MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES, PETITIONER V. LARRY LEON CHANEY, ET AL. No. 83-1878 In the Supreme Court of the United States October Term, 1984 On Writ of Certiorari to the United States Court of Appeals for the District of Columbia Circuit Brief for the Petitioner PARTIES TO THE PROCEEDING Margaret M. Heckler, Secretary of Health and Human Services, is the only petitioner. In addition to Larry Leon Chaney, the respondents are Alton Franks, Carl Morgan, Charles W. Davis, Robyn Parks, Doyle Skillern, Jerry Joe Bird, and Henry Martinez Porter. TABLE OF CONTENTS Opinions below Jurisdiction Statutes involved Statement Introduction and summary of argument Argument: I. The Food and Drug Administration's decision not to regulate the states' use of lethal drugs for capital punishment is not subject to judicial review under the Administrative Procedure Act A. Prosecutorial and administrative enforcement decisions are generally exempt from judicial review B. The FDA's decision is exempt from review because the governing statutes do not limit the agency's discretion 1. The FDCA does not limit the FDA's enforcement discretion 2. The preamble to a proposed but unadopted rule does not limit the FDA's enforcement discretion 3. The question whether there is law to apply does not depend upon a judicial assessment of "pragmatic considerations" C. The structure and legislative history of the FDCA show that Congress intended the FDA to have unreviewable enforcement discretion II. Even if reviewable, the FDA's enforcement decision was rational and should have been sustained A. The FDA lacks authority to regulate the states' use of lethal injections for capital punishment B. Other legitimate and substantial considerations support the FDA's determination not to initiate investigative or enforcement activity Conclusion Appendix OPINIONS BELOW The opinion of the court of appeals (Pet. App. 1a-58a) is reported at 718 F.2d 1174. The opinion on denial of rehearing (Pet. App. 59a-62a) is reported at 724 F.2d 1030. The opinion of the district court (Pet. App. 63a-79a) and the decision of the Food and Drug Administration (Pet. App. 81a-88a) are unreported. JURISDICTION The judgment of the court of appeals was entered on October 14, 1983. A petition for rehearing was denied on January 17, 1984 (Pet. App. 87a). By order of April 12, 1984, the Chief Justice extended the time in which to file a petition for a writ of certiorari to and including May 16, 1984. The petition was filed on that date and was granted on June 18, 1984 (J.A. 122). The jurisdiction of this Court is invoked under 18 U.S.C. 1254(1). STATUTES INVOLVED Relevant provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., and the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., are reproduced in an appendix to this brief (App., infra, 1a-2a). QUESTIONS PRESENTED 1. Whether the Administrative Procedure Act, 5 U.S.C. 701-706, authorizes judicial review of the Food and Drug Administration's decision not to regulate the states' use, in carrying out capital punishment by lethal injection, of drugs that have been approved for other purposes but that have not been found to be "safe and effective" as a means of causing death. 2. If the Food and Drug Administration's decision not to regulate the states' use of drugs in carrying out capital punishment by lethal injection is subject to judicial review, whether that decision was arbitrary and capricious. STATEMENT In recent years, numerous states have enacted statutes prescribing lethal injection of drugs as the method for carrying out the death penalty. /1/ In this case, prison inmates sentenced to death by lethal injection in Texas and Oklahoma petitioned the Food and Drug Administration (FDA) to block their executions on the ground that the states proposed to employ drugs that had been approved by the FDA as safe and effective for medical purposes but not for human execution. J.A. 16-33. Respondents asserted that their execution by this means would violate the "misbranding" and "new drug" provisions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(k), 352, 355(a). /2/ J.A. 20-22. They requested the FDA, among other things, /3/ to "(a)dopt a policy and procedure for the seizure and condemnation from prisons or state departments of correction of drugs which are destined or held for use as a means of execution" and to recommend the criminal prosecution of prison officals and others who "knowingly buy, possess, (sell) or use drugs for the unapproved use of lethal injections." J.A. 32-33. The FDA declined to take the requested enforcement actions. It concluded (Pet. App. 81a-86a) that it had no jurisdiction under the FDCA to investigate the states' practice of administering lethal injections in capital punishment cases and that it would decline to take action in any event as a matter of its enforcement discretion. The Commissioner of Food and Drugs stated (id. at 82a, 85a): Our conclusion that the use of lethal injection is not subject to our jurisdiction is supported by the relevant statutory provisions, by our current policy on the use of approved drugs for unapproved uses, and by a consideration of the proper role of the Federal Government with respect to the conduct of State criminal justice systems. * * * * * Were FDA clearly to have jurisdiction in the area, moreover, we believe we would be authorized to decline to exercise it under our inherent discretion to decline to pursue certain enforcement matters. The unapproved use of approved drugs is an area in which the case law is far from uniform. Generally, enforcement proceedings in this area are initiated only when there is a serious danger to the public health or a blatant scheme to defraud. We cannot conclude that those dangers are present under State lethal injection laws, which are duly authorized statutory enactments in furtherance of proper State functions. Plaintiffs then brought this suit for injunctive and declaratory relief in the United States District Court for the District of Columbia. J.A. 5-14. The district court dismissed the complaint on the ground that the enforcement decisions of an agency are not subject to judicial review. Pet. App. 63a-79a. Placing reliance on numerous cases involving enforcement discretion, including cases specifically involving the FDA, the district court concluded that "(i)t is by now well-established that decisions of executive departments and agencies to refrain from instituting investigative and enforcement proceedings are essentially unreviewable by the courts." Pet. App. 74a (emphasis in original). The district court added (id. at 76a): The record indicates that plaintiffs' petition was accorded careful consideration by the Commissioner, and his reasons for declining to initiate investigative and enforcement action were fully explained in a memorandum accompanying the denial of the petition. Whether the Commissioner might have reached a different decision in light of the political, scientific, and ethical controversy surrounding the use of prescription drugs to cause death by lethal injection is of no moment; the salient point is that under established authority the decision was his to make. A divided panel of the court of appeals vacated the district court's judgment and remanded with directions "to order the agency to fulfill its statutory function" (Pet. App. 36a). The court of appeals concluded that the FDA has authority under 21 U.S.C. 331(k) to regulate the use of drugs in administering capital punishment. That provision prohibits the "misbranding" of drugs while they are "held for sale." The court apparently reasoned (Pet. App. 14a-15a) that the states' use of the drugs for an unapproved purpose constitutes "misbranding" and that the drugs are "held for sale" when they are injected into the person being executed. The court of appeals also held that the FDA's decision not to initiate enforcement activity was subject to judicial review (Pet. App. 17a-30a). In the court's view (id. at 18a-22a), all agency action, including a decision not to begin enforcement proceedings, is presumptively reviewable except in those situations "where the governing statute is 'drawn in such broad terms that in a given case there is no law to apply'" (quoting S. Rep. 752, 79th Cong., 1st Sess. 26 (1945)). The court observed (Pet. App. 24a) that the "determination of whether there 'is law to apply' turns on such pragmatic considerations as whether judicial supervision is necessary to safeguard plaintiffs' interests, whether judicial review will unnecessarily impede the agency in effectively carrying out its congressionally assigned role, and whether the issues are appropriate for judicial review." In this case, the court found "law to apply" in the preamble to an FDA rule proposed for notice and comment in 1972 but never promulgated. The preamble stated (id. at 24a): Where the unapproved use of an approved new drug becomes widespread or endangers the public health, the (FDA) is obligated to investigate it thoroughly and to take whatever action is warranted to protect the public. * * * When necessary the (FDA) will not hesitate to take whatever action * * * may be required to bring possible harmful use of an approved drug under control. The court concluded (id. at 31a-35a) that the FDA's reasons for declining enforcement were irrational in light of the preamble and warned (id. at 37a): "We must be prepared to compel FDA to take action with respect to the (plaintiffs') prayer for relief where an acceptable explanation of (FDA's) inaction is not promptly forthcoming." /4/ Judge Scalia dissented (Pet. App. 39a-58a), stating (id. at 39a) that the majority's decision constituted "a clear intrusion upon powers that belong to Congress, the Executive Branch and the states." He pointed out (id. at 46a) that "far from there being a 'presumption of reviewability' with regard to enforcement determinations, the well known presumption is precisely the contrary." Finding no special circumstances justifying review in this case, Judge Scalia concluded that review was unavailable. He noted (id. at 48a-51a) that the preamble on which the majority relied was "full of flexible terms, the precise application of which was obviously intended to be, and could properly be, left to the discretion of the agency -- for example, whether an unapproved use has become 'widespread.'" Moreover, assuming that the FDA's decision not to undertake enforcement action was judicially reviewable, Judge Scalia found (Pet. App. 51a-58a) that the FDA's actions were not arbitrary and capricious. He concluded that the FDA had no statutory authority to take the requested action because "(u)nder no conceivable interpretation of the English language could (the drugs used in lethal injections) be deemed 'held for sale'" (id. at 55a). By