This is a preview of how your content will look on export. To export the complete content in DOC format, click the blue export button in the upper right corner of this page.
Food Law Casebook

  • 1 Chapter 1 - Introduction

    • 1.1 Definition of Food Law

      • 1.1.1 Adaptation of Food Law

      • 1.1.2 Phases of Food Law

        • 1.1.2.1 Commerce

        • 1.1.2.2 Food Safety

        • 1.1.2.3 Food Marketing

        • 1.1.2.4 Nutrition

        • 1.1.2.5 Food Systems

      • 1.1.3 Expansion of Food Law

        • 1.1.3.1 Base of Traditional Food Law

        • 1.1.3.2 Distinguishing Agricultural Law

        • 1.1.3.3 New Food Law: Adaptation

        • 1.1.3.4 Enlarged Audience

        • 1.1.3.5 Justification as a Distinctive Discipline

      • 1.1.4 Whitman v. American Trucking Assns.

        Whitman v. American Trucking Assns.

        1

        531 U.S. 457 (2001)

        2
        WHITMAN, ADMINISTRATOR OF ENVIRONMENTAL PROTECTION AGENCY, et al.
        v.
        AMERICAN TRUCKING ASSOCIATIONS, INC., et al.

        No. 99-1257.

        3

        United States Supreme Court.

        Argued November 7, 2000.
        Decided February 27, 2001.[1]

        4

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

        5

        [459] [459] Scalia, J., delivered the opinion of the Court, Parts I and IV of which were unanimous, Part II of which was joined by Rehnquist, C. J., and Stevens, O'Connor, Kennedy, Souter, Thomas, and Ginsburg, JJ., and Part III of which was joined by Rehnquist, C. J., and O'Connor, Kennedy, Thomas, Ginsburg, and Breyer, JJ. Thomas, J., filed a concurring opinion, post, p. 486. Stevens, J., filed an opinion concurring in part and concurring in the judgment, in which Souter, J., joined, post, p. 487. Breyer, J., filed an opinion concurring in part and concurring in the judgment, post, p. 490.

        6

        Solicitor General Waxman argued the cause for petitioners in No. 99-1257 and federal respondents in No. 99-1426. With him on the briefs were Assistant Attorney General Schiffer, Deputy Solicitor General Wallace, Jeffrey P. Minear, Christopher S. Vaden, David J. Kaplan, Mary F. Edgar, Gary S. Guzy, Gerald K. Gleason, and Michael L. Goo.

        7

        [460] Edward W. Warren argued the cause for American Trucking Associations et al., respondents in No. 99-1257 and cross-petitioners in No. 99-1426. With him on the briefs were Robert R. Gasaway, Jeffrey B. Clark, Daryl Joseffer, Charles Fried, Robin S. Conrad, Beth L. Law, Robert S. Digges, Gary H. Baise, David M. Friedland, Erika Z. Jones, Timothy S. Bishop, Jan S. Amundson, Dimetria G. (Jim) Daskal, Douglas I. Greenhaus, and Chet M. Thompson. Judith L. French, Assistant Attorney General of Ohio, argued the cause for respondents State of Ohio et al. in No. 99-1257. With her on the brief in No. 99-1257 and on the briefs for State of Ohio et al., respondents in support of crosspetitioners in No. 99-1426, were Betty D. Montgomery, Attorney General, Edward B. Foley, State Solicitor, Elise W. Porter, Frank J. Reed, Jr., and James G. Tassie, Assistant Attorneys General, Mark J. Rudolph, Jennifer M. Granholm, Attorney General of Michigan, Thomas Casey, Solicitor General, and Alan F. Hoffman and Pamela J. Stevenson, Assistant Attorneys General. Thomas F. Reilly, Attorney General of Massachusetts, Edward G. Bohlen, Assistant Attorney General, Lisa Heinzerling, John J. Farmer, Attorney General of New Jersey, and Howard L. Geduldig and John R. Renella, Deputy Attorneys General, filed briefs for the Commonwealth of Massachusetts et al., respondents in support of petitioners in No. 99-1257 and respondents in No. 99-1426. Howard I. Fox filed briefs for the American Lung Association, respondent in support of petitioners in No. 99-1257 and respondent in No. 99-1426. Henry V. Nickel, F. William Brownell, Lucinda Minton Langworthy, David E. Menotti, William F. Pedersen, Jeffrey A. Knight, G. William Frick, M. Elizabeth Cox, Russel S. Frye, Richard Wasserstrom, Grant Crandall, David F. Zoll, Alexandra Dapolito Dunn, Julie Becker, Harold P. Quinn, Jr., Newman R. Porter, David M. Flannery, and Kurt E. Blase filed briefs for Appalachian Power Co. et al., respondents in [461] No. 99-1257 and respondents in support of cross-petitioners in No. 99-1426. Robert E. Yuhnke filed a brief for Citizens for Balanced Transportation et al., respondents in No. 99-1426.[2]

        8
        [462] Justice Scalia, delivered the opinion of the Court.
        9

        These cases present the following questions: (1) Whether § 109(b)(1) of the Clean Air Act (CAA) delegates legislative power to the Administrator of the Environmental Protection Agency (EPA). (2) Whether the Administrator may consider the costs of implementation in setting national ambient air quality standards (NAAQS) under § 109(b)(1). (3) Whether the Court of Appeals had jurisdiction to review the EPA's interpretation of Part D of Title I of the CAA, 42 U. S. C. §§ 7501-7515, with respect to implementing the revised ozone NAAQS. (4) If so, whether the EPA's interpretation of that part was permissible.

        10
        I
        11

        Section 109(a) of the CAA, as added, 84 Stat. 1679, and amended, 42 U. S. C. § 7409(a), requires the Administrator of the EPA to promulgate NAAQS for each air pollutant for which "air quality criteria" have been issued under § 108, 42 U. S. C. § 7408. Once a NAAQS has been promulgated, the Administrator must review the standard (and the criteria [463] on which it is based) "at five-year intervals" and make "such revisions . . . as may be appropriate." CAA § 109(d)(1), 42 U. S. C. § 7409(d)(1). These cases arose when, on July 18, 1997, the Administrator revised the NAAQS for particulate matter and ozone. See NAAQS for Particulate Matter, 62 Fed. Reg. 38652 (codified in 40 CFR § 50.7 (1999)); NAAQS for Ozone, id., at 38856 (codified in 40 CFR §§ 50.9, 50.10 (1999)). American Trucking Associations, Inc., and its corespondents in No. 99-1257—which include, in addition to other private companies, the States of Michigan, Ohio, and West Virginia—challenged the new standards in the Court of Appeals for the District of Columbia Circuit, pursuant to 42 U. S. C. § 7607(b)(1).

        12

        The District of Columbia Circuit accepted some of the challenges and rejected others. It agreed with the No. 99— 1257 respondents (hereinafter respondents) that § 109(b)(1) delegated legislative power to the Administrator in contravention of the United States Constitution, Art. I, § 1, because it found that the EPA had interpreted the statute to provide no "intelligible principle" to guide the agency's exercise of authority. American Trucking Assns., Inc. v. EPA, 175 F. 3d 1027, 1034 (1999). The court thought, however, that the EPA could perhaps avoid the unconstitutional delegation by adopting a restrictive construction of § 109(b)(1), so instead of declaring the section unconstitutional the court remanded the NAAQS to the agency. Id., at 1038. (On this delegation point, Judge Tatel dissented, finding the statute constitutional as written. Id., at 1057.) On the second issue that the Court of Appeals addressed, it unanimously rejected respondents' argument that the court should depart from the rule of Lead Industries Assn., Inc. v. EPA, 647 F. 2d 1130, 1148 (CADC 1980), that the EPA may not consider the cost of implementing a NAAQS in setting the initial standard. It also rejected respondents' argument that the implementation provisions for ozone found in Part D, Subpart 2, of Title I of the CAA, 42 U. S. C. §§ 7511-7511f, were [464] so tied to the existing ozone standard that the EPA lacked the power to revise the standard. The court held that although Subpart 2 constrained the agency's method of implementing the new standard, 175 F. 3d, at 1050, it did not prevent the EPA from revising the standard and designating areas of the country as "nonattainment areas," see 42 U. S. C. § 7407(d)(1), by reference to it, 175 F. 3d, at 1047-1048. On the EPA's petition for rehearing, the panel adhered to its position on these points, and unanimously rejected the EPA's new argument that the court lacked jurisdiction to reach the implementation question because there had been no "final" implementation action. American Trucking Assns., Inc. v. EPA, 195 F. 3d 4 (CADC 1999). The Court of Appeals denied the EPA's suggestion for rehearing en banc, with five judges dissenting. Id., at 13.

        13

        The Administrator and the EPA petitioned this Court for review of the first, third, and fourth questions described in the first paragraph of this opinion. Respondents conditionally cross-petitioned for review of the second question. We granted certiorari on both petitions, 529 U. S. 1129 (2000); 530 U. S. 1202 (2000), and scheduled the cases for argument in tandem. We have now consolidated the cases for purposes of decision.

        14
        II
        15

        In Lead Industries Assn., Inc. v. EPA, supra, at 1148, the District of Columbia Circuit held that "economic considerations [may] play no part in the promulgation of ambient air quality standards under Section 109" of the CAA. In the present cases, the court adhered to that holding, 175 F. 3d, at 1040-1041, as it had done on many other occasions. See, e. g., American Lung Assn. v. EPA, 134 F. 3d 388, 389 (1998); NRDC v. Administrator, EPA, 902 F. 2d 962, 973 (1990), vacated in part on other grounds, NRDC v. EPA, 921 F. 2d 326 (CADC 1991); American Petroleum Institute v. Costle, 665 F. 2d 1176, 1185 (1981). Respondents argue that these [465] decisions are incorrect. We disagree; and since the first step in assessing whether a statute delegates legislative power is to determine what authority the statute confers, we address that issue of interpretation first and reach respondents' constitutional arguments in Part III, infra.

        16

        Section 109(b)(1) instructs the EPA to set primary ambient air quality standards "the attainment and maintenance of which . . . are requisite to protect the public health" with "an adequate margin of safety." 42 U. S. C. § 7409(b)(1). Were it not for the hundreds of pages of briefing respondents have submitted on the issue, one would have thought it fairly clear that this text does not permit the EPA to consider costs in setting the standards. The language, as one scholar has noted, "is absolute." D. Currie, Air Pollution: Federal Law and Analysis 4-15 (1981). The EPA, "based on" the information about health effects contained in the technical "criteria" documents compiled under § 108(a)(2), 42 U. S. C. § 7408(a)(2), is to identify the maximum airborne concentration of a pollutant that the public health can tolerate, decrease the concentration to provide an "adequate" margin of safety, and set the standard at that level. Nowhere are the costs of achieving such a standard made part of that initial calculation.

        17

        Against this most natural of readings, respondents make a lengthy, spirited, but ultimately unsuccessful attack. They begin with the object of § 109(b)(1)'s focus, the "public health." When the term first appeared in federal clean air legislation—in the Act of July 14, 1955 (1955 Act), 69 Stat. 322, which expressed "recognition of the dangers to the public health" from air pollution—its ordinary meaning was "[t]he health of the community." Webster's New International Dictionary 2005 (2d ed. 1950). Respondents argue, however, that § 109(b)(1), as added by the Clean Air Amendments of 1970, 84 Stat. 1676, meant to use the term's secondary meaning: "[t]he ways and means of conserving the health [466] of the members of a community, as by preventive medicine, organized care of the sick, etc." Ibid. Words that can have more than one meaning are given content, however, by their surroundings, FDA v. Brown & Williamson Tobacco Corp., 529 U. S. 120, 132-133 (2000); Jones v. United States, 527 U. S. 373, 389 (1999), and in the context of § 109(b)(1) this second definition makes no sense. Congress could not have meant to instruct the Administrator to set NAAQS at a level "requisite to protect" "the art and science dealing with the protection and improvement of community health." Webster's Third New International Dictionary 1836 (1981). We therefore revert to the primary definition of the term: the health of the public.

        18

        Even so, respondents argue, many more factors than air pollution affect public health. In particular, the economic cost of implementing a very stringent standard might produce health losses sufficient to offset the health gains achieved in cleaning the air—for example, by closing down whole industries and thereby impoverishing the workers and consumers dependent upon those industries. That is unquestionably true, and Congress was unquestionably aware of it. Thus, Congress had commissioned in the Air Quality Act of 1967 (1967 Act) "a detailed estimate of the cost of carrying out the provisions of this Act; a comprehensive study of the cost of program implementation by affected units of government; and a comprehensive study of the economic impact of air quality standards on the Nation's industries, communities, and other contributing sources of pollution." § 2, 81 Stat. 505. The 1970 Congress, armed with the results of this study, see The Cost of Clean Air, S. Doc. No. 91-40 (1969) (publishing the results of the study), not only anticipated that compliance costs could injure the public health, but provided for that precise exigency. Section 110(f)(1) of the CAA permitted the Administrator to waive the compliance deadline for stationary sources if, inter [467] alia, sufficient control measures were simply unavailable and "the continued operation of such sources is essential . . . to the public health or welfare." 84 Stat. 1683 (emphasis added). Other provisions explicitly permitted or required economic costs to be taken into account in implementing the air quality standards. Section 111(b)(1)(B), for example, commanded the Administrator to set "standards of performance" for certain new sources of emissions that as specified in § 111(a)(1) were to "reflec[t] the degree of emission limitation achievable through the application of the best system of emission reduction which (taking into account the cost of achieving such reduction) the Administrator determines has been adequately demonstrated." Section 202(a)(2) prescribed that emissions standards for automobiles could take effect only "after such period as the Administrator finds necessary to permit the development and application of the requisite technology, giving appropriate consideration to the cost of compliance within such period." 84 Stat. 1690. See also § 202(b)(5)(C) (similar limitation for interim standards); § 211(c)(2) (similar limitation for fuel additives); § 231(b) (similar limitation for implementation of aircraft emission standards). Subsequent amendments to the CAA have added many more provisions directing, in explicit language, that the Administrator consider costs in performing various duties. See, e. g., 42 U. S. C. § 7545(k)(1) (reformulate gasoline to "require the greatest reduction in emissions . . . taking into consideration the cost of achieving such emissions reductions"); § 7547(a)(3) (emission reduction for nonroad vehicles to be set "giving appropriate consideration to the cost" of the standards). We have therefore refused to find implicit in ambiguous sections of the CAA an authorization to consider costs that has elsewhere, and so often, been expressly granted. See Union Elec. Co. v. EPA, 427 U. S. 246, 257, and n. 5 (1976). Cf. General Mo- tors Corp. v. United States, 496 U. S. 530, 538, 541 (1990) [468] (refusing to infer in certain provisions of the CAA deadlines and enforcement limitations that had been expressly imposed elsewhere).

        19

        Accordingly, to prevail in their present challenge, respondents must show a textual commitment of authority to the EPA to consider costs in setting NAAQS under § 109(b)(1). And because § 109(b)(1) and the NAAQS for which it provides are the engine that drives nearly all of Title I of the CAA, 42 U. S. C. §§ 7401-7515, that textual commitment must be a clear one. Congress, we have held, does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions—it does not, one might say, hide elephants in mouseholes. See MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U. S. 218, 231 (1994); FDA v. Brown & Williamson Tobacco Corp., supra, at 159-160. Respondents' textual arguments ultimately founder upon this principle.

        20

        Their first claim is that § 109(b)(1)'s terms "adequate margin" and "requisite" leave room to pad health effects with cost concerns. Just as we found it "highly unlikely that Congress would leave the determination of whether an industry will be entirely, or even substantially, rateregulated to agency discretion—and even more unlikely that it would achieve that through such a subtle device as permission to `modify' rate-filing requirements," MCI Telecommunications Corp. v. American Telephone & Telegraph Co., supra, at 231, so also we find it implausible that Congress would give to the EPA through these modest words the power to determine whether implementation costs should moderate national air quality standards. Accord, Christensen v. Harris County, 529 U. S. 576, 590, n. (2000) (Scalia, J., concurring in part and concurring in judgment) ("The implausibility of Congress's leaving a highly significant issue unaddressed (and thus `delegating' its resolution to the administering agency) is assuredly one of the factors [469] to be considered in determining whether there is ambiguity" (emphasis deleted)).[3]

        21

        The same defect inheres in respondents' next two arguments: that while the Administrator's judgment about what is requisite to protect the public health must be "based on [the] criteria" documents developed under § 108(a)(2), see § 109(b)(1), it need not be based solely on those criteria; and that those criteria themselves, while they must include "effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air," are not necessarily limited to those effects. Even if we were to concede those premises, we still would not conclude that one of the unenumerated factors that the agency can consider in developing and applying the criteria is cost of implementation. That factor is both so indirectly related to public health and so full of potential for canceling the conclusions drawn from direct health effects that it would surely have been expressly mentioned in §§ 108 and 109 had Congress meant it to be considered. Yet while those provisions describe in detail how the health effects of pollutants in the ambient air are to be calculated and given effect, see § 108(a)(2), they say not a word about costs.

        22

        Respondents point, finally, to a number of provisions in the CAA that do require attainment cost data to be generated. Section 108(b)(1), for example, instructs the Administrator to "issue to the States," simultaneously with the criteria documents, "information on air pollution control techniques, which information shall include data relating to the cost of installation and operation." 42 U. S. C. § 7408(b)(l). And [470] § 109(d)(2)(C)(iv) requires the Clean Air Scientific Advisory Committee to "advise the Administrator of any adverse public health, welfare, social, economic, or energy effects which may result from various strategies for attainment and maintenance" of NAAQS.[4] 42 U. S. C. § 7409(d)(2)(C)(iv). Respondents argue that these provisions make no sense unless costs are to be considered in setting the NAAQS. That is not so. These provisions enable the Administrator to assist the States in carrying out their statutory role as primary implementers of the NAAQS. It is to the States that the CAA assigns initial and primary responsibility for deciding what emissions reductions will be required from which sources. See 42 U. S. C. §§ 7407(a), 7410 (giving States the duty of developing implementation plans). It would be impossible to perform that task intelligently without considering which abatement technologies are most efficient, and most economically feasible—which is why we have said that "the most important forum for consideration of claims of economic and technological infeasibility is before the state agency formulating the implementation plan," Union Elec. Co. v. EPA, 427 U. S., at 266. Thus, federal clean air legislation has, from the very beginning, directed federal agencies to develop and transmit implementation data, including cost data, to the States. See 1955 Act, [471] § 2(b), 69 Stat. 322; Clean Air Act of 1963, amending §§ 3(a), (b) of the CAA, 77 Stat. 394; 1967 Act, §§ 103(a)—(d), 104, 107(c), 81 Stat. 486-488. That Congress chose to carry forward this research program to assist States in choosing the means through which they would implement the standards is perfectly sensible, and has no bearing upon whether cost considerations are to be taken into account in formulating the standards.[5]

        23

        It should be clear from what we have said that the canon requiring texts to be so construed as to avoid serious constitutional problems has no application here. No matter how severe the constitutional doubt, courts may choose only between reasonably available interpretations of a text. See, e. g., Miller v. French, 530 U. S. 327, 341 (2000); Pennsylvania Dept. of Corrections v. Yeskey, 524 U. S. 206, 212 (1998). The text of § 109(b), interpreted in its statutory and historical context and with appreciation for its importance to the CAA as a whole, unambiguously bars cost considerations from the NAAQS-setting process, and thus ends the matter for us as well as the EPA.[6] We therefore affirm the judgment of the Court of Appeals on this point.

        24
        [472] III
        25

        Section 109(b)(1) of the CAA instructs the EPA to set "ambient air quality standards the attainment and maintenance of which in the judgment of the Administrator, based on [the] criteria [documents of § 108] and allowing an adequate margin of safety, are requisite to protect the public health." 42 U. S. C. § 7409(b)(1). The Court of Appeals held that this section as interpreted by the Administrator did not provide an "intelligible principle" to guide the EPA's exercise of authority in setting NAAQS. "[The] EPA," it said, "lack[ed] any determinate criteria for drawing lines. It has failed to state intelligibly how much is too much." 175 F. 3d, at 1034. The court hence found that the EPA's interpretation (but not the statute itself) violated the nondelegation doctrine. Id., at 1038. We disagree.

        26

        In a delegation challenge, the constitutional question is whether the statute has delegated legislative power to the agency. Article I, § 1, of the Constitution vests "[a]ll legislative Powers herein granted . . . in a Congress of the United States." This text permits no delegation of those powers, Loving v. United States, 517 U. S. 748, 771 (1996); see id., at 776-777 (Scalia, J., concurring in part and concurring in judgment), and so we repeatedly have said that when Congress confers decisionmaking authority upon agencies Congress must "lay down by legislative act an intelligible principle to which the person or body authorized to [act] is directed to conform." J. W. Hampton, Jr., & Co. v. United States, 276 U. S. 394, 409 (1928). We have never suggested that an agency can cure an unlawful delegation of legislative power by adopting in its discretion a limiting construction of the statute. Both Fahey v. Mallonee, 332 U. S. 245, 252-253 (1947), and Lichter v. United States, 334 U. S. 742, 783 (1948), mention agency regulations in the course of their nondelegation discussions, but Lichter did so because a subsequent Congress had incorporated the regulations into a revised version of the statute, ibid., and Fahey because the customary [473] practices in the area, implicitly incorporated into the statute, were reflected in the regulations, 332 U. S., at 250. The idea that an agency can cure an unconstitutionally standardless delegation of power by declining to exercise some of that power seems to us internally contradictory. The very choice of which portion of the power to exercise—that is to say, the prescription of the standard that Congress had omitted—would itself be an exercise of the forbidden legislative authority. Whether the statute delegates legislative power is a question for the courts, and an agency's voluntary selfdenial has no bearing upon the answer.

        27

        We agree with the Solicitor General that the text of § 109(b)(1) of the CAA at a minimum requires that "[f]or a discrete set of pollutants and based on published air quality criteria that reflect the latest scientific knowledge, [the] EPA must establish uniform national standards at a level that is requisite to protect public health from the adverse effects of the pollutant in the ambient air." Tr. of Oral Arg. in No. 99-1257, p. 5. Requisite, in turn, "mean[s] sufficient, but not more than necessary." Id., at 7. These limits on the EPA's discretion are strikingly similar to the ones we approved in Touby v. United States, 500 U. S. 160 (1991), which permitted the Attorney General to designate a drug as a controlled substance for purposes of criminal drug enforcement if doing so was "`necessary to avoid an imminent hazard to the public safety.' " Id., at 163. They also resemble the Occupational Safety and Health Act of 1970 provision requiring the agency to "`set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer any impairment of health' "—which the Court upheld in Industrial Union Dept., AFL—CIO v. American Petroleum Institute, 448 U. S. 607, 646 (1980), and which even then-Justice Rehnquist, who alone in that case thought the statute violated the nondelegation doctrine, see id., at 671 (opinion concurring in judgment), would have upheld if, like the statute [474] here, it did not permit economic costs to be considered. See American Textile Mfrs. Institute, Inc. v. Donovan, 452 U. S. 490, 545 (1981) (Rehnquist, J., dissenting).

        28

        The scope of discretion § 109(b)(1) allows is in fact well within the outer limits of our nondelegation precedents. In the history of the Court we have found the requisite "intelligible principle" lacking in only two statutes, one of which provided literally no guidance for the exercise of discretion, and the other of which conferred authority to regulate the entire economy on the basis of no more precise a standard than stimulating the economy by assuring "fair competition." See Panama Refining Co. v. Ryan, 293 U. S. 388 (1935); A. L. A. Schechter Poultry Corp. v. United States, 295 U. S. 495 (1935). We have, on the other hand, upheld the validity of § 11(b)(2) of the Public Utility Holding Company Act of 1935, 49 Stat. 821, which gave the Securities and Exchange Commission authority to modify the structure of holding company systems so as to ensure that they are not "unduly or unnecessarily complicate[d]" and do not "unfairly or inequitably distribute voting power among security holders." American Power & Light Co. v. SEC, 329 U. S. 90, 104 (1946). We have approved the wartime conferral of agency power to fix the prices of commodities at a level that "`will be generally fair and equitable and will effectuate the [in some respects conflicting] purposes of th[e] Act.' " Yakus v. United States, 321 U. S. 414, 420, 423-426 (1944). And we have found an "intelligible principle" in various statutes authorizing regulation in the "public interest." See, e. g., National Broadcasting Co. v. United States, 319 U. S. 190, 225-226 (1943) (Federal Communications Commission's power to regulate airwaves); New York Central Securities Corp. v. United States, 287 U. S. 12, 24-25 (1932) (Interstate Commerce Commission's power to approve railroad consolidations). In short, we have "almost never felt qualified to second-guess Congress regarding the permissible degree of policy judgment that can be left to those executing or applying [475] the law." Mistretta v. United States, 488 U. S. 361, 416 (1989) (Scalia, J., dissenting); see id., at 373 (majority opinion).

        29

        It is true enough that the degree of agency discretion that is acceptable varies according to the scope of the power congressionally conferred. See Loving v. United States, 517 U. S., at 772-773; United States v. Mazurie, 419 U. S. 544, 556-557 (1975). While Congress need not provide any direction to the EPA regarding the manner in which it is to define "country elevators," which are to be exempt from newstationary-source regulations governing grain elevators, see 42 U. S. C. § 7411(i), it must provide substantial guidance on setting air standards that affect the entire national economy. But even in sweeping regulatory schemes we have never demanded, as the Court of Appeals did here, that statutes provide a "determinate criterion" for saying "how much [of the regulated harm] is too much." 175 F. 3d, at 1034. In Touby, for example, we did not require the statute to decree how "imminent" was too imminent, or how "necessary" was necessary enough, or even—most relevant here—how "hazardous" was too hazardous. 500 U. S., at 165-167. Similarly, the statute at issue in Lichter authorized agencies to recoup "excess profits" paid under wartime Government contracts, yet we did not insist that Congress specify how much profit was too much. 334 U. S., at 783-786. It is therefore not conclusive for delegation purposes that, as respondents argue, ozone and particulate matter are "nonthreshold" pollutants that inflict a continuum of adverse health effects at any airborne concentration greater than zero, and hence require the EPA to make judgments of degree. "[A] certain degree of discretion, and thus of lawmaking, inheres in most executive or judicial action." Mistretta v. United States, supra, at 417 (Scalia, J., dissenting) (emphasis deleted); see 488 U. S., at 378-379 (majority opinion). Section 109(b)(1) of the CAA, which to repeat we interpret as requiring the EPA to set air quality standards at the level that is "requisite"—that [476] is, not lower or higher than is necessary—to protect the public health with an adequate margin of safety, fits comfortably within the scope of discretion permitted by our precedent.

        30

        We therefore reverse the judgment of the Court of Appeals remanding for reinterpretation that would avoid a supposed delegation of legislative power. It will remain for the Court of Appeals—on the remand that we direct for other reasons—to dispose of any other preserved challenge to the NAAQS under the judicial-review provisions contained in 42 U. S. C. § 7607(d)(9).

        31
        IV
        32

        The final two issues on which we granted certiorari concern the EPA's authority to implement the revised ozone NAAQS in areas whose ozone levels currently exceed the maximum level permitted by that standard. The CAA designates such areas "nonattainment," § 107(d)(1), 42 U. S. C. § 7407(d)(1); see also Pub. L. 105-178, § 6103, 112 Stat. 465 (setting timeline for new ozone designations), and it exposes them to additional restrictions over and above the implementation requirements imposed generally by § 110 of the CAA. These additional restrictions are found in the five substantive subparts of Part D of Title I, 42 U. S. C. §§ 7501-7515. Subpart 1, §§ 7501-7509a, contains general nonattainment regulations that pertain to every pollutant for which a NAAQS exists. Subparts 2 through 5, §§ 7511— 7514a, contain rules tailored to specific individual pollutants. Subpart 2, added by the Clean Air Act Amendments of 1990, § 103, 104 Stat. 2423, addresses ozone. 42 U. S. C. §§ 7511— 7511f. The dispute before us here, in a nutshell, is whether Subpart 1 alone (as the agency determined), or rather Subpart 2 or some combination of Subparts 1 and 2, controls the implementation of the revised ozone NAAQS in nonattainment areas.

        33
        [477] A
        34

        The Administrator first urges, however, that we vacate the judgment of the Court of Appeals on this issue because it lacked jurisdiction to review the EPA's implementation policy. Section 307(b)(1) of the CAA, 42 U. S. C. § 7607(b)(1), gives the court jurisdiction over "any . . . nationally applicable regulations promulgated, or final action taken, by the Administrator," but the EPA argues that its implementation policy was not agency "action," was not "final" action, and is not ripe for review. We reject each of these three contentions.

