Opinion ID: 724943
Heading Depth: 1
Heading Rank: 4

Heading: Manufacture of Veterinary Drugs as a Closely Regulated Industry

Text: 14 In New York v. Burger, 482 U.S. at 702-03, 107 S.Ct. at 2643-44, the Supreme Court set forth the standards for determining when the Colonnade-Biswell exception applies. 1 A warrantless inspection will be deemed reasonable only if the business is closely regulated and if three criteria are met: 15 First, there must be a substantial government interest that informs the regulatory scheme pursuant to which the inspection is made.... 16 Second, the warrantless inspections must be necessary to further [the] regulatory scheme. ... 17 Finally, the statute's inspection program, in terms of the certainty and regularity of its application, [must] provid[e] a constitutionally adequate substitute for a warrant. 18 Burger, 482 U.S. at 702-03, 107 S.Ct. at 2644 (quoting Donovan v. Dewey, 452 U.S. 594, 600, 602-03, 101 S.Ct. 2534, 2540, 69 L.Ed.2d 262 (1981)). We conclude that all of these standards are met in this case. 19 As a threshold matter, the veterinary drug industry is closely regulated. See generally 21 U.S.C. §§ 301-392; 21 C.F.R. Pts. 200-599. The Food, Drug, and Cosmetic Act prohibits the adulteration or misbranding of any drug, 21 U.S.C. § 331(b), whether that drug is intended for use by either humans or animals, 21 U.S.C. § 321(g)(1)(B). [V]irtually every phase of the drug industry is heavily regulated, from packaging, labeling, and certification of expiration dates, to prior FDA approval before new drugs can be marketed. United States v. Jamieson-McKames Pharmaceuticals, Inc., 651 F.2d 532, 537 (8th Cir.1981) (footnotes omitted), cert. denied, 455 U.S. 1016, 102 S.Ct. 1709, 72 L.Ed.2d 133 (1982); see, e.g., 21 U.S.C. § 351(a) (regulating manufacture), § 351(b) (regulating strength, quality, and purity), § 352(a), (b), (f), (g), (h), (p) (regulating packaging and labeling), § 355 (new drug approvals), § 360b (regulating new animal drug approvals). Regulations implementing the Act are quite extensive. See generally 21 C.F.R. Pts. 200-599. For example, good manufacturing practices for the preparation of human and animal drugs are set forth in detail. See 21 C.F.R. Pts. 210, 211. 2 The veterinary drug industry is certainly regulated as extensively as the vehicle dismantling industry, which the Supreme Court has held to be closely regulated. See Burger, 482 U.S. at 703-04, 107 S.Ct. at 2644-45. 20 Although duration of a particular regulatory scheme has some relevancy in determining whether an industry is closely regulated, Burger, 482 U.S. at 705, 107 S.Ct. at 2645, it is the pervasiveness and regularity of the federal regulation that ultimately determines whether a warrant is necessary. Donovan, 452 U.S. at 606, 101 S.Ct. at 2542. The pervasiveness and regularity of the current regulatory scheme is sufficient to make it closely regulated under Burger wholly apart from any consideration of duration. 3 21 FDA regulation of Argent's industry also meets the three enumerated criteria of Burger. First, there is a 'substantial' government interest that informs the regulatory scheme pursuant to which the inspection is made. Burger, 482 U.S. at 702, 107 S.Ct. at 2644. Argent argues that in some respects animal drug provisions are less stringent than human drug provisions, compare 21 U.S.C. § 355 (new drugs) with 21 U.S.C. § 360b (new animal drugs), and that regulation of animal drugs is primarily motivated by economic considerations rather than human safety, see 1 James T. O'Reilly, Food and Drug Administration § 16.01, at 16-3 & n. 9 (2d ed. 1995). Neither argument suggests that the government lacks a substantial interest in ensuring the safety and effectiveness of animal drugs. Congress has seen fit, either for human safety or for economic reasons, to regulate animal drugs to ensure their safety and effectiveness. Whether the interest is human health, economic health, or both, we conclude that it is substantial. 22 Second, the warrantless inspections [are] 'necessary to further [the] regulatory scheme.'  Burger, 482 U.S. at 702, 107 S.Ct. at 2644 (quoting Donovan, 452 U.S. at 600, 101 S.Ct. at 2539). Unannounced inspections have a deterrent effect; forcing inspectors to obtain a warrant before inspection might frustrate the purpose of the Act by alerting owners to inspections. See id. at 702-03, 107 S.Ct. at 2643-44; Biswell, 406 U.S. at 316, 92 S.Ct. at 1596. Moreover, this court has recognized the need for swift governmental action to remove misbranded products from the stream of commerce. United States v. An Article of Device Theramatic, 715 F.2d 1339, 1343 (9th Cir.1983) (Theramatic II ), cert. denied sub nom. Cloward v. United States, 465 U.S. 1025, 104 S.Ct. 1281, 79 L.Ed.2d 685 (1984). Thus, warrantless searches and seizures are necessary to further the regulatory scheme that ensures the integrity of veterinary drugs. 23 Finally, the regulatory scheme,  'in terms of the certainty and regularity of its application, [provides] a constitutionally adequate substitute for a warrant,'  thereby satisfying the third Burger requirement. Burger, 482 U.S. at 703, 107 S.Ct. at 2644 (quoting Donovan, 452 U.S. at 603, 101 S.Ct. at 2540). [T]he regulatory statute must perform the two basic functions of a warrant: it must advise the owner of the commercial premises that the search is being made pursuant to the law and has a properly defined scope, and it must limit the discretion of the inspecting officers. Id. Taken as a whole, the Act, the accompanying regulations, and the Supplemental Rules for Certain Admiralty and Maritime Claims provide a constitutionally adequate substitute for a warrant. Inspections are conducted with notice furnished at the time, and their scope is limited by statute. 21 U.S.C. § 374(a)(1). Seizures are limited to drugs that are adulterated or misbranded, 21 U.S.C. § 334(a)(1), the articles to be seized must be described with reasonable particularity, Supplemental Rules C(2), and the government's complaint must be verified on oath or solemn affirmation, id. Moreover, in most cases, the seizure is subject to the approval of one of the Food and Drug Administration's district offices, the appropriate office (or center) in the Food and Drug Administration headquarters, the Food and Drug Administration's Office of Enforcement, the Office of the Chief Counsel, and the Department of Justice. See FDA Regulatory Procedures Manual, ch. 6, at 173-85 (Aug. 1995). 4 24 We conclude, therefore, that Argent's operation, as regulated by the FDA, falls within the Colonnade-Biswell exception to the Fourth Amendment's warrant requirement. 25