a five-to-five vote, the court of appeals denied the government's suggestion for rehearing en banc (Pet. App. 59a-60a). /5/ In a statement joined by Judges Wilkey, Bork, and Starr, Judge Scalia stressed (id. at 60a) the significance of the holding of this case to "the enforcement authority of all federal agencies." Judge Scalia stated (ibid.) that the panel's finding of a "general presumption of reviewability" of enforcement decisions "distorts the law and usurps the authority of the Executive Branch." He also noted (id. at 61a) that the "pragmatic considerations" test referred to by the court of appeals was "not an application of the Supreme Court's guidance, but the substitution of an entirely different test -- which can be summarized by saying that we intervene when we think it a good idea." INTRODUCTION AND SUMMARY OF ARGUMENT A. In recent years, many state legislatures have concluded that the most painless and humane method of capital punishment is the use of lethal injections. /6/ An increasing number of states have accordingly enacted statutes prescribing this method of execution. Respondents petitioned the Food and Drug Administration to block the use of lethal injections, but the FDA declined to intervene. However, the United States Court of Appeals for the District of Columbia Circuit reviewed the FDA's decision under the Administrative Procedure Act and concluded that the agency's reasons were arbitrary and capricious. The impact of this decision on all administrative agencies can hardly be overstated. Prosecutorial and administrative enforcement decisions have traditionally been exempt from judicial review except in unusual circumstances. Thus, affirmance of the court of appeals' decision would cause substantial disruption of settled administrative practices and would "almost certainly result in the substitution of the preferences of the judicial branch for those of the executive." Pet. App. 39a (Scalia, J., dissenting). Even if narrowly confined, affirmance would have deleterious consequences. The effect of the court of appeals' decision is to require the FDA to intervene in a highly controversial area far removed from its mission of protecting the consuming public from unsafe and improperly labeled drugs. Furthermore, unless reversed, that decision is likely to interfere with state enforcement of capital punishment statutes that satisfy Eighth Amendment standards. At a minimum, the use of lethal injections will be prevented until a manufacturer or other party seeks FDA approval for the use of the drugs in executions and demonstrates that they are "safe and effective" in causing death (21 U.S.C. 355(a)). /7/ It is doubtful whether any manufacturer would seek such approval in view of the expense involved, the organized opposition to capital punishment, and the very small quantities of drugs that would be sold for this new use. Thus, the practical effect of affirming the court of appeals' decision might well be to prevent executions by lethal injection altogether. In that event, many states would probably return to what they have concluded are potentially more painful methods of capital punishment. B. These adverse consequences need not be suffered, because the court of appeals' decision is plainly wrong. In holding that the FDA's exercise of enforcement discretion was subject to judicial review, the court departed dramatically from settled principles of administrative law. The Administrative Procedure Act, 5 U.S.C. 701(a)(2), provides that final agency action is not subject to judicial review if it is "committed to agency discretion by law." This bar to judicial review applies where the governing "statutes are drawn in such broad terms that in a given case there is no law to apply." Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 410 (1971) (quoting S. Rep. 752, 79th Cong., 1st Sess. 26 (1945)). This is a paradigmatic case in which there is "no law to apply." The Federal Food, Drug and Cosmetic Act does not command the FDA to take investigative or enforcement action whenever a statutory violation is alleged or found. Indeed, the Act does not even suggest the standards to be used by the FDA in determining whether and when to undertake such action. Instead, the Act confers upon the Commissioner of Food and Drugs a "broad discretion -- broad enough undoubtedly to enable him to perform his duties fairly without wasting his efforts on what may be no more than technical infractions of law." United States v. Sullivan, 332 U.S. 689, 694 (1948). Because most statutes granting enforcement powers to administrative agencies are cast in similar terms, it is well established that agency enforcement decisions are rarely subject to judicial review. The court of appeals held that the FDA's decision was reviewable because, in the court's view, the agency had "made law to govern and guide its discretion in regulating the unapproved use of approved drugs" (Pet. App. 24a). But the "law" upon which the court relied was the preamble to a rule that was issued for notice and comment but was never adopted by the agency. This preamble does not place any restrictions on the FDA's enforcement discretion. In the first place, the preamble has nothing to do with the subject of enforcement discretion. Its sole subject is the interpretation of the FDCA's provisions regarding the lawful use of approved drugs for unapproved purposes. In an effort to show that the preamble limits the agency's enforcement discretion, the court of appeals seized upon a single sentence of the preamble and took that language completely out of context. Even if the preamble had discussed the issue of enforcement discretion, it would not have bound the agency or furnished a sufficient basis for judicial review. The preamble is not a legislative rule, and the FDA's regulations clearly provide that pronouncements such as the preamble do not impose any general legal requirements on the agency. 21 C.F.R. 10.85(j). Similarly, under accepted principles of administrative law, an agency is generally not bound by statements of this type, and there is no good reason for holding the FDA bound here. On the contrary, if informal agency statements regarding enforcement policy provided sufficient grounds for judicial review of enforcement decisions, agencies would be discouraged from explaining their enforcement policies or from issuing internal guidelines to ensure that their enforcement decisions are rational and consistent. The structure and legislative history of the FDCA reinforce the conclusion that FDA enforcement decisions are not reviewable. Judicial review of such decisions would place an intolerable burden on the agency and would divert scarce resources from the agency's important regulatory responsibilities. In addition, the legislative history of the FDCA unequivocally shows that Congress intended the FDA to have unreviewable enforcement discretion. C. Even if the FDA's decision was judicially reviewable, the decision was rational and should have been upheld. 1. The FDA concluded that it lacked authority under the FDCA to regulate the states' use of lethal injections for capital punishment. The agency's interpretation of the statute it administers is entitled to considerable deference and should have been sustained. Instead, the court of appeals held that the FDA had authority under the provisions of the FDCA prohibiting the "misbranding" of drugs or devices while they are "held for sale." The court theorized that the drugs are "held for sale" when they are forcibly injected into the person being executed. The statutory language lends no support to this surprising construction, and there is not a hint in the legislative history that Congress had any intention to regulate the methods used by states in carrying out lawful death sentences. The peculiar nature of the court of appeals' construction is highlighted by the fact that the misbranding provisions apply equally to "drugs" and "devices" and the fact that the statutory definition of a device seems clearly to encompass many of the paraphernalia traditionally used for executions, such as the gallows and the electric chair. See 21 U.S.C. 321(h), 331(k). By the court's reasoning, the FDA presumably would be obliged to regulate the use of these devices as well. 2. Even if the FDCA could somehow be stretched to reach the administration of lethal injections for purposes of capital punishment, the FDA articulated sound reasons for declining to intervene. Regulating the methods of capital punishment used by the states, whether or not technically within the scope of the FDCA, is certainly far removed from the FDA's central responsibilities. The FDA acted reasonably in conserving its limited enforcement resources for matters more closely related to its principal mission. The FDA also declined to intervene based upon a proper respect for principles of federalism. Enforcement of the criminal laws is of course one of the oldest and most important state functions. Finally, the FDA acted reasonably in relying on the absence of a "serious danger to the public health" (Pet. App. 85a). Unless the agency was prepared to regulate all forms of execution, the issue posed by respondents was not a question of "pain versus no pain, but rather pain of one sort substituted for pain of another -- and in all likelihood substitution of a lesser pain, since that is the principal purpose of the lethal injection statutes" (Pet. App. 51a (Scalia, J., dissenting) (emphasis in original)). ARGUMENT I. THE FOOD AND DRUG ADMINISTRATION'S DECISION NOT TO REGULATE THE STATES' USE OF LETHAL DRUGS FOR CAPITAL PUNISHMENT IS NOT SUBJECT TO JUDICIAL REVIEW UNDER THE ADMINISTRATIVE PROCEDURE ACT A. Prosecutorial And Administrative Enforcement Decisions Are Generally Exempt From Judicial Review Under the Administrative Procedure Act, 5 U.S.C. 701(a)(2), final agency action is not subject to judicial review if it is "committed to agency discretion by law." This bar to judicial review applies where the governing "'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 (1971) (quoting S. Rep. 752, 79th Cong., 1st Sess. 26 (1945)). Where statutes explicitly or implicitly impose standards governing the exercise of an agency's discretion, there is "law to apply," and judicial review is available under the APA to determine whether the agency has abused its discretion. 