        35

        At the same time the EPA proposed the revised ozone NAAQS in 1996, it also proposed an "interim implementation policy" for the NAAQS, see 61 Fed. Reg. 65752 (1996), that was to govern until the details of implementation could be put in final form through specific "rulemaking actions." The preamble to this proposed policy declared that "the interim implementation policy . . . represent[s] EPA's preliminary views on these issues and, while it may include various statements that States must take certain actions, these statements are made pursuant to EPA's preliminary interpretations, and thus do not bind the States and public as a matter of law." Ibid. If the EPA had done no more, we perhaps could accept its current claim that its action was not final. However, after the agency had accepted comments on its proposed policy, and on the same day that the final ozone NAAQS was promulgated, the White House published in the Federal Register what it titled a "Memorandum for the Administrator of the Environmental Protection Agency" that prescribed implementation procedures for the EPA to follow. 62 Fed. Reg. 38421 (1997). (For purposes of our analysis we shall assume that this memorandum was not itself action by the EPA.) The EPA supplemented this memorandum with an explanation of the implementation procedures, which it published in the explanatory preamble to its final ozone [478] NAAQS under the heading, "Final decision on the primary standard." Id., at 38873. "In light of comments received regarding the interpretation proposed in the Interim Implementation Policy," the EPA announced, it had "reconsidered that interpretation" and settled on a new one. Ibid. The provisions of "subpart 1 of part D of Title I of the Act" will immediately "apply to the implementation of the new 8-hour [ozone] standards." Ibid.; see also id., at 38885 (new standard to be implemented "simultaneously [with the old standard] . . . under the provisions of . . . subpart 1"). Moreover, the provisions of subpart 2 "will [also] continue to apply as a matter of law for so long as an area is not attaining the [old] 1-hour standard." Id., at 38873. Once the area reaches attainment for the old standard, however, "the provisions of subpart 2 will have been achieved and those provisions will no longer apply." Ibid.; see also id., at 38884-38885.

        36

        We have little trouble concluding that this constitutes final agency action subject to review under § 307. The bite in the phrase "final action" (which bears the same meaning in § 307(b)(1) that it does under the Administrative Procedure Act (APA), 5 U. S. C. § 704, see Harrison v. PPG Industries, Inc., 446 U. S. 578, 586 (1980)), is not in the word "action," which is meant to cover comprehensively every manner in which an agency may exercise its power. See FTC v. Standard Oil Co. of Cal., 449 U. S. 232, 238, n. 7 (1980). It is rather in the word "final," which requires that the action under review "mark the consummation of the agency's decisionmaking process." Bennett v. Spear, 520 U. S. 154, 177-178 (1997). Only if the "EPA has rendered its last word on the matter" in question, Harrison v. PPG Industries, Inc., supra, at 586, is its action "final" and thus reviewable. That standard is satisfied here. The EPA's "decisionmaking process," which began with the 1996 proposal and continued with the reception of public comments, concluded [479] when the agency, "in light of [these comments]," and in conjunction with a corresponding directive from the White House, adopted the interpretation of Part D at issue here. Since that interpretation issued, the EPA has refused in subsequent rulemakings to reconsider it, explaining to disappointed commenters that its earlier decision was conclusive. See 63 Fed. Reg. 31014, 31018-31019 (1998). Though the agency has not dressed its decision with the conventional procedural accoutrements of finality, its own behavior thus belies the claim that its interpretation is not final.

        37

        The decision is also ripe for our review. "Ripeness `requir[es] us to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.' " Texas v. United States, 523 U. S. 296, 300-301 (1998) (quoting Abbott Laboratories v. Gardner, 387 U. S. 136, 149 (1967)). The question before us here is purely one of statutory interpretation that would not "benefit from further factual development of the issues presented." Ohio Forestry Assn., Inc. v. Sierra Club, 523 U. S. 726, 733 (1998). Nor will our review "inappropriately interfere with further administrative action," ibid., since the EPA has concluded its consideration of the implementation issue. Finally, as for hardship to the parties: The respondent States must—on pain of forfeiting to the EPA control over implementation of the NAAQS—promptly undertake the lengthy and expensive task of developing state implementation plans (SIP's) that will attain the new, more stringent standard within five years. See 42 U. S. C. §§ 7410, 7502. Whether or not this would suffice in an ordinary case brought under the review provisions of the APA, see 5 U. S. C. § 704, we have characterized the special judicial-review provision of the CAA, 42 U. S. C. § 7607(b), as one of those statutes that specifically provides for "preenforcement" review, see Ohio Forestry Assn., Inc. v. Sierra Club, supra, at 737. Such statutes, we have said, permit "judicial review directly, even before the [480] concrete effects normally required for APA review are felt." Lujan v. National Wildlife Federation, 497 U. S. 871, 891 (1990). The effects at issue here surely meet that lower standard.

        38

        Beyond all this, the implementation issue was fairly included within the challenges to the final ozone rule that were properly before the Court of Appeals. Respondents argued below that the EPA could not revise the ozone standard, because to do so would trigger the use of Subpart 1, which had been supplanted (for ozone) by the specific rules of Subpart 2. Brief for Industry Petitioners and Intervenors in No. 97-1441 (and consolidated cases) (CADC), pp. 32-34. The EPA responded that Subpart 2 did not supplant but simply supplemented Subpart 1, so that the latter section still "applies to all nonattainment areas for all NAAQS,. . . including nonattainment areas for any revised ozone standard." Final Brief for EPA in No. 97-1441 (and consolidated cases) (CADC), pp. 67-68. The agency later reiterated that Subpart 2 "does not supplant implementation provisions for revised ozone standards. This interpretation fully harmonizes Subpart 2 with EPA's clear authority to revise any NAAQS." Id., at 71. In other words, the EPA was arguing that the revised standard could be issued, despite its apparent incompatibility with portions of Subpart 2, because it would be implemented under Subpart 1 rather than Subpart 2. The District of Columbia Circuit ultimately agreed that Subpart 2 could be harmonized with the EPA's authority to promulgate revised NAAQS, but not because Subpart 2 is entirely inapplicable—which is one of EPA's assignments of error. It is unreasonable to contend, as the EPA now does, that the Court of Appeals was obligated to reach the agency's preferred result, but forbidden to assess the reasons the EPA had given for reaching that result. The implementation issue was fairly included within respondents' challenge to the ozone rule, which all parties agree is final agency action ripe for review.

        39
        [481] B
        40

        Our approach to the merits of the parties' dispute is the familiar one of Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). If the statute resolves the question whether Subpart 1 or Subpart 2 (or some combination of the two) shall apply to revised ozone NAAQS, then "that is the end of the matter." Id., at 842— 843. But if the statute is "silent or ambiguous" with respect to the issue, then we must defer to a "reasonable interpretation made by the administrator of an agency." Id., at 844. We cannot agree with the Court of Appeals that Subpart 2 clearly controls the implementation of revised ozone NAAQS, see 175 F. 3d, at 1048-1050, because we find the statute to some extent ambiguous. We conclude, however, that the agency's interpretation goes beyond the limits of what is ambiguous and contradicts what in our view is quite clear. We therefore hold the implementation policy unlawful. See AT&T; Corp. v. Iowa Utilities Bd., 525 U. S. 366, 392 (1999).

        41

        The text of Subpart 1 at first seems to point the way to a clear answer to the question, which Subpart controls? Two sections of Subpart 1, 7502(a)(1)(C) and 7502(a)(2)(D), contain switching provisions stating that if the classification of ozone nonattainment areas is "specifically provided [for] under other provisions of [Part D]," then those provisions will control instead of Subpart 1's. Thus, it is true but incomplete to note, as the Administrator does, that the substantive language of Subpart 1 is broad enough to apply to revised ozone standards. See, e. g., § 7502(a)(1)(A) (instructing the Administrator to classify nonattainment areas according to "any revised standard, including a revision of any standard in effect on November 15, 1990"); § 7502(a)(2)(A) (setting attainment deadlines). To determine whether that language does apply one must resolve the further textual issue whether some other provision, namely Subpart 2, provides for the classification of ozone nonattainment areas. If [482] it does, then according to the switching provisions of Subpart 1 it will control.

        42

        So, does Subpart 2 provide for classifying nonattainment ozone areas under the revised standard? It unquestionably does. The backbone of the subpart is Table 1, printed in § 7511(a)(1) and reproduced in the margin here,[7] which defines five categories of ozone nonattainment areas and prescribes attainment deadlines for each. Section 7511(a)(1) funnels all nonattainment areas into the table for classification, declaring that "[e]ach area designated nonattainment for ozone . . . shall be classified at the time of such designation, under table 1, by operation of law." And once an area has been classified, "the primary standard attainment date for ozone shall be as expeditiously as practicable but not later than the date provided in table 1." The EPA argues that this text is not as clear or comprehensive as it seems, because the title of § 7511(a) reads "Classification and attainment dates for 1989 nonattainment areas," which suggests that Subpart 2 applies only to areas that were in nonattainment in 1989, and not to areas later designated nonattainment [483] under a revised ozone standard. The suggestion must be rejected, however, because § 7511(b)(1) specifically provides for the classification of areas that were in attainment in 1989 but have subsequently slipped into nonattainment. It thus makes clear that Subpart 2 is not limited solely to 1989 nonattainment areas. This eliminates the interpretive role of the title, which may only "she[d] light on some ambiguous word or phrase in the statute itself," Carter v. United States, 530 U. S. 255, 267 (2000) (internal quotation marks omitted) (quoting Pennsylvania Dept. of Corrections v. Yeskey, 524 U. S., at 212, in turn quoting Trainmen v. Baltimore & Ohio R. Co., 331 U. S. 519, 528-529 (1947)).

        43

        It may well be, as the EPA argues—and as the concurring opinion below on denial of rehearing pointed out, see 195 F. 3d, at 11-12—that some provisions of Subpart 2 are ill fitted to implementation of the revised standard. Using the old 1-hour averages of ozone levels, for example, as Subpart 2 requires, see § 7511(a)(1); 44 Fed. Reg. 8202 (1979), would produce at best an inexact estimate of the new 8-hour averages, see 40 CFR § 50.10, and App. I (1999). Also, to the extent that the new ozone standard is stricter than the old one, see Reply Brief for Petitioners in No. 99-1257, p. 17 ("the stricter 8-hour NAAQS"); 62 Fed. Reg. 38856, 38858 (1997) (8-hour standard of 0.09 ppm rather than 0.08 ppm would have "generally represent[ed] the continuation of the [old] level of protection"), the classification system of Subpart 2 contains a gap, because it fails to classify areas whose ozone levels are greater than the new standard (and thus nonattaining) but less than the approximation of the old standard codified by Table 1. And finally, Subpart 2's method for calculating attainment dates—which is simply to count forward a certain number of years from November 15, 1990 (the date the 1990 CAA Amendments took force), depending on how far out of attainment the area started—seems to make no sense for areas that are first classified under a new standard after November 15, 1990. [484] If, for example, areas were classified in the year 2000, many of the deadlines would already have expired at the time of classification.

        44

        These gaps in Subpart 2's scheme prevent us from concluding that Congress clearly intended Subpart 2 to be the exclusive, permanent means of enforcing a revised ozone standard in nonattainment areas. The statute is in our view ambiguous concerning the manner in which Subpart 1 and Subpart 2 interact with regard to revised ozone standards, and we would defer to the EPA's reasonable resolution of that ambiguity. See FDA v. Brown & Williamson Tobacco Corp., 529 U. S., at 132; INS v. Aguirre-Aguirre, 526 U. S. 415, 424 (1999). We cannot defer, however, to the interpretation the EPA has given.

        45

        Whatever effect may be accorded the gaps in Subpart 2 as implying some limited applicability of Subpart 1, they cannot be thought to render Subpart 2's carefully designed restrictions on EPA discretion utterly nugatory once a new standard has been promulgated, as the EPA has concluded. The principal distinction between Subpart 1 and Subpart 2 is that the latter eliminates regulatory discretion that the former allowed. While Subpart 1 permits the EPA to establish classifications for nonattainment areas, Subpart 2 classifies areas as a matter of law based on a table. Compare § 7502(a)(1) with § 7511(a)(1) (Table 1). Whereas the EPA has discretion under Subpart 1 to extend attainment dates for as long as 12 years, under Subpart 2 it may grant no more than 2 years' extension. Compare §§ 7502(a)(2)(A) and (C) with § 7511(a)(5). Whereas Subpart 1 gives the EPA considerable discretion to shape nonattainment programs, Subpart 2 prescribes large parts of them by law. Compare §§ 7502(c) and (d) with § 7511a. Yet according to the EPA, Subpart 2 was simply Congress's "approach to the implementation of the [old] 1-hour" standard, and so there was no reason that "the new standard could not simultaneously be implemented under . . . subpart 1." 62 Fed. Reg. [485] 38856, 38885 (1997); see also id., at 38873 ("[T]he provisions of subpart 1 . . . would apply to the implementation of the new 8-hour ozone standards"). To use a few apparent gaps in Subpart 2 to render its textually explicit applicability to nonattainment areas under the new standard utterly inoperative is to go over the edge of reasonable interpretation. The EPA may not construe the statute in a way that completely nullifies textually applicable provisions meant to limit its discretion.

        46

        The EPA's interpretation making Subpart 2 abruptly obsolete is all the more astonishing because Subpart 2 was obviously written to govern implementation for some time. Some of the elements required to be included in SIP's under Subpart 2 were not to take effect until many years after the passage of the CAA. See § 7511a(e)(3) (restrictions on "electric utility and industrial and commercial boiler[s]" to be "effective 8 years after November 15, 1990"); § 7511a(c)(5)(A) (vehicle monitoring program to "[b]egi[n] 6 years after November 15, 1990"); § 7511a(g)(1) (emissions milestone requirements to be applied "6 years after November 15, 1990, and at intervals of every 3 years thereafter"). A plan reaching so far into the future was not enacted to be abandoned the next time the EPA reviewed the ozone standard—which Congress knew could happen at any time, since the technical staff papers had already been completed in late 1989. See 58 Fed. Reg. 13008, 13010 (1993); see also 42 U. S. C. § 7409(d)(1) (NAAQS must be reviewed and, if appropriate, revised at least once every five years). Yet nothing in the EPA's interpretation would have prevented the agency from aborting Subpart 2 the day after it was enacted. Even now, if the EPA's interpretation were correct, some areas of the country could be required to meet the new, more stringent ozone standard in at most the same time that Subpart 2 had allowed them to meet the old standard. Compare § 7502(a)(2) (Subpart 1 attainment dates) with § 7511(a) (Subpart 2 attainment dates). Los Angeles, for instance, "would [486] be required to attain the revised NAAQS under Subpart 1 no later than the same year that marks the outer time limit for attaining Subpart 2's one-hour ozone standard." Brief for Petitioners in No. 99-1257, p. 49. An interpretation of Subpart 2 so at odds with its structure and manifest purpose cannot be sustained.

        47

        We therefore find the EPA's implementation policy to be unlawful, though not in the precise respect determined by the Court of Appeals. After our remand, and the Court of Appeals' final disposition of these cases, it is left to the EPA to develop a reasonable interpretation of the nonattainment implementation provisions insofar as they apply to revised ozone NAAQS.

        48
        * * *
        49

        To summarize our holdings in these unusually complex cases: (1) The EPA may not consider implementation costs in setting primary and secondary NAAQS under § 109(b) of the CAA. (2) Section 109(b)(1) does not delegate legislative power to the EPA in contravention of Art. I, § 1, of the Constitution. (3) The Court of Appeals had jurisdiction to review the EPA's interpretation of Part D of Title I of the CAA, relating to the implementation of the revised ozone NAAQS. (4) The EPA's interpretation of that Part is unreasonable.

        50

        The judgment of the Court of Appeals is affirmed in part and reversed in part, and the cases are remanded for proceedings consistent with this opinion.

        51

        It is so ordered.

        52

        Justice Thomas, concurring.

        53

        I agree with the majority that § 109's directive to the agency is no less an "intelligible principle" than a host of other directives that we have approved. Ante, at 474-476. I also agree that the Court of Appeals' remand to the agency to make its own corrective interpretation does not accord with our understanding of the delegation issue. Ante, at 472-473. I write separately, however, to express my concern [487] that there may nevertheless be a genuine constitutional problem with § 109, a problem which the parties did not address.

        54

        The parties to these cases who briefed the constitutional issue wrangled over constitutional doctrine with barely a nod to the text of the Constitution. Although this Court since 1928 has treated the "intelligible principle" requirement as the only constitutional limit on congressional grants of power to administrative agencies, see J. W. Hampton, Jr., & Co. v. United States, 276 U. S. 394, 409 (1928), the Constitution does not speak of "intelligible principles." Rather, it speaks in much simpler terms: "All legislative Powers herein granted shall be vested in a Congress." U. S. Const., Art. 1, § 1 (emphasis added). I am not convinced that the intelligible principle doctrine serves to prevent all cessions of legislative power. I believe that there are cases in which the principle is intelligible and yet the significance of the delegated decision is simply too great for the decision to be called anything other than "legislative."

        55

        As it is, none of the parties to these cases has examined the text of the Constitution or asked us to reconsider our precedents on cessions of legislative power. On a future day, however, I would be willing to address the question whether our delegation jurisprudence has strayed too far from our Founders' understanding of separation of powers.

        56

        Justice Stevens, with whom Justice Souter joins, concurring in part and concurring in the judgment.

        57

        Section 109(b)(1) delegates to the Administrator of the Environmental Protection Agency (EPA) the authority to promulgate national ambient air quality standards (NAAQS). In Part III of its opinion, ante, at 472-476, the Court convincingly explains why the Court of Appeals erred when it concluded that § 109 effected "an unconstitutional delegation of legislative power." American Trucking Assns., Inc. v. EPA, 175 F. 3d 1027, 1033 (CADC 1999) (per curiam). [488] I wholeheartedly endorse the Court's result and endorse its explanation of its reasons, albeit with the following caveat.

        58

        The Court has two choices. We could choose to articulate our ultimate disposition of this issue by frankly acknowledging that the power delegated to the EPA is "legislative" but nevertheless conclude that the delegation is constitutional because adequately limited by the terms of the authorizing statute. Alternatively, we could pretend, as the Court does, that the authority delegated to the EPA is somehow not "legislative power." Despite the fact that there is language in our opinions that supports the Court's articulation of our holding,[8] I am persuaded that it would be both wiser and more faithful to what we have actually done in delegation cases to admit that agency rulemaking authority is "legislative power."[9]

        59

        The proper characterization of governmental power should generally depend on the nature of the power, not on the identity of the person exercising it. See Black's Law Dictionary 899 (6th ed. 1990) (defining "legislation" as, inter alia, "[f]ormulation of rule[s] for the future"); 1 K. Davis & R. Pierce, Administrative Law Treatise § 2.3, p. 37 (3d ed. 1994) ("If legislative power means the power to make rules of conduct that bind everyone based on resolution of major policy issues, scores of agencies exercise legislative power routinely by [489] promulgating what are candidly called `legislative rules' "). If the NAAQS that the EPA promulgated had been prescribed by Congress, everyone would agree that those rules would be the product of an exercise of "legislative power." The same characterization is appropriate when an agency exercises rulemaking authority pursuant to a permissible delegation from Congress.

        60

        My view is not only more faithful to normal English usage, but is also fully consistent with the text of the Constitution. In Article I, the Framers vested "All legislative Powers" in the Congress, Art. I, § 1, just as in Article II they vested the "executive Power" in the President, Art. II, § 1. Those provisions do not purport to limit the authority of either recipient of power to delegate authority to others. See Bowsher v. Synar, 478 U. S. 714, 752 (1986) (Stevens, J., concurring in judgment) ("Despite the statement in Article I of the Constitution that `All legislative powers herein granted shall be vested in a Congress of the United States,' it is far from novel to acknowledge that independent agencies do indeed exercise legislative powers"); INS v. Chadha, 462 U. S. 919, 985-986 (1983) (White, J., dissenting) ("[L]egislative power can be exercised by independent agencies and Executive departments . . ."); 1 Davis & Pierce, Administrative Law Treatise § 2.6, at 66 ("The Court was probably mistaken from the outset in interpreting Article I's grant of power to Congress as an implicit limit on Congress' authority to delegate legislative power"). Surely the authority granted to members of the Cabinet and federal law enforcement agents is properly characterized as "Executive" even though not exercised by the President. Cf. Morrison v. Olson, 487 U. S. 654, 705-706 (1988) (Scalia, J., dissenting) (arguing that the independent counsel exercised "executive power" unconstrained by the President).

        61

        It seems clear that an executive agency's exercise of rulemaking authority pursuant to a valid delegation from Congress is "legislative." As long as the delegation provides a [490] sufficiently intelligible principle, there is nothing inherently unconstitutional about it. Accordingly, while I join Parts I, II, and IV of the Court's opinion, and agree with almost everything said in Part III, I would hold that when Congress enacted § 109, it effected a constitutional delegation of legislative power to the EPA.

        62

        Justice Breyer, concurring in part and concurring in the judgment.

        63

        I join Parts I, III, and IV of the Court's opinion. I also agree with the Court's determination in Part II that the Clean Air Act does not permit the Environmental Protection Agency to consider the economic costs of implementation when setting national ambient air quality standards under § 109(b)(1) of the Act. But I would not rest this conclusion solely upon § 109's language or upon a presumption, such as the Court's presumption that any authority the Act grants the EPA to consider costs must flow from a "textual commitment" that is "clear." Ante, at 468. In order better to achieve regulatory goals—for example, to allocate resources so that they save more lives or produce a cleaner environment—regulators must often take account of all of a proposed regulation's adverse effects, at least where those adverse effects clearly threaten serious and disproportionate public harm. Hence, I believe that, other things being equal, we should read silences or ambiguities in the language of regulatory statutes as permitting, not forbidding, this type of rational regulation.

        64

        In these cases, however, other things are not equal. Here, legislative history, along with the statute's structure, indicates that § 109's language reflects a congressional decision not to delegate to the agency the legal authority to consider economic costs of compliance.

        65

        For one thing, the legislative history shows that Congress intended the statute to be "technology forcing." Senator Edmund Muskie, the primary sponsor of the 1970 amendments [491] to the Act, introduced them by saying that Congress' primary responsibility in drafting the Act was not "to be limited by what is or appears to be technologically or economically feasible," but "to establish what the public interest requires to protect the health of persons," even if that means that "industries will be asked to do what seems to be impossible at the present time." 116 Cong. Rec. 32901-32902 (1970), 1 Legislative History of the Clean Air Amendments of 1970 (Committee Print compiled for the Senate Committee on Public Works by the Library of Congress), Ser. No. 93-18, p. 227 (1974) (hereinafter Leg. Hist.) (emphasis added).

        66

        The Senate directly focused upon the technical feasibility and cost of implementing the Act's mandates. And it made clear that it intended the Administrator to develop air quality standards set independently of either. The Senate Report for the 1970 amendments explains:

        67

        "In the Committee discussions, considerable concern was expressed regarding the use of the concept of technical feasibility as the basis of ambient air standards. The Committee determined that 1) the health of people is more important than the question of whether the early achievement of ambient air quality standards protective of health is technically feasible; and, 2) the growth of pollution load in many areas, even with application of available technology, would still be deleterious to public health. . . .

        "Therefore, the Committee determined that existing sources of pollutants either should meet the standard of the law or be closed down . . . ." S. Rep. No. 91-1196, pp. 2-3 (1970), 1 Leg. Hist. 402-403 (emphasis added).

        68

        Indeed, this Court, after reviewing the entire legislative history, concluded that the 1970 amendments were "expressly designed to force regulated sources to develop pollution control devices that might at the time appear to be economically or technologically infeasible." Union Elec. Co. [492] v. EPA, 427 U. S. 246, 257 (1976) (emphasis added). And the Court added that the 1970 amendments were intended to be a "drastic remedy to . . . a serious and otherwise uncheckable problem." Id., at 256. Subsequent legislative history confirms that the technology-forcing goals of the 1970 amendments are still paramount in today's Act. See Clean Air Conference Report (1977): Statement of Intent; Clarification of Select Provisions, 123 Cong. Rec. 27070 (1977) (stating, regarding the 1977 amendments to the Act, that "this year's legislation retains and even strengthens the technology forcing . . . goals of the 1970 Act"); S. Rep. No. 101-228, p. 5 (1989) (stating that the 1990 amendments to the Act require ambient air quality standards to be set at "the level that `protects the public health' with an `adequate margin of safety,' without regard to the economic or technical feasibility of attainment" (emphasis added)).

        69

        To read this legislative history as meaning what it says does not impute to Congress an irrational intent. Technology-forcing hopes can prove realistic. Those persons, for example, who opposed the 1970 Act's insistence on a 90% reduction in auto emission pollutants, on the ground of excessive cost, saw the development of catalytic converter technology that helped achieve substantial reductions without the economic catastrophe that some had feared. See § 6(a) of the Clean Air Act Amendments of 1970, amending §§ 202(b)(1)(A), (B), 84 Stat. 1690 (codified at 42 U. S. C. §§ 7521(b)(1)(A), (B)) (requiring a 90% reduction in emissions); 1 Leg. Hist. 238, 240 (statement of Sen. Griffin) (arguing that the emissions standards could "force [the automobile] industry out of existence" because costs "would not be taken into account"); see generally Reitze, Mobile Source Air Pollution Control, 6 Env. Law. 309, 326-327 (2000) (discussing the development of the catalytic converter).

        70

        At the same time, the statute's technology-forcing objective makes regulatory efforts to determine the costs of implementation both less important and more difficult. It [493] means that the relevant economic costs are speculative, for they include the cost of unknown future technologies. It also means that efforts to take costs into account can breed time-consuming and potentially unresolvable arguments about the accuracy and significance of cost estimates. Congress could have thought such efforts not worth the delays and uncertainties that would accompany them. In any event, that is what the statute's history seems to say. See Union Elec., supra, at 256-259. And the matter is one for Congress to decide.

        71

        Moreover, the Act does not, on this reading, wholly ignore cost and feasibility. As the majority points out, ante, at 466-467, the Act allows regulators to take those concerns into account when they determine how to implement ambient air quality standards. Thus, States may consider economic costs when they select the particular control devices used to meet the standards, and industries experiencing difficulty in reducing their emissions can seek an exemption or variance from the state implementation plan. See Union Elec., supra, at 266 ("[T]he most important forum for consideration of claims of economic and technological infeasibility is before the state agency formulating the implementation plan").

        72

        The Act also permits the EPA, within certain limits, to consider costs when it sets deadlines by which areas must attain the ambient air quality standards. 42 U. S. C. § 7502(a)(2)(A) (providing that "the Administrator may extend the attainment date . . . for a period no greater than 10 years from the date of designation as nonattainment, considering the severity of nonattainment and the availability and feasibility of pollution control measures"); § 7502(a)(2)(C) (permitting the Administrator to grant up to two additional 1-year extensions); cf. §§ 7511(a)(1), (5) (setting more rigid attainment deadlines for areas in nonattainment of the ozone standard, but permitting the Administrator to grant up to two 1-year extensions). And Congress can change those statutory limits if necessary. Given the ambient air quality [494] standards' substantial effects on States, cities, industries, and their suppliers and customers, Congress will hear from those whom compliance deadlines affect adversely, and Congress can consider whether legislative change is warranted. See, e. g., Steel Industry Compliance Extension Act of 1981, 95 Stat. 139 (codified at 42 U. S. C. § 7413(e) (1988 ed.)) (repealed 1990) (granting the Administrator discretion to extend the ambient air quality standard attainment date set in the 1977 Act by up to three years for steelmaking facilities).

        73

        Finally, contrary to the suggestion of the Court of Appeals and of some parties, this interpretation of § 109 does not require the EPA to eliminate every health risk, however slight, at any economic cost, however great, to the point of "hurtling" industry over "the brink of ruin," or even forcing "deindustrialization." American Trucking Assns., Inc. v. EPA, 175 F. 3d 1027, 1037, 1038, n. 4 (CADC 1999); see also Brief for Cross-Petitioners in No. 99-1426, p. 25. The statute, by its express terms, does not compel the elimination of all risk; and it grants the Administrator sufficient flexibility to avoid setting ambient air quality standards ruinous to industry.

