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Matched Legal Cases: ['§ 351', '§ 262', '§ 262', '§ 262', '§ 1254', '§ 610', '§ 640', '§ 640', '§ 1254', '§ 640']

HILLSBOROUGH COUNTY V. AUTO. MED. LABS., 471 U. S. 707 (1985)
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(a) No intent to preempt may be inferred from the comprehensiveness of the federal regulations. While the regulations when issued in 1973 covered only plasma to be used in injections, the FDA has not indicated that regulations issued since that time expanding coverage to other uses have affected its express disavowal in 1973 of any intent to preempt state and local regulation, and such expansion of coverage does not cast doubt on the continued validity of that disavowal. Even in the absence of the disavowal, the comprehensiveness of the FDA's regulations would not justify preemption. To infer preemption whenever a federal agency deals with a problem comprehensively would be tantamount to saying that, whenever the agency decides to step into a field, its regulations will be exclusive. Such a rule would be inconsistent with the federal-state balance embodied in this Court's Supremacy Clause jurisprudence. The adoption of the National Blood Policy in 1974, which chanrobles.com-red
sets forth a broad statement of goals with respect to blood collection and distribution and calls for cooperation between the Federal Government and the private sector, does not support the claim that the federal regulations have grown so comprehensive since 1973 as to justify the inference of complete preemption. Pp. 471 U. S. 716-719.
Vendors of blood products, such as TPC, are subject to federal supervision. Under § 351(a) of the Public Health Service Act, 58 Stat. 702, as amended, 42 U.S.C. § 262(a), such vendors must be licensed by the Secretary of Health and Human Services (HHS). Licenses are issued only on a showing that the vendor's establishment and blood products meet certain safety, purity, and potency standards established by the Secretary. 42 U.S.C. § 262(d). HHS is authorized to inspect such establishments for compliance. § 262(c). chanrobles.com-red
Ordinance 80-12 establishes a countywide identification system, which requires all potential donors to obtain from the County Health Department an identification card, valid for six months, that may be used only at the plasmapheresis center specified on the card. The ordinance incorporates by reference the FDA's blood plasma regulations, but also imposes donor testing and recordkeeping requirements beyond those contained in the federal regulations. Specifically, the ordinance requires that donors be tested for hepatitis prior to registration, that they donate at only one center, and that they be given a breath analysis for alcohol content before each plasma donation. See id. at 24-31.
The county has promulgated regulations to implement Ordinance 80-12. The regulations set the fee for the issuance of an identification card to a blood donor at $2. They also chanrobles.com-red
establish that plasma centers must pay the county a fee of $1 for each plasmapheresis procedure performed. See id. at 32-34.
In December, 1981, appellee filed suit in the United States District Court for the Middle District of Florida, challenging the constitutionality of the ordinances and their implementing regulations. Appellee argued primarily that the ordinances violated the Supremacy Clause, the Commerce Clause, and the Fourteenth Amendment's Equal Protection Clause. Appellee sought a declaration that the ordinances were unlawful and a permanent injunction against their enforcement. Id. at 5-20.
In November, 1982, following a bench trial, the District Court upheld all portions of the local ordinances and regulations except the requirement that donors be subject to a breath-analysis test. Id. at 40-46. The court rejected the Supremacy Clause challenge, discerning no evidence of federal intent to preempt the whole field of plasmapheresis regulation and finding no conflict between the Hillsborough County ordinances and the federal regulations.
Finally, the District Court found that, with one exception, the ordinances do not impermissibly burden interstate commerce. It concluded that the breath-analysis requirement would impose a large burden on plasma centers by forcing them to purchase fairly expensive testing equipment, and was not shown to achieve any purpose not adequately served by the subjective evaluations of sobriety already required by the federal regulations. chanrobles.com-red
Hillsborough County and the County Health Department appealed to this Court pursuant to 28 U.S.C. § 1254(2). [Footnote 1] We noted probable jurisdiction, 469 U.S. 1156 (1984), and we now reverse.
