Document: 358 U.S. 153 79 S.Ct. 160 3 L.Ed.2d 188 Arthur S. FLEMMING, Secretary of Health, Education, and Welfare, Petitioner,v.FLORIDA CITRUS EXCHANGE, Frank R. Schell, et al. No. 27. Argued Nov. 17, 1958. Decided Dec. 15, Rehearing Denied Jan. 26, 1959. See 948, 349. [Syllabus from pages 153-154 intentionally omitted] Mr. William W. Goodrich, New York City, for petitioner. Messrs. J. Hardin Peterson, Lakeland, Fla., Lewis Hall, Tallahassee, respondents. Justice BRENNAN delivered the opinion Court. 1 Commercially grown Florida Texas oranges have many years been colored with a red coal-tar color. In 1939 Food Drug Administration, after testing pursuant to § 406(b) Federal Food, Drug, Cosmetic Act,1 certified this color, FD&C Red 32 (hereafter 32), be harmless suitable use in food. However, on November 10, 1955, ordered two other coaltar colors removed list, new tests 1951—1953 cast doubt whether was harmless, public hearings were held upon matter notice published Register. The consequence Secretary's order that under 402(c) Act2 any food bearing or containing such would deemed adulterated. 2 validity attacked petitions 701(f) Act3 filed several Courts Appeals4 by persons organizations claiming adversely affected. Court Appeals Second Circuit sustained against general attack. Certified Color Industry Committee v. Education 236 F.2d 866. instant case,5 however, Fifth Circuit, divided vote, set aside order6 insofar as it certification external coloring oranges. 246 850. did not determine quantities used color-added harmful human consumption, but rather determined basis only suspect toxic therefore 'harmless food.' finding 'should supplanted' contrary 'unless there is evidence that, amounts used, manner use, are unsafe consumption.' at 861—862. word 'harmless' construed term 'of relation,' preventing denying continued absence could consumed 'without risk injury harm.' Id., page 858. further light its premise relation because congressional Committees had found practice adding color an economic necessity, incumbent 'required production' within meaning 406(a),7 if so, promulgate safe tolerance section. Until promulgated, court required certify without one. 860 862. We granted certiorari controversial question construction important statute designed protection health. Folsom Citrus Exchange, 356 911, 78 669, 585. 4 Senate House reported necessity production market.8 When mature tree, their skins, botanical reasons unnecessary detail here, frequently green Since consumer prone incorrectly interpret greenness sign immaturity, put through 'degreening' process which involves exposure ethylene gas. case certain California oranges, gas sufficient turn orange into one desired But degreening does produce oranges; yellow shade results. more produced immersing in, spraying them with, solution 32. infuses peel 0.0017% 0.0034% Other indicated taken whole, candied peel, marmalade juice contain less—in cases, much less—of It conceded no level ingestion involved consumption harmful. 5 hearing indicate poisonous effect animals. Feeding rats small 0.1% diet deleterious often fatal, liver damage enlargement heart evidence. larger quantities, 1.0% 2.0% diet, caused death twelve days week, respectively. health dogs taking 0.2% diets deteriorated rapidly; those 0.04% somewhat slowly, definitely; ill effects feeding low 0.01% diet. No administration test animals established. These similar tests, involving generally item rested. 6 argues legislative history consistent administrative interpretation Act establish his authority list continue listing confined colors, wholly innocuous demonstrated adverse physiological effect. argument runs agreed was, prohibited completely regard might possibly particular product. since Congress made known will specifically precisely is, 'harmless,' circumstances, provisions 406(a) relevance order. 7 erred judgment cannot stand. 8 First. §§ dealing expressly innovations 1938; counterpart original 1906 drug legislation. By these provisions, carefully distinguished treatment given colors. dealt substances food, now treated 402(a), deal Section Drugs Act, 34 Stat. 769, provided article should adulterated 'If added ingredient may render injurious * *.' This United States Lexington Mill & Elevator Co., 232 399, 337, 58 L.Ed. 658, following 'plain meaning' statutory language, placed burden Government establishing substance rule applied distinction where involved. aware difficulties questioned product evaluated existence area informal products themselves subjected character. Cf. S.Rep. 361, 74th Cong., 1st Sess., pp. 7—8. Of course, when litigation occurred, standard applied. W.B. Wood Manufacturing Co. States, Cir., 286 F. 84, 86—87. 9 background 1938 proposed enacted. obvious us approach different intended 402(c)9 addressed itself severable narrow problem language survived Act's broadest most adulteration, 402(a)(1).10 separate test: bears contains than batch has accordance regulations section 406 Plainly banned addition foods Secretary. established forth 406(b): 'The shall providing batches There appears Senator Copeland's memorandum first bills led 1944, 73d contained ones finally passed, clear indication purposes do away, area, approach. 77 Cong.Rec. 5721. making system, analysis concentrated themselves, examination context involved, conclusive adulteration. Thus laid down concentrates itself; listed harmless. address himself character first; once assured, plan freely foods, subject sections Act. Clearly rational ascribe Congress. true ultimate purpose here concerned adulteration protect health, makes certainly competent Congress, what recognized problems adopt caution treating definable area. relieves showing each raises possibility requires stuffs, whose positive values visual naturally unless they pass higher standard. 