Task: sc_respondent

What follows is an opinion from the Supreme Court of the United States. Your task is to identify the respondent of the case. The respondent is the party being sued or tried and is also known as the appellee. Characterize the respondent as the Court's opinion identifies them.

Identify the respondent by the label given to the party in the opinion or judgment of the Court except where the Reports title a party as the "United States" or as a named state. Textual identification of parties is typically provided prior to Part I of the Court's opinion. The official syllabus, the summary that appears on the title page of the case, may be consulted as well. In describing the parties, the Court employs terminology that places them in the context of the specific lawsuit in which they are involved. For example, "employer" rather than "business" in a suit by an employee; as a "minority," "female," or "minority female" employee rather than "employee" in a suit alleging discrimination by an employer.

Also note that the Court's characterization of the parties applies whether the respondent is actually single entitiy or whether many other persons or legal entities have associated themselves with the lawsuit. That is, the presence of the phrase, et al., following the name of a party does not preclude the Court from characterizing that party as though it were a single entity. Thus, identify a single respondent, regardless of how many legal entities were actually involved. If a state (or one of its subdivisions) is a party, note only that a state is a party, not the state's name.

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: Who is the respondent of the case?
年. attorney general of the United States, or his office
数. specified state board or department of education
日. city, town, township, village, or borough government or governmental unit
的. state commission, board, committee, or authority
月. county government or county governmental unit, except school district
用. court or judicial district
成. state department or agency
名. governmental employee or job applicant
时. female governmental employee or job applicant
件. minority governmental employee or job applicant
一. minority female governmental employee or job applicant
请. not listed among agencies in the first Administrative Action variable
中. retired or former governmental employee
据. U.S. House of Representatives
码. interstate compact
不. judge
新. state legislature, house, or committee
文. local governmental unit other than a county, city, town, township, village, or borough
下. governmental official, or an official of an agency established under an interstate compact
分. state or U.S. supreme court
入. local school district or board of education
人. U.S. Senate
功. U.S. senator
上. foreign nation or instrumentality
户. state or local governmental taxpayer, or executor of the estate of
为. state college or university
间. United States
号. State
取. person accused, indicted, or suspected of crime
回. advertising business or agency
在. agent, fiduciary, trustee, or executor
页. airplane manufacturer, or manufacturer of parts of airplanes
字. airline
有. distributor, importer, or exporter of alcoholic beverages
个. alien, person subject to a denaturalization proceeding, or one whose citizenship is revoked
作. American Medical Association
示. National Railroad Passenger Corp.
出. amusement establishment, or recreational facility
是. arrested person, or pretrial detainee
失. attorney, or person acting as such;includes bar applicant or law student, or law firm or bar association
表. author, copyright holder
除. bank, savings and loan, credit union, investment company
加. bankrupt person or business, or business in reorganization
败. establishment serving liquor by the glass, or package liquor store
生. water transportation, stevedore
信. bookstore, newsstand, printer, bindery, purveyor or distributor of books or magazines
类. brewery, distillery
置. broker, stock exchange, investment or securities firm
理. construction industry
本. bus or motorized passenger transportation vehicle
息. business, corporation
行. buyer, purchaser
定. cable TV
改. car dealer
市. person convicted of crime
期. tangible property, other than real estate, including contraband
以. chemical company
修. child, children, including adopted or illegitimate
元. religious organization, institution, or person
方. private club or facility
录. coal company or coal mine operator
区. computer business or manufacturer, hardware or software
单. consumer, consumer organization
位. creditor, including institution appearing as such; e.g., a finance company
型. person allegedly criminally insane or mentally incompetent to stand trial
法. defendant
县. debtor
存. real estate developer
品. disabled person or disability benefit claimant
前. distributor
称. person subject to selective service, including conscientious objector
注. drug manufacturer