It is a familiar and well-established principle that the Supremacy Clause, U.S.Const., Art. VI, cl. 2, invalidates state laws that "interfere with, or are contrary to," federal law. 22 U. S. 211 (1824) (Marshall, chanrobles.com-red
C.J.). Under the Supremacy Clause, federal law may supersede state law in several different ways. First, when acting within constitutional limits, Congress is empowered to preempt state law by so stating in express terms. Jones v. Rath Packing Co., 430 U. S. 519, 430 U. S. 525 (1977). In the absence of express preemptive language, Congress' intent to preempt all state law in a particular area may be inferred where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress "left no room" for supplementary state regulation. Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 331 U. S. 230 (1947). Preemption of a whole field also will be inferred where the field is one in which "the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject." Ibid.; see Hines v. Davidowitz,@ 312 U. S. 52 (1941).
Even where Congress has not completely displaced state regulation in a specific area, state law is nullified to the extent that it actually conflicts with federal law. Such a conflict arises when "compliance with both federal and state regulations is a physical impossibility," Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 373 U. S. 142-143 (1963), or when state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, supra, at 312 U. S. 67. See generally Capital Cities Cable, Inc. v. Crisp, 467 U. S. 691, 467 U. S. 698-699 (1984).
We have held repeatedly that state laws can be preempted by federal regulations as well as by federal statutes. See, e.g., Capital Cities Cable, Inc. v. Crisp, supra, at 467 U. S. 699; Fidelity Federal Savings & Loan Assn. v. De la Cuesta, 458 U. S. 141, 458 U. S. 153-154 (1982); United States v. Shimer, 367 U. S. 374, 367 U. S. 381-383 (1961). Also, for the purposes of the Supremacy Clause, the constitutionality of local ordinances is analyzed in the same way as that of statewide laws. See, e.g., City of Burbank v. Lockheed Air Terminal, Inc., 411 U. S. 624 (1973). chanrobles.com-red
The question whether the regulation of an entire field has been reserved by the Federal Government is, essentially, a question of ascertaining the intent underlying the federal scheme. See supra at 471 U. S. 712-713. In this case, appellee concedes that neither Congress nor the FDA expressly preempted state and local regulation of plasmapheresis. Thus, if the county ordinances challenged here are to fail, they must do so either because Congress or the FDA implicitly preempted the whole field of plasmapheresis regulation or because particular provisions in the local ordinances conflict with the federal scheme. According to appellee, two separate factors support the inference of a federal intent to preempt the whole field: the pervasiveness of the FDA's regulations and the dominance of the federal interest in this area. Appellee also argues that the challenged ordinances reduce the number of plasma donors, and that this effect conflicts with the congressional goal of ensuring an adequate supply of plasma.
The FDA's statement is dispositive on the question of implicit intent to preempt unless either the agency's position is inconsistent with clearly expressed congressional intent, @see 467 U. S. 842-845 (1984), or subsequent developments reveal a change in that position. Given appellee's first argument for implicit preemption -- that the comprehensiveness of the FDA's regulations evinces an intent to preempt -- any preemptive effect must result from the change since 1973 in the comprehensiveness of the federal regulations. [Footnote 2] To prevail on its second argument for implicit preemption -- the dominance of the federal interest in plasmapheresis regulation -- appellee must show either that this interest became more compelling since 1973 or that, in 1973, the FDA seriously underestimated the federal interest in plasmapheresis regulation.
The second obstacle in appellee's path is the presumption that state or local regulation of matters related to health and safety is not invalidated under the Supremacy Clause. Through the challenged ordinances, Hillsborough County has attempted to protect the health of its plasma donors by preventing them from donating too frequently. See Brief for Appellants 12. It also has attempted to ensure the quality of the plasma collected so as to protect, in turn, the recipients of such plasma.
Jones v. Rath Packing Co., 430 U.S. at 430 U. S. 525 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. at 331 U. S. 230) (citations omitted). Cf. Kassel v. Consolidated Freightways Corp., 450 U. S. 662, 450 U. S. 670 (1981) (deference to state regulation of safety under the dormant Commerce Clause); id. at 450 U. S. 681, n. 1 (BRENNAN, J., concurring in judgment) (same); id. at 450 U. S. 691 (REHNQUIST, J., dissenting) (same). Of course, the same principles apply where, as here, the field is said to have chanrobles.com-red
Given the clear indication of the FDA's intention not to preempt and the deference with which we must review the challenged ordinances, we conclude that these ordinances are not preempted by the federal scheme.
