 3'-phototransferase II is irrelevant because the FDA acted on the petition before the publication of the 1992 Statement of Policy. See Pls.' Reply at 11; see also 56 Fed. Reg. 20004 (1991) (requesting notice and comment on the food additive petition). Final action on this food additive petition, however, took place in 1994, nearly two years after publication of the Statement. See 59 Fed.Reg. 26711 (1994). FDA proceeded with the food additive petition process even after issuing the Statement of Policy, indicating that FDA did not believe the Statement constrained its authority to consider regulations on specific genetically engineered foods.

[4] Because the Statement of Policy is not a major federal action, the Court need not to address Defendants' alternative argument that the Statement was covered by a categorical exclusion to NEPA.

[5] Plaintiffs have argued that internal FDA documents which contemplate the preparation of an EIS and the agencies' invocation of a categorical exclusion in the Statement of Policy demonstrate that Defendants "have already admitted that the 1992 Policy is subject to NEPA review." Pls.' Mem. in Opp'n to Defs.' Mot. to Dismiss or for Summ.J. ["Pls.' Opp'n"] at 15. These facts do not, however, alter the analysis in this case. If the agency has not taken a major action, then NEPA does not apply regardless of whether FDA considered preparing an EIS or whether it claimed the Statement was covered by a categorical exception.

Plaintiffs have also argued that FDA regulations require the preparation of environmental assessments when the agency affirms a substance as GRAS or approves a food additive provision. See Pl.'s Response at 16; 21 C.F.R. § 25.20(i), (k). Yet for the purpose of reviewing Plaintiffs' challenge to the Statement of Policy, the agency has merely established a rebuttable presumption and not finally determined the GRAS status of any food substance.

[6] This section provides more extensively that:

The term `food additive' means any substance the intended use of which results or may result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use....

21 U.S.C. § 321(s)

[7] See Pls.' Mot. Ex. 2 (Plaintiff scientist affidavit describing dangers of rDNA technology), Ex. 3 (Scientist affidavit describing rDNA technology as "inherently risky"), Ex. 4 (Scientist affidavit describing risks of rDNA technology); Pls.' Reply Ex. 12 (Administrative Record at 18,952-53 [hereinafter AR]) (FDA scientist comments on the Statement of Policy, noting difference between genetic engineering and cross-breeding); Ex. 13 (AR at 19,179) (FDA scientist criticizing scientific basis of Statement of Policy); Ex. 15 (FDA scientists arguing that pre-market review of genetically engineered foods is necessary); AR at 18,130 (FDA scientist arguing that Food Additives Amendment should be applied to rDNA engineered foods); AR at 18,572 (FDA toxicology group head warning that genetically modified plants could have high levels of toxins).

[8] In other contexts, the FDA has identified that the presence of an increased risk to consumer safety constitutes a "material change." See e.g., 49 Fed.Reg. 13679 (pertaining to FDA requirement in 21 C.F.R. § 101.17(d)(1) that a special warning statement appear on the label of protein products intended for use in weight reduction due to health risks associated with very low calorie diets). Likewise, should a material consequence exist for a particular rDNA-derived food, the FDA has and will require special labeling. See Fed. Reg. 22991; AR at 37782-843, 39849-963 (discussing the requirement that laureate canola and high-oleic acid soybean oil have special labeling because they differ in composition and use from the traditional canola and soybean oil.). However, the Policy Statement at issue here provides only a very general rule regarding the entire class of rDNA derived foods. Thus, without a determination that, as a class, rDNA derived food pose inherent risks or safety consequences to consumers, or differ in some material way from their traditional counterparts, the FDA is without authority to mandate labeling.

[9] Plaintiffs' implication that this interpretation is not entitled to deference because it represents a change in policy is largely unsupported, and therefore, lacks merit.

[10] Disclosure of the conditions or methods of manufacture has long been deemed unnecessary under the law. The Supreme Court reasoned in 1924, "When considered independently of the product, the method of manufacture is not material. The act requires no disclosure concerning it." U.S. v. Ninety-Five Barrels (More or Less) Alleged Apple Cider Vinegar, 265 U.S. 438, 445, 44 S.Ct. 529, 68 L.Ed. 1094 (1924) (referring to the Food and Drug Act of June 30, 1906, Pub.L. No. 59-384, 34 Stat. 768, precursor to the FDCA).

[11] Plaintiffs' claim that the Statement of Policy nevertheless violates the Free Exercise Clause because it lacks a rational basis is without merit.

[12] On November 16, 1999, the Genetically Engineered Food Right To Know Act was introduced in the House of Representatives. The bill proposed amending FDCA, the Federal Meat Inspection Act, and the Poultry Products Inspection Act to require that food that contains a genetically engineered material, or that is produced with a genetically engineered material, be labeled accordingly. See H.R. 3377, 106th Cong. (1999).

212 F.Supp.2d 828 (2002)

[829] [830] [831] [832] [833] Adam J. Levitt, Wolf, Haldenstein, Adler, Freeman & Herz, LLC, Chicago, IL, David A.P. Brower, Daniel W. Krasner, Katherine B. DuBose, Wolf, Haldenstein, Adler, Freeman & Herz, LLC, New York City, Melvyn I. Weiss, Robert A. Wallner, Milberg, Wiess, Bershad, Hynes & Lerach, LLP, New York City, Herbert E. Milstein, Michael D. Hausfeld, Richard S. Lewis, Cohen, Milstein, Hausfeld & Toll, PLLC, Washington, DC, Stephen A. Weiss, Christopher A. Seeger, Seth A. Katz, Stuart P. Slotnick, Seeger Weiss, LLP, New York City, for Plaintiffs.

Edward M. Crane, Deborah F. Solmor, Skadden, Arps, Slate, Meagher & Flom (Illinois), Chicago, IL, Sheila L. Birnbaum, Katherine Armstrong, Skadden, Arps, Slate, Meagher & Flom, LLP, New york City, Jeffrey E. Stone, Cathy McNeil Stein, McDermott, Will & Emery, Chicago, IL, for Defendants.

MEMORANDUM OPINION AND ORDER

MORAN, Senior District Judge.

This controversy arises from the discovery of genetically modified corn in various food products. Plaintiffs Marvin Kramer, Mitchell and Claude Corbin, Corbin Farms LLC, Clint Killin, Charles Dupraz, William Furlong, Jemar, Inc., Marvin Luiken, Keith Mudd, Edward Olsen, Gerald Greiger, Verlon Ponto, Jon Untiedt, David Christoffer, Alan Roebke, Mica Schnoebelen, Joseph and Ardene Wirts, Southview Farms, Dennis and Donald Olsen, Gordon Stine, Don Sutter, and Bartt McCormack d/b/a Buford Station Farms allege that defendants Aventis CropScience USA Holdings, Inc. (Aventis) and Garst Seed Company (Garst) disseminated a product that contaminated the entire United States' corn supply, increasing their costs and depressing corn prices. Before us are fifteen separately filed cases, consolidated here for pretrial purposes by the Panel for Multidistrict Litigation. See 28 U.S.C. § 1407. Plaintiffs have filed a 57-count master second amended consolidated class action complaint, alleging common law claims for negligence, strict liability, private nuisance, public nuisance and conversion on behalf of a nationwide class of corn farmers against Garst, and on behalf of ten statewide classes against Aventis, as well as statutory claims against Aventis under the Tennessee Consumer Protection Act of 1997, Tenn.Code Ann. §§ 47-18-101 et seq., and the North Carolina Unfair Trade Practices Act, N.C. Gen.Stat. § 75-1.1 (1999). Defendants filed a motion to dismiss, arguing that the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136 et seq., preempts plaintiffs' state law claims, that the economic loss doctrine bars any recovery, and that the complaint fails to state a claim under any of plaintiffs' purported legal theories. For the following reasons, defendants' motion to dismiss is granted in part and denied in part.

BACKGROUND

Aventis^[1] genetically engineered a corn seed to produce a protein known as Cry9C [834] that is toxic to certain insects. The seeds are marketed under the brand name StarLink. Garst is a licensee who produced and distributed StarLink seeds. Aventis applied to register StarLink with the EPA, which is responsible for regulating insecticides under FIFRA, 7 U.S.C. §§ 136 et seq. The EPA noted that Cry9C had several attributes similar to known human allergens, and issued only a limited registration, permitting StarLink use for such purposes as animal feed, ethanol production and seed increase, but prohibiting its use for human consumption. Consequently, segregating it from non-StarLink corn, which was fit for human consumption, became of utmost importance. A little background about normal practices for cultivating, harvesting and distributing corn demonstrates the extensive steps necessary to prevent StarLink corn from entering the food supply.

Corn replicates by the transfer of pollen from one corn plant to another, including cross-pollination from one breed to another. Once airborne, corn pollen can drift over considerable distances, meaning that different corn varieties within a farm, and from neighboring farms, regularly cross-breed. With few exceptions, there are not procedures in place to segregate types of corn. Different corn breeds within an individual farm are commingled at the harvesting stage. Corn from hundreds of thousands of farms is then further commingled as it is gathered, stored and shipped through a system of local, regional and terminal grain elevators. Elevators, storage and transportation facilities are generally not equipped to test and segregate corn varieties. The commingled corn is then marketed and traded as a fungible commodity.

In light of these general practices in the corn industry, the EPA required special procedures with respect to StarLink. These included mandatory segregation methods to prevent StarLink from commingling with other corn in cultivation, harvesting, handling, storage and transport, and a 660-foot "buffer zone" around StarLink corn crops to prevent cross-pollination with non-StarLink corn plants. The limited registration also made Aventis responsible for ensuring these restrictions were implemented, obligating it (a) to inform farmers of the EPA's requirements for the planting, cultivation and use of StarLink; (b) to instruct farmers growing StarLink how to store and dispose of the StarLink seeds, seed bags, and plant detritus; and (c) to ensure that all farmers purchasing StarLink seeds signed a contract binding them to these terms before permitting them to grow StarLink corn.

StarLink was distributed throughout the United States from approximately May 1998 through October 2000. The limited registration initially limited StarLink cultivation to 120,000 acres. In January 1999, Aventis petitioned the EPA to raise this limit to 2.5 million acres. The EPA agreed, subject to an amended registration that required Aventis to

(a) inform purchasers (i.e. "Growers") at the time of StarLink seed corn sales, of the need to direct StarLink harvest to domestic feed and industrial non-food uses only;

(b) require all Growers to sign a "Grower Agreement" outlining field management requirements and stating the limits on StarLink corn use;

(c) deliver a Grower Guide, restating the provisions stated in the Grower Agreement, with all seed;

(d) provide all Growers with access to a confidential list of feed outlets and elevators [835] that direct grain to domestic feed and industrial uses;

(e) write to Growers prior to planting, reminding them of the domestic and industrial use requirements for StarLink corn;

(f) write to Growers prior to harvest, reminding them of the domestic and industrial use requirements for StarLink corn;

(g) conduct a statistically sound follow-up survey of Growers following harvest, to monitor compliance with the Grower Agreement.

Over this 29-month period, StarLink cultivation expanded from 10,000 acres to 350,000 acres.

In October 2000, after numerous reports that human food products had tested positive for Cry9C, a wave of manufacturers issued recalls for their corn products. On October 12, 2000, Aventis, at EPA's urging, applied to cancel the limited registration, effective February 20, 2001. Fear of StarLink contamination nonetheless continues to affect corn markets. Many U.S. food producers have stopped using U.S. corn, replacing it with imported corn or corn substitutes. South Korea, Japan and other foreign countries have terminated or substantially limited imports of U.S. corn. Grain elevators and transport providers are now mandating expensive testing on all corn shipments.

Plaintiffs allege that the widespread StarLink contamination of the U.S. corn supply is a result of defendants' failure to comply with the EPA's requirements. Aventis did not include the EPA-mandated label on some StarLink packages, did not notify, instruct and remind StarLink farmers of the restrictions on StarLink use, proper segregation methods and buffer zone requirements, and did not require StarLink farmers to sign the obligatory contracts. Prior to the 2000 growing season Aventis allegedly instructed its seed representatives that it was unnecessary for them to advise StarLink farmers to segregate their StarLink crop or create buffer zones because Aventis believed the EPA would amend the registration to permit StarLink use for human consumption. In July 2001, however, an EPA Scientific Advisory Panel reaffirmed its previous position on StarLink's allergenic qualities. Further, the FDA has declared StarLink to be an adulterant under the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq.

DISCUSSION

Fed.R.Civ.P. 8(a)(2) only requires "a short and plain statement of the claim showing that the pleader is entitled to relief." When deciding a Rule 12(b)(6) motion we must assume the truth of all well-pleaded factual allegations, making all possible inferences in the plaintiff's favor. Sidney S. Arst Co. v. Pipefitters Welfare Educ. Fund, 25 F.3d 417, 420 (7th Cir. 1994). We will dismiss a claim only if it appears "beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).

I. Preemption

FIFRA, 7 U.S.C. §§ 136 et seq., regulates the use, sale and labeling of pesticides such as the Cry9C protein found in StarLink corn. The EPA approved StarLink's label and issued a limited registration for it to be distributed. Defendants argue that FIFRA preempts plaintiffs' state law claims.

FIFRA does not preempt all state laws respecting pesticides. Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 614, 111 S.Ct. 2476, 115 L.Ed.2d 532 (1991). The statute expressly authorizes states to regulate pesticide use. 7 U.S.C. § 136v(a). But it also prohibits states from imposing any labeling requirements [836] beyond those imposed by the EPA. 7 U.S.C. § 136v(b).

The Supreme Court has made clear that "requirements" includes both positive law, in the form of statutory and regulatory obligations, and any common law standards which could give rise to civil damages. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (interpreting preemption clause in Public Health Cigarette Smoking Act of 1969, 15 U.S.C. §§ 1331-1340). FIFRA uses nearly identical language to the Cigarette Act, and its preemptive effect is equivalent. Shaw v. Dow Brands, Inc., 994 F.2d 364, 370-71 (7th Cir.1993).^[2] FIFRA therefore preempts any claims based on the inadequacy of StarLink's label or defendants' failure to warn StarLink farmers.

Moreover, plaintiffs cannot avoid preemption by artful pleading. We must scrutinize their allegations to ensure that they are not disguised failure-to-warn claims. See, e.g., Grenier v. Vermont Log Buildings, 96 F.3d 559, 564 (1st Cir.1996). If a claim amounts to a constructive challenge to the EPA-approved label, FIFRA preempts it. Courts have, however, recognized certain types of claims as falling outside of FIFRA. See, e.g., Worm v. American Cyanamid Co. (Worm I), 970 F.2d 1301, 1308 (4th Cir.1992) (state remedy for failure to comply with EPA requirements); Lowe v. Sporicidin Int'l, 47 F.3d 124, 130 (4th Cir.1995) (off-label representations inconsistent with the label); New York State Pesticide Coalition v. Jorling, 874 F.2d 115, 119 (2d Cir.1989) (failure to warn third parties); National Bank of Commerce v. Dow Chemical Co., 165 F.3d 602, 609 (8th Cir.1999) (design defects). Portions of the complaint implicate each of these, so we discuss them in turn.

First, plaintiffs allege that defendants sold StarLink seeds without the EPA-required label, and otherwise failed to comply with the limited registration's terms. There is no federal private right of action to redress FIFRA violations. Only the EPA has standing to enforce it. No Spray Coalition, Inc. v. City of New York, 252 F.3d 148, 150 (2d Cir.2001). FIFRA does not, however, prevent states from creating civil remedies for violating the federal standard. See, e.g., Lowe, 47 F.3d at 128; MacDonald v. Monsanto, 27 F.3d 1021, 1024 (5th Cir.1994). The statute only prohibits additional requirements, not identical ones. 7 U.S.C. § 136v(b). Although potential civil liability obviously increases the manufacturer's incentive to comply, if the state is merely adopting as its standard of care that which is already required under federal law, no additional obligation is imposed.^[3] FIFRA, therefore, does not preempt plaintiffs' negligence per se claims.

Next, plaintiffs assert that defendants made voluntary statements regarding StarLink beyond those on the EPA-approved label that contributed to the contamination. Claims based on off-label representations are preempted if they merely reiterate information contained in the label. Lowe, 47 F.3d at 130. They are not preempted, however, to the extent the representations [837] substantially differ from the label. Id.^[4] The complaint alleges that Aventis instructed seed representatives to tell farmers that StarLink was safe for human consumption and that the EPA was going to issue a tolerance for Cry9C in food products. Such statements directly contradict the approved label and therefore fall within Lowe.

Plaintiffs also advance the theory that defendants failed to adequately inform those who handled corn further down the distribution chain, e.g., grain elevator operators and transport providers, of the required warnings. Courts have noted the distinction between failure to warn the initial purchaser and failure to warn third parties.

FIFRA "labeling" is designed to be read and followed by the end user. Generally it is conceived as being attached to the immediate container of the product in such a way that it can be expected to remain affixed during the period of use.... By contrast, the target audience of the [state] notification program is those innocent members of the general public who may unwittingly happen upon an area where strong poisons are present, as well as those who contract to have pesticides applied.

New York State Pesticide Coalition, 874 F.2d at 119; see also Mortier, 501 U.S. at 603, 111 S.Ct. 2476 (upholding regulation requiring placards be posted to notify third parties of pesticide use). Parties who handle StarLink corn down the supply chain will not see the label on the original seed bag and, consequently, will not know that a particular batch of corn is unfit for human consumption and must be segregated and handled differently. States can reasonably require that pesticide manufacturers share the same EPA-approved warnings with parties beyond the immediate purchaser. Similar to permitting state causes of action for directly violating FIFRA, because the state standard here would mirror the federal one in substance, it does not interfere with the EPA's prerogative with respect to labeling and does not constitute an additional requirement.

Finally, plaintiffs allege that StarLink corn is a defective product. They assert that, as currently designed, StarLink cannot be safely used for its intended non-food purposes because it will inevitably commingle and cross-pollinate with the food supply. The EPA's approval of a product's FIFRA label does not constitute a finding or an endorsement that its design is safe. See generally Jeffers v. Wal-Mart Stores, Inc., 171 F.Supp.2d 617, 623-24 (S.D.W.Va.2001). Here we must be careful to determine whether their allegations are really challenging the product design, which is permissible, or effectively challenging the accompanying warnings, which would be preempted. The test most frequently articulated is, when confronted with a type of harm, would the manufacturer change the design or the label to prevent its recurrence? Worm v. American Cyanamid Co. (Worm II), 5 F.3d 744, 747-48 (4th Cir.1993).

Defendants' failure to prevent commingling has nothing to do with StarLink's design. Plaintiffs acknowledge that, although it is not the general practice, there are means to segregate types of corn such that they maintain their identity.^[5] It is a [838] matter of ensuring that everyone who handles the corn adheres to certain procedures. Confronted with commingling, a manufacturer would more likely change the warnings than the design. This constitutes a failure to warn, not a design defect, and therefore FIFRA preempts it.

The allegations regarding StarLink's tendency to cross-pollinate with non-StarLink corn can be read two ways. One is that defendants should have known that the 660-foot buffer zone was insufficient to prevent cross-pollination. The 660-foot requirement was incorporated in the limited registration and would have been communicated to farmers by the EPA-approved label. A state standard of care demanding more than a 660-foot buffer would be an additional requirement in the form of a different warning. FIFRA preempts such a claim.

It is also possible to view plaintiffs' cross-pollination charge as asserting that no buffer zone could prevent it. The theory posits that, given the way corn reproduces, cross-pollination between corn targeted for non-food uses and corn intended for the human food supply is inevitable. Defendants, therefore, had a duty to design insect-resistant corn such that it is fit for human consumption — use a protein that is safer than Cry9C. This still attacks the label because it is premised on the idea that the buffer zone warning was not sufficient to prevent cross-pollination. The EPA approved the label with the knowledge that StarLink was unfit for human consumption. It deemed the 660-foot buffer zone an adequate warning to preserve the integrity of the food supply. Plaintiffs' defect claims implicitly challenge this warning and are therefore preempted.

In summary, plaintiffs may proceed on the theory that defendants (1) violated duties imposed by the limited registration; (2) made representations to StarLink growers that contradicted the EPA-approved label; and (3) failed to inform parties handling StarLink corn downstream of the EPA-approved warnings.

II. Economic Loss Doctrine

This rule limits the types of damages plaintiffs may recover in tort. Physical injuries to persons or property are compensable; solely economic injuries are not. The difficult question is defining what constitutes an "economic" injury.

Although there is some variation at the margins among jurisdictions, they all recognize the same basic policy. For example, Illinois defines economic losses as

damages for inadequate value, costs of repair and replacement of the defective product, or consequent loss of profits — without any claim of personal injury or damage to other property ... as well as the diminution in the value of the product because it is inferior in quality and does not work for the general purposes for which it was manufactured and sold.

Moorman Mfg. Co. v. National Tank Co., 91 Ill.2d 69, 61 Ill.Dec. 746, 435 N.E.2d 443, 449 (1982). Wisconsin, by comparison, states:

Economic loss is generally defined as damages resulting from inadequate value because the product "is inferior and does not work for the general purposes for which it was manufactured and sold." It includes both direct economic loss and consequential economic loss. The former is loss in value of the product itself; the latter is all other economic losses attributable to the product defect.

Daanen & Janssen, 573 N.W.2d at 845 (citations omitted); see also Determan v. Johnson, 613 N.W.2d 259, 262 (Iowa 2000); Northwest Ark., Masonry, Inc. v. Summit Specialty Products, Inc., 29 Kan.App. 735, 31 P.3d 982, 987 (2001); Lloyd F. Smith [839] Co. v. Den-Tal-Ez, Inc., 491 N.W.2d 11, 15 (Minn.1992); Groppel Co. v. United States Gypsum Co., 616 S.W.2d 49, 55 n. 5 (Mo. Ct.App.1981); National Crane Corp. v. Ohio Steel Tube Co., 213 Neb. 782, 332 N.W.2d 39, 42 (1983); Steiner v. Ford Motor Co., 606 N.W.2d 881, 883 (N.D. 2000); Diamond Surface, Inc. v. State Cement Plant Comm'n, 583 N.W.2d 155, 161 (S.D.1998); McCrary v. Kelly Technical Coatings, Inc., 1985 WL 75663 at *3 (Tenn.Ct.App.1985). The recurring theme is that economic losses are about disappointed commercial expectations.

The classic case involves the purchase of a defective product.^[6] The suit seeks compensation for the cost of repairing or replacing the product, and profits lost due to the product being out of service. See, e.g., Seely v. White Motor Co., 63 Cal.2d 9, 45 Cal.Rptr. 17, 403 P.2d 145 (1965) (en banc) (lost profits due to defective delivery truck); Rardin v. T & D Machine Handling, Inc., 890 F.2d 24 (7th Cir.1989) (broken printing press). The rule includes a product that is of inferior quality, that fails to work for the general purpose for which it was manufactured, or that does harm to itself — if a product breaks down it is really just another form of the product failing to fulfill its expected performance. Purchasers who want to insure against these failures are free to negotiate those terms, or they may choose to forego these protections in exchange for a discounted price. In any event, parties can allocate the risks according to their own preferences. It is only when the product harms a person, or some property other then the product itself, that tort law provides a remedy.

The doctrine derives its origin from Justice Traynor's opinion in Seely, supra. The primary policy concerns are:

(1) to maintain the fundamental distinction between tort law and contract law; (2) to protect commercial parties' freedom to allocate economic risk by contract; and (3) to encourage the party best situated to assess the risk of economic loss, the commercial purchaser, to assume, allocate, or insure against that risk.

Daanen & Janssen, 573 N.W.2d at 846. In describing the distinction between contract and tort, the Wisconsin court observed: "The law of contracts is designed to effectuate exchanges and to protect the expectancy interest of parties to private bargained-for agreements.... Tort law is rooted in the concept of protecting society as a whole from physical harm to person or property." Id. Whenever plaintiff's losses can be characterized as failing to receive the benefit of one's bargain, contract (including any warranty or uniform commercial code protections) is the only remedy.

Although the concept is rooted in freedom-of-contract theory, privity of contract is generally not required. Daanen & Janssen, 573 N.W.2d at 849; Northwest Ark. Masonry, 31 P.3d at 988; Anderson Elec., Inc. v. Ledbetter Erection Corp., 115 Ill.2d 146, 104 Ill.Dec. 689, 503 N.E.2d 246, 249 (1986).^[7] If this were not [840] so, then manufacturers would become liable for economic expectations of secondary purchasers. Daanen & Janssen, 573 N.W.2d at 849. It also extends the rule to litigants who were both involved in a multiparty transaction but did not have any direct contractual relationship. Nigrelli Sys., Inc. v. E.I. DuPont de Nemours and Co., 31 F.Supp.2d 1134 (E.D.Wis.1999). The fact that plaintiffs had no viable contract remedy did not entitle them to recover in tort. We note, however, that in both scenarios the purchasers had an opportunity to negotiate warranty terms with someone — from the secondary seller or through some form of indemnity arrangement.

Another class of cases where courts typically invoke the economic loss doctrine are the so-called "bridge" cases, or, as we will describe them, "access" cases.^[8] In an access case plaintiffs seek compensation for profits lost because the alleged tort prevented customers from reaching their businesses. The paradigm case involves a bridge or road closure. See, e.g., Nebraska Innkeepers, Inc. v. Pittsburgh-Des Moines Corp., 345 N.W.2d 124 (Iowa 1984) (bridge providing access to plaintiffs' businesses closed due to defective steel); Dundee Cement Co. v. Chemical Labs., Inc., 712 F.2d 1166 (7th Cir.1983) (road accessing plaintiff's plant closed due to chemical spill). But the same principle applies any time a business seeks compensation for potential customers being unable to access their premises. See, e.g., In re Chicago Flood Litigation, 176 Ill.2d 179, 223 Ill. Dec. 532, 680 N.E.2d 265 (1997) (flooding to neighboring stores forced merchants whose stores were not physically invaded by water to close).

Although they are nominally under the same economic loss rule, there are really some different policy issues driving the doctrine in access cases. The usual concerns about interfering with contract law and the parties' freedom to allocate risks are not present because there is no contractual relationship. The parties are typically strangers and, with no foreknowledge of each other's activities, had no opportunity to assess and allocate risks ex ante. What these cases share in common with traditional economic loss doctrine jurisprudence is the lack of property damage. Moreover, because the only harms alleged were profits lost due to customers' inability to access the premises, these damages fit neatly within the rubric of "disappointed commercial expectations." Courts also emphasize the speculativeness and potential magnitude of damages in access cases. Lost profits are frequently speculative because we cannot predict potential customers' behavior to a sufficient degree of certainty. And the tort's effects on plaintiffs are not qualitatively different from the effects on society at large. In theory, any bridge or road closing affects everyone to some extent by eliminating one potential travel route. Given the unbounded group of potential plaintiffs, damages would be limitless. So, although the original policy bases for the economic loss doctrine are not present, because of the type of injury, these cases seem to fit, at least linguistically, within the economic loss doctrine.

The corollary to the economic loss rule is that it does not bar claims for injuries to other property, or claims alleged in combination with non-economic losses. Daanen & Janssen, 573 N.W.2d at 845. The question then becomes defining "other property." First, plaintiffs cannot rely on harm to property belonging to other people to show a non-economic injury. [841] They must have an ownership interest in the property. Northridge Co. v. W.R. Grace & Co., 162 Wis.2d 918, 471 N.W.2d 179, 183 (1991). Second, courts have uniformly held that if a defective part of a product harms the rest of the product, that does not constitute "other property." The product still harmed itself, and nothing else. See Cooperative Power Ass'n v. Westinghouse Electric Corp., 493 N.W.2d 661 (N.D.1992). A majority of courts have gone a step further, holding that if a product is integrated into a single system, other parts of that system do not constitute "other property." See Rockport Pharmacy, Inc. v. Digital Simplistics, Inc., 53 F.3d 195, 198 (8th Cir.1995) (Missouri law) (no recovery for lost data because defective part integrated into computer system); Transport Corp. of Amer. v. IBM Corp., 30 F.3d 953, 957 (8th Cir.1994) (Minnesota law) (same); Trans States Airlines v. Pratt & Whitney Canada, Inc., 177 Ill.2d 21, 224 Ill.Dec. 484, 682 N.E.2d 45, 58 (1997) (engine integrated into airplane frame); Northwest Ark. Masonry, 31 P.3d at 987 (cement mix integrated into wall); Midwhey Powder Co. v. Clayton Indus., 157 Wis.2d 585, 460 N.W.2d 426, 429 (App. 1990) (steam generators integrated into turbines). The modern trend is to focus on ex ante expectations. If the damage is of a type that the buyer could have foreseen resulting from the product failing to perform, it does not constitute harm to other property.

[T]he distinguishing central feature of economic loss is ... its relation to what the product was supposed to accomplish. For example, if a fire alarm fails to work and a building burns down, that is "economic loss" even though the building was physically harmed; but if the fire is caused by a short circuit in the fire alarm itself, that is not economic harm.

Tomka v. Hoechst Celanese Corp., 528 N.W.2d 103, 106 (Iowa 1995), quoting Fireman's Fund Am. Ins. Cos. v. Burns Elec. Security Serv., 93 Ill.App.3d 298, 48 Ill. Dec. 729, 417 N.E.2d 131, 133 (1st Dist. 1981); see also Dakota Gasification Co. v. Pascoe Bldg. Sys., 91 F.3d 1094, 1099 (8th Cir.1996) (North Dakota law); Trinity Indus., Inc. v. McKinnon Bridge Co., 77 S.W.3d 159, 173 n. 1 (Tenn.Ct.App.2001), appeal denied (Apr. 29, 2002). Minnesota has gone the furthest, holding that merchants cannot recover in tort for any property damage caused by the defective product. Hapka v. Paquin Farms, 458 N.W.2d 683, 688 (Minn.1990).^[9]

Non-StarLink corn crops are damaged when they are pollinated by StarLink corn. The pollen causes these corn plants to develop the Cry9C protein and renders what would otherwise be a valuable food crop unfit for human consumption. Non-StarLink corn is also damaged when it is commingled with StarLink corn. Once mixed, there is no way to resegregate the corn into its edible and inedible parts. The entire batch is considered tainted and can only be used for the domestic and industrial purposes for which StarLink is approved. None of that supply can ever be used for human food.

There are at least four different points along the supply chain at which StarLink could have entered the food corn supply, all of which are consistent with the complaint: (1) plaintiffs unknowingly purchased seed containing the Cry9C protein, i.e. their suppliers' inventory had been contaminated; (2) plaintiffs' crops were contaminated by pollen from StarLink corn on a neighboring farm; (3) plaintiffs' [842] harvest was contaminated by commingling with StarLink corn in a transport or storage facility; and (4) food manufacturers commingled the corn within their raw material storage or processing activities.^[10] The first situation would fall within the economic loss doctrine. Plaintiffs could have negotiated contractual protection from their suppliers and simply did not get what they had bargained for. In the fourth, plaintiffs would have suffered no harm to their property because the corn was commingled after they had relinquished their ownership interest in it. Scenarios 2 and 3, however, present viable claims for harm to their crops.

The StarLink situation does not fit neatly into traditional economic loss doctrine analysis. Plaintiffs here had no commercial dealings with defendants or defendants' customers. This is more than a lack of direct privity, and not a situation where a party could have negotiated warranty or indemnity protection and chose not to. Plaintiffs had no opportunity to negotiate contractual protection with anyone. Still, as the access cases aptly demonstrate, the economic loss doctrine has grown beyond its original freedom-of-contract based policy justifications. Farmers' expectations of what they will receive for their crops are just that, expectations. Absent a physical injury, plaintiffs cannot recover for drops in market prices. Nor can they recover for any additional costs, such as testing procedures, imposed by the marketplace. But if there was some physical harm to plaintiffs' corn crop,^[11] the lack of a transaction with defendants affects what will be considered "other property." Assuming plaintiffs did not buy corn seeds with the Cry9C protein, it cannot be said that a defective part of their crop injured the whole, that a defective product was integrated into a system or that the harm to their crop was a foreseeable consequence of the seeds' failure to perform. These facts are distinguishable from Hapka, 458 N.W.2d at 688 (holding farmer who purchased diseased seeds could not recover for harm to rest of crop). Plaintiffs' seeds, as purchased, were adequate. The StarLink contaminant was wholly external.

Nor does the StarLink controversy present the unlimited or speculative damage concerns common in access cases. There are a finite number of potential plaintiffs — only non-StarLink corn farmers — who can claim injury. This may be a sizeable group, and the damages may be tremendous, but the fact that defendants are alleged to have directly harmed a large number of plaintiffs is not a defense. StarLink's effects on commercial corn farmers are distinct and qualitatively different from society at large. And damages are easily measured through price changes because corn is a regularly traded commodity with a readily measurable market. Further, as discussed above, the contamination of plaintiffs' corn supply is a physical injury.

To the extent plaintiffs allege that their crops were themselves contaminated, either by cross-pollination in the fields or by commingling later in the distribution chain, they have adequately stated a claim for [843] harm to property. Once plaintiffs have established this harm they may be entitled to compensation for certain economic losses. See, e.g., Schiltz v. Cullen-Schiltz & Assoc., 228 N.W.2d 10, 21 (Iowa 1975) (holding plaintiff who established tangible harm may also recover cleanup costs because they are an integral part of direct property damage); Dundee Cement Co., 712 F.2d at 1170 (noting recovery of lost profits permitted where plaintiff's property was physically injured). But we caution that proving direct harm to their own property is a predicate to any recovery. We leave for another day the question of what, if any, consequential damages they may also collect, and now turn to the substance of plaintiffs' claims.

III. Negligence

Defendants challenge three separate elements: duty, proximate cause and damages. Although cast in terms of a balance between foreseeability, reasonableness and public policy, the essence of their argument is remoteness — any effect StarLink may have had on corn markets is too far removed from defendants' conduct. Defendants contend that the causal relationship involved six distinct steps: (1) the EPA approved the registration for Cry9C; (2) seed companies incorporated the StarLink technology into seed corn; (3) growers purchased StarLink seeds; (4) the StarLink seeds/corn was handled in such a way as to allow cross-pollination and commingling; (5) the tainted corn was introduced into the mainstream corn supply, leading to food product recalls; and (6) the discovery of StarLink in the main food supply hurt corn prices.

In presenting their version of the causal chain, however, defendants have imposed their own construction on the complaint. On a motion to dismiss we must not only accept plaintiffs' version, but also any set of facts consistent with it. First, defendants' argument used their own characterization of Aventis' role, or lack thereof, in bringing StarLink to market. Aventis denies any involvement in numerous steps leading to the widespread StarLink contamination. This is a simple factual dispute. The complaint plainly alleges that Aventis (or its predecessors) were involved in developing and licensing StarLink. Moreover, it alleges that pursuant to the limited registration Aventis was responsible for monitoring and enforcing compliance by StarLink farmers. For now we must accept plaintiffs' version of Aventis' involvement in introducing StarLink into the food supply.

We must also collapse defendants' purported chain from the other end. Although they attempt to characterize the complaint as asserting some remote duty to preserve the market price of corn, the duty alleged is to prevent contamination. The effects on corn markets are merely a way to measure the damages. As we discussed above, we read the complaint to allege direct harm to plaintiffs' corn. Defendants are correct that the complaint does not make this charge specifically, but it is a set of facts that is consistent with plaintiffs' allegations about the impact on the corn system as a whole. At this stage of litigation we must construe this ambiguity in plaintiffs' favor.

Presuming Aventis' more active involvement with StarLink, and presuming further that the latter physically harmed plaintiffs' corn, the chain becomes substantially shorter. Aventis had a duty to ensure that StarLink did not enter the human food supply, and their failure to do so caused plaintiffs' corn to be contaminated.

Lastly, Aventis argues that even if plaintiffs suffered direct harm to their corn, its SES program would fully compensate them. Plaintiffs have alleged otherwise, and for now, that is sufficient.

[844] IV. Conversion

Conversion is defined as "an intentional exercise of dominion or control over a chattel which so seriously interferes with the right of another to control it that the actor may justly be required to pay the other the full value of the chattel." Restatement (Second) of Torts § 222A. Plaintiffs argue that defendants' role in contaminating the corn supply amounts to a conversion of their property. We disagree.

The defining element of conversion, the one that distinguishes it from a trespass to chattels, is the extent of interference with the owner's property rights. If the damage is minor, in duration or severity, plaintiff may only recover for the diminished value. But if the damage is sufficiently severe, plaintiff may recover full value. Conversion is akin to a forced judicial sale. The defendant pays full value for the chattel, and receives title to it. Restatement § 222A comment c. Here, plaintiffs have not alleged that defendants destroyed their crops or deprived them of possession. Plaintiffs retained possession and still had total control over the corn. Most, if not all of it, was ultimately sold to third parties. The only damages were a lower price, for which plaintiffs could be compensated without forcing a sale.

It is possible to convert a chattel by altering it, without completely destroying it. In particular, commingling fungible goods so that their identity is lost can constitute a conversion. Restatement § 226 comment e. To do so, however, the perpetrator must alter the chattel in a way that is "so material as to change the identity of the chattel or its essential character." Restatement § 226 comment d. At worst, StarLink contamination changed plaintiffs' yield from being corn fit for human consumption to corn fit only for domestic or industrial use. Plaintiffs do not claim they were growing the corn to eat themselves, but for sale on the commodity markets. The crops were still viable for the purpose for which plaintiffs would normally use them, for sale on the open market. That the market had become less hospitable does not change the product's essential character. As above, the severity of the alteration is indicated by the decrease in market price. This could arguably constitute a trespass to chattels, but does not rise to the level of conversion.

Lastly, negligence cannot support a conversion claim. It requires intent. Restatement § 224. The complaint alleges that defendants did not take adequate precautions to ensure that StarLink corn was adequately segregated. Nowhere do plaintiffs claim that defendants intentionally commingled StarLink and non-StarLink corn, or deliberately contaminated the food supply. Even if defendants negligently failed to prevent cross-pollination and commingling, they would not be liable for conversion.

V. Nuisance

A. Private

The complaint alleges that defendants created a private nuisance by distributing corn seeds with the Cry9C protein, knowing that they would cross-pollinate with neighboring corn crops.^[12] "A private nuisance is a nontrespassory invasion of another's interest in the private use and enjoyment [845] of land." Restatement (Second) of Torts § 821D. We agree that drifting pollen can constitute an invasion, and that contaminating neighbors' crops interferes with their enjoyment of the land. The issue is whether defendants are responsible for contamination caused by their product beyond the point of sale.

Defendants argue that they cannot be liable for any nuisance caused by StarLink because they were no longer in control of the seeds once they were sold to farmers. But one can be liable for nuisance "not only when he carries on the activity but also when he participates to a substantial extent in carrying it on." Restatement § 834. Plaintiffs maintain that defendants' design of the StarLink technology, distribution of the seeds and, most importantly, their failure to fulfill their EPA-mandated duties, constitutes substantial participation.

The paradigm private nuisance case involves a suit between two neighboring landowners, one of whom alleges that the other's activities are somehow interfering with the first's enjoyment of the land. Suing the manufacturer of the product that the neighbor was using appears to be an extension of nuisance law into an area normally regulated by product liability. But there is precedent for such an application under certain circumstances, and it does fit within the definition of a nuisance.

Looking first at state law from the jurisdictions in question, we find that three have stretched nuisance liability particularly broadly. A Wisconsin court has gone so far as holding that a purchaser can state a nuisance claim directly against a manufacturer. Northridge Co. v. W.R. Grace & Co., 205 Wis.2d 267, 556 N.W.2d 345 (App.1996) (finding asbestos constituted a nuisance). Applying the longstanding rule that "one who has erected a nuisance will be responsible for its continuance, even after he has parted with the title and the possession," Lohmiller v. Indian Ford Water-Power Co., 51 Wis. 683, 8 N.W. 601, 602 (1881), the court held that "manufacturers can be liable for a nuisance long after they relinquish ownership or control over their polluting products." Northridge, 556 N.W.2d at 352.

An Illinois court has also taken a broad view of nuisance, sustaining a public nuisance claim against gun manufacturers. Young v. Bryco Arms, 327 Ill.App.3d 948, 262 Ill.Dec. 175, 765 N.E.2d 1 (1st Dist. 2001). The court relied extensively on language in a gun case from this district, Bubalo v. Navegar, Inc., 1998 WL 142359 (N.D.Ill. Mar.20, 1998).^[13] Both cases emphasized that plaintiffs had alleged malfeasance on the part of the manufacturers, in the form of intentionally marketing their products to appeal to criminals. Id. at *4; Young, 262 Ill.Dec. 175, 765 N.E.2d at 14. In doing so, they distinguished a Seventh Circuit case holding a chemical manufacturer not liable for chemicals released from a customer's facility because "[t]he uncontested record shows that when alerted to the risks associated with [the chemicals], [the manufacturer] made every effort to have [the customer] dispose of the chemicals safely." City of Bloomington v. Westinghouse Electric Corp., 891 F.2d 611, 614 (7th Cir.1989) (Indiana law), quoted in Bubalo, 1998 WL 142359 at *4 n. 2. Bubalo posited:

Suppose, however, that [the manufacturer] had not taken steps to alert customers of the risks of the product, or intentionally marketed the product to customers who it knew or should have known would dispose of [it] in a manner [846] that would harm the environment. Nothing in the opinion in City of Bloomington would preclude the imposition of liability on the manufacturer under those facts.