5 U.S.C. 706(2)(A). In Overton Park, for example, this Court held that the Secretary of Transportation's decision to route an interstate highway through a municipal park was subject to judicial review because the governing statutes specified the factors that had to be considered in making the decision. Indeed, the statutes expressly prohibited the use of parkland except in "the most unusual situations" (401 U.S. at 411). Because the statutes empowering administrative agencies usually provide some law to apply, this Court has noted that Section 701(a)(2) represents a "very narrow exception" to the provisions of the APA authorizing judicial review. Overton Park, 401 U.S. at 410. As the court of appeals correctly noted (Pet. App. 18a-19a), final agency action in general is presumptively reviewable. The court below erred, however, in refusing to recognize that this presumption does not apply in certain circumstances, including where efforts are made to obtain review of prosecutorial and administrative enforcement decisions. As Judge Scalia noted in dissent (Pet. App. 46a), "far from there being a 'presumption of reviewability' with regard to enforcement determinations, the well known presumption is precisely the contrary." Cf. Block v. Community Nutrition Institute, No. 83-458 (June 4, 1984), slip op. 8 ("The presumption favoring judicial review of administrative action is just that -- a presumption" and may be overcome.). Prosecutorial and administrative enforcement decisions have traditionally been committed to unreviewable executive discretion for two principal reasons. The first is the doctrine of separation of powers. /8/ Under the Constitution (Art. II, Section 3), it is the duty of the Executive, not the courts, to "take Care that the Laws be faithfully executed." Discharging this responsibility often involves making basic policy choices. An agency may decide that enforcement is most needed in certain areas rather than others and may target its efforts accordingly. An agency may also decide on policy grounds that one method of enforcement is preferable to available alternatives or that the previous pace of enforcement should be accelerated or slowed down. "It would be idle to pretend that the conduct of government litigation * * is a wholly mechanical procedure which involves no policy choices whatever." United States v. Mendoza, No. 82-849 (Jan. 10, 1984), slip op. 7. Our system of government entrusts such choices not to the judiciary but to officials accountable directly or indirectly to the electorate. See Chevron U.S.A. Inc. v. NRDC, No. 82-1005 (June 25, 1984), slip op. 27. Judicial review of enforcement decisions thus has been precluded to avoid "judicial 'second-guessing' of * * * administrative decisions grounded in social, economic, and political policy." United States v. Varig Airlines, No. 82-1349 (June 19, 1984), slip op. 16 (discussing discretionary function exception to Federal Tort Claims Act). Enforcement decisions are also committed to executive discretion because they characteristically involve complicated questions of administration that are ill-suited for review by the courts. /9/ In deciding whether to undertake enforcement action, an agency must do far more than merely determine whether there is a sound factual and legal basis for proceeding. The agency must decide which enforcement strategy will best carry out its statutory mandate and must decide how to allocate its scarce resources. It must compare the importance and cost of various potential cases, as well as the likelihood of success in each of those endeavors. It must consider both the benefits of undertaking a particular enforcement action and the potential for deleterious consequences if the effort proves unsuccessful. After considering these and other factors, an agency may rationally decide to pursue any of a number of different enforcement policies. For example, it may concentrate on a few of the most important or most highly visible cases. Or it may decide to undertake action in a much larger number of cases. Evaluating the relevant factors and developing a sound enforcement strategy are quintessentially the functions of a regulatory agency. They are not appropriate for judicial review. Because of these considerations, it has long been the rule that prosecutorial and administrative enforcement decisions generally are not reviewable. This Court has repeatedly held that prosecutorial decisions are exempt from judicial review. United States v. Batchelder, 442 U.S. 114, 124 (1979); Bordenkircher v. Hayes, 434 U.S. 357, 364 (1978); United States v. Nixon, 418 U.S. 683, 693 (1974); Linda R.S. v. Richard D., 410 U.S. 614, 619 (1973). See also Newman v. United States, 382 F.2d 479 (D.C. Cir. 1967) (Burger, J.). Cf. Oyler v. Boles, 368 U.S. 448, 456 (1962). The Court has treated civil and administrative enforcement decisions in like manner, since "(t)he decision to initiate administrative proceedings * * * is very much like the prosecutor's decision to initiate or move forward with a criminal prosecution." Butz v. Economou, 438 U.S. 478, 515 (1978). As long ago as the Confiscation Cases, 74 U.S. (7 Wall.) 454 (1869), this Court held that the Attorney General had unreviewable discretion to decline to bring suit seeking condemnation of a vessel used to aid the Confederacy during the Civil War. In FTC v. Klesner, 280 U.S. 19 (1929), the Court concluded that the Federal Trade Commission had unreviewable discretion to decline to pursue a citizen complaint of an alleged unfair trade practice. Writing for the Court, Justice Brandeis observed that "(a) person who deems himself aggrieved by the use of an unfair method of competition * * * may of course bring the matter to the Commission's attention and request it to file a complaint. But a denial of his request is final. And if the request is granted and a proceeding is instituted, he does not become a party to it or have any control over it." Id. at 25-26 (footnote omitted). Enactment of the APA did not change this rule. The Court has concluded that the general counsel of the National Labor Relations Board has unreviewable discretion to decide whether to bring an unfair labor practice complaint before the Board. NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 138 (1975); Vaca v. Sipes, 386 U.S. 171, 182 (1967). /10/ In Moog Industries, Inc. v. FTC, 355 U.S. 411 (1958), the Court observed that the FTC was not required to proceed against all companies suspected of similar antitrust violations. The Court stated (id. at 413): (A)lthough an allegedly illegal practice may appear to be operative throughout an industry, * * * whether all firms in the industry should be dealt with in a single proceeding or should receive individualized treatment are questions that call for discretionary determination by the administrative agency. * * * (T)he Commission alone is empowered to develop that enforcement policy best calculated to achieve the ends contemplated by Congress and to allocate its available funds and personnel in such a way as to execute its policy efficiently and economically. /11/ See also New Jersey v. United States, 168 F. Supp. 324 (D. N.J. 1958), aff'd, 359 U.S. 27 (1959); /12/ Panama Canal Co. v. Grace Line, Inc., 356 U.S. 309 (1958). More recently, in Southern Ry. v. Seaboard Allied Milling Corp., 442 U.S. 444 (1979), this Court held that the courts could not review the Interstate Commerce Commission's decision not to investigate charges by shippers that certain railroad rates were illegal. See also City of Chicago v. United States, 396 U.S. 162, 165 (1969). The Court in Southern Ry. noted (442 U.S. at 455) that the statutory provision governing the ICC's investigative power "is written in the language of permission and discretion" and that "(t)he statute is silent on what factors should guide the Commission's decision." The Court also relied on the structure and legislative history of the Interstate Commerce Act (id. at 456-460). As we will show, these same factors clearly demonstrate that the FDA's decision in the present case is likewise exempt from judicial review under the APA. The weight of lower court authority also holds that administrative enforcement decisions are not subject to judicial review. For instance, in National Milk Producers Federation v. Harris, 653 F.2d 339 (8th Cir. 1981), dairy producers sought to compel the FDA to initiate "investigative, enforcement, or prosecutorial" proceedings against persons alleged to be violating the FDCA by selling misbranded cheese substitutes in interstate commerce. The court of appeals held (id. at 343): The executive branch and its departments enjoy a discretion in the initiation of * * * enforcement * * * actions limited only by constitutional strictures and relevant statutory directives. Because the FDCA does not mandate enforcement actions, the court concluded (id. at 344) that a "complaint which seeks the initiation of investigative, enforcement, or prosecutorial proceedings fails to state a claim upon which * * * relief can be granted." In City of Seabrook v. Costle, 659 F.2d 1371, 1374-1375 (5th Cir. 1981), the court held that the Environmental Protection Agency has unreviewable discretion to decline to find that a state implementation plan violates the Clean Air Act. /13/ The court correctly reasoned (id. at 1374 (citations omitted)): The branches of government charged with the investigation of violations of the law and with enforcement of the law have traditionally been afforded broad discretion in carrying out these duties. We have held, for example, that the Attorney General's discretion "in choosing whether to prosecute or not to prosecute . . . is absolute." * * * The courts have recognized that, at least in the absence of a contrary statutory command, administrative agencies should be afforded similarly broad discretion. * * * This principle of almost absolute discretion in initiating enforcement action should apply with equal force to the decision to take the preliminary investigatory steps that would provide the basis for enforcement action. See also American Broadcasting Companies v. FCC, 662 F.2d 155, 157-159 (2d Cir. 1981), and American Broadcasting Companies v. FCC, 682 F.2d 25, 30-31 (2d Cir. 1982) (no judicial review of Federal Communication Commission's refusal to suspend and investigate tariff filings). The District of Columbia Circuit itself has similarly refused to permit judicial review of determinations by regulatory agencies not to initiate enforcement proceedings. In Kixmiller v. SEC, 492 F.2d 641 (D.C. Cir. 1974), the court held that the Securities and Exchange Commission's decision not to investigate the exclusion of certain materials from corporate proxy materials was not reviewable. The court wrote (id. at 645 (footnotes omitted)): "An agency's decision to refrain from an investigation or an enforcement action is generally unreviewable." In Investment Co. Institute v. FDIC, 728 F.2d 518 (D.C. Cir. 1984), the court refused to permit review of a determination by the Federal Deposit Insurance Corporation not to initiate cease and desist proceedings against a regulated bank for selling mutual fund shares through wholly owned subsidiaries. Holding that the matter was committed to agency discretion by law, the court