We reject the argument that an intent to preempt may be inferred from the comprehensiveness of the FDA's regulations at issue here. As we have pointed out, given the FDA's 1973 statement, the relevant inquiry is whether a finding of preemption is justified by the increase, since 1973, in the comprehensiveness of the federal regulations. Admittedly, these regulations have been broadened over the years. When they were adopted in 1973, these regulations covered only plasma to be used in injections. In 1976, the regulations were expanded to cover also plasma to be used for the manufacture of "noninjectable" products. 41 Fed.Reg. 10762 (1976). The original regulations also were amended to "clarify and strengthen the existing Source Plasma (Human) regulations in light of FDA inspectional and other regulatory experience." Ibid.; see also 39 Fed.Reg. 26161 (1974) (first proposing the amendments).
The FDA has not indicated that the new regulations affected its disavowal in 1973 of any intent to preempt state and local regulation, and the fact that the federal scheme was expanded to reach other uses of plasma does not cast doubt chanrobles.com-red
on the continued validity of that disavowal. [Footnote 3] Indeed, even in the absence of the 1973 statement, the comprehensiveness of the FDA's regulations would not justify preemption. In New York Dept. of Social Services v. Dublino, 413 U. S. 405 (1973), the Court stated that
Id. at 413 U. S. 415. There, in upholding state work-incentive provisions against a preemption challenge, the Court noted that the federal provisions
Ibid. But merely because the federal provisions were sufficiently comprehensive to meet the need identified by Congress did not mean that States and localities were barred from identifying additional needs or imposing further requirements in the field. See also De Canas v. Bica, 424 U. S. 351, 424 U. S. 359-360 (1976).
We are even more reluctant to infer preemption from the comprehensiveness of regulations than from the comprehensiveness of statutes. As a result of their specialized functions, agencies normally deal with problems in far more detail than does Congress. To infer preemption whenever an agency deals with a problem comprehensively is virtually tantamount to saying that, whenever a federal agency decides to step into a field, its regulations will be exclusive. Such a rule, of course, would be inconsistent with the federal-state balance embodied in our Supremacy Clause jurisprudence. See Jones v. Rath Packing Co., 430 U.S. at 430 U. S. 525. chanrobles.com-red
Appellee also relies on the promulgation of the National Blood Policy by the Department of Health, Education, and Welfare (HEW), as an indication that the federal regulatory scheme is now comprehensive enough to justify complete preemption. See Brief for Appellee 25-26. Such reliance is misplaced.
Id. at 32703. The National Blood Policy indicates that federal regulation will be employed only as a last resort:
Ibid. The adoption of this policy simply does not support the claim that the federal regulations have grown so comprehensive since 1973 as to justify the inference of complete preemption.
Instead, we must look for special features warranting preemption. Our case law provides us with clear standards to guide our inquiry in this area. For example, in the seminal case of Hines v. Davidowitz, 312 U. S. 52 (1941), the Court inferred an intent to preempt from the dominance of the federal interest in foreign affairs because "the supremacy of the national power in the general field of foreign affairs . . . is made clear by the Constitution," id. at 312 U. S. 62, and the regulation of that field is "intimately blended and intertwined with responsibilities of the national government," id. at 312 U. S. 66; see also Zschernig v. Miller, 389 U. S. 429, 389 U. S. 440-441 (1968). Needless to say, those factors are absent here. Rather, as we have stated, the regulation of health and safety matters is primarily, and historically, a matter of local concern. See Rice v. Santa Fe Elevator Corp., 331 U.S. at 331 U. S. 230. [Footnote 4] chanrobles.com-red
Appellee's final argument is that, even if the regulations are not comprehensive enough and the federal interest is not dominant enough to preempt the entire field of plasmapheresis regulation, the Hillsborough County ordinances must be struck down because they conflict with the federal scheme. Appellee argues principally that the challenged ordinances impose on plasma centers and donors requirements more stringent than those imposed by the federal regulations, and therefore that they present a serious obstacle to the federal goal of ensuring an "adequate supply of plasma." Tr. of Oral Arg. 24; see Brief for Appellee 30; 37 Fed.Reg. 17420 (1972). We find this concern too speculative to support preemption.
Brief for Appellee 30. Appellee argues that these increased financial burdens would reduce the number of plasma centers. In addition, appellee claims, the county requirements would reduce the number of donors who only occasionally sell their plasma, because such donors would be deterred by the identification card requirement. Id. at 30-31.
