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Del Monte Fresh Produce N.A., Inc. v. United States

April 19, 2010


The opinion of the court was delivered by: Henry H. Kennedy, Jr. United States District Judge


Del Monte Fresh Produce N.A., Inc. ("Del Monte") brings this action against the United States of America, alleging that the U.S. Food and Drug Administration ("FDA") has engaged in an unlawful pattern and practice of delay in sampling and inspecting Del Monte's produce for import to the United States. Del Monte seeks injunctive and declaratory relief pursuant to section 706(1) of the Administrative Procedure Act ("APA"), 5 U.S.C. § 701 et seq.. Before the Court is the motion of the United States to dismiss Del Monte's complaint [#10]. Upon consideration of the motion, the opposition thereto, and the record of this case, the Court concludes that the motion should be granted.


A. Statutory and Regulatory Background

1. FDA Inspection of Imported Food

The FDA has authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., to sample and inspect, inter alia, food an importer seeks to bring into the United States. 21 U.S.C. § 381(a). If the FDA determines that "it appears from the examination of such samples or otherwise" that the food "has been manufactured, processed, or packed under insanitary conditions" or is otherwise prohibited from entry under other sections of the U.S. Code, the food "shall be refused admission" to the United States. Id. FDA regulations provide that when the FDA requests "a sample of an article offered for import" for examination, the U.S. Bureau of Customs and Border Protection*fn1 "shall give to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample." Food and Drugs, Imports and Exports, 21 C.F.R. § 1.90; see also 21 U.S.C. § 381(a) (requiring such notice to the importer). The owner of the article "shall hold such article and not distribute it until further notice . . . of the results of examination of the sample." 21 C.F.R. § 1.90. It is the FDA's practice to issue a "Notice of Action" alerting an importer of its decision to release a particular shipment for, or to reject it from, import.

2. Suits for Agency Failure to Act

A party may sue under the APA if she is "suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute." 5 U.S.C. § 702. In the context of this provision and this case, "agency action" means "final agency action" and is defined as "the whole or a part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act." Id. §§ 704, 551(13) (emphasis added).

Pursuant to section 706(1) of the APA, if a party brings a claim arising from an agency's failure to act, a court may grant relief by "compel[ling] agency action unlawfully withheld or unreasonably delayed." Id. § 706(1).

The Supreme Court has made clear that a claim for relief under section 706(1) is limited to challenges to the omission of (1) "a discrete action" that is (2) "legally required." Norton v. S. Utah Wilderness Alliance ("SUWA"), 542 U.S. 55, 63 (2004) (emphasis in original). The Court has further explained that "[t]he limitation to discrete agency action precludes the kind of broad programmatic attack [the Court] rejected in Lujan v. National Wildlife Federation" ("Lujan"), 497 U.S. 871 (1990), id., in which it held that a party "cannot seek wholesale improvement of [an agency] program by court decree, rather than in the office of the Department or the halls of Congress," Lujan, 497 U.S. at 891 (emphasis in original).

B. Factual Background

Del Monte imports fresh produce into the United States and is therefore subject to the FDA's occasional inspection of samples of the fruits or vegetables it seeks to bring into the country. The basis of this action is Del Monte's allegation that the FDA often allows too much time to pass before completing those inspections, causing Del Monte's produce to become less fresh and therefore to lose value. As examples of this delay, Del Monte describes six instances between early 2008 and early 2009 in which the FDA requested a sample of a shipment of produce-specifically, in each instance, either bananas, cantaloupes, or plantains-and did not issue the resulting Notice of Action to Del Monte until so many days had passed-specifically, between six and eleven-that Del Monte was harmed.

Del Monte asserts in this action that "[s]ince at least 2006, FDA has engaged in, and continues to engage in, a pattern and practice of unreasonably and/or unlawfully delaying sampling, inspection, examination and release of perishable fresh produce imported or offered by Del Monte for import into the United States." Compl. ¶ 8.*fn2 Del Monte requests that the Court "[i]ssue an injunction compelling FDA to cease unreasonable and/or unlawful delay in sampling, inspecting, examining and releasing food that Del Monte seeks to import into the United States" and "[i]ssue a declaratory ...

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