noted (id. at 527) that "there is 'no law to apply' in reviewing a simple refusal to take enforcement action." In departing from this longstanding authority holding that prosecutorial and administrative enforcement decisions are not subject to judicial review, the court of appeals relied principally upon Dunlop v. Bachowski, 421 U.S. 560 (1975). This Court's opinion in Bachowski did not even discuss Section 701(a)(2) of the APA, but in any event that case is easily distinguishable from the present case. In Bachowski, a defeated candidate for union office sought to compel the Secretary of Labor to bring suit under provisions of the Labor-Management Reporting and Disclosure Act of 1959 (LMRDA), 29 U.S.C. 482(a) and (b), to have the election set aside. The Secretary argued that his decision was exempt from review under the APA both because "statutes preclude(d) judicial review" (5 U.S.C. 701(a)(1)) and because his decision was a matter "committed to agency discretion by law" (5 U.S.C. 701(a)(2)). In holding that the Secretary's refusal to bring suit was reviewable, this Court did not discuss the Secretary's contention that the decision was an unreviewable exercise of prosecutorial discretion, but instead merely expressed agreement (421 U.S. at 567 n.7) with the court of appeals' treatment of the issue. See Bachowski v. Brennan, 502 F.2d 79 (3d Cir. 1974). The court of appeals, in turn, had begun by noting numerous cases holding the exercise of enforcement discretion to be unreviewable (see 502 F.2d at 86-87), but the court distinguished the case before it on three grounds. First, the court concluded (id. at 87), based on the legislative history of the LMRDA, that in empowering the Secretary to bring suit to set aside an election, Congress intended the Secretary to act on behalf of aggrieved union members rather than merely on behalf of the public. Second, it noted (id. at 87-88) that union members have no remedy if the Secretary does not act. And third, the court observed (id. at 88) that the Secretary's discretion was restricted by statute because he was required to bring suit whenever there was probable cause to believe that there had been a violation affecting the outcome of the election and no settlement was reached. None of these factors applies in the instant case. FDA enforcement is intended to protect the general public, not to redress individual wrongs; persons facing execution by lethal injection can challenge the legality of that method of capital punishment in other proceedings; /14/ and under the FDCA, the FDA has the traditional broad scope of enforcement discretion. See 21 C.F.R. 10.45(d)(2)(i). /15/ Thus, this Court's summary treatment of the issue in Bachowski provides no basis for departing from the well-established rule that prosecutorial and administrative enforcement decisions are generally not subject to judicial review. B. The FDA's Decision Is Exempt From Review Because The Governing Statutes Do Not Limit The Agency's Discretion Even if the presumption against judicial review of enforcement decisions is cast aside, there is still no basis for review in this case. As noted, agency action is exempt from review under the APA where the governing statutes do not impose standards restricting the agency's discretion. This case falls squarely within that exemption. 1. The FDCA Does Not Limit The FDA's Enforcement Discretion. It is perfectly clear that the FDCA provides no "law to apply" in this case. The provisions of the Act granting the FDA investigative and enforcement authority are "written in the language of permission and discretion." Southern Ry., 442 U.S. at 455. The Secretary of Health and Human Services is expressly "authorized to conduct examinations and investigations for the purposes of (the FDCA)" (21 U.S.C. 372). The Secretary is also implicitly empowered to initiate civil actions to enjoin statutory violations (21 U.S.C. 332) and to condemn adulterated or misbranded foods, drugs, devices, and cosmetics (21 U.S.C. 334). However, no provision of the FDCA commands the FDA to initiate investigative or enforcement activity whenever a statutory violation is alleged or found. Nor does the Act provide standards to be used by the FDA in determining whether or when to undertake such activity. "The statute is silent on what factors should guide the (agency's) decision; * * * on the face of the statute there is simply 'no law to apply' in determining if the decision is correct." Southern Ry., 442 U.S. at 455. The court of appeals made only the most perfunctory effort to show that the FDCA provides law to apply, although in our view that is the dispositive question in this case. The court of appeals observed in a footnote (Pet. App. 26a n.29) that provisions of the FDCA specify that violators "shall" receive specified penalties. The insubstantial nature of this argument was demonstrated by Judge Scalia's observation in dissent that "(m)ost of the criminal code is cast in such mandatory terms, and yet prosecutors' discretion not to indict is the archetype of unreviewable enforcement discretion" (Pet. App. 48a). /16/ 2. The Preamble To A Proposed But Unadopted Rule Does Not Limit The FDA's Enforcement Discretion. Without any "law to apply" in the FDCA, the court of appeals turned to the preamble to a regulation that was proposed for notice and comment but was never adopted by the agency. See 37 Fed. Reg. 16503-16505 (1972). The entire weight of the court of appeals decision rests on this slender reed. The preamble, however, plainly does not provide a basis for judicial review. a. In the first place, the preamble cannot fairly be read to restrict the agency's enforcement discretion. The subject of the preamble and the proposed regulation was not the FDA's exercise of enforcement discretion but a question regarding the interpretation of the FDCA's drug approval provisions. Specifically, the question addressed was the application of the drug approval provisions when approved drugs are prescribed by physicians for an unapproved use after shipment in interstate commerce. The preamble concluded that physicians are not prohibited from prescribing approved drugs for unapproved uses but that in certain circumstances the unapproved use of an approved drug may justify FDA enforcement action. The preamble was solely concerned with this question of statutory interpretation and did not purport to address the issue of the FDA's enforcement discretion. The court of appeals, however, seized upon a single sentence in the preamble and wrenched it out of context. /17/ The sentence stated (see Pet. App. 24a (emphasis added)) that "(w)here the unapproved use of an approved new drug becomes widespread or endangers the public health, the Food and Drug Administration is obligated to investigate it thoroughly and to take whatever action is warranted to protect the public." In context, this sentence meant only that, when a possible violation occurs, the FDA is obligated to fulfill its statutory mandate. But as previously observed, an agency may fulfill its statutory enforcement responsibilities by pursuing any of a number of enforcement strategies. An agency is not generally required to investigate or initiate enforcement action whenever a possible violation is reported or suspected. The FDA has always exercised the traditional broad scope of enforcement discretion. Indeed, its rules specify that the agency regards its enforcement discretion to be unreviewable. 21 C.F.R. 10.45(d)(2) (i). See page 25 note 15, supra. It is far-fetched to suggest that the sentence in the preamble was meant to surrender any portion of that discretion. The wording of the preamble also refutes the suggestion that it was intended to limit the FDA's discretion. As Judge Scalia noted (Pet. App. 48a-49a), the sentence on which the court of appeals relied is full of flexible terms that do not provide a workable basis for judicial review. The sentence stated (see id. at 24a (emphasis added)) that "(w)here the unapproved use of an approved new drug becomes widespread or endangers the public health, the Food and Drug Administration is obligated to investigate it thoroughly and to take whatever action is warranted to protect the public." What is "widespread" use? What constitutes a sufficient danger to the public health? And in a given case, what action is "warranted"? It is evident that these questions cannot be answered intelligently without surveying the potential dangers posed by all the foods and drugs marketed in this country and all the resources at the FDA's command. We do not see how the courts could perform that function without taking over day-to-day operation of the agency. Moreover, the preamble addressed only one small portion of the FDA's investigative and enforcement responsibilities: the unapproved use of approved drugs. This is an area in which the agency's authority to proceed is less well settled than in cases involving more common types of violations, /18/ such as the promotion and sale of products for unproven uses. Neither the court of appeals nor respondents have suggested that the courts can review every FDA enforcement decision or even every decision involving the issue of misbranding. It is thus most unlikely that the FDA would have obligated itself to take investigative or enforcement action in all cases in an area near the fringes of the law, while reserving the discretion not to proceed in cases where its authority is far more firmly established. b. Even if the unadopted preamble had discussed the FDA's enforcement discretion, it would not bind the agency. Under most circumstances, of course, a rule that is proposed but not adopted has no legal effect. It cannot be judicially enforced any more than a bill that is not enacted into law. The court of appeals justified its reliance on the preamble on two grounds. First, the court stated that the FDA itself considers the preamble to be "binding" and "authoritative" (Pet. App. 25a & n.28). Second, the court observed that the preamble fell within the APA's definition of a rule, which it construed as "broad enough to include nearly every statement an agency may make" (id. at 25a, quoting Center for Auto Safety v. NHTSA, 710 F.2d 842, 846 (D.C. Cir. 1983)). Neither of these grounds is valid. The court of appeals' description of the status of the preamble in the FDA's eyes is misleading at best. Under the FDA's rules, a policy statement accompanying an unadopted regulation is considered to be an advisory opinion unless subsequently repudiated by the agency or overruled by a court. 