text:
87 S.Ct. 1526, 1530
18 L.Ed.2d 704
The TOILET GOODS ASSOCIATION, Inc., et al., Petitioners,
John W. GARDNER, Secretary of Health, Education, and Welfare et al. ABBOTT LABORATORIES et al., Petitioners, v. John W. GARDNER, Secretary of Health, Education, and Welfare et al. John W. GARDNER, Secretary of Health, Education, and Welfare et al., Petitioners, v. The TOILET GOODS ASSOCIATION, Inc., et al.
Nos. 336, 39, 438.
Supreme Court of the United States
Decided May 22, 1967, May 29, 1967.
Nathan Lewin, Washington, D.C., for petitioners.
Edward J. Ross, New York City, for respondents.
Mr. Justice HARLAN delivered the opinion of the Court.
In Toilet Goods Assn. v. Gardner, 387 U.S. 158, 87 S.Ct. 1520, 18 L.Ed.2d 697, we affirmed a judgment of the Court of Appeals for the Second Circuit holding that judicial review of a regulation concerning inspection of cosmetics factories was improper in a pre-enforcement suit for injunctive and declaratory judgment relief. The present case is brought here by the Government seeking review of the Court of Appeals' further holding that review of three other regulations in this type of action was proper. 360 F.2d 677. We likewise affirm.
For reasons stated in our opinion in Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 68, we find nothing in the Federal Food, Drug, and Cosmetic Act, (52 Stat. 1040, as amended), 21 U.S.C. § 301 et seq., that precludes resort to the courts for preenforcement relief under the Administrative Procedure Act, 5 U.S.C. §§ 701—704 (1964 ed., Supp. II), and the Declaratory Judgment Act, 28 U.S.C. § 2201. And for reasons to follow, we believe the Court of Appeals was correct in holding that the District Court did not err when it refused to dismiss the complaint with respect to these regulations.
The regulations challenged here were promulgated under the Color Additive Amendments of 1960, 74 Stat. 397, 21 U.S.C. §§ 321 376. These statutory provisions, in brief, allow the Secretary of Health, Education, and Welfare and his delegate, the Commissioner of Food and Drugs, 22 Fed.Reg. 1051, 25 Fed.Reg. 8625, to prescribe conditions for the use of color additives in foods, drugs, and cosmetics. The Act requires clearance of every color additive in the form of a regulation prescribing conditions for use of that particular additive, and also certification of each 'batch' unless exempted by regulation. A color additive is defined as 'a dye, pigment, or other substance * * * (which) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto * * *,' 21 U.S.C. § 321(t)(1).
Under his general rule-making power, § 701(a), 21 U.S.C. § 371(a), the Commissioner amplified the statutory definition to include as color additives all diluents, that is, 'any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed therein to facilitate the use of the mixture in coloring foods, drugs or cosmetics or in coloring the human body.' 21 CFR § 8.1(m). By including all diluents as color additives, the Commissioner in respondents' view unlawfully expanded the number of items that must comply with the premarketing clearance procedure.
The Commissioner also included as a color additive within the coverage of the statute any 'substance that, when applied to the human body results in coloring * * * unless the function of coloring is purely incidental to its intended use, such as in the case of deodorants. Lipstick, rouge, eye makeup colors, and related cosmetics intended for coloring the human body are 'color additives." 21 CFR § 8.1(f). Respondents alleged that in promulgating this regulation the Commissioner again impermissibly expanded the reach of the statute beyond the clear intention of Congress.
A third regulation challenged by these respondents concerns the statutory exemption for hair dyes that conform to a statutory requirement set out in § 601(e), 21 U.S.C. § 361(e). That requirement provides that hair dyes are totally exempt from coverage of the statute if they display a certain cautionary notice on their labels prescribing a 'patch test' to determine whether the dye will cause skin irritation on the particular user. The Commissioner's regulation recognizes that the exemption applies to the Color Additive Amendments, but goes on to declare: 'If the poisonous or deleterious substance in the 'hair dye' is one to which the caution is inapplicable and for which patch-testing provides no safeguard, the exemption does not apply; nor does the exemption extend to the poisonous or deleterious diluents that may be introduced as wetting agents, hair conditioners, emulsifiers, or other components in a color shampoo, rinse, tint, or similar dual-purpose cosmetics that alter the color of the hair.' 21 CFR § 8.1(u).
Respondents contend that this regulation too is irreconcilable with the statute: whereas the statute grants an across-the-board exemption to all hair dyes meeting the patch-test notice requirement, the regulation purports to limit that exemption to cover only those dyes as to which the test is 'effective.' Moreover, it is said, the regulation appears to limit the exemption only to the coor ing ingredient of the dye, and to require clearance for all other components of a particular hair dye.
We agree with the Court of Appeals that respondents' challenge to these regulations is ripe for judicial review under the standards elaborated in Abbott Laboratories v. Gardner, supra, namely the appropriateness of the issues for judicial determination and the immediate severity of the regulations' impact upon the plaintiffs.
The issue as framed by the parties is a straightforward legal one: what general classifications of ingredients fall within the coverage of the Color Additive Amendments? Both the Government and the respondents agree that for any color additive, distribution is forbidden unless the additive is (1) listed in a Food and Drug Administration regulation as safe for use under prescribed conditions, and (2) comes from a 'certified' batch, unless specifically exempted from the certification requirement. The only question raised is what sort of items are 'color additives.' The three regulations outlined above purport to elaborate the statutory definition; they include within the statutory term certain classes of items, e.g., diluents, finished cosmetics, and hair dyes, that respondents assert are not within the purview of the statute at all. We agree with the District Court and the Court of Appeals that this is not a situation in which consideration of the underlying legal issues would necessarily be facilitated if they were raised in the context of a specific attempt to enforce the regulations.1 Rather, 'to the extent that they purport to apply premarketing requirements to broad categories like finished products and non-coloring ingredients and define the hair-dye exemption, they appear, prima facie, to be susceptible of reasoned comparison with the statutory mandate without inquiry into factual issues that ought to be first ventilated before the agency.' 360 F.2d at 685.
For these reasons we find no bar to consideration by the courts of these issues in their present posture. Abbott Laboratories v. Gardner, supra; United States v. Storer Broadcasting Co., 351 U.S. 192, 76 S.Ct. 763, 100 L.Ed. 1081; Frozen Food Express v. United States, 351 U.S. 40, 76 S.Ct. 569, 100 L.Ed. 730.
This result is supported as well by the fact that these regulations are self-executing, and have an immediate and substantial impact upon the respondents. See Abbott Laboratories v. Gardner, 386 U.S. pp. 152—153, 87 S.Ct. pp. 1517—1518. The Act, as noted earlier, prescribes penalties for the distribution of goods containing color additives unless they have been cleared both by listing in a regulation and by certification of the particular batch. Faced with these regulations the respondents are placed in a quandary. On the one hand they can, as the Government suggests, refuse to comply, continue to distribute products that they believe do not fall within the purview of the Act, and test the regulations by defending against government criminal, seizure, or injunctive suits against them. We agree with the respondents that this proposed avenue of review is beset with penalties and other impediments rendering it inadequate as a satisfactory alternative to the present declaratory judgment action.
The penalties to which cosmetics manufacturers might be subject are extensive. A color additive that does not meet the premarketing clearance procedure is declared to be 'unsafe,' § 706(a), 21 U.S.C. § 376(a), and hence 'adulterated,' § 601, 21 U.S.C. § 361(e). It is a 'prohibited act' to introduce such material into commerce, § 301, 21 U.S.C. § 331, subjec t o injunction, § 302, 21 U.S.C. § 332, criminal penalties, § 303, 21 U.S.C. § 333, and seizure of the goods, § 304(a), 21 U.S.C. § 334(a). The price of noncompliance is not limited to these formal penalties. Respondents note the importance of public good will in their industry, and not without reason fear the disastrous impact of an announcement that their cosmetics have been seized as 'adulterated.'
The alternative to challenging the regulations through noncompliance is, of course, to submit to the regulations and present the various ingredients embraced in them for premarketing clearance. We cannot say on this record that the burden of such a course is other than substantial, accepting, as we must on a motion to dismiss on the pleadings, the allegations of the complaint and supporting affidavits as true. The regulations in this area require separate petitions for listing each color additive, 21 CFR §§ 8.1(f), 8.1(m), 8.4(c), at an initial fee, subject to refunds, of $2,600, a listing. 21 CFR § 8.50(c). One respondent Kolmar Laboratories, Inc., in affidavits submitted to the District Court, asserted that more than 2,700 different formulae would fall under the Commissioner's regulations and would cost some $7,000,000 in listing fees alone. According to the allegations the company also uses 264 diluents which under the challenged regulations must be included as color additives as well. Moreover, a listing is not obtained by mere application alone. Physical and chemical tests must be made and their results submitted with each petition, 21 CFR § 8.4(c), at a cost alleged by Kolmar of up to $42,000,000. Detailed records must be maintained for each listed ingredient, 21 CFR § 8.26, and batches of listed items must ultimately be certified, again at a substantial fee, 21 CFR § 8.51.
Whether on not these cost estimates are exaggerated2 it is quite clear that if respondents, failing judicial review at this stage, elect to comply with the regulations and await ultimate judicial determination of the validity of them in subsequent litigation, the amount of preliminary paper work, scientific testing, and recordkeeping will be substantial. The District Court found in denying the motion to dismiss: 'I conclude that in a substantial and practical business sense plaintiffs are threatened with irreparable injury by the obviously intended consequences of the challenged regulations, and that to resort to later piecemeal resolution of the controversy in the context of individual enforcement proceedings would be costly and inefficient, not only for the plaintiffs but as well for the public as represented by the defendants.' 235 F.Supp. 648, 651.