        74

        Section 109(b)(1) directs the Administrator to set standards that are "requisite to protect the public health" with "an adequate margin of safety." But these words do not describe a world that is free of all risk—an impossible and undesirable objective. See Industrial Union Dept., AFL—CIO v. American Petroleum Institute, 448 U. S. 607, 642 (1980) (plurality opinion) (the word "safe" does not mean "riskfree"). Nor are the words "requisite" and "public health" to be understood independent of context. We consider football equipment "safe" even if its use entails a level of risk that would make drinking water "unsafe" for consumption. And what counts as "requisite" to protecting the public health will similarly vary with background circumstances, such as the public's ordinary tolerance of the particular health risk in the particular context at issue. The Administrator can [495] consider such background circumstances when "decid[ing] what risks are acceptable in the world in which we live." Natural Resources Defense Council, Inc. v. EPA, 824 F. 2d 1146, 1165 (CADC 1987).

        75

        The statute also permits the Administrator to take account of comparative health risks. That is to say, she may consider whether a proposed rule promotes safety overall. A rule likely to cause more harm to health than it prevents is not a rule that is "requisite to protect the public health." For example, as the Court of Appeals held and the parties do not contest, the Administrator has the authority to determine to what extent possible health risks stemming from reductions in tropospheric ozone (which, it is claimed, helps prevent cataracts and skin cancer) should be taken into account in setting the ambient air quality standard for ozone. See 175 F. 3d, at 1050-1053 (remanding for the Administrator to make that determination).

        76

        The statute ultimately specifies that the standard set must be "requisite to protect the public health" "in the judgment of the Administrator," § 109(b)(1), 84 Stat. 1680 (emphasis added), a phrase that grants the Administrator considerable discretionary standard-setting authority.

        77

        The statute's words, then, authorize the Administrator to consider the severity of a pollutant's potential adverse health effects, the number of those likely to be affected, the distribution of the adverse effects, and the uncertainties surrounding each estimate. Cf. Sunstein, Is the Clean Air Act Unconstitutional?, 98 Mich. L. Rev. 303, 364 (1999). They permit the Administrator to take account of comparative health consequences. They allow her to take account of context when determining the acceptability of small risks to health. And they give her considerable discretion when she does so.

        78

        This discretion would seem sufficient to avoid the extreme results that some of the industry parties fear. After all, the EPA, in setting standards that "protect the public health" [496] with "an adequate margin of safety," retains discretionary authority to avoid regulating risks that it reasonably concludes are trivial in context. Nor need regulation lead to deindustrialization. Preindustrial society was not a very healthy society; hence a standard demanding the return of the Stone Age would not prove "requisite to protect the public health."

        79

        Although I rely more heavily than does the Court upon legislative history and alternative sources of statutory flexibility, I reach the same ultimate conclusion. Section 109 does not delegate to the EPA authority to base the national ambient air quality standards, in whole or in part, upon the economic costs of compliance.

        80

        [1] Together with No. 99-1426, American Trucking Associations, Inc., et al. v. Whitman, Administrator of Environmental Protection Agency, et al., also on certiorari to the same court.

        81

        [2] Briefs of amici curiae urging reversal were filed for the State of New York et al. by Eliot Spitzer, Attorney General of New York, Preeta D. Bansal, Solicitor General, Daniel X. Smirlock, Deputy Solicitor General, and Lisa Feiner and J. Jared Snyder, Assistant Attorneys General, and by the Attorneys General for their respective States as follows: Bill Lockyer of California, Richard Blumenthal of Connecticut, Andrew Ketterer of Maine, J. Joseph Curran, Jr., of Maryland, Philip McLaughlin of New Hampshire, D. Michael Fisher of Pennsylvania, Sheldon Whitehouse of Rhode Island, and William H. Sorrell of Vermont; for the State of North Carolina by Michael F. Easley, Attorney General, Daniel C. Oakley, Senior Deputy Attorney General, and Marc D. Bernstein, Assistant Attorney General; for the American Boiler Manufacturers Association by Gene E. Godley and Shannon H. Ratliff II; and for the American Crop Protection Association et al. by Herbert L. Fenster and Lawrence S. Ebner.

        82

        Briefs of amici curiae urging affirmance were filed for the State of California et al. by Bill Lockyer, Attorney General of California, Richard M. Frank, Chief Assistant Attorney General, Theodora P. Berger, Senior Assistant Attorney General, and Susan L. Durbin and Sean B. Hecht, Deputy Attorneys General, Richard Blumenthal, Attorney General of Connecticut, Thomas J. Miller, Attorney General of Iowa, Andrew Ketterer, Attorney General of Maine, J. Joseph Curran, Jr., Attorney General of Maryland, Patricia Madrid, Attorney General of New Mexico, Eliot Spitzer, Attorney General of New York, Preeta D. Bansal, Solicitor General, and Daniel X. Smirlock, Deputy Solicitor General, William H. Sorrell, Attorney General of Vermont, and Christine O. Gregoire, Attorney General of Washington; for the Commonwealth of Virginia by Mark L. Earley, Attorney General, William Hurd, Solicitor General, Roger L. Chaffe, Senior Assistant Attorney General, and Stewart T. Leeth, Assistant Attorney General; for the American Institute of Certified Public Accountants et al. by Theodore B. Olson, Douglas R. Cox, and Mark A. Perry; for the Association of American Physicians & Surgeons et al. by Erik S. Jaffe; for the Clean Air Trust et al. by Christopher H. Schroeder; for the Lincoln Institute for Research and Education et al. by William J. Olson, John S. Miles, Herbert W. Titus, and Lawrence J. Straw, Jr.; for the Manufacturers Alliance/MAPI Inc. et al. by David Schoenbrod and Marci A. Hamilton; for the United States Public Interest Research Group Education Fund by James Keith Weeks and David M. Driesen; and for Senator James H. Inhofe et al. by Paul Rosenzweig.

        83

        Briefs of amici curiae were filed for the AEI-Brookings Joint Center for Regulatory Studies et al.by Robert E. Litan; for Alcan Aluminum Corp. by Lawrence A. Salibra II; for Environmental Defense et al.by Richard L. Revesz and Ann Brewster Weeks; for General Electric Co. by Laurence H. Tribe, Jonathan S. Massey, Thomas C. Goldstein, Benjamin W. Heineman, Jr., Brackett B. Denniston III, and Matthew Tanzer; for the Institute for Justice et al. by William H. Mellor, Clint Bolick, Deborah Simpson, Timothy Lynch, and Ronald D. Rotunda; for Intel Corp. et al. by Richard P. Bress, Claudia M. O'Brien, and Gregory S. Slater; for the Mercatus Center by Ernest Gelhorn and Ann G. Weymouth; for the Pacific Legal Foundation et al. by M. Reed Hopper; for People for the U. S. A.et al.by Christopher C. Horner; for the Washington Legal Foundation et al.by Paul D. Clement, Jeffrey S. Bucholtz, Daniel J. Popeo, and Paul D. Kamenar; for Senator Orrin Hatch et al. by Carter G. Phillips, Alan Charles Raul, Stephen B. Kinnaird, Lloyd N. Cutler, and C. Boyden Gray; and for Gary E. Marchant et al. by Cary Coglianese.

        84

        [3] None of the sections of the CAA in which the District of Columbia Circuit has found authority for the EPA to consider costs shares § 109(b)(1)'s prominence in the overall statutory scheme. See, e. g., Michigan v. EPA, 213 F. 3d 663, 678-679 (CADC 2000); George E. Warren Corp. v. EPA, 159 F. 3d 616, 623-624 (CADC 1998); Natural Resources Defense Council, Inc. v. EPA, 824 F. 2d 1146, 1154-1163 (CADC 1987) (en banc).

        85

        [4] Respondents contend that this advice is required to be included in the NAAQS rulemaking record—which, if true, would suggest that it was relevant to the standard-setting process. But the provision respondents cite for their contention, 42 U. S. C. § 7607(d)(3), requires only that "pertinent findings, recommendations, and comments by the Scientific Review Committee" be included. The Committee's advice concerning certain aspects of "adverse public health . . . effects" from various attainment strategies is unquestionably pertinent; but to say that Committeegenerated cost data are pertinent is to beg the question. Likewise, while "all written comments" must be placed in the docket, § 7607(d)(4)(B)(i), the EPA need respond only to the "significant" ones, § 7407(d)(6)(B); comments regarding cost data are not significant if cost data are irrelevant.

        86

        [5] Respondents scarcely mention in their arguments the secondary NAAQS required by § 109(b)(2), 42 U. S. C. § 7409(b)(2). For many of the same reasons described in the body of the opinion, as well as the text of § 109(b)(2), which instructs the EPA to set the standards at a level "requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air " (emphasis added), we conclude that the EPA may not consider implementation costs in setting the secondary NAAQS.

        87

        [6] Respondents' speculation that the EPA is secretly considering the costs of attainment without telling anyone is irrelevant to our interpretive inquiry. If such an allegation could be proved, it would be grounds for vacating the NAAQS, because the Administrator had not followed the law. See, e. g., Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-843 (1984); Atlantic Mut. Ins. Co. v. Commissioner, 523 U. S. 382, 387 (1998). It would not, however, be grounds for this Court's changing the law.

        88

        [7] TABLE 1 Primary standard Area class Design value* attainment date** Marginal 0.121 up to 0.138 3 years after November 15, 1990 Moderate 0.138 up to 0.160 6 years after November 15, 1990 Serious 0.160 up to 0.180 9 years after November 15, 1990 Severe 0.180 up to 0.280 15 years after November 15, 1990 Extreme 0.280 and above 20 years after November 15, 1990 *The design value is measured in parts per million (ppm). **The primary standard attainment date is measured from November 15, 1990.

    • 1.2 Evolving Legal Definition of Food

      • 1.2.1 Statutory Definition

      • 1.2.2 Dual Classification: Food and Drug

      • 1.2.3 Emerging Sub-Classifications

  • 2 Chapter 2 – Organization of Food Law

    • 2.1 Forms of Food Law

    • 2.2 Government Regulation: Public Health and Safety Laws and Consumer Protection

      • 2.2.1 Fragmentation

      • 2.2.2 Food and Drug Administration (FDA)

        • 2.2.2.1 Regulatory Activity

        • 2.2.2.2 Administrative Adjudication

        • 2.2.2.3 Formal Rulemaking

        • 2.2.2.4 Informal Rulemaking

        • 2.2.2.5 Informal Guidance

        • 2.2.2.6 Informal and Public and Private Meetings

        • 2.2.2.7 Citizen Petitions

        • 2.2.2.8 Additional Petitions and Tools

        • 2.2.2.9 Enforcement

      • 2.2.3 Food Safety Inspection Service (USDA)

      • 2.2.4 Environmental Protection Agency (EPA)

      • 2.2.5 Federal Trade Commission (FTC)

        • 2.2.5.1 Food Safety Modernization Act

          The 2011 Food Safety Modernization Act (FSMA) ushered in a new federal food safety regime.  After a series of disease outbreaks in the United States were linked to foods like carrot juice, peanut butter, bagged spinach, pepper, cookie dough, and even dog food, consensus grew that legal and policy change was needed.  Although there was no shortage of disagreement on particulars, consumers, producers, activists, and politicians all agreed on the need for change.  One of FSMA’s key principles is an emphasis on prevention.  To oversimplify a bit, in the old regime agencies would use establishment-by-establishment inspections to detect safety risks and then use warning letters and enforcement actions to bring the wrongdoers into compliance.  Given the number of establishments, the number of inspectors, and resources available to federal inspectors, truly protecting food safety with intermittent inspections is all but impossible.  FSMA’s so-called risk-based approach seeks to focus regulatory attention on the points in the production and distribution of food most likely to produce safety problems and to require ex ante development of hazard management plans by each food producer.    

      • 2.2.6 State Law Enforcement Authorities

      • 2.2.7 Calls for Single Food Agency

    • 2.3 Government Programs

      • 2.3.1 USDA Mission

      • 2.3.2 US Farm Bill

      • 2.3.3 Delineation of USDA Programs

    • 2.4 Global Governance of Food

      • 2.4.1 Dynamic System of Systems

      • 2.4.2 Framework for Global Food Governance

        • 2.4.2.1 Trade Rounds and the World Trade Organization

        • 2.4.2.2 Legal Instruments

      • 2.4.3 Relevant Organizations

        • 2.4.3.1 Food and Agricultural Organization (FAO)

        • 2.4.3.2 World Health Organization (WHO)

        • 2.4.3.3 Codex Alimentarius Commission

        • 2.4.3.4 World Organization for Animal Health (OIE)

        • 2.4.3.5 Additional Organizations

      • 2.4.4 Standard Setting Process and Application

      • 2.4.5 European Food Law

    • 2.5 Self-Governance

      • 2.5.1 Theoretical Underpinnings

      • 2.5.2 New Governances Approaches

      • 2.5.3 Defining Characteristics of New Governance Forms of Law

      • 2.5.4 Concerns of New Governance

    • 2.6 Municipal Law

      • 2.6.1 Police Power

      • 2.6.2 Assistance to Federal Regulation

      • 2.6.3 Laboratories for Innovation

      • 2.6.4 Preemption Considerations

    • 2.7 Litigation

      • 2.7.1 Legal Tool

      • 2.7.2 No Private Right of Action

      • 2.7.3 Administrative Procedure Act

  • 3 Chapter 3 – Regulation of Food Commerce

    • 3.1 Introduction

    • 3.2 Regulation of Economically Motivated Adulteration (EMA)

      • 3.2.1 Background

        • 3.2.1.1 Perpetual Problem of Food Systems

        • 3.2.1.2 US Regulatory Response: 1906 and 1938 Food Acts

        • 3.2.1.3 Law’s Evolving Adaptation to EMA

      • 3.2.2 Statutory Basis

        • 3.2.2.1 Actions Constituting EMA

        • 3.2.2.2 Intent Basis: Economic Motivation

        • 3.2.2.3 Distinguishing EMA from other Forms of Adulteration and Fraud

      • 3.2.3 Regulatory Tools to Address EMA

        • 3.2.3.1 FDCA Section 402(b): Enforcement

        • 3.2.3.2 FDCA Section 401: Standards of Identity

        • 3.2.3.3 Import Alert: Border Enforcement

        • 3.2.3.4 Bioterrorism Act: Traceability

        • 3.2.3.5 FSMA: Preventive Controls

        • 3.2.3.6 Development of Technology and Standards

        • 3.2.3.7 Enhanced Coordination

        • 3.2.3.8 FTC: Unfair Method of Competition

        • 3.2.3.9 Litigation

        • 3.2.3.10 International Law

    • 3.3 Trade

      • 3.3.1 Background

        • 3.3.1.1 Tension Between Free Trade and Protectionism

        • 3.3.1.2 International Agreements: Law and Food

      • 3.3.2 GATT and WTO

        • 3.3.2.1 Trade Rules for Food Products

        • 3.3.2.2 WTO Dispute Resolution

        • 3.3.2.3 Trade Barrier Exceptions Under GATT and SPS Agreements

        • 3.3.2.4 TBT Agreement

      • 3.3.3 Additional International Agreements

        • 3.3.3.1 Agreement on Agriculture

        • 3.3.3.2 TRIPS

        • 3.3.3.3 Anti-Dumping Agreement

        • 3.3.3.4 Doha Round

        • 3.3.3.5 Regional and Bilateral Trade Agreements

  • 4 Food Safety

    • 4.1 Introduction to Food Safety

      The CDC estimates that 48 million people get sick, 128,000 are hospitalized, and 3000 people die from foodborne illness each year in the United States. Major known pathogens account for approximately 9 million of these cases, but it is extremely difficult to link an individual illness to a particular food except during an extreme outbreak.

      Consider the problem faced by food safety institutions. The average American eats nearly 2000 pounds (1 ton) of total food each year. That figure includes about 630 pounds of dairy (milk, yogurt, cheese, and ice cream), about 185 pounds of meat and poultry, nearly 275 pounds of fruit, and 415 pounds of vegetables. Produce accounts for about half of all illnesses, most often caused by norovirus. Within this category, it was leafy vegetables that cause nearly half. Most fatal illnesses are caused by Salmonella and Listeria passed to humans by meat and poultry. Meat and poultry account for fewer illnesses, but more deaths (29%).

      America imports about 15 percent of the U.S. food supply, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood. Americans consume twice as much fruit, and three times as many vegetables, from both Mexico and Canada as they did two decades ago.

      Between foreign and domestic production, distribution, preparation, and sale of foods, the food safety challenge is immense. Roughly, these challenges might be grouped into three classes. First, food that is contaminated, diseased, or contains harmful materials that are not detected or remedied. Second, faulty storage, handling, or processing, which might either introduce risks or fail to detect risks. Third, the intentional introduction of harmful materials into the food supply including toxins, food additives, chemicals, pesticides, drugs, packaging materials, or poisons. See generally Richard A. Merrill & Jeffrey K. Francer, Organizing Federal Food Safety Regulation, 31 Seton Hall L. Rev. 61 (2000); Institute of Medicine, Ensuring Safe Food: From Product to Consumption (1998).

      For many years, there was remarkable little in the way of federal food safety legislation. In 1906, Upton Sinclair published his famous novel The Jungle, a socialist screed aimed at revealing the plight of immigrants the working poor in advanced industrial capitalism. The book, however, had a much larger impact on food safety law than on anti-capitalist sentiments. Sinclair revealed the inner workings of the Chicago slaughterhouses and meatpacking plants. The result was none too pretty. His portrait of not just unsanitary, but downright disgusting conditions and practices caused a justifiable outcry among the American public and politicians. Contemporaneous reports documented “meat shoveled from filthy wooden floors, piled on tables rarely washed, pushed from room to room in rotten box carts.” Upton Sinclair, What Life Means to Me, Cosmopolitan Mag. (Oct. 1906).

      What resulted politically was the Pure Food and Drug Act of 1906 (PFDA), 34 Stat. 768 and the Federal Meat Inspection Act (FMIA), 34 Stat. 1260 (1907). The goal of the FMIA was to protect consumers “by ensuring that meat and meat food products are wholesome, not adulterated, and properly marked labeled, and packaged.” The Act’s method was to establish sanitary standards and mandate continuous inspection of cattle, sheep, goats, and equines before, during, and after slaughter. That is, a federal inspector (or inspectors) was placed in each facility to monitor the entire production process from start to finish. Consider how much staffing would be necessary to comprehensively and effectively inspect every piece of meat sold in the United States.

      The PFDA, by contrast, mandated nothing like continuous inspection for non-meat products. Rather, the PFDA simply forbid the “adulteration” of foods in interstate commerce. Yet, because the statute did not set standards for what a particular “food” was, it was extremely difficult to prove that a given food was “adulterated.”

      After several decades of struggling with the inadequacies of the PFDA, the FDA recommended that Congress enact new legislation in the 1930s. In a remarkable bout of administrative agency activism, the FDA developed an exhibit and ultimately a book known as the Chamber of Horrors in 1936. Chamber of horrors was published by Ruth deforest Lamb, FDA’s chief educational officer. It was the historical equivalent of an expose on the food industry, revealing a range of unpalatable industry practices. Although Chamber of Horrors did not have quite the impact of The Jungle, the book, together with the death of 107 people from unknowingly consumed the drug elixir of sulfanilamide, helped prompt the enact of the Food, Drug, and Cosmetic Act of 1938, that today remains the overarching framework for the federal regulation of food, drugs, and cosmetics.

      The FDCA expanded FDA authority to inspect food manufacturing and processing facilities, prohibited the sale of food prepared in unasanitary conditions, defined adulteration to include bacteria and chemicals that are potentially harmful, and created new authorization for the FDA to set mandatory standards for food. Although amended over the years to address particular concerns—-like pesticide residue in foods (see the Miller Pesticides Amendment of 1954), the FDCA’s basic structure has proven remarkably durable.

      By the turn of the century, however, the country was overdue for a food safety law update. The Food Safety and Modernization Act of 2011 (FSMA) was heralded as a complete overhaul of our approach to food safety regulation. Once again, the Act was passed after a series of foodborne illness outbreaks from products as diverse as bagged spinach, peanut butter, cookie dough, and pot pies. Coupled with a growing concern about the safety of imported food in an age of globalization and terrorism, FSMA sought to develop a new comprehensive approach to the food safety problem.

      At the core of FSMA is a commitment to prevention. Under the prior regime, FDA’s understaffed inspectors would collect data for warning letters and enforcement actions against food producers. If inspectors found evidence of adulteration, for example, an enforcement action might be commenced. In the new regime, FDA would work with producers to ensure that everyone in the food system had an adequate plan to identify points in the production process most likely to result in unsafe food and put in place a plan to manage those risks. The statute required new FDA regulations for Hazard Analysis and Preventative Controls, the establishment of minimum standards for safe production and harvesting of fruits and vegetables, new sanitary transportation rules, and the establishment of a new Foreign Supplier Verification program to ensure that all foreign suppliers of food could ensure that imported food is safe.

    • 4.2 Structure & Method of Food Safety Law

      • 4.2.1 The Federal Food Safety System: A Primer

        Renee Johnson, The Federal Food Safety System: A Primer, Congressional Research Service RS22600 (Dec. 16 2016) (excerpt)

        Background

        Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools, and other places outside the home.1 Federal laws give food manufacturers, distributors, and retailers the basic responsibility for assuring that foods are wholesome, safe, and handled under sanitary conditions. A number of federal agencies, cooperating with state, local, and international entities, play a major role in regulating food quality and safety under these laws.

        The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, the Centers for Disease Control and Prevention (CDC) reports that each year an estimated one in six Americans—a total of 48 million people—becomes sick from contaminated food foodborne illnesses caused by contamination from any one of a number of microbial pathogens.2 Of these, an estimated 128,000 cases require hospitalization and 3,000 cases result in death. In addition, experts have cited numerous other hazards to health, including the use of unapproved veterinary drugs, pesticides, and other dangerous substances in food commodities, of particular concern at a time when a growing share of the U.S. food supply is from overseas sources. These concerns, combined with the ongoing recurrence of major food safety-related incidents, have heightened public and media scrutiny of the U.S. food safety system and magnified congressional interest in the issue.

         

        The Agencies and Their Roles

        Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply. Federal responsibility for food safety rests primarily with the Food and Drug Administration (FDA), which is part of the U.S. Department of Health and Human Services (HHS), and the Food Safety and Inspection Service (FSIS), which is part of the U.S. Department of Agriculture (USDA). FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood, fish, and shellfish products. USDA’s Food Safety and Inspection Service (FSIS) regulates most meat and poultry and some egg and fish products.

        The Government Accountability Office (GAO) has identified as many as 15 federal agencies, including FDA and FSIS, as collectively administering at least 30 laws related to food safety.*** State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments. This organizational complexity, and trends in U.S. food markets—for example, increasing imports as a share of U.S. food consumption and increasing consumption of fresh, often unprocessed, foods— pose ongoing challenges to ensuring food safety.

        The division of food safety responsibility between FDA and USDA is rooted in the early history  of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the widespread marketing of intentionally adulterated foods, and its implementation was assigned to USDA’s Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat packing plants, and implementation was assigned to the USDA’s Bureau of Animal Industry. This bifurcated system has been perpetuated and split further into additional food safety activities  under additional agencies (for example, the Environmental Protection Agency, the National Marine Fisheries Service, and others) by a succession of statutes and executive directives. The separation of the two major food safety agencies was further reinforced when, in 1940, the President moved responsibilities for safe foods and drugs, other than meat and poultry, from USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in USDA. There has been discussion over time regarding whether this dispersal of food safety responsibilities has been problematic, or whether a reorganization would divert time and attention from other fundamental problems in the system. * * * 

        Over the years, GAO has published a series of reports highlighting how food safety oversight in the United States is fragmented and recommending broad restructuring of the nation’s food safety system. These GAO reports document examples where a number of federal agencies are responsible for some aspect of food safety or product quality, resulting in split agency jurisdiction for some foods. Limited coordination and sharing of information results in often overlapping and/or duplication of efforts. Similar observations are noted in a series of food safety studies by the National Research Council (NRC) and Institute of Medicine (IOM).6 The NRC/IOM studies further recommend that the core federal food safety responsibilities should reside within a single entity/agency; have a unified administrative structure, clear mandate, and dedicated budget; and maintain full responsibility for oversight of the entire U.S. food supply.

        Food and Drug Administration

        FDA has primary responsibility for the safety of most (about 80%-90%) of all U.S. domestic and imported foods.7 The FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. Examples of FDA-regulated foods are produce, dairy products, and processed foods. FDA also has oversight of all seafood and shellfish products, and most fish products (except for catfish). FDA has jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of FSIS. FDA shares some responsibility for the safety of eggs with FSIS. FDA has jurisdiction over establishments that sell or serve eggs or use them as an ingredient in their products.

        As described in a memorandum of understanding between FDA and FSIS:

        FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and parts of the Egg Products Inspection Act [21 U.S.C. §§1031 et seq.]. In carrying out its responsibilities under these acts, FDA conducts inspections of establishments that manufacture, process, pack, or hold foods, with the exception of certain establishments that are regulated exclusively by FSIS. FDA also inspects vehicles and other conveyances, such as boats, trains, and airplanes, in which foods are transported or held in interstate commerce.

        In addition, the 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353), amending the Federal Food, Drug, and Cosmetic Act (FFDCA). FSMA was the largest expansion of FDA’s food safety authorities since the 1930s.10 FSMA did not directly address meat and poultry products under USDA’s jurisdiction. New rules governing FDA’s food inspection regime of both domestic and imported foods under the agency’s jurisdiction are now being implemented. For more information, see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).

         In the Washington, DC, area, two FDA offices are the focal point for food safety-related activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for

        (1) conducting and supporting food safety research; (2) developing and overseeing enforcement of food safety and quality regulations; (3) coordinating and evaluating FDA’s food surveillance and compliance programs; (4) coordinating and evaluating cooperating states’ food safety activities; and (5) developing and disseminating food safety and regulatory information to consumers and industry. FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, are properly labeled, and produce no human health hazards when used in food-producing animals.

        The FDA also cooperates with over 400 state agencies across the nation to carry out a wide range of food safety regulatory activities. However, the state agencies are primarily responsible for actual inspection. FDA works with the states to set the safety standards for food establishments and commodities and evaluates the states’ performance in upholding such standards as well as any federal standards that may apply. FDA also contracts with states to use their food safety agency personnel to carry out certain field inspections in support of FDA’s own statutory responsibilities.

        Food Safety and Inspection Service

         FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and imported meat and poultry and their products sold for human consumption, comprising roughly 10%-20% of the U.S. food supply.11 As described in a memorandum of understanding between FDA and FSIS, FSIS’s jurisdiction is as follows:

        FSIS is responsible for implementing and enforcing the Federal Meat Inspection Act (21 U.S.C. 601, et seq.), the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), and parts of the Egg Products Inspection Act (21 U.S.C. 1031, et seq.). In carrying out its responsibilities under these acts, FSIS places inspectors in meat and poultry slaughterhouses and in meat, poultry,  and  egg  processing  plants.  FSIS  also  conducts  inspections  of  warehouses, transporters, retail stores, restaurants, and other places where meat, poultry, and egg products are handled and stored. In addition, FSIS conducts voluntary inspections under the Agriculture Marketing Act (7 U.S.C. 1621, et seq.).

        The Federal Meat Inspection Act (FMIA) of 1906, as amended, requires USDA to inspect all cattle, sheep, swine, goats, horses, mules, and other equines slaughtered and processed for human consumption. The Poultry Products Inspection Act (PPIA) of 1957, as amended, gives USDA the authority to inspect poultry meat. The PPIA mandates USDA inspection of any domesticated birds (chickens, turkeys, ducks, geese, guineas, ratites [ostrich, emu, and rhea], and squab (pigeons up to one month old]) intended for use as human food. The Egg Products Inspection Act, as amended, provides USDA authority to inspect liquid, frozen, and dried egg products. Each of these laws contains provisions governing USDA’s authority to label food products under its jurisdiction.

        Under the authority of the Agricultural Marketing Act of 1946 as amended, USDA’s FSIS may provide voluntary inspection for buffalo, antelope, reindeer, elk, migratory waterfowl, game birds, and rabbits. This type of inspection is performed by FSIS on a fee-for-service basis. However, these meat and poultry species are still within the purview of FDA under FFDCA, whether or not inspected under the voluntary FSIS program. FDA has jurisdiction over meat products from such species in interstate commerce, even if they bear the USDA inspection mark. FDA also has jurisdiction over shell eggs. In addition, the 2008 farm bill requires that FSIS inspect and grade farmed catfish products.