21 C.F.R. 10.85(d). /19/ Advisory opinions are usually requested by persons who may be affected by FDA action. Advisory opinions bind the agency in the sense that the agency is usually precluded from taking action against a person or firm that has relied on such an opinion. See 21 C.F.R. 10.85(e). /20/ However, the FDA's rules make clear that an advisory opinion does not establish legal standards or requirements that are binding in other contexts. The rules unequivocally state (21 C.F.R. 10.85(j) (emphasis added)): An advisory opinion may be used in administrative or court proceedings to illustrate acceptable and unacceptable procedures or standards, but not as a legal requirement. Accordingly, under its own rules, the FDA does not regard the unadopted preamble as a generally binding legal requirement. /21/ The other basis for the court of appeals' reliance on the preamble -- that it falls within the APA's definition of a rule -- is equally unsound. Assuming for the sake of argument that the preamble is a "rule" within the APA definition, /22/ "as a matter of administrative law, * * * it seems clear that agencies are not required, at the risk of invalidation of their action, to follow all of their rules." United States v. Caceres, 440 U.S. 741, 754 n.18 (1979). Legislative rules /23/ have the force and effect of law and thus generally bind an agency. Vitarelli v. Seaton, 359 U.S. 535 (1959); Service v. Dulles, 354 U.S. 363 (1957); 2 K. Davis, Administrative Law Treatise Section 7.21 (2d ed. 1979). By contrast, interpretative rules and other agency pronouncements -- guidelines, policy statements, advisory opinions, handbooks, manuals, instructions to staff -- are generally not binding and thus do not furnish law to apply under 5 U.S.C. 701(a)(2). See, e.g., Schweiker v. Hansen, 450 U.S. 785 (1981); Chrysler Corp. v. Brown, 441 U.S. 281, 301-302 (1979); Sullivan v. United States, 348 U.S. 170, 173 (1954); Gatter v. Nimmo, 672 F.2d 343, 347 (3d Cir. 1982); Pacific Gas & Electric Co. v. FPC, 506 F.2d 33 (D.C. Cir. 1974); Brennan v. Ace Hardware Corp., 495 F.2d 368, 376 (8th Cir. 1974); 2 K. Davis, supra, Section 7.21, at 100. As Professor Davis has written (2 K. Davis, supra, Section 7.21, at 105): "(w)hen a non-legislative rule explicitly states that it does not confer rights or impose obligations, the explicit statement should control in absence of a good reason to the contrary." The unadopted preamble at issue here is certainly not a legislative rule, /24/ and as previously shown, FDA regulations explicitly state that informal pronouncements such as the preamble do not impose generally binding legal requirements. 21 C.F.R 10.85(j). Thus, in the absence of a good reason to the contrary -- and there is none -- the preamble should not be held to bind the agency. Certainly this is not a case in which there has been detrimental reliance on the preamble. /25/ Respondents make no claim that they relied on the preamble when they decided to commit their capital offenses. Moreover, judicial enforcement of the preamble would have highly undesirable practical consequences. As noted, the preamble is, at most, an informal statement of policy that the agency itself does not regard as binding except in narrow circumstances. The court of appeals' holding boils down to the proposition that any such agency statement regarding its enforcement policy provides a sufficient basis for judicial review of the agency's enforcement decisions. Adoption of this view would penalize an agency for explaining its enforcement policies to the public or for promulgating internal guidelines in an effort to ensure that its enforcement decisions are rational and consistent. Yet both of those activities are beneficial and should be encouraged. /26/ 3. The Question Whether There Is Law To Apply Does Not Depend Upon A Judicial Assessment Of "Pragmatic Considerations." Since neither the FDCA nor the preamble provides any "law to apply" in this case, the only possible basis for the decision below is the court of appeals' conclusion (Pet. App. 24a) that "(t)he determination of whether there "is law to apply' turns on such pragmatic considerations as whether judicial supervision is necessary to safeguard plaintiffs' interests, whether judicial review will unnecessarily impede the agency in effectively carrying out its congressionally assigned role, and whether the issues are appropriate for judicial review." /27/ However, this test, which the court of appeals now regularly applies in cases in this area, /28/ is not faithful to the restrictions on judicial review imposed by Congress. The question whether a matter is "committed to agency discretion by law (5 U.S.C. 701(a)(2)) or whether there is "'law to apply'" (Overton Park, 401 U.S. at 410) is a straightforward question of statutory construction. It is not a policy question calling for judges to decide whether judicial supervision seems "necessary" or "appropriate" (Pet. App. 24a) based upon their "personal policy preferences" (Chevron U.S.A. Inc. v. NRDC, slip op. 27). As Judge Scalia aptly put it (Pet. App. 61a), the court of appeals' "pragmatic considerations" test means that the court is free to review discretionary administrative determinations whenever it "think(s) it a good idea." He added (id. at 61a-62a): "The recited 'pragmatic considerations' bear no rational relationship to 'whether there is law to apply.' One could with equivalent logic recite them as the definition of 'injury in fact' -- or of almost any other concept that needs evisceration." C. The Structure And Legislative History Of The FDCA Show That Congress Intended The FDA To Have Unreviewable Enforcement Discretion Both the structure and legislative history of the FDCA reinforce the conclusion that the FDA was intended to have unreviewable enforcement discretion. 1. In Southern Ry., this Court inferred from the structure of the Interstate Commerce Act that the ICC's enforcement decision was not reviewable. The Court relied upon the disruptive effect of permitting review: "If the Commission * * * must carefully analyze and explain its actions with regard to each component of each proposed schedule, and if it must increase the number of investigations it conducts, all in order to avoid judicial review and reversal, its workload would increase tremendously." 442 U.S. at 457. Similarly, court review of the FDA's enforcement decisions would seriously impair the agency's ability to carry out its congressionally assigned role. The FDA's regulatory and enforcement duties are far reaching. The FDA bears either sole or primary regulatory responsibility for the safety of all of the nation's human and veterinary drugs, most foods, biological products (e.g., vaccines and blood products), medical devices, and radiological products (e.g., X-ray machines, color television sets, and microwave ovens). The FDA implements its regulatory authority through both pre-marketing approval (which applies to most human and veterinary drugs, food additives, biological products, and certain medical devices) and extensive post-marketing enforcement programs, which consist primarily of scheduled inspections of manufacturing and holding facilities of all regulated products. Additionally, the FDA is the regulatory agency frequently called upon to deal with national emergencies such as the botulism scare of 1974 and, more recently, the Tylenol poisonings of 1983. Enforcement of the FDA's regulatory authority takes place through seizures under 21 U.S.C. 334, injunctive actions under 21 U.S.C. 332, and criminal prosecutions under 21 U.S.C. 333. Administrative remedies are also widely utilized. Judicial review of the FDA's myriad enforcement decisions would interfere greatly with these responsibilities. The court of appeals candidly admitted that review of such decisions requires a "searching and careful" scrutiny of "both the administrative record, particularly the uncontroverted evidence submitted by (respondents), and the agency's stated reasons for its action" (Pet. App. 31a). There is little doubt that such exacting review would pressure agencies to respond to requests for enforcement action with carefully phrased and factually detailed written decisions. /29/ Agencies would be forced by the threat of burdensome court proceedings and possible reversal to disclose sensitive and privileged information regarding their broad enforcement plans. They would also be compelled to expend resources that could be put to far better use. See L. Jaffe, Judicial Control of Administrative Action 272 (1965) ("Enforcement would become impossible if an agency were required to justify its prosecutorial choices."). 2. The legislative history of the FDCA also strongly supports the nonreviewability of the FDA's enforcement determinations. During Senate consideration of the bill that became the FDCA (S. 5, 75th Cong., 1st Sess. (1937)), Senator Moore observed (81 Cong. Rec. 2013-2014 (1937)) that doctors in his home state were "much concerned about the bill" (id. at 2014 (emphasis added)): The doctors point out that * * * the provision as to prosecution is permissive; that it would not be necessary under the bill to enforce the law. It would give the Secretary of Agriculture /30/ the right to be judge, jury, and trial attorney. He might or might not decide that he should present evidence of any violation to the proper authorities. Senator Moore was referring to a report of the Welfare Committee of the Medical Society of New Jersey, which was ordered printed in the Congressional Record. The report stated (81 Cong. Rec. 2015 (1937)) : The only part of the present S. 5 which is mandatory to the Secretary of Agriculture is chapter 3, Section 7, which requires the Secretary to hold hearings for "persons against whom proceedings are contemplated in accordance with regulation prescribed by himself" * * * * *. In the article by Dr. Woodward * * * he unequivocally condemned the discretionary features of the bill. The report continued (81 Cong. Rec. 2016 (1937) (emphasis added)): Consider now the administrative features of S. 5 * * *. We find in section 25 of S. 5 (now 21 U.S.C. 372) that "The Secretary is merely authorized to conduct examinations and investigations for the purposes of this act." But this is not the worst, because in section 8 (now 21 U.S.C. 336) we find that the Secretary or his agent is given the right to simply write a letter to an offender for whatever he may say that he "believes" to be a "minor violation." A minor violation is legally undefinable in any court; a man's belief is equally undefinable in a statute * * *. Thus we find that this clause provides for an administrative arbitrator who may legally limit the definitions of offense and the infliction of penalty on each violation detected; who may prosecute or withhold action as he sees fit, and thus may adjudicate each offense en camera; a combination of legislative, administrative, and judicial functions in one Cabinet official, to be delegated to a bureau chief. In his detailed response (81 Cong. Rec. 2016-2018 (1937)), Senator Copeland, the floor manager of the bill, in no way contradicted this characterization of the bill. A substitute proposed by Senator Moore was defeated by the Senate (id. at 2018), and the FDCA passed the Senate soon thereafter (id. at 2019). On the House side as well, it was recognized that the FDA would have broad discretionary authority, like that of a criminal prosecutor, in determining whether to seek enforcement. /31/ Congress thus clearly contemplated that the FDA would have no judicially cognizable duty to initiate proceedings to enforce the Act. /32/ As a commentator wrote shortly after the Act's passage: "Leaving aside the question of 'multiple seizures,' /33/ the exercise of discretion by the federal authorities in determining whether to institute criminal or libel for condemnation proceedings or both is not subject to judicial interference." Lee, The Enforcement Provisions of the Food, Drug, and Cosmetic Act, 6 Law & Contemp. Probs. 