Like the Court of Appeals, we think that this record supports those findings and conclusions. And as in Abbott Laboratories, supra, we have been shown no substantial governmental interest that should lead us to reach a conclusion different from the one we have reached in that case. We hold that this action is maintainable.
Mr. Justice BRENNAN took no part in the consideration or decision of this case.
Mr. Justice FORTAS, with whom THE CHIEF JUSTICE and Mr. Justice CLARK join, concurring in No. 336, and dissenting in Nos. 39 and 438.
I am in agreement with the Court in No. 336, Toilet Goods Assn. v. Gardner, 387 U.S. 158, 87 S.Ct. 1520, 18 L.Ed.2d 697, that we should affirm the decision of the Court of Appeals for the Second Circuit holding that the authority of the Secretary of Health, Education, and Welfare to promulgate the regulation there involved may not be challenged by injunctive or declaratory judgment action. The regulation (hereinafter referred to as the 'access' regulation) was issued under the 1960 Color Additive Amendments to the Federal Food, Drug, and Cosmetic Act. 74 Stat. 397, 21 U.S.C. §§ 321—376. It requires that manufacturers afford employees of the agency access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates, and provides that the Commissioner of Food and Drugs 'may immediately suspend certification service' so long as access is denied. 28 Fed.Reg. 6446, 21 CFR § 8.28.
I am, however, compelled to dissent from the decisions of the Court in No. 39, Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681, and No. 438, Gardner v. Toilet Goods Assn., 387 U.S. 167, 87 S.Ct. 1526, 18 L.Ed.2d 704. These cases also involve regulations promulgated under the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq. No. 438, like No. 336, arises under the Color Additive Amendments of 1960. The regulation implements the statutory definition of color additives to include diluents, finished cosmetics and certain hair dyes (the 'definition' regulations). The regulation in No. 39 implements amendments to the Act adopted in 1962 by requiring that 'every time' the proprietary or trade-mark name of a drug appears on labels and other printed materials, the 'established' or generic name must accompany it (the 'every time' regulation).
The issues considered by the Court are not constitutional questions. The Court does not rest upon any asserted right to challenge the regulations at this time because the agency lacks authority to promulgate the regulations as to the subject matters involved, or because its procedures have been arbitrary or unreasonable. Its decision is based solely upon the claim of right to challenge these particular regulations at this time on the ground that they are erroneous exercises of the agency's power. It is solely on this point that the Court in these two cases authorizes threshold or pre-enforcement challenge by action for injunction and declaratory relief to suspend the operation of the regulations in their entirety and without reference to particular factual situations.
With all respect, I submit that established principles of jurisprudence, solidly rooted in the constitutional structure of our Government, require that the courts should not intervene in the administrative process at this stage, under these facts and in this gross, shotgun fashion. With all respect, I submit that the governing principles of law do not permit a different result in these cases than in No. 336. In none of these cases is judicial interference warranted at this stage, in this fashion, and to test—on a gross, free-wheeling basis—whether the content of these regulations is within the statutory intendment. The contrary is dictated by a proper regard for the purpose of the regulatory statute and the requirements of effective administration; and by regard for the salutary rule that courts should pass upon concrete, specific questions in a particularized setting rather than upon a general controversy divorced from particular facts.
The Court, by today's decisions in Nos. 39 and 438, has opened Pandora's box. Federal injunctions will now threaten programs of vast importance to the public welfare. The Court's holding here strikes at progras for the public health. The dangerous precedent goes even further. It is cold comfort—it is little more than delusion—to read in the Court's opinion that 'It is scarcely to be doubted that a court would refuse to postpone the effective date of an agency action if the Government could show * * * that delay would be detrimental to the public health or safety.' Experience dictates, on the contrary, that it can hardly be hoped that some federal judge somewhere will not be moved as the Court is here, by the cries of anguish and distress of those regulated, to grant a disruptive injunction.
The difference between the majority and me in these cases is not with respect to the existence of jurisdiction to enjoin, but to the definition of occasions on which such jurisdiction may be invoked. I do not doubt that there is residual judicial power in some extreme and limited situations to enjoin administrative actions even in the absence of specific statutory provision where the agency has acted unconstitutionally or without jurisdiction—as distinguished from an allegedly erroneous action. But the Court's opinions in No. 39 and No. 438 appear to proceed on the principle that, even where no constitutional issues or questions of administrative jurisdiction or of arbitrary procedure are involved, exercise of judicial power to enjoin allegedly erroneous regulatory action is permissible unless Congress has explicitly prohibited it, provided only that the controversy is 'ripe' for judicial determination. This is a rule that is novel in its breadth and destructive in its implications as illustrated by the present application. As will appear, I believe that this approach improperly and unwisely gives individual federal district judges a roving commission to halt the regulatory process, and to do so on the basis of abstractions and generalities instead of concrete fact situations, and that it impermissibly broadens the license of the courts to intervene in administrative action by means of a threshold suit for injunction rather than by the method provided by statute.
The Administrative Procedure Act1 and fundamental principles of our jurisprudence2 insist that there must be some type of effective judicial review of final, substantive agency action which seriously affects personal or property rights. But, '(a)ll constitutional questions aside, it is for Congress to determine how the rights which it creates shall be enforced. * * * In such a case the specification of one remedy normally excludes another.' Switchmen's Union of North America v. National Mediation Board, 320 U.S. 297, 301, 64 S.Ct. 95, 97, 88 L.Ed. 61 (1943). Where Congress has provided a method of review, the requisite showing to induce the courts otherwise to bring a governmental program to a halt may not be made by a mere showing of the impact of the regulation and the customary hardships of interim compliance. At least in cases where the claim is of erroneous action rather than the lack of jurisdiction or denial of procedural due process, a suit for injunctive or declaratory relief will not lie absent a clear demonstration that the type of review available under the statute would not be 'adequate,' that the controversies are otherwise 'ripe' for judicial decision, and that no public interest exists which offsets the private values which the litigation seeks to vindicate. As I shall discuss, no such showing is or can be made here.
Since enactment of the Federal Food, Drug, and Cosmetic Act in 1938, the mechanism for judicial review of agency actions under its provisions has been well understood. Except for specific types of agency regulations ad actions to which I shall refer, judicial review has been confined to enforcement actions instituted by the Attorney General on recommendation of the agency. As the recurrent debate over this technique demonstrates, this restricted avenue for challenge has been deemed necessary because of the direct and urgent relationship of the field of regulation to the public health.3 It is this avenue that applies with respect to the regulations at issue in the present cases.
The scheme of the Act, in this respect, is as follows: 'Prohibited acts' are listed in § 301, 52 Stat. 1042, as amended, 21 U.S.C. § 331. Subsequent sections authorize the Attorney General to institute three types of proceedings. First, under § 302, 52 Stat. 1043, as amended, 21 U.S.C. § 332, he may apply to the district courts of the United States for injunctive relief. If an injunction is violated, jury trial is assured on demand of the accused. Second, under § 304, 52 Stat. 1044, as amended, 21 U.S.C. § 334, the Attorney General may institute libel proceedings in the district courts and seek orders for seizure of any misbranded or adulterated food, drug, device, or cosmetic. Third, criminal prosecution is authorized for violations, but before the Secretary may report a violation to the Attorney General for criminal prosecution, he must afford the affected person an opportunity to present his views. §§ 303, 305, 52 Stat. 1043, 1045, as amended, 21 U.S.C. §§ 333, 335.
The present regulations concededly would be reviewable in the course of any of the above proceedings. Apart from these general provisions, the Act contains specific provisions for administrative hearing and review in the courts of appeals with respect to regulations issued under certain, enumerated provisions of the Act—not including those here involved. These appear in § 701(f) of the Act, 52 Stat. 1055, as amended, 21 U.S.C. § 371(f). Section 701, by subdivision (a), contains the Secretary's general authority, exercised in the present cases, to promulgate 'regulations for the efficient enforcement of (the Act).' Subdivisions (e) and (f) provide for public hearings, administrative findings, and judicial review in a court of appeals with respect to those regulations specifically enumerated in subsection (e).4 The Court agrees that this procedure applies only to the enumerated types of regulations and that the present regulations are unaffected. Then, as to the enumerated regulations which are subject to judicial review—and only as to them—subparagraph (6) of subsection (f) specifies that '(t)he remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.' This 'saving clause' does not apply or refer to regulations other than those enumerated, and the Court's argument to the contrary is inconsistent with the clear wording and placement of the clause.5
At various times, § 701 has been amended to include types of regulations in addition to those initially subjected to § 701(f). Indeed, in the congressional action which included enactment of statutory provisions here in issue, the 1960 Color Additive Amendments, 74 Stat. 397, Congress amended § 701(e), 21 U.S.C. § 376(e) to include certain of the regulations authorized by the Color Additive Amendments. But, significantly, these did not include the regulations at issue in No. 336 and No. 438. The same is true with respect to the later Drug Amendments of 1962, 76 Stat. 780. Subsection (e) was again enlarged, but the provision involved in No. 39 was not included. These actions were taken in the course of vigorous debate as to the enforcement and review provisions which should be enacted with respect to the 1960 and 1962 amendments.