值. druggist, pharmacist, pharmacy
输. employee, or job applicant, including beneficiaries of
建. employer-employee trust agreement, employee health and welfare fund, or multi-employer pension plan
能. electric equipment manufacturer
大. electric or hydroelectric power utility, power cooperative, or gas and electric company
例. eleemosynary institution or person
度. environmental organization
始. employer. If employer's relations with employees are governed by the nature of the employer's business (e.g., railroad, boat), rather than labor law generally, the more specific designation is used in place of Employer.
到. farmer, farm worker, or farm organization
面. father
载. female employee or job applicant
点. female
密. movie, play, pictorial representation, theatrical production, actor, or exhibitor or distributor of
动. fisherman or fishing company
果. food, meat packing, or processing company, stockyard
图. foreign (non-American) nongovernmental entity
提. franchiser
发. franchisee
式. lesbian, gay, bisexual, transexual person or organization
国. person who guarantees another's obligations
登. handicapped individual, or organization of devoted to
错. health organization or person, nursing home, medical clinic or laboratory, chiropractor
者. heir, or beneficiary, or person so claiming to be
认. hospital, medical center
误. husband, or ex-husband
接. involuntarily committed mental patient
关. Indian, including Indian tribe or nation
重. insurance company, or surety
第. inventor, patent assigner, trademark owner or holder
地. investor
如. injured person or legal entity, nonphysically and non-employment related
设. juvenile
目. government contractor
开. holder of a license or permit, or applicant therefor
事. magazine
可. male
要. medical or Medicaid claimant
代. medical supply or manufacturing co.
小. racial or ethnic minority employee or job applicant
选. minority female employee or job applicant
标. manufacturer
明. management, executive officer, or director, of business entity
编. military personnel, or dependent of, including reservist
求. mining company or miner, excluding coal, oil, or pipeline company
列. mother
网. auto manufacturer
万. newspaper, newsletter, journal of opinion, news service
最. radio and television network, except cable tv
器. nonprofit organization or business
所. nonresident
内. nuclear power plant or facility
体. owner, landlord, or claimant to ownership, fee interest, or possession of land as well as chattels
通. shareholders to whom a tender offer is made
务. tender offer
此. oil company, or natural gas producer
商. elderly person, or organization dedicated to the elderly
序. out of state noncriminal defendant
化. political action committee
消. parent or parents
否. parking lot or service
保. patient of a health professional
使. telephone, telecommunications, or telegraph company
次. physician, MD or DO, dentist, or medical society
机. public interest organization
对. physically injured person, including wrongful death, who is not an employee
量. pipe line company
查. package, luggage, container
部. political candidate, activist, committee, party, party member, organization, or elected official
性. indigent, needy, welfare recipient
和. indigent defendant
更. private person
后. prisoner, inmate of penal institution
证. professional organization, business, or person
题. probationer, or parolee
确. protester, demonstrator, picketer or pamphleteer (non-employment related), or non-indigent loiterer
格. public utility
了. publisher, publishing company
于. radio station
金. racial or ethnic minority
公. person or organization protesting racial or ethnic segregation or discrimination
午. racial or ethnic minority student or applicant for admission to an educational institution
円. realtor
片. journalist, columnist, member of the news media
空. resident
态. restaurant, food vendor
管. retarded person, or mental incompetent
主. retired or former employee
天. railroad
自. private school, college, or university
我. seller or vendor
全. shipper, including importer and exporter
今. shopping center, mall
来. spouse, or former spouse
正. stockholder, shareholder, or bondholder
说. retail business or outlet
意. student, or applicant for admission to an educational institution
送. taxpayer or executor of taxpayer's estate, federal only
容. tenant or lessee
已. theater, studio
结. forest products, lumber, or logging company
会. person traveling or wishing to travel abroad, or overseas travel agent
段. trucking company, or motor carrier
计. television station
源. union member
色. unemployed person or unemployment compensation applicant or claimant
時. union, labor organization, or official of
交. veteran
系. voter, prospective voter, elector, or a nonelective official seeking reapportionment or redistricting of legislative districts (POL)
过. wholesale trade
电. wife, or ex-wife
询. witness, or person under subpoena
符. network
未. slave
程. slave-owner
常. bank of the united states
条. timber company
