GERARD E. LYNCH, Circuit Judge:
For nearly seventy years, antibiotics have provided dramatic medical advances in the treatment of bacterial infections.
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.
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.
The FDA has statutory authority to regulate new animal drugs
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.
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")
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
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
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
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.
Plaintiffs, a group of advocacy organizations,
On October 6, 2011, after the FDA answered the amended complaint, plaintiffs moved for summary judgment.
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.
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.
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.
The principal question presented by this appeal is whether 21 U.S.C. § 360b(e)(1)
21 U.S.C. § 360b(e)(1) addresses the FDA's power to withdraw approval for "new animal drug[s]."
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
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.
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
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.
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.
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
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."
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.
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
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
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.
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.
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.
Second, the function of the finding contemplated by § 360b(e)(1), and the mandate
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.
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.
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.
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.
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
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.
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
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.
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.
Alternatively, plaintiffs argue that even if the FDA is not required to proceed with
The FDA's notice withdrawing the 1977 NOOHs sets out the reasons for the action:
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:
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
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.
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
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.
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
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
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.
Like the majority, I begin with the text of the statute:
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.
"[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
"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 —
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.
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
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.
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.
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
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.
The majority asserts that § 514.115(b) does not represent an agency interpretation
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.
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
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:
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).
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
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
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.
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
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
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.
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
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.
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
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.
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:
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
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
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.
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
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.
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.