1998 WL 142359 at *4, quoted in Young, 262 Ill.Dec. 175, 765 N.E.2d at 14. In sustaining the nuisance claim the Illinois court found that the allegation of wrongdoing by the manufacturer "suggested a degree of participation not present in City of Bloomington and `within the meaning of [the] phrase [`to a substantial extent'] in the Restatement § 834.'" Young, 262 Ill. Dec. 175, 765 N.E.2d at 14 (edits in original, citations omitted).

Most analogous to the case at bar, in Page County Appliance Center, Inc. v. Honeywell, Inc., 347 N.W.2d 171, 177 (Iowa 1984), the Iowa Supreme Court explicitly rejected an argument identical to the one raised by defendants here. Plaintiff there alleged that radiation emanating from a neighbor's computer, manufactured by defendant, was affecting appliances in its store. Defendant maintained that it could not be liable for the nuisance because it had sold the computer to the neighbor and was no longer in control of the instrument. The court noted that the manufacturer had an ongoing contract to service and maintain the computer and, therefore, arguably had the ability to abate the nuisance. Relying on Restatement § 834, the court rejected defendant's lack-of-control argument, holding that "[the manufacturer's] material participation was a question of fact." Id.

Defendants point to a number of cases rejecting similar nuisance claims, particularly asbestos and gun cases. None is an authoritative state decision from the jurisdictions involved here.^[14] There are three federal cases interpreting relevant states' law, but they are all asbestos cases, which we distinguish below, and in jurisdictions where the state courts have not considered the central question of whether a manufacturer can be liable for a nuisance caused by its product beyond the point of sale. See Tioga Public School Dist. No. 15 v. United States Gypsum Co., 984 F.2d 915, 920 (8th Cir.1993); Appletree Square 1 Ltd. v. W.R. Grace & Co., 815 F.Supp. 1266, 1274 n. 13 (D.Minn.1993); County of Johnson v. United States Gypsum Co., 580 F.Supp. 284, 294 (E.D.Tenn.1984).^[15]

This brings us to the case at bar, which is much closer to mainstream nuisance doctrine than either the asbestos or gun cases. In the asbestos cases, the plaintiffs had themselves purchased the product, consented to having it installed on their property and then sued the manufacturer when it turned out to be harmful. There was no invasion of a neighboring property and plaintiffs had exclusive access to the nuisance-causing agent. Here, plaintiffs did not purchase StarLink seeds, and have alleged that pollen from neighboring farms did enter their premises.^[16] [847] Aside from the presence of an invasion, the fact that the alleged nuisance occurred on another's property means that, unlike asbestos purchasers, plaintiffs had no ability to access or control the nuisance themselves. In the gun cases, manufacturers successfully argued that they should not be held responsible for third parties' intentional misuse of their products. Here, however, plaintiffs have not alleged that StarLink farmers defied the manufacturers' instructions, but rather that the instructions themselves violated the EPA's mandates. Moreover, the gun cases alleged a public nuisance and did not implicate plaintiffs' ability to enjoy land or anyone's unreasonable use of land. Private nuisance jurisprudence has always focused on the use and enjoyment of land. See generally, City of St. Louis v. Varahi, Inc., 39 S.W.3d 531, 536 (Mo.Ct.App.2001). Plaintiffs here have alleged that they are unable to enjoy the profits of their land (selling food corn), because of an unreasonable activity on neighboring land (growing StarLink corn).

Another critical factor here is the impact of the limited registration, which negates many of the concerns courts have expressed about holding manufacturers liable for post-sale nuisances. For example, they emphasized that the manufacturers did not have any control over how the purchasers had used their products, or any access to abate the nuisance. See Detroit Bd. of Ed., supra. Aventis, on the other hand, had an affirmative duty to enforce StarLink farmers' compliance with the Grower Agreements. This arguably gave Aventis some measure of control over StarLink's use, as well as a means to abate any nuisance caused by its misuse. This mirrors Page County Appliance Center, supra, where the court found the manufacturer's ongoing service contract with the purchaser gave defendant enough access and control to create a question of fact as to its contribution to the nuisance. Aventis' duties under the limited registration were, by comparison, even more extensive. Similarly, defendants' failure to give StarLink farmers the warnings mandated by the limited registration, and (ultimately incorrect) representations that StarLink need not be segregated because the EPA was going to approve it for human consumption, are also arguably the type of culpable conduct relied upon in Young, 262 Ill.Dec. 175, 765 N.E.2d at 14.

In summary, of the states involved here Iowa, Wisconsin and Illinois have all held a manufacturer liable for a nuisance related to its product beyond the point of sale. See Page County Appliance Center, supra, Northridge, supra, Young, supra. Federal courts applying Minnesota, North Dakota and Tennessee law have declined to do so without any substantial discussion of the merits. See Tioga Public School Dist., supra; Appletree Square, supra; County of Johnson, supra. We have found no cases on point from Kansas, Missouri, Nebraska or South Dakota. The lack of state precedent matching these precise facts does not preclude us from applying widely accepted Restatement law to new factual situations. Residue from a product drifting across property lines presents a typical nuisance claim. All parties who substantially contribute to the nuisance are liable. The unique obligations imposed by the limited registration arguably put Aventis in a position to control the nuisance. On a motion to dismiss we may not speculate whether the as yet undeveloped facts will constitute substantial contribution. To the extent the allegations comport with our preemption analysis above, they do state a valid claim for private nuisance.

[848] B. Public

Plaintiffs also assert that StarLink's contamination of the general food corn supply constitutes a public nuisance. Beyond defendants' argument that they lacked control over the alleged nuisance, discussed above, they assert that plaintiffs cannot establish special harm. At the outset, we note the limited depth of review courts typically undertake on a motion to dismiss a public nuisance claim. "The pleading requirements are not strenuous because the `concept of common law public nuisance elude[s] precise definition.' ... The unreasonableness of the defendant's actions and the substantialness of the right invasion, which lead to the determination of nuisance, are questions of fact for the jury." Gilmore v. Stanmar, Inc., 261 Ill. App.3d 651, 199 Ill.Dec. 189, 633 N.E.2d 985, 993 (1st Dist.1994) (citations omitted).

To state a claim, plaintiffs must allege "an unreasonable interference with a right common to the general public." Restatement § 821B(1). The Restatement sweeps broadly in defining a "public right," including "the public health, the public safety, the public peace, the public comfort or the public convenience." Restatement § 821B(2)(a). Contamination of the food supply implicates health, safety, comfort and convenience, and certainly satisfies this permissive standard.

To state a private action for public nuisance, plaintiffs must also demonstrate that they have been harmed differently than the general public. Restatement § 821C. The harm must be of a different type, not merely a difference in severity or imposing a disproportionate share of the burden on plaintiffs. Among the Restatement's specific examples are physical harm to chattels, § 821C comment d, and pecuniary loss to businesses, § 821C comment h. Both are present here.

The closest analogy and most pertinent discussion is in Burgess v. M/V Tamano, 370 F.Supp. 247, 250 (D.Me.1973). There, commercial fisherman alleged that an oil spill harmed local waters and marine life. The court found that although fishing the waters was a right of the general public, it affected commercial fishermen differently because they depended on it for their livelihood. This was consistent with "the general principle that pecuniary loss to the plaintiff will be regarded as different in kind `where the plaintiff has an established business making commercial use of the public right with which the defendant interferes....'" Id., quoting Prosser, Law of Torts, § 88 at 590 (4th ed.1971). Here, plaintiffs are commercial corn farmers. While the general public has a right to safe food, plaintiffs depend on the integrity of the corn supply for their livelihood.

Defendants maintain that because plaintiffs purport to represent a group so numerous as a nationwide class of corn farmers, their damages cannot be considered special or unique. But the special damages requirement does not limit the absolute number of parties affected so much as it restricts the types of harm that are compensable. Class actions and special damages are not mutually exclusive. See, e.g., Burgess, 370 F.Supp. at 251 (sustaining public nuisance claims by two classes and dismissing a third based on the types of harm alleged). Commercial corn farmers, as a group, are affected differently than the general public.

VI. North Carolina Unfair Trade Practices Act

Plaintiffs next allege that Aventis' handling of StarLink violated the NCUTPA, N.C. Gen.Stat. § 75-1.1. Like many other states, the North Carolina legislature left the definition of deceptive trade practices purposefully vague, with the intention that courts construe it broadly. [849] Johnson v. Phoenix, 300 N.C. 247, 266 S.E.2d 610, 620 (1980). The dispute here, however, is not over whether any particular practice is illegal under the statute, but the statute's geographic reach. None of the named plaintiffs is from North Carolina. Nor does the complaint allege that any of them conduct business in North Carolina. Although the proposed nationwide class would certainly include North Carolina residents, it is axiomatic that the named plaintiffs must show personal injuries to state a claim and cannot rely on harm to unnamed class members. Lewis v. Casey, 518 U.S. 343, 357, 116 S.Ct. 2174, 135 L.Ed.2d 606 (1996).

Defendants argue that the North Carolina statute only applies to instate harms. To apply the statute extra-territorially, they contend, would offend the federal Constitution's due process and full faith and credit clauses. Plaintiffs, on the other hand, characterize this as nothing more than a choice-of-law problem. Because Aventis is headquartered in North Carolina, they reason, the unfair practices are likely centered there. Applying the "most significant relationship" rule, North Carolina's trade practice law should apply.^[17] So long as the conduct affects North Carolina commerce at all, plaintiffs maintain, even out-of-state injuries are compensable. These positions oversimplify matters. It is possible for a state to constitutionally regulate in-state conduct that has out-of-state effects. See, e.g., Avery v. State Farm Mutual Automobile Ins. Co., 321 Ill.App.3d 269, 254 Ill. Dec. 194, 746 N.E.2d 1242, 1254-55 (5th Dist.2001). The question is whether the NCUTPA does so. On the other hand, even if conflicts rules would choose North Carolina law, whether plaintiffs have stated a claim under the North Carolina statute is a separate issue. So, before tackling any constitutional or choice-of-law problem, we examine the statute itself.

The NCUTPA states, in relevant part:, "(a) Unfair methods of competition in or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are declared unlawful. (b) For purposes of this section, `commerce' includes all business activities, however denominated." N.C. Gen.Stat. § 75-1.1. This language reflects a 1977 amendment that removed the phrase "within this state," leaving the text without any geographic limitations. North Carolina courts have addressed neither the impact of this amendment, nor the NCUTPA's extraterritorial reach in general. Looking to local federal courts' interpretations, we find two distinct characterizations. The amendment extended the statute "to the limits of North Carolina's long-arm statute," Broussard v. Meineke Discount Muffler Shops, Inc., 945 F.Supp. 901, 917 (W.D.N.C.1996), or "to the full extent permissible under conflicts of law principles and the Constitution." Hardee's Food Sys., Inc., v. Beardmore, 1997 U.S. Dist. LEXIS 9671 at *7 (E.D.N.C. June 6, 1997). This disparity has led, in turn, to disagreement about whether the statute requires an instate injury. See, e.g., `In' Porters, S.A. v. [850] Hanes Printables, Inc., 663 F.Supp. 494, 501 (M.D.N.C.1987) (requiring substantial effect on in-state business operations); Hardee's Food Sys., Inc., v. Beardmore, 1997 U.S. Dist. LEXIS 9671 at *8-9 (E.D.N.C. June 6, 1997) (no in-state injury requirement).

Plaintiffs, relying on Hardee's, argue that `In' Porters is no longer good law. In fact, Hardee's is the only opinion we have found that rejects `In' Porters' reasoning, whereas several other decisions have expressly endorsed it. See, e.g., Broussard, 945 F.Supp. at 917; Merck & Co. v. Lyon, 941 F.Supp. 1443, 1463 (M.D.N.C.1996); Dixie Yarns, Inc. v. Plantation Knits, Inc., 1994 WL 910955 at *2-3 (W.D.N.C. July 12, 1994). Because these are co-equal district courts (interpreting state law), we consider them each as persuasive authority. Notably, the only court outside of North Carolina to consider this issue relied on `In' Porters, and it did so after Hardee's. See Lithuanian Commerce Corp. v. Sara Lee Hosiery, 47 F.Supp.2d 523, 537 (D.N.J.1999).

In construing this statute, the `In' Porters court looked to external sources. First, it sought to harmonize the NCUTPA with North Carolina's long-arm statute, N.C. Gen.Stat. § 1-75.4(4), which allows personal jurisdiction in cases involving foreign acts only if an injury occurs within North Carolina and the party was in, or had products in, North Carolina commerce at the time. 663 F.Supp. at 501. Second, it looked to the standards for applying the federal Sherman Act extraterritorially, which require that the foreign acts have a substantial effect on plaintiff's domestic operations. Id., citing Rose v. Vulcan Materials Co., 282 N.C. 643, 194 S.E.2d 521 (1973) (Sherman Act decisions instructive in determining the full reach of North Carolina's unfair trade act). Both analogies suggested that plaintiffs must establish a substantial effect on in-state operations — an in-state injury — to state a NCUTPA claim. Moreover, the court noted, such an interpretation was consistent with constitutional due process and commerce clause concerns.

The Hardee's court found the text's lack of any geographic restraints controlling. It noted other cases sustaining NCUTPA claims, where plaintiffs had minimal North Carolina operations. 1997 U.S. Dist. LEXIS 9671 at *8-9, citing Jacobs, 891 F.Supp. at 1111-12 (allowing suit by out-of-state franchisees against North Carolina franchiser) and Broussard, 945 F.Supp. at 917-18 (sustaining action against North Carolina trucking company by plaintiffs from several different states). And it found the additional profits defendants achieved by engaging in the alleged practices were a sufficient impact on local commerce.

We believe `In' Porters reflects the better interpretation. North Carolina courts have found that "the purpose of G.S. 75-1.1 is to provide a civil means to maintain ethical business standards of dealings between persons engaged in business and the consuming public within this state," United Virginia Bank v. Air-Lift Assoc., 79 N.C.App. 315, 339 S.E.2d 90, 93 (1986), quoted in `In' Porters, 663 F.Supp. at 502 (emphasis in `In' Porters). It was designed to address "primarily local concerns." ITCO Corp. v. Michelin Tire Corp., 722 F.2d 42, 48 n. 9 (4th Cir.1983). Plaintiffs point out that Illinois courts have found that the state had an interest in regulating the conduct of local businesses, even as to foreign consumers, and permitted out-of-state consumers to invoke Illinois' consumer protection statute. Avery, 254 Ill.Dec. 194, 746 N.E.2d at 1255. North Carolina courts have not ascribed such an intention to their legislature. Instead of emphasizing defendants' conduct, they have found that the statute focuses on [851] "the impact the practice has on the marketplace." Marshall v. Miller, 302 N.C. 539, 276 S.E.2d 397, 403 (1981). The relevant marketplace is North Carolina. Plaintiffs also point out that the NCUTPA does not require contractual privity. Although this is true, courts have frequently cited a direct contractual relationship with an in-state party as the nexus justifying their application of their local statute to that out-of-state plaintiff. See Jacobs, 891 F.Supp. at 1111; Broussard, 945 F.Supp. at 917-18. Plaintiffs here have alleged no such contact with any North Carolinian.

If, as Hardee's found, incremental profits by an in-state defendant alone were sufficient effect on in-state commerce to trigger the statute, that would dramatically extend its reach.

Were that the case, every product manufactured and sold, directly or indirectly, in North Carolina to foreigners which later turn out to be defective would create an unfair competition cause of action whether or not the injured party had ever directed its commercial efforts toward, or even set foot in this state.

Dixie Yarns, 1994 WL 910955 at *2. We also note that the two cases the Hardee's court primarily relied upon both applied the `In' Porters standard, emphasized the continuing contact plaintiffs had with North Carolina, and made express findings of in-state harm. Jacobs, 891 F.Supp. at 1111; Broussard, 945 F.Supp. at 917-18.

Following `In' Porters' use of the longarm analogy, we examine whether plaintiffs' contact with North Carolina would sustain personal jurisdiction there. The answer is decidedly no. Plaintiffs have not pled any contact with North Carolina. They have not alleged that they buy or sell any goods there, have any contact with a North Carolina company, or engage in any North Carolina commerce whatsoever. Because the named plaintiffs have not alleged that they experienced any harm within North Carolina, they cannot state a claim under the NCUTPA.

VII. Tennessee Consumer Protection Act

Plaintiff McCormack adds an additional claim under the TCPA, T.C.A. §§ 47-18-101 et seq., alleging that Aventis engaged in deceptive trade practices. Defendants assert that this claim must be dismissed because McCormack does not allege he had any consumer transaction with Aventis.

The CPA is worded broadly:

Any person who suffers an ascertainable loss of money or property, real, personal, or mixed, or any other article, commodity, or thing of value wherever situated, as a result of the use or employment by another person of an unfair or deceptive practice declared to be unlawful by this part, may bring an action individually to recover actual damages.

T.C.A. § 47-18-109(a)(1). Nothing in its text requires privity or restricts relief solely to direct purchasers.

Aventis' licensing of its StarLink process to seed growers brings it within the statute. It is well settled that the TCPA applies to sales to corporate entities, as well as to consumers. ATS Southeast, Inc. v. Carrier Corp., 18 S.W.3d 626, 626 (Tenn.2000). We see no reason to treat selling (or licensing) intellectual property any differently from selling (or leasing) a tangible item. In defining "consumer," the statute specifically refers to one who acquires "tangible or intangible" property. T.C.A. 47-18-103(2). Moreover, at least one court has sustained a claim where the product in question was an intangible: copyrighted music. See Bridgeport Music, Inc. v. 11C Music, 154 F.Supp.2d 1330 (M.D.Tenn.2001).

[852] Aventis offers two state court cases as standing for the proposition that a plaintiff must have been party to a consumer transaction with a defendant to bring a TCPA claim. In Messer Griesheim Indus. v. Cryotech of Kingsport, Inc., 45 S.W.3d 588, 610 (Tenn.Ct.App.2001), the court dismissed a claim against a party who was merely the financing lessor and did not offer a product for sale or distribution. And in State ex rel. Pierotti v. Sundquist, 1993 WL 166938 at *5 (Tenn.Ct.App. May 19, 1993), the court held that plaintiffs, who had a contractual relationship with a corporation, did not have standing to bring TCPA claim against the corporation's directors because there was no consumer relationship. But we find these distinguishable because neither relied on the fact the defendant did not sell something directly to the plaintiff. As a financing lessor and a corporate director, respectively, those defendants did not sell anything to anyone.

Bridgeport Music, supra, dispels the idea that the TCPA requires a direct transaction between the litigants. Plaintiff copyright holders alleged that defendants sold music to consumers as original, when in fact it infringed on plaintiffs' works. There was no contractual relationship between the litigating parties, but plaintiffs alleged their property rights were harmed by defendants' sales to third parties. The court found this was sufficient to state a TCPA claim and rejected an argument identical to defendants' here.

[Defendants] insist that Plaintiffs were not themselves purchasing goods and therefore cannot sue under the Act. This gloss on the statute is evidently of the Defendants' own creation. The TCPA was amended precisely to expand the class of potential plaintiffs, making relief available to "the consumer or other person." T.C.A. 47-18-109(a)(4). The disjunctive added in 1989 precludes any reading that imposes a "buying requirement" upon the plaintiff.

Bridgeport Music, 154 F.Supp.2d at 1333 (emphasis in Bridgeport Music). See also Olin Corp. v. Lambda Electronics, Inc., 39 F.Supp.2d 912, 914 (E.D.Tenn.1998) ("There is no authority that a `consumer transaction' is a sine qua non of TCPA applicability."). We agree with Bridgeport Music that the TCPA permits third parties to bring a claim if they are harmed by defendants' deceptive practices.

CONCLUSION

For the foregoing reasons, defendants' motion to dismiss is granted with respect to the claims for conversion and violations of the NCUTPA. The motion is denied with respect to the claims for negligence per se, public nuisance, private nuisance and violations of the TCPA. The negligence and strict liability claims are dismissed to the extent they rely on a failure to warn, but may proceed under the theories outlined above.

[1] A sequence of related corporate entitles was involved in the process of developing, registering and distributing StarLink. Aventis is the sole successor-in-interest with respect to StarLink, and the only named party among them. We will not distinguish between Aventis and its predecessors. and will refer simply to "Aventis."

[2] To the extent there is any disagreement among the courts of appeals, we are bound by the Seventh Circuit's interpretations of federal law, regardless of where these individual cases may have originated. Our opinion on certain plaintiffs' motions to remand discussed this choice-of-law issue in some detail. See In re StarLink, 211 F.Supp.2d 1060 (N.D.Ill.2002).

[3] At this point we express no opinion as to whether the ten jurisdictions in question recognize a civil remedy for the FIFRA violations alleged here. The parties have not fully briefed the issue, so we reserve judgment for a later day.

[4] We note that two other circuits have held that FIFRA more broadly preempts actions based on off-label statements. Taylor AG Indus. v. Pure-Gro, 54 F.3d 555, 561 (9th Cir. 1995); Papas v. Upjohn Co., 985 F.2d 516, 519 (11th Cir.1993). The Seventh Circuit explicitly declined to take a position on this split. Kuiper v. American Cyanamid Co., 131 F.3d 656, 662 (7th Cir.1997). We choose to follow Lowe for the reasons given there.

[5] At several points the complaint specifically refers to "identity preserved" corn.

[6] The doctrine has expanded to include most contractually acquired services. But there is considerably less uniformity among jurisdictions, particularly with respect to the growing number of exceptions courts have carved out, when applied to services. Because StarLink is a product, however, we need not be concerned with the nuances of applying the rule to services.

[7] There are cases holding that recovery was not barred because plaintiff had no direct relationship with defendant and, therefore, no opportunity to negotiate contractual protections. See Intamin, Inc. v. Figley-Wright Contractors, Inc., 608 F.Supp. 408, 411 (N.D.Ill. 1985). We note that Anderson Elec., supra, and Chicago Flood, supra, both rejected privity as a requirement post-Intamin.

[8] As we discuss below, there are fact patterns involving other means of access, besides bridges, that implicate the same principles. We prefer the more inclusive description, "access" cases, and will use this broader moniker.

[9] Although merchants' only remedy for property damage is the U.C.C., other types of buyers can still recover for harm to other property, and merchants can recover for personal injuries. Id.

[10] We note that defendants continually characterize the complaint as alleging that "the entire corn farming and production chain" was contaminated, not that plaintiffs' corn was directly harmed. Resolving the complaint's ambiguous phraseology in plaintiffs' favor, we find that they have sufficiently alleged that their crops were contaminated at some point within that chain.

[11] This includes corn commingled at grain elevators because plaintiffs retain ownership rights to corn stored there. Each contributing farmer owns a pro rata share of the entire, now tainted, supply. See generally, Missouri v. United States Bankr. Ct. of E.D. Ark., 647 F.2d 768, 775 n. 13 (8th Cir.1981).

[12] The private nuisance claims appear to be premised exclusively on cross-pollination in the fields, not commingling later in the distribution chain. Commingling could not constitute a private nuisance because it does not involve an invasion of any private interests in land. By contrast, the public nuisance claims, discussed below, may be premised on commingling because "[u]nlike a private nuisance, a public nuisance does not necessarily involve interference with use or enjoyment of land." Restatement § 821B comment h.

[13] Bubalo, decided nearly four years before Young, ultimately dismissed the nuisance claim out of reluctance to recognize a new theory of liability without any state decisional precedent. Id. at *5

[14] Other states have rejected nuisance claims against asbestos manufacturers on the merits, reasoning that once the product is sold, the manufacturer has no access to the product to control it or abate the nuisance. See, e.g., Detroit Bd. of Ed. v. Celotex Corp., 196 Mich. App. 694, 493 N.W.2d 513, 522 (1992).

[15] Of these three cases, only Tioga Public School Dist. contains any substantial discussion of this point, and it mostly reflects the federal court's unwillingness to make new state law. 984 F.2d at 920 ("[Plaintiff] has not presented us with any North Dakota cases extending the application of the nuisance statute to situations where one party has sold to the other a product that later is alleged to constitute a nuisance, nor has our research disclosed any such cases."). Appletree Square and County of Johnson both make only cursory reference to this issue.

[16] More analogous to the present posture would be landowners who alleged that asbestos had drifted over property lines from a neighboring building and contaminated their air. We are not aware of any reported cases addressing a nuisance claim under that fact pattern.

[17] It is not entirely clear which choice-of-law rule North Carolina courts would apply. The federal courts that have considered the question have reached different results. See, e.g., Santana, Inc. v. Levi Strauss & Co., 674 F.2d 269, 273-74 (4th Cir.1982) (applying most significant relationship); United Dominion Industries, Inc. v. Overhead Door Corp., 762 F.Supp. 126, 128-29 (W.D.N.C.1991) (collecting cases and applying lex loci dilecti). For that matter, we would not necessarily apply North Carolina's choice-of-law rules to the present case. Rather, we would apply the choice-of-law rules of the ten states in which the transferor courts are situated, which diverge considerably. Because our interpretation of the statute resolves the question before us, however, we will not address the choice-of-law question.

252 F.3d 148 (2001)

[149] Karl S. Coplan, Pace Environmental Litigation Clinic, Inc., White Plains, NY (Christopher Rizzo, Joel R. Kupferman and Beth Wilson, on the brief), for Plaintiffs-Appellants.

George Gutwirth, Office of the Corporation Counsel of the City of New York, New York, NY (Michael D. Hess, Corporation Counsel of the City of New York and Francis F. Caputo, Assistant Corporation Counsel, on the brief), for Defendants-Appellees.

Before: JACOBS, PARKER and KATZMANN, Circuit Judges.

PER CURIAM:

In an effort to control West Nile Virus — a fatal, mosquito-borne disease — the City of New York last summer undertook an insecticide spraying program, and may renew that program in the summer of 2001. Plaintiffs appeal an order of the United States District Court for the Southern District of New York (Martin, J.), denying, inter alia, a preliminary injunction against the renewed spraying and dismissing their claim under the citizen suit provision of the Resource Conservation Recovery Act ("RCRA"), 42 U.S.C. §§ 6972(a)(1)(A) and (B). Our jurisdiction extends to the district court's denial of the preliminary injunctive relief as well as the dismissal of plaintiffs' claims. See 28 U.S.C. § 1292(a); SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharmaceuticals, 211 F.3d 21, 25 (2d Cir.2000) (appellate courts may "dismiss the complaint on the merits if its examination of the record upon an interlocutory appeal reveals that the case is entirely void of merit").

I.

The RCRA provides for an injunction where:

the past or present handling, storage, treatment, transportation, or disposal of any solid or hazardous waste [ ] may present an imminent and substantial endangerment to health or the environment....

Id. § 6972(a) (emphasis added). The term "solid waste"

means any garbage, refuse, sludge, from a waste treatment plant, water supply treatment plant, or air pollution control facility and other discarded material ....

Id. § 6903(27) (emphasis added).

Plaintiffs claim, in essence, that (i) the spraying of the pesticides constitutes the "disposal" of a "solid waste" in a manner that renders it "discarded material" causing "imminent and substantial endangerment" to people, and (ii) the spraying into the air of densely populated areas is in violation of the label instructions and this improper use constitutes disposal of a hazardous solid waste without a permit, in violation of 42 U.S.C. § 6925(a).

[150] II.

We review the district court's denial of a preliminary injunction for abuse of discretion, see SG Cowen Securities Corp. v. Messih, 224 F.3d 79, 81 (2d Cir.2000), and we are "free to affirm an appealed decision on any ground [that] finds support in the record." Beal v. Stern, 184 F.3d 117, 122 (2d Cir.1999).

Ordinarily, a preliminary injunction may be granted when the party seeking the injunction establishes that "1) absent injunctive relief, it will suffer irreparable harm, and 2) either a) that it is likely to succeed on the merits, or b) that there are sufficiently serious questions going to the merits to make them a fair ground for litigation, and that the balance of hardships tips decidedly in favor of the moving party." Otokoyama Co. Ltd. v. Wine of Japan Import, Inc., 175 F.3d 266, 270 (2d Cir.1999). But when, as here, the moving party seeks a preliminary injunction that will affect "government action taken in the public interest pursuant to a statutory or regulatory scheme, the injunction should be granted only if the moving party meets the more rigorous likelihood-of-success standard." Beal, 184 F.3d at 122 (internal quotations omitted). And, when the injunction sought "will alter rather than maintain the status quo" the movant must show "clear" or "substantial" likelihood of success. Rodriguez v. DeBuono, 175 F.3d 227, 233 (2d Cir.1999) (internal citations and quotations omitted).

The district court did not abuse its discretion in denying injunctive relief. Plaintiffs argue that "[o]nce pesticides are sprayed onto or into the air, land, and waters of New York City, they become discarded solid wastes within the meaning of RCRA § 1004(27)." But we have indicated that material is not discarded until after it has served its intended purpose. Cf. Connecticut Coastal Fishermen's Assoc. v. Remington Arms Co., 989 F.2d 1305, 1316 (2d Cir.1993). We therefore agree with the district court that the pesticides are not being "discarded" when sprayed into the air with the design of effecting their intended purpose: reaching and killing mosquitoes and their larvae.

Plaintiffs argue that defendants' use (spraying along city streets) was contrary to the pesticides' labeling instructions (which permit use in wooded areas and grassy pastures), and that this improper use is tantamount to disposal of a hazardous solid waste without a permit, in violation of 42 U.S.C. § 6925(a). A use contrary to the label instructions would arguably violate the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136-136y; but FIFRA is not enforceable by a private right of action. Plaintiffs thus seek to stretch RFRA to cover conduct arguably regulated under FIFRA, so that RCRA's private right of action can be mobilized to vindicate FIFRA. The enforcement of FIFRA, however, is confided by Congress to the government alone. See Almond Hill School v. USDOA, 768 F.2d 1030, 1038 (9th Cir.1985) (citing Conf. Rep. No. 92-1540, reprinted in 1972 U.S.Code Cong. & Ad. News 4130, 4134) ("[An] explicit rejection of a proposed amendment to authorize private suits is a strong indication that Congress was opposed to private actions to enforce the provisions of FIFRA.").

The denial of the preliminary injunction and the dismissal of the claims under the RCRA are affirmed.

636 F.2d 750 (1980)

[751] Eugene I. Lambert, Washington, D. C., with whom Richard F. Kingham, Washington, D. C., was on brief, for the petitioner Rhone-Poulenc, Inc., Hess & Clark Division in case No. 79-1694.

Frederick S. Hird, Jr., Washington, D. C., with whom James L. Kaler, Washington, D. C., was on brief, for the petitioner Vineland Laboratories, Inc. in case No. 79-1706.

Donald O. Beers, Associate Chief Counsel for Enforcement, Food and Drug Administration, Rockville, Md., with whom Richard M. Cooper, Chief Counsel, and Robert M. Spiller, Jr., Associate Chief Counsel for Enforcement, Food and Drug Administration, Rockville, Md., and Robert B. Nicholson and Susan J. Atkinson, Attys., Dept. of Justice, Washington, D. C., were on brief for appellees.

Before WRIGHT, Chief Judge, ROBB, Circuit Judge and CORCORAN^[1], Senior United States District Judge for the District of Columbia.

Opinion PER CURIAM

PER CURIAM:

In Hess & Clark v. FDA, 161 U.S. App. D.C. 395, 495 F.2d 975 (1974) and Chemetron Corp. v. HEW, 161 U.S.App.D.C. 415, 495 F.2d 995 (1974), we held that the Commissioner of the Food and Drug Administration could not withdraw the agency's New Animal Drug Approvals for the drug diethylstilbestrol (DES)^[2] without holding an evidentiary hearing. The Agency has now held its hearing, and the Commissioner has again decided to ban DES as an animal drug. His decision is reported at 44 Fed.Reg. 54,851 (1979).

Rhone-Poulenc, Inc. and Vineland Laboratories, Inc. are manufacturers of DES. They have petitioned for review of the Commissioner's order pursuant to 21 U.S.C. § 360b(h) (1976). Because the Commissioner's decision is supported by substantial evidence and his refusal to issue an Environmental Impact Statement (EIS) was proper, we affirm.

I.

A new animal drug may not be marketed until the Commissioner has granted the manufacturer's application for a New Animal Drug Approval. 21 U.S.C. § 360b(d)(1) [752] (1976). The Commissioner may not approve any application until the manufacturer proves that the drug is safe. 21 U.S.C. § 360b(d)(1)(B) (1976). Even if the manufacturer sustains this burden, however, the Commissioner must withdraw his approval whenever he finds that "new evidence ... evaluated together with the evidence available to the [Commissioner] when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...." 21 U.S.C. § 360b(e)(1)(B) (1976). This section, referred to by the parties as the "safety clause", was one of two independent grounds relied upon by the Commissioner to withdraw his approval of DES.^[3]

In the Hess & Clark case we held that the "new evidence" requirement of the safety clause "plainly places on the FDA an initial burden to adduce the `new evidence' and what that evidence `shows'. Only when the FDA has met this initial burden of coming forward with the new evidence is there a burden on the manufacturer to show that the drug is safe." 161 U.S.App.D.C. at 412, 495 F.2d at 992. We must therefore review the record in this case to determine whether the FDA has presented new evidence raising questions about the safety of DES that are sufficiently serious to require the manufacturers to demonstrate that DES is safe. If it has done so, we must then decide whether the manufacturers have met their burden of showing that the drug is safe.

1. The FDA's New Evidence.

The FDA originally approved the use of DES in animals even though it was known to cause cancer in them. The agency believed that, properly administered, the drug would not remain in any edible portions of the animals receiving it, thereby eliminating any risk to human consumers. When, however, more sophisticated tests for detecting the presence of DES in animal tissues were developed the agency concluded that its belief was erroneous and that small amounts of DES were present in various edible portions of DES-treated animals. The Commissioner contends that the results of these tests meet the "new evidence" standard of the statute.

The Commissioner mainly relied upon radiotracer experiments which revealed the presence of small amounts of DES in cattle. In these studies radioactive carbon atoms were substituted for some of the non-radioactive carbon atoms normally found in the DES molecule. If radioactivity above the normal "background" amount was detected in the tissues of the animals which had been fed this "tagged" DES, it would be an indication that the DES was present. Additional tests were performed to confirm this conclusion. See generally 44 Fed.Reg. at 54,862-65.

Petitioners allege that a number of shortcomings in these experiments should prevent the Commissioner from relying upon them. The Commissioner considered each of these objections, however, and concluded that they were groundless. His conclusions are supported by the opinions of reputable scientists. See, e. g., 44 Fed.Reg. at 54,863, col. 1 & 3 (testimony of Dr. Williams that radioactivity found in the animals by one study was attributable to DES"); id. at 54,862-63 (Dr. Aschbacher's studies found DES in the animals); id. at 54,864 (Dr. Williams found that radioactivity was not due to "pseudo-DES"); id. at 54,870-71 (testimony of Williams and Weisinger that DES conjugates, which may be present in the animals rather than free DES, are likely [753] to break down into free DES in the human body). Petitioners argue strongly that other expert witnesses drew different conclusions from these data. Our task is not to resolve these scientific disputes, however. The expert opinions cited by the Commissioner constitute substantial evidence in the record supporting his finding that small amounts of DES (or DES conjugates likely to become DES when digested by human beings) are present in the animals.^[4] Our inquiry on this issue is therefore at an end. See 21 U.S.C. § 355(h) (1976).^[5]

2. The Safety of the Detected Residues.

The Commissioner did more than merely find that small residues of DES are present in the edible portions of the animals receiving it. He also reviewed the testimony and the scientific literature in an attempt to discover a "no-effect level" for DES, i. e., a dosage level at which DES would not cause cancer or other harmful effects in human beings. He concluded that no such level has been demonstrated and that DES is therefore "not shown to be safe" since there is no proof that small amounts of it are not harmful. 44 Fed.Reg. at 54,873-81.

By proceeding in this manner the Commissioner has met his "initial burden of coming forward with some evidence of the relationship between the residue and safety ...." Hess & Clark, supra at 413, 495 F.2d at 993. He is relying not only on the fact that larger amounts of DES are harmful, but upon studies which conclude that it is impossible to determine a safe level of DES in human beings. This evidence is sufficient to shift the burden of showing the safety of DES to the manufacturers. Id.

Petitioners responded to this burden by attempting to show that DES is similar to estrogens which occur naturally in the human body and that the small amounts of DES found by the Commissioner in the edible portions of the animals are insignificant when compared to the total amount of these naturally occurring estrogens. The Commissioner considered this argument but found that the manufacturers had not sustained their burden of proving that DES is similar to natural estrogens. This conclusion is supported by substantial evidence, see 44 Fed.Reg. at 54,871-73, and we will not disturb it.

Petitioner Vineland Laboratories also contends that the FDA should be bound by its previous determination that 2 parts per billion (ppb) is a safe level of DES in human beings.^[6] Because the radiotracer studies reveal the presence of DES at levels smaller than 2 ppb, Vineland argues that the Commissioner must come forward with new evidence that proves that such dosages are unsafe. We note however that the evidence that DES is associated with cancer in [754] human beings first came to light in 1971, after the 2 ppb standard was established. (Testimony of Dr. Raucher, J.A. at 89) This new evidence justified the Commissioner's decision to reevaluate the 2 ppb standard. Although there is no evidence that dosages of 2 ppb or less actually cause cancer or other harmful effects, the Commissioner was properly concerned about the effects of long-term exposures to small amounts of the drug. (Raucher testimony, J.A. at 90-93) He acted correctly by requiring the manufacturers to show that the newly detected residues were below a demonstrable no-effect level. The manufacturers' failure to provide such evidence means that the drug has not been shown to be safe.

3. Benefits-Burdens Analysis.

Although the Commissioner found that DES leaves residues that cannot be determined to be safe in the edible portions of animals receiving it, this did not end his inquiry. In Hess & Clark v. FDA we held that

[T]he typical issue for the FDA is not the absolute safety of a drug. Most drugs are unsafe in some degree. Rather, the issue for the FDA is whether to allow sale of the drug, usually under specific restrictions. Resolution of this issue inevitably means calculating whether the benefits which the drug produces outweigh the costs of its restricted use.

161 U.S.App.D.C. at 413-14, 495 F.2d at 993-94. (Footnotes omitted)

In his decision the Commissioner characterized this language as dictum and expressed the opinion that the statute does not allow him to consider the overall benefits of an animal drug. 44 Fed.Reg. at 54,881-83. He did evaluate the benefits of DES, however, and found that the manufacturers had not proved that these benefits outweigh the risks associated with DES.

The Commissioner's arguments regarding the propriety of risk-benefit analysis are repeated in the agency's brief. We decline the invitation to overrule our prior holding, however. The language quoted above was not dictum. Rather it expressly set forth one of the issues to be considered at the hearing. Whatever the merits of the Commissioner's arguments on this point may be, we are bound by the holding of the Hess & Clark court until we are instructed otherwise by the Supreme Court or an en banc decision of this court.

We find no reason to overturn the Commissioner's evaluation of the risks and benefits of DES, however. He discussed the shortcomings in the evidence presented by the manufacturers on this point in great detail. See 44 Fed.Reg. at 54,886-92. It would serve little purpose to repeat that discussion here, for we agree with the Commissioner that the manufacturers failed to come forward with sufficient evidence upon which any conclusions about the health benefits or the overall economic benefits of DES could be based. We therefore affirm his finding that the benefits of DES have not been shown to outweigh the risks associated with its continued use as an animal drug.

The Commissioner has satisfied his burden of coming forward with new evidence concerning the safety of DES. His conclusion that the drug is "not shown to be safe" is supported by substantial evidence. We therefore hold that he acted properly under 21 U.S.C. § 360b(e)(1)(B) (1976) in banning DES.

II.

Petitioners have also argued that the FDA was required to prepare an EIS before DES was banned. The Commissioner concluded, however, that banning DES would not "significantly affect the quality of the human environment" and that the National Environmental Policy Act (NEPA), 42 U.S.C. § 4332(C) (1976), therefore did not require him to issue an EIS. 44 Fed.Reg. at 54,894.

In reaching this decision the Commissioner relied upon a detailed "Environmental Impact Analysis Report" prepared by the agency's staff. (J.A. at 94-113) This report states that continued use of DES would provide some environmental benefits, namely, a decrease in animal wastes and a reduced need for food to be grown for the [755] animals. It notes that other growth promotants are available to replace DES, however, and concludes that their use will mitigate any environmental harm caused by the unavailability of DES.