On a number of occasions Congress considered and rejected the proposal that district courts be given power to restrain by injunction the enforcement of regulations.6 The bill that became law in 1938 originally contained provisions for hearings and judicial review in the district courts of certain specified types of regulations (substantially those later enacted as § 701, supra). District courts were also empowered to enjoin 'any regulation promulgated in accordance with section 24' (which would include the regulations at issue in these cases, promulgated under § 701(a)). S. 5, 75th Cong., 1st Sess. (1937). The House Committee eliminated the latter provision and substituted what became subsection (f). This draft authorized review in a district court of regulations under subsection (e) and of those orders only.7 Even this restricted provision for enjoining certain regulations met with bitter opposition because it 'would postpone indefinitely the consumer protection' or would 'hamstring' the Act's enforcement and 'amount to a practical nullification * * * of the bill.'8 The Conference Committee then drafted the bill which was enacted, including the House revision of the review provision which became § 701 except for a significant change: So concerned was the Congress lest the administration of the law should be subjected to judicial intervention that even with respect to th § pecified regulations in subsection (e) the reviewing power was placed in the courts of appeals rather than in the district courts.9 This was to meet the criticism that 'a single district judge could be found who would issue an injunction.' But this is exactly what the Court today decrees. Rejected along with the original House proposal was the suggestion from the Department of Justice, set out at 83 Cong.Rec. 7892 (1938), that the Congress should leave review in the hands of the district courts' traditional injunctive powers—although the Court today resuscitates that lost cause, too.
As this Court held in Ewing v. Mytinger & Casselberry, 339 U.S. 594, 600—601, 70 S.Ct. 870, 873, 94 L.Ed. 1088 (1950), 'This highly selective manner in which Congress has provided (in this Act) for judicial review reinforces the inference that the only review of the issue of probable cause (for seizure) * * * was the one provided in the libel suit.' In evaluating the destructive force and effect of the Court's action in these cases, it is necessary to realize that it is arming each of the federal district judges in this Nation with power to enjoin enforcement of regulations and actions under the federal law designed to protect the people of this Nation against dangerous drugs and cosmetics. Restraining orders and temporary injunctions will suspend application of these public safety laws pending years of litigation—a time schedule which these cases illustrate.10 They are disruptive enough, regardless of the ultimate outcome. The Court's validation of this shotgun attack upon this vital law and its administration is not confined to these suits, these regulations, or these plaintiffs—or even this statute. It is a general hunting license; and I respectfully submit, a license for mischief because it authorizes aggression which is richly rewarded by delay in the subjection of private interests to programs which Congress believes to be required in the public interest. As I read the Court's opinion, it does not seriously contend that Congress authorized or contemplated this type of relief. It does not rest upon the argument that Congress intended that injunctions or threshold relief should be available. The Court seems to announce a doctrine, which is new and startling in administrative law, that the courts, in determining whether to exercise jurisdiction by injunction, will not look to see whether Congress intended that the parties should resort to another avenue of review, but will be governed by whether Congress has 'prohibited' injunctive relief. The Court holds that 'judicial review of a final agency action by an aggrieved person will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress.' As authority for this, the Court produces little support. Board of Governors of Federal Reserve System v. Agnew, 329 U.S. 441, 67 S.Ct. 411, 91 L.Ed. 408 (1947), involved removal from office of certain bank directors. Had the Court not authorized review, the aggrieved individuals could only test the correctness of the administrator's decision by ignoring it and risking a prison term of five years. No evidence of congressional hostility to review was adduced.11 Heikkila v. Barber, 345 U.S. 229, 73 S.Ct. 603, 97 L.Ed. 972 (1953), does not even remotely support the Court's contention. On the contrary, it holds that a provision in the Immigration Act of 1917 to the effect that the decision of the Attorne G eneral is 'final' in deportation cases precludes direct attack upon a deportation order by means of suits for injunction or declaratory relief. What might be termed the other personal liberties cases relied upon by the Court are discussed below. But in cases like the present, where courts and administrative agencies both function, it has always—to this date been accepted that the intention of Congress—not its mere failure to prohibit—will be faithfully searched out by the courts and will be implemented except in the unusual and extraordinary situations where the result would be essentially to leave the parties without any adequate right to judicial review. Compare Leedom v. Kyne, 358 U.S. 184, 79 S.Ct. 180, 3 L.Ed.2d 210 (1958), with Switchmen's Union of North America v. National Mediation Board, supra; Myers v. Bethlehem Shipbuilding Corp., 303 U.S. 41, 58 S.Ct. 459, 82 L.Ed. 638 (1938); and Adams v. Nagle, 303 U.S. 532, 58 S.Ct. 687, 82 L.Ed. 999 (1938).
In effect, the Court says that the Food, Drug, and Cosmetic Act has always authorized threshold injunctions or declaratory judgement relief: that this relief has been available since the enactment of the law in 1938, and that it would have been granted in appropriate cases which are 'ripe' for review. I must with respect characterize this as a surprising revelation. Despite the highly controversial nature of many provisions of such regulations under the Act, this possibility has not been realized by ingenious and aggressive counsel for the drug and food and cosmetics industries until this time. The Court's opinion and the briefs cite only a single case in which such relief has been granted prior to the present cases, and that preceded enactment of the present statutory scheme. Morgan v. Nolan, 3 F.Supp. 143 (D.C.S.D.Ind.1933), aff'd, 69 F.2d 471 (C.A.7th Cir. 1934). The fact of the matter is that, except for the instances enumerated in §§ 701(e) and (f), the avenue for attack upon the statute and regulations has been by defense to specific enforcement actions by the agency. Congress has been well aware of this for more than a generation that the statute has been in effect.12
Where a remedy is provided by statute, I submit that it is and has been fundamental to our law, to judicial administration, to the principle of separation of powers in our Constitution, that the courts will withhold equitable or discretionary remedies unless they conclude that the statutory remedy is inadequate. Even then, as the Court recognizes, the case must be 'ripe' or appropriate for threshold judicial review. Any other doctrine than this—any doctrine which so far departs from judicial restraint and judicial recogniton of the power of the Congress and the administrative agencies—is bound to be disruptive. It would mean that provisions in regulatory statutes and regulations of a wide variety of administrative agencies would be subject to threshold attack because Congress has not, in addition to providing judicial review by prescribed procedures, also said to the courts, 'thou shalt not enjoin in limine.'
The limited applicability of the Administrative Procedure Act in these cases is entirely clear. That Act requires that unless precluded by Congress final agency action of the sorts involved here must be reviewable at some stage, and it recognizes that such review must be 'adequate.' It merely presents the question in these cases. It does not supply an answer. Certainly, it would be revolutionary doctrine that the Administrative Procedure Act authorizes threshold suits for injunction even where another and adequate review provision is available. The Court refers to the Administrative Procedure Act as 'seminal.' It is, in a real sense; but its seed may not produce the lush, tropical jungle of the doctrine that the Court will permit agency action to be attacked in limine by suit for injunction or declaratory action unless Congress expressly prohibits review of regulatory action. See 3 Davis, Administrative Law Treatise § 22.08 (1958).
I submit that if we are to judge and not to legislate policy, we should implement and not contradict the program laid out by the Congress. Congress did not intend that the regulations at issue in this case might be challenged in gross, apart from a specific controversy, or in the district courts, or by injunction or declaratory judgment action. On the contrary, the clear intent was that the regulations, being to protect the consumer from unsafe, potentially harmful, and 'misbranded' foods, drugs, devices, and cosmetics, were to be subject to challenge only by way of defense to enforcement proceedings. It was Congress' judgment, after much controversy, that the special nature of the Act and its administration required this protection against delay and disruption. We should not arrogate to ourselves the power to override this judgment. Not a single case cited by the majority in which agency action was held reviewable arose against this kind of background of legislative hostility to threshold review in the district courts.
The Court is in error, I submit, in its approach to this problem; and, as I shall attempt to show, it is in error in its decision that, even given this permissive approach to the use of judicial injunctive power, these controversies are 'ripe' or appropriate for decision.
I come then to the questions whether the review otherwise available under the statute is 'adequate,' whether the controversies are 'ripe' or appropriate for review in terms of the evaluation of the competing private and public interests. I discuss these together because the questions of adequacy and ripeness or appropriateness for review are interrelated. I again note that no constitutional issues are raised, and, indeed, no issues as to the authority of the agency to issue regulations of the general sort involved. The only issue is whether that authority was properly exercised.
