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:
TOILET GOODS ASSOCIATION, INC., et al. v. GARDNER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, et al.
No. 336.
Argued January 16, 1967.
Decided May 22, 1967.
Edward J. Boss argued the cause and filed a brief for petitioners.
Nathan Lewin argued the cause for respondents. With him on the briefs were Solicitor General Marshall, Assistant Attorney General Vinson, Beatrice Rosenberg, Jerome M. Feit and William W. Goodrich.
Mr. Justice Harlan
delivered the opinion of the Court.
Petitioners in this case are the Toilet Goods Association, an organization of cosmetics manufacturers accounting for some 90% of annual American sales in this field, and 39 individual cosmetics manufacturers and distributors. They brought this action in the United States District Court for the Southern District of New York seeking declaratory and injunctive relief against the Secretary of Health, Education, and Welfare and the Commissioner of Food and Drugs, on the ground that certain regulations promulgated by the Commissioner exceeded his statutory authority under the Color Additive Amendments to the Federal Food, Drug, and Cosmetic Act, 74 Stat. 397, 21 U. S. C. §§ 321-376. The District Court held that the Act did not prohibit this type of pre-enforcement suit, that a case and controversy existed, that the issues presented were justiciable, and that no reasons had been presented by the Government to warrant declining jurisdiction on discretionary grounds. 235 F. Supp. 648. Recognizing that the subsequent decision of the Court of Appeals for the Third Circuit in Abbott Laboratories v. Celebrezze, 352 F. 2d 286, appeared to conflict with its holding, the District Court reaffirmed its earlier rulings but certified the question of jurisdiction to the Court of Appeals for the Second Circuit under 28 U. S. C. § 1292 (b). The Court of Appeals affirmed the judgment of the District Court that jurisdiction to hear the suit existed as to three of the challenged regulations, but sustained the Government’s contention that judicial review was improper as to a fourth. 360 F. 2d 677.
Each side below sought review here from the portions of the Court of Appeals’ decision adverse to it, the Government as petitioner in Gardner v. Toilet Goods Assn., No. 438, and the Toilet Goods Association and other plaintiffs in the present case. We granted certiorari in both instances, 385 U. S. 813, as we did in Abbott Laboratories v. Gardner, No. 39, 383 U. S. 924, because of the apparent conflict between the Second and Third Circuits. The two Toilet Goods cases were set and argued together with Abbott Laboratories.
In our decisions reversing the judgment in Abbott Laboratories, ante, p. 136, and affirming the judgment in Gardner v. Toilet Goods Assn., post, p. 167, both decided today, we hold that nothing in the Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, bars a pre-enforcement suit 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. We nevertheless agree with the Court of Appeals that judicial review of this particular regulation in this particular context is inappropriate at this stage because, applying the standards set forth in Abbott Laboratories v. Gardner, the controversy is not presently ripe for adjudication.
The regulation in issue here was promulgated under the Color Additive Amendments of 1960, 74 Stat. 397, 21 U. S. C. §§ 321-376, a statute that revised and somewhat broadened the authority of the Commissioner to control the ingredients added to foods, drugs, and cosmetics that impart color to them. The Commissioner of Food and Drugs, exercising power delegated by the Secretary, 22 Fed. Reg. 1051, 25 Fed. Reg. 8625, under statutory authority “to promulgate regulations for the efficient enforcement” of the Act, § 701 (a), 21 U. S. C. § 371 (a), issued the following regulation after due public notice, 26 Fed. Reg. 679, and consideration of comments submitted by interested parties:
“(a) When it appears to the Commissioner that a person has:
“(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived;
“he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken.” 28 Fed. Reg. 6445-6446; 21 CFR § 8.28.