We have stated that "[w]hen the agency determines that [an EIS] is unnecessary, it must give a statement of its reasons, and where the agency's statement of explanation is sufficient, the NEPA criteria are satisfied." Asphalt Roofing Mfrs. Ass'n v. ICC, 186 U.S.App.D.C. 1, 12, 567 F.2d 994, 1005 (1977). In this case the Commissioner's explanation was a reasonable one, and petitioners have pointed to no evidence that would contradict it. We therefore uphold the Commissioner's failure to issue an EIS before withdrawing the New Animal Drug Approvals for DES.

CONCLUSION

For the above reasons the Commissioner's order withdrawing the FDA's approval of DES as an animal drug is

Affirmed.

[1] Sitting by designation pursuant to 28 U.S.C. § 294(e).

[2] DES is used as a growth promotant in cattle and sheep. It is given to the animals either orally by mixing it with their food, or as a subcataneous ear implant which dissolves over time. DES was also used as a growth promotant in poultry, but the FDA has withdrawn its approval of that use. See Bell v. Goddard, 366 F.2d 177, 183 (7th Cir. 1966).

[3] The Commissioner also acted under 21 U.S.C. § 360b(d)(1)(H) (1976), the so-called "Delaney clause". This section prohibits approval of drugs which have been shown to cause cancer in animals unless "no residue of such drug will be found (by methods of examination prescribed or approved by the [Commissioner] by regulations ...), in any edible portions of such animals after slaughter ...." The Commissioner has revoked his approval of the mouse uterine/paper chromatography method as the means of detecting DES under the Delaney clause but has not approved any method to replace it. He argues that the Delaney clause requires him to ban DES in the absence of any approved method of detection. Petitioners respond that the Commissioner must affirmatively find that some approved method has detected DES in the animals before he can rely upon the Delaney clause to ban the drug. In view of our resolution of the safety clause issue, we need not decide this question.

[4] Most of the radiotracer experiments studied cattle. The Commissioner discussed only one study of orally administered DES in sheep. See 44 Fed.Reg. at 54,864. This study found no radioactivity in any edible portions of the animals, although some was detected in the adrenal glands of some of the sheep. The Commissioner assumed that the relatively high limits of detection of this particular test made it impossible to detect amounts as small as those detected in the cattle. He concluded that the presence of radioactivity in the adrenal glands of sheep and the similarity between the digestive processes of sheep and cattle made it likely that small amounts of DES were also present in the edible portions of sheep. For the same reasons, he also concluded that small amounts of DES would remain in sheep which had received it through implants, although no studies of DES implants in sheep had been performed. Id.

Petitioners argue that this court should not allow the Commissioner to rely upon extrapolations from the studies of cattle. They contend that he should be required to produce studies which actually show DES to be present in sheep. We find the Commissioner's explanation satisfactory, however, in view of his expertise in dealing with animal drugs. We note that petitioners have not challenged in any way the accuracy of his conclusion that sheep are similar to cattle in all relevant respects.

[5] Because we find that the radiotracer studies constitute substantial evidence supporting the Commissioner's finding that DES residues are present in the animals, we will not address petitioners' attacks upon his other source of evidence for this conclusion — the Department of Agriculture's Monitoring Program, discussed at 44 Fed.Reg. 54,865-67.

[6] See 44 Fed.Reg. at 54,861: "2 ppb ... was once thought to be the safe dose for DES".

760 F.3d 151 (2014)

[152] Jennifer A. Sorenson (Mitchell S. Bernard, Avinash Kar, on the brief), Natural Resources Defense Council, New York, NY, for Plaintiffs-Appellees.

Ellen London (Amy A. Barcelo, Benjamin H. Torrance, Assistant United States Attorneys, David J. Horowitz, Deputy General Counsel, Elizabeth H. Dickinson, Chief Counsel, Food and Drug Division, Eric M. Blumberg, Deputy Chief Counsel, Litigation, Thomas J. Cosgrove, Associate Chief Counsel, Department of Health and Human Services, on the brief), for Preet Bharara, United States Attorney for the Southern District of New York, New York, NY, for Defendants-Appellants.

Before: KATZMANN, Chief Judge, LYNCH, Circuit Judge, and FORREST, District Judge.^[1]

Chief Judge KATZMANN dissents in a separate opinion.

GERARD E. LYNCH, Circuit Judge:

For nearly seventy years, antibiotics have provided dramatic medical advances in the treatment of bacterial infections.^[2] [153] For nearly as long, scientists have been concerned about the problem of antibiotic resistance. Through repeated exposure to antibiotics, some strains of bacteria develop resistance or immunity to particular antibiotics. Such resistance presents a serious threat to human health. Infections in humans caused by antibiotic-resistant bacteria result, on average, in longer hospital stays, worse side effects of treatment, and a greater likelihood of death. In an effort to forestall the development of antibiotic-resistant strains of bacteria, doctors exercise restraint in prescribing antibiotics and are careful to direct patients to use antibiotics only as prescribed.

However, for each dose of antibiotics given to humans for medical purposes, four doses are given to livestock for non-medical reasons to encourage faster, healthier growth. In 2009, 28.8 million pounds of antibiotics were administered to animals raised for food, most of it through animal feed. Unfortunately, research shows that bacteria that develop resistance to antibiotics used in animal feed can transfer to human beings and pose a risk to human health. For that reason, various public-interest organizations have sought to force the Food and Drug Administration ("FDA") to prohibit the use of certain antibiotics in animal feed. This case arises from one such effort.^[3]

In this lawsuit, the plaintiff organizations contend that the FDA is required by 21 U.S.C. § 360b(e)(1) to proceed with hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed, and that the FDA's denial of two citizen petitions demanding such hearings was arbitrary or capricious within the meaning of 5 U.S.C. § 706(2). The district court accepted plaintiffs' contention. Because we conclude that plaintiffs and the district court are incorrect, we reverse the judgment of the district court.

BACKGROUND

I. FDA Regulation of Animal Feed Antibiotics

The FDA has statutory authority to regulate new animal drugs^[4] introduced into interstate commerce. See 21 U.S.C. § 360b(a)(1). New animal drugs are prohibited unless specifically approved by the FDA following a new animal drug application ("NADA") made by a sponsor, which is usually the drug manufacturer that produced the drug.^[5] Because antibiotics can be used in animal feed to produce bigger animals that grow faster on less food, many drug manufacturers have sought approval to sell antibiotics for use in animal feed.

In 1951, the FDA approved the first use of antibiotics as ingredients in animal feed to encourage animal growth. Two years later, it approved the first use of antibiotics as drugs in animal feed. But by the late 1960s, the FDA "became concerned about the safety to man and animals of subtherapeutic antibiotic use" both as a general matter and specifically in the context of animal feed.^[6]See Tetracycline [154] (Chlortetracycline and Oxytetracycline)-Containing Premixes: Opportunity for Hearing, 42 Fed.Reg. 56264, 56266 (Oct. 21, 1977) ("Tetracycline NOOH"). Thus began the decades-long investigation of the danger posed by such use, and the concern about human safety has persisted ever since.

In 1970, prompted by a report published by the United Kingdom's Joint Committee on the Use of Antibiotics in Animal Husbandry and Veterinary Medicine, the FDA instituted a Task Force to study the problem. In 1972, the Task Force published its report, concluding that: (1) the use of antibiotics in "subtherapeutic amounts" favors the selection of antibiotic-resistant bacteria; (2) animals treated with such doses of antibiotics can serve as hosts for resistant bacteria, which can then be transferred to humans; (3) the prevalence of resistant bacteria had increased; and (4) resistant bacteria had been found in meat and meat products intended for human consumption. The Task Force's report proposed withdrawing approval for all then-approved subtherapeutic uses of antibiotics unless the manufacturers of the drugs submitted evidence regarding the safety and effectiveness of the drugs as used in animal feed.

In 1977, after receiving the requested information from the drug manufacturers and the recommendation of the Animal Feeds Subcommittee of the National Advisory Food and Drug Committee, the FDA's Bureau of Veterinary Medicine ("CVM")^[7] issued notices of opportunity for hearing ("NOOHs") with respect to both penicillin and tetracyclines, another family of antibiotics. Penicillin-Containing Premixes: Opportunity for Hearing, 42 Fed. Reg. 43772 (Aug. 30, 1977) ("Penicillin NOOH"); Tetracycline NOOH, 42 Fed. Reg. 56264 (Oct. 21, 1977). The notices detailed the history of subtherapeutic antibiotic drug use and the scientific data on the safety and effectiveness of such use, and concluded that the drug manufacturers had "failed to resolve the basic safety questions that underlie the subtherapeutic use of [antibiotics] in animal feed." The Penicillin NOOH went on to state that the Director of the CVM had

conclude[d], on the basis of new information before him with respect to these drug products, evaluated together with the evidence available to him when they were originally approved, that the drug products are not shown to be safe under the conditions of use prescribed, recommended, or suggested in their labeling. The evidence, in fact, indicate[d] that such penicillin use may be unsafe, particularly if the higher or therapeutic levels of penicillin should be used as substitutes for the levels currently used subtherapeutically.

42 Fed.Reg. at 43792. The Tetracycline NOOH stated that the use of such drugs was safe only for a list of specific and strictly limited uses. 42 Fed.Reg. at 56287.

Less than a year after the NOOHs were issued, congressional appropriations committees set aside funds so that the National Academies of Sciences ("NAS") could conduct further research on the safety and effectiveness of antibiotics in animal feed. The report issued by the House Appropriations Committee included thinly veiled suggestions that the FDA not go forward with the hearing process until the research was completed. See H.R.Rep. No. 95-1290, at 99 (1978). The NAS report, which was largely inconclusive but found that "subtherapeutic use of antimicrobials does [155] increase the prevalence of resistance among the E. coli and Salmonella of treated animals," also recommended that additional studies be conducted. National Academy of Sciences, The Effects on Human Health of Subtherapeutic Use of Antimicrobials in Animal Feed xiv (1980), http://www.nap.edu/catalog.php?record_id=21.

Two years later, the House committee reiterated its desire to see further evidence before approving the hearing process. A year after that, the Senate Committee on Appropriations noted that the additional studies recommended by the NAS had not yet been conducted and concluded that the "FDA will be expected to continue to hold in abeyance any implementation of its proposal pending the final results of the above research and evidentiary hearings." S.Rep. No. 97-248, at 79 (1981).

In 1981, several industry groups petitioned the FDA to withdraw the 1977 NOOHs. They also sought approval for new uses of antibiotics. On February 1, 1983, the FDA formally denied the petitions. Penicillin and Tetracycline (Chlortetracycline and Oxytetracycline) in Animal Feeds; Denial of Petitions, 48 Fed. Reg. 4544, 4556 (Feb. 1, 1983). The published notice accompanying the denials stated that "the Director [of the CVM] does not have any less concern at present about the safety issues that prompted adoption of [the NOOHs]. The Director has not changed his earlier conclusion that the available scientific information warrants the proposed actions." Id. at 4555. In conclusion, the FDA stated that

[t]he notices of opportunity for hearing represent the Director's formal position that use of the drugs is not shown to be safe. Therefore, the Director has concluded that he does not wish to withdraw the notices of opportunity for hearing. Instead, the Director wishes to place the notices in abeyance pending completion of the studies mandated by Congress.

The Commissioner [of the FDA] has reviewed the Director's decision and concurs with it.

That notice was signed by the Commissioner of the FDA.

Meanwhile, several additional studies were either commissioned by various government agencies or conducted by independent multinational organizations. In 1984, the FDA contracted with the Seattle-King County Health Department to conduct yet another study. That study sought to determine how easily antibiotic-resistant bacteria could travel from food animals to humans. It concluded that such transmission was likely. In 1987, the FDA asked the Institute of Medicine ("IOM") to conduct a review of the risks to human health from subtherapeutic uses of antibiotics in animal feed. IOM found "a considerable body of indirect evidence implicating both subtherapeutic and therapeutic use of antimicrobials as a potential human health hazard," although it could not establish a definitive direct link. In 1997, the World Health Organization held a meeting of experts to develop a report on the question. The WHO report recommended ceasing subtherapeutic use in animals of any antibiotic that is prescribed for use in humans to combat bacterial infections. Many other reports were also compiled and described in the FDA's draft Guidance for Industry #209, issued on June 28, 2010.

The FDA never held the hearings it proposed in the 1977 NOOHs. On March 9, 1999, a group of public-interest organizations petitioned the FDA, pursuant to § 512(e) of the Food, Drug, and Cosmetic Act ("FDCA"), to withdraw regulatory approval for the subtherapeutic use in animal feed of a specified list of antibiotics, which [156] included penicillin and tetracyclines. On April 7, 2005, an overlapping but distinct group of public-interest organizations petitioned the FDA a second time with the same request. Both petitions received preliminary responses, but the FDA issued no final response until after the instant lawsuit was filed.

In the meantime, the FDA issued a series of guidance documents to industry groups, in an effort to implement a voluntary program for gradually reducing the subtherapeutic use of antibiotics in animal feed. The primary mechanism for this hoped-for reduction was an agreement to limit the use of certain antibiotics to therapeutic uses authorized by veterinary prescription. The FDA's October 23, 2003 Guidance for Industry # 152 detailed the FDA's conclusions about the dangers posed by subtherapeutic use of antibiotics in animal feed. Guidance 152, by its terms, applied primarily to applications for regulatory approval for new uses of antibiotic drugs. On June 28, 2010, FDA released draft Guidance for Industry # 209, which set out its plan to avoid all uses of antibiotics that were not "judicious." A disclaimer on Guidance 209 specifies that "[i]t does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations."

At the time this lawsuit was filed, the FDA had issued no final response to the citizen petitions and none of the Guidances discussed above had been finalized.

II. The Instant Lawsuits

Plaintiffs, a group of advocacy organizations,^[8] filed this lawsuit in the United States District Court for the Southern District of New York on May 25, 2011. They pled two distinct claims. First, they claimed that 21 U.S.C. § 360b(e)(1) compelled the FDA to hold the hearing proposed by the 1977 NOOHs and, if appropriate, withdraw approval for the antibiotic uses the NOOHs listed.^[9] Second, they claimed that the FDA had unreasonably delayed by failing to respond finally to the 1999 and 2005 citizen petitions, and asked the court to order prompt responses. On July 7, 2011, they filed an amended complaint, which clarified their basis for standing to sue.

On October 6, 2011, after the FDA answered the amended complaint, plaintiffs moved for summary judgment.^[10] A month later, the FDA issued final responses denying the 1999 and 2005 citizen petitions, effectively mooting the plaintiffs' second claim. Essentially, the FDA took the position that an alternative strategy for combatting the ill effects of subtherapeutic use of antibiotics in animal feed would be more efficient than pursuing an effort to withdraw approval for any such uses. By way of explaining its decision, the FDA stated that proceedings to withdraw drug approvals are very costly and lengthy. The FDA also stated that any new proceedings [157] would require a new NOOH incorporating new scientific findings on the relationship between human health and subtherapeutic uses of antibiotics in animal feed. Moreover, the FDA argued, it could not grant the petitions because the withdrawal process had to proceed on a drug-by-drug basis. Accordingly, the FDA had decided to pursue an alternative but complementary course of voluntary measures. Shortly thereafter, the FDA formally withdrew the 1977 NOOHs. Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed, 76 Fed. Reg. 79697 (Dec. 22, 2011).

In light of these actions, the plaintiffs withdrew their claim to compel action on their petition, which had been mooted by the FDA's denial, and, on February 1, 2012, filed a supplemental complaint alleging that the denial of their petitions was arbitrary and capricious. The parties then filed renewed cross-motions for summary judgment. The district court ruled separately on the two remaining claims. In a March 22, 2012 order, the district court (Theodore H. Katz, Magistrate Judge) granted plaintiffs' motion for summary judgment on the NOOH claim.^[11]Natural Res. Def. Council, Inc. v. FDA ("NRDC I"), 884 F.Supp.2d 127 (S.D.N.Y.2012). The district court ruled that 21 U.S.C. § 360b(e) required the FDA to hold a hearing once it had made a finding that a particular drug use was not safe. It further ruled that the 1977 NOOH constituted or contained such a finding, and that withdrawal of the 1977 NOOH did not effect a withdrawal of that finding. It therefore ordered FDA to institute withdrawal proceedings for the uses discussed in the 1977 NOOH and, unless the manufacturers could rebut the finding, withdraw approval for those drug uses.

In a June 1, 2012 order, the district court (Theodore H. Katz, Magistrate Judge) granted plaintiffs' motion for summary judgment as to the claims that the denial of the citizen petitions was arbitrary and capricious. Natural Res. Def. Council, Inc. v. FDA("NRDC II"), 872 F.Supp.2d 318 (S.D.N.Y.2012). According to the district court, the reasons stated in the withdrawal were insufficient to meet even the very limited review authorized by the arbitrary-and-capricious standard. As to the FDA's claim that withdrawal proceedings are costly and lengthy, the district court ruled that the statute was clear and that these concerns were not relevant. In making this point, the district court relied primarily on Massachusetts v. EPA, 549 U.S. 497, 127 S.Ct. 1438, 167 L.Ed.2d 248 (2007). NRDC II, 872 F.Supp. at 333-34, 337-38. As to the FDA's claim that it was pursuing alternative voluntary measures to regulate the use of antibiotics, the district court again concluded that the statute was clear and that voluntary measures — effective or not — could not be substituted for the mandatory measures required by the text of the statute.

The government timely appealed both of the district court's judgments.

DISCUSSION

We review a district court's decisions on motions for summary judgment de novo. Chandok v. Klessig, 632 F.3d 803, 812 (2d Cir.2011). Summary judgment is appropriate if there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. Fed. R.Civ.P. 56(a). Here, the facts of the case are undisputed, and the questions posed are purely legal.

I. The Required Hearings Claim

A. The Statutory Text

The principal question presented by this appeal is whether 21 U.S.C. § 360b(e)(1) [158] requires the FDA to proceed with withdrawal hearings for certain previously approved subtherapeutic uses of antibiotics in animal feed because the FDA has made a finding that those uses are not shown to be safe for humans. The text of § 360b(e)(1) clearly requires withdrawal of approval once such a finding has been made; it does not equally clearly specify when the agency makes such a finding, and in particular whether the type of finding that mandates withdrawal of approval is a conclusion based on internal agency deliberations that precedes (and then requires) the holding of a hearing, or a finding that represents the conclusion reached as the result of such a hearing.

21 U.S.C. § 360b(e)(1) addresses the FDA's power to withdraw approval for "new animal drug[s]."^[12] The text of the statute states that

(1) The Secretary[^[13]] shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) of this section with respect to any new animal drug if the Secretary finds ...

(B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...;

Id.

The parties dispute the circumstances under which the mandatory language "shall ... issue an order withdrawing approval" comes into play. In particular, they dispute what it means for the Secretary to make a finding, and when that finding occurs. The text makes clear that an order withdrawing approval must be issued (and so far as relevant here may only be issued) upon the occurrence of two conditions precedent — a finding and a hearing. The parties, in effect, dispute the required and anticipated sequence of those conditions.

The government reads the statute as requiring the sequence: hearing, finding, order. In effect, it reads the provision to say, "If, after notice and a hearing, the secretary finds that a drug is not shown to be safe for use," she is required to withdraw approval of the drug. In this interpretation, the withdrawal process begins with a notice from the FDA to a drug sponsor of its concerns about an drug, and offering the opportunity for a hearing regarding the safety of the animal drug. If, at the conclusion of the hearing, upon consideration of the evidence presented, the secretary finds that the drug is indeed not shown to be safe for use, she must then issue an order withdrawing approval of the drug. That order of events depends upon [159] the conclusion that a finding that an animal drug is not shown to be safe can be made only after the drug's sponsor's due process rights — notice and an opportunity to be heard — have been respected. Therefore, the mandatory "shall" applies only to the action — withdrawal of approval — that the Secretary must take if the hearing results in a finding adverse to the drug. On the government's reading, the mandatory "shall" does not apply to the holding of the hearing itself, which the government argues is a discretionary action that the agency may undertake, or not, in its discretion, based on its judgment about whether the scientific evidence and sound public policy warrant instituting proceedings to withdraw approval.

By contrast, plaintiffs favor the sequence: finding, hearing, finding, order. In effect, they read the statute to say, "If the secretary finds a drug is not shown to be safe for use, she shall provide notice to the applicant, hold a hearing, issue a second finding, and then withdraw approval." In their interpretation, the initial finding that the drug is not shown to be safe is based on the agency's internal investigations of the scientific evidence, and comes before any hearing is held. On plaintiffs' reading, once the agency reaches the conclusion that the drug is not shown to be safe, the mandatory language of the statute becomes applicable — the agency must issue an order of withdrawal, though it must hold a hearing first. The mandatory "shall" thus in effect governs not only the remedy that must follow a formal conclusion after a hearing, but also the process itself; after reaching its initial conclusion that the drug is not shown to be safe, the agency is required to institute proceedings and effectuate them through a hearing, after which (if the evidence present at the hearing sustains the finding) she must issue an order of withdrawal.

As plaintiffs admit, their construction necessarily contemplates two findings that a drug is not shown to be safe for use: one (based on internal deliberations) that triggers the (mandatory) hearing, and another (after the sponsor has been given notice and an opportunity to be heard, and based on the evidence presented at that hearing) that supports the issuance of an order of withdrawal.^[14] Plaintiffs argue that the initial finding made by the agency is subject to rebuttal by the sponsor at the mandated hearing; in the absence of such rebuttal, the original finding "ripens" and requires issuance of an order of withdrawal.

The text of § 360b(e)(1) itself does not unambiguously express either of these sequences. The syntax makes at least two things clear. First, because the mandatory verb "shall" is linked to "issue an order withdrawing approval" of an NADA if the requisite finding is made, the statute is clear that the withdrawal of the approval is mandatory if the preconditions set in the statute are met. Second, the statute is clear that two such conditions must be met before the requirement that the Secretary "shall" withdraw her approval is triggered: a temporal condition (the withdrawal order may only be issued "after due notice and opportunity for hearing"), and a factual condition (withdrawal is required only "if the Secretary finds ... that such drug is not shown to be safe for use").

The syntax is not similarly clear as to the temporal relationship between the hearing and the finding, because the [160] phrase "after due notice and opportunity for hearing" is inserted somewhat awkwardly between "shall" and "issue." Different placement of the notice and hearing language could have decisively directed one or the other of the competing interpretations. Had Congress written, "If the Secretary finds [that the drug is not shown to be safe for use], she shall conduct a hearing on due notice to the applicant, and shall withdraw approval if the evidence at the hearing supports the finding," the plaintiffs would clearly be correct: after making a "finding," the Secretary would be required to withdraw approval of the drug, but only after a notice and hearing process. In contrast, if Congress had written, "The Secretary shall withdraw approval [of an NADA] if she finds, after due notice and opportunity for hearing to the applicant [that the drug is not shown to be safe]," the FDA's interpretation would clearly be correct. Unfortunately, it wrote neither, adopting a syntactically awkward variation that leaves the intended sequence ambiguous.

Although the grammar of the sentence as it is actually written does not absolutely compel either reading, we believe that the government's interpretation is far more plausible, both as a matter of language and as a matter of conventional legal practice.^[15] As noted above, the plaintiffs' reading requires not one but two findings, in a sentence that only refers to one. Congress expressly provided that withdrawal of approval is required (indeed, such withdrawal is authorized) only after a hearing is held and a finding is made. The hearing process is thus a critical precondition of the withdrawal order, and as plaintiffs concede, the entire purpose of the hearing is to determine whether the evidence does indeed show that the drug is not shown to be safe for use. The hearing thus eventuates in withdrawal of approval only if the Secretary concludes, based on the evidence of "experience and scientific data" presented at the hearing, that the [161] drug is not shown to be safe. Yet according to the plaintiffs' reading, the statute makes no explicit reference to any such finding at the culmination of the hearing — in plaintiffs' view, the only finding that Congress expressly requires, and the one that the grammatical construction of the sentence makes prerequisite to the withdrawal of approval, is the finding that the Secretary makes before the hearing even takes place.^[16]

Similarly, while the plaintiffs' reading would make the initial internal administrative finding of a lack of showing of safety the trigger for a mandatory hearing, the statute does not grammatically link the only "finding" referred to in the statute to a mandatory hearing, but rather to a mandatory withdrawal of approval. Moreover, the statute does not require withdrawal of approval based solely upon an internal, pre-hearing finding — withdrawal of approval must await the conclusion of the hearing, at which further findings would have to be made. At that point, the withdrawal is no longer the mandatory consequence of the initial finding — if the hearing demonstrated the safety of the drug, withdrawal of approval would not be required, or even permitted. It is, instead, the consequence of the further finding at the end of the hearing, based on the evidence presented there. According to plaintiffs, Congress meant to mandate that upon making the "finding" referred to in § 3609(e)(1)(A), the Secretary is required to hold a hearing, and yet Congress provided that upon making such a finding the Secretary "shall issue" not a notice of opportunity for a hearing, but a withdrawal of approval of the drug. In short, it would be singularly odd for Congress to have chosen the language that it did to describe the process that even the plaintiffs concede it intended.

The government's preferred reading yields no such difficulties. While it is true that the statute would read more smoothly, and would more clearly express the government's position, if the phrase "after due notice and an opportunity for hearing" were placed after "finds," rather than between "shall" and "issue," nothing in the statutory language needs to be twisted to yield the government's interpretation. Although the placement of the notice and hearing provision is awkward (on either side's interpretation), even as placed, it is entirely consonant with the government's reading. There is nothing syntactically difficult or odd about providing that the Secretary shall withdraw her approval of a drug, after a notice and hearing process, if a finding is made (after such process) that the drug is not shown to be safe.

B. Context

The parties call our attention to various aspects of the larger statutory context that might cast further light on the meaning of this particular provision. The cited portions of the statute, however, do not provide much help in clarifying the meaning of the provision in question, and certainly [162] do not provide sufficient instruction to overcome the reading derived from the language of the debated text itself.

As the parties note, different language within the same statutory subsection provides for emergency withdrawal of approval for animal drugs "if the Secretary ... finds" that the drugs pose an "imminent hazard to the health of man or of the animals." 21 U.S.C. § 360b(e)(1) (last paragraph). In such a case, the Secretary — but not any delegate — may immediately and without a hearing suspend approval for the drug in question. That provision can be used to support either side. On the one hand, plaintiffs argue that its language supports the notion that the Secretary can make "findings" by an internal administrative process, without notice or a hearing. On the other hand, the government argues that the special exception permitting emergency interim relief to prevent "imminent hazards," and the reservation of authority to make such emergency findings to the Secretary, serves to underscore the general and otherwise-applicable rule that findings that induce final agency actions adverse to applicants must be made after notice and hearing, and must represent the final conclusion of the agency, rather than an interim judgment delegable to lower-ranking officials. Neither of these inferences from the emergency suspension provision can be dismissed as implausible, but neither persuasively illuminates the process anticipated by the language in question in this case.

The district court also relied on a distinction between § 360b(e)(1) and the preceding subsection of the statute, § 360b(d)(1), to support its conclusion that findings could precede hearings for purposes of § 360b(e)(1). Section 360b(d)(1) — which lists the permissible grounds on which the Secretary may initially deny an application for approval of a new animal drug — clearly states that findings of fact must occur after a hearing, by placing the "after due notice [and] hearing" language immediately after the verb "finds."^[17] That difference in language, the district court concluded, suggests that Congress intended different schemes under the two subsections. The government challenges that reading, however, arguing that § 360b(d) is expressly connected to the language of the preceding § 360b(c)(1), which in turn explicitly contemplates that some findings may be made without a hearing.^[18] In that context, it makes sense that Congress would use more sharply contrasting language to distinguish the findings made under subsection (d) from those required in subsection (c). By contrast, under § 360b(e)(1), no order withdrawing approval may issue before a hearing unless the drug represents an "imminent hazard." In the government's reading, the difference in language between subsections (d) and (e) reflects the differing procedures for approval of a new drug and for the withdrawal of approval of a previously approved drug, rather than any intention to limit agency discretion to institute, pursue, or abandon procedures to withdraw drug approvals.

[163] Again, we find both parties' inferences from the language of § 360b(d) reasonable. But neither is sufficiently compelling either to strongly corroborate or to seriously undermine our reading of the text. As noted above, it is unquestionably clear from the text that the mandate to order withdrawal only applies after the agency has held a hearing. Indeed, it is clear from the text that an order withdrawing approval may not be entered (except in the emergency circumstances referred to in § 360b(e)(1)) without providing notice and a hearing to the drug's sponsor. It seems to us that, when a statute provides that an agency must take some action after a hearing "if it finds" something to be true, the more persuasive reading is that the finding referred to is the fruit of the required hearing.

C. The Relevant Regulations

Both parties argue that various regulations implementing the statute support their respective interpretations. For the reasons set forth below, we do not find these arguments especially helpful.

The government argues that the FDA's interpretation of the statute is entitled to deference. We generally give deference to an agency's interpretation of statutes that the agency administers. See Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 844-45, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). The Supreme Court has held that the FDA is entitled to deference when it interprets Title 21 of the United States Code, FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000), because the FDA, as designee of the Department of Health and Human Services, is the agency tasked with administering the FDCA. We will therefore defer to the FDA's interpretation if Congress has not directly spoken to the precise question at issue and the agency can point to an official interpretation that sets forth a permissible construction of the statute.

However, before we defer to an agency's interpretation of a statute, we must identify an agency document setting forth that interpretation. The level of deference to an agency's interpretation of its own statute depends on the nature of the document setting forth the interpretation. Regulations promulgated after a period of notice and comment are typically granted the relatively strong form of deference described by Chevron. See United States v. Mead Corp., 533 U.S. 218, 228-30, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001). We give substantially less deference to post hoc interpretations offered only for purposes of litigation, particularly when those interpretations represent a "departure from prior norms." See Am. Fed'n of State, County, & Mun. Emps. v. Am. Int'l Grp., Inc., 462 F.3d 121, 129 (2d Cir.2006), quoting Atchison, Topeka & Santa Fe Ry. Co. v. Wichita Bd. of Trade, 412 U.S. 800, 808, 93 S.Ct. 2367, 37 L.Ed.2d 350 (1973). The government urges us to apply Chevron deference to the FDA's interpretation of the statute as embodied in its notice and comment regulations.

The government, however, overlooks a basic predicate of administrative deference. In order to merit deference on a given issue, a particular regulation must shed light one way or the other on the issue. The government points to three regulations to support its position, but none of them help decide the question before us: whether the findings referred to in § 360b(e) precede hearings, or follow them. The government concedes that the regulations it cites do not explicitly undertake to interpret the statutory provision at issue and answer the question before us, but nevertheless argues that the regulations presuppose an answer to that question.

[164] First, the government relies on 21 C.F.R. § 5.84, which authorizes the Director of CVM, as the Secretary's delegate, to issue NOOHs on the latter's behalf.^[19] Specifically, the regulation provides that the Director may issue NOOHs or, if the sponsor has waived the right to a hearing, the Director may issue an order of withdrawal. But that regulation fails to give any indication about what, if any, conditions might require a hearing. The government argues that, because § 5.84 represents a partial delegation of the Secretary's duties under § 360b(e)(1) only for purposes of issuing NOOHs, it does not authorize the Director to make "findings," and that therefore the issuance of an NOOH is never preceded by a finding as defined in the statute. But the regulation merely states that "[t]he Director and Deputy Director [of the CVM] are authorized to issue [NOOHs] ... and to issue notices of withdrawal of approval when opportunity for hearing has been waived." 21 C.F.R. § 5.84(a)(1)-(2). It is thus equally plausible to read § 5.84 as delegating to the Director of CVM^[20] the responsibility for making any findings that might trigger the mandatory issuance of NOOHs and any resulting actions.

The government next points to 21 C.F.R. § 514.200(c), which sets out the possible responses a sponsor may make to an NOOH, and describes the requisite showing a sponsor must make to secure an actual hearing as opposed to a decision on the papers. It argues that that regulation precludes plaintiffs' reading because any pre-hearing findings are necessarily preliminary. Specifically, the regulation requires a sponsor seeking a hearing to

giv[e] the reason why the application should not be refused or should not be withdrawn, together with a well-organized and full-factual analysis of the clinical and other investigational data he is prepared to prove in support of his opposition to the Commissioner's proposal. A request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing there is a genuine and substantial issue of fact that requires a hearing. When it clearly appears from the data in the application and from the reasons and a factual analysis in the request for the hearing that no genuine and substantial issue of fact precludes the refusal to approve the application or the withdrawal of approval of the application (for example, no adequate and well-controlled clinical investigations to support the claims of effectiveness have been identified), the Commissioner will enter [165] an order on this data, stating his findings and conclusions.

21 C.F.R. § 514.200(c) (emphasis added). The government argues that, because a decision to grant a hearing represents only the Commissioner's determination that there may be a "genuine and substantial issue of fact preclud[ing] ... the withdrawal of approval of the application," it cannot represent a conclusive finding triggering a mandatory duty. By contrast, the plaintiffs argue, and the district court agreed, that not only does § 514.200(c) fail to support the position that findings may take place only after a hearing, but it also explicitly contemplates findings even in the absence of a hearing. If the sponsor's written response to a NOOH is insufficient, the Commissioner is to enter an order of withdrawal based on, among other things, the data in the initial application.

The regulation, it seems to us, simply provides a mechanism for a kind of "summary judgment" proceeding that might obviate an evidentiary hearing. If the applicant requests a hearing, the decision to withdraw approval of the drug must be based either on formal "findings" derived from the evidence adduced at a hearing or, where that the request for a hearing does not raise a genuine issue of disputed fact, on a summary judgment-like conclusion. To that extent, the regulation is consistent with the government's basic contention that "findings" normally result from an adjudicative process, and are made after that process is instituted. It does not, however, directly address — let alone lead us to conclusively reject — plaintiffs' contention that the entire proceeding is triggered by an agency "finding." We therefore conclude that this regulation does not embody an unambiguous interpretation of § 360b(e)(1) to which we must defer in this case.

Finally, the government urges us to take account of 21 C.F.R. § 10.55(b)(2)(i), which provides for the separation of investigative and adjudicative responsibilities within the FDA in the event of a hearing. Specifically, that regulation provides that, from the time of the announcement of a formal hearing, CVM will be "responsible for all investigative functions" and for presenting the FDA's case before the adjudicator. According to the government, this separation of functions "reflects FDA's understanding that throughout the withdrawal process, CVM does not speak on behalf of" the FDA. Because CVM cannot speak on behalf of the Commissioner once hearing proceedings have been instituted, the government argues that any "finding" by CVM cannot trigger a mandatory duty on the part of the Commissioner. That argument has one major flaw: the finding that plaintiffs argue triggered the FDA's duty to proceed with the hearing necessarily preceded the period of separation of administrative functions. Because functions are separated only upon publication of an NOOH, anything that precedes or is included in the NOOH might have represented an action by the Commissioner through her delegate, the Director of CVM.

We are therefore unable to identify a regulation promulgated by FDA pursuant to its notice and comment rulemaking authority that clearly reflects a definitive interpretation of § 360b(e)(1). While the regulations relied upon by the FDA do not expressly adopt or unambiguously require any particular interpretation of the contested language to which we must accord Chevron deference, they still provide some guidance. As we discuss below, we believe that the regulations relied upon by the FDA reflect a conventional understanding of the administrative process that is consistent with the interpretation of § 360b(e)(1) advanced by the government. We cannot conclude, however, that any of those regulations directly speak to the specific [166] question of statutory interpretation before us, or reflect a clear adoption by the agency of any position on that question.

Plaintiffs, for their part, also seek support in FDA regulations. They argue that the regulation most on point is 21 C.F.R. § 514.115(b)(3)(ii), which details the procedures for withdrawal of approval of an NADA. That regulation provides: "The Commissioner shall notify in writing the person holding an application approved pursuant to section 512(c) of the act and afford an opportunity for a hearing on a proposal to withdraw approval of such application if he finds" that one of the conditions described in § 360b is met. 21 C.F.R. § 514.115(b)(3) (emphasis added). That regulation unquestionably lends plausibility to plaintiffs' reading of the statute because it clearly contemplates that the Commissioner must make some sort of finding before the issuance of an NOOH. Indeed it was largely on the basis of § 514.115(b)(3)(ii) that the district court interpreted the statute to require the FDA to proceed with the hearing.

The government, however, argues that this regulation is inapposite because "identical words need not have identical meanings when used in different contexts" and the FDA's use of "finds" in the regulation refers only to a preliminary finding. While the government's argument is hardly compelling, the regulation can indeed be read as it proposes. Moreover, that the FDA regulation refers to a finding made by the Commissioner before instituting a hearing does not mean that the regulation is intended to set forth the agency's definitive interpretation, or indeed any interpretation at all, of the statutory language whose meaning the parties here dispute. In other words, plaintiffs' reliance on § 514.114(b)(3)(ii) suffers from the same flaw as the FDA's reliance on the regulations that it cites. All of the cited regulations are drafted to define administrative procedures, and not to interpret the mandate set forth by Congress in § 360b(e)(1). The use of certain language in those regulations or the nature of the procedures that they create may lend some support to the position of one side or the other, but the regulations simply cannot be said to answer the question before us.

In short, we are not required to defer to an agency's interpretation of a statute when its regulations do not directly address the question before the Court, and when the language of one regulation appears to be in tension with the agency's interpretation of the statute advanced for purposes of litigation. We therefore conclude that Chevron deference does not provide an answer to the question before us.

D. Background Legal Concepts

We take some comfort from the fact that our interpretation of the statutory text is consistent with ordinary understandings of administrative and judicial litigation processes. In interpreting a statute, courts generally presume that Congress acts "against the background of our traditional legal concepts." United States v. U.S. Gypsum Co., 438 U.S. 422, 437, 98 S.Ct. 2864, 57 L.Ed.2d 854 (1978). See also United States v. Pacheco, 225 F.3d 148, 157 (2d Cir.2000). Of course, Congress may depart from such traditions; it may use words in ways that are unconventional, or adopt innovative procedures. But when a statute does not provide clear direction, it is more likely that Congress was adopting, rather than departing from, established assumptions about how our legal or administrative system works. We will not lightly assume a less conventional meaning absent a clear indication that such a meaning was intended. In our view, the interpretation advanced by the government is more in accordance with such conventions.

[167] First, the government's interpretation is more consistent with our usual understanding of an administrative "finding." An agency "finding" typically represents an official determination, reflecting a final, deliberative decision issuing at the conclusion of a process, and taking a fixed form embodied in an identifiable document. Judicial or administrative findings most commonly are adopted not as a prerequisite but as a consequence of a hearing or other official proceeding. For example, Black's Law Dictionary defines the verb "find" as "To determine a fact in dispute by verdict or decision," Black's Law Dictionary 707 (9th ed.2009) (emphasis added), and the noun "finding of fact" as "A determination by a judge, jury, or administrative agency of a fact supported by the evidence in the record, usu. presented at the trial or hearing," id. at 708 (emphasis added). Thus a "finding" traditionally occurs after adversarial parties are given notice of a hearing and an opportunity to be heard there, at least if hearings are contemplated as part of the administrative scheme.

Other areas of the law define "findings" to mean written conclusions issued only at the completion of an administrative process. For example, for purposes of judicial review of agency adjudication under the Social Security Act, we have held that the term "findings" refers to the agency's on-the-record determinations at a hearing, and that the agency has an affirmative duty to develop the record during the hearing to facilitate judicial review. See Pratts v. Chater, 94 F.3d 34, 37 (2d Cir. 1996); see also 42 U.S.C. § 405(g). Similarly, albeit in a context that does not necessarily contemplate hearings, Federal Rule of Evidence 803(8)(A)(iii), which provides an exception to the hearsay rule for written public records and reports, permits admission into evidence "findings from a legally authorized investigation," and the Supreme Court has interpreted the rule as requiring a "conclusion ... based on a factual investigation." Beech Aircraft Corp. v. Rainey, 488 U.S. 153, 170, 109 S.Ct. 439, 102 L.Ed.2d 445 (1988) (emphasis added). In these instances, "findings" are written and issue only at the conclusion of the entire process.

We do not suggest that the term cannot be, or indeed is not, sometimes used in a different sense. As plaintiffs point out, even in this very regulatory scheme, the FDA uses the word "find" in a context that clearly refers to a preliminary finding that does not share the characteristics discussed above. See 21 C.F.R. § 514.115(b)(3)(ii), discussed above. Similarly, the emergency suspension proceedings in § 360b(e)(1) itself refer to findings that are made by the Secretary without a hearing, though, notably in that context, the finding is the basis for an action that has an immediate legal effect on the rights of a drug sponsor, rather than being the basis of a decision to institute a process that may eventually lead to such an effect. Nevertheless, where the context does not clearly indicate to the contrary, typical usage suggests that an administrative finding reflects the agency's final decision issued at the conclusion of a process, rather than a preliminary assessment that contemplates further proceedings before final action is taken.^[21]

Second, the function of the finding contemplated by § 360b(e)(1), and the mandate [168] that Congress attached to the making of such a finding, is consistent with this more natural meaning. As plaintiffs themselves emphasize, a finding by the Commissioner that a drug is not shown to be safe requires the FDA to "issue an order withdrawing approval" of the drug. 21 U.S.C. § 360b(e)(1). The FDA is not accorded discretion to adopt a different remedy. The consequences of such a withdrawal are significant for society and for the sponsor or manufacturer of the drug. It is logical to assume that Congress would mandate withdrawal of approval of a drug when it has been determined that the drug has not been shown to be safe by a formal decision of the agency, after a careful hearing at which evidence both for and against the safety of the drug has been presented. In contrast, it would seem peculiar for Congress (absent an emergency of the sort authorizing unilateral agency action provided for in the last paragraph of § 360b(e)(1)) to mandate such a strong remedy based not on a final decision by the agency head after a full deliberative process, but on a preliminary conclusion reached by lower-level officials before those affected have had an opportunity to be heard.