        Meat and poultry animals and products undergo continuous (i.e., 100%) inspection, which may in turn act as a deterrent to fraud in some cases. FSIS inspects all meat and poultry animals to look for signs of disease, contamination, and other abnormal conditions, both before and after  slaughter (“antemortem” and “postmortem,” respectively), on a continuous basis—meaning that no animal may be slaughtered and dressed unless an inspector has examined it. One or more federal inspectors are on the line during all hours the plant is operating. Processing plants visited once every day by an FSIS inspector are considered to be under continuous inspection in keeping with the laws. Inspectors monitor operations, check sanitary conditions, examine ingredient levels and packaging, review records, verify food safety plans, and conduct statistical sampling and testing of products for pathogens and residues during their inspections.

        FSIS is responsible for certifying that foreign meat and poultry plants are operating under an inspection system equivalent to the U.S. system before they can export their product to the United States. Meat and poultry imports are 100% visually inspected (process-based, documentation, labeling), although physical inspections of imports may be more random. FSIS conducts evaluations of foreign meat safety programs and visits establishments to determine whether they are providing a level of safety equivalent to that of U.S. safeguards. No foreign plant can ship meat or poultry to the United States unless its country has received such an FSIS determination.

        Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS is statutorily responsible for ensuring that the states’ programs are at least equal to the federal program. Plants processing meat and poultry under state inspection can market their products only within the state. If a state chooses to discontinue its own inspection program, or if FSIS determines that it does not meet the agency’s equivalency standards, FSIS must assume the responsibility for inspection if the formerly state-inspected plants are to remain in operation. FSIS also has cooperative agreements with more than two dozen states under which state inspection personnel are authorized to carry out federal inspection in meat and/or poultry plants. Products from these plants may travel in interstate commerce. * * * 

      • 4.2.2 Food Safety Modernization Act

        The 2011 Food Safety Modernization Act (FSMA) ushered in a new federal food safety regime.  After a series of disease outbreaks in the United States were linked to foods like carrot juice, peanut butter, bagged spinach, pepper, cookie dough, and even dog food, consensus grew that legal and policy change was needed.  Although there was no shortage of disagreement on particulars, consumers, producers, activists, and politicians all agreed on the need for change.  One of FSMA’s key principles is an emphasis on prevention.  To oversimplify a bit, in the old regime agencies would use establishment-by-establishment inspections to detect safety risks and then use warning letters and enforcement actions to bring the wrongdoers into compliance.  Given the number of establishments, the number of inspectors, and resources available to federal inspectors, truly protecting food safety with intermittent inspections is all but impossible.  FSMA’s so-called risk-based approach seeks to focus regulatory attention on the points in the production and distribution of food most likely to produce safety problems and to require ex ante development of hazard management plans by each food producer.    

      • 4.2.3 Center for Food Safety v. Hamburg

        Notes: <p>1. Compel agency action unlawfully withheld. The Administrative Procedure Act provides that federal courts may compel agency action unlawfully withheld or unreasonably delayed. 5 U.S.C. § 706 (1). Because agencies may choose to pursue a set of priorities different than a particular citizen or group or citizens prefers, courts tend to be quite deferential when evaluating such claims. In Norton v. Southern Utah Wilderness Alliance, the Supreme Court held that 706(1) only applies to discrete agency actions as opposed to general enforcement or policy priorities. Unreasonable delay challenges tend to be very difficult to win. The one exception is when a statute imposes specific deadlines for particular agency actions.</p> <p>2. Deadlines. Statutory deadlines were increasingly used by Congress over the past few decades. See Jacob E. Gersen &amp; Anne Joseph O’Connell, Deadlines in Administrative Law, 156 U. Penn. L. Rev. 924 (2008). One reason may be that deadlines allow Congress to control the agency’s policy priorities. Absent a deadline, the agency would be free to pursue other rules or regulations first, putting the statutory obligations further down the to do list. A deadline controls the order in which the agency embarks on different policies.</p> <p>2. Remedies. What is the remedy for the failure to meet a statutory deadline? Justice Scalia once argued that if an agency fails to enact a rule by the statutory deadline, the agency loses the legal authority to promulgate the rule at all. That argument, however, has failed to carry the day. In almost all cases, the remedy for failing to meet a deadline is either an order like the one issued in Hamburg—to meet with the parties and come up with a timeframe for taking the required action; or, an order to take action by a new court-ordered deadline. Such remedies are better than nothing, but when the agency failed to meet one deadline, it is hardly a sufficient remedy to impose another legal obligation to meet another deadline.</p> <p>3. First Wave and Second Wave. While challengers complained the <span class="caps">FDA</span> had failed to act quickly enough, the <span class="caps">FDA</span> argued that the new rules were complex and challenging. Rather than issue bad rules quickly, the agency sought to promulgate the required rules in stages or waves. What is wrong with the <span class="caps">FDA</span> attempting to take one step (or in this case, several steps) at a time? Should it matter if the timeline imposed by Congress is realistic? Consider that the package of financial regulation known colloquially as Dodd-Frank imposed hundreds of deadlines, the vast majority of which were missed by implementing agencies because they were unrealistic. See Jacob Gersen, Administrative Law Goes to Wall Street, 65 Admin. L. Rev. 689 (2013).</p> <p>4. Aftermath. In the aftermath of litigation, the <span class="caps">FDA</span> eventually implemented all of the new rules required by the Food Safety Modernization Act. We consider many of them later in this chapter.</p>
        1

        954 F.Supp.2d 965 (2013)

        2
        CENTER FOR FOOD SAFETY, et al., Plaintiffs,
        v.
        Margaret A. HAMBURG M.D., Defendant.

        No. C 12-4529 PJH.

        3

        United States District Court, N.D. California.

        April 22, 2013.

        4

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

        5

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

        6
        ORDER RE CROSS-MOTIONS FOR SUMMARY JUDGMENT
        7
        PHYLLIS J. HAMILTON, District Judge.
        8

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

        9
        BACKGROUND
        10

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

        11

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

        12

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

        13

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

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

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

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

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

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

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

        14

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

        15

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

        16
        DISCUSSION
        17
        A. Legal Standard
        18

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

        19

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

        20

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

        21

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

        22

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

        23

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

        24
        B. The Parties' Motions
        25

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

        26

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

        27

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

        28

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

        29

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

        30

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

        31

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

        32

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

        33

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

        34

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

        35

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

        36

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

        37

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

        38

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

        39

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

        40

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

        41

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

        42

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

        43

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

        44

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

        45

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

        46

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

        47
        CONCLUSION
        48

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

        49

        IT IS SO ORDERED.

        50

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

        51

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

        52

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

        53

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

      • 4.2.4 Federal Regulatory Regime

        One of the key features of Untied States food system—indeed, of food systems in most parts of the world—is decentralization. The sheer number of individuals and organizations involved in bringing a food from start to finish is staggering. Each link in the chain of production, distribution, and consumption or what we refer to as the PDC chain creates a risk of food contamination. Notwithstanding the horrific effects of recent food born illness outbreaks, it is somewhat remarkable that outbreaks are so few. This section provides an overview of the basic tools in the federal regulatory kit.

        • 4.2.4.1 Food Facility Registration

          As the excerpt from the Congressional Research Service report on agroterrorism notes, the Bioterrorism Act of 2001 included a for facility registration requirement. The Act mandates domestic and foreign facilities that manufacture, process, produce, pack, or hold food for human consumption in the United States to register with the FDA. See 21 C.F.R. 1.225-1.243. These registration rules were strengthened by FSMA which amended Section 415 of the FDCA Act, see 21 U.S.C. sec. 350(d). In particular, FSMA section 102© increased the frequency of registration and also expanded the scope of information that must be disclosed in the registration.

          Notes: <p>1. Registration, Who? It is the responsibility of the owner, operator, or agent in charge of a domestic or foreign facility that must register the facility. Notably, a domestic facility must register even if its products do not enter interstate commerce. 21 C.F.R. 1.225(b). Foreign facilities must register if products are exported to the United States unless the food from that facility undergoes further processing by another foreign facility before the food is exported. 21 C.F.R. 1.226(a). <br /> 2. Registration, What? A &#8220;food facility&#8221; is defined as &#8220;any factory, warehouse, or establishment . . . that manufactures, processes, packs, or holds food.&#8221; 21 U.S.C. 350(d)(b). Note that on its face, the definition of a &#8220;food facility&#8221; is extremely broad, seemingly covering virtually any building in which food is held. The statute, however, excepts large classes of actors.</p> <p>3. Registration, Exceptions. Section 415 of the <span class="caps">FDCA</span> exempts from any registration requirement the following classes of establishment: <br /> a. Farms. Exempted farms are facilities located in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both. Some farms may be subject to the Produce Safety Rule, discussed later in this chapter. <br /> b. Restaurants. Exempted restaurants are facilities that prepare and sell food directly to consumers for immediate consumption. 21 C.F.R. 1.227(b)(10. <br /> c. Retail food Establishments. Exempted retail food establishments sell food directly to consumers as their primary function. In essence, that means that annual sales directly to consumers are greater than annual sales to other buyers. 21 C.F.R. 1.226&#169;. The largest class of exempt retail food establishments are grocery stores and convenience stores. <br /> d. Nonprofit Food Establishments. Nonprofit Food Establishments (NFEs) are charitable organizations that meet the standard of section 501&#169;(3) of the Internal Revenue Code and that prepare or serve food directly to consumers for consumption. The canonical example of an <span class="caps">NFE</span> is the so-called soup kitchen, but the exemption also applies to food banks and nonprofit food delivery services. 21 C.F.R. 1.22(b)(7).</p> <p>4. Registration, to Whom? <span class="caps">FSMA</span>, <span class="caps">FDCA</span>, and the Bioterrorism Act require registration with the <span class="caps">FDA</span>. Facilities handling only meat, poly or egg products are regulated not by the <span class="caps">FDA</span>, but the <span class="caps">USDA</span>. As a consequence, <span class="caps">USDA</span>-regulated entities are also exempt from the registration requirements.</p> <p>5. Registration, Food. Recall that the definition of &#8220;food&#8221; in the <span class="caps">FDCA</span> excludes certain food contact substances and pesticides. Thus, facilities that produce food contact substances and pesticides are also exempt from registration, unless the food contact substance is used as a direct food additive.</p> <p>6. Registration, How Often? <span class="caps">FSMA</span> increased the frequency of registration from once to biennially in each even-numbered year.</p> <p>7. Registration, Information. Facilities must provide a name, address, phone number of the facility, the parent company, and the owner, operator, or agent in charge. Foreign facilities must also provide a US agent.</p> <p>8. Registration, Enforcement. The failure to register or rent a registration may subject a food facility to criminal protection. 21 C.F.R. 1.241. If the <span class="caps">FDA</span> judges that food from a facility could cause serious adverse health consequences or death to humans or animals, <span class="caps">FDA</span> may suspend the registration. No person may import, offer to import, or introduce into interstate or intrastate commerce any food from a facility whose registration has been suspended. 21 U.S.C. 350(d)(b)(4). An article of food offered for import shall be refused admission to the United States if it is from a facility whose registration has been suspended. 21 U.S.C. 381(l).</p>
          • 4.2.4.1.1 Agroterrorism: Threats and Preparedness

            Jim Monke, Agroterrorism: Threats and Preparedness (Congressional Research Service, RL32521, August 13, 2004) (excerpt)

            Overview of the Threat 

            The potential of terrorist attacks against agricultural targets (agroterrorism) is increasingly recognized as a national security threat, especially after the events of September 11, 2001. In this context, agroterrorism is defined as the deliberate introduction of an animal or plant disease with the goal of generating fear, causing economic losses, and/or undermining stability.

            Agroterrorism is a subset of the more general issues of terrorism and bioterrorism. People more generally associate bioterrorism with outbreaks of human illness (such as from anthrax or smallpox), rather than diseases first affecting animals or plants. Agriculture has several characteristics that pose unique problems for managing the threat:

            • Agricultural production is geographically disbursed in unsecured environments (e.g., open fields and pastures throughout the countryside). While some livestock are housed in secure facilities, agriculture in general requires large expanses of land that are difficult to secure from
            • Livestock are frequently concentrated in confined locations (e.g., feedlots with thousands of cattle in open-air pens, farms with tens of thousands of pigs, or barns with hundreds of thousands of poultry). Concentration in slaughter, processing, and distribution also makes large scale contamination more likely.
            • Live animals, grain, and processed food products are routinely transported and commingled in the production and processing syste These factors circumvent natural barriers that could slow pathogenic dissemination.
            • The presence (or rumor) of certain pests or diseases in a country can quickly stop all exports of a commodity, and can take months or years to
            • The past success of keeping many diseases out of the S. means that many veterinarians and scientists lack direct experience with foreign diseases. This may delay recognition of symptoms in case of an outbreak.
            • The number of lethal and contagious biological agents is greater for plants and animals than for humans. Most of these diseases are environmentally resilient, endemic in foreign countries, and not harmful to humans – making it easier for terrorists to acquire, handle, and deploy the pathog

            Thus, the general susceptibility of the agriculture and food industry to bioterrorism is difficult to address in a systematic way due to the highly dispersed, yet concentrated nature of the industry and the inherent biology of growing plants and raising animals.

            The results of an agroterrorist attack may include major economic crises in the agricultural and food industries, loss of confidence in government, and possibly human casualties. Humans could be at risk in terms of food safety or public health, especially if the chosen disease is transmissible to humans (zoonotic). But an agroterrorist attack need not cause human casualties for it to be effective or to cause large scale economic consequences.

            The production agriculture sector would suffer economically in terms of plant and animal health, and the supply of food and fiber may be reduced, especially in certain regions. The demand for certain types of food may decline based on which products are targeted in the attack (e.g., dairy, beef, pork, poultry, grains, fruit, or vegetables), while demand for other types of food may rise due to food substitutions.

            An agroterrorism event would cause economic losses to individuals, businesses, and governments through costs to contain and eradicate the disease, and to dispose of contaminated products. Economic losses would accumulate throughout the farm- to-table continuum as the supply chain is disrupted, especially if domestic markets for food become unstable or if trade sanctions are imposed by other countries on U.S. exports. The economic impact can spread to farmers, input suppliers, food processors, transportation, retailers, and food service providers. 

            Public opinion may be particularly sensitive to a deliberate outbreak of disease affecting the food supply. Public confidence in government could be eroded if authorities appear unable to prevent such an attack or to protect the population’s food supply. As the United States evolved away from an agrarian society during the 20th century, food and the fear of inadequate food supplies moved further from the minds of most U.S. residents. However, because food remains an important part of everyone’s daily routine and survival, significant threats to the currently-held notion of food security in the U.S. could cause a reordering of people’s priorities.

            Because an agroterrorist attack may not necessarily cause human casualties, be immediately detected, or have the “shock factor” of an attack against the more visible public infrastructure or human populations, agriculture may not be a terrorist’s first choice of targets. Nonetheless, some types of agroterrorism could be relatively easily achieved and have significant economic impacts. Thus, the possibilities are treated seriously, especially in the post-September 11 world.  

            * * *

            Bioterrorism Preparedness Act. The Public Health Security and Bioterrorism Preparedness and Response Act (P.L.107-188, June 12, 2002) contained several provisions important to agriculture. These provisions accomplish the following:

            • Expand Food and Drug Administration (FDA) authority over food manufacturing and imports (particularly in sections 303-307).
            • Tighten control of biological agents and toxins (“select agents” as discussed in sections 211-213, the “Agricultural Bioterrorism Protection Act of 2002”) through rules issued by the Animal and Plant Health Inspection Service (APHIS) and the Centers for Disease Control and Prevention.
            • Authorize expanded agricultural security activities and security upgrades at USDA facilities (sections 331-335).
            • Address criminal penalties for terrorism against enterprises raising animals (section 336) and violation of the select agent rules (section 231). 

            New FDA Rules on Food Processors and Importers. The Bioterrorism Preparedness Act responded to long-standing concerns about whether the Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) had the authority to assure food safety. FDA was instructed to implement new rules for (1) registration of food processors, (2) prior notice of food imports, (3) administrative detention of imports, and (4) record-keeping.

            Proposed rules were issued in the spring 2003 followed by a comment period. On October 10, 2003, FDA published two interim final rules for registration of food facilities and prior notice of imports. Those rules were implemented on December 12, 2003, but FDA allowed flexible enforcement during a transition period. The rule on administrative detention of imports was effective upon enactment, with FDA procedures announced on May 27, 2004.    The final rule for record keeping is forthcoming.24

            Registration of Food Processors. The Act required FDA to establish a one-time registration system for any domestic or foreign facility that manufactures, processes, packs, and handles food. All food facilities supplying food for the United States were required to register with the FDA by December 12, 2003. Registering involved providing information about the food products (brand names and general food categories), facility addresses, and contact information. Restaurants, certain retail stores, farms, non-profit food and feeding establishments, fishing vessels, and trucks and other motor carriers were exempt from registration requirements. However, many farms had a difficult time determining whether they needed to register based on the amount of handling or processing they performed.

            Registration documents are protected from public disclosure under the Freedom of Information Act (FOIA). The registry provides, for the first time, a complete list of companies subject to FDA authority, and will enhance the agency's capability to trace contaminated food. Critics argued that registration created a record keeping burden without proof that facilities will be able to respond in an emergency. 

        • 4.2.4.2 Inspection of Enterprises

          • 4.2.4.2.1 United States v. New England Grocers Supply Co.
            Notes: <p>1. Search, Seizure, and Warrants. It is blackletter law that a warrant is required for a search to be considered reasonable under the Fourth Amendment, whether the search is of a home or a business. See See v. City of Seattle, 387 U.S. 541, 545 (1967). For businesses, however, the Court has also relaxed the requirement because there is said to be a lesser expectation of privacy. New York v. Burger, 482 U.S. 691, 699 (1987). Moreover, the warrant requirement has been further relaxed to account for administrative inspections “designed to enforce regulatory statutes.” Id. at 700.</p> <p>2. Pervasively Regulated Industries. As the Supreme Court said in United States v. Biswell, 406 U.S. 311 (1972), “When a dealer chooses to engage in a pervasively regulated business and to accept a federal license, he does so with the knowledge that his business records, . . . will be subject to effective inspection.” Biswell at 406 U.S. at 316. Biswell was a case involving warrantless inspection in the gun industry, but many circuits including the Eight, Ninth, and Sixth, have subsequently held the same is true for <span class="caps">FDCA</span> inspections. See United States v. Jamieson–McKames Pharmaceuticals, Inc., 651 F.2d 532 (8th Cir.1981) (holding drug manufacturing industry; United States v. Argent Chemical Laboratories, Inc., 93 F.3d 572 (9th Cir.1996) (finding pharmaceutical industry “closely regulated”); United States v. Acklen, 690 F.2d 70, 75 (6th Cir.1982) (same).</p> <p>3. What is Reasonable? In what is known as the Colonnade-Biswell doctrine, the Supreme Court has articulated three criteria to determine what constitutes a reasonable warrantless government inspection:</p> <p>This warrantless inspection, however, even in the context of a pervasively regulated business, will be deemed to be reasonable only so long as three criteria are met. First, there must be a “substantial” government interest that informs the regulatory scheme pursuant to which the inspection is made. See Donovan v. Dewey, 452 U.S., at 602, 101 S.Ct., at 2540 (“substantial federal interest in improving the health and safety conditions in the Nation's underground and surface mines”); United States v. Biswell, 406 U.S., at 315, 92 S.Ct., at 1596 (regulation of firearms is “of central importance to federal efforts to prevent violent crime and to assist the States in regulating the firearms traffic within their borders”); Colonnade Corp. v. United States,397 U.S., at 75, 90 S.Ct., at 776 (federal interest “in protecting the revenue against various types of fraud”).</p> <p>Second, the warrantless inspections must be “necessary to further [the] regulatory scheme.” Donovan v. Dewey, 452 U.S., at 600, 101 S.Ct., at 2539. For example, in Dewey we recognized that forcing mine inspectors to obtain a warrant before every inspection *703 might alert mine owners or operators to the impending inspection, thereby frustrating the purposes of the Mine Safety and Health Act-to detect and thus to deter safety and health violations. Id., at 603, 101 S.Ct., at 2540.</p> <p>Finally, “the statute's inspection program, in terms of the certainty and regularity of its application, [must] provid[e] a constitutionally adequate substitute for a warrant.” Ibid. In other words, the regulatory statute must perform the two basic functions of a warrant: it must advise the owner of the commercial premises that the search is being made pursuant to the law and has a properly defined scope, and it must limit the discretion of the inspecting officers. See Marshall v. Barlow's, Inc., 436 U.S., at 323, 98 S.Ct., at 1826; see also id., at 332, 98 S.Ct., at 1830 (<span class="caps">STEVENS</span>, J., dissenting). To perform this first function, the statute must be “sufficiently comprehensive and defined that the owner of commercial property cannot help but be aware that his property will be subject to periodic inspections undertaken for specific purposes.” Donovan v. Dewey,452 U.S., at 600, 101 S.Ct., at 2539. In addition, in defining how a statute limits the discretion of the inspectors, we have observed that it must be “carefully limited in time, place, and scope.” United States v. Biswell, 406 U.S., at 315, 92 S.Ct., at 1596.</p> <p>New York v. Burger, 482 U.S. 691, 702-03 (1987).</p> <p>4. From routine administrative inspection to criminal investigation. The defendants in new England Grocers Supply argued that even if no warrant was required, the inspections became unreasonable once the <span class="caps">FDA</span> agents had probable cause to suspect violations of the Act. As the court held, however, so long as the inspection is otherwise valid, there is no legal requirement to suspend the inspection and obtain a warrant once there is reason to believe violations have occurred.</p>
            1

            488 F.Supp. 230 (1980)

            2
            UNITED STATES of America, Plaintiff,
            v.
            NEW ENGLAND GROCERS SUPPLY CO. et al., Defendants.

            Crim. A. No. 76-368-C.

            3

            United States District Court, D. Massachusetts.

            March 5, 1980.
            As Amended April 30, 1980.

            4

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

            5

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

            6
            OPINION
            7
            CAFFREY, Chief Judge.
            8

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

            9

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

            10
            I
            11

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

            12

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

            13

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

            14

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

            15

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

            16

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

            17

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

            18

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

            19

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

            20

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

            21

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

            22

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

            23
            II
            24

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

            25

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

            26

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

            27

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

            28

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

            29

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

            30

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

            31

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

            32

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

            33
            III
            34

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

            35

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

            36

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

            37

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

            38

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

            39

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

            40

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

            41

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

            42

            "A food shall be deemed to be adulterated —

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

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

            "The following acts and the causing thereof are prohibited:

            * * * * * *

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

            43

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

            44

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

            45

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

            46

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

            47

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

            48

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

            49

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

            50

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

            51

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

            52

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

            53

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

            54

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

          • 4.2.4.2.2 Federal Inspections

            Renee Johnson, The Federal Food Safety System: A Primer, Congressional Research Service RS22600 (Dec. 16 2016) (excerpt)

            Notes: <p>1. Some <span class="caps">FDA</span> Inspection Numbers. As the <span class="caps">CRS</span> Report explains, more than 300,000 domestic and foreign food facilities are registered withe the <span class="caps">FDA</span>, of which about 88,000 are domestic. Somewhere between 70-90 percent of these facilities are inspected even once in a given year. Unannounced compliance inspections range from once every five years to once every ten years. Those facilities that are judged to be &#8220;high-risk&#8221; are usually visited once per year. Some 98 percent of food import lines are not inspected by <span class="caps">FDA</span>. It is hard to avoid the conclusion that <span class="caps">FDA</span> inspections cannot possibly detect the vast majority of food safety risks. Even if the specter of a potential inspection keeps most facilities honest, an inspection every five to ten years is not the sort of threat likely to create a powerful incentive.</p> <p>2. Some <span class="caps">USDA</span> Inspection Numbers. The Food Safety and Inspection Service (<span class="caps">FSIS</span>) is an entity located within the United States Department of Agriculture (<span class="caps">USDA</span>). <span class="caps">FSIS</span> conducts inspections in about 6,000 establishments, including about 350 so-called Talmadge-Aiken plants, where are facilities in which state inspectors perform inspections under federal inspectors' supervision.</p> <p>3. Needles, Haystacks, and Illness. Needless to say, these numbers present a daunting challenge for government inspectors. Efforts in recent years have turned to methods like audits and an emphasis on ensuring facilities have adequate hazard protection plans in place, rather than relying on frequent physical inspections. If ex ante inspections are unlikely to ensure safe food, what are the other legal or technological alternatives?</p>

            Federal Food Safety Inspections

            As of February 2016, a reported more than 300,000 domestic and foreign food facilities were registered with the agency and are potentially subject to inspection FDA reports. Of these, about 88,000 facilities are domestic (U.S.) registrations, and 212,000 facilities are foreign registrations. Registration of domestic and foreign food facilities is required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act,” P.L. 107-188).28 Most recent available information for FY2012 indicate that FDA and the states under contract with FDA inspected 24,462 domestic food facilities and 1,342 foreign food facilities.  http://wwfda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm. 

            Data compiled by FDA indicate that, on average, between 10% and 30% of all domestic facilities are inspected by FDA annually, most of which are considered “high-risk” facilities. Estimates of unannounced compliance inspections of domestic establishments by FDA officials range from once every five years to once every 10 years, on average, although the agency claims to visit about 6,000 so-called “high-risk” facilities on an annual basis. In general, FDA relies on notifications from within the industry or from other federal or state inspection personnel to alert it to situations calling for increased inspection. 

            FDA inspection rates of imported foods are much lower, with a reported roughly 2% of all food import lines being physically examined by FDA. Previously, GAO reported that FDA inspections covered only about 1% of the food imported under its jurisdiction. Although FDA is not able to physically inspect a large percentage of food entering the United States, FDA electronically screens all import entries using an automated system known as Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information technology system. In addition, FDA can issue import bulletins to signal field inspectors to pay special attention to a particular product, or a range of products from a particular producer, shipper, or importer. 

            Food Safety and Inspection Service

            The number of regulated meat and poultry facilities under USDA’s jurisdiction is much lower and has remained mostly stable over time. Much of the agency’s work is conducted in cooperation with federal, state, and municipal agencies, as well as private industry. FSIS currently conducts inspections in 6,389 establishments. This compares to 2002, when USDA reported that it conducted inspections in about 6,000 establishments. This total includes Talmadge-Aiken plants, wherein state inspectors perform inspections under federal inspectors’ supervision. There were 350 Talmadge-Aiken plants in 2015, up from 235 in 2002.

            Of the total number of meat, poultry, and egg establishments under FSIS jurisdiction, about 1,100 plants either slaughter or slaughter and process livestock or poultry. More than 4,000 facilities only process meat and poultry, and about 80 process egg products. FSIS also reinspects imported meat, poultry, and egg products at about 140 import reinspection facilities. 

             

          • 4.2.4.2.3 Inspections, Searches, and Seizures

            The Fourth Amendment of the U.S. Constitution states as follows:

            • The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized. 

            U.S. Const., Amend. IV.  In brief, before searching or seizing, state actors must traditionally obtain a warrant supported by probable cause that a crime has been committed.  Subject to many nuances and caveats that are beyond our topic of study, evidence obtained during an illegal—that is to say, warrantless—search may not generally be used to prosecute a criminal case.  The Fourth Amendment protects against unreasonable searches and seizures.  

            FDA and USDA have been given inspection authority by virtue of a range of federal statutes like the Meat Inspection Act.  Is such inspection authority constiututional or does it consist of a warrantless or unreasonable search.  Is an inspection the same legal entity as a search?  What if evidence of illegal activity is discovered during an inspection?  Can that evidence always, sometimes, or never be used to sanction the facility?  The next cases illustrate how courts have grappled with these questions.  

          • 4.2.4.2.4 Photography

            May FDA inspectors take pictures of the facilities that are undergoing inspection? FDA has repeatedly answered the question in the affirmative, telling inspectors that photography is a critical part of the inspection process. The food industry disagrees and has argued that photographs are authorized neither by statute nor by judicial doctrine. For an overview of these issues, see Neal D. Fortin, Is a Picture Worth More than 1,000 Words? The Fourth Amendment and the FDA's Authority to Take Photographs Under the Federal Food, Drug, and Cosmetic Act, 1 J. Food L. & Pol'y 239 (2005). The following excerpt summarizes the apparent view of the courts on the matter.

