Hillsborough County, Florida v. Automated Medical Laboratories, Inc, 83-1925
| Citation | 85 L.Ed.2d 714,471 U.S. 707,105 S.Ct. 2371 |
| Decision Date | 03 June 1985 |
| Docket Number | No. 83-1925,83-1925 |
| Parties | HILLSBOROUGH COUNTY, FLORIDA, et al., Appellants v. AUTOMATED MEDICAL LABORATORIES, INC |
| Court | United States Supreme Court |
In 1980, appellant Hillsborough County adopted ordinances and promulgated implementing regulations governing blood plasma centers within the county. One ordinance requires that blood donors be tested for hepatitis, that they donate at only one center, and that they be given a breath-analysis test for alcohol content before each donation. Pursuant to § 351 of the Public Health Service Act, the Food and Drug Administration (FDA) has promulgated federal regulations establishing minimum standards for the collection of blood plasma. Appellee operator of a blood plasma center located in appellant county filed suit in Federal District Court, challenging the constitutionality of the ordinances and implementing regulations on the ground, inter alia, that they violated the Supremacy Clause, and seeking declaratory and injunctive relief. The District Court upheld the ordinances and regulations, except the requirement that the donor be subject to a breath-analysis test. The Court of Appeals affirmed in part and reversed in part, holding that the FDA's regulations pre-empted all provisions of the ordinances and implementing regulations.
Held: Appellant county's ordinances and implementing regulations are not pre-empted by the federal regulations. Pp. 712-723.
(a) No intent to pre-empt 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 pre-empt 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 pre-emption. To infer pre-emption 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 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 pre-emption. Pp. 716-719.
(b) Nor can an intent to pre-empt be inferred from the purported dominant federal interest in the field of blood plasma regulation. The factors indicating federal dominance are absent here. The regulation of health and safety matters is primarily and historically a matter of local concern, and the National Blood Policy is not a sufficient indication of federal dominance. Pp. 719-720.
(c) Any concern that the challenged ordinances impose on plasma centers and donors requirements more stringent than those imposed by the federal regulations and therefore present a serious obstacle to the federal goal of ensuring an "adequate supply of plasma" is too speculative to support pre-emption. The District Court's findings rejecting appellee's factual assertions with respect to this concern, the lack of evidence of a threat to the "adequacy" of the plasma supply, and the lack of any statement by the FDA on the subject of "adequacy," all lead to the conclusion that appellant county's requirements do not imperil the federal goal. And where the record does not indicate that appellee has received the necessary federal exemption from the good-health requirement needed to collect plasma from individuals with hepatitis, appellee lacks standing to challenge the ordinances on the ground that they conflict with the federal regulations because they prevent individuals with hepatitis from donating their plasma. Pp. 720-722.
722 F.2d 1526 (CA11 1984), reversed and remanded.
Emeline C. Acton, Tampa, Fla., for appellants.
Paul J. Larkin, Jr., Washington, D.C., for the United States as amicus curiae in support of the appellants, pro hac vice, by special leave of Court.
Larry A. Stumpf, Rochester, N.Y., for the appellee.
Richard Landfield, Washington, D.C., for the American Blood Resources Ass'n as amicus curiae in support of the appellee, by special leave of Court.
The question presented is whether the federal regulations governing the collection of blood plasma from paid donors pre-empt certain local ordinances.
Appellee Automated Medical Laboratories, Inc., is a Florida corporation that operates, through subsidiaries, eight blood plasma centers in the United States. One of the centers, Tampa Plasma Corporation (TPC), is located in Hillsborough County, Florida. Appellee's plasma centers collect blood plasma from donors by employing a procedure called plasmapheresis. Under this procedure, whole blood removed from the donor is separated into plasma and other components, and "at least the red blood cells are returned to the donor," 21 CFR § 606.3(e) (1984). Appellee sells the plasma to pharmaceutical manufacturers.
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).
Pursuant to § 351 of the Act, the Food and Drug Administration (FDA), as the designee of the Secretary, has established standards for the collection of plasma. 21 CFR §§ 640.60-640.76 (1984). The regulations require that a licensed physician determine the suitability of a donor before the first donation and thereafter at subsequent intervals of no longer than one year. § 640.63(b)(1). A physician must also inform the donor of the hazards of the procedure and obtain the donor's consent, § 640.61, and must be on the premises when the procedure is performed, § 640.62. In addition, the regulations establish minimum standards for donor eligibility, §§ 640.63(c)-(d), specify procedures that must be followed in performing plasmapheresis, § 640.65, and impose labeling requirements, § 640.70.
In 1980, Hillsborough County adopted Ordinances 80-11 and 80-12. Ordinance 80-11 imposes a $225 license fee on plasmapheresis centers within the county. It also requires such centers to allow the County Health Department "reasonable and continuing access" to their premises for inspection purposes, and to furnish information deemed relevant by the Department. See App. 21-23.
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 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 pre-empt the whole field of plasmapheresis regulation and finding no conflict between the Hillsborough County ordinances and the federal regulations.
In addition, the District Court rejected the claim that the ordinances violate the Equal Protection Clause because they regulate only centers that pay donors for plasma, and not centers in which volunteers donate whole blood. The court identified a rational basis for the distinction: paid donors sell plasma more frequently than volunteers donate whole blood, and paid donors have a higher rate of hepatitis than do volunteer donors.
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.
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