Hillsborough County v. Auto. Med. Labs., 471 U.S. 707 (1985)

Hillsborough County, Florida v.

Automated Medical Laboratories, Inc.
No. 83-1925

Argued April 16, 1985
Decided June 3, 1985
471 U.S. 707

APPEAL FROM THE UNITED STATES COURT OF APPEALS FOR THE

ELEVENTH CIRCUIT

Syllabus

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 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 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.