And of course, as plaintiffs in effect concede, Congress clearly has not done so. While the language of the statute dictates that withdrawal of approval is the necessary consequence of a finding that an animal drug is not shown to be safe, the statute requires notice to the sponsor and an opportunity for a hearing before a final order of withdrawal may issue, and plaintiffs agree that such an order may issue only if the hearing results in a finding by the Secretary that the drug is not shown to be safe. Under the literal words of the statute, as well as in accordance with common sense, the agency must issue an order withdrawing approval when it finds that the drug is not shown to be safe — something that, as a matter of statutory command and due process, may only occur after the hearing.

Third, the administrative process contemplated by the government's interpretation of the statute accords with our traditional expectations of governmental enforcement of legal rules. The traditional model of administrative or judicial enforcement features an investigation by executive or administrative personnel, followed by the issuance of a case-initiating document that sets forth the conclusions or charges reached by the prosecuting authority, followed by a hearing. That process culminates in a final adjudication that is reached by the agency and embodied in a formal decision, and imposes whatever remedies or penalties are applicable. In civil and criminal actions, the initial conclusions of the administrative agency or executive officer that lead to the filing of a lawsuit and an adjudication by a court are not thought of as "findings" and do not mandate final action; a remedy (discretionary or mandatory) is contingent on the ultimate finding of the court.

The same is typically true of administrative processes. Commonly, an agency seeking to take action adverse to the interests of an affected party brings a charge that leads to a hearing process; only after the hearing does the final agency action result in formal findings and a resultant order.^[22] The government's interpretation [169] of the statute — and the regulations it has issued that implement it — is essentially consistent with this model. The plaintiffs' interpretation departs from it, by insisting that a preliminary conclusion sufficient to trigger a full-dress hearing should be treated as an agency "finding" that mandates action.

Fourth, interpreting the statute to mandate action upon a "finding" that is not the result of the required hearing presents the problem of identifying when and how such a finding has been made. Under the plaintiffs' interpretation, the "finding" that would trigger these mandatory consequences is not, as in the normal understanding of an agency finding, a formal decision embodied in documentary form. The most plausible place to look for a formal finding that precedes and therefore could trigger a hearing under the plaintiffs' interpretation is in the NOOHs issued by the CVM in 1977 which set forth the scientific conclusions of the Director regarding the safety issues affecting animal antibiotics and initiate the process by which the agency can withdraw approval of their subtherapeutic use.

But if the NOOHs contain or embody the findings on which plaintiffs rely, plaintiffs are confronted with the problem that those NOOHs have been withdrawn. Nothing in the statute or regulations explicitly restricts the FDA's ability to withdraw an NOOH after it has issued. Thus, at this moment, there is no operative document that contains any formal finding, final or preliminary, that any use of animal antibiotics pose health threats to humans. Accordingly, the plaintiffs must, and do, argue that the withdrawal of the NOOHs does not effectively withdraw the finding that was documented in them. They reason that "findings" need not be reflected in any one document but rather comprise the FDA's considered collective judgment about the science underlying antibiotic resistance and its effects on human safety. To withdraw the findings, plaintiffs argue, the FDA must publicly recant its earlier position on the safety of the use of antibiotics in animal feed. According to plaintiffs, the agency's continued insistence, up to and including in briefing and oral argument on this appeal, that such use of antibiotics does pose risks for humans actually "reaffirmed" the findings first announced in the 1977 NOOHs. In short, the "finding" that subtherapeutic uses of antibiotics in animal feed is not shown to be safe resides not in any formal legal conclusion but in the scientific judgment of the relevant FDA officials, current and past, that such uses may be dangerous. By the plaintiffs' argument, once the Secretary reaches a conclusion that a drug use is not shown to be safe, she is required to act on that opinion.

The withdrawal of the NOOHs, however, simply makes more stark a problem inherent in the plaintiffs' argument. The underlying logic of the plaintiffs' position is that the finding of the Secretary that triggers a hearing must precede even the NOOH itself, for it is this finding that triggers the obligation of the FDA to hold a hearing that, assuming that it results in yet another finding adverse to the drug, is the precursor to a mandatory order withholding approval of the drug. In other words, once the Secretary reaches a certain conclusion, an NOOH must issue, and a hearing must commence.

[170] That interpretation is problematic. Administrative findings, whether or not preceded by adversarial evidentiary hearings, are ordinarily clothed in the garb of decision, and reflect a formal determination. The fact that plaintiffs argue that the findings originated with the 1977 NOOHs underscores that conclusion, since the NOOHs have the level of formality we typically expect findings to have. But if the NOOHs embody (or contain) the requisite findings, and revocation of the NOOHs does not suffice to withdraw them, where do the findings exist? In the thoughts and beliefs of the Secretary or Commissioner? Scattered across various agency documents reflecting such thoughts?

That is not merely a formal or metaphysical point, but an intensely practical one. By the language of the statute, once a finding is made, agency action is mandatory, and in default of that action, the courts may compel the agency to act. Under the government's interpretation of the statute, the mandate that the courts are to enforce is straightforward. If, after holding a hearing and reviewing the evidence presented, the agency formally finds that a particular use of an animal drug has not been shown to be safe for humans, but fails to withdraw approval of the use of that drug and instead adopts some other approach for dealing with the prospective danger, the courts must enforce the congressional mandate and require the Secretary to withdraw approval.^[23]

Under the plaintiffs' interpretation, in contrast, the courts must first determine whether an entirely subjective and unexpressed finding has been made during internal agency deliberations. On the facts of this case, plaintiffs would have us seek such a finding in the now-withdrawn 1977 NOOH, and would have us conclude that the finding continues to exist based on various statements of FDA representatives in public and before the Congress, in litigation, and in the actions taken by the FDA to encourage voluntary reductions in animal antibiotic use. That is itself sufficiently problematic, but in principle plaintiffs' position would permit lawsuits contending that the Secretary or her delegates have actually made findings that remain entirely unexpressed in any formal document, because they have formed opinions based on internal agency deliberations or on a review of scientific studies.^[24]

Fifth, the traditional model of enforcement action described above contemplates considerable discretion on the part of an agency to decide, for prudential reasons, whether to initiate action or not, and whether to desist from proceeding before a final conclusion is reached. Such discretion is a typical and often necessary feature of the administrative process. Agencies have many responsibilities, and limited resources. Deciding whether and when to deploy those resources in an arduous, contested adversarial process is an important [171] and difficult responsibility. It is rare that agencies lack discretion to choose their own enforcement priorities. Indeed, the Supreme Court has long applied a presumption against judicial review of agency decisions declining to proceed with enforcement actions because such decisions are, for purposes of the Administrative Procedure Act ("APA"), "committed to agency discretion." Heckler v. Chaney, 470 U.S. 821, 832-33, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), quoting 5 U.S.C. § 701(a)(2).

Plaintiffs' interpretation of § 360b(e)(1) would deny that discretion to the FDA. Were the "finding" that requires the withdrawal of approval located not in the final decision of the Commissioner at the conclusion of a hearing at which all relevant evidence is publicly presented, but in a determination by the head of the CVM, based on an internal consideration of studies conducted by the agency or in the academic literature, that the scientific evidence warrants initiating a hearing so that the Commissioner might eventually reach such a final decision, the agency would be required to take irrevocable action whenever the CVM forms such an opinion that a drug is not shown to be safe, regardless of whether the FDA believes that proceeding further is worth the diversion of resources from other agency priorities. Ordinarily, administrative discretion is at its zenith when an agency decides whether to initiate enforcement proceedings. The government's position is consistent with this longstanding discretion; the plaintiffs' position is not.

In canvassing these various principles and practices, we do not suggest that they are mandatory and inescapable presumptions about administrative law. Administrative procedure is flexible, and different approaches may be appropriate in different contexts. We have pointed to what we believe are the more common understandings or expectations about agency findings, orderly procedure, administrative discretion, and judicial review. We are confident that numerous exceptions and counter-examples exist. More importantly, it is beyond doubt that Congress has the power to alter these assumptions, in any particular case or in general, by adopting legislation that imposes contrary mandates on administrative agencies.^[25] Moreover, given the preeminent importance of health and safety in the usage of powerful bioactive substances such as human and animal drugs, it would hardly be surprising for Congress to impose limits on traditional agency discretion or to mandate actions protective of human safety. But the issue here is not whether Congress can impose the sort of mandate plaintiffs would find in the statute — of course it can — but whether Congress has done so.

E. Summary

Our survey of the text, the context, the regulations, and the background legal principles leave us firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage, that the FDA retains the discretion to institute or terminate proceedings [172] to withdraw approval of animal drugs by issuing or withdrawing NOOHs, and that the statutory mandate contained in § 360b(e)(1) applies to limit the FDA's remedial discretion by requiring withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety.

That conclusion begins, as it must, with the text of the statute. Although the text is not unambiguously clear, we believe that the FDA put forth the more natural reading. The statute requires the FDA to withdraw approval of an animal drug only "after due notice and opportunity for hearing" has been afforded, and then only "if the Secretary finds" that the drug is not shown to be safe. 21 U.S.C. § 360B(e)(1). That language most naturally refers to a finding that is issued as a result of the hearing. That interpretation, moreover, avoids injecting a second, unexpressed "finding" into the sequence of events mentioned in the statute.

Although the regulations implementing the statute do not directly address the question of interpretation posed by the plaintiffs, and contain at least some language that arguably supports the plaintiffs' reading of some terms in the statute, the overall thrust of the regulations is consistent with the government's interpretation, and with what we regard as the more natural reading of the statutory language. Moreover, the procedure set forth in those regulations, and our reading of the text, are consistent with common assumptions about agency procedure. Under that procedure, relevant experts within the agency (the staff of the CVM) first assess the scientific issues regarding the risks and benefits of the drug, and a high-ranking agency official (the Director of the CVM) exercises discretion to institute a proceeding that can lead to the revocation of approval of the drug. Then (if the sponsor of the drug requests a hearing and raises genuine issues of material fact about the preliminary conclusions set forth in the NOOH) the staff proceeds to present evidence at a hearing featuring the separation of functions between the "prosecuting" officials instituting the hearing and the objective decisionmaker who will hear the evidence. At the conclusion of that hearing, that decisionmaker issues findings that must be approved by a higher-ranking official, the Commissioner of the FDA. If the ultimate agency finding, which is subject to judicial review, is that the drug is not shown to be safe, the statute permits only one remedy — withdrawal of approval.^[26]

Our interpretation of the statute is consistent with the regulations and with conventional procedure. That alone does not make it correct; Congress undoubtedly has the power to alter those conventions. We believe, however, that if Congress intended to do so, and to mandate the commencement of the notice and hearing process whenever the agency staff formed a scientific opinion adverse to the drug, it would have stated those intentions explicitly. Far from doing so, it has utilized language that is not only consistent with the traditional administrative process, but that is more naturally read as adopting it.

II. The Citizen Petitions

Alternatively, plaintiffs argue that even if the FDA is not required to proceed with [173] hearings, its decision denying plaintiffs' 1999 and 2005 citizen petitions and withdrawing the 1977 NOOHs represented arbitrary or capricious agency action in violation of the APA. See 5 U.S.C. § 706(2)(A). In particular, plaintiffs argue that the FDA's denials were based on factors not explicitly mentioned by the statute, namely cost, time, and a preference for voluntary compliance over adversary proceedings.

The FDA's notice withdrawing the 1977 NOOHs sets out the reasons for the action:

FDA is taking this action, and closing the corresponding dockets, because: FDA is engaging in other ongoing regulatory strategies developed since the publication of the 1977 NOOHs with respect to addressing microbial food safety issues; FDA would update the NOOHs to reflect current data, information, and policies if, in the future, it decides to move forward with withdrawal of the approved uses of the new animal drugs described in the NOOHs; and FDA would need to prioritize any withdrawal proceedings (for example, take into account which withdrawal(s) would likely have the most significant impact on the public health) if, in the future, it decides to seek withdrawal of the approved uses of any new animal drug or class of drugs.

Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed, 76 Fed.Reg. 79697, 79697 (Dec. 22, 2011). The letters in which the FDA finally denied of the citizen petitions further elaborate on the decision to withdraw the NOOHS and deny the petitions, stating "reviewing safety information for antimicrobial drugs approved before 2003, and pursuing withdrawal proceedings in some cases, would take many years and would impose significant resource demands on the [FDA]." J.A. at 622; J.A. at 627. In the letters the FDA describes its plan to "work[] cooperatively" with the animal pharmaceutical industry to "ensur[e] the judicious use of medically important antimicrobial drugs in food-producing animals." Id.

In arguing that such denial is arbitrary or capricious, plaintiffs claim that the FDA ignored the reams of scientific data presented in the petitions and that the reasons given by the FDA are illegitimate because they are orthogonal to what plaintiffs persuaded the district court is the governing criterion described in the statute: "whether the drugs at issue pose a threat to human health." See NRDC II, 872 F.Supp.2d at 338.

Plaintiffs argue that this case is best analogized to Massachusetts v. EPA, 549 U.S. 497, 127 S.Ct. 1438, 167 L.Ed.2d 248 (2007), in which the Supreme Court invalidated the denial of a petition seeking to require the Environmental Protection Agency ("EPA") to regulate greenhouse gases. But Massachusetts dealt with a much different statutory provision, one which unambiguously compelled agency action. In that case, a group of states, municipalities, and non-profit organizations sought to force the EPA to regulate four greenhouse gases as air pollutants under Section 202(a)(1) of the Clear Air Act, which provides that:

The [EPA] Administrator shall by regulation prescribe ... standards applicable to the emission of any air pollutant from any class or classes of new motor vehicles or new motor vehicle engines, which in his judgment cause, or contribute to, air pollution which may reasonably be anticipated to endanger public health or welfare.

42 U.S.C. § 7521(a)(1) (emphasis added). The Supreme Court agreed with the plaintiffs that the text of the Clean Air Act required the EPA to regulate greenhouse [174] gases. In reaching that conclusion, the Court understood the "judgment" contemplated by the statute as limited to the scientific question whether a particular pollutant contributed to air pollution. Put differently, the Supreme Court read the Clean Air Act not to grant the EPA discretion to choose to regulate only those pollutants that it deemed feasible or wise to regulate. As the Court had it, "the use of the word `judgment' is not a roving license to ignore the statutory text." Massachusetts, 549 U.S. at 533, 127 S.Ct. 1438. Once the EPA determined that carbon dioxide contributed to air pollution, the Court concluded, the statute required it to regulate the emission of that gas.

Massachusetts v. EPA is therefore fully distinguishable from the present case. The Clean Air Act limited the EPA Administrator's "judgment" to the scientific question of whether the pollutant in question causes dangerous air pollution; nothing in § 360b(e)(1) limits the considerations that the FDA may take into account in deciding whether to initiate the hearing process by issuing an NOOH. Moreover, unlike the Clean Air Act, which explicitly and unambiguously requires the regulation of pollutants ("The Administrator shall by regulation prescribe ... standards"), as explained above, § 360b(e)(1) does not mandate that the FDA take any action until and unless certain findings are made after a hearing.^[27] In short, the Clean Air Act provision at issue in Massachusetts v. EPA unambiguously required the EPA to undertake action to create emission standards (leaving it to the EPA's expertise to determine the substance of the standards) whenever it forms a scientific judgment that a particular pollutant contributes to dangerous air pollution, while the provision of the FDCA at issue in this case requires the FDA to take a specific remedial step when, after a hearing, it has made certain findings, without imposing any absolute requirement that the agency investigate the need for withdrawing approval of animal drugs under any particular circumstance.

The present case is therefore more analogous to New York Public Interest Research Group v. Whitman, 321 F.3d 316 (2d Cir.2003), in which we interpreted section 502(i) of the Clean Air Act, 42 U.S.C. § 7661a(i)(1). That provision required the Administrator of the EPA to give notice and, if appropriate, impose the relevant sanctions, "[w]henever the Administrator makes a determination that a permitting authority is not adequately administering and enforcing a program ... in accordance with the requirements of this subchapter." Id. (emphasis added) We held that the use of the word "determination" "grants discretion." Whitman, 321 F.3d at 330. Rejecting the view that the EPA was required to issue a notice of deficiency whenever it found defects in a state permitting program, we noted that "Congress could have fashioned a regime under which, for example, an interested party could initiate the process leading to a determination of whether `a permitting authority is adequately administering and enforcing a program,'" but that by referring [175] to a "determination" on the part of the agency, Congress left it to the discretion of the EPA Administrator whether and when to initiate enforcement proceedings. Id. at 331, quoting 42 U.S.C. 7661a(i)(1).^[28]

For the reasons set forth above, we conclude that the decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary determination left to the prudent choice of the FDA.^[29]

On that basis, it is relatively easy for us to accept the FDA's determination that its preferred program of voluntary compliance offers greater prospect for immediate and significant reductions in animal antibiotic use than the pursuit of a potentially contentious withdrawal hearing. That is the sort of prudential judgment better suited to expert administrators than to federal judges. We are bolstered in this conclusion by the nature of the problem confronted by the FDA. Nothing in the NOOHs suggests that penicillin and tetracycline, when administered to animals, are inherently dangerous to human health; such antibiotics are widely, effectively, and beneficially used in human medical care. And while we are hesitant, for the reasons set forth above, to ascribe scientific conclusions to the FDA based on our reading of a melange of different studies, regulatory documents, and litigation positions, it appears clear that while the agency regards the indiscriminate and extensive use of such drugs in animal feed as threatening, it does not necessarily believe that the administration of antibiotics to animals in their feed is inherently dangerous to human health.

Under these circumstances, we cannot conclude that it is arbitrary or capricious for the FDA to pursue polices intended to reduce the use of animal feed containing antibiotics through a variety of steps short of withdrawing approval for the use of antibiotics in feed via a protracted administrative process and likely litigation. As it was neither arbitrary nor capricious for the FDA to deny the petitions for the reasons it did, the district court's decision to the contrary was error.

In letters recently submitted to the Court by the government, the government notes that the FDA is "encouraged" by the "overwhelmingly cooperative" reaction of the animal feed industry to the guidelines for voluntary compliance that the agency has issued in lieu of proceeding with the process initiated in 1977 with the issuance of the Penicillin and Tetracycline NOOHs, Gov't Letter dated March 27, 2014, and asserts that the high level of cooperation by drug manufacturers "demonstrate[s] that the cooperative approach ... has [176] been effective in enabling FDA to achieve its goals of phasing out the use of medically important antimicrobial drugs for food-production purposes," Gov't Letter Dated July 1, 2014. In light of the discussion above, it should be obvious that we express no opinion on the effectiveness of the FDA's approach to what it agrees is a significant regulatory concern about the overuse of antibiotics in animal feed, and that in determining the issues in this case, we place no weight on the agency's informal assurances that its program is successful. It is not for us to determine whether the agency has been prudent or imprudent, wise or foolish, effective or ineffective in its approach to this problem. Whether the agency's long inaction in the face of the dangers highlighted in the 1977 NOOH's represented politically-inspired foot-dragging or wise caution in developing a cost-effective approach, it was for the agency, and not the courts, to determine how best to proceed.

CONCLUSION

For the foregoing reasons, the decisions of the district court are REVERSED, and the case is remanded to the district court with instructions to deny the plaintiffs' motion for summary judgment, grant the defendants' motion for summary judgment, and dismiss the action.

KATZMANN, Chief Judge, dissenting:

In 1977, nearly four decades ago, the Food and Drug Administration ("FDA") formally declared that the subtherapeutic use of penicillin and tetracyclines in animal feed "ha[s] not been shown to be safe." Penicillin-Containing Premixes; Opportunity for Hearing, 42 Fed.Reg. 43,772, 43,772 (Aug. 30, 1977) [hereinafter Penicillin NOOH]; Tetracycline (Chlortetracycline and Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42 Fed.Reg. 56,264, 56,264 (Oct. 21, 1977) [hereinafter Tetracycline NOOH]. It has never abandoned that position. Indeed, the FDA has consistently reaffirmed that using low doses of antibiotics on healthy livestock to promote growth could accelerate the development of antibiotic-resistant bacteria, causing "a mounting public health problem of global significance." FDA, Guidance for Industry # 209: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals 4 (April 13, 2012). The FDA has nevertheless refused to move forward with the statutorily-prescribed process for withdrawing approval from the subtherapeutic use of penicillin and tetracyclines. It has also refused to begin the process of withdrawing approval from the subtherapeutic use of other medically important antibiotics on animals.

The majority begins by recognizing that antibiotic resistance presents a serious global health problem, and that the indiscriminate use of antibiotics on animals contributes to that problem. Its ruling nevertheless seems to accept the view that Congress gave the FDA discretion to do virtually nothing about that problem for over 30 years — and then, when it finally decided to act, to adopt a different regulatory strategy than Congress expressly provided. More precisely, it permits the FDA to renounce the statutory withdrawal procedure in favor of its own "voluntary compliance" strategy, which consists of asking animal drug sponsors to voluntarily relabel their products in order to prevent them from being used to promote animal growth. See FDA, Guidance for Industry # 213: New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals (December 2013).

I cannot agree with the majority's conclusions. In light of the statutory structure and its purposes, I am convinced that 21 U.S.C. § 360b(e)(1) requires the FDA [177] to continue the proposed withdrawal proceedings for the subtherapeutic use of penicillin and tetracyclines in animal feed. I am likewise convinced that the agency's decision to deny the citizen petitions was arbitrary and capricious under Massachusetts v. EPA, 549 U.S. 497, 127 S.Ct. 1438, 167 L.Ed.2d 248 (2007), because it failed to address the statutory question of whether the animal drug uses at issue were shown to be safe.

Today's decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug. It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results, and I must therefore respectfully dissent.

I. The Required Hearings Claim

A. Text

Like the majority, I begin with the text of the statute:

The Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application ... with respect to any new animal drug if the Secretary finds —

. . .

(B) that new evidence ... shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved....

21 U.S.C. § 360b(e)(1).

I agree with the majority that the bare text of this statute is ambiguous, and that both plaintiffs and the FDA have presented plausible readings. In plaintiffs' view, "if the Secretary finds ... that new evidence... shows that [a] drug is not shown to be safe" then "[t]he Secretary shall, after due notice and opportunity for a hearing to the applicant, issue an order withdrawing approval of ... [that] drug." Id. In that case, the FDA is statutorily required to institute withdrawal proceedings whenever it makes a preliminary finding that a particular animal drug has not been shown to be safe for its approved use. In the government's view, on the other hand, "if the Secretary finds," "after due notice and an opportunity for a hearing to the applicant," "that new evidence ... shows that [any new animal] drug is not shown to be safe" then "[t]he Secretary shall ... issue an order withdrawing approval of ... [such] drug." Id. On that reading, the FDA is never statutorily required to initiate or continue withdrawal proceedings for a drug — no matter how terrifyingly unsafe that drug may be. Instead, the FDA has complete discretion to decide when (and whether) to begin the process of withdrawing approval for drugs that it has determined are not shown to be safe; the only statutory requirement is that if the FDA chooses to hold a hearing, and finds after that hearing that a drug has not been proven safe for its approved use, then the FDA must withdraw its approval.

In an ideal world, Congress would have written a statute that clearly selects between one of these two possible readings. But as the statutory language is ambiguous, we must do our best to determine which of these two meanings Congress intended to convey. To answer that question, I turn to the purpose and structure of the statute as a whole.

B. Purpose and Structure

"[W]e begin ... any exercise of statutory construction with the text of the provision in question, and move on, as need be, to the structure and purpose of the Act in which it occurs." N.Y. State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655, 115 S.Ct. 1671, 131 L.Ed.2d 695 (1995). The statute [178] at issue here, 21 U.S.C. § 360b, is part of the Federal Food, Drug, and Cosmetic Act ("FDCA"), enacted in 1938 to protect American consumers from unsafe food, drugs, medical devices, and cosmetics. See Federal Food, Drug, and Cosmetic Act, Pub.L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-399f).

"The FDCA statutory regime is designed primarily to protect the health and safety of the public at large." POM Wonderful LLC v. Coca-Cola Co., ___ U.S. ___, 134 S.Ct. 2228, 2234, 189 L.Ed.2d 141 (2014); see also FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) ("Viewing the FDCA as a whole, it is evident that one of the Act's core objectives is to ensure that any product regulated by the FDA is `safe' and `effective' for its intended use. This essential purpose pervades the FDCA." (citations omitted)). The same purpose is reflected in the FDA's mission, as defined by Congress:

The Administration shall —

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that —

. . .

(B) human and veterinary drugs are safe and effective....

21 U.S.C. § 393(b). Of course, this broad statutory mandate to "promote the public health" and "ensur[e] that human and veterinary drugs are safe and effective" does not compel the agency to use any particular method to attain those goals. After all, "no legislation pursues its purposes at all costs ... and it frustrates rather than effectuates legislative intent simplistically to assume that whatever furthers the statute's primary objective must be the law." Rodriguez v. United States, 480 U.S. 522, 525-26, 107 S.Ct. 1391, 94 L.Ed.2d 533 (1987). But in construing § 360b, we must surely keep in mind that the primary purpose of the FDCA (and of the FDA itself) is to protect the public by prohibiting commerce in unsafe food and drugs.

The structure of § 360b reflects that primary purpose, ensuring that no animal drug can be sold on the national market for a particular use unless the FDA is convinced that drug has been shown to be safe for that use. Speaking in broad outlines, § 360b(a) generally prevents any person from distributing a new animal drug unless that drug has been approved by the FDA.^[30] Section 360b(b) requires any person applying for approval of a new animal drug to submit (inter alia) studies showing that drug is safe and effective, and § 360b(c) then requires the FDA to determine whether there is any statutory reason not to approve the new drug. Among the statutory grounds for disapproval, of course, is that the drug has not been shown to be safe. 21 U.S.C. § 360b(d)(1)(B).

The statutorily-defined process for approving a new animal drug is marked by the strict limits it places on the FDA's discretion. Within 180 days after receiving [179] an application, the FDA "shall either" enter an order of approval, if it finds no reason to disapprove the application, or else give the applicant notice of an opportunity for a hearing. Id. § 360b(c)(1)(A)-(B). If the applicant requests a hearing, the FDA "shall" provide one within ninety days. Id. § 360b(c)(1). After the hearing, the FDA "shall" issue a final order within ninety days. Id. If it finds that any of the statutory grounds for disapproval apply, it "shall" refuse to approve the application; otherwise, it "shall" approve the application. Id. § 360b(d)(1). At each step, the FDA is constrained to follow the approval process laid out by the statute; and it is strictly forbidden at each stage of the process from approving any drug that is not shown to be safe, or from disapproving any drug without first giving its sponsor the opportunity for a hearing. The initial approval provisions in § 360b(c)-(d) are thus designed to ensure that the FDA fulfills its statutory role of keeping unsafe drugs off of the market, while also providing due process to drug sponsors.

On plaintiffs' interpretation, the withdrawal provision at § 360b(e)(1)(B) fits comfortably within that statutory scheme. It requires the FDA to commence withdrawal proceedings whenever the FDA preliminarily determines that an approved animal drug is no longer shown to be safe for its approved use. The FDA must then provide notice and an opportunity for the drug's sponsor to be heard; and if, after the hearing, it continues to find that the approved drug use is no longer shown to be safe, it must withdraw its approval of that use. In other words, plaintiffs' interpretation reads the initial approval provisions and the withdrawal provision in parallel: both require the FDA, if it thinks a drug is not shown to be safe for a particular use, to provide a hearing and then (if still unconvinced) to disapprove that drug for that use. Both parts of the statute thus work together to make sure there are no unsafe drugs on the national market. The initial approval provisions ensure that the FDA will keep new animal drugs off the market unless they are shown to be safe, while the withdrawal provision ensures that the FDA will withdraw approval from an existing drug if it is not shown to be safe.

The FDA's position, on the other hand, sets the approval provisions and the withdrawal provision entirely at odds. The former provisions clearly indicate that the FDA has no discretion to admit a new animal drug to the market if it initially finds that drug is not shown to be safe for its proposed use; instead, the agency must begin the rejection process by providing an opportunity for a hearing. But according to the FDA, the withdrawal provision then gives the agency complete discretion to leave an approved animal drug on the market even if it later learns that drug is utterly unsafe. That interpretation cannot be reconciled with the purpose of the FDCA, and it cannot be reconciled with the mission of the FDA itself. I see no reason to believe that Congress carefully cabined the FDA's ability to admit new drugs to the market, but then sub silentio left the agency entirely free to leave dangerous drugs on the market once admitted.^[31]

[180] The FDA argues that the formal withdrawal process contemplated by the statute can be expensive and time-consuming, and that its voluntary compliance strategy will reach the same result more quickly and at lower cost. There is a certain irony in the FDA's argument that the formal withdrawal process is too time-consuming, given that the agency has now delayed even beginning that process for thirty-seven years. In any case, the minimum due process protections provided by the statute — notice and an opportunity to be heard — are the same for both the initial approval process and for the withdrawal process. If the FDA preliminarily determines that a new animal drug is not shown to be safe, it must provide the drug's sponsor with the opportunity to be heard, even though the resulting hearings may be long and expensive. See id. § 360b(c)-(d). The agency has no discretion to deny those hearings. So too here: if the FDA preliminarily determines that an approved animal drug is not shown to be safe, it must provide the drug's sponsor with the opportunity to be heard, and then (if still not convinced the drug is safe) must withdraw its approval. Id. § 360b(e)(1)(B). Providing drug sponsors an opportunity to be heard may be tedious and costly, but Congress has determined that the agency must use that process-both when it finds a new animal drug is not shown to be safe, and when it finds an existing animal drug is not shown to be safe.^[32] To the extent that statutory mandate prevents the FDA from pursuing other regulatory strategies, "this is the congressional design." Massachusetts v. EPA, 549 U.S. 497, 533, 127 S.Ct. 1438, 167 L.Ed.2d 248 (2007).

That same congressional design appears in 21 U.S.C. § 355, the FDCA provision regulating the approval and withdrawal of approval for non-animal drugs. Sections 355 and 360b were once a single statutory section, see FDCA § 505, 52 Stat, at 1052-53, and the language of the latter was largely modeled on the former. See H.R.Rep. No. 90-875, at 5 (1967) (noting that the two sections correspond); S.Rep. No. 90-1308, at 5 (1968) (same). Both statutory sections apply much the same process for the approval of drugs, using the same language to prevent the FDA from approving new drugs unless they have been shown to be safe. Compare 21 U.S.C. § 355(c)-(d) with id. § 360b(c)-(d). And both use the same syntax in their respective withdrawal provisions, meaning that both share the same textual ambiguity as to whether the FDA is required to hold a withdrawal hearing once it makes a preliminary finding that a particular drug is not shown to be safe.^[33]

But the available evidence indicates that courts have uniformly construed § 355(e) to require the FDA to move forward with withdrawal proceedings if it makes a preliminary finding that a drug is not shown to be safe. In dicta, the Supreme Court characterized § 355(e) in language that almost exactly mirrors the plaintiffs' interpretation [181] of § 360b(e)(1)(B): "If the FDA discovers after approval that a drug is unsafe or ineffective, it `shall, after due notice and opportunity for hearing to the applicant, withdraw approval of' the drug." Brown & Williamson, 529 U.S. at 134, 120 S.Ct. 1291 (quoting 21 U.S.C. § 355(e)). The precise interpretation of § 355(e) was not before the Court in that case; but its analysis assumed that once the FDA determines a product under its jurisdiction is not shown to be safe, it is statutorily required to begin withdrawal proceedings.^[34]See id. at 135, 120 S.Ct. 1291 ("[I]f tobacco products were [covered] under the FDCA, the FDA would be required to remove them from the market."); see also American Public Health Ass'n v. Veneman, 349 F.Supp. 1311, 1315-16 (D.D.C.1972) (holding that the FDA must commence withdrawal proceedings after announcing in the Federal Register that certain drugs were not shown to be effective for their approved uses). Given the parallel structure of the two statutes, § 360b(e)(1)(B) should be interpreted as § 355(e) has been: to require the agency to commence withdrawal proceedings if it initially finds that a drug has not been shown to be safe for its approved use.

C. The Relevant Regulations

Like the statute, the regulations implementing § 360b(e)(1)(B) show that the agency's duty to institute withdrawal proceedings is mandatory. In particular, 21 C.F.R. § 514.115(b) states: "The Commissioner shall notify in writing the person holding [an animal drug application] and afford an opportunity for a hearing on a proposal to withdraw approval of such application if he finds ... that such drug is not shown to be safe...." 21 C.F.R. § 514.115(b)(3)(ii). Unlike the statute, the meaning of this regulation is entirely clear. If the FDA makes an initial finding that a particular drug is not shown to be safe, it "shall" then provide the drug's sponsor with an opportunity to be heard. In sum, this regulation imposes exactly the mandatory duty that plaintiffs see in the statute: once the FDA makes a preliminary finding that a particular drug is not shown to be safe, it must commence withdrawal proceedings.^[35]

The majority asserts that § 514.115(b) does not represent an agency interpretation [182] of the statute, and so is not entitled to the deference we afford under Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). I am not sure I agree. But even if so, the regulation at least counsels strongly in favor of plaintiffs' interpretation. It makes clear that the FDA expects the withdrawal procedure to begin with an initial agency finding that a particular drug is not shown to be safe, followed immediately by notice and an opportunity for a hearing.^[36] With or without Chevron deference, I would still interpret the statute to accord with that regulatory scheme.^[37]

D. Counterarguments

For the reasons described above, I believe 21 U.S.C. § 360b(e)(1)(B) compels the FDA to initiate withdrawal proceedings once it makes a preliminary finding that a drug is no longer shown to be safe. I now turn to the counterarguments that the majority finds persuasive.

1. Text

The majority's primary objection is that my interpretation of this provision contravenes either basic principles of due process or else the statutory text. As I construe the statutory text, "if the Secretary finds" that a drug is not shown to be safe, "[t]he Secretary shall, after due notice and opportunity for a hearing to the applicant, issue an order withdrawing approval of" the drug. 21 U.S.C. § 360b(e)(1). That reading grammatically links the agency's pre-hearing finding to a mandatory withdrawal order. Taken literally, it would require the FDA to withdraw approval from a drug whenever it made a pre-hearing finding that drug was not shown to be safe — making the hearing a pointless exercise. That result would contravene basic principles of due process. See Hamdi v. Rumsfeld, 542 U.S. 507, 533, 124 S.Ct. 2633, 159 L.Ed.2d 578 (2004) (plurality opinion) (noting that due process requires notice and a meaningful opportunity to be heard).

There is an easy solution to this due process problem, however: to read the statute "against the background of our traditional legal concepts," United States v. U.S. Gypsum Co., 438 U.S. 422, 437, 98 S.Ct. 2864, 57 L.Ed.2d 854 (1978), as implicitly guaranteeing the drug sponsor a meaningful opportunity to rebut the agency's preliminary finding. On that reading, the statute adopts the following procedure: When the FDA makes a preliminary finding that a drug is not shown to be safe, it [183] must offer the drug's sponsor a hearing. If after that hearing the FDA continues to find that the drug is not shown to be safe, then it must issue an order withdrawing approval of the drug. Alternatively, if after that hearing the FDA finds the drug's sponsor has presented persuasive evidence that the drug is safe, it will announce that finding and end the withdrawal process. This procedure constrains the FDA to proceed to a hearing if it makes a preliminary finding that a drug is not shown to be safe, but also preserves the right of the drug's sponsor to rebut that preliminary finding by presenting evidence at the hearing.

The majority recognizes that this interpretation would solve the due process problem, but objects that it is not true to the statutory text. It observes that the text of § 360b(e)(1) only refers to a single finding, while this interpretation implies both a pre-hearing finding and a post-hearing finding. It also observes that the statute literally requires the agency to issue a withdrawal order if it makes the finding described in the statute. The majority infers that the finding described in the statute must therefore be a post-hearing finding, since (to preserve due process) only a post-hearing finding can absolutely require a withdrawal order.

If Congress were always perfectly precise in its language, the majority's argument would have some force. In fact, however, Congress does draft statutes that refer only to a single finding but that obviously imply both a pre-hearing and post-hearing finding. To list a few:

If ... the Administrator [of the Environmental Protection Agency ("EPA")] determines that [a person has violated a rule governing an exemption], the Administrator shall ... after providing written notice to the person who holds such exemption and an opportunity for a hearing, by order terminate such exemption....

15 U.S.C. § 2603(c)(4)(B).

If the Secretary [of Education] determines that an accrediting agency or association has failed to apply effectively the criteria in this section, or is otherwise not in compliance with the requirements of this section, the Secretary shall... after notice and opportunity for a hearing, limit, suspend, or terminate the recognition of the agency or association....

20 U.S.C. § 1099b(l)(1).

[I]f the Secretary [of the Treasury] determines that any substantial obligation under any agreement is not being fulfilled, he may, after notice and opportunity for hearing to the person maintaining the fund, treat the entire fund or any portion thereof as an amount withdrawn from the fund in a nonqualified withdrawal.

26 U.S.C. § 7518(e)(2).

The Administrator [of the EPA] shall review approved plans from time to time and if he determines that revision or corrections are necessary ... he shall, after notice and opportunity for public hearing, withdraw his approval of such plan.

42 U.S.C. § 6947(a)(2).

Despite their literal text, none of these statutes (as far as I know) have been interpreted to require or permit an agency to take action based solely on its pre-hearing finding. Instead, these statutes are naturally read in the same way that I read § 360b(e)(1): as implying that the agency can only take final action after both a pre-hearing and a post-hearing finding, even though the statutory text only explicitly mentions one such finding. Given these examples, I see nothing "singularly odd," supra, at 161, in believing that Congress [184] used the same shorthand in this statute that it did in those statutes — especially since the agency regulations implementing this statute explicitly envision a prehearing finding as well as a post-hearing finding. See 21 C.F.R. § 514.115(b).

2. Background Legal Concepts

The majority argues next that its interpretation is more consistent with our ordinary understanding of administrative and judicial processes. In the majority's view, the normal administrative sequence runs "hearing, finding, order," and my interpretation violates that sequence by reading the statute to refer to a pre-hearing finding.

I concede that in many contexts, a "finding" is a post-hearing determination. But as the majority recognizes, see supra, at 167, the word "finding" can equally refer to a pre-hearing determination — and here, the agency's own regulations clearly adopt that sense. Section 514.115(b) explicitly states that the agency will only issue a notice of opportunity for a hearing if it "finds" that one of the statutory grounds for withdrawal applies. 21 C.F.R. § 514.115(b); see also Sterling Drug, Inc. v. Weinberger, 384 F.Supp. 557, 558 (S.D.N.Y.1974) (referring to the agency's pre-hearing determination under 21 U.S.C. § 355(e) that a drug was ineffective as a "finding").

Nearby provisions of the statute also explicitly contemplate pre-hearing findings. When the FDA receives a new animal drug application, if it "finds that none of the grounds for denying approval" in the statute apply, it must approve the drug; if it finds otherwise, it must give notice of an opportunity for a hearing. 21 U.S.C. § 360b(c)(1). The FDA's own brief describes that pre-hearing determination as a "finding." Br. for Defendants-Appellants at 25; see also id. (noting that a hearing is required "[o]nly if FDA preliminarily `finds' ... a reason for disapproval"). Likewise, under the imminent hazard provision — as the majority notes — the Secretary first "finds that there is an imminent hazard" and then give[s] the applicant prompt notice of his action and afford[s] the applicant the opportunity for an expedited hearing. 21 U.S.C. § 360b(e)(1); see supra, at 167-68.

These examples point to a larger problem with the majority's analysis: namely, that it takes too limited a view of the normal administrative sequence. Agency action often begins not with a hearing, but with a preliminary agency finding that triggers notice and an opportunity for a hearing. After all, agencies do not arbitrarily decide to initiate hearings; instead, they begin the hearing process only when they find there is some reason to do so. As described above, 21 U.S.C. § 360b and 21 C.F.R. § 514.115(b) are not unique in explicitly envisioning that a formal agency determination can occur before and lead to a hearing. See 15 U.S.C. § 2603(c)(4)(B); 20 U.S.C. § 1099b(l)(1); 26 U.S.C. § 7518(e)(2); 42 U.S.C. § 6947(a)(2). And as the majority recognizes, administrative enforcement proceedings often begin with the agency's preliminary findings in the form of "a case-initiating document that sets forth the [agency's] conclusions or charges." Supra, at 168. In other words, the normal administrative sequence in many cases is not simply "hearing, finding, order," but instead "preliminary finding, hearing, final finding, order." In many cases, the agency's preliminary findings are not attached to any mandatory consequences — especially not in the enforcement context, where agency discretion is at its height. See Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985). But if Congress so chooses, it can [185] require an agency to act on the basis of its preliminary findings. Cf. id. at 834, 105 S.Ct. 1649 (explaining that Congress can "withdr[a]w discretion from the agency and provide[] guidelines for exercise of its enforcement power"). That in no way contravenes our basic understanding of the administrative process.