70, 76 (1939). II. EVEN IF REVIEWABLE, THE FDA'S ENFORCEMENT DECISION WAS RATIONAL AND SHOULD HAVE BEEN SUSTAINED Even if the FDA's decision not to regulate the states' use of drugs in carrying out capital punishment were reviewable, it nonetheless should have been upheld. In those special circumstances in which judicial review of administrative enforcement decisions is allowed, the scope of review is limited to determining whether the agency has stated a rational basis for its decision. Dunlop v. Bachowski, 421 U.S. at 568, 572-573. That standard was easily met here. A. The FDA Lacks Authority To Regulate The States' Use Of Lethal Injections For Capital Punishment The FDA denied respondents' petition, first because it concluded (Pet. App. 82a) that "the use of lethal injection by State penal systems is a practice over which FDA has no jurisdiction." An agency's interpretation of the statute it administers is entitled to considerable deference. As this Court recently noted (Chevron U.S.A. Inc. v. NRDC, No. 82-1005 (June 24, 1984), slip op. 4-5 (footnotes omitted)): When a court reviews an agency's construction of the statute which it administers, it is confronted with two questions. First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. Here, it certainly cannot be argued that "Congress has directly spoken to the precise question at issue." Neither the court of appeals nor respondents have produced a shred of evidence that Congress wanted the FDA to regulate the methods of capital punishment used by the states. Moreover, Congress's silence on this point cannot be attributed to the fact that no state employed lethal injections when the FDCA was enacted in 1938. The provisions of the FDCA upon which the court of appeals relied apply to all "drugs" and "devices." A "drug" is broadly defined to include any "articles (other than food) intended to affect the structure or any function of the body of man" (21 U.S.C. 321(g)(1)(C)). This definition arguably could encompass the cyanide tablets used in gas chambers. Likewise, a "device" is defined to include any "instrument, apparatus, implement, machine, contrivance * * * or other similar or related article * * * which is * * * intended to affect the structure or any function of the body of man" (21 U.S.C. 321(h) and (3)). The electric chair and gallows could also be argued to fall within this definition. In 1938, the state and federal governments regularly used these methods of capital punishment. Yet there is no indication that any member of Congress even considered the possibility that enactment of the FDCA might affect these practices. Since Congress did not intend the FDA to regulate capital punishment, the remaining question is whether the FDA's construction of the statute is a permissible one. In this case, the FDA's interpretation is plainly correct. The statutory provisions upon which the court of appeals relied, 21 U.S.C. 331(k) and 352(f), prohibit the "misbranding" of drugs while they are "held for sale." Without exploring all of the elements needed to make these provisions applicable, it seems clear that Section 331(k) and 352(f) do not apply in the unique situation at issue here because the alleged act of misbranding does not occur while the drugs are "held for sale." It is true that the phrase "held for sale" has been given an expansive reading by the courts in the context of the FDA's traditional enforcement activity. See, e.g., United States v. Diapulse Corp., 514 F.2d 1097 (2d Cir.), cert. denied, 423 U.S. 838 (1975). However, there is no basis to apply it in a context so far afield from the FDA's traditional enforcement activity as the imposition of capital punishment. The court of appeals' and respondent's interpretation of this phrase is not supported by either the statutory language or a scintilla of evidence regarding Congress's intent. According to respondents and the court of appeals, the misbranding takes place when the drugs are used by prison officials for a purpose (capital punishment) that is not listed on their labels. /34/ See Pet. App. 16a-17a. The court of appeals acknowledged (see id. at 14a) that the drugs are not "held for sale" in any literal sense when they are injected into the condemned prisoner against his will. But the court relied (id. at 14a-15a) upon legislative history showing that Section 331(k) was intended to exercise the full reach of federal power under the Commerce Clause for the purpose of protecting "consumers." We readily agree that Congress's purpose in enacting Section 331(k) was to extend the greatest possible protection to persons to whom drugs may be administered for conventional purposes. But, as noted, there is absolutely no evidence that Congress intended to regulate the use of drugs or devices, pursuant to a lawful court order, for the purpose of capital punishment. Unsupported by either the statutory language or any proof of congressional intent, the court of appeals' and respondents' strained interpretation of the statute must fail. /35/ The "misbranding" provisions were not violated. B. Other Legitimate And Substantial Considerations Support The FDA's Determination Not To Initiate Investigative Or Enforcement Activity Even if the FDCA could somehow be stretched to reach the administration of lethal injections for purposes of capital punishment, the FDA properly exercised its "inherent discretion to decline to pursue certain enforcement matters" (Pet. App. 85a). In the first place, the FDA recognized that any efforts to assert jurisdiction would result in protracted and quite possibly unsuccessful litigation with the states. /36/ See Pet. App. 32a, 82a-85a; United States v. Evers, 643 F.2d 1043 (5th Cir. 1981). It is certainly within an administrative agency's discretion to shun burdensome cases where its jurisdiction appears dubious at best. The FDA had three additional sound reasons for its decision. To begin with, regulating the method of capital punishment used by the states, whether or not technically within the scope of the FDCA, is far removed from the FDA's central responsibilities. Surely the FDA acted reasonably in conserving its limited enforcement resources for matters more closely related to its principal mission. /37/ The FDA's decision also was based upon appropriate respect for principles of federalism. The FDA stated (Pet. App. 82a) that its decision was "supported * * * by a consideration of the proper role of the Federal Goverment with respect to the conduct of State criminal justice systems." See also id. at 85a. Enacting laws to prevent and punish crime is among the most important powers of the states, and in prescribing lethal injection as the method of execution, the states acted within federal constitutional limits. The FDA was reasonable in deferring to the states' authority in this field. Finally, the FDA acted reasonably in relying (Pet. App. 85a) in the alternative on the absence of a "serious danger to the public health." The court of appeals disagreed (id. at 5a), asserting that there was "a substantial threat of torturous pain to persons being executed." However, not only is the factual predicate for the court's conclusion dubious (see id. at 51a-52a & n.5), but the court appears entirely to have missed the point. The proper inquiry is not whether death by lethal injection involves pain but whether it involves more pain than death by alternative methods of execution, such as the electric chair, the firing squad, or the gas chamber. As Judge Scalia put it (id. at 51a (emphasis in original)), "it is not a matter of pain versus no pain, but rather pain of one sort substituted for pain of another -- and in all likelihood substitution of a lesser pain, since that is the principal purpose of the lethal injection statutes." Such comparisons were made by the legislatures that enacted the lethal injection statutes. The FDA acted responsibly in declining to review their determinations on this unique subject. /38/ Thus, even if the FDA's decision not to initiate enforcement proceedings were judicially reviewable, that decision was rational and should not have been disturbed. CONCLUSION Thejudgment of the court of appeals should be reversed. Respectfully submitted. REX E. LEE Solicitor General RICHARD K. WILLARD Acting Assistant Attorney General KENNETH S. GELLER Deputy Solicitor General SAMUEL A. ALITO, JR. Assistant to the Solicitor General LEONARD SCHAITMAN JOHN M. ROGERS Attorneys THOMAS SCARLETT Chief Counsel MICHAEL P. PESKOE Associate Chief Counsel for Drugs Food and Drug Administration AUGUST 1984 /1/ These statutes include: Ark. Stat. Ann. Section 41-1352 (Supp. 1983); Idaho Code Section 19-2716 (Supp. 1983); Ill. Ann. Stat. ch. 38, Section 119-5 (Smith-Hurd Supp. 1984); Mass. Ann Laws ch. 279, Section 61 (Law. Coop. Supp. 1984); Mont. Code Ann. Section 49-19-103(3) (1983) (prisoner given choice of hanging or lethal injection); Nev. Rev. Stat. Section 176.355 (1979); N.J. Stat. Ann. Section 2C:49-2 (West Supp. 1984-1985); N.M. Stat. Ann. Section 31-14-11 (Supp. 1983); N.C. Gen. Stat. Section 15-187 (1983) (choice of lethal gas or lethal injection); Okla. Stat. Ann. tit. 22, Section 1014 (Supp. 1983); S.D. Codified Laws Ann. Section 23A-27A-32 (Supp. 1984); Tex. Code Crim. Proc. Ann. art. 43.14 (Vernon Supp. 1984); Utah Code Ann. Section 77-18-5.5 (1983) (choice of firing squad or lethal injection); Wash. Rev. Code Section 10.95.180 (Supp. 1984) (choice of hanging or lethal injection). /2/ The FDCA prohibits "the doing of any act" that results in a drug's being "misbranded" what it is "held for sale" (21 U.S.C. 331(k)). The FDCA also provides that a drug is misbranded "(u) nless its labeling bears * * * adequate directions for use" (21 U.S.C. 352(f)). The FDCA prohibits the introduction of a "new drug" into interstate commerce or its delivery for introduction into interstate commerce unless it has been approved by the FDA as "safe and effective" (21 U.S.C. 355). A drug is considered to be a "new drug" if, inter alia, it is not generally recognized as safe and effective for use under the conditions "prescribed, recommended, or suggested in (its) labeling." 