          • 4.2.4.2.5 United States v. Acri Wholesale Grocery, 409 F. Supp. 529 (S.D. Iowa 1976).
            I. PHOTOGRAPHS
            The defendants initially contend the trial court erred in admitting into evidence photographs taken during the inspections. In the first instance, defendants argue that the photographs were taken without their permission and are, therefore, inadmissible because the photographic activities were outside the scope of 21 U.S.C. s 374(a) (1970). Section 374(a) provides in pertinent part:
            (a) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, *533 at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials; containers, and labeling therein.
            Pursuant to Section 374(a), a flexible standard of ‘reasonableness' defines the contours of an FDA inspection. Cf. Durovic v. Palmer, 342 F.2d 634 (7th Cir. 1965). The Court believes, under the circumstances present in this case, the photographing of warehouse conditions by FDA agents was not unreasonable. The agents were in the warehouse pursuant to lawful authority and following all procedural requirements mandated under Section 374, supra. Further, although it is an unnecessary basis for an inspection, the defendants fully consented to the inspections by FDA. See United States v. Del Campo Baking Mfg. Company, 345 F.Supp. 1371 (D.Del.1972).2 The photographs were taken as part of the inspection, and the inspectors made no efforts to conceal the fact that photographs were being taken. Moreover, in this case the photographs introduced into evidence at trial were merely cumulative of the inspectors' testimony regarding the insanitary conditions in the warehouse.
            Defendants also argue their rights under the Fourth Amendment to the United States Constitution were violated by the inspectors photographic activities which exceeded their statutory authority. However, as previously discussed, the FDA agents were properly acting pursuant to statutory procedures. Assuming arguendo, the photographing of evidence in this case is a ‘search and seizure’ under the Fourth Amendment, the Court believes that once the validity of the inspection is established, the propriety of a photographic ‘search’ is coextensive with the validity of the inspection. Cf. Carter v. Beto, 426 F.2d 242 (5th Cir. 1970). The Court therefore finds that the inspection was conducted pursuant to proper authority, and that no illegal or unwarranted intrusion resulted from the photographic activities.
            Finally, it is asserted by the defendants that they should have been given Miranda3 warnings prior to any protographic activities. The Court finds this contention meritless. Defendants were neither in ‘custody’ nor deprived of their freedom at any time in question. See United States v. Thriftimart, Inc., 429 F.2d 1006, 1011 n.6 (9th Cir. 1970), cert. denied, 400 U.S. 926, 91 S.Ct. 188, 27 L.Ed.2d 185; United States v. Del Campo Baking Mfg. Company, supra. Moreover, and contrary to defendants' contention, there is no evidence of record that the focus of the Government's intent in inspecting the warehouse had, at any relevant time, shifted from a mere inspection to a criminal investigation.
          • 4.2.4.2.6 Durovic v. Palmer
            Notes: <p>1. Statutes and the Constitution. Section 704 of the <span class="caps">FDCA</span>, 21 U.S.C. 374 authorizes inspections &#8220;at reasonable times and within reasonable limits and in a reasonable manner.&#8221; By and large this means that inspections usually occur during normal business hours rather than in midnight raids. Durovic sought to argue that an inspection outside of normal business hours is not at a reasonable time and therefore not authorized by the statute. Although this turned out to be a losing argument, note the close relationship between the statutory and constitutional tests. In order to pass constitutional muster according to the Colonnade-Biswell doctrine, the inspection must be authorized by a statute limiting discretion and providing notice. If an inspection is not authorized by statute meeting these requirements, then any occurring inspection would likely be a prohibited warrantless unreasonable search. What does section 704 authorize? Inspections occurring a reasonable times. If the actual <span class="caps">FDA</span> inspection occurred at an unreasonable time, then it is an inspection not authorized by the statute. If it is not authorized by the statute, the inspection constitutes an unconstitutional search. The constitutional validity of a given inspection then can turn on the seemingly mundane issue of what constitutes a reasonable time for an inspection.</p> <p>2. Rules of Reasonableness. Section 704 authorizes <span class="caps">FDA</span> employees to enter and inspect a food enterprise, factory, warehouse, establishment, or vehicle, after presenting appropriate credentials and a written notice. 21 U.S.C. 374(A). The statutory requirements for reasonable time, reasonable limits, and reasonable manners have been interpreted in a series of <span class="caps">FDA</span> Rules and Policies. See, e.g., U.S. Food and Drug Administration Investigations Operations manual 2014. As noted in Durovic, the &#8220;reasonable time&#8221; requirement typically means normal business hours. The &#8220;reasonable limits&#8221; requirement typically means that the area or goods inspected must be relevant to the goal of the inspection. The &#8220;reasonable manner&#8221; requirement has been interpreted to mean that inspectors must present their credentials to gain entry into the facility and must issue the firm a Notice of Inspection at the commencement of the inspection.</p> <p>3. Inspect What? In addition to equipment, storage facilities, foods, containers, and labels, <span class="caps">FDA</span> inspection authority includes the power to obtain company records of the interstate shipment of foods. <span class="caps">FDA</span>, Draft Guidance, Records Access Authority under Sections 414 and 704 Federal Food, Drug, &amp; Cosmetic Act: Questions and Answers (Feb. 2012). Excepted from the records authority are records of recipes, financial data, pricing data, personnel data, sales data, and research data. 21 U.S.C. 350&#169;. Moreover, any confidential or trade secret information is protected from public disclosure. The food industry is notoriously secretive and it is not hard to imagine the anxiety about opening recipe records to government inspectors. See generally Trade Secrets, U.S. Food &amp; Drug Administration (June 1, 2010).</p>
            1

            342 F.2d 634 (1965)

            2
            Stevan DUROVIC, Plaintiff-Appellant,
            v.
            Robert N. PALMER, R. D. Sherman, R. W. Case, Hon. Anthony J. Celebrezze, Boisfeuilliet Jones, John H. Guill, Jr., Defendants-Appellees.

            No. 14651.

            3

            United States Court of Appeals Seventh Circuit.

            March 5, 1965.

            4

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

            5

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

            6

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

            7
            SWYGERT, Circuit Judge.
            8

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

            9

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

            10

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

            11

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

            12

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

            13

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

            14

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

            15

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

            16

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

            17

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

            18

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

            19

            The judgment of dismissal is affirmed.

            20

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

            21
            SCHNACKENBERG, Circuit Judge (dissenting).
            22

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

          • 4.2.4.2.7 Munsell v. Dept. of Agriculture, 509 F.3d 572 (D.C. Cir. 2007).

            Munsell v. Dept. of Agriculture, 509 F.3d 572 (D.C. Cir. 2007) provides an overview the statutory history of the Meat Inspection Act, the Poultry Products Inspection Act, and the Food Safety Inspection Service—the other major federal food inspection agency. Although all of the claims brought were eventually dismissed, the case illustrates a fairly common procedural posture for those hoping to challenge the inspection regime.

            Notes: <p>1. <span class="caps">FSIS</span> Authority. <span class="caps">FSIS</span> is given inspection authority by virtue of three different statutes: the Federal Meat Inspection Act of 1906 (<span class="caps">FMIA</span>), the Poultry Products Inspection Act of 1957 (<span class="caps">PPIA</span>), and the Egg Product Inspection Act of 1970 (<span class="caps">EPIA</span>). <span class="caps">FSIS</span> carries out mandatory inspections at facilities that slaughter livestock or poultry and that process eggs.</p> <p>2. The <span class="caps">FMIA</span>, enacted in the early 1900's, requires that certain animals&#8212;cattle, sheep, swine, goats, horses and mules&#8212;be visually inspected before entering a slaughter facility. See 21 C.F.R. 603. A federal inspector must conduct both an inspection before slaughter (an antemortem inspection) and an inspection after slaughter (a postmortem inspection). 21 C.F.R. 604. At facilities that &#8220;process&#8221; meat food products, an inspector checks facilities regularly but is not constantly present. While the <span class="caps">FMIA</span> provides for both civil and criminal penalties, the simple refusal to certify the meat product tends to be a powerful tool for ensuring compliance.</p> <p>3. The <span class="caps">PPIA</span> dictates inspection for poultry and poultry products capable for use as human food. 21 C.F.R. 451. While the text of the <span class="caps">PPIA</span> does not require antemortem inspection of all poultry, <span class="caps">FSIS</span> has discretion to so require. The Act does require postmortem inspection on a bird-by-byrd basis whenever processing operations are being conducted. 21 U.S.C. 455(b). <span class="caps">USDA</span> Rules, however, provide for sampling techniques and fewer inspectors than traditionally used. The next case considers a challenge to the rule.</p> <p>4. The <span class="caps">EPIA</span> requires inspection for (a) egg products and (b) shell eggs. A shell egg or egg is defined to include eggs of the domesticated chicken, turkey, duck, goose, or guinea. 21 U.S.C. 1033(b). An &#8220;egg product&#8221; is &#8220;any dried, frozen, or liquid eggs, with or without added ingredients.&#8221; 21 U.S.C. 1033(f). The <span class="caps">USDA</span> and <span class="caps">FDA</span> share enforcement authority under the statute. How? <span class="caps">FDA</span> has authority over shell eggs, while <span class="caps">USDA</span> has authority over egg products. <span class="caps">FDA</span> inspectors inspect egg packers at least once every there months. <span class="caps">USDA</span> inspection of egg products is more rigorous and extensive. An official inspector must be present at all times when eggs are being processed. The inspector must examine the eggs both before and after breaking. 9 C.F.R. 420. U.S. egg farmers produce about 79 billion eggs each year. Approximately 30 percent go into egg products, meaning that approximately 23 billion eggs are required by law to be inspected both before and after they are cracked into egg products. We leave it to the reader to judge whether such an inspection regime is likely to be effective.</p> <p>5. Inspectors and the Constitution. One of Munsell's claims was that <span class="caps">FSIS</span> inspectors retaliated against him for complaining and pointing to ConAgra (correctly, as it turned out) as the likely source of an E Coli outbreak. He claimed to have been harassed by the agency, who threatened him with regulatory sanctions, requested unexplained changes to his hazard plan, and routinely rejected his proposed changes. Setting aside the factual merits of his allegations, his basic claim was that inspectors used their discretion to violate his constitutional rights. The remedy for such a claim, if it exists, is known as a Bivens action. As the D.C. Circuit explains, part of the judicial calculus about when to provide a Bivens remedy turns on whether there are other adequate remedies to address the underlying wrong. Did the D.C. Circuit hold there was or was not an adequate alternative remedy?</p>

            EDWARDS, Senior Circuit Judge:

            In October 2004, appellants, Montana Quality Foods and Processing, Inc. and its president John W. Munsell (“Munsell/MQF”), filed a lawsuit in District Court against the Department of Agriculture (“USDA”), the Secretary of Agriculture in his official capacity, and Nathaniel Clark, who was then the District Office Manager of USDA's Food Safety and Inspection Service (“FSIS”) in Minneapolis, Minnesota, in his personal capacity. Munsell/MQF claimed that FSIS officials used USDA enforcement powers to retaliate against Munsell for statements he made concerning USDA's handling of an E. coli outbreak in 2002. In August 2005, appellants filed an amended complaint, adding as a plaintiff the American Association of Meat Processors (“AAMP”), a trade association representing small meat processors that are subject to USDA inspection and oversight. Munsell/MQF, on their own behalf, and AAMP, on behalf of its association members, each sought declaratory and injunctive relief, presumably under the Administrative Procedure Act (“APA”), challenging a USDA enforcement Directive and seeking protection from future acts of retaliation by FSIS officials. Munsell/MQF also sought a money damages remedy under Bivens v. Six Unknown Named Agents of Federal Bureau of Narcotics, 403 U.S. 388, 91 S.Ct. 1999, 29 L.Ed.2d 619 (1971), on the grounds that Munsell's First Amendment rights were violated when agency officials retaliated against him.
             
            In 2005, during the course of the litigation in the District Court, Munsell sold all of MQF's meat processing facilities, thereby eliminating all of MQF's business operations that were subject to USDA regulation and oversight. The Government filed a motion to dismiss, challenging appellants' standing, claiming that the action by Munsell/MQF was moot, and asserting that the entire action should be dismissed because appellants had failed to exhaust their administrative remedies. The District Court declined to rule on standing and mootness and instead granted the motion to dismiss **48 *575 on exhaustion grounds. The District Court first held that the governing statutory exhaustion requirement under 7 U.S.C. § 6912(e) is jurisdictional. The District Court then determined that appellants had failed to exhaust the applicable administrative appeal procedure prescribed by 9 C.F.R. § 306.5, concluded that the court lacked subject matter jurisdiction, and dismissed all of appellants' APA claims. The District Court also found that Munsell/MQF's Bivens action was barred due to their failure to exhaust administrative remedies. Munsell v. Dept. of Agric., 435 F.Supp.2d 149 (D.D.C.2006). Munsell/MQF and AAMP appealed the District Court's dismissal, and the Government parties cross-appealed on standing and mootness. Guided by the Supreme Court's decision in Arbaugh v. Y & H Corp., 546 U.S. 500, 126 S.Ct. 1235, 163 L.Ed.2d 1097 (2006), and other relevant precedent, we hold that 7 U.S.C. § 6912(e) does not impose a jurisdictional exhaustion requirement. We therefore conclude that the District Court erred in holding that plaintiffs' failure to exhaust their administrative remedies deprived the court of subject matter jurisdiction.
             
            We affirm the judgment in favor of appellees on different grounds, however. First, we affirm the dismissal of Munsell/MQF's claims for injunctive and declaratory relief on standing and mootness grounds. Second, we affirm the dismissal of Munsell/MQF's Bivens action, because, even assuming that such an action might lie against USDA officials, Munsell/MQF failed to exhaust their administrative remedies before seeking judicial relief on their constitutional claims. Third, we dismiss for want of standing AAMP's action seeking protection for its members from future acts of retaliation by USDA, and dismiss AAMP's claims on behalf of Munsell/MQF as moot. Finally, although we find that the action filed by AAMP challenging USDA's enforcement Directive on behalf of its members is not moot and it does not fail for want of standing or exhaustion, we affirm the dismissal of AAMP's action for injunctive and declaratory relief because it is unripe for judicial review.
             
            I. BACKGROUND
            Congress enacted the Federal Meat Inspection Act in 1907 in response to unsanitary conditions in the nation's meat packing industry. The purpose of the Act is to assure that meat and meat food products are “wholesome, not adulterated, and properly marked, labeled, and packaged.” 21 U.S.C. § 602. The Act directs USDA to inspect the sanitary conditions of meat processing plants and to “prescribe the rules and regulations of sanitation under which these establishments [are] maintained.” Id. § 608. The Act grants the Secretary authority to “make such rules and regulations as are necessary for the efficient execution” of the Act. Id. § 621.
             
            In 1996, USDA's FSIS issued a final rule requiring all meat processing plants to develop and implement controls to address food safety hazards that are likely to occur in their operation. See 61 Fed.Reg. 38,806 (July 25, 1996). This regulation is known as Hazard Analysis and Critical Control Point (“HACCP”). See 9 C.F.R. pt. 417. Under HACCP, plants are given considerable flexibility to design plans that achieve the ends of preventing food safety hazards. See id. § 417.2. FSIS inspectors evaluate plants' hazard prevention through direct observation and testing, and by examining plants' records. See id. § 417.8.
             
            There are a range of enforcement actions that FSIS may take, including withholding the mark of inspection from meat products or suspending the assignment of inspectors to a plant. See 9 C.F.R. pt. 500. Without USDA approval, a meat processing **49 *576 plant is effectively expelled from the marketplace. These enforcement actions can be financially ruinous, especially for smaller firms.
             
            FSIS actions regulating meat processors may be appealed administratively. Id. §§ 500.5(c)-(e). Enforcement actions that are not held “in abeyance” can be appealed through a formal hearing process. Id. § 500.5(d). However, when an enforcement action is held in abeyance, administrative appeals must be made to the “immediate supervisor” of the official making the enforcement determination. Id. §§ 306.5, 500.5(c).
             
            Munsell's family first started operating a meat processing plant in Montana in 1946. Am. Compl. ¶ 14, Joint Appendix (“JA”) 19. During the time frame relevant to this case, the processing plant was incorporated in the name of MQF, with Munsell as MQF's chief executive officer and owner. MQF's meat processing business typically bought ten-pound lots of coarse ground beef (“chubs”) from larger meat suppliers and further processed the beef for sale to individual consumers. Id. ¶ 15, JA 19. The plant was subject to inspection and regulation by USDA under the Federal Meat Inspection Act.
             
            For a time preceding the events leading to this litigation, Munsell had been displeased with USDA's oversight of MQF's meat processing operation. In September 2001, he urged agency officials to adopt two procedural changes that he believed would protect small meat processors from economic harm resulting from contamination at large meat facilities. In particular, Munsell suggested the segregation of large plant meat products and the creation of a record of source beef to facilitate the traceback of adulterated meat to contamination in large plants. Id. ¶ 30, JA 24. FSIS officials declined to adopt Munsell's recommendations.
             
            Roughly five months later, on January 28, 2002, FSIS alerted Munsell that a ground beef sample taken from MQF's facilities five days prior tested positive for E. coli contamination. Id. ¶ 21, JA 21. Munsell voluntarily agreed to recall 270 pounds of ground beef he had provided to customers. Id. MQF was also required to reassess its HACCP and submit to 15 days of sampling of its products. Id. ¶ 22, JA 21–22.
             
            Two days later, Munsell asked FSIS officials to test unopened chubs of beef that MQF had on hand from the two firms that had supplied the coarse ground beef that had tested positive for E. coli on January 28. But FSIS officials declined to test the unopened chubs of beef. Id. ¶ 25, JA 22. Based on his fear that a large supplier was distributing contaminated beef, Munsell began segregating his meat by supplier, to more readily facilitate traceback to identify the source of any new contamination. Id. ¶ 26, JA 22–23.
             
            Shortly thereafter, Munsell complained to Nathaniel Clark, the District Office Manager of the Minneapolis office of the FSIS, about how FSIS was handling the E. coli outbreak, and reiterated his belief that procedures needed to be put in place to traceback contaminated meat found at small processors. An FSIS official continued taking samples of MQF's meat between February 19 and 21, 2002, and again found E. coli contamination. Based on his earlier segregation of meat by supplier, Munsell determined that the source of the contamination was a large supplier, ConAgra. Id. ¶ 26, JA 23. The next day Munsell requested FSIS officials to test an unopened chub—before it passed through MQF's facility—to confirm that ConAgra was the source of the contamination. FSIS officials refused. Id. ¶ 27, JA 23.
             
            During the month of February 2002, Munsell also communicated with congressional **50 *577 officials concerning his own plant and his fears of an E. coli threat at a large meat processor. On February 7 and 8, Munsell contacted the offices of Senator Max Baucus and Congressman Denny Rehberg of Montana to express his concerns. Id. ¶ 31, JA 24. On February 8, Senator Baucus and Congressman Rehberg sent a letter to Nathaniel Clark, expressing Munsell's concerns and suggesting that Clark hold a meeting with Munsell in order to address them. Letter from Senator Max Baucus and Congressman Denny Rehberg to Dr. Nathaniel Clark, District Manager, FSIS (Feb. 8, 2002), JA 201–02. On February 25, Munsell informed congressional staff that he could verify that the E. coli contamination found at MQF was brought into his plant from a large supplier. He expressed concern that large amounts of unprocessed beef could be distributed across the country, potentially leading to consumer illness and death. Am. Compl. ¶ 32, JA 25.
             
            Munsell alleges that FSIS inspectors then took retaliatory action against him. Clark contacted Munsell on February 26, 2002, to notify him that FSIS planned to suspend inspection of MQF's facilities. Id. ¶ 40, JA 27. The next day FSIS issued a formal Notice of Intended Enforcement to Munsell. Id. On March 5, 2002, an FSIS official notified Munsell that his proposed corrective action of insisting that large plant suppliers provide MQF with “certification for pathogen free beef” had been rejected, and that the FSIS had decided to move forward with the enforcement action. Id.
             
            On March 8, 2002, facing the prospect of having FSIS inspection suspended, Munsell proposed a regime of sampling and laboratory analysis of incoming beef. On March 12, 2002, with this costly measure in place, Clark informed Munsell that FSIS would hold MQF's suspension in abeyance—meaning that inspections would continue to be carried out. Id. ¶ 41, JA 27–28. With the suspension in abeyance, however, the formal hearing appeals process described in 9 C.F.R. § 500.5(d) was foreclosed.
             
            Between February 26 and July 1, 2002, FSIS required MQF to rewrite its HACCP plan on at least ten separate occasions. Am. Compl. ¶ 43, JA 28. Munsell alleges that these demands for revised plans sometimes came from the agency without explanations, that FSIS rejected revised plans that MQF had drawn verbatim from the guidance of USDA officials, and that FSIS rejected plan revisions that had previously been approved. Id.Eventually, MQF was forced to hire expert consultants to usher the HACCP process to conclusion and approval. Id. Munsell alleges that, from February 26 to July 3, 2002, due to FSIS's misconduct, MQF was unable to grind its own beef, i.e., beef not purchased as chubs from large plants.
             
            While the HACCP rewrite process was underway, Munsell continued to complain about FSIS's actions towards him, as well as the general way in which E. coli contamination was being handled. On March 21, 2002, Montana congressional delegation staff and Munsell held a conference call with FSIS Associate Deputy Administrator for Field Operations William Smith to seek resolution of Munsell's concerns. Decl. of John W. Munsell ¶ 23, JA 192. At that meeting, Munsell complained to FSIS about its decisions to initiate enforcement actions against MQF, reject MQF's HACCP revisions, and require MQF to conduct testing and analysis of incoming beef in order to have the suspension of inspectors held in abeyance. Id. On May 3, 2002, Munsell met with FSIS management in Minneapolis to complain of the actions taken against MQF. Id. ¶ 24, JA 192–93.
             
            *578 **51 Munsell's concerns about E. coli contamination at ConAgra were borne out. On June 30, 2002, ConAgra announced a recall of 350,000 pounds of contaminated beef. Am. Compl. ¶ 37, JA 26. Munsell's conflict with USDA was not over, however. The next day he again communicated to USDA staff his displeasure with “USDA's continuing rejection of my HACCP plan revisions.” Decl. of John W. Munsell ¶ 25, JA 193. Notwithstanding a letter dated July 22, 2002, in which Smith stated to members of Congress that “ the concerns raised by Mr. Munsell have been satisfactorily addressed,” id. ¶ 26, JA 193, Munsell continued to press his complaints, emailing FSIS officials in October 2002 and lobbying Senator Conrad Burns to hold congressional hearings on his concerns. Id. ¶ 27–28, JA 194.
             
            On March 31, 2004, FSIS revised Directive 10,010.1, which governs how FSIS officials handle E. colisampling. FSIS Directive, 10,010.1 Revision 1 (Mar. 31, 2004), JA 156–83. On October 13, 2004, Munsell and MQF filed suit in the District Court. AAMP was later added as a plaintiff. All appellants sought injunctive and declaratory relief against USDA under the APA. In addition, Munsell and MQF sought damages against an individual FSIS officer, District Manager Clark, under a Bivens theory of liability.
             
            After initiation of this suit, Munsell divested MQF of its meat processing facility, and Munsell/MQF were no longer subject to USDA regulation and oversight. Decl. of Cheryl A. Hicks, ¶ 12, JA 42; Application for Federal Meat, Poultry, or Import Inspection (Aug. 1, 2005) (change of ownership), JA 49–50; Email from John Munsell to Wendy Wirth (July 15, 2005) (authorizing reassignment of MQF's USDA establishment number to new owners), JA 52; Grant of Inspection (Aug. 1, 2005) (updating FSIS grant of inspection to reflect change of owner), JA 54.
             
             
            II. ANALYSIS
             
            [The court analyzed the question and determined there was no jurisdictional bar to hearing the case, but the forward looking claims brought by Munsell were moot because he no longer owned the company and the backward looking claims had not exhausted the agency appeals process and so could not yet yet be resolved in court.]
             
             
            E. The Bivens Claim
            In addition to their action seeking injunctive and declaratory relief under the APA, Munsell/MQF also seek damages from Nathaniel Clark, a USDA official who oversaw the disputed enforcement actions against MQF. Appellants invite this court to allow a Bivens cause of action in a case such as this, in which it has been alleged that USDA officials pursued retaliatory enforcement actions in order to chill constitutionally protected speech. Appellants' Br. at 26–30.
             
            In Bivens v. Six Unknown Named Agents of Federal Bureau of Narcotics, 403 U.S. 388, 91 S.Ct. 1999, 29 L.Ed.2d 619 (1971), the Supreme Court held that a violation of the Fourth Amendment “by a federal agent acting under color of his authority gives rise to a cause of action for damages consequent upon his unconstitutional conduct.” Id. at 389., 91 S.Ct. 1999 In that case, agents of the Federal Bureau of Narcotics entered into the petitioner's home and arrested him without a warrant or probable cause. The Bivens Court rejected the view that state law causes of action—primarily based on privacy rights—provided a sufficient remedy to protect petitioner's Fourth Amendment interests. Reasoning that Fourth Amendment protections were not limited by state law, that interests protected by state trespass and invasion of privacy laws may be “inconsistent or even hostile” to those protected by the Fourth Amendment, and that “damages have been regarded as the ordinary remedy for an invasion of personal interests in liberty,” the Court held that “petitioner is entitled to recover money damages for any injuries he has suffered as a result of the agents' violation of the Amendment.” Id. at 390–97, 91 S.Ct. 1999.
             
            The Court subsequently applied Bivens in other contexts.  In Davis v. Passman, 442 U.S. 228, 99 S.Ct. 2264, 60 L.Ed.2d 846 (1979), the Court found that the Due Process Clause of the Fifth Amendment created a right of action for damages where a woman had been dismissed from her employment in the offices of a Congressman on the basis of her sex. The Court reasoned that the Civil Rights Act, by excluding legislative employees, did not evidence a congressional intent to foreclose a constitutional damages remedy. 442 U.S. at 247, 99 S.Ct. 2264. And in Carlson v. Green, 446 U.S. 14, 100 S.Ct. 1468, 64 L.Ed.2d 15 (1980), the Court found that the Eighth Amendment created a cause of action against federal prison officials, complementary to the remedy under the Federal Tort Claims Act against the federal government. 446 U.S. at 19–23, 100 S.Ct. 1468. And in Hartman v. Moore, 547 U.S. 250, 126 S.Ct. 1695, 164 L.Ed.2d 441 (2006), the Court found that federal prosecutors and postal inspectors who use their powers to retaliate against individuals for engaging in protected speech are “subject **61 *588 to an action for damages on the authority of Bivens.547 U.S. at 256, 126 S.Ct. 1695.
             
            In Carlson, the Court established two exceptions to the Bivens doctrine, stating
            Bivens established that the victims of a constitutional violation by a federal agent have a right to recover damages against the official in federal court despite the absence of any statute conferring such a right. Such a cause of action may be defeated in a particular case, however, in two situations. The first is when defendants demonstrate special factors counseling hesitation in the absence of affirmative action by Congress. The second is when defendants show that Congress has provided an alternative remedy which it explicitly declared to be a substitute for recovery directly under the Constitution and viewed as equally effective.
            446 U.S. at 18–19, 100 S.Ct. 1468 (internal quotation marks and citations omitted). Applying the criteria announced in Carlson, the Court has found that Bivens actions are barred against federal officers in several contexts. In each of these cases, the Court has found that constitutional damages actions were inappropriate where a sufficient alternative remedial structure already existed.
             
            In Bush v. Lucas, 462 U.S. 367, 103 S.Ct. 2404, 76 L.Ed.2d 648 (1983), the Court determined that there was no Bivens remedy for a federal employee seeking recovery for First Amendment violations alleged to have occurred in his workplace. The Court summed up the Bivens inquiry as follows:
            The federal courts' statutory jurisdiction to decide federal questions confers adequate power to award damages to the victim of a constitutional violation. When Congress provides an alternative remedy, it may, of course, indicate its intent, by statutory language, by clear legislative history, or perhaps even by the statutory remedy itself, that the courts' power should not be exercised. In the absence of such a congressional directive, the federal courts must make the kind of remedial determination that is appropriate for a common-law tribunal, paying particular heed, however, to any special factors counseling hesitation before authorizing a new kind of federal litigation.
            462 U.S. at 378, 103 S.Ct. 2404. After reviewing the “elaborate remedial system that has been constructed step by step, with careful attention to conflicting policy considerations,” id. at 388, 103 S.Ct. 2404, designed to redress complaints from federal employees, and weighing “the respective costs and benefits that would result from the addition of another remedy for violations of employees' First Amendment rights,” id., the Court declined “to create a new substantive legal liability without legislative aid ... because we are convinced that Congress is in a better position to decide whether or not the public interest would be served by creating it.” Id. at 390, 103 S.Ct. 2404 (internal quotation marks omitted).
             