There is, of course, no abstract or mechanical method for determining the adequacy of review provisions. Where personal status or liberties are involved, the courts may well insist upon a considerable ease of challenging administrative orders or regulations. Cf. Rusk v. Cort, 369 U.S. 367, 82 S.Ct. 787, 7 L.Ed.2d 809 (1962); but cf. Heikkila v. Barber, 345 U.S. 229, 73 S.Ct. 603, 97 L.Ed. 972 (1953).13 But in situations where a regulatory scheme designed to protect the public is involved, this Court has held that postponement of the opportunity to obtain judicial relief in the interest of avoiding disruption of the regulatory plan is entirely justifiable. Ewing v. Mytinger & Casselberry, 339 U.S. 594, 70 S.Ct. 870, 94 L.Ed. 1088 (1950); cf. Myers v. Behl ehem Shipbuilding Corp., 303 U.S. 41, 58 S.Ct. 459, 82 L.Ed. 638 (1938).14 The Ewing case dramatically illustrates the point. It involves the same statute and enforcement plan as are now before us. Appellee filed suit in the United States District Court to restrain enforcement of the provision of the Food, Drug, and Cosmetic Act which authorizes multiple seizure of misbranded products. Appellee claimed that the provision was unconstitutional under the Due Process Clause, and that the agency had acted arbitrarily 'in instituting' (through the Attorney General) multiple seizures without affording appellee an opportunity for hearing as to whether there was 'probable cause' for the seizures. A three-judge district court was convened. It held for appellee on both issues and granted an injunction. This Court reversed on the grounds that no hearing is necessary for the administrative determination of probable cause, and that, in any event, the District Court had no jurisdiction to review that determination.15
It is no answer to Ewing to point out, as the Court does, that the precise determination attacked by the plaintiff was that of probable cause for recommending multiple seizures. The important point is that the Court held that the processes of the District Court could not be invoked except in the enforcement action provided by Congress. The following quotation from Mr. Justice Douglas' opinion for the Court demonstrates the controlling force of Ewing in the present case:
'Judicial review of this preliminary phase of the administrative procedure does not fit the statutory scheme nor serve the policy of the Act. Congress made numerous administrative determinations under the Act reviewable by the courts. * * * This highly selective manner in which Congress has provided for judicial review reinforces the inference that the only review of the issue of probable cause which Congress granted was the one provided in the libel suit. Cf. Switchmen's Union of North America v. National Mediation Board, 320 U.S. 297, 305—306, 64 S.Ct. 95, 99, 88 L.Ed. 61. * * * If the District Court can step in, stay the institution of seizures, and bring the administrative regulation to a halt until it hears the case, the public will be denied the speedy protection which Congress provided by multiple seizures.' 339 U.S., at 600—601, 70 S.Ct., at 873.
In Ewing, the company's only recourse was to defend in the seizure actions, availing itself of consolidation of the multiple suits if it so desired. 339 U.S., at 602, 70 S.Ct., at 874. Despite the hardshp and destructive publicity of multiple seizures—a more serious variety of the kind of hardship which seems profoundly to affect the Court in the present cases—this Court refused to hold that the remedy of judicial review by defense in these actions was inadequate. On the contrary, it held that 'Congress weighed the potential injury to the public from misbranded articles against the injury to the purveyor of the article from a temporary interference with its distribution and decided in favor of the speedy, preventive device of multiple seizures.' 339 U.S., at 601, 70 S.Ct., at 874.
I submit that this Court's action in Nos. 39 and 438 sharply departs from Ewing and from the principles of judicial restraint and respect for congressional enactments and administrative agencies which have to this day been fundamental to our jurisprudence. The Court refers in passing to the injunctions here as 'traditional avenues of judicial relief.' But there is nothing 'traditional' about the courts providing injunctive relief against agency action in situations where the Congress has prescribed another avenue which is available to the plaintiffs. Eloquent testimony of this is the paucity of pertinent precedents.
The three decisions of this Court principally relied upon by the majority here are primarily noteworthy for their difference rather than their analogy. In each of them the particular statutory scheme involved expressly provided for the jurisdiction of the court in which the suit was brought. In none of them is the action maintained despite congressional provision of another and different remedy.
Columbia Broadcasting System v. United States, 316 U.S. 407, 62 S.Ct. 1194, 86 L.Ed. 1563 (1942), concerning a regulation promulgated by the FCC which would have refused a license to any station which entered into defined types of network contracts. CBS, a network and not a station licensee, brought an action to enjoin enforcement of the regulation, claiming that it was beyond the Commission's power. The action was brought under § 402(a) of the Communications Act itself (48 Stat. 1093) which makes applicable the provisions of the Urgent Deficiencies Act to 'suits to enforce, enjoin,' etc., any order of the Commission with certain exceptions not here relevant. Thus, the statute itself provided for injunctive action against orders of the Commission. The only problem in the case was whether the particular order was 'reviewable' at all on suit of CBS and, if so, whether the action was premature—not whether the courts might, consistently with the congressional scheme, entertain suit for injunction in proper circumstances, because that was settled by specific provisions in the Act. The Court held that the action could be maintained. And it held that CBS had no adequate alternative remedy. At most, CBS could have intervened in a proceeding controlled by a station applying for a license—if there were such a proceeding.16 The Court therefore held that CBS could challenge the regulation before it was invoked against a licensee. This is a far cry from the present cases in which despite the absence of statutory authorization of district court jurisdiction over the injunctive procedure, and in face of the regulatory design, the manufacturers seek to invoke the courts' general equity power to override what appears to be the studied and deliberate intention of the Congress.
In United States v. Storer Broadcasting Co., 351 U.S. 192, 76 S.Ct. 763, 100 L.Ed. 1081 (1956), the FCC promulgated a rule limiting to five the number of television stations which would be licensed to a single person. The same day it denied, on the basis of the rule, an application by Storer, which owned five stations, for an additional station. Storer appealed, not to the District Court, but to the Court of Appeals, for review of the Commission's rulemaking order. The Court of Appeal h ad jurisdiction by specific statutory provision to entertain petitions to review final orders of the Commission upon application of '(a)ny party aggrieved.' 64 Stat. 1130, 5 U.S.C. § 1034. This Court held that Storer had standing to maintain the petition for review, that the rule was a 'final order' for review purposes and that the controversy with respect to the limitation rule was 'ripe' for review. Again, the important point to note is that the case did not involve the assertion of district court jurisdiction in the absence of statute, or the overriding of administrative design or congressional intent. Storer utilized a procedure expressly made available by the statute. It sought review in the Court of Appeals where the Commission action was reviewed on the basis specified by statute, including the weight given to the agency findings and record. It did not commence a separate action, not provided for in the statute, in which the District Court's original jurisdiction was invoked. Storer, in brief, involves an action pursuant to the statute, and not in conflict with its plan as is true of the present cases.
The third case is Frozen Food Express v. United States, 351 U.S. 40, 76 S.Ct. 569, 100 L.Ed. 910 (1956). The ICC issued an order, after investigation and hearing, listing commodities which it found not to be 'agricultural' for purposes of an exemption from the requirement of obtaining a certificate of convenience and necessity under the Interstate Commerce Act. A motor carrier sued in the United States District Court to enjoin and set aside the Commission's order. The statute under which the suit was brought expressly gives the district courts jurisdiction to enjoin, etc., 'any order of the Interstate Commerce Commission.' 28 U.S.C. § 1336. Accordingly, here, too, there was no question of the courts furnishing a forum which the regulatory statute did not provide. This case, like Columbia Broadcasting and Storer, supra, therefore, does not touch the key problem of the instant cases. It is relevant only on the issue of 'ripeness'—an intensely particularized inquiry involving considerations which, as I shall discuss, should lead to rejection of the instant actions.17
Considering the impact of these three cases on the problem of 'ripeness' in the instant cases, I first note that each of these three cases is, in effect, two-dimensional. The meaning, effect, and impact of the accused rule or decision are clear, simple, and obvious. None is part of the warp and woof of an elaborate administrative pattern, intimately woven into the congressional design. None of them is apt to take different shape or to be modified by practical administrative action. None of them is subject to the give-and-take of the administrative process as it works, for example, in the realities of the complex world of food, drug, and cosmetic regulation. None of them is subject to exception upon application. None of them depends upon the independent judgment of the Attorney General for enforcement. These are stark, simple, two-dimensional regulations which do not depend upon the specifics of a particular situation for judgment as to their consonance with statutory authority nor are they subject to change in the process of administrative application. In short, in the three cases the courts proceeded within the procedural framework enacted by Congress, and the circumstances were such that the courts could make a sensible, realistic judgment as to whether the administrative rule matched the statutory authority.18 These factors are entirely absent in the present cases. Analysis of the regulations in the present cases will, I believe, demonstrate the point.
In No. 336 (involving the regulation requiring 'free access' to plants, processes, and formulae with respect to all 'color additives') the Court concludes 'that the legal issue as presently framed is not appropriate for judicial resolution.' It bases its conclusion upon two factors: (1) that the Secretary may or may not order inspection, and, if denied access, he may or may not decide to use the authority of the regulation to withdraw or suspend certification without which the manufacturer may not continue his business in the products; and (2) that judgment as to whether the regulation is authorized depends upon an understanding of the types of enforcement problems encountered by FDA, the need for supervision and the safeguards devised to protect legitimate trade secrets. The Court also says that it is an adequate remedy for the manufacturer to defer challenge until after access is demanded and denied and further certification services by the agency are suspended. The suspension of certification services means a shutdown, at least pro tanto, but the Court says, with an optimism which is probably not shared by the industry, that 'prompt' challenge through administrative procedure and court review can then be had.
Precisely the same considerations demonstrate, I submit, that the regulations in No. 39 and No. 438 should similarly be immune from attack in these suits. In No. 438, the accused regulations were also issued under § 701(a), the general power to promulgate regulations for the efficient administration of the Act, specifically the 1960 amendments to promote 'safety-in-use' of color additives. As the Court states, by the regulations in No. 438 the Commissioner 'amplified the statutory definition' of color additives to include diluents and certain cosmetics and hair dyes. By provisions in the statute, 74 Stat. 399, 21 U.S.C. § 376(a)(1)(A), a product containing a 'color additive' shall be deemed 'adulterated' unless the color additive and its proposed use have been submitted to FDA, tested and listed in an FDA regulation as safe and unless the particular additive comes from a certified batch, or has been exempted from certification. Distribution of a product without compliance runs the risk of seizure, injunction, or criminal prosecution upon action of the Attorney General. Again, there is no question that the Commissioner could refine and 'amplify' the definition of 'color additives.' The argument is whether he could do it in this particular way, to include these particular items.