The majority argues next that the statute cannot refer to a pre-hearing "finding" because it will be impossible to determine when the agency has made that finding. In the majority's view, if the pre-hearing finding triggers the withdrawal process, it must precede (and require) the issuance of an NOOH. Therefore, the majority concludes, that pre-hearing finding can only exist as an intangible conclusion in the mind of the Secretary (or perhaps the collective mind of the agency); and it is hard to believe that Congress would compel an agency to act based on the internal beliefs of its officers or employees. Alternatively, the majority argues that if the pre-hearing finding is embodied in an NOOH itself, then plaintiffs cannot compel the FDA to act because the FDA has withdrawn the two NOOHs it issued.

The majority's first argument attacks a straw man. No one contends that the statute can require the FDA to act based on "an entirely subjective and unexpressed finding ... made during internal agency deliberations." Supra, at 170. Plaintiffs contend only that if the FDA does issue an NOOH announcing that a drug is not shown to be safe, it must then move forward with the withdrawal process.^[38] In other words, the statutory phrase "if [the FDA] finds" does not mean "if the FDA subjectively believes"; it instead means "if the FDA formally states a preliminary finding." That interpretation in no way requires courts to review the internal thoughts or beliefs of the agency — only the agency's official public statements about a particular drug. It consequently raises none of the problematic reviewability issues that the majority suggests. To the contrary, "the mandate that the courts are to enforce" under this interpretation is just as "straightforward" as under the majority's. Supra, at 170.

Alternatively, the majority argues that the plaintiffs cannot compel agency action based on the findings expressed in the 1977 NOOHs because those NOOHs have now been withdrawn. That argument mistakes the medium for the message. The findings that the FDA made in 1977 were that the use of penicillin and tetracyclines had not been shown to be safe; the NOOHs were the medium through which the FDA announced those findings. As described above, the statute does not compel the FDA to take any action until it makes some formal public announcement of its preliminary findings. But once the FDA announces its findings, it cannot avoid withdrawal proceedings just by retracting the announcement. Instead, it can only avoid withdrawal proceedings by retracting the findings — that is, by announcing that those preliminary findings were mistaken.

Here, the FDA has never retracted its preliminary findings. To the contrary, the agency "has not issued a single statement since the issuance of the 1977 NOOHs that undermines [its] original findings." NRDC v. FDA ("NRDC I"), 884 F.Supp.2d 127, 150 (S.D.N.Y.2012) (opinion below). And the FDA made clear in the notices withdrawing the 1977 NOOHs that [186] its action was based on its choice to pursue a new regulatory approach, rather than on any doubt about its findings that the subtherapeutic use of these drugs in animal feed was not shown to be safe. Because the agency has never formally repudiated the preliminary findings announced in the 1977 NOOHs, I would hold that it remains bound by those findings under the statute.^[39]

3. Agency Discretion

Finally, the majority argues that its interpretation is more consonant with our tradition of agency discretion in the enforcement context. The FDA puts this position more strongly, arguing that its decision to refrain from withdrawal proceedings is entirely immune from judicial review under Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985).

The Administrative Procedure Act (APA) embodies a "basic presumption of judicial review." Lincoln v. Vigil, 508 U.S. 182, 190, 113 S.Ct. 2024, 124 L.Ed.2d 101 (1993) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 140, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967)); see 5 U.S.C. § 702 ("A person suffering legal wrong because of agency action ... is entitled to review thereof."); Bowen v. Mich. Academy of Family Physicians, 476 U.S. 667, 670, 106 S.Ct. 2133, 90 L.Ed.2d 623 (1986) (noting "the strong presumption that Congress intends judicial review of administrative action"). Under 5 U.S.C. § 701(a)(2), however, judicial review is not available for "agency action [that] is committed to agency discretion by law." Id. This "very narrow exception" applies "in those rare instances where statutes are drawn in such broad terms that in a given case there is no law to apply." Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971) (internal quotation marks omitted). In such circumstances, judicial review would be useless, because the reviewing court "would have no meaningful standard against which to judge the agency's exercise of discretion." Heckler, 470 U.S. at 830, 105 S.Ct. 1649.

The Supreme Court has explained that § 701(a)(2) creates a presumption against judicial review for "certain categories of administrative decisions that courts traditionally have regarded as committed to agency discretion." Vigil, 508 U.S. at 191, 113 S.Ct. 2024 (internal quotation marks omitted). One such category of administrative decisions are agency refusals to institute investigative or enforcement proceedings. See Heckler, 470 U.S. at 830-31, 105 S.Ct. 1649 ("[A]n agency's decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency's absolute discretion."). Although an agency's decision not to take enforcement action is presumptively unreviewable, "the presumption may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers." Id. at 832-33, 105 S.Ct. 1649. If Congress specifies by statute the conditions under which an agency must bring enforcement proceedings, then a court can review whether the agency has followed Congress's directions. But if Congress merely authorizes the agency to bring enforcement proceedings, without specifying when the agency is required to do so, then the agency's decision not to bring a particular enforcement proceeding is unreviewable. See id. at 834-35, 838, 105 S.Ct. 1649; see also Vigil, 508 U.S. at 193, 113 S.Ct. 2024 ("Congress may always circumscribe agency discretion... by putting restrictions in the operative [187] statutes...."). Heckler therefore "requires careful examination of the statute on which the claim of agency illegality is based," to determine the extent to which Congress has placed judicially enforceable limits on the agency's discretion. Webster, 486 U.S. at 600, 108 S.Ct. 2047.

As I discuss in more detail below, it is not clear whether the withdrawal proceedings contemplated by § 360b(e)(1)(B) should be characterized as enforcement proceedings under Heckler. I believe they should not. But even if withdrawal proceedings were a form of enforcement, I would still conclude that § 360b(e)(1)(B) places judicially enforceable limits on the FDA's discretion over whether to commence those proceedings. In my view, the statute precisely specifies when the FDA is required to commence withdrawal proceedings: when the agency finds that a particular drug is not shown to be safe. Congress has thus "indicated an intent to circumscribe agency ... discretion, and has provided meaningful standards for defining the limits of that discretion." Heckler, 470 U.S. at 834, 105 S.Ct. 1649. Because the statute makes withdrawal proceedings mandatory under particular circumstances, we have "law to apply" in determining whether the agency has complied with the statutory command. See Citizens to Preserve Overton Park, 401 U.S. at 410, 91 S.Ct. 814. I would therefore hold that even if Heckler's presumption against review applies, that presumption is overcome by the statutory text.

I recognize that Congress often affords great discretion to agencies in the enforcement context, and rightly so. Enforcement decisions often require "a complicated balancing of a number of factors which are peculiarly within [the agency's] expertise," including the resources available to the agency, the seriousness of the violation, the likelihood of a successful outcome, and many others. Heckler, 470 U.S. at 831-32, 105 S.Ct. 1649. Nevertheless, Congress also sometimes decides to constrain agency discretion in order to ensure that its statutory purposes are fully carried out. Cf. id. at 834-35, 105 S.Ct. 1649. As the majority recognizes, there are particularly good reasons to believe that Congress would cabin the FDA's discretion in this context: "[G]iven the preeminent importance of health and safety in the usage of powerful bioactive substances such as human and animal drugs, it would hardly be surprising for Congress to impose limits on traditional agency discretion or to mandate actions protective of human safety." Supra, at 171. In my opinion, § 360b(e)(1)(B) does indeed constrain the FDA's discretion in order to protect the public from unsafe drugs. I would therefore affirm the district court's decision that the agency must proceed to a hearing on whether to withdraw approval from the subtherapeutic use of penicillin and tetracyclines in animal feed.

II. The Citizen Petitions

The second issue presented in this case is whether the FDA acted arbitrarily and capriciously by denying the 1999 and 2005 citizen petitions. Those petitions asked the FDA to initiate (and conclude) proceedings to withdraw approval from the subtherapeutic use of medically important antibiotics on animals. In effect, the petitions asked the FDA to make the same preliminary finding for all medically important antibiotics that it had already made for penicillin and tetracyclines, and then to move forward on withdrawal proceedings regarding the subtherapeutic use of all of those antibiotics. The FDA denied those petitions. In so doing, it did not address the plaintiffs' scientific evidence that the subtherapeutic use of medically important antibiotics on animals was not shown to be safe; instead, the agency [188] said only that it preferred to employ a voluntary compliance strategy rather than formal withdrawal proceedings.

The FDA argues that withdrawal proceedings are a form of enforcement action, and so its refusal to initiate those proceedings is presumptively unreviewable under Heckler. It further argues that nothing in the statute rebuts that presumption, because the statute places no limit on the FDA's discretion over whether to find that a particular drug is not shown to be safe.

While the majority opinion does not explicitly consider whether withdrawal proceedings should be characterized as a form of enforcement action, it implicitly accepts the FDA's view by analogizing this case to N.Y. Public Interest Grp. v. Whitman, 321 F.3d 316 (2d Cir.2003), which dealt with the EPA's "discretion to determine whether to engage its formal enforcement mechanism." Id. at 330. Whitman made clear that its logic was limited to the enforcement context. Indeed, it relied on Heckler for the proposition that "an agency's decision not to invoke an enforcement mechanism provided by statute is not typically subject to judicial review." Id. at 331.

I agree with the FDA that if Heckler and Whitman governed this case, then we could not disturb the agency's decision to deny the citizen petitions. But Heckler and Whitman do not govern here, because the withdrawal proceedings contemplated by § 360b(e)(1)(B) are not a form of agency enforcement action. Instead, this case falls squarely under the framework established by Massachusetts v. EPA, 549 U.S. 497, 127 S.Ct. 1438, 167 L.Ed.2d 248 (2007), which forbids an agency from relying on outside factors in refusing to make a particular statutory determination.

A. Nature of Withdrawal Proceedings

The Supreme Court has never clearly defined what agency actions are "enforcement" actions within the meaning of Heckler. The prototypical enforcement action, of course, is an action taken by the agency to punish a past violation of the law that the agency administers, or to enjoin an ongoing violation of that law. See Heckler, 470 U.S. at 831, 105 S.Ct. 1649 (discussing "an agency's decision not to prosecute or enforce, whether through civil or criminal process"); see also NRDC II, 872 F.Supp.2d at 333 ("[E]nforcement proceedings are traditionally undertaken upon a finding that an entity has violated an existing regulation or law."). In this area, "an agency's refusal to institute proceedings shares to some extent the characteristics of the decision of a prosecutor not to indict," Heckler, 470 U.S. at 832, 105 S.Ct. 1649; the agency must weigh its resources and its priorities in determining whether a particular violator should be pursued. Cf. Whitman, 321 F.3d at 332 (noting the impracticality of requiring the EPA to challenge every violation "no matter how slight, isolated, or technical"). At the same time, Heckler indicates that its concept of an "enforcement action" may extend somewhat beyond the prototypical meaning of the term. In Heckler itself, the plaintiffs asked the FDA not only "to recommend the prosecution" of those who used certain drugs for lethal injection, but also (inter alia) "to affix warnings to the labels of [those] drugs stating that they were unapproved and unsafe for human execution" and "to send statements to the drug manufacturers and prison administrators stating that the drugs should not be so used." 470 U.S. at 824, 105 S.Ct. 1649. The Court characterized all of these requests as seeking "investigatory and enforcement actions," id., even though the latter two do not directly punish or enjoin any statutory violation.

As it is unclear what qualifies as an "enforcement action," it is doubly unclear whether the withdrawal proceedings contemplated by § 360b(e)(1)(B) fall into that category. These withdrawal proceedings [189] share some characteristics with a traditional enforcement action; for instance, they envision an adversarial process, in which the agency attacks the safety of a particular drug and its sponsor defends it. See 21 U.S.C. § 360b(e)(1); 21 C.F.R. §§ 12.1-.159,514.201 (describing hearing procedures). And like traditional enforcement actions, they implicate the agency's ability to manage its resources and set administrative priorities. See Heckler, 470 U.S. at 834, 105 S.Ct. 1649.

At the same time, withdrawal proceedings are also similar in many ways to rulemaking proceedings, which we know fall outside the Heckler presumption. See Massachusetts v. EPA, 549 U.S. at 527-28, 127 S.Ct. 1438. First, the FDA "has chosen to utilize withdrawal proceedings as the primary means of formally regulating approved drugs," the function normally served by notice-and-comment rulemaking. NRDC II, 872 F.Supp.2d at 333. Second, withdrawal proceedings (like approval proceedings) establish a general standard of conduct; they apply to anyone marketing a drug, not just the drug's sponsor. Cf. A.L. Pharma, Inc. v. Shalala, 62 F.3d 1484, 1487 (D.C.Cir.1995) (characterizing the approval of a new animal drug as a "rule"). They also have only future effect; they can prevent regulated entities from marketing a previously-approved drug in the future, but they cannot punish any past violation of the law. See Attorney General's Manual on the Administrative Procedure Act 14 (1947) [hereinafter Attorney General's Manual] ("Rule making is agency action which regulates the future conduct of either groups of persons or a single person.... The object of the rule making proceeding is the implementation or prescription of law or policy for the future, rather than the evaluation of a respondent's past conduct."); see also id. (contrasting rulemaking with adjudication, which normally involves "a decision as to whether past conduct was unlawful, so that the proceeding is characterized by an accusatory flavor and may result in disciplinary action"); 5 U.S.C. § 551(4) (defining a "rule" under the APA in part as an "agency statement of general or particular applicability and future effect"). Because withdrawal of approval has only future effect, the FDA must invoke a completely separate set of enforcement procedures in order to enjoin or punish any person who markets a drug from which approval has been withdrawn. See, e.g., 21 U.S.C. § 335b(b)(1)(A) (establishing procedures by which the Secretary may assess a civil penalty); see also Cutler v. Hayes, 818 F.2d 879, 893 & n. 116 (D.C.Cir.1987) (distinguishing the "enforceable statutory directive" to withdraw approval for unsafe drugs under 21 U.S.C. § 355(e) from typical FDA enforcement actions). Finally, although I "hesitate to place too much significance on the location of a statute in the United States Code," Jones v. R.R. Donnelley & Sons Co., 541 U.S. 369, 376, 124 S.Ct. 1836, 158 L.Ed.2d 645 (2004), it is worth noting that the FDCA's traditional enforcement mechanisms fall in a different subchapter (titled "Prohibited Acts and Penalties") from the substantive regulatory section governing withdrawal proceedings. In sum, withdrawal proceedings are in many ways "essentially legislative in nature," Attorney General's Manual at 14, rather than essentially enforcement-oriented.

Though I recognize the decision is close, I would hold that withdrawal proceedings under § 360b(e)(1)(B) are not enforcement actions within the meaning of Heckler and Whitman.^[40] Given that these withdrawal [190] proceedings resemble rulemaking at least as much as they do enforcement, I think it better to apply "the strong presumption that Congress intends judicial review of administrative action," Bowen, 476 U.S. at 670, 106 S.Ct. 2133, rather than the "very narrow exception" applicable for actions committed to agency discretion by law, Citizens to Preserve Overton Park, 401 U.S. at 410, 91 S.Ct. 814. That strong presumption seems particularly appropriate here, where there is every reason to believe that Congress did not mean to give the FDA unlimited discretion to leave unsafe drugs on the market for extended periods of time. Cf. Bowen, 476 U.S. at 670, 106 S.Ct. 2133 ("[J]udicial review of a final agency action ... will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress." (quoting Abbott Labs., 387 U.S. at 140, 87 S.Ct. 1507)); A.L. Pharma, 62 F.3d at 1487, 1490-92 (reviewing the FDA's denial of a citizen petition asking it to withdraw approval of an approved animal drug); cf. also supra, at 171 (recognizing there is good reason to believe Congress would limit the FDA's discretion in this sphere "given the preeminent importance of health and safety in the usage of powerful bioactive substances").

B. Arbitrary and Capricious Action

Given that the denial of the citizen petitions is subject to judicial review, I think that Massachusetts v. EPA squarely requires us to hold that denial was arbitrary and capricious. In Massachusetts v. EPA, the Court addressed a statute with a discretionary determination that triggered a mandatory consequence:

The Administrator [of the EPA] shall by regulation prescribe ... standards applicable to the emission of any air pollutant from any ... new motor vehicles or new motor vehicle engines, which in his judgment cause, or contribute to, air pollution which may reasonably be anticipated to endanger public health or welfare.

42 U.S.C. § 7521(a)(1). As construed by the Court, that statute gives the Administrator discretion to determine whether any particular air pollutant causes or contributes to air pollution that might endanger public health or welfare. But if the Administrator does judge that a particular air pollutant endangers public health, then he must prescribe emission standards. See Massachusetts v. EPA, 549 U.S. at 532-33, 127 S.Ct. 1438.

A group of concerned organizations filed a citizen petition asking the EPA to issue regulations governing greenhouse gas emissions from motor vehicles, on the ground that those emissions endangered public health by causing global warming. 549 U.S. at 510, 127 S.Ct. 1438. The agency responded by refusing to decide whether greenhouse gas emissions from motor vehicles endangered public health; instead, it denied the citizen petition based on "a laundry list of reasons not to regulate," including its belief that regulating motor vehicle emissions would not be an effective means of addressing global warming. Id. at 533, 127 S.Ct. 1438.

The Court held that the EPA's action was arbitrary and capricious, because its reasons for denying the petition were "divorced from the statutory text." Id. at 532, 127 S.Ct. 1438. The statutory provision authorizing the agency to exercise its judgment was "not a roving license to ignore statutory text," but only "a direction to exercise discretion within defined statutory limits." Id. at 533, 127 S.Ct. 1438. Since the discretionary "judgment" contemplated by the statute asked only whether a particular air pollutant endangered public health, the EPA could not rely on other reasons — such as the cost or inefficiency of new regulations — in deciding [191] whether or not to regulate. Instead, the EPA could only avoid regulating greenhouse gas emissions from motor vehicles if it found that "greenhouse gases do not contribute to climate change," or that "the scientific uncertainty is so profound that it precludes [the agency] from making a reasoned judgment" on that issue. Id. at 533-34, 127 S.Ct. 1438. The agency's discretion was thus limited to considering the scientific question described in the statute, not any other factors the agency might deem relevant. Cf. Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) (noting that an agency acts arbitrarily and capriciously if it "has relied on factors which Congress has not intended it to consider").

Like Massachusetts v. EPA, this case involves a statute that (as I interpret it) follows a discretionary determination with a mandatory consequence. If the FDA (in its discretion) determines that a particular drug is not shown to be safe, then it shall commence (mandatory) withdrawal proceedings. See 21 U.S.C. § 360b(e)(1)(B). But just as in Massachusetts v. EPA, the agency's discretion is limited to making the determination required by the statute; it cannot refuse to make that determination just because it would prefer a different regulatory strategy than the statute specifies.

The FDA offers reasons for inaction that are eerily similar to those rejected by the Court in Massachusetts v. EPA; it complains that withdrawal proceedings "would take many years and would impose significant resource demands," and claims that its voluntary compliance approach will work just as well. Letter from Leslie Kux, Assistant Acting Commissioner for Policy, FDA, to Sarah Klein, Center for Science in the Public Interest 3-4 (Nov. 7, 2011). Again, there is some irony in the FDA's protestation that withdrawal proceedings could take many years; the agency failed to respond to the citizen petitions for twelve and six years, respectively, and its own voluntary compliance strategy contemplates a three-year "phase in." See NRDC II, 872 F.Supp.2d at 339; Guidance for Industry # 213, at 9. But that is beside the point. Even if the agency's reasons were indisputably sound, they are not contemplated by the statute. Because the FDA must "exercise [its] discretion within defined statutory limits," Massachusetts v. EPA, 549 U.S. at 533, 127 S.Ct. 1438, it must respond to the citizen petition by evaluating the statutory question of whether the drug uses at issue are shown to be safe.

The majority contends that Massachusetts v. EPA is distinguishable because the statute in that case "unambiguously compelled agency action" and "limited [the agency's] `judgment' to the scientific question." Supra, at 173, 174. I respectfully believe that the first distinction is incorrect, and that the second begs the question.

As for the first: The statute construed in Massachusetts v. EPA was just like the statute at issue here — part discretionary (as to the agency's "judgment"), and part mandatory (as to the ensuing regulation). Indeed, the Court recognized in its opinion that the EPA was not necessarily required to take any action beyond adequately responding to the citizen petition. See 549 U.S. at 534-35, 127 S.Ct. 1438 ("We need not and do not reach the question whether on remand EPA must make an endangerment finding, or whether policy concerns can inform EPA's actions in the event that it makes such a finding."). I do not understand how that can be read to "unambiguously compel[]" agency action.

As for the second: Nothing in the Clean Air Act explicitly "limited the EPA's Administrator's `judgment' to the scientific [192] question," supra, at 174, any more than 21 U.S.C. § 360b(e)(1)(B) explicitly limits the FDA's judgment to the scientific question. See Massachusetts v. EPA, 549 U.S. at 549-53, 127 S.Ct. 1438 (Scalia, J., dissenting). Instead, the question presented in Massachusetts v. EPA was whether the statute implicitly limited the agency's judgment to the scientific question, by specifying only that question for the agency's consideration. The Court held that it did: although the agency may have "significant latitude as to the manner, timing, content, and coordination of its regulations with other agencies, ... its reasons for action or inaction must conform to the authorizing statute." Id. at 533, 127 S.Ct. 1438 (majority opinion). Exactly the same logic applies here: the FDA's "reasons for action or inaction" must conform to the authorizing statute, meaning that they must rest on the statutory question of whether the drugs have been "shown to be safe," 21 U.S.C. § 360b(e)(1)(B). Like the EPA with air pollutants, the FDA cannot "choose to regulate only those [drugs] that it deem[s] feasible or wise to regulate." Supra, at 174.

The majority apparently believes that the FDA's approach is permissible because although the agency regards "the indiscriminate and extensive use of [medically important antibiotics] in animal feed as threatening, it does not necessarily believe that the administration of antibiotics to animals in their feed is inherently dangerous to human health." Supra, at 175. I see no reason why that should matter to our analysis. As the majority recognizes at the opening of its opinion, antibiotic resistance "presents a serious threat to human health," and can result in "longer hospital stays, worse side effects of treatment, and a greater likelihood of death." Supra, at 153. The FDA agrees. See J.A. 405 (reproducing statements from the FDA website). The agency likewise agrees that the overuse of antibiotic drugs on livestock can contribute to the development of antibiotic resistance. NRDC II, 872 F.Supp.2d at 340. This problem, like global warming, is tied to the combined effects of many small actions. Each individual animal dose of antibiotics may not endanger human health; but that is no reason to think that Congress gave the agency discretion to ignore the larger problem.

In any case, the 2005 citizen petition specifically asks the FDA to withdraw approval from the indiscriminate "herdwide/flockwide" use of these antibiotics. J.A. 262. If indeed the FDA regards such indiscriminate uses as threatening — or more precisely, as "not shown to be safe," 21 U.S.C. § 360b(e)(1)(B) — then it should withdraw the relevant approvals. At the very least, it should be required to squarely address the scientific issue of whether those uses have been shown to be safe, which is the sole issue that the statute makes relevant.

Today as in 1977, drug manufacturers have "failed to resolve the basic safety questions that underlie the subtherapeutic use of [antibiotics] in animal feed." Supra, at 154 (alteration in original) (quoting Penicillin NOOH, 42 Fed.Reg. at 43,792); see Tetracycline NOOH, 42 Fed.Reg. at 56,288. In not addressing those safety questions, the FDA has shirked its statutory responsibilities. I would hold that action was arbitrary and capricious.

III. Conclusion

After thirty-seven years of delay, the FDA has finally come up with a strategy for confronting the dangers caused by the subtherapeutic use of medically important antibiotics on animals. That strategy is to ask pharmaceutical manufacturers to voluntarily [193] relabel their drugs to prevent these uses. See Guidance for Industry # 213. Meanwhile, the FDA continues to avoid the withdrawal procedure contemplated by the statute, claiming that procedure is too slow and too expensive. "One can only wonder what conceding the absence of an effective regulatory mechanism signals to the industry which the FDA is obliged to regulate." NRDC II, 872 F.Supp.2d at 339 n. 23.

I agree with the majority that it is not our duty to judge the wisdom of the FDA's approach. But it is emphatically our duty to judge whether the FDA's actions conform with the dictates of Congress. For the reasons I have given, I am convinced that they do not. As I interpret 21 U.S.C. § 360b(e)(1)(B), it requires the FDA to pursue formal withdrawal proceedings whenever it makes a preliminary finding that an animal drug is not shown to be safe for its approved use. And under Massachusetts v. EPA, it also requires the agency to address that preliminary question based on the scientific evidence available-not based on its preference for a different regulatory strategy. Whatever the merits of the FDA's voluntary compliance strategy, the agency may not escape its statutory responsibilities "simply by asserting that its preferred approach would be better policy." Engine Mfrs. Ass'n v. EPA, 88 F.3d 1075, 1089 (D.C.Cir.1996).

To be clear, the statute does not restrain the agency from employing other strategies in tandem with formal withdrawal proceedings. As the district court below noted, nothing prevents the agency from simultaneously initiating withdrawal proceedings and also seeking voluntary compliance. See NRDC II, 872 F.Supp.2d at 340. But while the FDA is free to take any additional steps it thinks are appropriate, it must at least carry out the minimum responsibilities placed on it by the statute. If the FDA finds those statutory responsibilities are unmanageable, then it should ask Congress — not us — to provide it with broader discretion.

Because the majority decides otherwise, I respectfully dissent.

[1] The Honorable Katherine B. Forrest, of the United States District Court for the Southern District of New York, sitting by designation.

[2] The first major antibiotic, penicillin, was discovered in 1928 by the Scottish scientist Alexander Fleming. Its precise chemical structure was first described in 1945 by the American scientist Dorothy Hodgkin, and a method for its mass production was developed that same year. Despite the importance of her discovery, Hodgkin was not among the scientists awarded the 1945 Nobel Prize in Chemistry for the production of therapeutic penicillin. Hodgkin later received that prize in 1964 for her discovery of the structure of vitamin B12. See Joachim Pietzsch, The Nobel Prize in Chemistry 1964: Dorothy Crowfoot Hodgkin, Nobelprize.org, available at http://www.nobelprize.org/nobel_prizes/chemistry/laureates/1964/perspectives.html (last visited July 29, 2013).

[3] For another case arising from an effort to force the FDA to limit nontherapeutic uses of antibacterial agents in a different context, see Natural Res. Def. Council v. FDA, 710 F.3d 71 (2d Cir.2013).

[4] The term "new animal drug" is defined in 21 U.S.C. § 321(v); see note 11, infra, for the text of that section.

[5] Generic-drug applications receive a slightly different label, "abbreviated NADA."

[6] "Subtherapeutic" uses are those that seek "increased rate of [weight] gain, disease prevention[,] etc.," as opposed to uses to treat illnesses or other pathological conditions. 21 C.F.R. § 558.15(a). Other sources prefer the term "nontherapeutic," for the same meaning.

[7] The Bureau of Veterinary Medicine is now known as the Center for Veterinary Medicine. In the interest of simplicity, we use the abbreviation CVM to refer to that subdivision of the FDA regardless of its official title at any given time.

[8] The plaintiffs are the Natural Resources Defense Council, Inc., the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, Inc., and the Union of Concerned Scientists, Inc.

[9] Plaintiffs also pled claims pursuant to § 706(1) of the Administrative Procedure Act ("APA"), which generally authorizes courts presented with challenges to agency inaction to "compel agency action unlawfully withheld or unreasonably delayed." 5 U.S.C. § 706(1). Because the essence of plaintiffs' APA claim is that the FDCA requires the FDA to hold the hearings described in the 1977 NOOHs, the question posed by § 706 is identical to that posed by the text of § 360b(e) itself.

[10] The parties did not conduct discovery.

[11] The parties had consented to trial before a magistrate judge.

[12] "New animal drug" is elsewhere defined, subject to limited exceptions, as "any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed, ... the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof." 21 U.S.C. § 321(v) (2008).

[13] Although the statute refers to the Secretary of Health and Human Services, the Secretary has delegated her duties under the FDCA to the Commissioner of the Food and Drug Administration.

[14] The hearing would have an Alice-in-Wonderland quality (sentence first, trial afterward) unless it were understood that the Secretary may only ultimately withdraw approval if the evidence presented at the hearing warrants a finding that the drug is not shown to be safe. There would be no purpose to a hearing if the agency's initial internal conclusion of itself mandated withdrawal, regardless of the outcome of the hearing.

[15] In his thoughtful dissenting opinion, Judge Katzmann correctly notes that "[W]e begin... any exercise of statutory construction with the text of the provision in question, and move, as need be, to the structure and purpose of the Act in which it occurs." (Dissenting opinion, post, at 177, quoting N.Y. State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655, 115 S.Ct. 1671, 131 L.Ed.2d 695 (1995)). This principle guides our analysis, and confirms our respectful disagreement with Judge Katzmann's conclusion regarding the interpretation of the statute.

Insofar as the dissent's analysis refers to the purpose of the statute, it hinges on the unquestioned goal of Congress to protect human health. But this is largely a red herring. As Judge Katzmann acknowledges (Dissenting opinion, post, at 178), that goal does not require us to interpret any ambiguity in the statute in the manner that we think is most conducive to protecting the public health; the statute reflects in its language particular judgments about how that goal should be pursued and when it must yield to or be balanced with other concerns. Our views regarding how the FDA can best serve its mission of protecting human health through the use of drugs to treat animals or the analytic import of other prospectively ambiguous Congressional statutes must defer to the most reasonable reading of the text before us. Section 360b(e)(1) is most "naturally read" (Dissenting opinion, post, at 183) in the manner that makes best sense of the statutory language itself. That in turn compels us to conclude that where a statute explicitly considers only a single finding and directs that any such finding mandates the agency to take decisive action, the statute only involves a single finding by that agency.

Insofar as the dissent addresses the statutory structure, it primarily relies on a perceived parallel between the procedures for initial approval of a drug and withdrawal of that approval. But this attempted parallel ignores the fact that a withdrawal procedure occurs after a drug has already been found safe — a difference that amply justifies a different process.

[16] Put another way, plaintiffs' interpretation is internally inconsistent. On the one hand, it relies on the literal language of the statute to insist that upon the "finding" of lack of showing of safety — by which plaintiffs mean the preliminary internal conclusion of the agency that leads to the issuance of an NOOH — withdrawal of approval is mandatory, but on the other they acknowledge that that preliminary "finding" does not and cannot in fact mandate withdrawal of approval, because it leads only to a hearing that may or may not result in a finding that the drug is not shown to be safe. Plaintiffs insist that the "finding" or preliminary assessment of the agency mandates that the agency hold a hearing, but the finding referred to in § 360b(e)(1) requires that the Secretary issue an order withdrawing approval of the drug. Only a finding that is made after notice and an opportunity for a hearing can have this effect.

[17] 21 U.S.C. § 360b(d)(1) states: "If the Secretary finds, after due notice to the applicant in accordance with subsection (c) of this section and giving him an opportunity for a hearing, in accordance with said subsection, that [one of nine specified conditions is satisfied,] he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that [those conditions are not met], he shall issue an order approving the application."

[18] Specifically, the Secretary is authorized to approve an application for a new animal drug if she "finds that none of the grounds for denying approval specified in [§ 360b(d)] applies." 21 U.S.C. § 360b(c)(1).

[19] 21 C.F.R. § 5.84 has been formally withdrawn in an amendment of the regulations governing the FDA organizational structure, promulgated by a rule that is "editorial in nature." Revision of Organization and Conforming Changes to Regulations, 77 Fed.Reg. 15961-02 (Mar. 19, 2012) (codified at 21 C.F.R. Chapter I). The substance of the delegation from the Secretary to the CVM contained within 21 C.F.R. § 5.84 is now authorized by FDA Staff Manual Guides, Volume II — Delegation of Authority, SMG § 1410.503 (Feb. 24, 2011). As the modification to the regulations was editorial rather than substantive, the language of the delegation remains the same, and both parties implicitly agree that § 5.84 remains in effect, we address the regulation here.

[20] As the district court noted, the Commissioner of the FDA ratified the judgment reflected in the 1977 NOOHs by concurring — in a policy statement published in the Federal Register — with the Director's 1983 decision not to rescind those NOOHs. Penicillin and Tetracycline (Chlortetracycline and Oxytetracycline) in Animal Feeds; Denial of Petitions, 48 Fed.Reg. 4554, 4556 (Feb. 1, 1983) ("The Commissioner has reviewed the Director's decision and concurs with it. In addition, for the reasons discussed above, the Commissioner has decided that he will not withdraw the advance notice of hearing or the proposal to restrict therapeutic approvals to prescription use, but will hold them in abeyance.").

[21] Looking beyond the specific context of the Federal Food, Drug, and Cosmetic Act, Judge Katzmann cites a number of statutes in which Congress has used language similar to that at issue here. (Dissenting opinion, post, at 183). Significantly, however, he cites no judicial interpretation of this language that supports plaintiffs' readings (or, for that matter, that supports ours). The fact that Congress has created similar ambiguities in other contexts tells us nothing about how to resolve the ambiguity. Similarly, we are unpersuaded by the dissent's suggestion that the Supreme Court offhandedly endorsed plaintiffs' view of § 360(b)(1)(B) in Brown & Williamson (Dissenting opinion, post, at 180-81). In the cited passage, 529 U.S. at 134, 120 S.Ct. 1291, the Court simply repeats, in a slightly condensed form, the ambiguous language of the statute itself.

[22] To take only one example of this familiar process, when the Securities and Exchange Commission seeks to impose a cease-and-desist order against a corporation for violating Section 21C of the Securities Exchange Act of 1934, the Commission's staff issues a notice of a hearing prior to the issuance of such an order. It is the final decision of the Commission, not the charges contained in the notice, that constitute the "findings" of the agency, lead to the issuance of the order, and trigger judicial review.

[23] Moreover, upon the issuance of findings for or against the demonstration of the safety of the drug at the conclusion of a hearing, judicial review of whether the findings are adequately supported by the record will be available.

[24] The dissent disavows any reliance on the subjective views of FDA officials (Dissenting opinion, post, at 185), but then falls back on essentially the same argument about what the agency really believes by arguing that the now-withdrawn NOOHs were merely the "medium" for the "message" they contained: the prior internal agency conclusions that penicillin and tetracycline had not after all been shown to be safe (Dissenting opinion, post, at 185-86). The dissent concludes that withdrawal of the formal document on which it relies as a basis for judicial review is insufficient unless the agency has actually changed its mind, and deduces from a variety of sources that it has not.

[25] Such was the situation in the recently decided Cook v. FDA, 733 F.3d 1 (D.C.Cir.2013). There, the D.C. Circuit found the FDA failed to enforce a statute that included a clear Congressional mandate for the FDA to take action in particular circumstances. The FDA argued that because enforcement is a matter of agency discretion, the decision to not enforce the statute was not subject to judicial review. Id. at 5. The court found the relevant statute to be "unambiguously binding" on the FDA in mandating that particular actions be taken. Id. at 7 (citation omitted). Thus, the case addressed an instance of explicit legislative instruction stripping an agency of discretion. Such clear legislative instruction is noticeably absent here.

[26] Our reading thus emphatically recognizes the mandatory language of the statute. Where the FDA would otherwise have considerable discretion to take whatever action might be appropriate to protect the public safety in light of the results of the hearing, Congress has specifically mandated in § 360b(e)(1) that only one response is appropriate.

[27] Plaintiffs' reliance on Brown & Williamson is also misplaced. In that case, the Supreme Court held that the FDA lacked statutory authority to regulate the sale of tobacco products. 529 U.S. at 125-26, 120 S.Ct. 1291. In the course of its analysis, the Court noted that if it had statutory jurisdiction to regulate tobacco products, FDA would have been required by its organic statute to remove them from the market altogether. Id. at 135-36, 120 S.Ct. 1291. There was no question in that case, however, that FDA had made "findings" about the safety of tobacco before issuing a final rule governing youth access to tobacco products. The Supreme Court did not address whether, if tobacco fell within its jurisdiction, the FDA would have been required to initiate, or forbidden from abandoning, a course of hearings that might or might not have resulted in such findings.

[28] As further evidence of the absence of a statutory mandate, we noted the lack of any time statutory time limits on the agency's action, 321 F.3d at 331 n. 8, a factor also applicable here.

[29] We respectfully disagree with Judge Katzmann's assertion (Dissenting opinion, post, at 187-88) that because we find Whitman to offer a helpful analogy to determine whether the FDA abused its discretion, we are implicitly equating a withdrawal action to an enforcement action. Whitman provides guidance in that the relevant statutory language in that case ("Whenever the Administrator makes a determination," 321 F.3d at 330, quoting 42 U.S.C. § 7661(a)(i)(1)) left the mandatory agency action conditional upon a discretionary agency finding, much like the statutory provision at issue here (action is required only "if the Secretary finds" that certain conditions adhere). The relevant parallel in these cases is one of analogical statutory construction that leaves action dependent upon agency discretion, a construction distinguishable from the unequivocal imperative in the statute at issue in Massachusetts v. EPA. Whether a withdrawal action is an enforcement action is not relevant to our conclusion.

[30] To be more precise, § 360b(a) declares that a new animal drug "shall, with respect to any particular use or intended use of such drug, be deemed unsafe" unless it has been approved by the FDA or a special exception applies. Section 351(a)(5) then declares that any new animal drug deemed unsafe under § 360b(a) shall be deemed "adulterated," and § 331(a) prohibits introducing any adulterated drug into interstate commerce. Throughout the discussion below, I omit similarly tangential details of the FDCA's intricate statutory scheme.

[31] The statute does contemplate certain grounds that would prevent a new drug from being initially approved, but that would not require withdrawal of an approved drug. Compare 21 U.S.C. § 360b(d)(1)(C) (barring approval of a new drug for which "the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity"), and id. § 360b(d)(1)(H) (barring approval where a new drug's "labeling is false or misleading in any particular"), with id. § 360b(e)(2)(B)-(C) (giving the Secretary discretion to decide whether to withdraw approval from drugs under those conditions). That is, where Congress wanted to give the FDA the discretion that the agency seeks here, Congress expressly granted it.

[32] The sole exception comes in § 360b(e)(1)'s "imminent hazard" provision, which permits the Secretary of Health and Human Services to immediately suspend approval of a particular animal drug use without a hearing if he finds that use presents an imminent hazard to human or animal health.

[33] For comparison, the first sentence of § 355(e) reads: "The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds that [any of the listed statutory grounds apply]." 21 U.S.C. § 355(e).

[34] The majority indicates that Brown & Williamson is inapposite because the FDA had already made "findings" showing that tobacco products were unsafe. But the "findings" referred to in that case were the result of a notice-and-comment rulemaking procedure, not the formal evidentiary hearing process envisioned by § 355(e) (or § 360b(e)(1)) and its accompanying regulations. Compare Brown & Williamson, 529 U.S. at 126-28, 134-35, 120 S.Ct. 1291, with 21 C.F.R. § 10.50(c)(16)-(17). In other words, Brown & Williamson clearly assumes that the agency can be bound in this context by a finding that does not result from any formal evidentiary hearing.

[35] The regulation is plainly mandatory. See Lopez v. Davis, 531 U.S. 230, 241, 121 S.Ct. 714, 148 L.Ed.2d 635 (2001) (noting the use of the word "shall" to "impose discretionless obligations"). That alone may well be enough to resolve this case, since "[w]here the rights of individuals are affected, it is incumbent upon agencies to follow their own procedures." Morton v. Ruiz, 415 U.S. 199, 235, 94 S.Ct. 1055, 39 L.Ed.2d 270 (1974). I say "may well be enough" because some agency regulations do not create judicially enforceable obligations. See Leslie v. Attorney General, 611 F.3d 171, 176 (3d Cir.2010) ("[N]ot every promulgated regulation is of such a nature that a violation should invalidate agency action."). The parties have not thoroughly briefed whether 21 C.F.R. § 514.115(b)(3)(ii) can, of its own force, require the FDA to carry out withdrawal hearings. Because I think the statute provides sufficient grounds to reach that result, I need not decide whether the regulation does as well.