The petitioners maintain that this regulation is an impermissible exercise of authority, that the FDA has long sought congressional authorization for free access to facilities, processes, and formulae (see, e. g., the proposed “Drug and Factory Inspection Amendments of 1962,” H. R. 11581, 87th Cong., 2d Sess.; Hearings before the House Committee on Interstate and Foreign Commerce on H. R. 11581 and H. R. 11582, 87th Cong., 2d Sess., 67-74; H. R. 6788, 88th Cong., 1st Sess.), but that Congress has always denied the agency this power except for prescription drugs. § 704, 21 U. S. C. § 374. Framed in this way, we agree with petitioners that a “legal” issue is raised, but nevertheless we are not persuaded that the present suit is properly maintainable.
In determining whether a challenge to an administrative regulation is ripe for review a twofold inquiry must be made: first to determine whether the issues tendered are appropriate for judicial resolution, and second to assess the hardship to the parties if judicial relief is denied at that stage.
As to the first of these factors, we agree with the Court of Appeals that the legal issue as presently framed is not appropriate for judicial resolution. This is not because the regulation is not the agency’s considered and formalized determination, for we are in agreement with petitioners that under this Court’s decisions in Frozen Food Express v. United States, 351 U. S. 40, and United States v. Storer Broadcasting Co., 351 U. S. 192, there can be no question that this regulation — promulgated in a formal manner after notice and evaluation of submitted comments — is a “final agency action” under § 10 of the Administrative Procedure Act, 5 U. S. C. § 704. See Abbott Laboratories v. Gardner, ante, p. 136. Also, we recognize the force of petitioners’ contention that the issue as they have framed it presents a purely legal question : whether the regulation is totally beyond the agency’s power under the statute, the type of legal issue that courts have occasionally dealt-with without requiring a specific attempt at enforcement, Columbia Broadcasting System v. United States, 316 U. S. 407; cf. Pierce v. Society of Sisters, 268 U. S. 510, or exhaustion of administrative remedies, Allen v. Grand Central Aircraft Co., 347 U. S. 535; Skinner & Eddy Corp. v. United States, 249 U. S. 557.
These points which support the appropriateness of judicial resolution are, however, outweighed by other considerations. The regulation serves notice only that the Commissioner may under certain circumstances order inspection of certain facilities and data, and that further certification of additives may be refused to those who decline to permit a duly authorized inspection until they have complied in that regard. At this juncture we have no idea whether or when such an inspection will be ordered and what reasons the Commissioner will give to justify his order. The statutory authority asserted for the regulation is the power to promulgate regulations “for the efficient enforcement” of the Act, § 701 (a). Whether the regulation is justified thus depends not only, as petitioners appear to suggest, on whether Congress refused to include a specific section of the Act authorizing such inspections, although this factor is to be sure a highly relevant one, but also on whether the statutory scheme as a whole justified promulgation of the regulation. See Wong Yang Sung v. McGrath, 339 U. S. 33, 47. This will depend not merely on an inquiry into statutory purpose, but concurrently on an understanding of what types of enforcement problems are encountered by the FDA, the need for various sorts of supervision in order to effectuate the goals of the Act, and the safeguards devised to protect legitimate trade secrets (see 21 CFR § 130.14 (c)). We believe that judicial appraisal of these factors is likely to stand on a much surer footing in the context of a specific application of this regulation than could be the case in the framework of the generalized challenge made here.
We are also led to this result by considerations of the effect on the petitioners of the regulation, for the test of ripeness, as we have noted, depends not only on how adequately a court can deal with the legal issue presented, but also on the degree and nature of the regulation's present effect on those seeking relief. The regulation challenged here is not, analogous to those that were involved in Columbia Broadcasting System, supra, and Storer, supra, and those other color additive regulations with which we deal in Gardner v. Toilet Goods Assn., post, p. 167, where the impact of the administrative action could be said to be felt immediately by those subject to it in conducting their day-to-day affairs. See also Federal Communications Comm’n v. American Broadcasting Co., 347 U. S. 284.