            Applying the standards announced in Passman and Bush v. Lucas, the Court has found other administrative schemes sufficient to obviate the need for a Bivens remedy. In Schweiker v. Chilicky, 487 U.S. 412, 108 S.Ct. 2460, 101 L.Ed.2d 370 (1988), the Supreme Court held that the Social Security Act's scheme of administrative and judicial remedies was sufficient to eliminate the need for a Bivens remedy. Considering Bivens claims on behalf of members of the armed services, the Court has also held that “the unique disciplinary structure of the Military Establishment” constituted a special factor making a Bivens action “inappropriate.” United **62 *589 States v. Stanley, 483 U.S. 669, 679, 107 S.Ct. 3054, 97 L.Ed.2d 550 (1987).
             
            Most recently, in Wilkie v. Robbins, 551 U.S. 537, 127 S.Ct. 2588, 168 L.Ed.2d 389 (2007), the Supreme Court affirmed the “familiar sequence” for determining whether to extend a Bivens remedy. 127 S.Ct. at 2598. First, the Court analyzed whether an “alternative, existing process for protecting the interest amounts to a convincing reason for the Judicial Branch to refrain from providing” a Bivens remedy. Second, the Court made a “remedial determination that is appropriate for a common-law tribunal, paying particular heed ... to any special factors counseling hesitation.” Id. (internal quotation marks and citations omitted).
             
            In Wilkie, petitioner claimed to have been the subject of a multiyear campaign of harassment by government officials—including trespass, unfavorable regulatory actions, and interference in his business operations—carried out to force him to grant an easement to his property. The Court found that petitioner had “an administrative, and ultimately a judicial, process for vindicating virtually all of his complaints.” Id. at 2600. The Court found, however, that this “patchwork” of state and federal remedies—which included review under the APA—did not lead to an inference that “Congress expected the Judiciary to stay its Bivens hand,” and, therefore, the Court engaged in the common-law balancing inquiry. Id.
             
             
            In conducting this inquiry, the Court in Wilkie distinguished the case in which a petitioner “describes the wrong ... as retaliation for standing on his right as a property owner to keep the Government out,” from a case in which a petitioner claims that “the Government may not retaliate [against him] for exercising First Amendment speech rights.” Id. at 2601. The decision notes that in a typical First Amendment retaliation case, the “purpose and motivation” behind the Government's conduct is to chill speech—which is always impermissible. Id. On the other hand, in a property rights case of the sort under review in Wilkie, the Government was merely “trying to induce someone to grant an easement for public use” which was “a perfectly legitimate purpose.” Id. The petitioner did not challenge “the object the Government [sought] to achieve.” Id. And, “for the most part,” the petitioner did not claim that the “means the Government used were necessarily illegitimate.” Id. Rather, the Wilkie petitioner simply claimed that Government officials “demanded too much and went too far.” Id. The Court concluded that “the line-drawing difficulties [created by the petitioner's claims] are immediately apparent,” id., and ultimately declined to allow an action under Bivens.
             
             
            It is not entirely clear what the result should be in a case of this sort, involving a claim that FSIS officials used USDA enforcement powers to retaliate against Munsell for statements he made concerning USDA's handling of an E. coli outbreak in 2002. The Government argues that the APA provides a sufficient remedy for Munsell, and therefore no Bivens action is needed. Br. for Appellees at 25–29. The APA does indeed create a mechanism for persons subject to USDA enforcement actions to pursue challenges based on alleged constitutional violations. See 5 U.S.C. § 706(2)(B). In Nebraska Beef, Ltd. v. Greening, 398 F.3d 1080 (8th Cir.2005), the court held that APA review is thus a viable alternative sufficient to bar a Bivens remedy against USDA enforcement officials. Observing that “[t]he Supreme Court has been wary of extending Bivensremedies into new contexts,” 398 F.3d at 1084, the Nebraska Beef court held that, “[w]hen Congress has created a comprehensive **63 *590 regulatory regime, the existence of a right to judicial review under the APA is sufficient to preclude a Bivens action.” Id.
             
            The Eighth Circuit decision in Nebraska Beef leaves some weighty issues unanswered. The decision was rendered before the Supreme Court issued Wilkie. This is noteworthy, because, rather than apply the traditional common-law balancing inquiry endorsed by Wilkie, Nebraska Beef applies the Eighth Circuit's “presumption against judicial recognition of direct actions for violations of the Constitution by federal officials or employees.” Id. (quoting McIntosh v. Turner, 861 F.2d 524, 526 (8th Cir.1988)). In addition, the constitutional wrong that the plaintiff sought to remedy in Nebraska Beef is unclear. We do not know whether the alleged misconduct in Nebraska Beef was motivated by a “legitimate purpose” as in Wilkie or involved a First Amendment retaliation claim of the sort at issue in this case. Cf. Hartman, 547 U.S. at 256, 126 S.Ct. 1695. Finally, we are unaware of any Supreme Court decision holding that APA review alone is sufficient to eliminate the need for a Bivens remedy.
             
            The Government argues that, “[e]ven apart from the mechanism that Congress has provided for reviewing constitutional challenges to FSIS action, special factors would preclude the creation of a damages remedy against the officials charged with protecting the nation's meat supply.” Br. for Appellees at 29. The Government's “special factors” argument is not without force:
             
            [T]he Federal Meat Inspection Act was passed after Upton Sinclair's book, THE JUNGLE, exposed the unsanitary conditions in the meat packing industry. A system of federal inspection was created and the inspectors subjected to strict regulation lest their corruption—or the appearance of it—undermine the quality of meat or the public's trust in their supervision of meat quality. The Federal Meat Inspection Act [“FMIA”] provided that the federal inspectors shall have access to all parts of a plant at all times, and included a broad anti-gratuity provision forbidding officers or employees authorized to perform duties under the FMIA from accepting gratuities.
             
            Congress was thus at pains to shield the decisions of federal food safety officials from improper influence by the meat processing plants they regulate. The threat of a damages action can influence an official's conduct as much, if not more, than the temptation of a gratuity, since such a threat can be used by an unscrupulous plant to inhibit aggressive regulation.
            Where, as here, federal officials administer a comprehensive federal regulatory regime in which relationships between the regulator and the regulated are frequently hostile and adversarial, it is for Congress to decide whether the public interest would be furthered by a cause of action requiring regulators to pay damages personally unless they can convince a jury that their conduct in aggressively regulating was not the product of an unconstitutional motive. Congress's failure to expose federal food safety officials to personal liability cannot be deemed inadvertent. Accordingly, a court may not imply such a remedy....
            Br. for Appellees at 29–31 (internal citations and quotation marks omitted).
             
            Even assuming, arguendo, that the existence of APA review might factor into a determination as to whether a Bivens remedy is available, its relevance would be minimal in a case involving claimants who are ineligible for relief under the APA. Because appellants such as Munsell/MQF **64 *591 are no longer subject to USDA oversight, their claims under the APA are moot. The only viable relief for appellants like Munsell/MQF, who allegedly have been driven from business by the retaliatory actions of agency officials, would be backward-looking damages claims. Munsell/MQF allege that USDA officials engaged in a series of enforcement actions with the purpose of harassing Munsell for his constitutionally protected speech. Appellants argue that these officials, animated by retributive animus, ultimately succeeded in driving Munsell/MQF out of the meat processing business. Thus, in a case of this sort, were the possibility of APA review deemed sufficient to foreclose a Bivens remedy, the very success of the unconstitutional conduct in removing Munsell/MQF from the regulated arena would make APA review unavailable and insulate the conduct entirely from judicial review. That would make little sense.
             
            * * * 
             
            We need not now decide whether to extend the Bivens remedy to the current case. Even assuming, arguendo, that appellants might have a Bivens action, they have failed to exhaust their administrative remedies on their constitutional claims. Just as the PLRA exhaustion requirement applies to Bivens actions against prison officials, see Porter v. Nussle, 534 U.S. 516, 524, 122 S.Ct. 983, 152 L.Ed.2d 12 (2002)(under PLRA, “federal prisoners suing under [Bivens] must first exhaust inmate grievance procedures”), 7 U.S.C. § 6912(e)'s express language makes it clear that judicial review is only available to appellants like Munsell/MQF after all administrative remedies have been exhausted.
             
            There is a strong rationale for requiring constitutional claims against USDA to be raised first in the administrative process, as mandated by § 6912(e). In Bivens actions, plaintiffs typically claim that government officials have exceeded the scope of their authority and, in doing so, violated rights protected by the Constitution. Bringing such claims to the agency in the first instance allows the agency to clarify its position about the conduct of the accused official. Cf. Wilkie, 127 S.Ct. at 2601. In these fact intensive cases, an administrative process will also create a record on which a Bivens claim can be evaluated. Bringing the complaint directly to the agency also may allow the agency to remedy the alleged offending conduct and, at the least, avoid continuing constitutional harm.
             
            The administrative process in this case is not burdensome. 9 C.F.R. § 306.5 establishes an extremely straightforward process for appealing the decisions of FSIS officials: “Any appeal from a decision of any Program employee shall be made to his/her immediate supervisor having jurisdiction over the subject matter of **65 *592 the appeal....” Munsell took advantage of that process for his claims that the agency was acting unreasonably by failing to require the traceback of contaminated meat and placing an unjustified burden on small meat processors. He did not, however, raise his constitutional claims while pursuing challenges to the enforcement action. It would have been a simple matter for Munsell to do this, and it would have given the agency an opportunity to “nip in the bud” any unconstitutional conduct on the part of one of its officers.
             
            The fact that USDA's administrative appeals process does not allow for money damages does not create an exception to the exhaustion requirement. See Booth v. Churner, 532 U.S. 731, 734, 121 S.Ct. 1819, 149 L.Ed.2d 958 (2001). The rationale for requiring exhaustion does not depend on the existence of money damages as a remedy. So long as the administrative process offers the possibility of some redress for the alleged unconstitutional conduct—including reprimanding the responsible official and barring similar future conduct—the administrative process can serve its proper function.
             
            * * *
             
             
             
             
            III. CONCLUSION
            For the foregoing reasons, appellants' actions are hereby dismissed.
            So ordered.
             
        • 4.2.4.3 Prevention, Inspection, and Risk

          Given the enormous challenges that inspection poses as a regulatory strategy for ensuring food safety, the past sevearl decades have seen a push towards alternative tools to protect the food supply.  Three themes are commonly observed in policy debates.  First, an emphasis on risk estimation.  Although sometimes connoting particular quantitative methods, the basic idea is straightforward.  The particular risks posed to the food supply should be identified and estiamted. Without knowing—and often quantifying—what the risks of contamination or adulteration are, it is difficult to protect against them.   Second, resources should be allocated to points in the food chain that are particularly vulnerable.  Rather than inspecting every egg both before and after cracking, target locations or moments of particular vulnerability to contamination. Or, rely more extensively on auditing and sampling methods.  Third, decentralize the formulation of hazard prevention and response to regulated parties. Most food etablishments must today parepare a Hazard Analysis Critical Control Point plan. An overview is included below. While a HACCP sounds technical, it is really nothing more than working through what and where the risks to food safety are in a given facility and making a plan on how to prevent and respond.  Over time, federal agencies increasingly oversee the formulation and adoption of these private plans for food safety action rather than imposing particular requirements in rules or regulations.  One way of understanding this trend is as a shift away from command and control regulatory tools.  In the environmental policy domain, this has meant relying on performance controls that leave it up to regulated parties to decide how to best reduce pollution to a given level, rather than technology controls that demand a particular kind of scrubber be used to reduce pollution.   In the food context, rather than relying on finished product inspectino, the HACCP model is a systematic preventative appraoch to food safety that addresses physical, chemical, and biological hazards at each stage of the food production process. HACCP is thus a methodological innovation and it is used by both USDA and FDA.  

          Although HACCP has only recently found favor with government regulators, it has been around at least since the 1950s, apparently developed jointly by the Pillsbury Company and the National Aeronautics and Space Administration (NASA), who needed safe food that could be consumed in space. See Food Code 2001, Recommendations of the United States Public Health Service, Food and Drug Administration 424 (2001). Down on earth, Pillsbury introduced the HACCP system after food safety problems with their baby food. See William H. Sperber and Richard F. Stier, Happy 50th Birthday to HACCP: Retrospective and Prospective, Food Sfaety Mag. (2009/2010). In the mid 1980's, the National Academy of Sciences (NAS) wrote that “government agencies responsible for control of microbiological hazards in foods should promulgate appropriate regulations that would require industry to utilize the HACCP systems in their food protection programs.” An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients 329, National Research Council, National Academy of Sciences (1985).  FDA adopted the HACCP principles for seafood inspection in 1995, followed by the USDA for meat and poultry inspection in 1997. Roberts, Food Law at 142.       

           

          • 4.2.4.3.1 HACCP Principles & Application Guidelines
            1

            Introduction

            2

            HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.

            3

            HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.

            4

            The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.

            5

            * * * 

            6

            Education and Training

            7

            The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP.

            8

            Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.

            9

            Developing a HACCP Plan

            10

            The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan.

            11

            In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.

            12

            Figure 1. Preliminary Tasks in the Development of the HACCP Plan

            Preliminary Tasks in the Development of the HACCP Plan

            14

            Assemble the HACCP Team

            15

            The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level.

            16

            Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and verification; (e) recommend appropriate corrective actions when a deviation occurs; (f) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan.

            17

            Describe the food and its distribution

            18

            The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.

            19

            Describe the intended use and consumers of the food

            20

            Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).

            21

            Develop a flow diagram which describes the process

            22

            The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.

            23

            Verify the flow diagram

            24

            The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented.

            25

            After these five preliminary tasks have been completed, the seven principles of HACCP are applied.

            26

            Conduct a hazard analysis (Principle 1)

            27

            After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.

            28

            A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed.

            29

            The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2.

            30

            The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise.

            31

            After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan.

            32

            Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.

            33

            * * * 

            34

            Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk).

            35

            For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. * * *

            36

            The hazard analysis summary could be presented in several different ways. One format is a table***. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.

            37

            Determine critical control points (CCPs) (Principle 2)

            38

            A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.

            39

            Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree***. Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge.

            40

            Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.

            41

            Establish critical limits (Principle 3)

            42

            A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.

            43

            Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (aw), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.

            44

            An example is the cooking of beef patties * * * . The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility.* * * 

            45

            Establish monitoring procedures (Principle 4)

            46

            Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.

            47

            An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.

            48

            Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.

            49

            All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.

            50

            When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.

            51

            Most monitoring procedures need to be rapid because they relate to on-line, "real-time" processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.

            52

            Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.

            53

            With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.

            54

            Establish corrective actions (Principle 5)

            55

            The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.

            56

            Establish verification procedures (Principle 6) 

            57

            Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. * * * 

            58

            One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.

            59

            Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.

            60

            Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a significant product, process or packaging change occurs; or new hazards are recognized.

            61

            In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.

            62

            Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) (3).

            63

            * * *

            64

            Establish record-keeping and documentation procedures (Principle 7)

            65

            * * *

            66

             

            67
            IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN
            68

            The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.

            69

            Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.

          • 4.2.4.3.2 American Federation of Government Employees, AFL-CIO v. Glickman, 215 F.3d 7 (D.C. Cir. 2000).

            American Federation of Government Employees entails a challenge FSIS's move to the HACCP model.

            Notes: <p>1. Text. The court holds that relying on establishment personnel rather than government employees to inspect poultry violates the text of the <span class="caps">PPIA</span>. The statutory text says that the Secretary shall cause to be made by inspectors appointed for that purpose a post-mortem examination and inspection of the carcasses and parts thereof of all [livestock] to be prepared at any slaughtering, &#8230; or similar establishment&#8230;.” 21 U.S.C. § 604). For poultry, § 455(b) of the <span class="caps">PPIA</span> states: “[t]he Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed&#8230;.” 21 U.S.C. § 455(b). Is the text of the statute so clear that an &#8220;inspector&#8221; must be a government employee?</p> <p>2. Text and Purpose. Would it matter to the court if it could be definitively shown that the new inspection regime was vastly superior to the old in terms of avoiding adulteration?</p> <p>3. Umpires and Pitchers. The court notes that the government believes an inspector can perform an inspection by watching another person perform an inspection. On this logic, urges the court, an umpire is a pitcher because an umpire watches a pitcher pitch. Does this metaphor seem on point? Surely an inspector could watch her own employees perform tasks like testing or observing chickens and still be performing the role of inspecting. Nevertheless, a unanimous panel held that the task of inspection could not be delegated to private employees without running afoul of the <span class="caps">FMIA</span> and the <span class="caps">PPIA</span>.</p>
            1
            Before: EDWARDS, Chief Judge, RANDOLPH and GARLAND, Circuit Judges.
            2
            Opinion
            Opinion for the Court filed by Circuit Judge RANDOLPH.
             
            RANDOLPH, Circuit Judge:
            The Federal Meat Inspection Act (“FMIA”), 21 U.S.C. § 604, and the Poultry Products Inspection Act (“PPIA”), 21 U.S.C. § 455, require inspectors appointed by the Department of Agriculture (“USDA”) to perform a “post-mortem inspection” of the carcasses and parts of all livestock and birds processed for human consumption. The question in this appeal from the judgment of the district court is whether the statutes permit federal inspectors to step back from the processing lines and perform their inspection duties by overseeing inspections conducted by plant employees.
             
            I
            Inspectors from the USDA's Food Safety and Inspection Service (“FSIS”) generally conduct post-mortem inspections while stationed at fixed points along the slaughter processing line. Using organoleptic methods, that is, relying on sight, touch and smell, the inspectors examine the head, viscera, and exterior of each carcass for signs of adulteration, such as tumors, inflammation, parasites, and other diseases. See 9 C.F.R. pts. 310–11, §§ 381.76–94. If the inspector detects no signs of adulteration, the carcass is passed and marked with the USDA legend. See 9 C.F.R. §§ 310.8, 381.79. Under the FMIA, if the inspector finds any lesion or other condition “that might render the *9 **9 meat or any part unfit for food purposes, or otherwise adulterated,” the carcass (and its parts) must be retained for veterinary disposition. 9 C.F.R. § 310.3. A carcass or part found to “be unsound, unhealthful, unwholesome, or otherwise adulterated” is condemned and marked as such. Id. § 310.5. Similar procedures apply to inspections under the PPIA. See id. §§ 381.81–89.
             
            The method of inspection just described had remained unchanged for decades. Then, in the mid–1990s, FSIS embarked on a comprehensive food safety initiative targeting the agency's resources at what it perceived as a serious health risk—foodborne pathogens, such as salmonella and E. coli, which cannot be detected by organoleptic inspection. At the same time it determined to make changes in the current inspection process to combat these microbial causes of foodborne illness, FSIS addressed what it considered to be another failure of the present regulatory system—that it provides processing plants with little incentive to detect and eliminate unacceptable carcasses before presenting them for inspection. For these reasons, FSIS decided to require “industry to assume responsibility for producing safe products, reducing foodborne pathogens, and ... to shift Agency inspection resources to those areas which present the greatest public health risk.” John W. McCutcheon Decl. at ¶ 10.
             
            In July 1996, FSIS took the first step in implementing its new initiative by promulgating the Pathogen Reduction/Hazard Analysis and Critical Control Points (“HACCP”) final rule. See 61 Fed.Reg. 38,806 (1996). The rule “requires plants to implement science-based process control systems as a means of preventing food safety hazards, sets certain food safety performance standards, and establishes testing programs to ensure those standards are met.” Food Safety and Inspection Service, HACCP–Based Inspection Models 1 (1998). It provides the industry with complete control over production decisions and execution, subject only to the performance standards set by FSIS. FSIS believes that heightening the industry's responsibility for safe meat and poultry products will increase “the incentives and flexibility establishments need to innovate and improve food safety.” HACCP Final Rule, 61 Fed.Reg. 38,808.
             
            Such advances, according to FSIS, cannot be achieved without substantial changes to its approach to inspection. As the agency put it, the roles of establishments and federal inspectors need to be “realigned to accord with the HACCP philosophy.” Id. To design and test new inspection models, FSIS initiated the Inspection Models Development Project (the “Models Project”). Under the regulatory framework proposed in the Models Project, the task of separating normal from abnormal carcasses and parts will be carried out solely by industry personnel. Federal inspectors will be responsible for monitoring the plant's performance in sorting and for verifying its compliance with performance standards and regulatory requirements. Under the new model, a finding that a product is not adulterated will be based on FSIS's determination that the establishment's food safety and sanitation control systems are preventing adulteration.1
             
            Under the new inspection models, FSIS has said that “slaughter process control will be an industry responsibility subject to FSIS oversight and verification.” HACCP–Based Meat and Poultry Inspection Concepts: In–Plant Slaughter Inspection Models Study Plan, 63 Fed.Reg. 40,381, 40,381 (1998). It explained, “[e]stablishment employees will conduct anatomical *10 **10 and pathological examinations of carcasses, and FSIS inspectors will oversee, evaluate, and verify the effectiveness and reliability of the establishments' slaughter process controls.” Id. FSIS plans the transition to industry-based inspection to occur in stages. At the outset, establishment employees will only be responsible for identifying and removing trimmable defects. They will later assume responsibility for generalized condemnable conditions. And at the final stage, employees will perform “all tasks related to slaughter control,” with the inspectors' role limited to oversight and verification. Food Safety and Inspection Service, HACCP–Based Inspection Models Project In–Plant Slaughter 10 (1998).
             
            Draft guidance put out by FSIS gives some indication of what oversight and verification entails. Though the descriptions vary slightly depending on the class of animals, oversight amounts to inspectors observing establishment personnel as they process carcasses and remove unacceptable products from the food supply. By verification, FSIS means that inspectors will randomly sample and examine carcasses that have been passed to determine if the establishment is complying with the relevant performance standards.
             
            The appellants are a group of federal meat and poultry inspectors, their union, and the Community Nutrition Institute. They brought this suit to enjoin the Secretary from “authorizing anything other than the carcass-by-carcass postmortem inspection by a federal government inspector.” Brief for Appellants at 5. Following cross-motions for summary judgment, the district court ruled in the government's favor on the basis that the word “inspection” did not clearly require an organoleptic inspection. See American Fed'n of Gov't Employees, AFL–CIO v. Glickman, No. 98–0893, Memorandum and Order (D.D.C. Sept. 23, 1999).
             
            II
            The statutory language with which we are concerned, the language supposedly allowing FSIS's oversight and verification regime, is as follows. For meat, § 604 of the FMIA provides: “the Secretary shall cause to be made by inspectors appointed for that purpose a post-mortem examination and inspection of the carcasses and parts thereof of all [livestock] to be prepared at any slaughtering, ... or similar establishment....” 21 U.S.C. § 604 (emphasis added). For poultry, § 455(b) of the PPIA states: “[t]he Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed....” 21 U.S.C. § 455(b) (emphasis added).
             
            The government does not deny that in the ninety or so years since passage of the FMIA in 1907, “inspection” has been taken to mean an organoleptic examination of the carcass, an inspection, that is, using the senses. Now the government has discovered another meaning. A “federal employee has performed an inspection of a carcass,” the government tells us, “when he has watched a plant employee conduct the kind of examination, organoleptic or otherwise, that is necessary to determine whether the carcass is fit for human consumption. And in making these observations, the oversight inspector will observe all of the carcasses that pass along the slaughter line.” Brief for the Appellees at 29.
             
            In other words, the government believes that federal employees fulfill their statutory duty to inspect by watching others perform the task. One might as well say that umpires are pitchers because they carefully watch others throw baseballs. The government thinks it can arrive at its position on the basis that the word “inspection” is undefined in the statutes. But the lack of a statutory definition does not render a term ambiguous. See Bass v. Stolper, Koritzinsky, Brewster & Neider, S.C., 111 F.3d 1322, 1325 (7th Cir.1997). It simply leads us to give the term its ordinary, common meaning. See Perrin v. *11 **11 United States, 444 U.S. 37, 42, 100 S.Ct. 311, 62 L.Ed.2d 199 (1979); Johnson v. SEC,87 F.3d 484, 487 (D.C.Cir.1996). And when we treat the word “inspection” in that manner, it is easy to see why there is nothing to the government's point that “an oversight inspector will necessarily observe all carcasses and parts that pass along the slaughter line.” See John W. McCutcheon Decl. at ¶ 21. Every inspection entails an observation, but not every observation amounts to an inspection. One may observe something without paying close attention to it, and without giving it a critical appraisal, although that is what these statutes demand. The military commander may observe his troops without inspecting them. The foreman of an assembly line may do the same with widgets.
             
            Both statutes clearly contemplate that when inspections are done, it will be federal inspectors—rather than private employees—who will make the critical determination whether a product is adulterated or unadulterated.2 To the extent federal employees are doing any systematic inspecting under the Models Project, they are inspecting people not carcasses. Delegating the task of inspecting carcasses to plant employees violates the clear mandates of the FMIA and PPIA. See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842–43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). For that reason, we reverse the grant of summary judgment and remand to the district court for further proceedings consistent with this opinion.
            So ordered.
            3
             
            Notes. 
            4
            The Models Project encompasses several phases. The first phase involves collecting baseline data of current performance under federal inspection in order to ensure that the new system achieves similar standards. This is followed by a period of testing the new inspection models at certain volunteer plants. Testing began in three such plants in September 1999, and FSIS has set tentative start-up dates for eighteen others.
            “The term ‘inspector’ means: (1) an employee or official of the United States Government ..., or (2) any employee or official of the government of any State....” 21 U.S.C. § 453(k).
          • 4.2.4.3.3 Supreme Beef Processors, Inc. v. U.S. Dept. of Agriculture, 275 F.3d 432 (5th Cir. 2001).
            1
            PATRICK E. HIGGINBOTHAM, Circuit Judge:
             
            Certain meat inspection regulations promulgated by the Secretary of Agriculture, which deal with the levels of Salmonellain raw meat product, were challenged as beyond the statutory authority granted to the Secretary by the Federal Meat Inspection Act. The district court struck down the regulations. We hold that the regulations fall outside of the statutory grant of rulemaking authority and affirm.
             
            I
            The Federal Meat Inspection Act authorizes the Secretary of Agriculture to “prescribe the rules and regulations of sanitation” covering
            slaughtering, meat canning, salting, packing, rendering, or similar establishments in which cattle, sheep, swine, goats, horses, mules and other equines are slaughtered and the meat and meat food products thereof are prepared for commerce....1
            Further, the Secretary is commanded to,
            where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, ... refuse to allow said meat or meat food products to be labeled, marked, stamped, or tagged as “inspected and passed.”2
            In sum, the FMIA instructs the Secretary to ensure that no adulterated meat products pass USDA inspection, which they must in order to be legally sold to consumers.3
            The FMIA contains several definitions of “adulterated,” including 21 U.S.C. § 601(m)(4), which classifies a meat product as adulterated if “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”4 Thus, the FMIA gives the Secretary the power to create sanitation regulations and commands him to withhold meat approval where the meat is processed under insanitary conditions. The Secretary has delegated the authority under the FMIA to the Food Safety and Inspection Service.
             
            In 1996, FSIS, after informal notice and comment rulemaking, adopted regulations *435 requiring all meat and poultry establishments to adopt preventative controls to assure product safety. These are known as Pathogen Reduction, Hazard Analysis and Critical Control Point Systems or “HACCP.”5 HACCP requires, inter alia, that meat and poultry establishments institute a hazard control plan for reducing and controlling harmful bacteria on raw meat and poultry products. In order to enforce HACCP, FSIS performs tests for the presence of Salmonella in a plant's finished meat products.
             