[36] Other agency pronouncements confirm that the FDA has interpreted the statutory finding described in § 360b(e)(1)(B) to be a preliminary finding that begins the withdrawal process. See Guidance for Industry # 209, at 19 ("[I]nitiating action to withdraw an approved new drug application ... would require the agency to make the showing required under [§ 360b(e)(1)]."); see also 21 C.F.R. § 514.80(a)(3) ("FDA reviews the records and reports required in this section to facilitate a determination under [§ 360b(e)] as to whether there may be grounds for suspending or withdrawing approval...."); Letter from Leslie Kux, Assistant Acting Commissioner for Policy, FDA, to Sarah Klein, Center for Science in the Public Interest 2 (Nov. 7, 2011) ("If the [agency] concludes that grounds exist to withdraw a new animal drug approval, ... FDA must provide the drug's sponsor with notice and an opportunity for a formal administrative hearing (`NOOH').").

[37] By contrast, I agree with the majority that none of the other regulations cited by the FDA help our analysis, because none of them address the interpretive question before us: whether the agency is required, after making an initial finding that a drug is not shown to be safe, to commence withdrawal proceedings. I also reject the agency's bid for Auer deference to its argument that § 514.115(b) and the statute refer to different findings, since "Auer deference is warranted only when the language of the regulation is ambiguous." Christensen v. Harris Cnty., 529 U.S. 576, 588, 120 S.Ct. 1655, 146 L.Ed.2d 621 (2000).

[38] Because the FDA did issue two NOOHs in this case, we are not called on to decide here whether the statute might require the FDA to commence withdrawal proceedings if it used some other means to announce its position that a particular drug had not been shown to be safe.

[39] For the same reason, I would also hold that the withdrawal of the NOOHs did not moot plaintiffs' claim. See NRDC I, 884 F.Supp.2d at 149-51.

[40] We are not called on to decide in this case whether withdrawal proceedings initiated under the other subsections of 21 U.S.C. 360b(e) are likewise outside the scope of Heckler and Whitman.

822 F.Supp.2d 406 (2011)

[409] Christina Maria Killerlane, Law Offices of James J. Killerlane, White Plains, NY, for Plaintiff.

Kenneth A. Schoen, Scott H. Goldstein, Bonner, Kiernan, Trebach & Criciata, New York, NY, for Defendants.

OPINION AND ORDER

SEIBEL, District Judge.

Before the Court is Defendants' Motion to Dismiss Plaintiff's Amended Complaint for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6), (Doc. 19), and Defendants' unopposed Motion for Judicial Notice, (Doc. 22). For the reasons stated below Defendants' Motion for Judicial Notice is GRANTED and Defendants' Motion to Dismiss is GRANTED in part and DENIED in part.

I. Background

The following facts are assumed to be true for purposes of the motion.

Plaintiff Lee Porrazzo consumed approximately ten six-ounce cans of tuna fish per week from approximately January 2006 to October 2008. (Am. Compl. ¶ 1.)^[1] The tuna fish was canned by Defendant Bumble Bee Foods, LLC ("Bumble Bee"). (Id.) Plaintiff purchased this tuna fish, which was frequently on sale, from Defendant Stop & Shop Supermarket Company ("Stop & Shop"). (Id.) During this time Bumble Bee promoted its tuna fish as an "excellent and safe source of high quality protein, vitamins, minerals and Omega-3 fatty acids, as well as being low in saturated fats and carbohydrates[,] and touted its product as being `heart healthy.'" (Id. ¶ 3.) The Bumble Bee tuna fish did not provide any warning that it contained mercury, "an odorless, colorless, tasteless, poisonous, heavy metal." (Id. ¶ 4.)

At some point between January 2006 and October 2008, Plaintiff began to experience, two to three times per week, "episodes of chest pains, heart palpitations, sweatiness, dizziness, and lightheadedness," which led him to believe that he had a heart condition. (Id. ¶ 5.) Plaintiff sought medical attention and underwent numerous tests to understand the cause of his symptoms, but none of these tests provided an answer. (Id. ¶ 5.) On April 14, 2006, Plaintiff went to the White Plains Hospital Emergency Room because he believed (incorrectly) that he was having a heart attack. (Id. ¶ 6.)

On or about October 1, 2008, Plaintiff's primary care practitioner ordered a heavy metals blood test, which showed that there was an elevated level of mercury in Plaintiff's blood. (Id. ¶ 7.) Specifically, Plaintiff's blood mercury level was 23 mcg/L as opposed to the less than 10 mcg/L, which is normal. (Id.) On the same date, the New York State Department of Health contacted Plaintiff by telephone, advised him that he had a dangerous level of mercury in his blood, asked him questions, filled out a questionnaire, and instructed him to stop eating tuna fish. (Id. ¶ 8.) Plaintiff stopped eating tuna fish, and a blood test on November 4, 2008, revealed that his mercury levels had returned to normal. (Id. ¶ 9.) Plaintiff no longer suffered the heart attack-like symptoms previously [410] described, but he alleges that he "remains worried today about what effects the mercury has had on his health." (Id.)

Plaintiff filed the Amended Complaint on August 31, 2010, alleging claims for: (1) breach of implied warranty of merchantability and fitness for consumption; (2) failure to warn under both strict liability and negligence theories; (3) "emotional distress;" (4) violations of New York State Agriculture and Markets Law; and (5) violations of New York State General Business Law. (Doc. 9.)

II. Legal Standards

A. Motion to Dismiss

"To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. "While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (alteration, citations, and internal quotation marks omitted). While Federal Rule of Civil Procedure 8 "marks a notable and generous departure from the hyper-technical, code-pleading regime of a prior era,. . . it does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Iqbal, 129 S.Ct. at 1950.

In considering whether a complaint states a claim upon which relief can be granted, the court may "begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth," and then determine whether the remaining well-pleaded factual allegations, accepted as true, "plausibly give rise to an entitlement to relief." Id. Deciding whether a complaint states a plausible claim for relief is "a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. "[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged— but it has not `show[n]'—`that the pleader is entitled to relief'" Id. (second alteration in original) (quoting Fed.R.Civ.P. 8(a)(2)).

B. Consideration of Documents Outside the Pleadings

When deciding a motion to dismiss, the Court is entitled to consider the following:

(1) facts alleged in the complaint and documents attached to it or incorporated in it by reference, (2) documents "integral" to the complaint and relied upon in it, even if not attached or incorporated by reference, (3) documents or information contained in [a] defendant's motion papers if plaintiff has knowledge or possession of the material and relied on it in framing the complaint, (4) public disclosure documents required by law to be, and that have been, filed with the Securities and Exchange Commission, and (5) facts of which judicial notice may properly be taken under Rule 201 of the Federal Rules of Evidence.

Weiss v. Inc. Vill. of Sag Harbor, 762 F.Supp.2d 560, 567 (E.D.N.Y.2011) (internal quotation marks omitted); accord Chambers v. Time Warner, Inc., 282 F.3d [411] 147, 152-53 (2d Cir.2002). A document is considered "integral" to the complaint where the plaintiff has "reli[ed] on the terms and effect of [the] document in drafting the complaint." Chambers, 282 F.3d at 153 (emphasis omitted). Such reliance "is a necessary prerequisite to the court's consideration of the document on a dismissal motion; mere notice or possession is not enough." Id.; see Faulkner v. Beer, 463 F.3d 130, 134 (2d Cir.2006) (integral documents may include documents partially quoted in complaint or on which plaintiff relied in drafting complaint). If a document outside of the complaint is to form the basis for dismissal, however, two requirements must be met in addition to the requirement that the document be "integral" to the complaint: (1) "it must be clear on the record that no dispute exists regarding the authenticity or accuracy of the document," and (2) "[i]t must also be clear that there exist no material disputed issues of fact regarding the relevance of the document." Faulkner, 463 F.3d at 134.

III. Discussion

A. Documents the Court May Consider

Before addressing the merits of Defendants' Motion to Dismiss, I must first address which documents may properly be considered on this motion. Defendants' request that I take judicial notice of the following documents of the United States Food and Drug Administration ("FDA"):

• "What You Need to Know About Mercury in Fish and Shellfish," published by the United States Department of Health and Human Services and the United States Environmental Protection Agency, (Goldstein Cert. Ex. A)^[2];

• "Backgrounder for the 2004 FDA/EPA Consumer Advisory: What You Need to Know About Mercury in Fish and Shellfish," published by the United States Food and Drug Administration and the United States Environmental Protection Agency, (Goldstein Cert. Ex. B);

• Letter from Lester M. Crawford, D.V.M., Ph.D., United States Commissioner of Food and Drugs, to Bill Lockeyer, Attorney General of the State of California, dated August 12, 2005, re: a suit filed on June 21, 2004 in San Francisco Superior Court, (Goldstein Cert. Ex. C);

• Section 540.600 of the Federal Food and Drug Administration's Compliance Policy Guide, which allows up to one part of methyl mercury per million non-mercury parts of the edible portion of seafood, (Goldstein Cert. Ex. D);

• FDA Letter Responding to Martek Petition, dated September 8, 2004, (Goldstein Cert. Ex. E).

"Rule 201 of the Federal Rules of Evidence permits judicial notice of a fact that is `either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot be reasonably[] questioned.'" U.S. v. Bryant, 402 Fed.Appx. 543, 545 (2d Cir.2010). Further, it is well-established that courts may take judicial notice of publicly available documents on a motion to dismiss. See Byrd v. City of N.Y., No. 04-CV-1396, 2005 WL 1349876, at *1 (2d Cir. June 8, 2005) ("[M]aterial that is a matter of public record may be considered in a motion to dismiss."); Blue Tree Hotels Inv. (Can.) v. Starwood Hotels & Resorts Worldwide, Inc., 369 F.3d 212, 217 (2d [412] Cir.2004) (courts can "look to public records, including complaints filed in state court, in deciding a motion to dismiss"); In re Yukos Oil Co. Secs. Litig., No. 04-CV-5243, 2006 WL 3026024, at *21 (S.D.N.Y. Oct. 25, 2006) ("Court may take judicial notices of [published] articles on a motion to dismiss without transforming it into a motion for summary judgment") (citing Kramer v. Time Warner, Inc., 937 F.2d 767, 773 (2d Cir.1991)). "In the motion to dismiss context, . . . a court should generally take judicial notice `to determine what statements [the documents] contain[] . . . not for the truth of the matters asserted.'" Schubert v. City of Rye, 775 F.Supp.2d 689, 698 (S.D.N.Y.2011) (alterations in original) (quoting Kramer v. Time Warner Inc., 937 F.2d 767, 774 (2d Cir.1991)). Because the documents of which Defendants request I take judicial notice are all publicly available on the FDA website, this unopposed motion is granted and I take judicial notice of these documents for the fact that the statements were made, not for their truth.

B. Federal Preemption

Defendants contend that Plaintiff's state law claims must be dismissed because they are "preempted by a `pervasive federal regulatory scheme implemented by and through the FDA' which specifically addresses and regulates the extent to which the Defendants could distribute canned tuna containing legally permitted levels of methylmercury and whether it was required to warn consumers of trace amounts." (Defs.' Mem. 25-26.)^[3] In particular, Defendants assert that "the FDA has already extensively regulated this arena by establishing the maximum concentration of methylmercury for a can of tuna to be considered fit for consumption, issuing advisories to target groups and implementing a comprehensive education campaign while expressly rejecting the notion of and/or need for warning the general population of the presence of methylmercury in tuna." (Id. at 29-30.)

The Supremacy Clause, U.S. Const., art. VI, cl. 2, "invalidates state laws that `interfere with, or are contrary to,' federal law." Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 712, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985) (quoting Gibbons v. Ogden, 9 Wheat. 1, 211, 6 L.Ed. 23 (1824)). "[S]tate laws can be pre-empted by federal regulations as well as by federal statutes," id. at 713, 105 S.Ct. 2371; see Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982) (agency "regulations have no less pre-emptive effect than federal statutes"), at least where the regulations "are properly adopted in accordance with statutory authorization," City of N.Y. v. FCC, 486 U.S. 57, 63, 108 S.Ct. 1637, 100 L.Ed.2d 48 (1988). Preemption inquiries are "guided by the rule that [t]he purpose of Congress is the ultimate touchstone in every pre-emption case." Altria Grp., Inc. v. Good, 555 U.S. 70, 76, 129 S.Ct. 538, 172 L.Ed.2d 398 (2008) (alteration in original and internal quotation marks omitted). In addressing questions of preemption, courts are to begin their analysis "with the assumption that the historic police powers of the States [are] not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Id. at 77, 129 S.Ct. 538 (alteration in original). This assumption "applies with particular force when Congress has legislated in a field traditionally occupied by the States." Id.

[413] In Fellner v. Tri-Union Seafoods, L.L.C., the Third Circuit addressed a case almost identical to this one and found that the plaintiff's state law claims were not preempted. 539 F.3d 237 (3d Cir.2008). Specifically, in Fellner the plaintiff alleged that her diet consisted almost exclusively of the defendant's canned tuna products for a period of five years, that those tuna products contained methylmercury, and that due to defendant's failure to warn of the dangers of methylmercury, plaintiff contracted mercury poisoning and suffered physical and emotional injuries. As in the case at bar, the Fellner defendant argued that Plaintiff's state law claims were preempted by federal law. The Third Circuit disagreed:

This is a situation in which the FDA has promulgated no regulation concerning the risk posed by mercury in fish or warnings for that risk, has adopted no rule precluding states from imposing a duty to warn, and has taken no action establishing mercury warnings as misbranding under federal law or as contrary to federal law in any other respect. Fellner's lawsuit does not conflict with the FDA's "regulatory scheme" for the risks posed by mercury in fish or the warnings appropriate for that risk because the FDA simply has not regulated the matter. Fellner's duty-to-warn claim does not conflict with an FDA determination deliberately to forego warnings because the FDA took no action to preclude state warnings—at least, no binding action via ordinary regulatory procedures . . . . Finally, Fellner's lawsuit does not conflict with the FDCA's food misbranding provision or the FDA's actions thereunder because the FDA has not exercised its misbranding authority under the FDCA with respect to methylmercury warnings for fish.

Fellner, 539 F.3d at 256.

As far as this Court is aware, since the time of the Fellner decision the FDA has promulgated no new regulations with respect to methylmercury in tuna. Moreover, the Fellner court had before it the same supporting documents that were submitted to me on this motion—namely, the five documents of which I have been asked to take judicial notice.^[4]

Although I am not bound by the Fellner Court's decision, I find its reasoning and approach to this issue persuasive. Thus, for substantially the same reasons cited by the Fellner court, I decline to find that Plaintiff's state law claims here are preempted by a pervasive federal regulatory scheme implemented by and through the FDA.^[5]

[414] C. Proximate Cause

Defendants next assert that all of Plaintiff's claims must be dismissed because Plaintiff fails to allege that he sustained any injuries that were proximately caused by his consumption of Defendants' canned tuna fish. (Defs.' Mem. at 14.) Specifically, Defendants assert that despite Plaintiff's consultations "with numerous physicians. . . there was no diagnosis of any specific ailment," and although Plaintiff claims that he remains worried about what effects the mercury has had on his health, "he has not alleged the existence of any actual ill health effects caused by consumption of tuna." (Id.) Defendants also assert that Plaintiff has not alleged "that the elevated mercury level in his blood was proximately caused by his consumption of Bumble Bee canned tuna fish." (Defs.' Reply at 8.)^[6]

"Under New York law, [i]t is well settled that, whether [an] action is pleaded in strict products liability, breach of warranty or negligence, it is a consumer's burden to show that a defect in the product was a substantial factor in causing the injury." Viscusi v. P & G-Clairol, Inc., 346 Fed. Appx. 715, 716 (2d Cir.2009) (alterations in original and internal quotation marks omitted); see Colon ex rel. Molina v. BIC USA, Inc., 199 F.Supp.2d 53, 82 (S.D.N.Y. 2001) ("To make out a prima facie case for negligence in New York, a plaintiff must show (1) that the manufacturer owed plaintiff a duty to exercise reasonable care; (2) a breach of that duty by failure to use reasonable care so that a product is rendered defective, i.e. reasonably certain to be dangerous; (3) that the defect was the proximate cause of the plaintiff's injury; and (4) loss or damage. . . . Strict liability in New York requires a showing that (1) a defective product (2) caused plaintiff's injury."); Fahey v. A.O. Smith Corp., 77 A.D.3d 612, 908 N.Y.S.2d 719, 723 (2d Dep't 2010) ("Whether an action is pleaded in strict products liability, breach of warranty, or negligence, the plaintiffs must prove that the alleged defect is a substantial cause of the events which produced the injury.").

Defendants' contention that Plaintiff has not alleged that he suffered injury [415] is unavailing. While Plaintiff has not conclusively proven that he sustained long-term physical injuries from his ingestion of mercury, he has pleaded that he suffered from an extremely elevated blood mercury level, and a series of heart attack-like symptoms including episodes of chest pains, heart palpitations, sweatiness, and dizziness and lightheadedness, all of which constitute injury. (Am. Compl. ¶¶ 5, 6, 23, 25, 39, 41, 44.). See Vamos v. Coca-Cola Bottling Co., 165 Misc.2d 388, 627 N.Y.S.2d 265, 270-71 (N.Y.Civ.Ct.1995) (plaintiff who "had a rapid heartbeat, an upset stomach, was nauseous and sweating. . . and vomited, and . . . had diarrhea" suffered injury for purposes of products liability; "extent and permanency" of plaintiff's injury "relate to the issue of damages," not liability); Mitchell v. Coca-Cola Bottling Co., 11 A.D.2d 579, 200 N.Y.S.2d 478, 479-80 (3d Dep't 1960) (nausea and vomiting resulting from drinking soda containing foreign substance is recoverable injury). Thus, at this stage, Plaintiff's factual allegations are sufficient for me to find it plausible that Plaintiff suffered an injury.

I also find that Plaintiff has plausibly alleged that Defendants' conduct was the proximate cause of his injuries. "Proximate cause requires only some direct relation between the injury asserted and the injurious conduct alleged, and excludes only those link[s] that are too remote, purely contingent, or indirect." Staub v. Proctor Hosp., ___ U.S. ___, 131 S.Ct. 1186, 1192, 179 L.Ed.2d 144 (2011) (internal quotation marks omitted). Moreover, "[t]he issue of proximate cause may be determined as a matter of law [only] where no reasonable person could find causation based on the facts alleged in the complaint." Pelman v. McDonald's Corp., 237 F.Supp.2d 512, 538 (S.D.N.Y.2003) (finding "[n]o reasonable person could find probable cause based on the facts in the Complaint without resorting to `wild speculation'"). Plaintiff asserts that Bumble Bee canned tuna fish was his major source of protein from approximately January 2006 to October 2008, (Am. Compl. ¶ 3), that it contained mercury, (id. ¶ 4), that during that time period he began to experience physical symptoms that led him to believe he had a heart condition, (id. ¶¶ 56), that an October 2008 heavy metals blood test revealed that Plaintiff had a very elevated blood mercury level, (Id. ¶ 8), that Plaintiff was informed of these test results and instructed to stop eating tuna fish, which he did, and that his mercury levels returned to normal and his symptoms abated, within a month thereafter, (id. ¶¶ 8-9). Based on the foregoing, Plaintiff asserts that he was "caused to sustain serious personal injuries" as a result of the defendants' tuna fish products which contained "poisonously high levels of mercury." (Id. ¶ 39.) This timeline provides more than sufficient factual allegations to make it plausible that Plaintiff's ingestion of Defendants' tuna fish was the cause of his injuries.^[7] Viewing the facts in [416] the Amended Complaint in the light most favorable to the Plaintiff, as I must on a motion to dismiss, I find that Plaintiff has sufficiently alleged a direct causal relationship between his consumption of Defendants' tuna fish and his injuries. Defendants' Motion to Dismiss on this basis is therefore denied.

D. Emotional Distress Claim

Defendants next assert that Plaintiff's claims for emotional distress must be dismissed because Plaintiff fails to allege a physical injury which was proximately caused by his consumption of Defendants' canned tuna fish. As described above, I find he has sufficiently pleaded the same. But emotional distress is a prayer for relief, not a separate cause of action, see Brennan v. N.Y. Law Sch., No. 10-CV-0338, 2011 WL 2899154, at *1 (S.D.N.Y. Jul. 11, 2011) (granting Plaintiff's "motion to amend to add a request for emotional distress damages to the prayer for relief"); Galotti v. Town and City of Stamford, No. 96-CV-0224, 1996 WL 684409, at *5 (D.Conn. Nov. 19, 1996) ("Damages for emotional distress may be recovered . . . . However, they should be included as part of the `prayer for relief' section of the complaint. They are not to be pled as a separate count."), and Plaintiff's claims for emotional distress are therefore dismissed. That Plaintiff's claims for emotional distress are dismissed does not, however, preclude Plaintiff's ability to recover emotional distress damages if he is successful on his remaining claims. See Goldberg v. N.Y. Times, 66 A.D.2d 718, 411 N.Y.S.2d 294, 295 (1st Dep't 1978) ("The relief sought, though erroneously stated as a separate cause, should be deemed part of the prayer for damages.").

E. Plaintiff's Product Liability Claims

Defendants also contend that Plaintiff's common law claims—Counts I through IV, for breach of the implied warranties of merchantability and fitness for consumption^[8] and failure to warn—must be dismissed because, among other things: (1) consumers reasonably expect canned tuna fish to contain mercury, which naturally occurs in fish and which Defendants cannot, through ordinary care, remove; and (2) Plaintiff overconsumed the product.

1. Legal Standards

Under New York law, "[a] manufacturer who places a defective product on the market that causes injury may be liable for the ensuing injuries." Liriano v. Hobart Corp., 92 N.Y.2d 232, 237, 677 N.Y.S.2d 764, 700 N.E.2d 303 (1998). In an action for strict products liability,

a manufacturer, wholesaler, distributor, or retailer who sells a product in a defective condition is liable for injury which results from the use of the product regardless of privity, foreseeability or the exercise of due care. The plaintiff need only prove that the product was defective as a result of either a manufacturing flaw, improper design, or a failure to provide adequate warnings regarding the use of the product and that the defect was a substantial factor in bringing about the injury.

Leary ex rel. Debold v. Syracuse Model Neighborhood Corp., 9 Misc.3d 292, 799 [417] N.Y.S.2d 867, 872-73 (Sup.Ct.2005) (internal citations and quotation marks omitted); see Liriano, 92 N.Y.2d at 237, 677 N.Y.S.2d 764, 700 N.E.2d 303 ("A product may be defective when it . . . is not accompanied by adequate warnings . . . .").

A manufacturer may also be held liable under New York law for breach of implied warranty of merchantability when its products are not "fit for the ordinary purposes for which such goods are used." New York U.C.C. § 2-314(2)(c). Specifically, a Plaintiff may recover "upon a showing that [a] product was not minimally safe for its expected purpose," and the focus of a breach of implied warranty inquiry is whether the product meets "the expectations for the performance of the product when used in the customary, usual and reasonably foreseeable manners." Denny v. Ford Motor Co., 87 N.Y.2d 248, 258-59, 639 N.Y.S.2d 250, 662 N.E.2d 730 (1995).

2. Reasonability of Tuna Consumption

Defendants contend that Plaintiff's consumption of its canned tuna fish was unreasonable as a matter of law and that Plaintiff's claims therefore cannot survive. (See Defs.' Mem. at 22 ("[A] diet consisting of nearly 1,500 cans or over 500 lbs of tuna in thirty-three months is undisputedly outside the `intended use' of the product").) Defendants' contention is unavailing. Plaintiff's daily consumption of one to two cans of tuna fish cannot, as a matter of law at this stage, be said to be unreasonable.<sup>[9]</sup> Indeed, Plaintiff was arguably exactly the type of consumer that Defendants desired—a consumer who purchased and consumed their product regularly. Moreover, even if Plaintiff's consumption of such quantities of tuna was unreasonable, Defendants still would be liable for failure to warn if Plaintiff's conduct was foreseeable. See Liriano, 92 N.Y.2d at 240, 677 N.Y.S.2d 764, 700 N.E.2d 303 (manufacturer of defectively designed product liable for failure to warn of dangers resulting from both intended use of product and foreseeable misuses). It is plausibly foreseeable that an individual who is trying to pursue a heart healthy diet could consume one to two cans of canned tuna fish daily, particularly when it was advertised as "low in fat, high in protein and thus, `heart healthy.'" (Pl.'s Mem. 14.)^[10] In any [418] event, the question of whether Plaintiff's daily consumption of tuna fish was indeed unreasonable or unforeseeable is properly left for a jury to determine. See Lugo v. LJN Toys, Ltd., 75 N.Y.2d 850, 852, 552 N.Y.S.2d 914, 552 N.E.2d 162 (1990) (question of "whether the product was defective and reasonably safe for its intended use or a reasonably foreseeable unintended use" is for jury); Heller v. Encore of Hicksville, 53 N.Y.2d 716, 718, 439 N.Y.S.2d 332, 421 N.E.2d 824 (1981) ("It was within the province of the jury to determine" whether defendant failed to warn plaintiff of a "foreseeable" risk); Johnson v. Johnson Chem. Co., 183 A.D.2d 64, 588 N.Y.S.2d 607, 610 (2d Dep't 1992) ("Whether a particular way of misusing a product is reasonably foreseeable, and whether the warnings which accompany a product are adequate to deter such potential misuse, are ordinarily questions for the jury."). Defendants' motion to dismiss on this basis is therefore denied.

3. Reasonable Expectations and Obviousness of Danger

In order to succeed on either a failure to warn claim, or a breach of implied warranty claim, a plaintiff must also establish that the danger inherent in the injurious product was not open and obvious and thus something which a reasonable consumer would ordinarily anticipate finding therein. See Fitzgerald v. Fed. Signal Corp., 63 A.D.3d 994, 883 N.Y.S.2d 67, 69 (2d Dep't 2009) (dismissing plaintiff's strict products liability claim based on defendant's alleged duty and failure to warn of risk of hearing loss from prolonged exposure to sirens because "risk alleged is `open and obvious' and `readily apparent as a matter of common sense'"); Lamb v. Kysor Indus., 305 A.D.2d 1083, 759 N.Y.S.2d 266, 268 (4th Dep't 2003) (no duty to warn of open and obvious danger of placing fingers in path of power saw); Belling v. Haugh's Pools, Ltd., 126 A.D.2d 958, 511 N.Y.S.2d 732, 733 (4th Dep't 1987) (no duty to warn of open and obvious danger of diving into shallow pool); Langiulli v. Bumble Bee Seafood, Inc., 159 Misc.2d 450, 604 N.Y.S.2d 1020, 1021 (Sup. Ct.1993) (breach of warranty claim stated when "consumer is injured by conditions which he could not have reasonably anticipated to be present in the product purchased"). Whether a danger is in fact common knowledge among the public is ordinarily a question of fact that cannot be resolved at the motion to dismiss stage. See In re Methyl Tertiary Butyl Ether ("MTBE") Prods. Liab. Litig., 175 F.Supp.2d 593, 626 n. 50 (S.D.N.Y.2001) (denying defendant's motion to dismiss plaintiffs' failure to warn claims because court could not determine, as matter of law, that "it is common knowledge that gasoline must be handled with care"); Rudloff v. Wendy's Rest. 12 Misc.3d 1081, 821 N.Y.S.2d 358, 369 (City Ct. Buffalo 2006) (relevant question on breach of implied warranty claim is whether one would reasonably anticipate substance would be present, and this question is ordinarily one of fact for jury). But see Kaplan v. Am. Multi-Cinema, Inc., 21 Misc.3d 1103(A), 873 N.Y.S.2d 234, *2 (Civ.Ct.2008) (table decision) (determining as matter of law that one reasonably expects un-popped kernels in popcorn); Vitiello v. Captain Bill's Rest., 191 A.D.2d 429, 594 N.Y.S.2d 295, 296 (2d Dep't 1993) (determining, as matter of law, that one reasonably expects fish filet is not free of all bones).

This is not a case where I can say as a matter of law at this stage that the dangers of mercury poisoning from consumption of canned tuna fish are open and obvious, and that an ordinary consumer would necessarily be aware that canned tuna fish contains high levels of methylmercury, the consumption of which could [419] lead to mercury poisoning. This is particularly so because mercury is "an odorless, colorless, tasteless," metal, and thus nothing about the appearance of the fish itself would reveal either that it contains mercury or that such mercury may be dangerous if consumed on a daily basis. (Am. Compl. ¶ 3.) There may be many consumers who are unaware that canned tuna fish—which they believe is a low-fat, heart-healthy, source of protein—in fact contains mercury which can, in high quantities, be harmful to their health. Thus, although the facts as developed may permit the conclusion, by the Court on summary judgment or by the jury at trial, that consumers do reasonably expect mercury in their tuna and understand that it can be harmful, the allegations of the Amended Complaint do not support such a conclusion, and it is not obvious to the Court as a matter of "judicial experience and common sense." Iqbal, 129 S.Ct. at 1950.

4. Failure to Warn

Plaintiff here has adequately set forth a strict liability failure to warn claim. As noted above, he has established both injury and proximate cause, and has sufficiently alleged that the dangers of mercury poisoning from consumption of canned tuna fish are not open and obvious. Further, there is no suggestion at this stage that this particular Plaintiff was, in fact, aware either that canned tuna fish contained methylmercury or that there were risks inherent in the consumption of fish which contained high concentrations of this substance. See Colon ex rel. Molina, 199 F.Supp.2d at 85 ("A failure-to-warn inquiry focuses on three factors: obviousness of risk from actual use of product, knowledge of the particular user, and proximate cause."). Finally, the fact that methylmercury in tuna may be "naturally occurring" does not necessarily mean Defendants cannot be strictly liable for failing to warn customers of same.

Defendants nonetheless contend that Stop & Shop cannot be held liable for failure to warn because "there are no circumstances under which the alleged defect could have been discovered during a normal inspection while the tuna cans were in Defendant Stop & Shop's possession." (Defs.' Mem. 23.) "There is no question," however, "that under New York law the seller of a defective product may be strictly liable for any resultant injury even though the seller was not responsible for the defect." Davila v. Goya Foods, Inc., No. 05-CV-8607, 2007 WL 415147, at *6 (S.D.N.Y. Feb. 7, 2007). Thus, an injured plaintiff in a strict liability failure to warn case may recover from both manufacturers and retail sellers of the product. See Adeyinka v. Yankee Fiber Control, Inc., 564 F.Supp.2d 265, 274-75 (S.D.N.Y.2008) (strict liability for product defects "also extends to sellers who by reason of their continuing relationships with manufacturers, are most often in a position to exert pressure for the improved safety of products and can recover increased costs within their commercial dealings, or through contribution or indemnification in litigation") (internal quotation marks omitted). The retailer can be held strictly liable for failure to warn regardless of whether it could discover the defect upon normal visual inspection of the product. See Leary ex rel. Debold, 799 N.Y.S.2d at 873 ("Distributors and retailers may be held strictly liable to injured parties, even though they may be innocent conduits in the sale of the product. . . . It is well settled that strict products liability extends to retailers and distributors in the chain of distribution even if they never inspected, controlled, installed or serviced the product") (internal quotation [420] marks omitted).^[11] Defendants' motion to dismiss Plaintiff's strict liability failure to warn claim (Counts I and II) against both Bumble Bee and Stop & Shop is therefore denied.

Plaintiff has also adequately alleged a negligent failure to warn claim against Bumble Bee, because "[r]egardless of the descriptive terminology used to denominate the cause of action (viz, `strict liability' or `negligence'), where the theory of liability is failure to warn, negligence and strict liability are equivalent." Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 97 (4th Dep't 1979); see Anderson v. Hedstrom Corp., 76 F.Supp.2d 422, 439 (S.D.N.Y.1999) ("Where liability is predicated on a failure to warn, New York views negligence and strict liability claims as equivalent.") (internal quotation marks omitted); Denny, 87 N.Y.2d at 258, 639 N.Y.S.2d 250, 662 N.E.2d 730 ("Failure to warn claim . . . couched in terms of strict liability, is indistinguishable from a negligence claim.") (internal quotation marks omitted). Defendants' motion to dismiss Plaintiff's claim against Bumble Bee for negligent failure to warn is thus likewise denied.

Defendants are correct, however, that Plaintiff's negligent failure to warn claim cannot be sustained against Stop & Shop. Under a negligence theory of liability, a "retailer . . . can be held liable . . . for the sale of a defective product or for failure to warn only if it fails to detect a dangerous condition that it could have discovered during the course of a normal inspection while the product was in its possession." Pelman, 237 F.Supp.2d at 523. Consequently, Defendants' motion to dismiss Plaintiff's claim (within Count II) for negligent failure to warn against Stop & Shop is granted.

5. Breach of Implied Warranty of Merchantability

Plaintiff has also adequately asserted a breach of implied warranty of merchantability claim here. "To establish that a product is defective for purposes of a breach of implied warranty of merchantability claim, a plaintiff must show that the [421] product was not reasonably fit for its intended purpose, an inquiry that focuses on the expectations for the performance of the product when used in the customary, usual[,] and reasonably foreseeable manners." O'Sullivan v. Duane Reade, Inc., 27 Misc.3d 1215(A), 910 N.Y.S.2d 763, *6 (N.Y.Sup.2010) (table decision) (internal quotation marks omitted); see New York U.C.C. § 2-314(2)(c); Derienzo v. Trek Bicycle Corp., 376 F.Supp.2d 537, 570 (S.D.N.Y.2005); Denny, 639 N.Y.S.2d at 256, 662 N.E.2d 730; Wojcik v. Empire Forklift, Inc., 14 A.D.3d 63, 783 N.Y.S.2d 698, 701 (3d Dep't 2004).^[12] Further, "[i]n a breach of implied warranty action, the inquiry is not whether there were safer designs available." Groome v. Matsushita Elec. Corp. of Am., No. 92-CV-3073, 2000 WL 341134, at *6 (E.D.N.Y. Mar. 30, 2000); see Bah v. Nordson Corp., No. 00-CV-9060, 2005 WL 1813023, at *13 (S.D.N.Y. Aug. 1, 2005) ("[W]hether or not there were feasible safer alternative designs... is irrelevant to the merits of Plaintiff's breach of implied warranty claim."); Gonzalez by Gonzalez v. Morflo Indus., Inc., 931 F.Supp. 159, 165 (E.D.N.Y.1996) ("Plaintiff's recovery in a breach of warranty action depends on a showing that the product was not minimally safe for its expected purpose, regardless of the feasibility of making the product safer."); Rudloff, 821 N.Y.S.2d at 368 (neither origin of object nor efforts to prevent object's presence are determinative factors in reasonable expectations test).

The relevant question here, therefore, is whether the presence of mercury in Defendants' canned tuna, without any accompanying warnings, renders it not reasonably fit for the ordinary purpose for which it was intended. In other words, Plaintiff's claim for breach of implied warranty turns upon whether: 1) the customary, usual, and reasonably foreseeable use of tuna fish includes the type of consumption Plaintiff engaged in—namely, eating approximately one to two cans of tuna fish daily for more than two years; and 2) Plaintiff reasonably expected mercury— which, when consumed in those quantities, [422] could be poisonous—to be present in the fish. As explained above, at this stage Plaintiff has plausibly alleged as much. (The Court on summary judgment or a jury could, of course, conclude otherwise.) Furthermore, Plaintiff's ability to recover under his breach of implied warranty claim is not affected by the feasibility of making the product safer, and thus whether mercury is naturally present in tuna and/or can be removed through the use of ordinary care is irrelevant. Because Plaintiff plausibly alleges that he was, indeed, "injured by conditions which he could not have reasonably anticipated to be present in the product purchased," Langiulli, 604 N.Y.S.2d at 1021, Defendants' motion to dismiss Plaintiff's claim for breach of the implied warranty of merchantability as to Bumble Bee is denied.

With respect to Plaintiff's claim for breach of implied warranty of merchantability against Stop & Shop (Count II), however, such claim must fail. For claims for breach of warranty and negligence, a retailer "cannot be held liable for injuries sustained from the contents of a sealed product even though a test might have disclosed a potential danger" because "[t]here [i]s no obligation upon it to make such a test." Brownstone v. Times Square Stage Lighting Co., 39 A.D.2d 892, 333 N.Y.S.2d 781, 782 (1st Dep't 1972); see Cosgrove v. Delves' Estate, 35 A.D.2d 730, 315 N.Y.S.2d 369, 371 (2d Dep't 1970) (dismissing claim for breach of warranty against retailer because "evidence established that she could not have discovered any danger by mere inspection [and s]he was not obligated under these circumstances to ... test" the product); Alfieri v. Cabot Corp., 17 A.D.2d 455, 235 N.Y.S.2d 753, 757 (1st Dep't 1962) (retail seller not liable "even though it might have discovered the dangerous character ... by a test [because t]here was no obligation upon it to make such test"). Because Stop & Shop is a retail seller that cannot be held liable under breach of warranty for a defect it could not discover through ordinary inspection, Defendants' motion to dismiss Count II, as to a breach of implied warranty, is granted.

F. Counts III and IV

Defendants also contend that Counts III and IV should be dismissed because "Plaintiff improperly couches a common law claim for punitive damages, which is a prayer for relief, as a cause of action ... [and] there is no independent cause of action for punitive damages" under New York law. (Defs.' Mem. 22.) Counts III and IV appear to merely duplicate the claims that are set forth in Counts I and II. Thus, to the extent that Counts III and IV are, in fact, simply requests for punitive damages, they are dismissed as "separate claim[s] for punitive damages . . . [which] cannot be maintained" because "[i]t is settled that there is no independent cause of action for punitive damages." Mayes v. UVI Holdings, 280 A.D.2d 153, 723 N.Y.S.2d 151, 157 (1st Dep't 2001) (internal quotation marks omitted). That Counts III and IV are dismissed does not, however, preclude Plaintiff's ability to recover punitive damages if he is successful on his remaining claims. See Goldberg, 411 N.Y.S.2d at 294 ("The relief sought, though erroneously stated as a separate cause, should be deemed part of the prayer for damages.").

G. NYS Agriculture & Markets Law Claims

Finally, Defendants assert that Counts V and VI should be dismissed because Defendants' manufacture and sale of its canned tuna fish does not violate any provision of the New York Agriculture and Markets ("A & M") Law. (Defs.' Mem. 24.) [423] Plaintiff, however, contends that Defendants' product was `adulterated' and `misbranded' in violation of Sections 199, 200, and 201 of this Statute. (Pl.'s Mem. 23.)

Section 199-a(1) of the A & M Law provides that "No person or persons, firm, association or corporation shall within this state manufacture, compound, brew, distill, produce, process, pack, transport, possess, sell, offer or expose for sale, ... any article of food which is adulterated or misbranded within the meaning of this article." Section 200 of this law defines adulterated food and provides that food shall be deemed 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 subdivision if the quantity of such substance in such food does not ordinarily render it injurious to health.

2. If it bears or contains any added poisonous or added deleterious substance other than one which is (a) a pesticide chemical in or on a raw agricultural commodity, (b) a food additive, or (c) a color additive, which is unsafe within the meaning of section two hundred two, or if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section four hundred eight-a of the federal food, drug and cosmetic act, as amended, or if is, or it bears or contains, any food additive which is unsafe within the meaning of section four hundred nine of such federal act, as amended; provided, that where a pesticide chemical has been in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section four hundred eight of such federal act, and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating or milling, the residue of such pesticide chemical remaining in or on such processed food shall not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of such residue in the processed food, when ready to eat, is not greater than the tolerance prescribed for the raw agricultural commodity.

3. If it consists in whole or in part of a diseased, contaminated, filthy, putrid or decomposed substance, or if it is otherwise unfit for food.

....

5. If it is the product of a diseased animal or of an animal which has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse.

....

9. If damage or inferiority has been concealed in any manner.

....

11. If it falls below the standard of purity, quality or strength which it purports or is represented to possess.

N.Y. Agric. & Mkts. Law § 200.

Plaintiff asserts in Count V that "by manufacturing, selling, processing, marketing and packaging canned tuna fish adulterated with poisonously high levels of mercury, the defendants violated [A & M] Law Sections 199-a(1), 200(1), 200(2), 200(3), 200(5), 200(9) and 200(11)." (Am. Compl. ¶ 52.) In Langiulli, 604 N.Y.S.2d at 1022, the court held that the apparent thrust and intent of Sections 199 and 200 of the A & M Law "is to prohibit the sale of impure or contaminated products, and [they] are not in fact aimed at the presence [424] of foreign objects in the product." Thus, the court determined, a foreign substance such as a tuna bone in a can of tuna fish does not "adulterate" the tuna fish for purposes of this statute. Id. Based on this logic, Defendants assert that because mercury is natural to canned tuna, and because unlike with "a lingering fish bone, which with extraordinary care might have been removed, there is simply no way to remove mercury from tuna," there is an even more compelling argument that Defendants' canned tuna should not be deemed "adulterated" by virtue of the mercury found therein. (Defs.' Mem. 24-25.) Aside from the fact that the impossibility of removing mercury from tuna is not part of the record before me, I do not find Defendants' argument persuasive. If mercury naturally occurs in canned tuna and cannot be removed, it is less "foreign" than a bone in a purportedly boneless product would be. In fact, it appears to this Court that mercury could be the sort of substance from which the legislators wanted to protect consumers, because the statute specifically contemplates that substances which are "not [] added substance[s]"—which would include naturally occurring substances—could in some circumstances be an adulterant: Section 200(1) of the A & M Law provides that foods that contain poisonous or deleterious substances that are not added substances will not be considered adulterated "if the quantity of such substance in such food does not ordinarily render it injurious to health." N.Y. Agric. & Mkts. Law § 200(1). The flip side obviously is that a non-added (naturally occurring) substance can be an adulterant if it ordinarily renders the food injurious to health. Here, Plaintiff has alleged that Defendants' tuna fish, in the quantity Plaintiff consumed (which I have determined was not unreasonable as a matter of law), does, in fact, ordinarily render it injurious to health due to the high concentration of mercury therein (although a jury might also find that Plaintiff's consumption was not "ordinary"). Thus, taking Defendants' contention that mercury is natural to tuna fish (and thus not an added substance) as true, Plaintiff has at this stage adequately pleaded a violation of Section 200(1) of the New York State Agriculture and Markets Law. It may be that as the facts are developed, the Court on summary judgment or a jury could conclude that the mercury in tuna does not "ordinarily" render it harmful, but such a conclusion cannot be drawn from the Amended Complaint. Plaintiff has similarly sufficiently pleaded a violation of Section 200(11) because Defendants' tuna fish arguably fell below the standard of quality—namely, that it was a heart-healthy product—that Defendants represented it possessed. Defendants' motion to dismiss these claims is therefore denied.