10 significance here. established, either respect humans contends impossible experienced beings unrestricted permitted articles On hand, instance record.11 questions present broad inquiries, difficult proof, doubtless apt long-drawn-out investigation even pursued. Yet shown properties. overall cf. Dotterweich, 320 277, 280, 64 134, 136, 88 48, specific terms seems intend verdict 'not proven' mentioned preclude like themselves. 11 persuaded respondents' argument, adopted Appeals, words 'poisonous' relative words, referring vacuo, way organic system. course before depend it. examples remind pure water rate four gallons hour common table salt ounces. appear administered toxicologically significant levels; played relatively part animals, less, 1%.12 Obviously trifling percentages poisonous.13 sense, we think laboratory performed speaking 'harmless.' believe attempt analyze uses being market place, then feed experimentally proportions appeared used. very procedure turned back 12 respondents contend maintains various lists all cosmetic uses, another drugs cosmetics, third 21 CFR 9.3, 9.4, 9.5, he statute, bear 'absolute' alleged give From said follow must, forbidding restrict prohibition capable draw inference. Provisions repeated portions cosmetics. 501(a)(4), 52 1049, U.S.C. 351(a)(4), U.S.C.A. proscribes uncertified coloring, refers 504, 1052, 354, authorizes drugs.' Comparable cosmetics 601(e) 604, 1054, 1055, 361(e), 364, 364. contemplated foods. And fact category, distinguishing between inconsistent our distinctions can run such, conducted us. far cry saying permits generic internal say commands inquired except contexts products. 13 Second. viewing harmlessness applications, correct, insist, below indicated, tolerances though point allows 'cannot avoided good manufacturing practice.' They argue provision maximum application skins applies own applicable analogy.14 power permit system tolerances. correct. 14 detailed thorough piece Its quite specific, duty courts construing mindful draftsmanship. Here again, explicit must sensitive written, recall 'It ascertain—neither add nor subtract, neither delete distort.' 62 Cases Jam 340 593, 596, 71 515, 518, 95 566. 406(a), provides tolerances, constitutes definition 'unsafe,' 402(a)(2), 'any 406.' entirely distinct prohibitions stated sanction otherwise amount 402(a)(1). Accordingly, authorizing establishment apply 402(a)(1) (2) 402(c)'s flat Respondents direct substantial history. Nor some form analogy. command plain: certified; certified, all. also, toxicity ingredient, whole chosen evidently took view considerations benefits appeal urged favor prevail, sorts poisons, avoided, policy expressed enactment. distinction; done so apparent uniformity 15 Third. After promulgation order, afforded temporary relief economically interested Legislation enacted summer 1956 afford period approximately three (until March 1, 1959) during allowed solely oranges.15 not, view, affect situation presented judicial review; remains tested permanent accordingly operates legislatively ordained stay affects similarly situated. H.R.Rep.No.1982, p. 3, S.Rep.No. 2391, 84th 2d Code Cong. Adm.News, 1956, 3055. nature 'stay,' automatic resumption status quo expiration, respondents, stay, agree parties moot. rule, prospective operation, facts business upheld, practical span remain affected proper legal legislation expires. Under 402 lawful, grounds legally object them. setting part, reversed. 16 Reversed. amended, 1040, 301 seq. 406(b), 346(b), 346(b) provides: diluents.' 402(c), 1047, 342(c), prohibits introduction delivery interstate commerce, receipt thereof, commerce. 1042, 331, 331. Sanctions acts, injunction proceedings, criminal prosecutions, seizure actions, 302—304, 1043, 1044, 332—334, 332—334. 'In actual controversy subsection (e), person who time prior ninetieth day issued file petition circuit wherein resides principal place business, review summons served States. Secretary, promptly service petition, transcript proceedings record based order.' 371(f), 371(f). Review sought Seventh dismissed adjudicated. firms engaged growing, packing marketing One also patented whereby order: '* removes skin meeting minimum maturity standards prescribed State Texas; provided, nothing herein entered hereto restore drugs, operate authorize conforming specifications appearing C.F.R. 135.3 (1949 ed.) only; further, necessary time; certificates Red. limited certificate investigations conducting determination any, defined.' 346(a), '(a) Any thereof clause 402(a); limiting quantity therein thereon extent finds exceeding limits fixed 402(a). While regulation reason substance, considered (1) determining tolerated take account article, ways same substances.' 1; H.R.Rep. 1982, 2, U.S.Code Adm. News enactment proviso That paragraph citrus fruit acted commonly fruit.' 342(c). suggest somehow suggests intent leniently reference 406, see note 7, supra, revised substantially factual context, 402(a)(2) subsequent revisions itself, latest Additives Amendment 1958, Public Law 85—929, September 6, 1784. 12, infra. Considerably regularly entry accounted actually Neither difference speculatively. urges emphasize inevitable waste orange-coloring process. To underlines question; inquiry it; harmful, none need be. A single dose 100 milligrams (0.0035 oz. avoirdupois, 1/3 weight aspirin tablet) rapid diarrheic dogs. respondent assails validity, framework experimental justified poisonous, 859, agreement. Appeals' staying toto until developed tolerance. authorized stand take, reach contention. July 9, c. 530, 70 512, Act: 'Provided laws processing (other designated trade 'packing house elimination'), 1959, F.D. C. 32, External D. 21, Regulations, 9: preceding

Category: 8