## Facts

- Hillsborough County, Florida adopted ordinances and regulations governing commercial blood-plasma collection centers to protect donor safety and plasma quality.
- The county required, among other things, that paid donors be tested for hepatitis, donate at only one center, and take a breath-alcohol test before each donation.
- The FDA, acting under § 351 of the Public Health Service Act, had issued detailed regulations setting minimum standards for blood-plasma collection.
- Automated Medical Laboratories, Inc. (AML), a plasma-center operator in the county, sought declaratory and injunctive relief, arguing the county scheme was invalid under the Supremacy Clause.
- When the FDA issued initial plasma regulations (1973), it expressly disclaimed intent to preempt state and local regulation; later federal actions expanded regulation and adopted a National Blood Policy encouraging cooperation in blood collection and distribution.
- The district court upheld the county scheme except it invalidated the breath-analysis requirement.
- The Eleventh Circuit held the FDA regulations preempted all county provisions; the Supreme Court granted review and reversed.

## Issues

1. Whether FDA regulations under the Public Health Service Act expressly preempt local regulation of blood-plasma collection.
2. Whether the federal regulatory scheme and related federal policy impliedly preempt local ordinances by occupying the field.
3. Whether the county’s additional requirements conflict with federal law by making compliance impossible or by obstructing federal objectives.

## Decision

- The Supreme Court unanimously reversed the Eleventh Circuit.
- The Court held the county ordinances and implementing regulations were not preempted by federal law.
- The Court found no express preemption, no field preemption based solely on regulatory detail, and no conflict preemption because compliance with both regimes was possible and local rules did not obstruct federal objectives.
- The Court gave significant weight to the FDA’s stated position that its regulations were not intended to preempt state and local regulation.

## Legal Principles

- In areas of traditional state police power (health and safety), courts apply a presumption against preemption absent a clear statement of federal intent.
- Express preemption requires clear statutory or regulatory language; silence and general regulatory authority are insufficient.
- Field preemption is not established merely because federal regulation is comprehensive; courts will not infer exclusivity solely from regulatory detail.
- Conflict preemption requires either impossibility of dual compliance or a showing that state or local law stands as an obstacle to federal purposes and objectives.
- Federal “minimum standards” regulations generally permit more stringent state or local requirements unless federal law clearly indicates otherwise.
- An agency’s express, contemporaneous disavowal of preemptive intent is strong evidence against implied preemption, particularly where federal policy contemplates cooperative regulation.

## Conclusion

The Court held that federal regulation of blood-plasma collection set baseline standards and did not displace local health-and-safety rules absent clear preemptive intent or an actual conflict with federal objectives.


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