Plaintiff's claims under Sections 200(2), 200(3), 200(5), and 200(9), cannot, however, survive. First, with respect to Section 200(2), despite Plaintiff's assertion to the contrary, there is no indication that Defendants' canned tuna contained "any added poisonous or added deleterious substance." The Amended Complaint does not allege any addition and is consistent with Defendants' claim that the mercury was already part of the fish before it was canned or sold. See People ex rel. Brown, 171 Cal.App.4th at 1573, 90 Cal.Rptr.3d 644 (affirming trial court's determination that preponderance of the evidence supports finding that methylmercury in tuna is naturally occurring). Next, with respect to Section 200(3), while Defendants' canned tuna contained mercury, it was not "contaminated" by such mercury because contamination under this section ordinarily refers to an external substance that adulterates the food product, see, e.g., J & R [425] Salvage & Storage Co. v. Barber, 65 A.D.2d 894, 410 N.Y.S.2d 413, 414 (3d Dep't 1978) (finding bags of coffee beans that were "heavily covered with mouse and rat excreta pellets" were "contaminated" under Section 200(3) of the A & M Law), and Plaintiff has not alleged that the mercury was external or added. Additionally, Defendants' tuna fish was not inherently "unfit for food;" it was perhaps merely unfit for consumption when eaten in certain quantities. Thus Plaintiff's claim under Section 200(3) cannot survive. Plaintiff's claim under Section 200(5) also cannot survive a motion to dismiss because Plaintiff has not alleged that Defendants' canned tuna is the product of a "diseased" animal, nor is there any reason to assume that the tuna was "diseased" by virtue of its high concentration of mercury. Finally, Plaintiff's claim under section 200(9) does not survive because the Complaint contains no facts suggesting that Defendants' canned tuna fish was inferior to ordinary canned tuna fish—indeed, it is apparently no different than any other canned tuna fish on the market—and Plaintiff does not allege that Defendants took any affirmative action to conceal the existence of the mercury. Thus, Defendants' motion to dismiss Plaintiff's claims under Sections 200(2), 200(3), 200(5) and 200(9) of the New York State Agriculture and Markets Law (Count V) is granted.

Although Defendants assert in their motion papers that both Counts V and VI of Plaintiff's Complaint, alleging violations of New York State Agriculture and Markets Law, must be dismissed because they fail to state a claim, Defendants' arguments in their motion papers are limited to Plaintiff's claims in Count V under Section 200, with respect to adulterated food, and they do not address the merits of Plaintiff's claims in Count VI under Section 201, with respect to misbranding. Likewise, Defendants have not included any discussion of Count VII of Plaintiff's Amended Complaint, which alleges that "defendants engaged in deceptive acts and practices in violation of New York State General Business Law Section 349(a)." (Am. Compl. ¶ 58.) Thus Counts VI and VII—which in any event appear to the Court, at least at first blush, to state a claim—will stand.

IV. Leave To Amend

Leave to amend a complaint should be freely given when justice so requires. Fed.R.Civ.P. 15(a)(2). It is within the sound discretion of the district court to grant or deny leave to amend. McCarthy v. Dun & Bradstreet Corp., 482 F.3d 184, 200 (2d Cir.2007). "Leave to amend, though liberally granted, may properly be denied for: `undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, futility of amendment, etc.'" Ruotolo v. City of N.Y., 514 F.3d 184, 191 (2d Cir.2008) (quoting Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962)). Amendment is futile when the claim as amended cannot "withstand a motion to dismiss pursuant to Rule 12(b)(6)," and "[i]n deciding whether an amendment is futile, the court uses the same standard as those governing the adequacy of a filed pleading." MacEntee v. IBM, 783 F.Supp.2d 434, 446 (S.D.N.Y.2011) (internal quotation marks omitted). Where the problem with a claim "is substantive[,] better pleading will not cure it," and "[r]epleading would thus be futile." Cuoco v. Moritsugu, 222 F.3d 99, 112 (2d Cir.2000). Leave to amend may also be denied where the party fails to identify with sufficient specificity the facts that would save his Complaint were he granted leave to amend. See Arnold v. KPMG LLP, 334 Fed.Appx. 349, 352-53 [426] (2d Cir.2009), cert. denied, ___ U.S. ___, 130 S.Ct. 503, 175 L.Ed.2d 348 (2009).

A pre-motion conference was held on August 17, 2010, at which time Plaintiff was granted leave to amend his Complaint and was advised by the Court that he "ought to put everything in there that [he's] got because[i]f [Defendants'] motion is well taken, [he]'ll already have had [his] chance to amend." (Hr'g Tr. 5, Aug. 17, 2010.) Plaintiff filed his Amended Complaint on August 31, 2010. (Doc. 9.) He has not requested leave to file a Second Amended Complaint, demonstrated how further amendment would cure the deficiencies that remain in his pleadings, as identified in Defendants' papers, or submitted to the Court a Proposed Second Amended Complaint addressing such deficiencies. Accordingly, I decline to grant leave to amend sua sponte. See, e.g., Walton v. Morgan Stanley & Co., 623 F.2d 796, 799 n. 7 (2d Cir.1980) ("[A]ppellants never sought leave to amend their complaint either in the district court or as an alternative form of relief in this court after [appellee] raised the issue of the sufficiency of appellants' complaint. Accordingly, we see no reason to grant such leave sua sponte."); In re Eaton Vance Mut. Funds Fee Litig., 380 F.Supp.2d 222, 242 (S.D.N.Y.2005) (denying leave to amend because "the plaintiffs have had two opportunities to cure the defects in their complaints, including a procedure through which the plaintiffs were provided notice of defects in the Consolidated Amended Complaint by the defendants and given a chance to amend their Consolidated Amended Complaint," and "plaintiffs have not submitted a proposed amended complaint that would cure these pleading defects"), aff'd sub nom. Bellikoff v. Eaton Vance Corp., 481 F.3d 110, 118 (2d Cir. 2007) (plaintiffs "were not entitled to an advisory opinion from the Court informing them of the deficiencies in the complaint and then an opportunity to cure those deficiencies") (internal quotation marks omitted); see also Ruotolo, 514 F.3d at 191 (affirming denial of leave to amend "given the previous opportunities to amend").

V. Conclusion

For the reasons stated above, Defendants' Motion for Judicial Notice is GRANTED, and Defendants' Motion to Dismiss is GRANTED as to Counts 111 and IV, as to the allegations for breach of implied warranty and negligent failure to warn against Stop & Shop within Count II, and as to the allegations within Count V as to subsections 200(2), 200(3), 200(5), and 200(9), and DENIED in all other respects. The Clerk of the Court is respectfully directed to terminate the pending motions, (Docs. 19, 22). The remaining parties are directed to appear for a status conference on October 14, 2011, at 11:00 a.m.

SO ORDERED.

[1] "Am. Compl." refers to Plaintiff's Amended Complaint, filed on August 31, 2010. (Doc. 9.)

[2] "Goldstein Cert." refers to the October 20, 2010 Certification of Scott H. Goldstein in support of Defendants' motion requesting judicial notice. (Doc. 22.)

[3] "Defs.' Mem." refers to Defendants Bumble Bee Foods, LLC and the Stop & Shop Supermarket Company, LLC's Memorandum of Law in Support of Their Motion to Dismiss Plaintiff's Amended Complaint for Failure To State a Claim. (Doc. 19.)

[4] The district court in Fellner took judicial notice of all these documents except for the FDA's Letter Responding to the Martek Petition, (Goldstein Cert. Ex. E). See Fellner, 539 F.3d at 242-43. Although the lower court did not take formal judicial notice of that last document, the circuit court nonetheless specifically addressed it and opined that it failed to see how it "might preempt Fellner's lawsuit" or how it spoke "to a relevant issue," because it "concerned not the risks of mercury in fish specifically but rather the impact of dietary supplements of `omega-3 fatty acids' on heart disease," and the "FDA merely explained that it would decline to require that the omega-3 fatty acid health claim be accompanied by a mercury warning, not that all mercury warnings should be affirmatively prohibited." Fellner, 539 F.3d at 253 n. 10.

[5] Defendants contend that Plaintiff's Opposition, which relies heavily on the Fellner decision, is "devoid of any mention of the live circuit split on this issue." (Defendants Bumble Bee Foods, LLC and the Stop & Shop Supermarket Company, LLC's Reply Brief in Further Support of Defendants' Motion to Dismiss ("Defs.' Reply"), Doc. 21.) Defendants' base their assertion that there is a "live circuit split" on their claim that "the California Supreme Court affirmed a thirty-eight page decision which concluded that: (1) California warning laws were preempted by a conflict with the FDCA; and (2) methylmercury in tuna is naturally occurring. People ex rel. Brown [v. Tri-Union Seafoods, LLC] at 171 Cal.App.4th 1549 [90 Cal.Rptr.3d 644] (1st Dist.2009)." (Id.) This assertion is disingenuous. To begin, the California Supreme Court did not express any opinion with respect to the Court of Appeal's affirmation of the trial court's ruling in that case. Instead, the California Supreme Court merely denied a request for depublication of the Appellate Court's opinion, People v. Tri-Union Seafoods, No. A116792, 2009 Cal. LEXIS 6018 (June 24, 2009), an action which "is not an expression of the court's opinion of the correctness of the result of the decision or of any law stated in the opinion." Cal. R. Ct. 8.1125(d). Moreover, the California Appellate Court, which did express an opinion regarding the trial court's decision, was explicit that it affirmed the lower court's judgment "solely on the ground that substantial evidence supports the trial court's finding that methylmercury in tuna is naturally occurring." People ex rel. Brown, 171 Cal.App.4th at 1576, 90 Cal. Rptr.3d 644 (1st Dist.2009). The assertion that either the California Supreme or Appellate Court made any determination with respect to preemption is simply wrong. Furthermore, even if either court had reached the preemption issue and determined that state law was preempted in the circumstances present here, this would not create a "circuit split," which occurs when two or more federal courts of appeal differ in their interpretations. In any event, as noted above, I agree with the Fellner court's analysis of the preemption issue here.

[6] "Defs.' Reply" refers to Defendants Reply Brief in Further Support of Defendants' Motion to Dismiss, filed on January 14, 2011. (Doc. 21.)

[7] Defendants argue that Plaintiff concedes that the cause of his symptoms could not be determined. (See Defs.' Mem. 13 ("[D]espite consulting with numerous doctors, no one was able to causally relate any of the plaintiff's health problems with his alleged elevated mercury levels and alleged tuna consumption."); Defs.' Reply 8 ("[D]espite a multitude of exams and testing by several medical providers plaintiff was not found to have any physical ailment.").) In so doing Defendants disingenuously interpret statements in paragraphs six and seven of the Amended Complaint that clearly refer to the period before Plaintiff's blood was tested for mercury. That Plaintiff's mercury levels were dangerously high until he stopped eating Defendants' tuna fish, whereupon they returned to normal and his symptoms disappeared, more than plausibly supports the conclusion that the tuna caused the elevated mercury and the elevated mercury caused his symptoms. No more is required at the motion to dismiss stage. That the cause of the symptoms was not initially apparent does nothing to undermine the plausibility of the allegations.

[8] Plaintiff also recites formulaic elements for breach of express warranty, (see Am. Compl. ¶¶ 19, 22, 35, 38), but provides no facts with respect to any express warranty. Accordingly, the Amended Complaint is dismissed to the extent it alleges a breach of express warranty.

[9] Defendants attempt to analogize this case to Pelman, which held that fast food restaurants have no duty to warn customers that certain foods, like hamburgers and french fries, if consumed over a prolonged period of time, may lead to obesity. 237 F.Supp.2d at 531-34, 540-43. That case is not, however, instructive here. The Pelman court stated unequivocally that "[i]t is well-known that fast food in general, and McDonalds' products in particular, contain high levels of cholesterol, fat, salt, and sugar, and that such attributes are bad for one." Id. at 532. By contrast, there is no indication in the record here, at least at this stage, that it is common knowledge that canned tuna fish contains high levels of methylmercury and that ingestion of such fish in large quantities can have deleterious health effects. Thus, unlike the Pelman Plaintiffs, Plaintiff here was allegedly endeavoring to eat a heart-healthy diet, but because he was unaware that canned tuna fish contained high levels of methylmercury, he inadvertently exposed himself to an unhealthy and potentially dangerous substance.

I likewise do not find determinative Comment (h) to Section 402A of the Restatement (2d) of Torts, which asserts that if an "injury results . . . from abnormal consumption, as where a child eats too much candy and is made ill, the seller is not liable." I simply cannot determine as a matter of law, at least at this stage, that eating one to two cans of tuna fish daily in an apparent effort to pursue a heart-healthy diet is unreasonable or unforeseeable, and akin to child who eats too much candy and thereby makes herself ill.

[10] "Pl.'s Mem." refers to Plaintiff's memorandum of law in opposition to Defendants' motion to dismiss, filed on January 15, 2011. (Doc. 20.)

[11] Defendants argue that under New York law "a retailer is liable for the sale or failure to warn of a defective product, `only if it fails to detect a dangerous condition that it could have discovered during the course of a normal inspection while the product was in its possession,'" (Defs. Reply 13), citing Pelman, 237 F.Supp.2d at 523, Luckern v. Lyonsdale Energy Ltd. P'ship, 281 A.D.2d 884, 722 N.Y.S.2d 632, 636 (4th Dep't 2001), and Sideris v. Simon A. Rented Servs., 254 A.D.2d 408, 678 N.Y.S.2d 771, 772 (2d Dep't 1998). These cases do not, however, relieve Stop & Shop of liability because they do not address strict liability claims. In both Pelman and Luckern the courts dealt exclusively with claims that arose under negligence and breach of warranty, not strict liability, and thus they are not analogous here. In Sideris, plaintiff was injured when she slipped and fell on a floor mat at the restaurant where she was employed. 678 N.Y.S.2d at 772. She brought claims against the company that rented the mat to the restaurant, under "negligence and, purportedly, breach of implied warranty and strict products liability" theories. Id. The Sideris court, in a two-page opinion, reversed the lower court's denial of summary judgment because "plaintiff failed to proffer sufficient proof to demonstrate the existence of a material issue of fact." Id. The court further asserted that the lower court's judgment was also improper because defendant "demonstrated that it had satisfied its duty to inspect by inspecting all mats both before and upon delivery." Id. (internal citation omitted). It is not clear from this short opinion whether the court believed that defendant's duty to inspect applied to each of plaintiff's causes of actions, or whether it was applicable only to plaintiff's claims for negligence and/or breach of implied warranty. If the Sideris court in fact intended to assert that defendant could avoid being held liable under a theory of strict liability if it fulfilled its duty to inspect, this view appears to contradict the vast majority of New York cases that address this issue.

[12] Plemmons v. Steelcase Inc. held that under New York law, in addition to the reasonable expectation test cited above, "[a] breach of implied warranty claim requires proof of the following three elements: (1) that the product was defectively designed or manufactured; (2) that the defect existed when the manufacturer delivered it to the purchaser or user; and (3) that the defect is the proximate cause of the accident." No. 04-CV-4023, 2007 WL 950137, at *3 (S.D.N.Y. Mar. 29, 2007) (internal quotation marks omitted). Plemmons cited to three cases all of which were applying maritime law. See Silivanch v. Celebrity Cruises, Inc., 171 F.Supp.2d 241, 259 (S.D.N.Y.2001); In re American Export Lines, Inc., 620 F.Supp. 490, 518 (S.D.N.Y. 1985); Cigna Prop. & Casual Ins. Co. v. Bayliner Marine Corp., No. 92-7891, 1995 WL 125386, at *12 (S.D.N.Y. Mar. 22, 1995).

Since Plemmons, some courts addressing breach of implied warranty claims under New York law have picked up the Plemmons language and asserted that the aforementioned three elements are required for establishing a breach of implied warranty, see, e.g., Oscar v. BMW of N. Am., LLC, 274 F.R.D. 498 (S.D.N.Y.2011); Pinello v. Andreas Stihl Ag & Co. KG, No. 08-CV-0452, 2011 WL 1302223 (N.D.N.Y. Mar. 31, 2011); Dayton Superior Corp. v. Spa Steel Prods., Inc., No. 08-CV-1312, 2010 WL 3825619 (N.D.N.Y. Sept. 24, 2010); Lewis v. White, No. 08-CV-7480, 2010 WL 6465230 (S.D.N.Y. Jul. 1, 2010); Lewis v. Abbott Labs., No. 08-CV-7480, 2009 WL 2231701 (S.D.N.Y. Jul. 24, 2009); Barrett v. Black & Decker, No. 06-CV-1970, 2008 WL 5170200 (S.D.N.Y. Dec. 9, 2008); Dalton v. Stedman Mach. Co., No. 05-CV-0452, 2008 WL 351676 (N.D.N.Y. Feb. 7, 2008), while others have simply looked to the reasonable expectations test to identify such a breach, see, e.g., Scientific Components Corp. v. Sirenza Microdevices, Inc., 399 Fed.Appx. 637 (2d Cir.2010); O'Sullivan, 910 N.Y.S.2d 763; Ferraro v. Perry's Brick Co., 30 Misc.3d 1213(A), 924 N.Y.S.2d 308 (Civ.Ct.2011) (table decision).

380 F.Supp. 1061 (1974)

Flatow & Hinojosa, Marc Flatow, Houston, Tex., for plaintiff.

[1062] Vinson, Elkins, Searls, Connally & Smith, Raybourne Thompson, Jr., and Robert A. Rowland, III, Houston, Tex., for defendant.

MEMORANDUM AND ORDER:

SEALS, District Judge.

This action is before the Court on a Motion for Summary Judgment filed by Defendant. In this diversity suit, 28 U. S.C. § 1332(a)(1), Plaintiff seeks to recover for injuries to his teeth and gums which were allegedly suffered while he was eating the contents of a can of Defendant's Oyster Stew Soup. Plaintiff claims that the injuries were caused by a small deleterious object in the soup. Plaintiff surrendered this object to Defendant for examination and it has been identified as a small irregularly shaped oyster pearl.

Plaintiff sets forth two theories of recovery: strict liability in tort and negligence in the manufacture and labeling of this product. Defendant contends that on the undisputed facts before the Court, Plaintiff cannot prevail on a theory of strict liability and that there is no evidence in the record to raise an issue of negligence. In ruling on Defendant's motion this Court is, of course, bound to apply those principles of products liability and negligence law which would be applied by the courts of this State. Erie R.R. Co. v. Thompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938).

Texas courts have long recognized that the manufacturers of food products warrant that they are wholesome and fit for human consumption. Jacob E. Decker & Sons, Inc. v. Capps, 139 Tex. 609, 164 S.W.2d 828 (Tex. 1942); Griggs Canning Co. v. Josey, 164 S.W.2d 835, 139 Tex. 623, (Tex. 1942); See also Walker v. Great Atlantic & Pacific Tea Co., 131 Tex. 57, 112 S.W.2d 170 (Tex. 1938). The warranty was imposed by operation of law as a matter of public policy:

It seems to be the rule that where food products sold for human consumption are unfit for that purpose, there is such an utter failure of the purpose for which the food is sold, and the consequences of eating unsound food are so disastrous to human health and life, that the law imposes a warranty of purity in favor of the ultimate consumer as a matter of public policy. Jacob E. Decker & Sons, Inc. v. Capps, supra, at 829.

In McKisson v. Sales Affiliates, Inc., 416 S.W.2d 787 (Tex. 1967), this strict liability concept applicable to foodstuffs was extended to include consumer products generally. See also, Putnam v. Erie City Manufacturing Company, 338 F.2d 911 (5th Cir. 1964). The McKisson court adopted the Restatement, Second, Torts § 402A which provides as follows:

Special Liability of Seller of Product for Physical Harm to User or Consumer

1. One who sells any product in a defective condition unreasonably dangerous to the user or consumer or his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

2. The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation and sale of his product, and

(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

In order to prevail under this strict liability standard Plaintiff must establish that: 1) the product in question was defective; 2) the defect existed at the time the products left the hands of the defendant; 3) that because of the [1063] defect the product was unreasonably dangerous to the user or consumer (plaintiff); 4) that the consumer was injured or suffered damages; 5) and that the defect (if proved) was the proximate cause of the injuries suffered. Gravis v. Parke-Davis & Co., 502 S.W.2d 863 (Tex.Civ.App. 1973); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir., 1974).

Defendant argues that, as a matter of law, the can of Oyster Stew Soup at issue here was not unfit, unwholesome, defective, or unreasonably dangerous. As indicated in Reyes v. Wyeth Laboratories, supra, "defective condition" and "unreasonably dangerous" are essentially synonymous. Further, in light of the Texas Supreme Court's adoption of Section 402A of the Restatement in McKisson, supra, it is apparent that a food product is defective or unreasonably dangeous if it is unwholesome or unfit for human consumption and vice versa.

Defendant's position is bottomed on what may be labeled the "foreign-natural" doctrine. This doctrine, which has been neither accepted nor rejected by Texas courts, apparently first emerged in Mix v. Ingersoll Candy Co., 6 Cal.2d 674, 59 P.2d 144 (1936). There plaintiff brought suit for injuries caused by a fragment of chicken bone contained in a chicken pie. The court held that the chicken pie was not unfit for human consumption as a matter of law:

"Although it may frequently be a question for a jury as the trier of facts to determine whether or not the particular defect alleged rendered the food not reasonably fit for human consumption, yet certain cases present facts from which the court itself may say, as a matter of law that the alleged defect does not fall within the terms of the statute. It is insisted that the court may so determine herein only if it is empowered to take judicial notice of the alleged fact that chicken pies usually contain chicken bones. It is not necessary to go so far as to hold that chicken pies usually contain chicken bones. It is sufficient if it may be said that as a matter of common knowledge chicken pies occasionally contain chicken bones. We have no hesitancy in so holding, and we are of the opinion that despite the fact that a chicken bone may occasionally be encountered in a chicken pie, such chicken pie, in the absence of some further defect, is reasonably fit for human consumption. Bones which are natural to the type of meat served cannot legitimately be called a foreign substance, and a consumer who eats meat dishes ought to anticipate and be on his guard against the presence of such bones. At least he cannot hold the restaurant keeper whose representation implied by law is that the meat dish is reasonably fit for human consumption, liable for any injury occurring as a result of the presence of a chicken bone in such chicken pie." At 148 (Emphasis supplied)

Probably a majority of jurisdictions having occasion to treat the problem have adopted the Mix rationale. See, for example: Webster v. Blue Ship Tea Room, Inc., 347 Mass. 421, 198 N.E.2d 309 (Mass. 1964), (fish bone in New England fish chowder); Allen v. Grafton, 170 Ohio St. 249, 164 N.E.2d 167 (1960) (oyster shell in oyster); Adams v. Great Atlantic & Pacific Tea Co., 251 N.C. 565, 112 S.E.2d 92 (partially crystalized grain of corn in a package of corn flakes); Brown v. Nebiker, 229 Iowa 1223, 296 N.W. 366 (1941), (sliver of bone in pork chop); Courter v. Dilbert Bros., Inc., 19 Misc.2d 935, 186 N. Y.S. 334 (1958), (prune pit in jar of prune butter); Norris v. Pig'N Whistle Sandwich Shop, 79 Ga.App. 369, 53 S. W.2d 718 (1949), (particle of bone in pork chop sandwich); Goodwin v. Country Club of Peoria, 323 Ill.App. 1, 54 N. E.2d 612 (1944), (turkey bone in cream turkey).

A relatively recent expression of the foreign-natural view is found in Musso v. Picadilly Cafeterias, Inc., 178 So.2d 421 (La.App. 1965). While eating at [1064] defendant's cafeteria, plaintiff encountered a cherry stone or pit in a slice of cherry pie. The court stated that vendors are strictly liable for injuries occasioned by the serving of food which is unwholesome or deleterious or which contains a vice or defect, but, held that a restauranteur is not liable for injuries resulting from substances natural to the food served and inadvertently left therein. The court's reasoning is attractively simple: if the food contains only natural substances it cannot be unfit or unwholesome. The essence of the foreign-natural rule and the rationale behind it is captured in the following passage from Musso:

The rationale of the majority rule as expressed in the cited authorities is that substances which are a natural part of the food served are not considered foreign matter or substances if inadvertently left therein. On this premise it is reasoned that the presence of substances natural to the ingredients or finished product does not constitute breach of the vendor's implied warranty that the food is wholesome and fit for human consumption. The cases further hold that the warranty implicit in the sale of food must be construed in the light of the common knowledge with reference to the nature and character of the food being served. In this respect it is further reasoned common experience dictates that one eating the meat of animals, fowl or fish should do so with the knowledge such foods may contain pieces of bone. At 426.

Not all jurisdictions have followed the foreign-natural view; it has been rejected by several courts in favor of a "reasonable expectation" test. In Zabner v. Howard Johnson's Inc., 201 So.2d 824 (Fla.App. 1967), a consumer was injured by a piece of walnut shell concealed in a dish of maple walnut ice cream. Following the foreign-natural test the trial court entered judgment for the defendant. After tracing the history of this doctrine and its application the appellate court opted in favor of a test of "reasonable expectation." "The test should be what is `reasonably expected' by the consumer in the food as served, not what might be natural to the ingredients of that food prior to preparation."

Observing that natural substances can often be as dangerous to the consumer as foreign objects such as a pebble or a piece of glass or wire, the Zabner court stated: "[The] naturalness of the substance to any ingredients in the food served is important only in determining whether the consumer may reasonably expect to find such substance in the particular type of dish or style of food served." The key question under the reasonable expectation test is whether the consumer ought to have anticipated the injury producing object in the final product not whether the object is foreign or natural. What the consumer might reasonably expect, the court noted, is a jury question in most cases.

The reasonable expectation view is also well stated in Betehia v. Cape Cod Corp., 10 Wis.2d 323, 103 N.W.2d 64 (1960):

The test should be what is reasonably expected by the consumer in the food as served, not what might be natural to the ingredients of that food prior to preparation. What is to be reasonably expected by the consumer is a jury question in most cases; at least, we cannot say as a matter of law that a patron of a restaurant must expect a bone in a chicken sandwich either because chicken bones are occasionally found there or are natural to chicken.

The test as applied to an action for breach of the implied warranty is keyed to what is "reasonably" fit. If it is found that the chicken bone the size alleged ought to be anticipated in a chicken sandwich and guarded against by the consumer plaintiff, then the sandwich was reasonably fit under the implied warranty. At 69.

See also, Bryer v. Rath Packing Co., 221 Md. 105, 156 A.2d 442, 77 A.L.R.2d 1 [1065] (1959); Wood v. Waldorf System, Inc., 79 R.I. 1, 83 A.2d 90 (1951); and Bonenberger v. Pittsburgh Mercantile Company, 345 Pa. 559, 28 A.2d 913 (1942).

Texas courts have never been in a position requiring an election between these two competing doctrines. A great number of cases involving harmful objects have been litigated but the objects were so obviously "foreign" that the issue did not arise. See, Athens Canning Co. v. Ballard, 365 S.W.2d 369 (Tex.Civ. App. 1963), (burr in a can of purple hull peas); Brumit v. Cokins, 281 S.W. 2d 154 (Tex.Civ.App. 1955), (glass in a milk-shake); Campbell Soup Company, Inc. v. Ryan, 328 S.W.2d 821 (Tex.Civ. App. 1959), (metal washer in a TV chicken dinner); Sweeney v. Cain, 243 S.W. 2d 874 (Tex.Civ.App. 1951), ("greenish brown slimy looking stuff with black spots on it" in a bottle of Coca-Cola).

Making an Erie educated guess, this Court holds that, if faced with the problem, Texas courts would follow the reasonable expectation rule as it is stated in Zabner. It is obvious that the "reasonable expectation" approach is considerably more compatible and consistent with Section 402A which has been adopted as the law of Texas in product liability cases. Section 402A makes the seller liable for injuries caused by defective or unreasonably dangerous products. "Defective condition" is defined in Comment (g) as ". . . a condition not contemplated by the ultimate consumer, which will be unreasonably dangerous to him." An article is "unreasonably dangerous" according to Comment (i) if it is ". . . dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics." These Comments have been viewed as persuasive if not controlling in the application of Section 402A. Garcia v. Sky Climber, Inc., 470 S.W.2d 261 (Tex.Civ.App. 1971).

If Texas courts were to follow the "reasonable expectation" test they logically should reach a result consistent in every case with the Restatement definitions of "defective condition" and "unreasonably dangerous." This would not necessarily be true under the foreign-natural doctrine. It would be possible under that approach only if it is assumed that consumers always contemplate the presence of every species of object which might be categorized as natural to the food they are eating regardless of how infrequently the object might appear in common experience. That is obviously a faulty assumption which Texas courts are not at all likely to make.

Andrews, J., concurring in Zabner, supra, suggests that the difficulty with the foreign-natural test as a problem solving device lies not in its theory but in its artificial application. He contends that courts too often apply it at a preliminary stage of production focusing on a single ingredient rather than the final consumer product. "By moving the focus of the test to the consumable item the foreign-natural distinction as measured by the consumer's reasonable expectations becomes a valid and relevant standard."

If this analysis is correct, the only way of avoiding misapplication of the foreign-natural theory is to focus on what the consumer might reasonably expect to find in the final product. This being the case it would make even more sense to discard the foreign-natural distinction and go directly to the reasonable expectation issue. The use of these labels does not advance the inquiry and unnecessarily increases the possibility of confusion on the ultimate issue.

Loyacano v. Continental Insurance Company, 283 So.2d 302 (La.App. 1973) is an example of the confusion which adherence to the foreign-natural distinction can create. There the plaintiff sued for injuries caused by a bone fragment concealed in a ground meat patty. The court first professed adherence to the foreign-natural distinction of Musso, supra, and then stated:

In Musso there was ample evidence to show the probability of expectancy of [1066] cherry pits in pitted cherries, but unfortunately there is no evidence in the present case concerning the probability of pieces of bone appearing in hamburger. Simply as a matter of general knowledge, we cannot say that we can take judicial notice that a hamburger patty should not contain any pieces of bone whatsoever. . . . It may be said that a product can be considered defective if it does not meet the reasonable expectations of the ordinary consumer as to its safety. It is not the fact that a defect is a natural one which is important to this inquiry, but the fact that the ordinary consumer would expect that he might encounter it, and thus he would normally take his own precautions. A package of ground meat is not expected to be consumed from the sealed package as a bottle of soda water or milk, but is expected to be processed or otherwise altered before consumption by the purchaser. Therefore, it seems to us that the strict liability imposed upon vendors of sealed packages of that nature, cannot be imposed upon the vendor here, except insofar as a foreign object would be concerned. For a natural object, such as a bone, from the only evidence produced in this case, it appears that the inquiry should be directed to the size of the bone left in the ground meat. At 305.

The court went on to hold defendant liable for the injury stating that defendant had not presented sufficient evidence to prove its lack of negligence in handling the ground meat. Lenmon, J., in a concurring opinion, indicates that Musso is the source of the problem and advocates a rethinking of the foreign-natural distinction, possibly portending changes to come in Louisiana jurisprudence. Texas courts have not descended into this quagmire and this Court is confident that they will not.

Having settled on the "reasonable expectation" standard the question before this Court can be restated. Can it be said, as a matter of law, that the consumer can reasonably expect to encounter a pearl in a can of Defendant's Oyster Stew Soup. This Court thinks not. It is clearly an issue for the jury to decide. With the undisputed facts reflected in the pleadings, interrogatories and affidavits on file herein it would be impossible for this Court to ascertain what the common consumer experience is with respect to pearls in canned oyster stew. Defendant's Motion For Summary Judgment on the issue of strict liability is therefore denied.

Defendant's motion going to Plaintiff's negligence theory of recovery is also denied. Even where there are no facts in dispute, it is usually for the jury to decide whether the conduct in question meets the reasonable man standard. Cf., Wright & Miller, Federal Practice and Procedure, § 2729 at 572. On the facts reflected in this record the Court cannot say that Defendant was not negligent in the manufacture and labeling of this product as a matter of law.

673 F.2d 189 (1982)

Patrick S. Moore, Walter M. Ketchum, Ltd., Chicago, Ill., for plaintiffs-appellants.

David E. Bennett, Chadwell, Kayser, Ruggles, McGee & Hastings, Ltd., Chicago, Ill., for defendant-appellee.

Before CUMMINGS, Chief Judge, and PELL and SPRECHER, Circuit Judges.

PELL, Circuit Judge.

This is an appeal from the dismissal of a complaint filed by the plaintiffs, Kenneth and Dorothy Garrison, against the defendant, Heublein, Inc., the manufacturer and distributor of Smirnoff vodka.^[1] In that complaint, the plaintiffs alleged that Kenneth Garrison has suffered physical and mental injuries as a result of consuming the defendant's product over a twenty-year period. They urged that the defendant is liable for those injuries on five separate theories: negligence, willful and wanton conduct, products liability, fraud, and false and misleading advertising. The crux of each of those claims is not that the product was adulterated or tainted, but rather that the defendant failed to warn the plaintiff of certain "propensities" of the product.^[2]

[190] In response to the defendant's motion under Fed.R.Civ.P. 12(b)(6), the court dismissed the complaint for failure to state a claim upon which relief can be granted. In its order, the court noted that each of the plaintiffs' theories of recovery "rest[s] on the claim that defendant had a duty to disclose, by labels and advertising, that consumption of its products may be hazardous to the consumer's health and physical and economic well-being." The court observed that the imposition of such a duty would have to be based on the "premise that liquor poses latent risks not appreciated by users." Rejecting that premise, the court found that, in light of common knowledge concerning alcohol and its effects, "the defendant has no duty to add, by labels or advertising, to the flow of information."

In this appeal, the plaintiffs challenge the district court's dismissal in two respects. First, they argue that the court did not apply the proper standard in ruling on the defendant's Rule 12(b)(6) motion. Second, they attack the substance of the decision, arguing that the court erred in ruling, as a matter of law, that the defendant does not have a duty to warn. In support of their second argument, they assert the following points: (1) that the defendant's product is defective because of the absence of warnings of dangers inherent in its use; (2) that the defendant has a duty to warn because the dangers of the products are not obvious; and (3) that, even if the dangers can be characterized as obvious, policy reasons dictate that a duty to warn be imposed. For the reasons noted below, we reject these arguments and affirm the judgment of the district court.

I

The proper standard for appraising the sufficiency of a complaint is "that a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957); Reichenberger v. Pritchard, 660 F.2d 280 (7th Cir. 1981). The plaintiffs' contention that the district court misapplied that standard is mistaken. Clearly, under the standard, "`want of merit may consist in an absence of law to support a claim of the sort made.'" 2A Moore's Federal Practice ¶ 12.08 at 2271 (2d ed. 1981) (quoting De Loach v. Crowley's, Inc., 128 F.2d 378, 380 (5th Cir. 1942)). That was precisely the basis for the court's dismissal. It found each of the plaintiffs' theories of recovery premised on an alleged duty to disclose which, as a matter of law, does not exist. Because, under Illinois law, the determination of whether a duty to warn exists is a question of law, Genaust v. Illinois Power Company, 62 Ill.2d 456, 466, 343 N.E.2d 465, 471 (1976), the court's analysis was procedurally correct. Our review, then, must focus on the soundness of the underlying substantive legal determination.^[3]

II

Although the plaintiffs allege five separate theories of recovery, their appellate argument concerning the defendant's duty to warn relies to a great extent upon concepts developed in the field of strict liability. Because that theory involves the lowest threshold for establishing such a duty, a failure in that regard would necessarily undercut the duty component of the other counts. Thus, it is appropriate to begin our inquiry by focusing on that area of law.

The doctrine of strict products liability, as articulated in the Restatement (Second) of Torts § 402A, has been adopted as law in Illinois. Genaust v. Illinois Power Company, supra; Suvada v. White Motor Co., 32 Ill.2d 612, 210 N.E.2d 182 (1965). That section imposes liability upon "[o]ne who sells any product in a defective condition [191] unreasonably dangerous to the user or consumer...."

Initially, the plaintiffs attempt to bring themselves within the doctrine by relying on Illinois cases which hold "that a failure to warn of a product's dangerous propensities may [itself] serve as the basis for holding a manufacturer or seller strictly liable in tort." See Woodill v. Parke Davis & Co., 79 Ill.2d 26, 29, 37 Ill.Dec. 304, 306, 402 N.E.2d 194, 196 (1980).^[4] That move, however, is of little value to the plaintiffs. It only demonstrates that, in circumstances when a warning is necessary, the failure to give that warning may support a strict liability action. It does not answer the critical question, that is, whether a warning is necessary in this case.

In Lawson v. G. D. Searle & Company, 64 Ill.2d 543, 1 Ill.Dec. 497, 356 N.E.2d 779 (1976), the Supreme Court of Illinois provided an insight into the proper approach for reaching an answer to that more basic question. In that case, the court approved the following jury instruction:

A product faultlessly made may be deemed to be unreasonably dangerous if it is not safe for such a use that is to be expected to be made of it and no warning is given.

64 Ill.2d at 547, 1 Ill.Dec. at 499, 356 N.E.2d at 781 (emphasis added). The court noted that the instruction paralleled certain comments to section 402A of the Restatement.^[5] Thus, those comments can lend to an understanding of this area of law.

Comment h restates the basic predicate of the Lawson jury instruction: "A product is not in a defective condition when it is safe for normal handling and consumption." The comment then qualifies that general proposition by noting that "[w]here, however, [a seller] has reason to anticipate that danger may result from a particular use, as where a drug is sold which is safe only in limited doses, he may be required to give adequate warning of the danger (see comment j), and a product sold without such warning is in a defective condition."

The plaintiffs rely on the latter language to support their contention that a warning is necessary in this case. They ignore, however, the fact that that qualification itself contains a caveat, the reference to comment j. That comment dealing with "directions and warning," is most salient to our present inquiry. It states in part that:

a seller is not required to warn with respect to products, or ingredients in them, which are only dangerous, or potentially so, when consumed in excessive quantity, or over a long period of time, when the danger, or potentiality of danger, is generally known and recognized.... [T]he dangers of alcoholic beverages are an example, as are also those of foods containing such substances as saturated fats, which may over a period of time have a deleterious effect upon the human heart.

This treatment of dangers "generally known and recognized" is also apparent in comment i, which describes the requirement of unreasonable dangerousness under section 402A:

The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. Good whiskey is not unreasonably dangerous merely because it will make some people drunk, and is especially dangerous to alcoholics....

This position is consistent with the Illinois Supreme Court's finding in Genaust v. Illinois Power Company, 62 Ill.2d at 466, 343 N.E.2d at 471, that the determination of whether a duty to warn exists involves a question of foreseeability, which must be resolved under a standard of objective reasonableness. In that case, the court refused to impose on the manufacturer of metal [192] antennas a duty to warn consumers of the danger of electrical arcing if the product was used in close proximity to power wires. The court found that, because "it is common knowledge that metal will conduct electricity..., it is not objectively reasonable to expect that a person ... would attempt to install a metal tower and antenna in such close proximity to electrical wires." Id.

Likewise, in this case, we find that even though there are dangers involved in the use of alcoholic beverages, because of the common knowledge of those dangers, the product cannot be regarded as unreasonably unsafe. See Prosser, Law of Torts 660 (4th ed. 1971).^[6] And, in light of the approach to the duty to warn approved in Lawson, a product that is not unsafe "for such a use that is to be expected to be made of it" requires no warning.^[7] Thus, we affirm the district court's finding that the defendant in this case has no duty to warn.