21 U.S.C. 321(p). /3/ Respondents requested that the FDA take the following actions (J.A. 32-33): 1. Affix a boxed warning to the labels of the drugs specified in the State statutes stating that these drugs are not approved for use as a means of execution, are not considered safe and effective as a means of execution, and should not be used as a means of execution. 2. Prepare and send to the manufacturers of the drugs and to the prisons and departments of correction in Texas, Oklahoma, Idaho, and New Mexico notices advising that the drugs specified for use in an execution in those States' statutes or prison policies are not approved for use as a means of execution, are not considered safe and effective as a means of execution, and should not be used as a means of execution. 3. Place an article in the Drug Bulletin (an FDA medical newsletter sent to physicians) advising that the drugs specified for use as lethal injections are not approved for use as a means of execution, are not considered safe and effective as a means of execution, and should not be used as a means of execution. 4. Adopt a policy and procedure for the seizure and condemnation from prisons or State departments of correction of drugs which are intended to be used as a means of execution. 5. Recommend the prosecution of manufacturers, wholesalers, retailers, and pharmacists who knowingly sell drugs for the unapproved use of lethal injection and prison officials who knowingly buy, possess, or use drugs for the unapproved use of lethal injections. /4/ Although the court of appeals acknowledged that "the state may take the life of a person as punishment" and that the "FDA is not responsible for the execution of these prisoners," the court observed that the "FDA's impermissible refusal to exercise enforcement discretion over the use of drugs for lethal injection * * * may also implicate the Eighth Amendment's prohibition of cruel and unusual punishment." Pet. App. 37a, 38a. /5/ Judges Wilkey, Ginsburg, Bork, Scalia, and Starr voted to grant rehearing en banc; Judges Wright, Tamm, Wald, Mikva, and Robinson voted against rehearing en banc. Judge Edwards abstained. /6/ See, e.g., Note, Criminal Procedure -- Capital Punishment -- Texas Statutes Amended to Provide for Execution by Intravenous Injection of a Lethal Substance, 9 St. Mary's L.J. 359, 361 (1977) (Texas lethal injection statute introduced "primarily because of a belief by proponents that death by lethal injection is more humane and more dignified than death by electrocution"); Gardner, Executions and Indignities: An Eighth Amendment Assessment of Methods of Inflicting Capital Punishment, 39 Ohio St. L.J. 96, 128-129 (1978). /7/ The court of appeals held that the FDCA's misbranding provisions (21 U.S.C. 331(k), 352(f)) are violated when prescription drugs approved by the FDA for other purposes are employed for capital punishment, a use for which FDA approval has not been sought or granted. The court apparently concluded that the drugs are misbranded because their labeling does not bear "adequate directions for use" (21 U.S.C. 352(f)) in causing death. Such labeling could not accompany the drugs, however, absent the approval of a new drug application (21 U.S.C. 321 (p)(1), 355; see also page 3 note 2, supra). By regulation (21 C.F.R. 201.100(c)(2)) a new drug must generally bear the labeling "authorized by (its) approved new drug application." See also United States v. Articles of Drugs (Rucker), 625 F.2d 665, 675 (5th Cir. 1980). Accordingly, the drugs would have to be approved as safe and effective in causing death (21 U.S.C. 355) before they could be lawfully labeled for that purpose. /8/ See, e.g., United States v. Ross, 719 F.2d 615, 620 (2d Cir. 1983); United States v. Torquato, 602 F.2d 564, 569 (3d Cir.), cert. denied, 444 U.S. 941 (1979); United States v. Johnson, 577 F.2d 1304, 1307 (5th Cir. 1978). /9/ See, e.g., Inmates of Attica Correctional Facility v. Rockefeller, 477 F.2d 375, 380 (2d Cir. 1973); Newman v. United States, 382 F.2d 479, 480 (D.C. Cir. 1967). /10/ The court of appeals erroneously stated (Pet. App. 28a n.35) that the general counsel's decisions are unreviewable because 29 U.S.C. 153(d) explicitly precludes review. That provision states that "(t)he General Counsel * * * shall have final authority, on behalf of the Board, in respect of the investigation of charges and issuance of complaints" (emphasis added). The meaning of that provision is that the general counsel's decision is not subject to administrative review. The Board has delegated to him the authority to make the final administrative decision on its behalf. The opinion in NLRB v. Sears, Roebuck & Co., 421 U.S. at 138, cited the statute to support this point, and it cited Vaca v. Sipes, supra, on the issue of judicial review. /11/ The Court stated (355 U.S. at 414) that the question whether the proceedings in a particular case should be held in abeyance pending anticipated future proceedings against competitors was reviewable to determine whether there had been a "patent abuse of discretion." Obviously the timing of such proceedings might affect the companies' relative competitive advantage. That is an entirely different question from whether a decision not to take enforcement action is reviewable. /12/ In New Jersey v. United States, supra, the Court summarily affirmed a decision holding that the Interstate Commerce Commission had unreviewable discretion to decline to investigate a railroad's proposed suspension of service. The three-judge court had held (168 F. Supp. at 329) that the ICC's decision was agency action committed by law to agency discretion. /13/ Such a finding enables the EPA to issue a compliance order or initiate a civil action for injunctive relief or the assessment of a civil penalty. 42 U.S.C. (Supp. V) 7413. /14/ The primary purpose of the Eighth Amendment is to proscribe "tortures" and other "barbarous" methods of punishment. Gregg v. Georgia, 428 U.S. 153, 170 (1976) (plurality opinion); In re Kemmler, 136 U.S. 436, 447-449 (1890) (holding electrocution not cruel and unusual method of execution); Wilkerson v. Utah, 99 U.S. 130, 136 (1879) (holding firing squad not cruel and unusual method of execution). Lethal injection statutes have been challenged under the Eighth Amendment on direct appeal from the judgment imposing the death sentence (see, e.g., Earvin v. State, 582 S.W.2d 794, 799 (Tex. Crim. App.) (execution by lethal injection not cruel and unusual punishment)), cert. denied, 444 U.S. 919 (1979), and in habeas corpus proceedings (see, e.g., Ex parte Granviel, 561 S.W.2d 503 (Tex. Crim. App. 1978) (execution by lethal injection not cruel and unusual punishment)). /15/ 21 C.F.R. 10.45(d)(2) and (i) provides: (2) The Commissioner shall object to judicial review of a matter if: (i) The matter is committed by law to the discretion of the Commissioner, e.g., a decision to recommend or not to recommend civil or criminal enforcement action under sections 302, 303, and 304 of the act * * *. /16/ The court of appeals also relied (Pet. App. 26a n.29) on 21 U.S.C. 336, which provides that the Secretary of HHS is not required "to report for prosecution, or for the institution of libel or injunction proceedings, minor violations * * * whenever he believes that the public interest will be adequately served by a suitable written notice or warning." This provision does not impliedly require the FDA to take enforcement action whenever there is a violation that is not "minor." Insofar as respondents requested that the FDA take purely administrative action, the provision does not apply because it pertains only to the reference of cases to the Department of Justice for litigation. And insofar as respondents sought the initiation of litigation, the provision is equally inapplicable because the legislative history makes clear that it was not intended to alter the Justice Department's traditional prosecutorial discretion. See 83 Cong. Rec. 7792 (1938) (remarks of Rep. Lea) ("I call attention * * * to the fact that the mere circumstance that the Secretary does not report the offense does not excuse the accused from prosecution. The Attorney General may proceed in case he desires to do so."); id. at 7794 ("(T)here is nothing more common in the administration of justice than the exercise of the discretion of a prosecuting attorney where he knows it is impracticable to prosecute purely technical violations of the law."). Rather, the legislative history shows that the provision was intended to give statutory recognition to one aspect of the FDA's much broader enforcement discretion. During floor debate, it was noted that "there will be * * * thousands of technical violations of the food and drug law which cannot as a practical matter be prosecuted." 83 Cong. Rec. 7793 (1938) (remarks of Rep. Lea). The House Report stated (H.R. Rep. 2139, 75th Cong., 3d Sess. 5 (1938)) that 21 U.S.C. 336 gives "definite legislative sanction to the procedure." It should also be noted that 21 U.S.C. 336 was enacted as a companion provision to 21 U.S.C. 335, which provides that the Secretary of HHS must give potential criminal defendants an opportunity for a hearing before referring a case to the Justice Department for prosecution. In light of this somewhat unusual provision, 21 U.S.C. 336 was designed simply to make clear that even if the Secretary finds after the hearing that there has been a "minor" or technical violation, the Secretary is not obligated to report the case to the Justice Department. See 83 Cong. Rec. 7792 (1938) (remarks of Rep. Lea) (discussing Sections 335 and 336 as interrelated provisions). Respondents rely (Br. in Opp. 21) on provisions of the FDCA authorizing judicial review of various FDA regulations and orders. See 21 U.S.C. 346a(i), 348(g), 355(h), 360g. They also rely on 21 U.S.C. 332(a), which gives the district courts jurisdiction to restrain certain statutory violations. Obviously none of these statutes places the slightest restriction on FDA's enforcement discretion. /17/ The court quoted (Pet. App. 24a, 25a) two other sentneces from the preamble, but neither can possibly be read to limit the FDA's enforcement discretion. The first of these stated merely that the FDA would not "hesitate to take whatever action * * * may be required." The second stated that certain conduct constituted a statutory violation and "is punishable accordingly." /18/ See United States v. Evers, 643 F.2d 1043 (5th Cir. 1981). /19/ 21 C.F.R. 10.85(d) provides in pertinent part: (d) A statement of policy or interpretation made in the following documents, unless