Now, with all respect I submit that this controversy is clearly, transparently, and obviously unsuited to adjudication by the courts in limine or divorced from a particular controversy. Every reason advanced in No. 336 (the 'excess' regulation) is applicable here with equal or greater force to repel this effort to secure judicial review at this stage. (1) In No. 336, the Court pointed out that the Commissioner might or might not demand access and withdraw certification in a particular case. Similarly, in the present case it is impossible to ascertain at this stage how and whether in a particular situation the regulation will apply to that situation. First and most obvious is the fact that any manufacturer may apply for an exemption from the regulation if, as applied to his particular situation, it is unfair or unduly burdensome or—more significantly—if it falls outside of the statutory intendment. And even more than in the case of the access regulation, the definitional regulation is not self-enforcing. Indeed, in respect of the access regulation the Commissioner may resort to a measure of self-help by withholding certification services, whereas if the FDA wishes to take action against a manufacturer who refuses to submit a 'color additive' to the agency on the ground that it is not ov ered, the agency must institute an independent proceeding in court which it can do only if the Attorney General agrees with its conclusions.
(2) In No. 336, the Court was influenced by the obvious fact that adjudication of the legality of the access regulation requires an understanding of the enforcement problems of the agency and the actual needs for supervision. I agree. But I respectfully suggest that if this is true of a simple investigatory and enforcement regulation like that requiring access to plants and processes, it is much more compelling in respect of a complex regulation defining 'color additives.' How, for example, can a court possibly judge whether a substance should be included in the definition outside of the context of a specific controversy and in the absence of detailed information as to the agency problem?
The Court, however, describes the issue in No. 438 as 'a straightforward legal one: what general classifications of ingredients fall within the coverage of the Color Additive Amendments?' The Court says that 'this is not a situation in which consideration of the underlying legal issues would necessarily be facilitated if they were raised in the context of a specific attempt to enforce the regulations.' With all respect, these statements are totally divorced from reality. For example, the statute itself includes within the definition of a 'color additive' any 'other substance' which 'when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting color thereto.' § 201(t)(1), 74 Stat. 397, 21 U.S.C. § 321(t)(1). Can it be seriously contended that the question, for example whether a particular diluent—solvent or substance serving to dilute—meets this definition is 'a straightforward legal one,' decision of which would not 'necessarily be facilitated' if raised in specific context? I note that the Court recognizes the frailty of its pronouncement in a footnote in which it says that 'If in the course of further proceedings the District Court is persuaded that technical questions are raised that require a more concrete setting for proper adjudication, a different issue will be presented'! But I submit, with respect, that this question which, even standing alone, would dictate our rejection of the action in No. 438, can and must be faced, here and now; and the answer to it is clear and obvious. It is clear beyond question, merely on the basis of the nature of the agency action, that these regulations on their face raise questions which should not be adjudicated in the abstract and in the general, but which require a 'concrete setting' for determination. A threshold injunction is entirely unsuitable in these circumstances. It places the administration of a public-safety statute at the mercy of counsel's ability to marshall and deploy horrible examples which logic may accommodate, but the reality of administration would repel. Our training as lawyers and judges, our respect for the administrative process, and our awareness of the complexities of life should warn us not to fall into the trap of abstract, generalized, gross review.
The regulation in No. 39 relates to a 1962 amendment to the Act requiring manufacturers of prescription drugs to print on the labels or other printed material, the 'established name' of the drug 'prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug.' § 502(e)(1), 76 Stat. 790, 21 U.S.C. § 352(e)(1). Obviously, this requires some elucidation, either case-by-case or by general regulation or pronouncement, because the statute does not say that this must be done 'every time,' or only once on each label or in each pamphlet, or once per panel, etc., or that it must be done differently on labels than on circulars, or doctors' literature than on directions to the patients, etc. This is exactly the traditional purpose and function of an ami nistrative agency. The Commissioner, acting by delegation from the Secretary, took steps to provide for the specification. He invited and considered comments and then issued a regulation requiring that the 'established name' appear every time the proprietary name is used. A manufacturer—or other person who violates this regulation—has mislabeled his product. The product may be seized; or injunction may be sought; or the mislabeler may be criminally prosecuted. In any of these actions he may challenge the regulation and obtain a judicial determination.
The Court, however, moved by petitioners' claims as to the expense and inconvenience of compliance and the risks of deferring challenge by noncompliance, decrees that the manufacturers may have their suit for injunction at this time and reverses the Third Circuit. The Court says that this confronts the manufacturer with a 'real dilemma.' But the fact of the matter is that the dilemma is no more than citizens face in connection with countless statutes and with the rules of the SEC, FTC, FCC, ICC, and other regulatory agencies. This has not heretofore been regarded as a basis for injunctive relief unless Congress has so provided. The overriding fact here is—or should be—that the public interest in avoiding the delay in implementing Congress' program far outweighs the private interest; and that the private interest which has so impressed the Court is no more than that which exists in respect of most regulatory statutes or agency rules. Somehow, the Court has concluded that the damage to petitioners if they have to engage in the required redesign and reprint of their labels and printed materials without threshold review outweighs the damage to the public of deferring during the tedious months and years of litigation a cure for the possible danger and asserted deceit of peddling plain medicine under fancy trademarks and for fancy prices which, rightly or wrongly, impelled the Congress to enact this legislation. I submit that a much stronger showing is necessary than the expense and trouble of compliance and the risk of defiance. Actually, if the Court refused to permit this shotgun assault, experience and reasonably sophisticated common sense show that there would be orderly compliance without the disaster so dramatically predicted by the industry, reasonable adjustments by the agency in real hardship cases, and where extreme intransigence involving substantial violations occurred, enforcement actions in which legality of the regulation would be tested in specific, concrete situations. I respectfully submit that this would be the correct and appropriate result. Our refusal to respond to the vastly overdrawn cries of distress would reflect not only healthy skepticism, but our regard for a proper relationship between the courts on the one hand and Congress and the administrative agencies on the other. It would represent a reasonable solicitude for the purposes and programs of the Congress. And it would reflect appropriate modesty as to the competence of the courts. The courts cannot properly—and should not—attempt to judge in the abstract and generally whether this regulation is within the statutory scheme. Judgment as to the 'every time' regulation should be made only in light of specific situations, and it may differ depending upon whether the FDA seeks to enforce it as to doctors' circulars, pamphlets for patients, labels, etc.
I submit, therefore, that this invitation to the courts to rule upon the legality of these regulations in these actions for injunction and declaratory relief should be firmly rejected. There is nothing here approaching the stringent showing that should be required before the courts will undertake to provide a remedy that Congress has not authorized but which, on the contrary, it has deliberately declined to afford. Those challenging the regulations have a remedy and there are no special reasons to relieve them of the necessity of deferring their challenge to the regulations uti l enforcement is undertaken. In this way, and only in this way, will the administrative process have an opportunity to function—to iron out differences, to accommodate special problems, to grant exemptions, etc. The courts do not and should not pass on these complex problems in the abstract and the general—because these regulations peculiarly depend for their quality and substance upon the facts of particular situations. We should confine ourselves—as our jurisprudence dictates—to actual, specific, particularized cases and controversies, in substance as well as in technical analysis. And we should repel these attacks, for we have no warrant and no reason to place these programs, essential to the public interest, and many others which this Court's action today will affect, at the peril of disruption by injunctive orders which can be issued by a single district judge. In short, the parties have an 'adequate remedy' to test the regulations; these controversies are not 'ripe' for judicial decision; and it is not appropriate that the courts should respond to the call for this private relief at disproportionate burden to the public interest. With all respect, we should refuse to accept the invitation to abandon the traditional insistence of the courts upon specific, concrete facts, and instead entertain this massive onslaught in which it will be utterly impossible to make the kind of discrete judgments which are within judicial competence. With all respect we should not permit the administration of a law of the Congress to be disrupted by this non-adjudicable mass assault.
We use 'necessarily' advisedly, because this case arises on a motion to dismiss. The District Court also denied respondents' motion for summary judgment, and called for an evidentiary hearing. If in the course of further proceedings the District Court is persuaded that technical questions are raised that require a more concrete setting for proper adjudication, a different issue will be presented.
The Court of Appeals observed that 'Very likely these figures are exaggerated * * *.' 360 F.2d, at 682, n. 5. The District Court stated that 'While this amount is immediately suspect, there can be little doubt but that the added records-keeping and laboratory testing costs in themselves will be extremely burdensome for all of the plaintiffs.' 235 F.Supp. 648, 652. (Footnote omitted.)
378, 5 U.S.C. §§ 701—704 (1964 ed., Supp. II).
See St. Joseph Stock Yards Co. v. United States, 298 U.S. 38, 84, 56 S.Ct. 720, 740, 80 L.Ed. 1033 (1936) (concurring opinion of Mr. Justice Brandeis). Hart & Wechsler, The Federal Courts and the Federal System 312—340 (1953). Compare, 4 Davis, Administrative Law Treatise § 28.18 (1958).
See Ewing v. Mytinger & Casselberry, 339 U.S. 594, 601, 70 S.Ct. 870, 874, 94 L.Ed. 1088 (1950).
