What follows is an opinion from the Supreme Court of the United States. Your task is to identify the federal agency involved in the administrative action that occurred prior to the onset of litigation. If the administrative action occurred in a state agency, respond "State Agency". Do not code the name of the state. The administrative activity may involve an administrative official as well as that of an agency. If two federal agencies are mentioned, consider the one whose action more directly bears on the dispute;otherwise the agency that acted more recently. If a state and federal agency are mentioned, consider the federal agency. Pay particular attention to the material which appears in the summary of the case preceding the Court's opinion and, if necessary, those portions of the prevailing opinion headed by a I or II. Action by an agency official is considered to be administrative action except when such an official acts to enforce criminal law. If an agency or agency official "denies" a "request" that action be taken, such denials are considered agency action. Exclude: a "challenge" to an unapplied agency rule, regulation, etc.; a request for an injunction or a declaratory judgment against agency action which, though anticipated, has not yet occurred; a mere request for an agency to take action when there is no evidence that the agency did so; agency or official action to enforce criminal law; the hiring and firing of political appointees or the procedures whereby public officials are appointed to office; attorney general preclearance actions pertaining to voting; filing fees or nominating petitions required for access to the ballot; actions of courts martial; land condemnation suits and quiet title actions instituted in a court; and federally funded private nonprofit organizations.

Opinion:
GARDNER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, et al. v. TOILET GOODS ASSOCIATION, INC., et al.
No. 438.
Argued January 16, 1967.
Decided May 22, 1967.
Nathan Lewin argued the cause for petitioners. With him on the briefs were Solicitor General Marshall, As sistant Attorney General Vinson, Beatrice Rosenberg, Jerome M. Feit and William W. Goodrich.
Edward J. Ross argued the cause and filed a brief for respondents.
Mr. Justice Harlan
delivered the opinion of the Court.
In Toilet Goods Ass'n. v. Gardner, ante, p. 158, 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, ante, p. 136, 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 pre-enforcement 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 coloring 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. 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; Frozen Food Express v. United States, 351 U. S. 40.
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, ante, pp. 152-153. 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, subject to 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 or not these cost estimates are exaggerated 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.
Affirmed.
Mr. Justice Brennan took no part in the consideration or decision of this case.
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 recordskeeping and laboratory testing costs in themselves will be extremely burdensome for all of the plaintiffs.” 235 F. Supp. 648, 652. (Footnote omitted.)

Question: What is the agency involved in the administrative action?

Choices:
Army and Air Force Exchange Service
Atomic Energy Commission
Secretary or administrative unit or personnel of the U.S. Air Force
Department or Secretary of Agriculture
Alien Property Custodian
Secretary or administrative unit or personnel of the U.S. Army
Board of Immigration Appeals
Bureau of Indian Affairs
Bureau of Prisons
Bonneville Power Administration
Benefits Review Board
Civil Aeronautics Board
Bureau of the Census
Central Intelligence Agency
Commodity Futures Trading Commission
Department or Secretary of Commerce
Comptroller of Currency
Consumer Product Safety Commission
Civil Rights Commission
Civil Service Commission, U.S.
Customs Service or Commissioner or Collector of Customs
Defense Base Closure and REalignment Commission
Drug Enforcement Agency
Department or Secretary of Defense (and Department or Secretary of War)
Department or Secretary of Energy
Department or Secretary of the Interior
Department of Justice or Attorney General
Department or Secretary of State
Department or Secretary of Transportation
Department or Secretary of Education
U.S. Employees' Compensation Commission, or Commissioner
Equal Employment Opportunity Commission
Environmental Protection Agency or Administrator
Federal Aviation Agency or Administration
Federal Bureau of Investigation or Director
Federal Bureau of Prisons
Farm Credit Administration
Federal Communications Commission (including a predecessor, Federal Radio Commission)
Federal Credit Union Administration
Food and Drug Administration
Federal Deposit Insurance Corporation
Federal Energy Administration
Federal Election Commission
Federal Energy Regulatory Commission
Federal Housing Administration
Federal Home Loan Bank Board
Federal Labor Relations Authority
Federal Maritime Board
Federal Maritime Commission
Farmers Home Administration
Federal Parole Board
Federal Power Commission
Federal Railroad Administration
Federal Reserve Board of Governors
Federal Reserve System
Federal Savings and Loan Insurance Corporation
Federal Trade Commission
Federal Works Administration, or Administrator
General Accounting Office
Comptroller General
General Services Administration
Department or Secretary of Health, Education and Welfare
Department or Secretary of Health and Human Services
Department or Secretary of Housing and Urban Development
Administrative agency established under an interstate compact (except for the MTC)
Interstate Commerce Commission
Indian Claims Commission
Immigration and Naturalization Service, or Director of, or District Director of, or Immigration and Naturalization Enforcement
Internal Revenue Service, Collector, Commissioner, or District Director of
Information Security Oversight Office
Department or Secretary of Labor
Loyalty Review Board
Legal Services Corporation
Merit Systems Protection Board
Multistate Tax Commission
National Aeronautics and Space Administration
Secretary or administrative unit or personnel of the U.S. Navy
National Credit Union Administration
National Endowment for the Arts
National Enforcement Commission
National Highway Traffic Safety Administration
National Labor Relations Board, or regional office or officer
National Mediation Board
National Railroad Adjustment Board
Nuclear Regulatory Commission
National Security Agency
Office of Economic Opportunity
Office of Management and Budget
Office of Price Administration, or Price Administrator
Office of Personnel Management
Occupational Safety and Health Administration
Occupational Safety and Health Review Commission
Office of Workers' Compensation Programs
Patent Office, or Commissioner of, or Board of Appeals of
Pay Board (established under the Economic Stabilization Act of 1970)
Pension Benefit Guaranty Corporation
U.S. Public Health Service
Postal Rate Commission
Provider Reimbursement Review Board
Renegotiation Board
Railroad Adjustment Board
Railroad Retirement Board
Subversive Activities Control Board
Small Business Administration
Securities and Exchange Commission
Social Security Administration or Commissioner
Selective Service System
Department or Secretary of the Treasury
Tennessee Valley Authority
United States Forest Service
United States Parole Commission
Postal Service and Post Office, or Postmaster General, or Postmaster
United States Sentencing Commission
Veterans' Administration or Board of Veterans' Appeals
War Production Board
Wage Stabilization Board
State Agency
Unidentifiable
Office of Thrift Supervision
Department of Homeland Security
Board of General Appraisers
Board of Tax Appeals
General Land Office or Commissioners
NO Admin Action
Processing Tax Board of Review

Answer: 61