subsequently repudiated by the agency or overruled by a court, will constitute an advisory opinion: (1) Any portion of a Federal Register notice other than the text of a proposed or final regulation, e.g., a notice to manufacturers or a preamble to a proposed or final regulation. /20/ 21 C.F.R. 10.85(e) provides (emphasis added): (e) An advisory opinion represents the formal position of FDA on a matter and except as provided in paragraph (f) of this section, obligates the agency to follow it until it is amended or revoked. The Commissioner may not recommend legal action against a period or product with respect to an action taken in conformity with an advisory opinion which has not been amended or revoked. /21/ See United States v. Articles of Drug * * * Promise Toothpaste, No. 83-C-6129 (N.D. Ill. July 30, 1984), slip op. 11-15 (portions of unadopted preamble, particularly those dealing with enforcement decisions, should not be regarded as advisory opinion; at most, advisory opinion restricts FDA authority to proceed against persons who have relied on opinions); McIlwain v. Hayes, 530 F. Supp. 973, 977-978 n.8 (D.D.C. 1981), aff'd, 690 F.2d 1041 (D.C. Cir. 1982). /22/ The APA's definition of a rule is broad and ambiguous. The APA states (5 U.S.C. 551(4)) that a "'rule' means the whole or a part of an agency statement of general or particular applicability and future effect designed to implement * * * law or policy." Whether an advisory opinion falls within the APA's definition of a rule is subject to dispute and may vary from case to case. See 2 K. Davis, Administrative Law Treatise Section 7.4 (2d ed. 1979). Because the definition of a rule is so unclear, questions of administrative law can seldom be answered simply by applying that definition. As Professor Davis has observed, "(o)ften the best solution * * * is * * * to skip the labeling and to proceed directly to the problem at hand." K. Davis, Administrative Law Text Section 5.01, at 123 (1972). /23/ "Legislative rules" have been defined as rules that are "'issued by an agency, pursuant to statutory authority and * * * implement the statute. * * * Such rules have the force and effect of law.'" Batterton v. Francis, 432 U.S. 416, 425 n.9 (1977) (quoting U.S. Dep't of Justice, Attorney General's Manual on the APA 30 n.3 (1947)). "Interpretative rules," which lack the force and effect of law, have been defined as "rules or statements issued by an agency to advise the public of the agency's construction of the statutes and rules which it administers." Ibid. See also Chrysler Corp. v. Brown, 441 U.S. 281, 302 n.31 (1979); 2 K. Davis, supra, Section 7.8. /24/ Nor is this a case involving the extinguishment of rights that would otherwise have been available by statute. Compare Morton v. Ruiz, 415 U.S. 199, 236 (1974). Neither respondents nor any other member of the public ever had a statutory right to insist that the FDA pursue every possible case. /25/ See United States v. Caceres, 440 U.S. at 752-753 & n.15. /26/ See 2 K. Davis, supra, chs. 9, 10 (statements by enforcement officers concerning how enforcement discretion will be exercised are generally not binding). /27/ The court did not "delve into a detailed analysis" of these considerations because it believed that the preamble provided "law to apply" (Pet. App. 24a). /28/ See Falkowski v. EEOC, 719 F.2d 470, 480 n.16 (D.C. Cir. 1983), petition for cert. pending, No. 83-2034; Investment Co. Institute v. FDIC, 728 F.2d at 526 & n.6 (majority of panel expresses "discomfort with the test" to which circuit is bound); American Friends Service Committee v. Webster, 720 F.2d 29, 39-45 & nn.10, 13 (D.C. Cir. 1983) (literal application of Overton Park test provides "limited guidance"; must be supplemented by "more pragmatic anałysis"); Local 1219, American Fed'n of Gov't Employees v. Donovan, 683 F.2d 511, 515 (D.C. Cir. 1982); Natural Resources Defense Council, Inc. v. SEC, 606 F.2d 1031, 1044 (D.C. Cir. 1979). /29/ Where agency action is subject to judicial review, this Court has frequently observed that "the orderly functioning of the process of review requires that the grounds upon which the administrative agency acted be clearly disclosed." SEC v. Chenery Corp., 318 U.S. 80, 94 (1943); see also, e.g., Motor Vehicle Mfrs. Ass'n v. State Farm Mutual, No. 82-354 (June 24, 1983), slip op. 12-13; FTC v. Sperry & Hutchinson Co., 405 U.S. 233, 249 (1972); FPC v. United Gas Pipe Line Co., 393 U.S. 71, 73 (1968). /30/ Enforcement of the FDCA was originally the responsibility of the Secretary of Agriculture. Act of June 25, 1938, ch. 675, Section 201(c) and (d), 52 Stat. 1041. /31/ Representative Lea, in connection with the section of the bill that became 21 U.S.C. 336, stated (83 Cong. Rec. 7793-7794 (1938)): (I)n this particular case we are dealing with the duties of a purely administrative official and this is far different from dealing with a judicial officer, even somewhat different from dealing with the Department of Justice. However, there is nothing more common in the practice of criminal law than for the prosecuting attorney to exercise his judgment as to the cases he will prosecute. * * * * * * * * (T)here is nothing more common in the administration of justice than the exercise of the discretion of a prosecuting attorney where he knows it is impracticable to prosecute purely technical violations of the law. This is a candid recognition of that practical situation, and I believe it will work for the betterment of law enforcement. * * * /32/ The legislative history on which the court of appeals relied (Pet. App. 26a n.29, citing S. Rep. 646, 74th Cong., 1st Sess. 10 (1935)) relates to statutory language that was never enacted and, in fact, was specifically rejected by Congress. Several years before the enactment of the FDCA, a predecessor bill was introduced. S. 5, 74th Cong., 2d Sess. (1936). As reported by the Senate committee, Section 702 of that bill contained the following language (S. 5, supra, at 23 (language marked out)): The district courts * * * are hereby vested with jurisdiction, on petition by any interested person, * * * to grant appropriate injunctive relief from any act or omission of any officer, representative, or employee of the Department in the administration of this Act, if it has been shown that such act or omission is unreasonable, arbitrary, or capricious, or not in accordance with the facts or law * * *. The House committee omitted this language altogether, stating (H.R. Rep. 2755, 74th Cong., 2d Sess. 8 (1936)) that "(t)he committee was not aware of any precedent for such a proposition." See also Kleinfeld, Legislative History of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosm. L.J. 532, 564-565 (1946). The entire bill subsequently died because of a disagreement between the House and Senate over another issue. 80 Cong. Rec. 10514-10519, 10680 (1936); see Kleinfeld, supra, 1 Food Drug Cosm. L.J. at 566. When a different Senate Bill 5 passed the 75th Congress to become the FDCA, the only express reference to review of the agency's refusal to act was the provision (now 21 U.S.C. 371(f)(1) and (3)) for court of appeals review of the Secretary's refusal to "issue, amend, or repeal" certain regulations -- a limited provision clearly not applicable to the instant case. /33/ The FDCA limits the discretion of the FDA to institute a seizure proceeding for misbranding if another such proceeding is pending in any court based upon the same alleged misbranding. See 21 U.S.C. 334(a)(1). This limitation obviously does not affect the FDA's discretion not to institute proceedings. /34/ This case concerns the FDA's authority to regulate the states' use of drugs, lawfully in interstate commerce, for the unapproved purpose of causing death, and not the marketing of drugs for an unapproved use. If a manufacturer or anyone else in the chain of distribution directly or indirectly were to suggest that a drug may properly be used for an unapproved use, the Act would be violated. Thus, if a drug were marketed for the purpose of causing death without being approved for that use, a violation would occur. In this case, however, it has not been alleged or shown that any manufacturer or distributor directly or indirectly promotes the use of the drugs at issue for the purpose of carrying out death sentences. /35/ In concluding that the FDA possessed the authority to grant respondents' requested relief, the court of appeals repeatedly referred to the FDA's actions regarding drugs used to destroy animals and drugs administered to prisoners participating in research projects. Pet. App. 11a-12a, 31a-32a. These situations, however, are clearly distinguishable. The FDA has special statutory authority in both of these areas. See 21 U.S.C. 355(i), 357(d), 360j(g) (research projects); 21 U.S.C. 360b(a)(1) (animal drugs). The FDA has asserted authority over the marketing of drugs to destroy animals. See United States v. Beuthanasia-D Regular, (1979 Transfer Binder) Food, Drug, Cosm. L. Rep. (CCH) Paragraph 38,265 (D. Neb.). And the drugs dispensed to prisoners in research projects, participation in which is voluntary, are administered for conventional purposes and not for the purpose of punishment. /36/ Subsequent events have proven this prospect accurate. When a Texas prisoner sentenced to death by lethal injection obtained a district court injunction requiring the FDA to seize the State's drugs (O'Bryan v. Heckler, Civ. No. 84-996 (D.D.C. Mar. 30, 1984), vacated, No. 84-996 (D.C. Cir. Mar. 30, 1984), stay denied, No. A-791 (Mar. 30, 1984)), the State immediately sued the FDA to block the seizure. McKaskle v. United States Food and Drug Administration, No. H-84-1544 (S.D. Tex.). /37/ Respondents insist (Br. in Opp. 14 & n.8) that the FDA did not base its decision on the need to conserve its enforcement resources for other endeavors. However, the FDA clearly and repeatedly invoked the well-known doctrine of prosecutorial discretion (see Pet. App. 85a), and one of the bases for that doctrine is the view that agencies must have the freedom to concentrate their enforcement resources in a manner that achieves optimum results. We do not believe that the FDA was obligated to spell out all the familiar grounds for this doctrine. Respondents' close parsing of the FDA's decision illustrates how burdensome it would be for agencies if their enforcement decisions were subject to judicial review. /38/ Contrary to respondents' suggestion (Br. in Opp. 23-24), the Supremacy Clause does not preclude the FDA from deferring to the states' considered judgment that lethal injection is the least painful method of capital punishment. State law cannot interfere with lawful FDA action, but the Supremacy Clause does not command the federal government to take enforcement action in every possible case. APPENDIX