are not the kind of conduct that can be said to be grounded in the policy of the regulatory regime. The focus of the inquiry is not on the agent's subjective intent in exercising the discretion conferred by statute or regulation, but on the nature of the actions taken and on whether they are susceptible to policy analysis.
111 S. Ct. at 1274-75. When applicable regulations provide federal employees with discretion, it must be presumed that an action taken under the regulation is cloaked within the policies upon which the regulation was established. Id. at 1274. "A discretionary act is one that involves choice or judgment; there is nothing in that description that refers exclusively to policy making or planning functions." Id. at 1275. If the Court finds that discretionary actions are grounded in the policies of the agency's regulations, the agency is protected by the discretionary function exception.
Under this analysis, negligence is not a consideration. General Public Utilities Corp. v. United States, 745 F.2d 239, 243 (3d Cir. 1984), cert. denied, 469 U.S. 1228, 84 L. Ed. 2d 365, 105 S. Ct. 1227 (1985). Therefore, the Court cannot consider alleged violations of a laboratory procedures manual because this argument simply is the basis of the plaintiffs' claim of negligence. The proper focus under the discretionary function exception is on the discretion provided by the regulations, statutes and policies of the FDA. Gaubert, 111 S. Ct. at 1274.
The mission of the FDA is the protection of public health. United States v. Bacto-Unidisk, 394 U.S. 784, 798, 22 L. Ed. 2d 726, 89 S. Ct. 1410 (1969). The enforcement provisions of the Federal Food, Drug, and Cosmetics Act ("FFDCA"), 21 U.S.C. §§ 301-394, "commit complete discretion to the Secretary to decide how and when they should be exercised." Heckler v. Chaney, 470 U.S. 821, 835, 84 L. Ed. 2d 714, 105 S. Ct. 1649 (1985). The FFDCA prohibits the "introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated . . ." 21 U.S.C. § 331(a). The FFDCA classifies food as adulterated when the food "bears or contains any poisonous or deleterious substance which may render it injurious to health . . ." 21 U.S.C. § 342(a)(1). The authority to ensure that imported foods meet the standards set by the Act has been delegated from the Secretary of Health and Human Services to the FDA. 21 C.F.R. § 5.10(a)(1).
The FFDCA permits the Secretary of Health and Human Services to request samples of food which are being imported or offered for import into the United States. 21 U.S.C. § 381. However, it does not require such action. Section 381(a), in pertinent part, provides:
The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. . . If it appears from the examination of such samples or otherwise that . . . (3) such article is adulterated, misbranded, or in violation of section 355 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this subsection shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act [ 21 U.S.C.A. s 951 et seq.].
21 U.S.C. § 381(a). Further, the plain language of § 381 of the FFDCA does not limit the FDA in its determination of adulteration solely by an examination of samples. As § 381 provides, the FDA may refuse admission of food into the United States "if it appears from the examination of such samples or otherwise that . . . such article is adulterated . . ." 21 U.S.C. § 381. (emphasis added). Therefore, the language of the statute clearly affords the FDA with the discretion to act without requesting or relying on the results of the testing of samples.
Under this authorization, FDA had the discretion to act during the Chilean grape crisis. The FDA acted to protect the public from the risk of exposure to poisonous fruit which it learned could be coming from Chile. It had the discretion to test the fruit and determine whether the fruit was adulterated. It also had the discretion to refuse entry into the United States. The actions taken were not violative of any regulatory or statutory provisions. The acts taken were in accordance with the FDA's authority to determine whether or not a specific product should be allowed entrance into the United States. This conduct is grounded in the policy of protecting the public health. The actions were clearly in furtherance of the FDA's statutory mission to protect the American public from adulterated food. All the acts involved judgment and choice and were grounded in policy.
Accordingly, the FDA is protected by the discretionary function exception of 28 U.S.C. § 2680(a). Therefore, the Court lacks subject-matter jurisdiction.
An appropriate Order follows.
AND NOW, this 29th day of December, 1992, upon consideration of Defendant United States of America's Motion to Dismiss and the responses thereto, IT IS HEREBY ORDERED that Defendant's Motion is GRANTED.
IT IS FURTHER ORDERED that the following Complaints are DISMISSED WITH PREJUDICE :
(1) Compania Sud Americana De Vapores v. United States, Civil Action No. 92-1208;
(2) Carben, Inc. v. United States, Civil Action No. 92-1204;
(3) New Market Invest Corp. v. United States, Civil Action No. 92-1279; and
(4) Fisher Bros. Sales, Inc. v. United States, Civil Action No. 92-2818;
BY THE COURT:
HERBERT J. HUTTON, J.