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.

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.

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.