The plaintiffs' final attempt to counter this implication of the common knowledge of the dangers of alcohol by arguing that, as a matter of policy, the "manufacturer of [an] obviously defective product ought not to escape because the product was obviously a bad one,"^[8] must also be rejected. Their objection might be appropriate as a challenge to an "obvious danger doctrine" under which a manufacturer is discharged from his duty to warn merely by establishing that a defect is obvious. See Harris v. Karri-On Campers, Inc., 640 F.2d 65, 76 (7th Cir. 1981) (interpreting West Virginia law). That, however, is not our approach in this case. We are not saying that a duty to warn cannot arise simply because a defect in a product is obvious, even if that defect causes the product to remain unreasonably dangerous.^[9] Rather, we are saying that the dangers of the use of alcohol are common knowledge to such an extent that the product cannot objectively be considered to be unreasonably dangerous.

Because the district court was correct in finding that the defendant does not have a duty to warn a consumer of the common "propensities" of alcohol, and such a duty is essential to each of the plaintiffs' theories of recovery, we affirm the judgment of the district court.

[1] Jurisdiction is based on diversity of citizenship. The plaintiffs are both citizens of the State of Illinois. The defendant is a citizen of the State of Connecticut. The amount in controversy exceeds $10,000, exclusive of interest and costs.

[2] The plaintiffs claimed that the product has propensities "to cause physical damage to the consumer;" "to cause impairment to physical and motor skills for a period of time after consumption;" "to cause impairment to mental capacity and facilities for a period of time after consumption;" to affect the personality of the consumer; to be addictive; and to create dangers in the operation of a motor vehicle. The plaintiffs also complained that the defendant failed to state the ingredients of the product and the amount of the product that can be safely consumed.

[3] We agree with the district court's premise that the legal sufficiency of each of the plaintiffs' theories of recovery, as alleged in their complaint, hinges on whether a duty to warn exists.

[4] Such cases characterize the "failure to warn" as the "defect" in order to conform to the language of the Restatement. See, e.g., Nelson v. Hydraulic Press Manufacturing Company, 84 Ill.App.3d 41, 45, 39 Ill.Dec. 422, 425, 404 N.E.2d 1013, 1016 (2d Dist. 1980).

[5] The Court referred to comments h, i, and k.

[6] The plaintiffs' reliance on certain passages in the Report to the President and the Congress on Health Hazards Associated with Alcohol and Methods to Inform the General Public of these Hazards, U.S. Department of the Treasury and U.S. Department of Health and Human Services (1980), which illustrate that there are misperceptions about the use of alcohol, is not sufficient to upset the district court's finding, with which we agree, that it is common knowledge that certain dangers, including those alleged in the plaintiffs' complaint, are involved in the use of alcohol. See Pritchard v. Liggett & Myers Tobacco Company, 295 F.2d 292, 302 (3d Cir. 1961) (concurring opinion).

[7] The alternative analytical approaches suggested by the plaintiffs, see Nelson v. Hydraulic Press Manufacturing Company, supra (balancing test), and Illinois State Trust Company v. Walker Manufacturing Company, 73 Ill.App.3d 585, 29 Ill.Dec. 513, 392 N.E.2d 70 (5th Dist. 1979) (unequal knowledge), are inapposite in that they do not specifically deal with the question of the common knowledge of a product's dangers.

[8] Palmer v. Massey Ferguson, Inc., 3 Wash.App. 508, 517, 476 P.2d 713, 719 (Wash.1970).

[9] For example, presumably a duty to warn would arise in the case of an obviously unguarded blade in a power-driven saw if the danger of injury was found to be unreasonable notwithstanding the obviousness of the defect.

18 Ariz. App. 10 (1972)
499 P.2d 741

[11] Kanne & Bickart, by Lawrence J. Marks, Phoenix, for appellants.

Renaud, Cook, Miller & Cordova, by Robert H. Renaud, Phoenix, for appellee.

HATHAWAY, Judge.

Appellants, plaintiffs in the superior court, brought a tort action against the appellee bottling company. The action resulted from plaintiff Lillian Slonsky's consumption of a soft drink which allegedly contained foreign material, including metallic filings. The action came to trial before a jury and the court directed a verdict in favor of appellee-defendant at the end of the plaintiffs' case. The defendant contended (1) that the evidence was insufficient on the issue of whether there had been tampering or reasonable opportunity for tampering; (2) that there was no evidence that the drink was deleterious. Before granting the motion for a directed verdict, the court indicated dissatisfaction with the evidence that "... the contents of this bottle was deleterious, toxic, posisonous, harmful."

Appellants contend on appeal that the evidence was sufficient to raise a jury question as to appellee's liability and that the trial court erred in its direction of verdict against them. We agree.

"A defendant's motion for directed verdict admits the truth of whatever evidence the opposing party has introduced and any inferences reasonably drawn therefrom. (Citations omitted) On such a motion the evidence must be treated and viewed in a light most favorable to the party against whom the motion is sought. (Citation omitted) The motion should be granted only where the evidence is not sufficient to support a contrary verdict or so weak that a court would feel constrained to set aside such a verdict on a motion for a new trial. (Citations)" Davis v. Weber, 93 Ariz. 312, 314, 380 P.2d 608, 610.

The evidence discloses that on August 21, 1968, while Lillian Slonsky was sitting under a hair-dryer at the Wild Hair Beauty Salon in Westown, Arizona, her daughter brought her a Fresca from the establishment's vending machine. After having consumed a substantial portion of the drink, she heard a sound apparently of some metallic contents within the bottle and upon looking into the bottle saw a piece of metal and some sediment. She looked in the mirror and saw that her tongue looked purple. Thereafter, she became nauseated and her daughter took her to a doctor. Mrs. Slonsky vomited at the doctor's office, was ill for 3 or 4 days and was unable to resume her normal activities for about 2 weeks.

Mrs. Slonsky's daughter testified that she observed no indentation in the cap or crown of the bottle before opening it, and observed nothing different about it from any other bottle cap, nor was there anything unusual in the opening of the bottle. Upon looking inside the bottle, she saw pieces of metal, "crud" and sand. She verified her mother's illness.

One of the hairdressers testified that she saw some metal particles, some green slime and some "white looking stuff" in the bottle. According to her, looking at the contents of the bottle made her sick. The other [12] hairdresser, Mrs. Slonsky's attendant at the time, observed a little bit of "gunk" in the bottle and stated that it looked dark and appeared to be a residue. She indicated that the residue appeared to contain metal. She also verified Mrs. Slonsky's illness at the time and stated that she never observed anyone around, or tampering with the bottles which were used to load the machine. Customers were never permitted to load the machine.

In regard to the deleterious nature of the drink, we are of the opinion that the evidence is clearly ample.

"One who sells any product in a defective condition unreasonably dangerous to the user or consumer ... is subject to liability for physical harm thereby caused to the ultimate user or consumer ..., if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

The rule stated ... applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or the consumer has not brought the product from or entered into any contractual relation with the seller." Restatement of Torts, 2nd, § 402A.

Strict liability in tort has been adopted in Arizona as the rule in product liability cases. See the concurring opinion in Nalbandian v. Byron Jackson Pumps, Inc., 97 Ariz. 280, 399 P.2d 681 (1965) and O.S. Stapley Co. v. Miller, 103 Ariz. 556, 447 P.2d 248 (1968). See Crystal Coca-Cola Bottling Co. v. Cathey, 83 Ariz. 163, 317 P.2d 1094 (1957) and Coca-Cola Bottling Co. v. Fitzgerald, 3 Ariz. App. 303, 413 P.2d 869 (1966), for Arizona authority dealing with the subject of contaminated soft drinks on the basis of res ipsa loquitur. In a similar case from Kentucky, the plaintiff was permitted to litigate on the basis of strict liability in tort and absence of privity was not permitted to reject the claim. Allen v. Coca-Cola Bottling Co., 403 S.W.2d 20 (Ky. 1966).

The evidence in the following cases was considered sufficient for submission to the jury: Where a foreign unwholesome substance was found in a sealed package or bottle or food or beverage, an inference arises, or presumption of negligence on the part of the manufacturer, Opelika Coca-Cola Bottling Co. v. Johnson, 46 Ala.App. 298, 241 So.2d 327, (Ala. Civ. App. 1970), cert. denied, 286 Ala. 460, 241 So.2d 331; evidence of foreign material in a soft drink bottle prior to removal of the cap, Glasper v. Wright Root Beer Co., 216 So.2d 586 (La. App. 1968); where the cellulose particles in a bottle of soft drink caused plaintiff's gastroenteritis was jury question, Jackson v. Cushing Coca-Cola Bottling Co., 445 P.2d 797 (Okl. 1968); unwholesomeness of thread-like objects in bottle of soft drink was jury question, Perez v. Glens Falls Coca-Cola Bottling Co., 30 A.D.2d 755, 291 N.Y.S.2d 198 (1968); bottle containing foreign matter which appeared to be pieces of cigar, raised jury question, Gardner v. Sumner, 40 Ala.App. 340, 113 So.2d 523 (1959); burnt match or other piece of wood, jury question, Jasper Coca Cola Bottling Company v. Breed, 40 Ala.App. 449, 115 So.2d 126 (1959); brown substance stuck to sides and bottom of bottle held sufficient, Machuga v. Coca-Cola Bottling Co., 153 N.E.2d 713 (Ohio App. 1957). Also see 52 A.L.R.2d 159.

Adulterated food was defined in A.R.S. Sec. 36-902 (the pertinent statute in 1968) as food with which "a substance has been mixed or packed therewith, .... injuriously affecting its.... purity ...." or food which "consists wholly or partially of a filthy, decomposed or putrid .... substance .... ." Added Laws 1971. Fowler v. Coastal Coca-Cola Bottling Co., 252 S.C. 579, 167 S.E.2d 572 (1969) holds that a violation of a state pure food and drug act is negligence per se. Also see cases collected in Anno. 52 A.L.R. 2d 117, 143 [13] (§ 12). Upon consideration of the authorities and the evidence, we are satisfied that the evidence was sufficient to present a jury question on the deleterious quality of the drink.

On the question of whether the condition of the beverage was substantially unchanged from the time it left the bottler, we find the following testimony highly relevant. Lillian Slonsky testified that a man from the bottling company came by and "... looked at the bottle and he mentioned that it appeared to be ... a clip that holds the hoses or something. And it may — the hoses that the Fresca goes through, and it may have gotten into the bottle somehow...." This, together with the testimony that (1) the bottle appeared to be properly sealed and nothing out of the ordinary was noticed concerning the cap or the bottle, (2) the loading of the machine was done by (beauty salon) personnel and (3) no one was observed tampering with the bottles, appears to adequately establish that the soft drink was in substantially the same condition at the time of consumption as when it left the bottler.

The judgment is reversed.

KRUCKER, C.J., and, HOWARD, J., concur.

NOTE: This cause was decided by the Judges of Division Two as authorized by A.R.S. § 12-120, subsec. E.

6 Cal.2d 674 (1936)

Fred A. Steiner and W. W. B. Seymour for Appellant.

Sanders & Jacques for Respondents.

Mark M. Cohen and Irwin M. Fulop, as Amici Curiae on Behalf of Respondents.

CURTIS, J.

This is an appeal on the judgment roll alone from a judgment in favor of defendants in an action brought against them by plaintiff for damages for personal injuries resulting from the swallowing of a fragment of chicken bone contained in a chicken pie sold and served by the defendants to plaintiff in a public restaurant conducted by them.

Two causes of action were separately alleged in plaintiff's complaint, one for damages for injuries resulting from an alleged breach of an implied warranty, the other for personal injuries resulting from the alleged negligence of defendants and their servants in the preparation and serving of the chicken pie. A general and a special demurrer was sustained by the trial court without leave to amend, and upon motion of defendants the trial court entered its judgment of dismissal of both causes of action. The basic question, therefore, presented is whether or not either or both of the counts state a cause of action.

The facts upon which the action is based upon either theory, as alleged in the complaint, may be summarized as [676] follows: On December 17, 1932, plaintiff entered the confectionery shop and restaurant conducted and operated by the Ingersoll Candy Company, a corporation, and John G. Beck, defendants herein, seated himself at a table, and purchased and paid for an article of food known as chicken pie. It was served to him by one of the employees of the defendants, and eaten by him in the restaurant. According to the allegations of plaintiff's complaint, the chicken pie so served contained "a dangerous, harmful and injurious subject, to-wit, a sharp and pointed fragment and/or sliver of chicken bone, which might be and was highly injurious to anyone eating said chicken pie". The plaintiff unknowingly swallowed the fragment of chicken bone, and "was severely injured and suffered great bodily pain and anguish". By the action he sought to recover damages in the sum of $10,000.

It is apparent that the first count attempts to state a cause of action for breach of the implied warranty established by subdivision 1 of section 1735 of the Civil Code which was enacted in 1931 as a part of the Uniform Sales Act. Said provision is as follows: "Subject to the provisions of this act and of any statute in that behalf, there is no implied warranty or condition as to the quality or fitness for any particular purpose of goods supplied under a contract to sell or a sale, except as follows: (1) Where the buyer, expressly or by implication, makes known to the seller the particular purpose for which the goods are required, and it appears that the buyer relies on the seller's skill or judgment (whether he be the grower or manufacturer or not), there is an implied warranty that the goods shall be reasonably fit for such purpose."

[1] The first question, therefore, squarely presented is: Does the transaction between a restaurant keeper and a guest constitute a sale to which an implied warranty attaches under section 1735 of the Civil Code?

We are satisfied that logically the answer must be in the affirmative. It was definitely determined in the recent case of Gindraux v. Maurice Mercantile Co., 4 Cal.2d 206 [47 PaCal.2d 708], that upon the sale of foodstuff by a retail dealer to a purchaser for human consumption, an implied warranty arose that the commodity was reasonably fit for such purpose and the dealer could be held [677] liable for damage suffered as the result of eating the foodstuff (in that case, salami), which was not reasonably fit for human consumption. We can see no legal or logical difference between the sale of food by a grocer, in which case the warranty clearly exists, and a sale of a meal by a restaurant keeper. It is argued, however, that in the case of a restaurant keeper or lunch counter proprietor the transaction constitutes not a sale of goods but the furnishing of services, and this being so, as section 1735 of the Civil Code has reference only to a sale of goods, said section has no application to such a transaction. It follows that the problem presented is primarily this: When food is served in a restaurant, does the transaction constitute a sale of food, or is it a sale of service?

It must be conceded that there is considerable authority for the position that a restaurant keeper does not sell the food which he serves his customers. Among the leading cases cited in support of this theory are: Travis v. Louisville & N. R. R. Co., 183 Ala. 415 [62 So. 851]; Merrill v. Hodson, 88 Conn. 314 [91 Atl. 533, Ann. Cas. 1916D, 917, L.R.A. 1915B, 481]; Roseberry v. Wachter, 33 Del. 253 [138 Atl. 273]; Rowe v. Louisville & Nashville R. R. Co., 29 Ga. App. 151 [113 S.E. 823]; Kenny v. Wong Len, 81 N. H. 427 [128 Atl. 343]; Nisky v. Childs Co., 103 N. J. L. 464, 465 [135 Atl. 805, 50 A.L.R. 227]; Bigelow v. Maine Cent. R. Co., 110 Me. 105 [85 Atl. 396, 43 L.R.A. (N. S.) 627]; Valeri v. Pullman Co., 218 Fed. 519. It will thus be seen that Alabama, Connecticut, Delaware, Georgia, Maine, New Hampshire, New Jersey, and the federal courts adhere to the theory that the transaction constitutes a sale of services and not a sale of food.

On the other hand, there are decisions of other states, which we consider better reasoned, which have come to the conclusion that there is no fundamental difference between the sale of food by a dealer and a sale of a meal by a restaurant keeper. The leading case so holding is the case of Friend v. Childs Dining Hall Co., 231 Mass. 65 [120 N.E. 407, 5 A.L.R. 1100]. In that case the Massachusetts Supreme Court reached the conclusion that, under the Massachusetts Sale Act, which is similar to section 1735 of the California Civil Code, such a transaction constituted a sale of food, and by reason of such fact an implied warranty [678] existed on the part of a restaurant keeper that the food so sold and served was reasonably fit for human consumption. Later cases in the same jurisdiction uphold this doctrine. (Barringer v. Ocean S. S. Co., 240 Mass. 405 [134 N.E. 265], and Smith v. Gerrish, 256 Mass. 183 [152 N.E. 318].)

The rule is the same in New York. (Temple v. Keeler, 238 N.Y. 344 [144 N.E. 635, 35 A.L.R. 920]; Rinaldi v. Mohican Co., 225 N.Y. 70 [121 N.E. 471]. See, also, Race v. Krum, 222 N.Y. 410 [118 N.E. 853, L.R.A. 1918F, 1172], Muller v. Childs Co., 118 App. Div. 881 [171 N.Y. Supp. 541], and Barrington v. Hotel Astor, 184 App. Div. 317 [171 N.Y. Supp. 840].) In Illinois, Indiana and in Missouri the intermediate courts have arrived at the same conclusion. (Greenwood v. John R. Thompson Co., 213 Ill. App. 371; Smith v. Carlos, (Mo. App.) 247 S.W. 468; Heise v. Gillette, 83 Ind. App. 551 [149 N.E. 182].)

Defendants argue that it is the established law of California that when the owner of a restaurant furnishes food to a customer he merely furnishes services of which food is a part, and cites Loucks v. Morley, 39 Cal.App. 570 [179 P. 529], and Stell v. Townsends California Glace Fruits, Inc., 138 Cal.App. Supp. 777 [28 PaCal.2d 1077], in support of this contention. The case of Loucks v. Morley, supra, involved the construction of code section 1775 of the Civil Code, since repealed, which imposed an implied warranty upon "one who makes a business of selling provisions for domestic use". The grounds of the decision were twofold, namely, that a restaurant keeper furnishes service to his patrons rather than sells provisions, and that the furnishing of food for immediate consumption upon the premises was not strictly and accurately within the definition of the term, "for domestic use". The first conclusion was based upon the old common-law reasoning, as expressed in the quaint phrase with reference to innkeepers and victualers, quoted in Beal on Innkeepers and Hotels, section 169, and reiterated in practically all of the cases adhering to the old rule, "He does not sell but utters his provisions." The second conclusion was based upon the fact that the dictionary defined "domestic" as "belonging to the house or household; concerning or relating to the home or family", and the fact that the word itself, in its [679] derivation from "domus", a house, suggested its inherent import. By this reasoning, it was decided that "for domestic use", necessarily meant for use in the home. The two associates of the writer of the opinion concurred only in the judgment, and by setting forth as their reason for such concurrence the second ground of the opinion, in effect withheld their approval of the first ground. It is apparent, therefore, that this reason became thereby only the personal opinion of the justice who wrote the opinion. Such conclusion cannot, therefore, have any controlling weight here. It should perhaps be noted that section 1775 of the Civil Code upon which the case of Loucks v. Morley, supra, was based was repealed prior to the time the cause of action in the instant case arose, and section 1735 of the Civil Code is now the section which controls the question of implied warranty of the quality of food served by restaurants.

The case of Stell v. Townsends California Glace Fruits, Inc., supra, which is a decision of the appellate division of the Superior Court of the City and County of San Francisco, was based solely on the question of negligence, and the real point was whether or not negligence had been proven. The decision expressly states, "The complaint in the present case, however, is not based upon a breach of warranty or on any contractual liability. It charges commission of a tort in the alleged failure of the defendant to use reasonable care in selecting, preparing, and serving food for consumption by plaintiff as a patron." It is obvious, therefore, that what is said in the decision with reference to implied warranty was unnecessary to the opinion and is clearly dicta.

One other California case has been cited as pertinent to this question, the case of San Francisco v. Larsen, 165 Cal. 179 [131 P. 366]. That action was for the recovery of a license tax imposed on defendant under an ordinance. The city charter then in effect exempted from paying such tax, "any person who at any fixed place of business in the city and county, sells or manufactures goods, wares and merchandise". Although the court reached the conclusion that the business of a restaurant keeper was not exempt from the levy of the license tax under the provisions of the charter, it made the following statement: "It cannot be denied that the eating of food by a customer at a restaurant, [680] in the regular course of business, involves a sale of the food eaten. The price of the food alone is usually not specified, but it is included in a lump sum with the charge for services and use of its dishes, chair, and table. It is nevertheless a sale of the food consumed, within the technical definition of that term."

We therefore hold unequivocally that the transaction between a restaurant keeper and customer constitutes a sale and that as a necessary incident to such sale there exists an implied warranty which imposes upon the restaurant keeper the obligation to furnish to patrons food "reasonably fit" for human consumption, and that if a patron suffer injury as a result of eating food which is not reasonably fit for human consumption, the retaurant keeper is liable in damages therefor.

[2] No contention is made that plaintiff could not recover on the count of negligence if it has been properly pleaded and proved. In fact, such liability is expressly conceded by the arguments of defendants which are to the effect that no liability exists under the theory of implied warranty, but that the restaurant keeper's obligation is limited to the exercise of due care in the preparation and service of food furnished guests. It was held in the case of Stell v. Townsends California Glace Fruits, Inc., supra, that a duty of exercising due care in the furnishing and serving of food to guests exists on the part of a restaurant keeper, and that he is liable in damages for any breach of such duty. In Massachusetts, it is recognized that a cause of action may be predicated upon either the theory of an implied warranty or upon negligence. (Friend v. Childs Dining Hall Co., supra; Ash v. Childs Dining Hall Co., 231 Mass. 86 [120 N.E. 396, 4 A.L.R. 1556].) It follows that the plaintiff was justified in including both counts in his complaint.

Defendants claim that regardless of whether or not the plaintiff correctly included in his complaint a cause of action based upon the theory of implied warranty and a cause of action based upon negligence, the trial court was justified in sustaining a demurrer to both counts for the reason that in neither count was the cause of action properly pleaded. Defendants complain that in both counts material allegations were lacking. Although we are of the opinion that both counts of the complaint might well have been pleaded [681] with more particularity, we prefer to rest our decision upon the broader ground that the facts stated in both counts of the complant were insufficient on which to base an action no matter how the pleading was drawn.

[3] We will first discuss the question of whether or not the facts pleaded in the first count were sufficient to support a judgment based upon an implied warranty. Bearing in mind the exact wording of section 1735 of the Civil Code whereby the implied warranty is imposed upon a restaurant keeper, is there an obligation imposed by the statute upon a restaurant keeper to furnish perfect food to his patrons at all hazards; that is to say, is his obligation that of an absolute insurer of his food? The answer, in our opinion, must be in the negative. The words of the code section are that the food furnished by the restaurant keeper shall be "reasonably" fit for such purpose,--human consumption. It may well happen in many cases that the slightest deviation from perfection may result in the failure of the food to be reasonably fit for human consumption. On the other hand, we are of the opinion, that in certain instances a deviation from perfection, particularly if it is of such a nature as in common knowledge could be reasonably anticipated and guarded against by the consumer, may not be such a defect as to result in the food being not reasonably fit for human consumption. [4] The facts presented in the instant case we think present such a situation. We have examined a great many cases dealing with the question of the liability of restaurant keepers which arose out of the serving of food which was held to be unfit for human consumption, and we have failed to find a single case in which the facts are similar to the instant case, or in which a court has extended the liability based upon an implied warranty of a restaurant keeper to cover the presence in food of bones which are natural to the type of meat served. All of the cases are instances in which the food was found not to be reasonably fit for human consumption, either by reason of the presence of a foreign substance, or an impure and noxious condition of the food itself, such as for example, glass, stones, wires or nails in the food served, or tainted, decayed, diseased, or infected meats or vegetables. [5] Although it may frequently be a question for a jury as the trier of facts to determine whether or not the particular defect alleged rendered the food not reasonably [682] fit for human consumption, yet certain cases present facts from which the court itself may say as a matter of law that the alleged defect does not fall within the terms of the statute. It is insisted that the court may so determine herein only if it is empowered to take judicial notice of the alleged fact that chicken pies usually contain chicken bones. It is not necessary to go so far as to hold that chicken pies usually contain chicken bones. It is sufficient if it may be said that as a matter of common knowledge chicken pies occasionally contain chicken bones. We have no hesitancy in so holding, and we are of the opinion that despite the fact that a chicken bone may occasionally be encountered in a chicken pie, such chicken pie, in the absence of some further defect, is reasonably fit for human consumption. Bones which are natural to the type of meat served cannot legitimately be called a foreign substance, and a consumer who eats meat dishes ought to anticipate and be on his guard against the presence of such bones. At least he cannot hold the restaurant keeper whose representation implied by law is that the meat dish is reasonably fit for human consumption, liable for any injury occurring as a result of the presence of a chicken bone in such chicken pie. In the case of Goetten v. Owl Drug Co., L. A. No. 15624 (post, p. 683 [59 PaCal.2d 142]), this day decided, we held that the application of the rule of implied warranty might impose a heavy burden upon the keeper of restaurants and lunch counters, but that considerations of public policy and public health and safety are of such importance as to demand that such obligation be imposed. This is true, but we do not believe that the onerous rule should be carried to absurd limits. Certainly no liability would attach to a restaurant keeper for the serving of a T-bone steak, or a beef stew, which contained a bone natural to the type of meat served, or if a fish dish should contain a fish bone, or if a cherry pie should contain a cherry stone--although it be admitted that an ideal cherry pie would be stoneless. The case of a chicken bone in a chicken pie is, in our opinion, analogous to the cited examples, and the facts set forth in the first count of the complaint do not state a cause of action.

[6] With reference to the count based upon negligence, the same logic and reasoning apply. The facts pleaded do not establish a lack of due care on the part of the restaurant [683] keeper. We do not believe it is a question of contributory negligence on the part of the customer, but a question of whether or not a restaurant keeper in the exercise of due care is required to serve in every instance a perfect chicken pie, in that all bones are entirely eliminated. If the customer has no right to expect such a perfect product, and we think he is not so entitled, then it cannot be said that it was negligence on the part of the restaurant keeper to fail to furnish an entirely boneless chicken pie. The facts set forth in the second count do not, therefore, state a cause of action.

The logic of our decision with reference to both counts of the complaint leads to an affirmance of the trial court in sustaining the demurrer to both counts of the complaint and the entry of judgment in favor of the defendants.

The judgment is affirmed.

Shenk, J., Thompson, J., Seawell, J., Waste, C.J., and Langdon, J., concurred.

589 N.E.2d 547 (1992)
147 Ill.2d 408
168 Ill.Dec. 147

[548] Marc A. Lapp, of Burroughs, Simpson, Hepler, Broom & Macdonald, Edwardsville, for appellant.

William A. Mudge, of Lucco, Brown & Mudge, Edwardsville, for appellee.

Justice FREEMAN, delivered the opinion of the court:

Appellant, Nestle-Beich, Inc. (Nestle), appeals the decision of the appellate court reversing the grant of summary judgment in its favor in a personal injury action brought by appellee, Elsie M. Jackson (Jackson). (212 Ill.App.3d 296, 155 Ill.Dec. 508, 569 N.E.2d 1119.) We affirm.

FACTUAL BACKGROUND

In May 1988, Jackson purchased a sealed can of Katydids, chocolate-covered, pecan and caramel candies manufactured by Nestle. Shortly thereafter, Jackson bit into one of the candies and allegedly broke a tooth on a pecan shell embedded in the candy. As a result, Jackson filed a complaint asserting breach of implied warranty (count I) and strict products liability (count II) against Nestle.

Nestle moved for summary judgment on the basis of the foreign-natural doctrine. That doctrine provides that, if a substance in a manufactured food product is natural to any of the ingredients of the product, there is no liability for injuries caused thereby; whereas, if the substance is foreign to any of the ingredients, the manufacturer will be liable for any injury caused thereby. Mix v. Ingersoll Candy Co. (1936), 6 Cal.2d 674, 59 P.2d 144 (chicken bone in chicken pie); Goodwin v. Country Club of Peoria (1944), 323 Ill.App. 1, 54 N.E.2d 612 (turkey bone in creamed turkey dish).

In granting Nestle's motion, the trial court concluded that Illinois law is "that a food product is not rendered unwholesome by reason of inclusion therein of a substance natural to an ingredient" of the product.

In reversing, the appellate court thoroughly reviewed the rationales underlying the foreign-natural doctrine and the reasonable expectation test, which is applied in certain jurisdictions. The reasonable expectation test provides that, regardless whether a substance in a food product is natural to an ingredient thereof, liability will lie for injuries caused by the substance where the consumer of the product would not reasonably have expected to find the substance in the product. See, e.g., Zabner v. Howard Johnson's, Inc. (Fla.App.1967), 201 So.2d 824 (walnut shell in maple walnut ice cream).

The appellate court concluded "that the foreign-natural doctrine originally set forth in Mix and adopted * * * in Goodwin should not be followed." (212 Ill.App.3d at 305, 155 Ill.Dec. 508, 569 N.E.2d 1119.) The court determined that the doctrine was based on the faulty assumption that consumers know that prepared food products will or might contain whatever any of their ingredients, in a natural state, contain. Ultimately, [549] the court held that the naturalness of the harmful ingredient of a food product does not absolutely bar recovery but is only one factor to be considered in determining whether the presence of the ingredient breached a warranty or rendered the product unreasonably dangerous. (212 Ill.App.3d at 306, 155 Ill.Dec. 508, 569 N.E.2d 1119.) We agree with the appellate court's conclusion that the foreign-natural doctrine is unsound and should be abandoned.

NESTLE'S ARGUMENTS

In appealing the appellate court's decision, Nestle first asserts that the decision "has, in practice, created a strict liability situation[]" because the court "failed to change the general test" for determining the existence of a breach of warranty with respect to food products, viz., the presence of foreign matter in the food or its diseased, decayed or otherwise spoiled and poisonous condition. (32 Ill.L. & Prac. Sales § 152, at 463 (1957).) Nestle reasons that if, as the appellate court held, the naturalness of the harmful ingredient does not bar recovery, its mere presence will henceforth breach the warranty.

We are somewhat perplexed by Nestle's assertion that the appellate court failed to change the test of breach of warranty, with respect to food products, in light of Nestle's conclusion that, as a result of the court's decision, naturalness, the linchpin of that test, will no longer bar recovery. We would ask Nestle how that can be unless the appellate court's decision effectively changed the test. In addition, we find that test, as stated in Illinois Law & Practice, simply of no assistance to Nestle. That work cites Goodwin and it is the continuing validity of Goodwin which is at issue here.

Although not explicitly, the appellate court's decision does, effectively, establish the same test for both breach of warranty and strict products liability claims in food cases, as Nestle appears to argue. That test is the reasonable expectation of the consumer with respect to the ingredients of the food product involved. However, Nestle offers no sound argument for holding that the appellate court could not do so. Therefore, we find this line of argument completely unavailing to Nestle.

Nestle further asserts that the appellate court's decision "fails to acknowledge that the unique situation of natural food hazards is worthy of treatment different than other products[] * * * by applying the foreign-natural doctrine, reasonable expectation test or some hybrid of the two[]" because "perfection in removing naturallyoccurring substances is impossible on each and every occasion."

We do not find this argument to be a valid criticism of the appellate court's opinion. In so arguing, Nestle itself fails to acknowledge that the appellate court effectively adopted the reasonable expectation test as the measure of the viability of both breach of warranty and strict products liability claims in food cases. That is, the appellate court's decision does treat manufacturers such as Nestle differently than manufacturers of other products.

The crux of Nestle's arguments on appeal is that we should adopt the Louisiana version of the foreign-natural doctrine. In Louisiana, if injury is caused by a foreign substance in a food product, the manufacturer is subject to being held strictly liable. In contrast, if the substance causing injury is natural to the product or its ingredients, the manufacturer may be held liable only if the presence of the substance resulted from its negligence in the manufacture of the product. Title v. Pontchartrain Hotel (La.App.1984), 449 So.2d 677; Musso v. Picadilly Cafeterias, Inc. (La.App.1965), 178 So.2d 421.

We decline Nestle's invitation to adopt the Louisiana version of the foreign-natural doctrine in place of the reasonable expectation test. We agree with Jackson that the Louisiana approach comes too close to the outdated and discredited doctrine of caveat emptor.

Moreover, contrary to Nestle's implication in arguing for the adoption of Louisiana's approach, the appellate court's decision in the instant case is not the first to extend the modern-day doctrine of strict [550] liability to food products in Illinois. In Warren v. Coca-Cola Bottling Co. (1988), 166 Ill.App.3d 566, 117 Ill.Dec. 30, 519 N.E.2d 1197, the court recognized that causes of action for breach of implied warranty, strict products liability and negligence properly lay against the manufacturer of an article of food or drink intended for human consumption and sold in a sealed container. Accordingly, the decision in the instant case does not impose burdens upon manufacturers of food products sold or used in Illinois which they have not previously borne.

Additionally, we must reject the underlying theme of Nestle's appeal. Nestle asserts that manufacturers of food products whose manufacture involves a risk that harmful matter which is natural to any of their ingredients will not be eliminated from the finished product should be exempted from strict liability due to the difficulty of eliminating such matter.

Preliminarily, we would note that this argument is essentially an argument for recognizing a state of the art defense in food product cases. However, in Illinois the state of the art has never been a defense to strict products liability. Murphy v. Chestnut Mountain Lodge, Inc. (1984), 124 Ill.App.3d 508, 79 Ill.Dec. 914, 464 N.E.2d 818; Gelsumino v. E. W. Bliss Co. (1973), 10 Ill.App.3d 604, 295 N.E.2d 110.

Moreover, we do not find that manufacturers of products such as Nestle describes serve so important a public service that they merit treatment substantially different from that of manufacturers of other products. In this regard, we believe the consumer's reasonable expectation as to the contents of food products, as the gauge of strict liability, adequately balances consumers' interest in defect-free products and such manufacturers' interest in reasonable costs of doing business.

With an awareness of that test, consumers and their attorneys need ask themselves only one question before deciding to bring an action of this type: Would a reasonable consumer expect that a given product might contain the substance or matter causing a particular injury? If the answer is in the affirmative, we would expect that consumers and their attorneys would think twice about suing the manufacturer. Similarly, with an awareness of that test, manufacturers can act accordingly with respect to their means of production. Additionally, if the answer to the foregoing question is in the negative, we would expect that manufacturers and their attorneys would think twice about declining to offer a settlement of this type of action. The test thus provides a reasonable and concrete standard to govern actions of this sort.

Moreover, we believe that the fact that the reasonable expectation test comports with the rationale underlying strict products liability strongly recommends the test as the dispositive inquiry in this type of case. That rationale provides that an allegedly defective product must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. (Restatement (Second) of Torts § 402A, Comment i, at 352 (1965).) The similarity between the language of the reasonable expectation test and the Restatement is striking and strongly recommends the former as the rule of decision in this type of case.

Nestle further argues that a fundamental basis of strict products liability, viz., that manufacturers who create risks posed by a defective product and who reap a profit by placing it in the stream of commerce should bear the losses caused thereby, does not apply in this case. That principle does not apply, Nestle reasons, because the manufacturer of natural food products does not create the risk. Rather, the risk is created by nature and all a manufacturer can do is its best to minimize the risk. We find this reasoning unpersuasive.

In so arguing, Nestle ignores that strict liability, in theory, is intended to apply to all products placed in the stream of commerce regardless whether they have undergone some processing or not. Accordingly, a supplier of poisonous mushrooms which are neither cooked, canned, packaged nor otherwise treated is subject [551] to strict liability. (Restatement (Second) of Torts § 402A, Comment e, at 350 (1965).) If such a supplier would be strictly liable for injuries caused by its product, we see no reason why Nestle should not be. Both would have sold a product which injured a consumer as a result of an aspect of the product's or an ingredient's natural state. In the mushroom supplier's case, that aspect would be their poisonousness. In Nestle's case, that aspect would be that the meat of pecans, an ingredient of Katydids, is found inside a hard shell. That Nestle actually processes the ingredients in its product before placing it in the stream of commerce and thereby has some opportunity to discover and eliminate the risk of injury posed by its ingredients, unlike the seller of poisonous mushrooms, actually militates in favor of, rather than against, imposing strict liability against Nestle.

Furthermore, we do not believe that Nestle's product merits inclusion in that group of products "which, in the present state of human knowledge," are "incapable of being made safe for their intended and ordinary use," i.e., unavoidably unsafe products, and which are not subject to strict liability. Simply put, Nestle's product lacks the social utility of those products which justifies their exemption from such liability. Restatement (Second) of Torts § 402A, Comment k, at 353 (1965); cf. Ill. Rev.Stat.1989, ch. 111½, par. 5101 et seq. (exempting from strict liability those engaged in, inter alia, procuring, furnishing, processing, or distributing human whole blood, plasma, blood products, blood derivatives and products, corneas, bones, organs or other human tissue for the purpose of injection, transfusion, transplantation in the human body).

Nestle also argues that two other rationales for strict products liability, viz., that consumers cannot adequately protect themselves from defective products and that manufacturers such as Nestle are in a better position to identify and guard against potential defects, are inapplicable in this case. We disagree.

Rather than imposing an obligation upon consumers of Nestle's product to protect themselves by "think[ing] and chew[ing] carefully," we believe that the obligation of protection is better placed on Nestle and like manufacturers. In this regard, we agree with the following observation:

"With the prevalence of processed foods on the market today and the development of technology in the food industry, consumers increasingly rely upon food processors to inspect and purify the foods they consume. Many products today are even packaged in such a manner that inspection by the consumer is difficult if not impossible. One might imagine a consumer in a jurisdiction that applies the foreign-natural test tearing away the crust from a beef pot pie to search for tiny bones, or picking apart a cherry-nut ice cream cone to remove stray shells or pits.

In an era of consumerism, the foreign-natural standard is an anachronism. It flatly and unjustifiably protects food processors and sellers from liability even when the technology may be readily available to remove injurious natural objects from foods. The consumer expectation test, on the other hand, imposes no greater burden upon processors or sellers than to guarantee that their food products meet the standards of safety that consumers customarily and reasonably have come to expect from the food industry." Note, Products Liability— The Test of Consumer Expectation for "Natural" Defects in Food Products, 37 Ohio St.L.J. 634, 651-52 (1976).

With respect to Nestle's argument that it is in no better position than consumers of its Katydids to identify the risks associated therewith, we disagree that the common knowledge that pecans are hard-shelled nuts makes it common knowledge that processed foods containing pecan meats may also contain pecan shell. Moreover, contrary to Nestle's assertion, we do not believe that "the practical difficulties of food separation are common knowledge" to all consumers. As a result, we do not believe that consumers of its Katydids must be required to "think and chew carefully" when consuming them.

[552] Nestle further argues that another of the rationales for strict liability, the difficulty of proving negligence, can be satisfied here by requiring the manufacturer to prove its freedom from negligence, as is done in Louisiana. We disagree.

Even if we had no doubt that that is the approach taken in Louisiana, we do not believe its adoption in Illinois would be salutary to our jurisprudence. We do not believe it wise to begin carving out exceptions to strict products liability by placing upon manufacturers a burden of proving freedom from negligence. If we were to find Nestle entitled to such treatment, we would be hardpressed to reject the arguments of any manufacturer for similar treatment. Eventually, the exceptions would swallow the rule of strict liability. We cannot countenance such a possibility.

Lastly, Nestle argues that another of the rationales for strict liability, viz., that it is more effective than negligence liability in inducing the manufacture of safer products, also does not apply here given the nature of the product involved. We disagree.

Even under the reasonable expectation test of strict liability we approve in this case, manufacturers, such as Nestle, of products posing the risk involved in this case can take one simple and relatively inexpensive step to make their products safer and to avoid liability for injuries caused thereby. Specifically, they can place an adequate warning to the consumer on their product's container of the possibility or risk of injury posed thereby. (Restatement (Second) of Torts § 402A, Comment j, at 353 (1965).) The relative ease with which such a measure may be taken also militates in favor of holding manufacturers of such products subject to strict liability in the absence thereof.

In this regard, we note that, even if we agreed with Nestle that its Katydids merit classification as an unavoidably unsafe product, we would nonetheless find it subject to strict liability due to the absence of a warning of the unavoidable risk of injury it posed. See Restatement (Second) of Torts § 402A, Comment k, at 353 (1965) (an unavoidably unsafe product is not defective or unreasonably dangerous when properly prepared and accompanied by proper directions and warning).

For all of the reasons stated herein, we affirm the judgment of the appellate court.

Appellate court affirmed.

Justice HEIPLE, dissenting:

The majority decision overturns the long-standing doctrine in Illinois regarding the sale, purchase and consumption of food products. Since 1944, Illinois has followed the so-called foreign-natural doctrine. (Goodwin v. Country Club of Peoria (1944), 323 Ill.App. 1, 54 N.E.2d 612.) Stated in its simplest terms, the foreign-natural doctrine provides that the vendor of food is not liable for injuries due to unremoved but naturally occurring ingredients such as nut shells, fruit pits, fish bones and so forth but is liable for foreign objects in the food such as glass shards or pieces of metal. The majority opinion in the instant case discards the foreign-natural doctrine and substitutes the reasonable expectation test. In its essence, that test provides that the vendor of a food product is liable for injuries caused by an ingredient in the food whether natural or foreign whenever the consumer of the product would not reasonably have expected to find the substance in the product.