This is not a situation in which primary conduct is affected — when contracts must be negotiated, ingredients tested or substituted, or special records compiled. This regulation merely states that the Commissioner may authorize inspectors to examine certain processes or formulae; no advance action is required of cosmetics manufacturers, who since the enactment of the 1938 Act have been under a statutory duty to permit reasonable inspection of a “factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials; containers, and labeling therein.” § 704 (a). Moreover, no irremediable adverse consequences flow from requiring a later challenge to this regulation by a manufacturer who refuses to allow this type of inspection. Unlike the other regulations challenged in this action, in which seizure of goods, heavy fines, adverse publicity for distributing “adulterated” goods, and possible criminal liability might penalize failure to comply, see Gardner v. Toilet Goods Assn., post, p. 167, a refusal to admit an inspector here would at most lead only to a suspension of certification services to the particular party, a determination that can then be promptly challenged through an administrative procedure, which in turn is reviewable by a court. Such review will provide an adequate forum for testing the regulation in a concrete situation.
It is true that the administrative hearing will deal with the “factual basis” of the suspension, from which petitioners infer that the Commissioner will not entertain and consider a challenge to his statutory authority to promulgate the regulation. Whether or not this assumption is correct, given the fact that only minimal, if any, adverse consequences will face petitioners if they challenge the regulation in this manner, we think it wiser to require them to exhaust this administrative process through which the factual basis of the inspection order will certainly be aired and where more light may be thrown on the Commissioner’s statutory and practical justifications for the regulation. Compare Federal Security Adm’r v. Quaker Oats Co., 318 U. S. 218. Judicial review will then be available, and a court at that juncture will be in a better position to deal with the question of statutory authority. Administrative Procedure Act § 10 (e) (B)(3), 5 U. S. C. § 706 (2)(C).
For these reasons the judgment of the Court of Appettls is
Affirmed.
Mr. Justice Douglas dissents for the reasons stated by Judge Tyler of the District Court, 235 F. Supp. 648, 651-652.
Mr. Justice Brennan took no part in the consideration or decision of this case.
[For concurring opinion of Mr. Justice Fortas, see post, p. 174.]
The Color Additive Amendments provide for listings of color additives by the Secretary “if and to the extent that such additives are suitable and safe . . . .” § 706 (b) (1), 21 U. S. C. § 376 (b)(1). The Secretary is further authorized to provide “for the certification, with safe diluents or without diluents, of batches of color additives . . . §706 (c), 21 U. S. C. §376 (c). A color additive is “deemed unsafe” unless it is either from a certified batch or exempted from the certification requirement, §706 (a), 21 U. S. C. §376 (a). A cosmetic containing such an “unsafe” additive is deemed to be adulterated, §601 (e), 21 U. S. C. §361 (e), and is prohibited from interstate commerce. § 301 (a), 21 U. S. C. § 331 (a).
See 21 CFR §§ 8.28(b), 130.14r-130.26. We recognize that a denial of certification might under certain circumstances cause inconvenience and possibly hardship, depending upon such factors as how large a supply of certified additives the particular manufacturer may have, how rapidly the administrative hearing and judicial review are conducted, and what temporary remedial or protective provisions, such as compliance with a reservation pending litigation, might be available to a manufacturer testing the regulation. In the context of the present case we need only say that such inconvenience is speculative and we have been provided with no information that would support an assumption that much weight should be attached to this possibility.
The statute and regulations are not explicit as to whether review would lie, as Judge Friendly suggested, 360 F. 2d, at 687, to a court of appeals under §§ 701 (f) and 706 (d) of the Act, or to a district court as an appeal from the Commissioner’s “final order,” 21 CFR § 130.26, under § 10 of the Administrative Procedure Act. See 21 CFR § 130.31; compare §505, 21 U. S. C. §355. For purposes of this ease it is only necessary to ascertain that judicial review would be available to challenge any specific order of the Commisioner denying certification services to a particular drug manufacturer, and we therefore need not decide the statutory question of which forum would be appropriate for such review.
Petitioners also cite the Commissioner’s refusal, in the context of a public hearing on certain drug regulations, to entertain objections to his statutory authority to promulgate them on the ground that “This is a question of law and cannot be resolved by the taking of evidence at a public hearing.” 31 Fed. Reg. 7174.
See 3 Davis, Administrative Law Treatise §20.03, at 69 (1958).

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