Document: 471 U.S. 707 105 S.Ct. 2371 85 L.Ed.2d 714 HILLSBOROUGH COUNTY, FLORIDA, et al., Appellantsv.AUTOMATED MEDICAL LABORATORIES, INC. No. 83-1925. Argued April 16, 1985. Decided June 3, Syllabus In 1980, appellant Hillsborough County adopted ordinances and promulgated implementing regulations governing blood plasma centers within the county. One ordinance requires that donors be tested for hepatitis, they donate at only one center, given a breath-analysis test alcohol content before each donation. Pursuant to § 351 of Public Health Service Act, Food Drug Administration (FDA) has federal establishing minimum standards collection plasma. Appellee operator center located in county filed suit Federal District Court, challenging constitutionality on ground, inter alia, violated Supremacy Clause, seeking declaratory injunctive relief. The Court upheld regulations, except requirement donor subject test. Appeals affirmed part reversed part, holding FDA's pre-empted all provisions regulations. Held: Appellant county's are not by Pp. 712-723. (a) No intent pre-empt may inferred from comprehensiveness While when issued 1973 covered used injections, FDA indicated since time expanding coverage other uses have affected its express disavowal any state local regulation, such expansion does cast doubt continued validity disavowal. Even absence disavowal, would justify pre-emption. To infer pre-emption whenever agency deals with problem comprehensively tantamount saying decides step into field, will exclusive. Such rule inconsistent federal-state balance embodied this Court's Clause jurisprudence. adoption National Blood Policy 1974, which sets forth broad statement goals respect distribution calls cooperation between Government private sector, support claim grown so comprehensive as inference complete 716-719. (b) Nor can an purported dominant interest field regulation. factors indicating dominance absent here. regulation health safety matters is primarily historically matter concern, sufficient indication dominance. 719-720. (c) Any concern challenged impose requirements more stringent than those imposed therefore present serious obstacle goal ensuring "adequate supply plasma" too speculative findings rejecting appellee's factual assertions lack evidence threat "adequacy" supply, "adequacy," lead conclusion do imperil goal. And where record indicate appellee received necessary exemption good-health needed collect individuals lacks standing challenge ground conflict because prevent hepatitis donating their 720-722. 722 F.2d 1526 (CA11 1984), remanded. 1 Emeline C. Acton, Tampa, Fla., appellants. 2 Paul J. Larkin, Jr., Washington, D.C., United States amicus curiae appellants, pro hac vice, special leave Court. 3 Larry A. Stumpf, Rochester, N.Y., appellee. 4 Richard Landfield, American Resources Ass'n appellee, 5 Justice MARSHALL delivered opinion 6 question presented whether paid certain ordinances. 7 * Automated Medical Laboratories, Inc., Florida corporation operates, through subsidiaries, eight States. centers, Tampa Plasma Corporation (TPC), County, Florida. Appellee's employing procedure called plasmapheresis. Under procedure, whole removed separated components, "at least red cells returned donor," 21 CFR 606.3(e) (1984). sells pharmaceutical manufacturers. 8 Vendors products, TPC, supervision. 351(a) 58 Stat. 702, amended, 42 U.S.C. 262(a), vendors must licensed Secretary Human Services (HHS). Licenses showing vendor's establishment products meet safety, purity, potency established Secretary. 262(d). HHS authorized inspect establishments compliance. 262(c). 9 (FDA), designee Secretary, §§ 640.60-640.76 require physician determine suitability first donation thereafter subsequent intervals no longer year. 640.63(b)(1). A also inform hazards obtain donor's consent, 640.61, premises performed, 640.62. addition, establish eligibility, 640.63(c)-(d), specify procedures followed performing plasmapheresis, 640.65, labeling requirements, 640.70. 10 Ordinances 80-11 80-12. Ordinance imposes $225 license fee plasmapheresis It allow Department "reasonable continuing access" inspection purposes, furnish information deemed relevant Department. See App. 21-23. 