CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT.
Marshall, J., delivered the opinion for a unanimous Court.
JUSTICE MARSHALL delivered the opinion of the Court.
The question in this case is whether the discretionary function exception of the Federal Tort Claims Act (FTCA or Act), 28 U. S. C. § 2680(a), bars a suit based on the Government's licensing of an oral polio vaccine and on its subsequent approval of the release of a specific lot of that vaccine to the public.
On May 10, 1979, Kevan Berkovitz, then a 2-month-old infant, ingested a dose of Orimune, an oral polio vaccine manufactured by Lederle Laboratories. Within one month, he contracted a severe case of polio. The disease left Berkovitz almost completely paralyzed and unable to breathe without the assistance of a respirator. The Communicable Disease Center, an agency of the Federal Government, determined that Berkovitz had contracted polio from the vaccine.
Berkovitz, joined by his parents as guardians, subsequently filed suit against the United States in Federal District Court.*fn1 The complaint alleged that the United States was liable for his injuries under the FTCA, 28 U. S. C. §§ 1346 (b), 2674, because the Division of Biologic Standards (DBS), then a part of the National Institutes of Health, had acted wrongfully in licensing Lederle Laboratories to produce Orimune and because the Bureau of Biologics of the Food and Drug Administration (FDA) had acted wrongfully in approving release to the public of the particular lot of vaccine containing Berkovitz's dose. According to petitioners, these actions violated federal law and policy regarding the inspection and approval of polio vaccines.
The Government moved to dismiss the suit for lack of subject-matter jurisdiction on the ground that the agency actions fell within the discretionary function exception of the FTCA. The District Court denied this motion, concluding
that neither the licensing of Orimune nor the release of a specific lot of that vaccine to the public was a "discretionary function" within the meaning of the FTCA. Civ. Action No. 84-2893 (WD Pa., Apr. 30, 1986). At the Government's request, the District Court certified its decision for immediate appeal to the Third Circuit pursuant to 28 U. S. C. § 1292(b), and the Court of Appeals accepted jurisdiction.
A divided panel of the Court of Appeals reversed. 822 F.2d 1322 (1987). The court initially rejected the Government's argument that the discretionary function exception bars all claims arising out of the regulatory activities of federal agencies. The court stated that "the discretionary function exception is inapplicable to non-discretionary regulatory actions," id., at 1328, and noted that employees of regulatory agencies have no discretion to violate the command of federal statutes or regulations. Contrary to petitioners' claim, however, the court held that federal law imposed no duties on federal agencies with respect to the licensing of polio virus vaccines or the approval of the distribution of particular vaccine lots to the public. Likening the applicable regulatory scheme to the scheme found to confer discretionary regulatory authority in United States v. Varig Airlines, 467 U.S. 797 (1984), the court concluded that the licensing and release of polio vaccines were wholly discretionary actions and, as such, could not form the basis for suit against the United States. A dissenting judge argued that the relevant statutes and regulations obligated the DBS to require the submission of test data relating to a vaccine from the manufacturer and to deny a license when the test data showed that the vaccine failed to conform with applicable safety standards. Reading the complaint in this case as alleging a failure on the part of the DBS to act in accordance with these directives, the dissenting judge concluded that the discretionary function exception did not bar petitioners' suit.
We granted certiorari, 484 U.S. 1003 (1988), to resolve a conflict in the Circuits regarding the effect of the discretionary
function exception on claims arising from the Government's regulation of polio vaccines. Compare 822 F.2d 1322, supra, with Baker v. United States, 817 F.2d 560, 564-566 (CA9 1987) (holding that discretionary function exception did not bar suit alleging a negligent decision to license a polio vaccine); Loge v. United States, 662 F.2d 1268, 1272-1273 (CA8 1981) (holding that discretionary function exception did not bar suit alleging negligence in both the licensing of a polio vaccine and the release of a particular vaccine lot). We now reverse the Third Circuit's judgment.
The FTCA, 28 U. S. C. § 1346(b), generally authorizes suits against the United States for damages
"for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred."*fn2
The Act includes a number of exceptions to this broad waiver of sovereign immunity. The exception relevant to this case provides that no liability shall lie for
"[a]ny claim . . . based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the ...