21 U.S.C. § 371(e) refers only to regulations under § 401, 52 Stat. 1046, as amended, 21 U.S.C. § 341 (identity and quality standards for food), § 403(j), 52 Stat. 1048, as amended, 21 U.S.C. § 343(j) (misbranded food purporting to serve special dietary purposes), § 404(a), 52 Stat. 1048, as amended, 21 U.S.C. § 344(a) (conditions imposed on manufacture of food as the result of health requirements), § 406, 52 Stat. 1049, as amended, 21 U.S.C. § 346 (tolerances for pesticides), § 501(b), 52 Stat. 1049, as amended, 21 U.S.C. § 351(b) (deviations from strength, quality, or purity standards, for drugs), § 502(d), 52 Stat. 1050, as amended, 21 U.S.C. § 352(d) (warnings with respect to habit-forming drugs), and § 502(h), 52 Stat. 1051, as amended, 21 U.S.C. § 352(h) (packing and labeling of deteriorative drugs). In addition, particular sections expressly incorporate the §§ 371(f) and (g) procedures: § 506, 55 Stat. 851, as amended, 21 U.S.C. § 356 (certain portions of regulations pertaining t c ertification of drugs containing insulin), § 507, 59 Stat. 463, as amended, 21 U.S.C. § 357 (with respect to regulations dealing with antibiotic drugs). Finally, § 505(h), 52 Stat. 1053, as amended, 21 U.S.C. § 355(h) provides that denials of certification for new drugs may be reviewed in the courts of appeals.
The saving clause, subdivision (6) of subsection (f), specifically and carefully refers to the 'remedies provided for in this subsection.' (Emphasis added.) Its wording and placement would be anomalous if the saving clause were intended to have general applicability. The legislative history of the saving clause, and particularly the failure of more broadly conceived provisions to obtain acceptance by the Congress, corroborates the evidence of the clause's ultimate language and position that it was to have restricted application. See Dunn, Federal Food, Drug, and Cosmetic Act, A Statement of Its Legislative Record 184, 225, 609—610 (1938) (hereinafter cited as Dunn).
Contrary to the majority's contention, the reason for the clause and for its location in subsection (f) is clear and common-sensical. It was intended to save the remedies of injunction and declaratory judgment where the agency promulgated a subsection (e) regulation without the hearings and findings needed to permit review in the Court of Appeals. In short, as its placement indicates, it was intended to complete the scheme of pre-effectiveness review as to those carefully enumerated regulations with respect to which Congress deemed pre-enforcement review to be advisable. It has no broader application.
It will come as a shock to the agency, Congress, and practitioners, that for almost 30 years this undetected, omnibus 'saving clause' has slumbered in the Act.
Section 23 of S. 2800, introduced in the 73d Cong., 2d Sess. (1934), for example, was such a provision and was expressly discussed on the floor of the Senate. 78 Cong.Rec. 8958—8959 (1934); Dunn 157—159. A successor bill, S. 5, 74th Cong., 1st Sess. (1935), contained a similar provision, § 702, and was approved by the Senate. 79 Cong.Rec. 8356 (1935). See Dunn 330 331, 510.
H.R.Rep. No. 2139, 75th Cong., 3d Sess. (1938).
Id., Pt. II (minority statement).
H.R.Conf.Rep. No. 2716, 75th Cong., 3d Sess. (1938).
The 'every time' regulation was published about four years ago, on June 20, 1963, 28 Fed.Reg. 6375. As a result of litigation begun in September of 1963, it has not yet been put into force. The 'definition' regulations and the 'access' regulation with respect to color additives were published on June 22, 1963, 28 Fed.Reg. 6439, 6446. Litigation was begun in November of 1963, and the regulations are not yet operative.
As to the other nonpersonal liberty cases cited by the Court: In Shields v. Utah Idaho Central R. Co., 305 U.S. 177, 59 S.Ct. 160, 83 L.Ed. 111 (1938), the Government did not oppose resort to the injunction remedy, and the Court enumerated special cicumstances why that remedy was peculiarly needed. Id., at 183 184, 59 S.Ct., at 163—164. And in Stark v. Wickard, 321 U.S. 288, 64 S.Ct. 559, 88 L.Ed. 733 (1944), the Court noted that the aggrieved parties had no other forum in which to contest the order in question, and it found 'plain' evidence of a congressional intent to allow review.
Indeed, Congressman Lea, principal floor manager for the bill which became the 1938 Act, told his colleagues that the review provisions of the new bill were not retroactive, and that pre-existing regulations were therefore unreviewable unless re-enacted. 83 Cong.Rec. 7776-7777 (1938).
See, Jaffe, Judicial Control of Administrative Action 372.
In Ewing, 339 U.S., at 599, 70 S.Ct., at 873, a case under the Federal Food, Drug, and Cosmetic Act, the Court held 'it is not a requirement of due process that there be judicial inquiry before discretion can be exercised. It is sufficient, where only property rights are concerned, that there is at some stage an opportunity for a hearing and a judicial determination. Phillips v. Comissioner of Internal Revenue, 283 U.S. 589, 596—597, 51 S.Ct. 608, 611, 75 L.Ed. 1289; Bowles v. Willingham, 321 U.S. 503, 520, 64 S.Ct. 641, 650, 88 L.Ed. 892; Yakus v. United States, 321 U.S. 414, 442—443, 64 S.Ct. 660, 675, 676, 88 L.Ed. 834.'
Where Congress has created a right but provided no avenue for judicial protection against its obliteration, suit for injunctive relief may be available under 28 U.S.C. § 1337, relating to proceedings 'arising under any Act of Congress regulating commerce or protecting trade and commerce against restraints and monopolies.' See Leedom v. Kyne, 358 U.S. 184, 79 S.Ct. 180, 3 L.Ed.2d 210 (1958), where this Court authorized suit in the district courts to set aside an NLRB certification of a bargaining unit in which the Board had included both supervisory and nonsupervisory personnel—concededly without authority of statute. But cf. Switchmen's Union of North America v. National Mediation Board, 320 U.S. 297, 64 S.Ct. 95 (1943).
As a leading commentator has noted, the basic issue was that of CBS' standing. Jaffe, op. cit. supra, at 394.
Mr. Justice Harlan dissented in Frozen Food Express on the ground that 'the case falls squarely within those carefully developed rules which require that judicial intervention be withheld until administrative action has reached its complete development.' 351 U.S. at 45, 76 S.Ct., at 572.
Although Frozen Fod Express involved problems of definition, they were not comparable to the complex, subtle, technical considerations involved in the 'definition' or 'every time' regulations here.


text: Look for double the mobile exploits this year vs. 2010 and particularly watch out for mobile applications that are really malware, says IBM's X-Force security research team.Those are two warnings from the "X-Force 2011 Mid-Year Trend and Risk Report", which says that mobile application markets are a haven for malware.Exploits of mobile operating systems will go from 18 in 2009 to about 35 by the end of 2011, the report says, as the number of vulnerabilities will go from about 65 to more than 180 over the same period.MOBILE THREAT"The first half of 2011 saw an increased level of malware activity targeting the latest generation of smart devices, as attackers are finally warming to the opportunities these devices represent," the new report says.The report uses Android devices as an example, and notes that since the operating system is open, many developers write applications to it. Some of these apps are malicious, so users should be careful which ones they choose and where they get them from. "One of the most popular and effective ways to distribute Android malware is through application markets. Besides Google's own official market, there are many unofficial third-party markets," the report says.Another problem with mobile devices, particularly phones, is that users are at the mercy of their phone manufacturer to patch known operating system vulnerabilities. Known vulnerabilities may go unpatched, not because patches don't exist, but because they aren't provided by individual phone makers. "Many mobile phone vendors don't push out security updates for their devices," the report says.Network defenders face a growing threat from weaknesses in software. These weaknesses are assessed via Common Vulnerability Scoring System (CVSS), with those scoring 10 out of 10 deemed critical. The percentage of critical vulnerabilities has jumped in the first halfof 2011 vs all of 2010 from 1% to 3%.That's still a small percentage, but it is triple last year. And the actual number of critical vulnerabilities so far this year is already larger than last, the report says. "Almost every one of these critical vulnerabilities is a serious remote code execution issue impacting an important enterprise class software product," the according to the report.Vulnerabilities are getting more concentrated among fewer vendors, the study finds. In 2009, the 10 software companies with the most reported vulnerabilities accounted for a quarter of all the vulnerabilities reported. This year so far, that number has jumped to a third (34%). IBM X-Force didn't name the top 10. "The bottom line is that enterprise IT staff are spending just as much, if not more time installing patches this year as they have in the past," the report says.The report does point out some bright spots:* Web application vulnerabilities dropped from 49% of all disclosures to 37%, the first decline in five years.* Vulnerabilities ranked high and critical are at a four-year low.* Spam and traditional phishing are declining.Read more about wide area network in Network World's Wide Area Network section.

subset: commoncrawl


text:
If your PC displays errors about the clock or CMOS when starting the PC, the CMOS battery on the motherboard probably needs to be replaced.
Desktop PCs use a battery to keep time when the they are off, much like a watch. Like a watch, the battery needs to be replaced when it runs low on power. Replace the battery using the steps below.
Show me how
warning:The edges of metal panels can cut skin. Be careful not to slide skin along any interior metal edge of the computer.
caution:This product contains components that can be damaged by electrostatic discharge (ESD). To reduce the chance of ESD damage, work over a non-carpeted floor, use a static dissipative work surface (such as a conductive foam pad), and wear an ESD wrist strap connected to a grounded surface.
note:Print this document for reference while working on the PC.