11 80-12 establishes countywide identification system, potential card, valid six months, specified card. incorporates reference but testing recordkeeping beyond contained Specifically, prior registration, breath analysis id., 24-31. 12 implement set issuance card $2. They pay $1 performed. 32-34. 13 December 1981, Middle Florida, argued Commerce Fourteenth Amendment's Equal Protection Clause. sought declaration were unlawful permanent injunction against enforcement. Id., 5-20. 14 November 1982, following bench trial, portions 40-46. court rejected challenge, discerning finding 15 violate regulate plasma, volunteers blood. identified rational basis distinction: sell frequently blood, higher rate volunteer donors. 16 Finally, found that, exception, impermissibly burden interstate commerce. concluded large forcing them purchase fairly expensive equipment, was shown achieve purpose adequately served subjective evaluations sobriety already required 17 Laboratories appealed Eleventh Circuit, part. held acknowledged congressional pre-empt. Relying pervasiveness however, it implicit laws subject. danger ordinances, reasoning "[i]f scheme remains effect, national policy promoting uniformity guaranteeing healthy adversely affected." 1533. 18 thus affirmed, albeit grounds, invalidation requirement. judgment upholding remaining view decision, did reach challenges scheme. Ibid. 19 pursuant 28 1254(2).1 We noted probable jurisdiction, 469 1156, 900, 83 916 (1984), we now reverse. II 20 familiar well-established principle Const., Art. VI, cl. 2, invalidates "interfere with, or contrary to," law. Gibbons v. Ogden, Wheat. 1, 211, L.Ed. 23 (1824) (Marshall, C.J.). law supersede several different ways. First, acting constitutional limits, Congress empowered stating terms. Jones Rath Packing Co., 430 519, 525, 97 1305, 1309, 51 604 (1977). pre-emptive language, Congress' particular area sufficiently make reasonable "left room" supplementary Rice Santa Fe Elevator Corp., 331 218, 230, 67 1146, 1152, 91 1447 (1947). Pre-emption "the system assumed preclude enforcement same subject." Ibid.; see Hines Davidowitz, 312 52, 61 399, 581 (1941). completely displaced specific area, nullified extent actually conflicts arises "compliance both physical impossibility," Lime & Avocado Growers, Inc. Paul, 373 132, 142-143, 1210, 1217-1218, 248 (1963), "stands accomplishment execution full purposes objectives Congress," supra, U.S., 67, S.Ct., 404. generally Capital Cities Cable, Crisp, 467 691, 698-699, 104 2694, 2700, 81 580 22 repeatedly well statutes. See, e.g., 699, 2700; Fidelity Savings Loan Assn. De la Cuesta, 458 141, 153-154, 102 3014, 3022-3023, 73 664 (1982); Shimer, 367 374, 381-383, 1554, 1559-1561, 908 (1961). Also, analyzed way statewide laws. City Burbank Lockheed Air Terminal, 411 624, 93 1854, 36 547 (1973). III arguing pre-empted, faces uphill battle. hurdle overcome statement, 1973, intend response comments expressing licensing facilities "would State plasmapheresis," explained accompanying "[t]hese intended usurp powers authorities localities." 38 Fed.Reg. 19365 24 entire been reserved is, essentially, ascertaining underlying 712-713. case, concedes neither nor expressly preempted Thus, if here fail either implicitly According two separate field: area. argues reduce number donors, effect adequate 25 dispositive unless agency's position clearly expressed intent, Chevron U.S.A. Natural Defense Council, 837, 842-845, 2778, 2781-2783, 694 developments reveal change position. Given argument pre-emption—that evinces pre-empt—any result regulations.2 prevail second pre-emption—the regulation—appellee show became compelling seriously underestimated 26 path presumption related invalidated under Through attempted protect preventing frequently. Brief Appellants 12. ensure quality collected protect, turn, recipients "Where . said traditionally occupied 'we start assumption historic police superseded Act clear manifest Congress.' " 1309 (quoting 1152) (citations omitted). Cf. Kassel Consolidated Freightways 450 662, 670, 101 1316, (1981) (deference dormant Clause); 681, n. 1321 (BRENNAN, J., concurring judgment) (same); 1326 (REHNQUIST, dissenting) (same). Of course, principles apply where, here, agency, delegation. provision scheme, strong enough constitutionally coexist IV 27 intention deference review conclude these reject issue As pointed out, inquiry justified increase, Admittedly, broadened over years. When injections. 