            The Salmonella performance standards set out a regime under which inspection services will be denied to an establishment if it fails to meet the standard on three consecutive series of tests.6 The regulations declare that the third failure of the performance standard “constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan ... for that product, and will cause FSIS to suspend inspection services.”7 The performance standard, or “passing mark,” is determined based on FSIS's “calculation of the national prevalence of Salmonella on the indicated raw product.”8
             
            In June, 1998, plaintiff-appellee Supreme Beef Processors, Inc., a meat processor and grinder, implemented an HACCP pathogen control plan, and on November 2, 1998, FSIS began its evaluation of that plan by testing Supreme's finished product for Salmonella. After four weeks of testing, FSIS notified Supreme that it would likely fail the Salmonella tests. Pursuant to the final test results, which found 47 percent of the samples taken from Supreme contaminated withSalmonella,9 FSIS issued a Noncompliance Report, advising Supreme that it had not met the performance standard. Included in the report was FSIS's warning to Supreme to take “immediate action to meet the performance standards.” Supreme responded to FSIS's directive on March 5, 1999, summarizing the measures it had taken to meet the performance standard and requesting that the second round of testing be postponed until mid-April to afford the company sufficient time to evaluate its laboratory data. FSIS agreed to the request and began its second round of tests on April 12, 1999.
             
            On June 2, 1999, FSIS again informed Supreme that it would likely fail the Salmonella tests and, on July 20, issued another Noncompliance Report—this time informing Supreme that 20.8 percent of its samples had tested positive for Salmonella. Supreme appealed the Noncompliance Report, citing differences between the results obtained by FSIS and Supreme's own tests conducted on “companion parallel samples.” Those private tests, Supreme asserted, had produced only a 7.5 percent Salmonella infection level, satisfying the performance standard. FSIS denied the appeal; but based on Supreme's commitment to install 180 degree water source on all boning and trimming lines, granted the company's request to postpone the next round of Salmonella testing for 60 days. FSIS later withdrew the extension, however, after learning that Supreme was merely considering installation of the water source.
            The third set of tests began on August 27, 1999, and after only five weeks, FSIS advised Supreme that it would again fall short of the ground beef performance standard. *436 On October 19, 1999, FSIS issued a Notice of Intended Enforcement Action, which notified Supreme of the agency's intention to suspend inspection activities. The Notice gave Supreme Beef until October 25, 1999 to demonstrate that its HACCP pathogen controls were adequate or to show that it had achieved regulatory compliance. Although Supreme Beef promised to achieve the 7.5 percent performance standard in 180 days, it failed to provide any specific information explaining how it would accomplish that goal, and FSIS decided to suspend inspection of Supreme's plant.
             
            On the day FSIS planned to withdraw its inspectors, Supreme brought this suit against FSIS's parent agency, the USDA, alleging that in creating the Salmonella tests, FSIS had overstepped the authority given to it by the FMIA. Along with its complaint, Supreme moved to temporarily restrain the USDA from withdrawing its inspectors. The district court granted Supreme's motion and, after a subsequent hearing, also granted Supreme's motion for a preliminary injunction.
             
            The National Meat Association filed a motion to intervene as a plaintiff in the district court. The district court denied the motion on the grounds that NMA was adequately represented by Supreme in this litigation. The district court allowed NMA and other industry groups, as well as various consumer advocacy groups, to file briefs.
             
            On cross-motions for summary judgment, the district court granted summary judgment in favor of Supreme, finding that the Salmonella performance standard exceeded the USDA's statutory authority and entering a permanent injunction against enforcement of that standard against Supreme. The USDA now appeals.
             
            II
            We first must address the USDA's suggestion of mootness. In September, 2000, during the pendency of this appeal, Supreme filed for Chapter 11 bankruptcy. The USDA moved to lift the stay on the appeal and filed a suggestion of mootness with this Court. Supreme argued that it intended to resume operations after reorganization and that the injunction against enforcement of the Salmonella performance standard was critical to that reorganization. A motions panel of this Court denied the motion to remand the case with instructions to dismiss as moot on January 2, 2000. On May 9, 2001, the Bankruptcy Court converted Supreme's case into a Chapter 7 liquidation.
             
            The USDA has again raised the question of mootness. While we are not bound by the earlier determination of the motions panel, which in any event was made while Supreme was still in Chapter 11, rather than Chapter 7, proceedings,10 Supreme asserts that it has substantial assets and could emerge solvent from the Chapter 7 liquidation proceeding. “In general a matter is moot for Article III purposes if the issues presented are no longer live or the parties lack a legally cognizable interest in the outcome.”11 The possibility that Supreme may continue to function as a meat processor even after *437 its Chapter 7 proceeding satisfies Article III.12
             
            The USDA argues that this case is moot because even if Supreme reopens “it is conceivable that it will not open at the same establishment where the violations of the Salmonella standard occurred and will not use the same suppliers.” However, the district court's order is not specific to Supreme's place of business nor its suppliers. The Amended Final Judgment provides in part:
            1. 9 C.F.R. 310.25(b) is hereby declared to be outside the statutory authority of the United States Secretary of Agriculture (the “Secretary”) and the United States Department of Agriculture (the “USDA”)....
            This injunction issued because the district court determined that the USDA was without statutory authority to promulgate the Salmonella performance standards—it cannot be logically restricted to a particular facility.
             
            Furthermore, NMA, having submitted a brief as an amicus curiae supporter of Supreme, again moved to intervene as an appellee, arguing that were we to find that the case was moot with respect to Supreme, NMA's interests were no longer adequately represented by Supreme and this inadequacy only arose during the pendency of the appeal.
             
            We granted NMA's motion to intervene. “A party is entitled to an intervention of right if (1) the motion to intervene is timely; (2) the potential intervener asserts an interest that is related to the property or transaction that forms the basis of the controversy in the case into which [it] seeks to intervene; (3) the disposition of that case may impair or impede the potential intervener's ability to protect [its] interest; and (4) the existing parties do not adequately represent the potential intervener's interest.”13 The district court denied NMA's motion to intervene because it found that NMA's interests were adequately represented by Supreme. In all other respects, NMA satisfies the requirements of intervention as of right under Rule 24(a),14 and we address only adequacy of representation here.
             
            We recognize that while Supreme retains a legally cognizable interest in the outcome of this case, this is because of the possibility that Supreme will emerge from bankruptcy as an entity wishing to carry out meat processing operations. It is also possible, we understand, that Supreme will not so emerge from bankruptcy and be dissolved, perhaps during the pendency of any petition for panel rehearing, rehearing en banc, or writ of certiorari before the U.S. Supreme Court. NMA need only show that Supreme's representation *438 “may be” inadequate,15 and we find the possibility that the case could be mooted by decisions made in Supreme's Chapter 7 proceeding sufficient to satisfy this requirement of Rule 24(a). Were Supreme to cease to exist as a legal entity, or were the case to otherwise become moot with respect to Supreme, NMA would be put in the position of having to re-litigate identical issues on which Supreme was successful in the district court. The interest in avoiding piecemeal litigation is thus served by allowing NMA's intervention.16
             
            Having concluded that this case is not moot, we now turn to the question of whether the Salmonella performance standard represents a valid exercise of rulemaking authority under the FMIA.
             
            III
            Our analysis in this case is governed by the approach first enunciated by the Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.17 The Chevron inquiry proceeds in two steps. First, the court should look to the plain language of the statute and determine whether the agency construction conflicts with the text.18 Then, “[i]f the agency interpretation is not in conflict with the plain language of the statute, deference is due.”19 The district court held the Salmonella performance standard invalid as exceeding the statutory authority of the USDA under the first step of the Chevron inquiry.
             
            A
            Following Chevron, we first repair to the text of the statute that the USDA relies upon for its authority to impose the Salmonella performance standard. The USDA directs us to 21 U.S.C. § 601(m)(4), which provides that a meat product is adulterated
            if it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
            This statutory definition is broader than that provided in 21 U.S.C. § 601(m)(1), which provides that a meat product is adulterated
            if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health.
            Thus if a meat product is “prepared, packed or held under insanitary conditions” such that it may be adulterated for purposes of § 601(m)(1), then it is, by definition, adulterated for purposes of § 601(m)(4). The USDA is then commanded to refuse to stamp the meat products “inspected and passed.”20
             
            The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry *439 products, is not an adulterant per se,21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.”22 This is because normal cooking practices for meat and poultry destroy the Salmonellaorganism,23 and therefore the presence of Salmonella in meat products does not render them “injurious to health”24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.
             
            Supreme maintains that since Salmonella-infected meat is not adulterated under § 601(m)(1), the presence or absence of Salmonella in a plant cannot, by definition, be “insanitary conditions” such that the product “may have been rendered injurious to health,” as required by § 601(m)(4). The USDA, however, argues that Salmonella 's status as a non-adulterant is not relevant to its power to regulate Salmonella levels in end product. This is because the USDA believes that Salmonella levels can be a proxy for the presence or absence of means of pathogen25 controls that are required for sanitary conditions under § 601(m)(4). However, as we discuss, and as the USDA admits, the Salmonella performance standard, whether or not it acts as a proxy, regulates more than just the presence of pathogen controls.
             
            The district court agreed with Supreme and reasoned that “[b]ecause the USDA's performance standards and Salmonellatests do not necessarily evaluate the conditions of a meat processor's establishment, they cannot serve as the basis for finding a plant's meat adulterated under § 601(m)(4).”26 The district court therefore held that the examination of a plant's end product is distinct from “conditions” within the plant for purposes of § 601(m)(4) because Salmonella may have come in with the raw material.
             
            We must decide two issues in order to determine whether the Salmonella performance standard is authorized rulemaking under the FMIA: a) whether the statute allows the USDA to regulate characteristics of raw materials that are “prepared, packed or held” at the plant, such as Salmonella infection; and b) whether § 601(m)(4)'s “insanitary conditions” such that product “may have been rendered injurious to health” includes the presence of Salmonella-infected beef in a plant or the increased likelihood of cross-contamination with Salmonella that results from grinding such infected beef. Since we are persuaded that the Salmonella performance standard improperly regulates the *440 Salmonella levels of incoming meat and that Salmonella cross-contamination cannot be an insanitary condition such that product may be rendered “injurious to health,” we conclude that the Salmonella performance standard falls outside of the ambit of § 601(m)(4).
             
            B
            1
            In order for a product to be adulterated under § 601(m)(4), as the USDA relies on it here,27 it must be “prepared, packed or held under insanitary conditions ... whereby it may have been rendered injurious to health.”28 The use of the word “rendered” in the statute indicates that a deleterious change in the product must occur while it is being “prepared, packed or held” owing to insanitary conditions. Thus, a characteristic of the raw materials that exists before the product is “prepared, packed or held”29 in the grinder's establishment cannot be regulated by the USDA under § 601(m)(4).30 The USDA's interpretation ignores the plain language of the statute, which includes the word “rendered.” Were we to adopt this interpretation, we would be ignoring the Court's repeated admonition that, when interpreting a statute, we are to “give effect, if possible, to every clause and word of a statute.”31
            9The USDA claims, however, that the Salmonella performance standard serves as a proxy for the presence or absence of pathogen controls, such that a high level of Salmonella indicates § 601(m)(4) adulteration.32 Supreme oversimplifies *441 its argument by claiming, essentially, that the USDA can never use testing of final product for a non-adulterant, such as Salmonella, as a proxy for conditions within a plant.
             
            We find a similar, but distinct, defect in the Salmonella performance standard. The USDA admits that the Salmonellaperformance standard provides evidence of: (1) whether or not the grinder has adequate pathogen controls; and (2) whether or not the grinder uses raw materials that are disproportionately infected with Salmonella. Supreme has, at all points in this litigation, argued that it failed the performance standard not because of any condition of its facility, but because it purchased beef “trimmings” that had higher levels of Salmonella than other cuts of meat. The USDA has not disputed this argument, and has merely argued that this explanation does not exonerate Supreme, because the Salmonella levels of incoming meat are fairly regulated under § 601(m)(4).33 Our textual analysis of § 601(m)(4) shows that it cannot be used to regulate characteristics of the raw materials that exist before the meat product is “prepared, packed or held.” Thus, the regulation fails, but not because it measures Salmonella levels and Salmonella is a non-adulterant. The performance standard is invalid because it regulates the procurement of raw materials.
             
            2
            Our determination here is not in tension with the Second Circuit's decision interpreting identical language under the Food, Drug, and Cosmetic Act in United States v. Nova Scotia Food Products Corp.34 In Nova Scotia the defendant challenged an FDA regulation requiring the heating of smoked fish to combat the toxin formation of Clostridium botulinum spores, which cause botulism. The defendant argued that “the prohibition against ‘insanitary conditions' embraces conditions only in the plant itself, but does not include conditions which merely inhibit the growth of organisms already in the food when it enters the plant in its raw state.”35 The court gave “insanitary conditions” a broad reading and upheld the regulation.36 Nevertheless, it conceded that “a plausible argument can, indeed, be made that the references are to insanitary conditions in the plant itself, such as the presence of rodents or insects....”37
             
            While this may appear to conflict with our determination that pre-existing characteristics of raw materials before they are “prepared, packed or held” are not within *442 the regulatory reach of § 601(m)(4), the regulations at issue in Nova Scotia did not attempt to control the levels of Clostridium botulinum spores in incoming fish, as the performance standard does to Salmonella in incoming raw meat. Instead, the regulations in Nova Scotia required the use of certain heating and salination procedures to inhibit growth of the spores.38
             
            Nova Scotia did not consider the argument before us today, which is that the statute does not authorize regulation of the levels of bacterial infection in incoming raw materials. The argument that Nova Scotia entertained was that “Congress did not mean to go so far as to require sterilization sufficient to kill bacteria that may be in the food itself rather than bacteria which accreted in the factory through the use of insanitary equipment.”39 The required sterilization under the regulations at issue in Nova Scotia obviously occurred within the plant and did not regulate the quality of incoming fish.
             
            3
            The USDA and its amicus supporters argue that there is no real distinction between contamination that arrives in raw materials and contamination that arises from other conditions of the plant. This is because Salmonella can be transferred from infected meat to non-infected meat through the grinding process. The Salmonella performance standard, however, does not purport to measure the differential between incoming and outgoing meat products in terms of the Salmonellainfection rate. Rather, it measures final meat product for Salmonella infection. Thus, the performance standard, of itself, cannot serve as a proxy for cross-contamination because there is no determination of the incoming Salmonella baseline.
            Moreover, the USDA has not asserted that there is any correlation between the presence of Salmonella and the presenceof § 601(m)(1) adulterant pathogens. The rationale offered by the USDA for the Salmonella performance standard—that “intervention strategies aimed at reducing fecal contamination and other sources of Salmonella on raw product should be effective against other pathogens”40—does not imply that the presence of Salmonella indicates the presence of these other, presumably § 601(m)(1) adulterant, pathogens.41 Cross-contamination of Salmonella alone cannot form the basis of a determination that a plant's products are *443 § 601(m)(4) adulterated, because Salmonella itself does not render a product “injurious to health” for purposes of both §§ 601(m)(1) and 601(m)(4).
             
            Not once does the USDA assert that Salmonella infection indicates infection with § 601(m)(1) adulterant pathogens.42Instead, the USDA argues that the Salmonella infection rate of meat product correlates with the use of pathogen control mechanisms and the quality of the incoming raw materials. The former is within the reach of § 601(m)(4), the latter is not.
             
            IV
            Because we find that the Salmonella performance standard conflicts with the plain language of 21 U.S.C. § 601(m)(4), we need not reach Supreme's numerous alternative arguments for invalidating the standard, which were not addressed by the district court.
             
            V
            We AFFIRM and REMAND with instructions that the final judgment of the district court be amended to include the National Meat Association.
            2
            Notes
            Id.
            The FMIA requires that adulterated meat products be stamped “inspected and condemned” and destroyed. 21 U.S.C. § 606.
            9 C.F.R. Pt. 417.
            Id. § 310.25(b).
            Id. § 310.25(b)(3)(iii).
            Id. § 310.25(b)(2) tbl. 2 n.a.
            The performance standard for raw ground beef is 7.5 percent. Id.
            AT&T Communications of the Southwest, Inc. v. City of Dallas, 243 F.3d 928, 930 (5th Cir.2001) (stating that although a motions panel had denied a motion to vacate as moot, court could consider arguments on appeal and “overturn [the motions panel] where necessary.” (quoting Mattern v. Eastman Kodak, Co., 104 F.3d 702, 704 (5th Cir.1997))).
            Since we find that Article III is satisfied by Supreme's continuing legally cognizable interest in the outcome, we need not address its argument that this case falls into that category of disputes capable of repetition yet evading review.
            Fed.R.Civ.P. 24(a). There can be no serious dispute that NMA's original motion to intervene was timely and that NMA has an interest in this lawsuit, given that it deals with the application of a performance standard that affects NMA's members. NMA has standing to pursue this appeal. “An association has standing to bring a suit on behalf of its members when: (1) its members would otherwise have standing to sue in their own right; (2) the interests it seeks to protect are germane to the organization's purpose; and (3) neither the claim asserted nor the relief requested requires the participation of individual members.” Central and South West Services, Inc. v. EPA, 220 F.3d 683, 698 (5th Cir.2000).
            See, e.g., Goodman v. Heublein, 682 F.2d 44, 47 (2d Cir.1982) (granting motion to intervene in part to avoid piecemeal litigation).
            Id.
            See American Pub. Health Ass'n v. Butz, 511 F.2d 331, 334 (D.C.Cir.1974) (“[T]he presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601(m)].”). The USDA agrees in this case that Salmonella is not an adulterant per se, meaning it is not a § 601(m)(1) adulterant. Appellant's Brief at 11.
            Butz, 511 F.2d at 334 (“American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.”).
            Cf. Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 41 (D.C.Cir.1982) (stating that Salmonella is a per se adulterant in shrimp).
            The USDA uses the term “pathogen” to refer to both § 601(m)(1) adulterants, such as pathogenic E.coli, and non-adulterants, such as Salmonella. Thus, under the proxy theory, Salmonella control correlates with adulterant-pathogen control.
            The USDA does not contend that failure of the Salmonella performance standard serves as a proxy for contamination with filth, the other prong dealt with by § 601(m)(4). Even if the USDA made such an assertion, § 601(m)(4) speaks of insanitary conditions such that a product “becomes” contaminated with filth, which has a similar textual meaning as “rendered.”
            21 U.S.C. § 601(m)(4) (emphasis added).
            This case does not require us to define precisely when a product begins the process of being “prepared, packed or held.” We recognize only that this process cannot begin until the raw materials are brought to the plant. Thus, the condition of the raw materials may not be regulated by § 601(m)(4).
            However, measures that would alter such a characteristic, such as heating fish to destroy the bacteria that causes botulism, are within the scope of § 601(m)(4). See Part III.B.2.
            We note that the USDA's assertions on this point are suspect. It is clear that the motivation behind the Salmonella performance standard was the regulation of Salmonella itself, and the FSIS has admitted as much in the Final Rule, though this admission is absent from the USDA's briefs in this case. See Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule, 61 Fed.Reg. 38806, 38850(“Because testing for E. coli cannot serve as a surrogate for the presence of Salmonella, FSIS's specific public health objective of reducing nationwide Salmonella levels on raw meat and poultry products, including raw ground products, requires a standard and testing regime that are directed at that pathogen.” (emphasis added)). The difficulty with this, of course, is that the USDA has no statutory authority to regulate the levels of non-adulterant pathogens.
            While we do not question the agency's expertise, we also note that several equivocal statements about the effectiveness of Salmonella levels as a proxy for pathogen controls appear in the Final Rule. See Id. at 38835 (“And, interventions targeted at reducing Salmonella may be beneficial in reducing contamination by other enteric pathogens.” (emphasis added)); Id. at 38846 (“[I]ntervention strategies aimed at reducing fecal contamination and other sources of Salmonella on raw product should be effective against other pathogens.”).
            The USDA repeatedly asserts that it has the power to regulate the Salmonella levels of incoming raw materials used in grinding establishments. See, e.g., Appellant's Reply Brief at 12 (“To operate in a sanitary manner, a plant must match the level of its pathogen controls to the nature of the meat it purchases. The greater the risk of contamination in the incoming product, the greater the need for strategies to reduce microbial contamination.”); 61 Fed.Reg. at 38846 (“Establishments producing raw ground product from raw meat or poultry supplied by other establishments cannot use technologies for reducing pathogens that are designed for use on the surfaces of whole carcasses at the time of slaughter. Such establishments may require more control over incoming raw product, including contractual specifications to ensure that they begin their process with product that meets the standard .... ”) (emphasis added).
            Id. at 246 (“When agency rulemaking serves the purposes of the statute, courts should refuse to adopt a narrow construction of the enabling legislation which would undercut the agency's authority to promulgate such rules.”).
            Id. at 243 (describing time-temperature-salinity regulations for hot-process smoked fish). This is consistent with the entirety of cases dealing with this statute, none of which concern “conditions” extrinsic to the place where the products are “prepared, packed or held.” See, e.g., United States v. Gel Spice Co., Inc., 773 F.2d 427, 430 (2d Cir.1985) (rodent infestation in plant); United States v. King's Trading, Inc., 724 F.2d 631, 632 (8th Cir.1983) (rodent infestation in warehouse); United States v. 1,638 Cases of Adulterated Alcoholic Beverages and Other Articles of Food, 624 F.2d 900, 901–02 (9th Cir.1980) (flooding in storage area); United States v. Certified Grocers Co-op., 546 F.2d 1308, 1310–11 (7th Cir.1976) (rodent infestation in warehouse). Even the USDA does not argue that § 601(m)(4) reaches “conditions” external to the establishment, but rather that control of pathogen levels in incoming raw materials are necessary to maintain sanitary conditions inside of the establishment. See Appellant's Brief at 38–39.
            Id. at 246.
            One might speculate that such a conclusion would create problems for the USDA, because a statement that Salmonella was a proxy for, for example, pathogenic E. coli could arguably require the determination that the presence of Salmonella rendered a product § 601(m)(1) adulterated. This would prevent Salmonella-infected meat from being sold in the United States to consumers.
            The amicus curiae consumer groups in their brief appear not to recognize the distinction between a correlation between Salmonella and other enteric pathogens in raw materials and a correlation between reductions in Salmonella and reductions in other enteric pathogens when the same control methods are used. See Brief of Amicus Curiae Consumer Groups at 10–11.
          • 4.2.4.3.4 Food & Water Watch, Inc v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)
            Notes: <p>1. <span class="caps">FSIS</span>, <span class="caps">PPIA</span>, and <span class="caps">NPIS</span>. As the opinion discusses in some detail, <span class="caps">FSIS</span> administers the <span class="caps">PPIA</span>. Historically, <span class="caps">FSIS</span> inspected poultry using four systems. Offline inspectors ensure compliance with food safety regulations, verify sanitation procedures, and collect samples for testing. Online inspectors inspect the actual poultry. At issue in the case was the New Poultry Inspection System (<span class="caps">NPIS</span>), which shifted from inspector-based sorting and evaluation to establishment-based sorting and evaluation. That is, <span class="caps">NPIS</span> relocates inspection responsibilities to firms rather than government personnel.</p> <p>2. Food Safety Harms. The plaintiffs in Food &amp; Water Watch alleged that the new inspection procedures would increase the risk of food borne illness and therefore sought to stop the program. To satisfy the constitutional requirements for standing in Article <span class="caps">III</span>, plaintiffs must show injury-in-fact. Directly regulated parties typically have no trouble satisfying this requirement because a given federal regulation requires them to take an action or suffer penalties. Poultry facilities would have no difficulty demonstrating standing. For third parties&#8212;individuals not directly regulated by the Rule, showing that they are or are likely to be harmed by the rule is far more difficult. Note that in practice this may mean rules deemed undesirable by regulated parties will be litigated, but rules deemed desirable by regulated parties are less likely to be litigated.</p>
            1

            Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)

            2

            Before: HENDERSON, MILLETT and WILKINS, Circuit Judges. (foornotes omitted) 

            3

            WILKINS, Circuit Judge:

            4

            Margaret Sowerwine and Jane Foran, individual consumers of poultry, and Food & Water Watch, Inc. (“FWW”), their organizational advocate, fear that new regulations promulgated by the United States Department of Agriculture (“USDA”) may result in an increase in foodborne illness from contaminated poultry. To prevent the regulations from going into effect, Plaintiffs sought declaratory and injunctive relief. The District Court concluded that Plaintiffs failed to demonstrate an injury in fact and dismissed Plaintiffs’ claims for lack of standing.

            5

             * * *

            6

            I.

            7

            The Poultry Products Inspection Act (“PPIA”), 21 U.S.C. §§ 451472, was born out of a Congressional interest in protecting consumer health and welfare by enabling the Secretary of Agriculture (“Secretary”) to ensure that poultry products were “wholesome, not adulterated, and properly marked, labeled, and packaged.” 21 U.S.C. § 451. The PPIA accomplishes this goal, in part, by requiring the Secretary **371 *910 to ensure that inspectors1 conduct a post-mortem inspection of all poultry processed for human consumption. Id. § 455(b). The PPIA also requires condemnation and destruction for human food purposes of all poultry that is found to be adulterated, unless the poultry can be reprocessed under an inspector’s supervision so that it is found to be not adulterated. Id. § 455(c). The PPIA defines “adulterated” to include various conditions, including containing, among other things, “any poisonous or deleterious substance which may render it injurious to health”; various additives that are unfit for human consumption; consisting in whole or in part of any “filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food”; or packaging in conditions where it “may have been rendered injurious to health.” Id. § 453(g). Carcasses that pass inspection receive an official legend indicating that it was inspected by the USDA. Id. § 453(h)(12); 9 C.F.R. § 381.96.

            8

            The Food Safety and Inspection Service (“FSIS”) administers the PPIA. See 7 C.F.R. §§ 2.18(a)(1)(ii)(A), 2.53(a)(2)(i). Historically, FSIS has permitted chicken and turkey—the poultry products of concern to Plaintiffs—to be inspected under one of four inspection systems: the Streamlined Inspection System, the New Line Speed Inspection System, the New Turkey Inspection System, and traditional inspection (collectively, “the existing inspection systems”). Modernization of Poultry Slaughter Inspection, 77 Fed.Reg. 4408, 4410 (proposed Jan. 27, 2012). Under the existing inspection systems, FSIS inspectors perform either an online or offline role. See id. Offline inspectors ensure compliance with food safety regulations, verify sanitation procedures, and collect samples for pathogen testing. See id. One or more online FSIS inspectors inspect each poultry carcass with its viscera2 immediately following the separation of the viscera from the carcass. See id. Under the existing inspection systems, the inspectors conduct an “organoleptic” inspection, using sight, touch, and smell to evaluate the carcasses. See Brief for Appellees, Food & Water Watch, Inc. v. Vilsack, No. 15–5037 (D.C. Cir.), Doc. No. 1553589, at 3; see also 77 Fed.Reg. at 4410 (noting that inspectors “examine each eviscerated carcass for visual defects”). Poultry establishment personnel do not conduct any sorting or evaluation of carcasses; the poultry establishments provide a “helper” who takes action only upon an FSIS inspector’s direction. 77 Fed.Reg. at 4410.

            9

            The inspection method at issue in this case, the New Poultry Inspection System (“NPIS”), alters the responsibilities of the FSIS inspectors and the establishment personnel. The NPIS rules institutionalize the shift from inspector-based sorting and evaluation to establishment-based sorting and evaluation. Under the NPIS, poultry establishment personnel sort the poultry carcasses and take corrective action prior to an FSIS inspection. See id. at 4421.

            10

            *911 **372 The NPIS grew out of FSIS’s concern that agency resources were not being used in the most effective way to ensure food safety. See id. at 4410. In an effort to develop new methods to more effectively inspect poultry, in 1996 FSIS promulgated the “Pathogen Reduction/Hazard Analysis and Critical Control Points” (“HACCP”) rule. Id. at 4413; Pathogen Reduction; Hazard Analysis and Critical Control Points, 61 Fed.Reg. 38806 (July 25, 1996). HACCP required poultry establishments to develop controls to ensure product safety and empowered the establishments to make their own determinations about how to meet the FSIS regulatory requirements. 77 Fed.Reg. at 4413. FSIS subsequently announced an HACCP-based inspection models project (“HIMP”) that would allow FSIS to test and develop new inspection models. HACCP–Based Meat and Poultry Inspection Concepts, 62 Fed.Reg. 31553 (June 10, 1997). The pilot HIMP method made poultry establishment personnel “responsible for identifying and removing normal from abnormal carcasses and parts.” 77 Fed.Reg. at 4413.