Unplug all cables except for the power. Write down each cable location if you do not already know where it connects.
Unplug the power cable and with the power cable removed press the Power button on the front of the PC.
note:Your PC may look different than the images used in this document. The steps and images used in this document can be applied to most PC case designs. If opening the case or accessing the battery is difficult, refer to the Upgrading and Servicing Guide for your PC. If available, Upgrading and Servicing Guides can be downloaded from the manuals section of your PC support page.
Remove the screws on the rear of the PC.
Slide the side panel off from the rear of the PC.
Locate the battery. It is a small shiny round metal wafer (like a larger version of a watch battery).
Remember which direction the battery is installed. Usually the engraved side, the positive side, is face up. Remove the battery from the main board.Example 1Example 2
Call a local computer supply store to see if a replacement is available. Use the inscriptions on the battery to answer any questions that the computer supply store may ask.
Acquire the battery and replace it in the same socket it was removed from. Make sure the new battery is installed in exactly the same orientation as the previous battery.
warning:There is danger of explosion if the battery is not correctly replaced! Replace only with the same (or equivalent) type of battery.
Replace a side panel by matching the side panel tabs with the tab openings in the case.
Insert the side panel and slide it forward.
Fasten the screws to secure the side panel.
Connect all cables and turn on the PC to set the time.


text:
OCEAN CITY – Spring showers bring May flowers or just flooding in Ocean City's case. The University of Maryland Environmental Finance Center is about half way through its study of the town's stormwater infrastructure and presented preliminary recommendations to the Mayor and City Council this week.
According to Gail Blazer, the town last year received a grant from the Department of Natural Resources to research the feasibility to develop a stormwater utility for the town.
Environmental Finance Center at the University of Maryland Director Joanne Throwe presented the council with an update on the study, which began last October.
"It is such a beautiful town but you're taking care of waste water, you're taking care of your drinking water, but it seems to be that storm water falls off the radar," Throwe said. "It is one of those unseen problems that doesn't get the visibility and so the opportunity to help Ocean City and look at ways to possibly pay for stormwater infrastructure."
According to Throwe the project's purpose is to develop recommendations for a sustainable way to pay for a stormwater management program for the town. The town's budget does not include dedicated funding for stormwater management activities. Funds are currently being drawn on an as-need basis from the maintenance and wastewater budgets. There are gaps in the current stormwater management strategy that have led to public health, economic, and safety concerns, she said.
"This is an education for many people involved in this project and for many people in the community as well," Throwe said. "They see stormwater as what waste water is in this community. They think it goes to a waste water treatment plant. This goes right directly into the bay."
The study's purpose is to address the public health, economic and safety concerns, which include an aging conveyance system, flooding, water pollution and inadequate system maintenance. Those concerns can be addressed if the town is able to embrace alternative strategies for financing stormwater management.
The study has taken the opportunity to address the public as much as possible and their concerns. They have conducted key interviews and meetings with community members, such as, public outreach meetings, the Chamber of Commerce, large and small commercial businesses, Ocean City town officials, Worcester County officials, the Economic Development Committee and the Coastal Bays Program.
"We're not going to be able to address all the flooding problems obviously but by having a dedicated revenue system we will be able to address some of the problems," Throwe said.
The study's team has also conducted in-person and over-the-phone interviews with communities that implemented a stormwater utility such as Lewes, Del., and Virginia Beach, Va.
In Lewes, a stormwater utility fee was established in 2010. The fee runs residents $5 a month, commercial businesses $10 a month, and industries $20 a month. The fee generates $200,000 per year.
Preliminary recommendations include installing a stormwater utility fee for Ocean City. The town is looking at a total revenue needed of approximately $1.3 million a year and $10 million over the next 10 years for stormwater management. A potential residential fee would be anywhere from $2 to $5 a month. Commercial property fees could be based on an ERU which equals 2,500 square feet. Per ERU a fee could be placed of $2 to $5 as well, with 25 ERU's set as a maximum.
According to Throwe, "Ocean City has a better than average chance of having a dedicated stormwater revenue stream because of the commitment and support of a dedicated town staff, a well-informed city council, and an engaged public who understand the pressing need for funding and the potential results of inaction."
"I'm totally sold on the fact that it is a problem and we need to do something about it," Councilman Joe Hall said. "The problem is creating a new revenue source and saying to the people this is something that is going to work, we are going to be effective."
Throwe responded that one of the reasons for the potential revenue source would be an operations and maintenance program.
"This is a fee it's not a tax," she said. "A fee offers services and what we're covering would be a much better maintenance program…we could do so much with a steady revenue stream."
City Engineer Terry McGean said most of the funds would be used for the maintenance of Ocean City's existing conveyance system.
"We have almost 75,000 of linear feet of corrugated metal storm drain piping that is over 20 years old in the city," he said. "It has not been holding up very well, and we are seeing more and more of these pipes fail."
Joe Hall asked why stormwater revenue couldn't be added to an existing utility such as the wastewater utility fee.
"The concern would be if you tie it to wastewater it's going to go to wastewater," Throwe said. "You really do need to create something dedicated to just stormwater."
Council Secretary Lloyd Martin said there are different aspects that still need to be looked at, for example the different sizes of residential homes and how it would relate to residential fees. He said there is no way the council could make a decision that day, especially sense the study is only half way done.


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David Baltimore
Our editors will review what you've submitted and determine whether to revise the article.
- Born:
- March 7, 1938 (age 85) New York City New York
- Awards And Honors:
- Nobel Prize (1975)
- Subjects Of Study:
- cancer oncogenic virus retrovirus reverse transcriptase transcription
David Baltimore, (born March 7, 1938, New York, New York, U.S.), American virologist who shared the Nobel Prize for Physiology or Medicine in 1975 with Howard M. Temin and Renato Dulbecco. Working independently, Baltimore and Temin discovered reverse transcriptase, an enzyme that synthesizes DNA from RNA. Baltimore also conducted research that led to an understanding of the interaction between viruses and the genetic material of the cell. The research of all three men contributed to an understanding of the role of viruses in the development of cancer.
Baltimore and Temin both studied the process by which certain tumour-causing RNA viruses (those whose genetic material is composed of RNA) replicate after they infect a cell. They simultaneously demonstrated that these RNA viruses, now called retroviruses, contain the blueprint for an unusual enzyme—a polymerase called reverse transcriptase—that copies DNA from an RNA template. The newly formed viral DNA then integrates into the infected host cell, an event that can transform the infected cell into a cancer cell.
Baltimore received an undergraduate degree in chemistry from Swarthmore College, Pennsylvania (B.A., 1960), and went on to study animal virology at the Rockefeller Institute (now Rockefeller University) in New York City, where he obtained a doctorate in 1964, and at the Massachusetts Institute of Technology (MIT) in Boston. He worked with Dulbecco at the Salk Institute in La Jolla, California (1965–68), studying the mechanism of replication of the poliovirus.
Baltimore joined the faculty of MIT in 1968, accompanied by Alice Huang, a postdoctoral fellow who had worked on vesicular stomatitus virus (VSV) at the Salk Institute. In Boston, Baltimore and Huang, who had married, showed that VSV, an RNA virus, reproduced itself by means of an unusual enzyme (an RNA-dependent RNA polymerase) that copies RNA by a process not involving DNA.
Baltimore then turned his attention to two RNA tumour viruses—Rauscher murine leukemia virus and Rous sarcoma virus—to discover whether a similar enzyme was at work in their replication. It was through these experiments that he discovered reverse transcriptase. This discovery proved an exception to the "central dogma" of genetic theory, which states that the information encoded in genes always flows unidirectionally from DNA to RNA (and thence to proteins) and cannot be reversed. Since its discovery, reverse transcriptase has become an invaluable tool in recombinant DNA technology.
Baltimore became director of the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts, in 1983 and in 1990 left to become president of Rockefeller University. In 1989 he figured prominently in a public dispute over a 1986 paper published in the journal Cell that he had coauthored while still at MIT. The coauthor of the article, Thereza Imanishi-Kari, was accused of falsifying data published in the paper. Baltimore, who was not included in charges of misconduct, stood behind Imanishi-Kari, although he did retract the article. Because of his involvement in the case, however, he was asked to resign as president of Rockefeller University, and in 1994 he returned to MIT. In 1996 a U.S. government panel cleared Imanishi-Kari of the charges of scientific misconduct. The case was analyzed in The Baltimore Case (1998) by Daniel Kevles.
Baltimore was president of the California Institute of Technology from 1997 to 2006, when he was elected to a three-year term as president of the American Association for the Advancement of Science (AAAS). Among his other appointments, he served as a member of the Encyclopædia Britannica Editorial Board of Advisors.


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Committed to assisting research and academic libraries in the continuous improvement of management sys-
tems, ARL has worked since 1970 to gather and disseminate the best practices for library needs. As part of
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What are SPEC Kits?