On the basis of the record before it, the District Court rejected each of appellee's factual assertions. The District Court found that appellee's cost-of-compliance estimates "were clouded with speculation." App. 42. It also found that appellee had presented no facts to support its conclusion that "the vendor population would decrease by twenty-five chanrobles.com-red
percent." Ibid. These findings of fact can be set aside only if they are clearly erroneous, Fed.Rule Civ.Proc. 52(a); see Anderson v. Bessemer City, 470 U. S. 564 (1985), and hence come to us with a strong presumption of validity.
More importantly, even if the Hillsborough County ordinances had, in fact, reduced the supply of plasma in that county, it would not necessarily follow that they interfere with the federal goal of maintaining an adequate supply of plasma. Undoubtedly, overly restrictive local legislation could threaten the national plasma supply. Neither Congress nor the FDA, however, has struck a particular balance between safety and quantity; as we have noted, the regulations, which contemplated additional state and local requirements, merely establish minimum safety standards. See 38 Fed.Reg.19365 (1973); supra at 471 U. S. 710-711. Moreover, the record in this case does not indicate what supply the Federal Government considers "adequate," and we have no reason to believe that any reduction in the quantity of plasma donated would make that supply "inadequate."
Finally, the FDA possesses the authority to promulgate regulations preempting local legislation that imperils the supply of plasma and can do so with relative ease. See supra at 471 U. S. 713. Moreover, the agency can be expected to monitor, on a continuing basis, the effects on the federal program of local requirements. Thus, since the agency has not suggested that the county ordinances interfere with federal goals, we are reluctant, in the absence of strong evidence, to find a threat to the federal goal of ensuring sufficient plasma.
Our analysis would be somewhat different had Congress not delegated to the FDA the administration of the federal program. Congress, unlike an agency, normally does not follow, years after the enactment of federal legislation, the effects of external factors on the goals that the federal legislation sought to promote. Moreover, it is more difficult for Congress to make its intentions known -- for example by amending a statute -- than it is for an agency to amend its regulations or to otherwise indicate its position. chanrobles.com-red
In summary, given the findings of the District Court, the lack of any evidence in the record of a threat to the "adequacy" of the plasma supply, and the significance that we attach to the lack of a statement by the FDA, we conclude that the Hillsborough County requirements do not imperil the federal goal of ensuring sufficient plasma. [Footnote 5]
Appellee also argues that the county ordinances conflict with the federal regulations because they prevent individuals with hepatitis from donating their plasma. See supra at 471 U. S. 710. Such plasma is used for the production of hepatitis vaccines, and the federal regulations provide for its collection pursuant to special authorization and under carefully controlled conditions. 21 CFR § 610.41 (1984). To the extent that the Hillsborough County ordinances preclude individuals with hepatitis from donating their plasma, the ordinances are said to stand in the way of the accomplishment of the federal goal of combating hepatitis.
In order to collect plasma from individuals with hepatitis, however, a plasma center must obtain from the FDA, pursuant to § 640.75, an exemption from the good-health requirements of § 640.63(c). The record does not indicate that appellee has received the required exemption. As a result, appellee could not collect plasma from individuals with hepatitis even in the absence of the county ordinances. Thus, appellee lacks standing to challenge the ordinances on this ground. [Footnote 6] chanrobles.com-red
For the purposes of § 1254(2), local ordinances are treated in the same manner as state statutes. See, e.g., New Orleans v. Dukes, 427 U. S. 297, 427 U. S. 301 (1976) (per curiam); Doran v. Salem Inn, Inc., 422 U. S. 922, 422 U. S. 927, n. 2 (1975).
Two of the amici argue that the county ordinances interfere with the federal interest in uniform plasma standards. There is no merit to that argument. The federal interest at stake here is to ensure minimum standards, not uniform standards. Indeed, the FDA's 1973 statement makes clear that additional, nonconflicting requirements do not interfere with federal goals, and we have found no reason to doubt the continued validity of that statement. See supra at 471 U. S. 714.
Since the ordinances incorporate the FDA's regulations, see supra at 471 U. S. 710, they may in fact also provide for the type of exemptions authorized by 21 CFR § 640.75 (1984). If the ordinances were interpreted that way, there would be, of course, no conflict.