            11

            The HIMP pilot was challenged as a violation of the PPIA because FSIS inspectors did not inspect poultry carcasses themselves, leaving all inspection to establishment personnel with FSIS oversight. Am. Fed’n of Gov’t Empls., AFL–CIO v. Glickman (AFGE I ), 215 F.3d 7, 9–10 (D.C.Cir.2000). This Court held that such delegation violated the PPIA. Id. at 11. In response to AFGE I, “FSIS modified HIMP to position one inspector at a fixed location near the end of the slaughter line in each poultry slaughter establishment” who was responsible for evaluating each carcass after establishment personnel had sorted and processed it. 77 Fed.Reg. at 4413. The modified HIMP program was also challenged, and this Court held that the program did not violate the PPIA. Am. Fed’n of Gov’t Empls., AFL–CIO v. Veneman, 284 F.3d 125, 130–31 (D.C.Cir.2002). However, we cautioned that “[i]f the USDA undertakes a rulemaking to adopt as a permanent change something along the lines of the modified program, experience with the program’s operation and its effectiveness will doubtless play a significant role” and warned that our opinion “may not necessarily foreshadow the outcome of judicial review of such future regulations.” Id. at 130–31.

            12

            Twenty young chicken and five turkey establishments participated in HIMP, and FSIS collected and analyzed the data from these establishments. 77 Fed.Reg. at 4414. Using this data, FSIS concluded that the HIMP procedures “improved performance related to food safety and non-food-safety standards ... especially in reducing pathogen levels” and proposed the NPIS to replace the existing inspection systems, excluding the traditional inspection system. Id. at 4421. Under the proposed NPIS rule, “establishments [would] be required to sort carcasses, to dispose of carcasses that must be condemned, and to conduct any necessary trimming or reprocessing activities before carcasses are presented to the online FSIS carcass inspector.” Id. The carcasses would pass along a production line for the online inspector at a speed of 175 birds per minute for young chickens, and 55 birds per minute for turkeys. Id. at 4423. While establishment personnel sort carcasses, FSIS inspectors would reallocate their time by increasing offline inspection activities. Id. at 4420, 4422. FSIS projected that 99.9% of young chickens and poultry would be produced under the NPIS. Id. at 4436. After a notice and comment period, FSIS adopted a final NPIS rule with a number of modifications, which included making adoption of the NPIS optional, and lowering the birds per minute speed of young chickens to 140 birds per minute. **373 *912 Modernization of Poultry Slaughter Inspection, 79 Fed.Reg. 49566, 49570 (Aug. 21, 2014)

            13

            On September 11, 2014, Plaintiffs filed their complaint in this case, claiming that the NPIS constitutes “an unprecedented elimination of inspection resources for a secret set of young chicken and turkey slaughterhouses.” Compl. ¶ 1, J.A. 9. In this spirit, Plaintiffs alleged eight claims against Defendants: (1) violation of 21 U.S.C. § 455(c) by allowing condemnation of young chicken and turkey carcasses by NPIS establishment personnel; (2) violation of 21 U.S.C. § 455(c) by allowing reprocessing of young chickens and turkeys by NPIS establishment personnel without inspector supervision; (3) violation of 21 U.S.C. § 455(b) because each young chicken and turkey carcass will not receive a post-mortem inspection in NPIS establishments; (4) violation of the PPIA’s branding requirements; (5) violation of 21 U.S.C. § 455(b) and 9 C.F.R. § 381.1 because each chicken and turkey viscera will not be federally inspected; (6) violation of 21 U.S.C. § 463(c) for failure to provide an opportunity for oral presentation of views; (7) violation of the Administrative Procedure Act (“APA”) by failing to provide adequate opportunity for notice and comment; and (8) violation of the APA because the final NPIS rules are arbitrary and capricious. Plaintiffs sought declaratory and injunctive relief. On the same day they filed the complaint, Plaintiffs moved for a preliminary injunction on Claims 1, 2, 6, and 7. The District Court heard the motion on October 17, 2014.

            14

            On February 9, 2015, the District Court dismissed the case for lack of subject matter jurisdiction because Plaintiffs lacked standing, and denied the motion for preliminary injunction and all other pending motions as moot. Food & Water Watch, Inc. v. Vilsack, 79 F.Supp.3d 174, 206 (D.D.C.2015). With respect to the Individual Plaintiffs, the District Court found that they did not suffer an injury in fact in order to establish standing. Id. at 190–95. The District Court also found that FWW lacked standing as an organization, and that Plaintiffs did not suffer a procedural injury sufficient to establish standing. Id. at 199–206. Plaintiffs appeal the dismissal on these grounds.

            15

            * * *

            16

             III.

            17

            Plaintiffs first contend that the Individual Plaintiffs, Sowerwine and Foran, have alleged an injury in fact. Plaintiffs also submit that FWW would have associational standing on behalf of its members. See, e.g., Sierra Club v. EPA, 754 F.3d 995, 999 (D.C.Cir.2014) (explaining that associational standing requires an organization to show, among other things, that “at least one of [the organization’s] members would have standing to sue”). Because the analyses for both the Individual Plaintiffs and FWW’s members are identical, see id., we address them jointly here.

            18

            For the Individual Plaintiffs or FWW’s individual members to establish standing, they must show (i) they have “suffered a concrete and particularized injury in fact, (ii) that was caused by or is fairly traceable to the actions of the defendant, and (iii) is capable of resolution and likely to be redressed by judicial decision.” Osborn v. Visa, 797 F.3d 1057, 1063 (D.C.Cir.2015) (internal quotation marks omitted). Here, because Plaintiffs are not directly subjected to the regulation they challenge, “standing is ‘substantially more difficult to establish.’ ” Public Citizen, Inc. v. Nat’l Highway Traffic Safety Admin. (Public Citizen I ), 489 F.3d 1279, 1289 (D.C.Cir.2007) (citing Defs. of Wildlife, 504 U.S. at 562, 112 S.Ct. 2130). In order to have suffered an injury in fact, Plaintiffs must have suffered an injury that is “(1) concrete, (2) particularized, and (3) actual or imminent.” Id. at 1292. A concrete injury is “direct, real, and palpable—not abstract.” Id. A particularized injury is “personal, individual, distinct, and differentiated—not generalized or undifferentiated.” Id. An actual or imminent injury is “certainly impending and immediate—not remote, speculative, conjectural, or hypothetical.” Id. at 1293.

            19

            Here, Plaintiffs claim their injury in fact is an increased risk of foodborne illness from unwholesome, adulterated poultry resulting from the Defendants’ regulation.4 Increased-risk-of-harm cases implicate the requirement that an injury be actual or imminent because “[w]ere all purely speculative increased risks deemed injurious, the entire requirement of actual or imminent injury would be rendered moot, because all hypothesized, nonimminent injuries could be dressed up as increased risk of future injury.” Id. at 1294 (quoting NRDC v. EPA (NRDC II ), 464 F.3d 1, 6 (D.C.Cir.2006)) (internal quotation marks omitted). Furthermore, “[t]he Supreme Court has repeatedly held that disputes about future events where the possibility of harm to any given individual is remote and speculative are properly left to the policymaking Branches, not the Article III courts.” Id. at 1295. As a result, this Court has limited its jurisdiction over cases alleging the possibility of increased-risk-of-harm to those where the plaintiff can show “both (i) a substantially increased risk of harm and (ii) a substantial probability of harm with that increase taken into account.” Id. at 1295 (emphasis in original); accord Susan B. Anthony List, 134 S.Ct. at 2341 (“An allegation of future injury may suffice if the threatened injury is ‘certainly impending,’ or there is a “ ‘substantial risk’ ” that the harm will occur.’ ” (quoting Clapper v. Amnesty Int’l USA, ––– U.S. ––––, 133 S.Ct. 1138, 1147 n. 5, 1150, 185 L.Ed.2d 264 (2013))). “The word ‘substantial’ of course poses questions of degree, questions far from fully **376 *915 resolved.” Va. State Corp. Comm’n v. FERC, 468 F.3d 845, 848 (D.C.Cir.2006).

            20

            Although Plaintiffs may establish standing by demonstrating an increased risk of harm, “[i]n applying the ‘substantial’ standard, we are mindful ... that the constitutional requirement of imminence ... necessarily compels a very strict understanding of what increases in risk and overall risk levels can count as ‘substantial.’ ” Public Citizen I, 489 F.3d at 1296. Accordingly, “the proper way to analyze an increased-risk-of-harm claim is to consider the ultimate alleged harm—such as death, physical injury, or property damage ...—as the concrete and particularized injury and then to determine whether the increased risk of such harm makes injury to an individual citizen sufficiently ‘imminent’ for standing purposes.” Id. at 1298.

            21

             

            22

            The Individual Plaintiffs’ and FWW members’ alleged harm is the foodborne illness that would result from consuming adulterated, unwholesome chicken produced under the NPIS. In order to have standing, therefore, Plaintiffs at least need to plausibly allege that the NPIS substantially increases the risk of foodborne illness when compared to the existing inspection methods. Accordingly, in order to satisfy this Court’s two-part analysis, the Plaintiffs must demonstrate, under the relevant standard, (1) that the NPIS substantially increases the risk of contracting foodborne illness compared to the existing inspection methods, and (2) a substantial probability that the Individual Plaintiffs and FWW members will contract a foodborne illness given that increase of risk. A failure to satisfy either of these prongs would deprive this Court of jurisdiction to hear Plaintiffs’ case. See Public Citizen I, 489 F.3d at 1295.

            23

            A.

            24

            Plaintiffs argue that their complaint and submissions in support of their motion for preliminary injunction sufficiently establish that the NPIS substantially increases the risk of harm that will arise from consuming unwholesome, adulterated poultry. Defendants submit that Plaintiffs have failed to demonstrate a substantially increased risk of harm.

            25

            We find that Plaintiffs’ complaint, as well as their various submissions in support of their motion for preliminary injunction, fails to plausibly allege that the NPIS taken as a whole substantially increases the risk of foodborne illness as a result of unwholesome, adulterated poultry. First, a careful examination of Plaintiffs’ allegations demonstrates that they have not plausibly alleged that the NPIS substantially increases the risk of foodborne illness compared to the existing inspection systems. To be sure, Plaintiffs’ submissions contained detailed allegations about how HIMP, and by extension, the NPIS, differs from the existing poultry inspection systems. See Compl. ¶¶ 31–77, J.A. 16–25. The complaint is replete with what Plaintiffs argue are the NPIS’s inadequacies. See Compl. ¶¶ 78–126, J.A. 25–29. The complaint also outlines what Plaintiffs perceive are the flaws with the HIMP studies and analyses. See Compl. ¶¶ 148–61, J.A. 33–35. However, these differences and perceived flaws do not demonstrate a substantial increase in the risk of foodborne illness under the NPIS compared to the existing inspection systems. 

            26

            To the extent that the presence of adulterated, unwholesome poultry could give rise to an inference of resulting foodborne illness, these allegations still fall short because they fail to allege that the NPIS as a whole will produce significantly more adulterated, unwholesome chicken compared to the existing inspection systems. Plaintiffs’ allegations focus on certain discrete aspects of the NPIS: the reduced number of **377 *916 online federal inspectors, the speed at which the online federal inspectors must evaluate carcasses, and the substitution of establishment personnel for federal inspectors. See Compl. ¶¶ 78–121, J.A. 25–29. However, Plaintiffs’ complaint contains only a single allegation that references another key aspect the NPIS: the reallocation of resources for offline inspection. Compl. ¶ 183, J.A. 39. Under the NPIS, additional offline verification inspectors will check to see to that inspection protocols are being followed and conduct pathogen testing. See 77 Fed.Reg. at 4422. Plaintiffs’ complaint makes no allegation regarding the impact of increased offline verification inspectors on the presence of adulterated, unwholesome poultry. Although Plaintiffs fault Defendants for failing to account for a reduction in online inspectors in Defendants’ risk assessment, Plaintiffs’ failure to account for the increase in offline inspections and their attendant impact on poultry production prevents us from inferring that the NPIS as a whole substantially increases the risk of foodborne illness.

            27

            Other allegations in the complaint reveal the same problem. For example, the complaint outlines HIMP personnel’s alleged failure to catch disease-related conditions on poultry. See Compl. ¶ 177, J.A. 38 (“An FWW analysis of the data for 14 HIMP plants found that out of 229 [Noncompliance Reports] filed from March to August 2011, 208 (90 percent) were for visible fecal contamination that was missed by company employees.”). Although these allegations, at best, give rise to the inference that establishment personnel will not be as effective in identifying adulterated poultry, they do not allege how NPIS inspection as a whole will impact the amount of adulterated poultry. Notably, these allegations do not allege that these results are worse than what plants do under existing inspection systems. Thus, they fail to plausibly allege that the regulations substantially increase the risk of foodborne illness.

            28

            Plaintiffs’ submissions in support of their motion for preliminary injunction suffer from the same defect. The sworn affidavits from existing USDA inspectors go into great detail about the differences between the NPIS and existing poultry inspection systems. One inspector explained that under the existing inspection systems, they “would have 3 inspectors on each line, with 90 birds per minute split among them, so that each inspector was looking at 30 birds per minute” but under HIMP, one inspector looks “at up to 200 birds, or more, per minute.” J.A. 298. Another inspector claimed, “I know I cannot detect all of the carcasses with Food Safety defects, and it is reasonable to assume that some are going out to the public.” J.A. 306. A third inspector said, “I know the kinds of unwholesome, mutilated, and diseased chickens that are processed and shipped out for sale and I feel it is important to share this information with consumers and taxpayers” because the HIMP system “is tantamount to having the wolves watch the proverbial henhouse, but these chickens are real and they could very likely hurt or kill someone.” J.A. 317. Another inspector who worked previously for a chicken production company and serves currently as a USDA inspector outlined the various pressures that poultry production personnel are under to increase the number of birds that are shipped out to consumers. J.A. 32124. Although these statements may be alarming, even taken as true, they do not allege that there **378 *917 is a substantially increased risk of foodborne illness because they do not allege that the risk of unwholesome, adulterated poultry is higher under the NPIS as a whole than the existing inspection systems.

            29

            Plaintiffs could perhaps overcome this deficiency by providing the Court with an alternative basis from which to infer that NPIS inspection results in a substantially increased risk of unwholesome, adulterated poultry. Here, if Plaintiffs could plausibly allege through their use of statistics that NPIS poultry creates a substantial increase in the risk of foodborne illness, they would allege a sufficient injury for standing. We have, in the past, refused to require a quantitative analysis in order to establish standing in increased-risk-of-harm cases, see NRDC II, 464 F.3d at 7, and we likewise refuse to hold that statistics are required for such cases. However, we remain mindful that “[d]etermining whether a complaint states a plausible claim [of injury] is context-specific, requiring the reviewing court to draw on its experience and common sense.” Ashcroft v. Iqbal, 556 U.S. 662, 663–64, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Accordingly, where a plaintiff’s allegations incorporate statistics and the plaintiff contends that the statistics demonstrate a substantial increase in the risk of harm, the plaintiff must allege something from which the Court can infer that risk. Using our experience and common sense, we cannot make this inference from Plaintiffs’ statistics. 

            30

            A review of Plaintiffs’ statistics demonstrates their failure to plausibly allege a substantial increase in the risk of harm. Plaintiffs point to isolated statistics where Defendants found Salmonella rates to be “higher” in chicken processed in HIMP establishments than in non-HIMP establishments, but the complaint does not specify how much higher the rates were. See Compl. ¶¶ 162–164, J.A. 35–36. Plaintiffs also submitted selections from an FSIS report that found under some scenarios, “a 0.2% increase in the proportion of samples testing Campylobacter positive,” but the same page of this report concluded that under most projected scenarios, the samples testing positive for Salmonella or Campylobacter would decrease. J.A. 430. Plaintiffs also alleged that 0.1% of Campylobacter illnesses would be attributable to the NPIS “under some scenarios.” Compl. ¶ 180, J.A. 39. Plaintiffs likewise relied on Defendants’ risk assessment assumption that annual Salmonella and Campylobacter illness “attribut[able] to poultry are about 174,686 and 169,005, respectively.” J.A. 430. Plaintiffs plucked these statistics from Defendants’ studies but provide no allegations from which we can infer that the statistics reflect a substantial increase in the risk of harm. Indeed, Defendants’ risk assessment concluded under most scenarios that annual illnesses from Salmonella and Campylobacter would remain unchanged or would decrease under the NPIS. J.A. 430–31. Even Plaintiffs’ complaint acknowledges that the risk of Campylobacter increase is “ambiguous.” Compl. ¶ 180, J.A. 39. An ambiguous increase in risk is hardly a substantial increase in risk.

            31

            Plaintiffs’ statistics suffer from additional problems. First, these studies predate the final rule’s amendments. Although not necessarily a problem by itself, the rule’s amendments specifically lowered the line speeds (one of Plaintiffs’ chief criticisms) and made the transition to NPIS inspection voluntary. Plaintiffs make no allegations about the impact of these changes on their statistical claims. Furthermore, Plaintiffs fail to account for how increased allocations in offline inspections would impact the risk. In this context, Plaintiffs’ statistics do not plausibly allege that NPIS inspection as a whole substantially increases the risk that poultry will be contaminated **379 *918 with Salmonella or Campylobacter compared to the existing inspection systems. Because Plaintiffs have failed to plausibly allege that the NPIS substantially increases the risk of producing unwholesome, adulterated poultry compared to the existing inspection systems, they do not have standing. 

            32

            ***

            33

            VI.

            34

            For the foregoing reasons, we hold that Plaintiffs have failed to show any cognizable injury sufficient to establish standing. Accordingly, we affirm the District Court.

            35

            So ordered. 

            36

            (Concurring Opinions of Judge Henderson and Judge Millit omitted)

            37

             

        • 4.2.4.4 Enforcement

          Section 301 of the FDCA, Section 610 of the FMIA, Section 458 of the PPIA, and Section 1037 of the EPIA are the enforcement provisions of the major federal food safety statutes. The standard menu of agency enforcement mechanisms include inspections, warning letters, suspension of registration, recall, injunction, seizure, retention, and criminal prosecution.

          • 4.2.4.4.1 Food Safety Rights of Action
            • 4.2.4.4.1.1 Rogers v. Tyson Foods, Inc.
              Notes: <p>1. No private right of action. As the court explained, there is no private right of action in the <span class="caps">PPIA</span>. In In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 788 (3d Cir. 1999) holds that there is no private right of action in the <span class="caps">FDCA</span>. As a consequence, ordinary citizens may not bring suit in federal court even if they are harmed by a company's failure to comply with federal food safety requirements. That leaves two possibilities. First, agency agency enforcement. The federal agency with jurisdiction over the given facility that must elect to enforce the statutory requirements. Given the number of facilities already emphasized and the limited resources of the agencies, there is only so much enforcement possible.</p> <p>2. State Law. A second path of enforcement relies on neither federal agency enforcement, nor private rights of action in federal court, bur rather state law claims in state courts. Tyson Foods entails one example. Tyson argued that the <span class="caps">PPIA</span> preempted all state law claims even though the <span class="caps">PPIA</span> (and also the <span class="caps">FDCA</span>) do not provide a private right of action in federal court. The court disagreed, concluding that &#8220;complete preemption&#8221; can only exist when the federal law provides a private right of action. As the court notes at the end of the opinion, this does not mean that Tyson has no preemption defense. Rather, preemption may be asserted as a defense in statute court. There is no basis for federal jurisdiction, however, and no grounds for removal to federal court.</p>
              1

              308 F.3d 785 (2002)

              2
              Timothy A. ROGERS, Wendy A. Rogers, and Alan Westfall, on behalf of themselves and all others similarly situated, Plaintiffs-Appellants,
              v.
              TYSON FOODS, INCORPORATED, Defendant-Appellee.

              No. 02-1040.

              3

              United States Court of Appeals, Seventh Circuit.

              Argued September 18, 2002.
              Decided October 22, 2002.
              Rehearing and Suggestion for Rehearing Denied November 22, 2002.

              4

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

              5

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

              6

              Before BAUER, MANION, and ROVNER, Circuit Judges.

              7

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

              8
              MANION, Circuit Judge.
              9

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

              10
              I.
              11

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

              12

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

              13
              II.
              14

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

              15

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

              16

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

              17

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

              18

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

              19

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

              20

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

              21

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

              22

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

              23

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

              24

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

              25

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

              26

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

              27

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

              28
              III.
              29

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

              30

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

              31

              REVERSED and REMANDED.

              32

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

      • 4.2.5 State and Local Food Regulation

        Absent private rights of action to enforce federal food safety laws and given the limited resources of federal agencies relative to the sheer volume of food and food facilities, the state and local law often serves as the front line in the fight against food safety. By nature, state and local legal requirements vary from jurisdiction to jurisdiction. Nevertheless, the basic structure and allocation of oversight and enforcement authority is relatively consistent across states.

        The regulation of retail food sales and distribution has been left largely to the states.  Some states delegate lincensing and inspection to local government units, while others do not.  Restaurant inspection, food trucks, farmers markets, and grocery stores are all largely controlled by state and local law.  This section contains and illustrative set of cases and legal materials.


        • 4.2.5.1 Basis of Authority

          • 4.2.5.1.1 Good Laws, Good Food: Putting Local Food Policy to Work for Our Communities
            1
            FEDERALISM AND THE INTERPLAY OF FEDERAL, STATE, LOCAL, AND TRIBAL
            2

            The United States is governed using a system of federalism. This means that both the federal and state governments have their own spheres of responsibility and authority. The U.S. Constitution limits the areas over which the federal government has authority, leaving certain areas to the states to govern exclusively. The federal government is not allowed to directly govern those areas. In the areas where the federal government does have authority to govern, federal laws generally override state laws.

            3

            The interplay between state and local governments works slightly differently. Local governments do not have any express authority under the U.S. Constitution. Instead, local governments have the power given to them by their state under that state’s constitution or statutes. Thus, all states have the same amount of constitutionally-derived power and authority vis-à-vis the federal government, but they determine on their own how to apportion this state power between the state and local governments. This means that the amount and type of authority given to local governments varies greatly from state to state and, as described below, can even vary from city to city within one state. Because there is so much variation in local governments’ authority, this toolkit cannot lay out all of the specific authorities given to local governments in each state, but will help to provide you with some tools to figure out what powers your local government has.

            4

            The interplay between Native American tribal governments and state or federal government is a bit more complicated. In the U.S., Native American tribes are considered to have “tribal sovereignty,” a term that describes “the right of federally recognized tribes to govern themselves and the existence of a government- to-government relationship with the United States.” This also means that a tribal group has “the right to form its own government, adjudicate legal cases within its borders, levy taxes within its borders, establish its membership, and decide its own future fate.” As a result, tribes cannot be preempted by state laws like local governments can; however, they can be preempted by the federal government. State law can only preempt tribal law when Congress has given that state the authority to do so. While this interplay is worth noting, as the focus of this toolkit is on local governments, our analysis of tribal law is limited. * * *  

            5

            HOW LOCAL GOVERNMENT GETS THE POWER TO ACT State laws play a significant role in local government. First, because local governments do not have any power except that given to them by the state, the state constitution or state legislation must authorize local governments to act in certain ways. Second, because state laws can preempt, or bar, local authority to act on certain issues, states almost always have ultimate authority over local governments. Third, because statewide rules and regulations must generally be followed in all local areas, state laws play a significant role in local areas. When recommending policy change, food policy councils need to understand how their locality gets its authority and what types of powers it does or does not have. In order to conserve their energy to push for policy changes that are actually possible for the city or county to enact, food policy councils should be sensitive to the restrictions their municipality faces with regard to the ability to enact certain types of laws or regulations.

            6

            General Background: Dillon’s Rule & Home Rule In general, local governments have no inherent powers granted to them by the U.S. Constitution. Judge John Dillon of the Iowa Supreme Court recognized this fact over 100 years ago, which is why this lack of local power is now known as Dillon’s Rule. Dillon’s Rule holds that local governments have only those powers that are expressly given to them by the state; according to Dillon’s Rule, local governments only have those powers that are:

            7
            • “granted in express words;
            • necessarily implied or necessarily incident to the powers expressly granted; and
            • absolutely essential to the declared objects and purposes of the corporation— not simply convenient, but indispensable.”
            8

            Therefore if the power in question is not expressly authorized by a state statute or the state constitution, or cannot be implied directly from another authorized power, it is presumed that a municipality does not have that power. States that are considered Dillon’s Rule states, or that do not give broad Home Rule powers to local areas, including Arkansas, Connecticut, and New York, generally depend on the state legislature for legislation enabling them to act. In such states, local governments generally get some authority to act from state enabling statutes, which limit the authorization of local power to a particular defined area. An enabling statute is a “law that permits what was previously prohibited or that creates new powers.” In this context, this means a statute giving local municipalities the authority to enact local ordinances on particular topics. Absent enabling legislation, cities in these states might not have the authority to enact ordinances or take action on certain food policy matters. In New York, for example, municipalities were not allowed to permit community gardens on land they held until 1978, when the legislature passed enabling legislation granting them that ability. It is worth noting though that while Dillon’s Rule was originally intended to be strictly construed, some courts have more recently interpreted the granted powers broadly. 

            9

            Home Rule, on the other hand, is a broad grant of power from the state that allows municipalities to independently handle local matters without the need for special legislation by the state, as long as the municipal laws do not conflict with state laws. This power to exercise certain functions is transferred from the state to local governments through the state’s constitution or state legislation. Whether the power originates from the former or the latter, Home Rule powers are shaped by the language of the delegation from the state legislature or the interpretation of this delegation by state courts. Thus, even though “all but few states have some form of home rule authority,” the specific details of the power granted varies from state to state. 

            10

            The majority of the states with Home Rule authorization also give municipalities the permission to enact a Home Rule Charter, which is a “local government’s organizational plan or framework, analogous to a constitution, drawn [up] by the municipality itself and adopted by popular vote of the citizenry.”  A typical Home Rule grant allows a local government to “make and enforce local police, sanitary and other regulations as are not in conflict with [the municipality’s] charter or with the [state’s] general laws,” while others provide authority over any local matter that is “not expressly denied by [the state’s] general law or [the municipality’s] charter.” Unlike with enabling statutes, under Home Rule, when authorization is vague, it is assumed that the municipality has the power unless it is explicitly denied. If your state has granted municipalities broad Home Rule authority or allowed Home Rule Charters and your municipality has enacted such a charter, your municipality will likely have greater independence, and its powers may be controlled by this charter, rather than by state enabling statutes.

            11

            As it is unclear what constitutes a “local matter,” interpreting the exact scope of the power granted to local government is usually left to the discretion of the state legislature (if Home Rule was granted through legislation) or state courts (if Home Rule was granted through the state constitution). Either way, it is clear that the scope of Home Rule authority varies greatly depending on each state’s authorizing language and how that language is interpreted. For example, it would seem that a constitutional grant of Home Rule authority would be stronger than a statutory grant; however, though Idaho allows certain Home Rule powers in its constitution, including the creation of Home Rule Charters, the scope of Idaho municipalities’ governing powers are more limited than in Indiana, where Home Rule was granted through statute. This is because Idaho’s constitution only allows for a strict construction of police powers, the powers that give cities the capacity to preserve public security, order, health, and justice. By contrast, Indiana’s law also allows municipalities some functional powers, which includes the city’s ability to choose the public goods and services it provides and at what levels.

            12

            Not only do states allow varying amounts of power depending on the particular area of the law, but they can also distinguish between the levels of local government. The powers delegated to counties may not be the same as those delegated to cities. Further, states such as Arizona, Missouri, and Delaware require a minimum population size before a municipality can create a Home Rule Charter. Thus, in some states, only certain cities are granted Home Rule authority while others are not. 

            13

            It is worth noting that, while in tension, Dillon’s Rule and Home Rule are not polar opposites; states can be considered a Dillon’s Rule State while still allowing some Home Rule authority, and vice versa. Further, while it may appear that Dillon’s Rule States have much less power available to them, this is not necessarily true. North Carolina, for example, is considered a Dillon’s Rule State, yet local governments there have the same powers, and in some cases, powers that are considered even “greater than those enjoyed by local governments in states [with Home Rule].” Thus, it important to keep in mind when assessing whether your state adheres predominantly to Dillon’s Rule or Home Rule, that it is just as significant to understand how that Rule is actually carried out in your state and locality. Further, regardless of whether your state is considered Home Rule or Dillon’s Rule, state government can still preempt local government at any time unless the local power is protected by the state’s constitution or federal laws.

            14

            * * *  

You've reached the bottom of your content preview.
To view the rest in your browser, click here.
To export the complete content in DOC format, click the blue export button in the upper right corner of this page.

(Note: If you view the entire playlist, any changes you've made to export settings will be lost. Large playlists may temporarily freeze your browser while loading, as well.)