Published six times per year, SPEC Kits contain the most valuable, up-to-date information on the latest issues of
concern to libraries and librarians today. They are the result of a systematic survey of ARL member libraries on
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survey results; survey questions with tallies and selected comments; the best representative documents from
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SPEC Kits can be ordered directly from the ARL Publications Distribution Center. To order, call (301) 362-8196,
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Information on SPEC Kits and the SPEC survey program can be found at http://www.arl.org/resources/pubs/
spec/index.shtml. The executive summary for each kit after December 1993 can be accessed free of charge at


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Mitsubishi Electric Can Display the Cloud with WD390U-EST Extreme Short Throw Projector Shown at FETC Education Conference in Orlando
No Computer Needed – Simple, Easy Connectivity Transforms Education and Presentation Market While Saving Customers Time and Money
ORLANDO, Fla., January 28, 2013 —As one of the world's leading display manufacturers, Mitsubishi Electric is the first to take projection to the next level with its WD390U-EST projector: now content can be presented with no computer attached. Shown for the first time at the Florida Educational Technology Conference in Orlando, January 29-31, 2013 in Booth #1113, the Mitsubishi WD390U-EST cloud projector is poised to change the way users select a projector for their classrooms.
Called a "cloud projector," the Mitsubishi WD390U-EST uses its built-in, thin client function to serve as a dynamic display device. And because a computer isn't needed for new builds or technology upgrades, school districts and businesses adapting this new kind of projector can save money in these tough economic times.
Projector industry experts recognize the exceptional benefits this new technology offers: "By making it easy to get a document from your networked computer, server, smart phone, or other mobile device to the projection screen, the WD390U-EST provides PC-free projection that is both comprehensive and easy to use," said Bill Livolsi, Associate Editor, Projector Central.
Users simply log onto their network and begin displaying content in seconds, whether from a local server, the internet or the cloud, giving teachers and presenters access to files through the projector itself. As long as the new WD390U-EST extreme short throw projector is connected and logged on to a network, a Bluetooth-enabled keyboard and mouse, users can access content on a server, with such storage now referred to as "cloud content."
No-fuss projection also means teachers don't have to lug computers around, connect a computer to a projector and hope there are no technical issues, or carry presentation materials with them. School districts can store and distribute standardized teaching materials and content, and teachers can access these course materials in a snap, saving time for both teachers and IT professionals.
"Teachers have a unique set of issues when they present in the classroom and shouldn't have to worry about technical problems when uploading their lessons or run late because of technical difficulties," said Wayne Kozuki, product manager, Mitsubishi Electric Visual Solutions America, Inc. "Our new WD390U-EST solves all those problems by making it really easy—teachers simply log on to the network, access their lessons and begin. This also is a great benefit for standardizing instructional technology and materials on a school-wide or district level. It's the logical next step in presentation technology."
By using free SidePad and WiFi Doc applications, the WD390U-EST projector also supports BYOD (Bring Your Own Display) initiatives with flexibility. Teachers and presenters can use a mobile device such as a tablet or a smart phone to access, mirror and control a computer that is connected to the projector and the same Wi-Fi network, and present Powerpoint®, Excel®, Word®, TXT, PPD and JPG files from their iOS or Android devices directly through the projector. For the first time, presenters are untethered from their computers and can control and present from any location within the classroom or meeting space. Both the SidePad and Wifi Doc apps are free downloads via the Apple® App store or Google Play.
Using Texas Instruments DLP® technology, the new projector boasts 3000 lumens of brightness as well as one of the longest estimated lamp lives available – up to 6000* hours in low mode. And in a continued nod to cost savings, a high-power, 10-watt speaker with variable audio output is built in so even when the projector is in stand-by mode, the speaker can still be used, eliminating the cost and necessity of external amplifiers and speakers.
Mitsubishi's WD390U-EST projector is built with a specially crafted lens that provides excellent ultra short-throw focus performance, and can project a 70-inch (diagonal) wide-screen WXGA image from less than 23-inches away. Teachers and presenters can move in front of the image without creating distracting shadows on the screen.
The WD390U-EST offers HDMI™ support as well as easy set-up options for multiple video inputs. It has an RS232 connector and a built-in RJ45 input that offers plug-and-play connectivity with third-party remote management products such as those made by Crestron and AMX, as well as Mitsubishi's ProjectorView™ Global+.
The projector comes with Mitsubishi's three-year limited warranty on parts and labor, and a one-year limited warranty on the lamp; terms and conditions apply. Like all Mitsubishi data projectors, these new projectors are covered by the Express Replacement Assistance (ERA) Program, a comprehensive nationwide service that offers next business-day replacement** for down units that are under warranty.
"Mitsubishi continues to bring new technological innovation to its products," said James Chan, vice president, marketing, Mitsubishi Electric Visual Solutions America, Inc. "This new cloud projector is just the latest in a long line of Mitsubishi firsts."
The Mitsubishi WD390U-EST will be available in March at a competitive price. Additional models will be announced throughout the first half of 2013.
About Mitsubishi Electric Visual Solutions America, Inc. Headquartered in Irvine, Calif., Mitsubishi Electric Visual Solutions America, Inc. is a US subsidiary of Mitsubishi Electric Corporation of Tokyo, Japan. Mitsubishi Electric Visual Solutions America manufactures and markets projectors, data wall display systems, LCD digital signage monitors and players, industrial printers, photo kiosks and digital photo printers.
# # #
*For an explanation of how this estimate was calculated, visit http://www.mitsubishi-presentations.com/wp-content/files_mf/lamp_and_lamp_life_document_v09132009.pdf. This estimate does not extend or otherwise modify the warranty for the lamp.
**Where applicable.
ProjectorView is a trademark of Mitsubishi Electric. DLP is a registered trademark of Texas Instruments. Other names are trademarks of their respective owners.


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President Barack Obama had a dinner date last week with a dozen of his worst enemies, thus proving that the governmental stalemate in Washington, D.C., is driving him to unusual acts of political creativity -- or desperation.
The president personally picked up the tab for the private dinner at the Jefferson Hotel, and the guests were all Republican senators, including John McCain (Ariz.), Lindsey Graham (S.C.), Tom Coburn (Okla.), Bob Corker (Tenn.), Kelly Ayotte (N.H.), Dan Coats (Ind.), Richard Burr (N.C.), Mike Johanns (Neb.), Pat Toomey (Pa.), Ron Johnson (Wis.), John Hoeven (N.D.) and Saxby Chambliss (Ga.).
Coming out of hotel after the two-hour meal, the senators had nothing but nice things to say about the gathering. Most of the dinner discussion was about the deficit and budget issues, one unidentified senator told CNN. That might make a few Democrats uneasy, fearing Mr. Obama may be opening the way to a deal that will trade away too much, but senators who supped with the president indicated there is still a long way to go before anyone gives up anything. Nevertheless, one of the senators told CNN he and his colleagues saw a sincerity in Mr. Obama they had not perceived before and the result was "a very positive meeting."
This week, Mr. Obama is scheduled to have lunch at the capitol with more GOP senators, and he is seeking a meeting with House Republicans as well. This is a significant shift for a president who, throughout his first term, was criticized by inside-the-Beltway critics for preferring cozy dinners with his family to cocktails with power brokers.
Personal contact has always been essential to getting things done in Washington and is even more important when governmental power is divided. In the 1980s, Ronald Reagan had to make deals with a Democratic Congress. In the 1990s Bill Clinton had to work out compromises with a Republican House. Presidents Reagan and Clinton were both champion schmoozers. But those were the days when there was still a functioning center in the House and Senate. Now, Democratic and Republican lawmakers are so deeply divided and rigid in their ideology that it often appears they can barely stand to be in the same building, let alone at the same dinner table. In a political system already designed to divide power, the lack of people willing to reach out, give ground and cut deals has meant that Congress and the president have lurched from one confrontation to the next with little useful work getting done.
Criticized for the failure to come up with a budget bargain before automatic across-the-board budget cuts kicked in, President Obama said in a recent press conference that he is "not a dictator" and cannot just force Congress to do his bidding. If not a dictator, neither has he proven to be a savvy, hands-on politician in the style of Lyndon Johnson, Reagan or Mr. Clinton. The days when LBJ slapped backs, twisted arms and brokered deals with a few powerful committee chairmen are long gone, of course, and that makes a charm offensive less effective than it once would have been. But nothing else is working -- not even taking his case to the people -- so Mr. Obama is giving charm a try.
Can hosting a dinner or showing up for lunch with Republicans do that much to soften the hard line they have taken on raising taxes on the rich or tampering with the wide open market for firearms? It seems unlikely. On the other hand, at least some Republican lawmakers may have grown weary of appeasing the most vociferous loudmouths in their party. They may actually want to start governing again, too.
Disillusioned voters have run out of patience with elected officials in both parties who claim to speak for the American people but who have proven incapable of sitting down and speaking to each other. Mr. Obama's dinner diplomacy is a very small but positive sign that do-nothing politicians may at last be ready to do something.
Two-time Pulitzer Prize winner David Horsey is a political commentator for the Los Angeles Times. Go to latimes.com/news/politics/topoftheticket/ to see more of his work.


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(1) Son of Simon of Cyrene and brother of Rufus (Mark 15:21).
(2) Acts 4:6; otherwise unknown.
(3) Acts 19:33.
(4) 1 Tim. 1:20.
(5) 2 Tim. 4:14. The individuals in the scripture references for numbers 3, 4, and 5 are all connected with Ephesus.
(6) King of Macedon, surnamed the Great; born 356 B.C., died 323 B.C. He made himself ruler over a wide empire stretching from Greece to the Indus, including Syria and Egypt. Josephus records a meeting between him and the high priest Jaddua (Neh. 12:11, 22). This story is that Alexander was marching against Jerusalem when the high priest came to meet him in his robes of hyacinth and gold and accompanied by a train of priests and citizens arrayed in white. Alexander was so moved by the solemn spectacle that he did reverence to the high priest, visited Jerusalem, and conferred important privileges on the Jews.