471 U.S. 707 (1985), 83-1925, Hillsborough County, Florida v. Automated Medical Laboratories, Inc.

Docket Nº:No. 83-1925
Citation:471 U.S. 707, 105 S.Ct. 2371, 85 L.Ed.2d 714, 53 U.S.L.W. 4612
Party Name:Hillsborough County, Florida v. Automated Medical Laboratories, Inc.
Case Date:June 03, 1985
Court:United States Supreme Court

Page 707

471 U.S. 707 (1985)

105 S.Ct. 2371, 85 L.Ed.2d 714, 53 U.S.L.W. 4612

Hillsborough County, Florida


Automated Medical Laboratories, Inc.

No. 83-1925

United States Supreme Court

June 3, 1985

Argued April 16, 1985




In 1980, appellant Hillsborough County adopted ordinances and promulgated implementing [105 S.Ct. 2372] 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 preempted all provisions of the ordinances and implementing regulations.

Held: Appellant county's ordinances and implementing regulations are not preempted by the federal regulations. Pp. 712-723.

(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

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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. 716-719.

(b) Nor can an intent to preempt 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 preemption. 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, reversed and remanded.

MARSHALL, J., delivered the opinion for a unanimous Court.

Page 709

MARSHALL, J., lead opinion

JUSTICE MARSHALL delivered the opinion of the Court.

The question presented is whether the federal regulations governing the collection of blood plasma from paid donors preempt 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).

Page 710

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 [105 S.Ct. 2374] 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

Page 711

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.

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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Automated Medical Laboratories appealed to the Court of Appeals for the Eleventh Circuit, which affirmed in...

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