当. u.s. job applicants or employees
情. Army and Air Force Exchange Service
口. Atomic Energy Commission
合. Secretary or administrative unit or personnel of the U.S. Air Force
车. Department or Secretary of Agriculture
实. Alien Property Custodian
组. Secretary or administrative unit or personnel of the U.S. Army
版. Board of Immigration Appeals
周. Bureau of Indian Affairs
址. Bonneville Power Administration
记. Benefits Review Board
二. Civil Aeronautics Board
同. Bureau of the Census
业. Central Intelligence Agency
权. Commodity Futures Trading Commission
其. Department or Secretary of Commerce
进. Comptroller of Currency
试. Consumer Product Safety Commission
验. Civil Rights Commission
料. Civil Service Commission, U.S.
传. Customs Service or Commissioner of Customs
述. Defense Base Closure and REalignment Commission
集. Drug Enforcement Agency
多. Department or Secretary of Defense (and Department or Secretary of War)
无. Department or Secretary of Energy
员. Department or Secretary of the Interior
报. Department of Justice or Attorney General
他. Department or Secretary of State
無. Department or Secretary of Transportation
服. Department or Secretary of Education
线. U.S. Employees' Compensation Commission, or Commissioner
这. Equal Employment Opportunity Commission
制. Environmental Protection Agency or Administrator
将. Federal Aviation Agency or Administration
处. Federal Bureau of Investigation or Director
高. Federal Bureau of Prisons
子. Farm Credit Administration
道. Federal Communications Commission (including a predecessor, Federal Radio Commission)
章. Federal Credit Union Administration
手. Food and Drug Administration
库. Federal Deposit Insurance Corporation
三. Federal Energy Administration
从. Federal Election Commission
支. Federal Energy Regulatory Commission
家. Federal Housing Administration
长. Federal Home Loan Bank Board
付. Federal Labor Relations Authority
秒. Federal Maritime Board
路. Federal Maritime Commission
完. Farmers Home Administration
象. Federal Parole Board
则. Federal Power Commission
现. Federal Railroad Administration
京. Federal Reserve Board of Governors
转. Federal Reserve System
辑. Federal Savings and Loan Insurance Corporation
限. Federal Trade Commission
力. Federal Works Administration, or Administrator
学. General Accounting Office
外. Comptroller General
调. General Services Administration
项. Department or Secretary of Health, Education and Welfare
北. Department or Secretary of Health and Human Services
工. Department or Secretary of Housing and Urban Development
笑. Interstate Commerce Commission
监. Indian Claims Commission
任. Immigration and Naturalization Service, or Director of, or District Director of, or Immigration and Naturalization Enforcement
相. Internal Revenue Service, Collector, Commissioner, or District Director of
微. Information Security Oversight Office
册. Department or Secretary of Labor
联. Loyalty Review Board
平. Legal Services Corporation
增. Merit Systems Protection Board
听. Multistate Tax Commission
解. National Aeronautics and Space Administration
等. Secretary or administrative unit of the U.S. Navy
得. National Credit Union Administration
收. National Endowment for the Arts
安. National Enforcement Commission
价. National Highway Traffic Safety Administration
藏. National Labor Relations Board, or regional office or officer
命. National Mediation Board
应. National Railroad Adjustment Board
看. Nuclear Regulatory Commission
索. National Security Agency
资. Office of Economic Opportunity
产. Office of Management and Budget
串. Office of Price Administration, or Price Administrator
布. Office of Personnel Management
原. Occupational Safety and Health Administration
知. Occupational Safety and Health Review Commission
级. Office of Workers' Compensation Programs
水. Patent Office, or Commissioner of, or Board of Appeals of
击. Pay Board (established under the Economic Stabilization Act of 1970)
好. Pension Benefit Guaranty Corporation
物. U.S. Public Health Service
放. Postal Rate Commission
亿. Provider Reimbursement Review Board
经. Renegotiation Board
模. Railroad Adjustment Board
之. Railroad Retirement Board
台. Subversive Activities Control Board
州. Small Business Administration
配. Securities and Exchange Commission
画. Social Security Administration or Commissioner
统. Selective Service System
共. Department or Secretary of the Treasury
连. Tennessee Valley Authority
海. United States Forest Service
节. United States Parole Commission
退. Postal Service and Post Office, or Postmaster General, or Postmaster
間. United States Sentencing Commission
比. Veterans' Administration
问. War Production Board
至. Wage Stabilization Board
备. General Land Office of Commissioners
你. Transportation Security Administration
黑. Surface Transportation Board
或. U.S. Shipping Board Emergency Fleet Corp.
与. Reconstruction Finance Corp.
影. Department or Secretary of Homeland Security
话. Unidentifiable
视. International Entity
Answer:

Answer: 标