1976, expanded cover manufacture "noninjectable" products. 41 10762 (1976). original amended "clarify strengthen existing Source (Human) light inspectional regulatory experience." 39 26161 (1974) (first proposing amendments). 29 new fact disavowal.3 Indeed, even New York Dept. Social Dublino, 413 405, 2507, 37 688 (1973), stated "[t]he subjects modern social legislation often very nature intricate complex responses Congress, without necessarily intending enactment exclusive means meeting problem." 415, 2514. There, work-incentive "had authorize govern programs had own cooperatively requirements." But merely need mean localities barred identifying additional needs imposing further field. Canas Bica, 424 351, 359-360, 96 933, 938-939, 47 43 30 reluctant specialized functions, agencies normally deal problems far detail Congress. virtually rule, our 1309. 31 Moreover, address detailed manner speak variety means, including preambles, interpretive statements, comments, expect intentions pre-emption, pause mere volume complexity seldom infer, solely entirety safety. 32 relies promulgation Health, Education, Welfare (HEW), 25-26. reliance misplaced. 33 1974 "a pluralistic evolutionary approach solution problems." 32702 (1974). contains regulations; instead, call sector: 34 "These policies methods implementation. developing most effective suitable reaching goals, involve, appropriate, public sectors cooperative effort provide best attainable services." 32703. 35 indicates employed last resort: "[I]f sector unable satisfactory progress toward policies, legislative and/or considered." simply B unpersuaded argument. Undoubtedly, every merits definition, concern. That cannot mean, statute ousts Neither us rank enactments order "importance" hold top scale, Instead, look features warranting Our case provides guide For example, seminal (1941), foreign affairs supremacy power general made Constitution," 62, 401, "intimately blended intertwined responsibilities government," 66, 403; Zschernig Miller, 389 429, 440-441, 88 664, 670-671, 683 (1968). Needless say, Rather, stated, primarily, historically, 1152.4 There merit Nothing takes out health-and-safety category converts overriding C final struck down principally plasma." Tr. Oral Arg. 24; 30; 17420 (1972). find 40 claims trial increase direct costs production $1.50 per litre, total (including indirect costs) $7 litre approximately 15% cost production." 30. increased financial burdens centers. claims, who occasionally deterred identification-card 30-31. On it, assertions. cost-of-compliance estimates "were clouded speculation." 42. facts vendor population decrease twenty-five percent." These aside erroneous, Fed.Rule Civ.Proc. 52(a); Anderson Bessemer City, 470 564, 1504, 84 518 (1985), hence come validity. More importantly, had, fact, reduced county, follow interfere maintaining overly restrictive could threaten supply. FDA, quantity; noted, contemplated standards. (1973); ----. what considers "adequate," reason believe reduction quantity donated "inadequate." possesses authority promulgate pre-empting imperils relative ease. expected monitor, basis, effects program requirements. suggested 44 somewhat delegated administration program. unlike follow, years after legislation, external promote. difficult known—for example amending statute—than amend otherwise 45 summary, significance attach plasma.5 46 vaccines, authorization carefully controlled conditions. 610.41 stand combating hepatitis. 640.75, 640.63(c). exemption. result, ground.6 V 48 80-12, Circuit reversed, remanded proceedings consistent opinion. 49 ordered. 1254(2), treated Orleans Dukes, 427 297, 301, 2513, 2515, 511 (1976) (per curiam ); Doran Salem Inn, 422 922, 927, 95 2561, 2565, 648 (1975). argue statutes amendments departing earlier statement; changes technical inferring follows underestimate Two amici uniform stake standards, makes additional, nonconflicting statement. Since incorporate ----, type exemptions 640.75 If interpreted there be, conflict.

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