Opinion ID: 187230
Heading Depth: 3
Heading Rank: 1

Heading: USDA's use regulations[8]

Text: We first address the question whether USDA can regulate the use of biological products under VSTA. VSTA authorizes USDA to promulgate regulations under two circumstances set forth in 21 U.S.C. § 154. First, section 154 authorizes USDA to promulgate such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment ... of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals. 21 U.S.C. § 154. This language authorizes regulations directed at discrete activities preparation, sale, barter, exchange and shipmentand discrete productsviruses, serums, toxins or analogous products. [9] But this language is also limited to products that are worthless, contaminated, dangerous, or harmful and plainly the rapid BSE test kit cannot be so described. Section 154 further provides that USDA may promulgate such rules and regulations as may be necessary ... otherwise to carry out this chapter. Id. USDA contends that under Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), this broad language authorizes it to regulate the use of biological products. We conclude instead that the applicable standard of review is that set out in Skidmore v. Swift & Co., 323 U.S. 134, 65 S.Ct. 161, 89 L.Ed. 124 (1944). Ordinarily, we review an agency's interpretation of a statute that it administers under Chevron. We first ask whether Congress has directly spoken to the precise question at issue. Id. at 842, 104 S.Ct. 2778. If so, that is the end of the matter and we must give effect to the unambiguously expressed intent of Congress. Id. at 842-43, 104 S.Ct. 2778. However, if the statute is silent or ambiguous with respect to the specific issue, we move to the second step and must defer to the agency's interpretation as long as it is based on a permissible construction of the statute. Id. at 843, 104 S.Ct. 2778. In this case, however, we agree with Creekstone that Chevron does not apply to the otherwise to carry out language because that language was not added to the statute until 1985, see Food Security Act of 1985, Pub.L. No. 99-198, § 1768(b), 99 Stat. 1354, 1654 (1985)almost ten years after USDA promulgated the predecessor of section 102.5(d). See Deletion of Special Licenses, 41 Fed.Reg. 44,358, 44,359 (Oct. 8, 1976). USDA may not reasonably rely on statutory language that did not exist when it first adopted its regulation. See Pub. Citizen, Inc. v. U.S. Dep't of Health & Human Servs., 332 F.3d 654, 659 (D.C.Cir.2003) (applying Skidmore deference to regulation promulgated before amendment of statute). As the district court correctly noted, however, even without Chevron deference, USDA's use regulations nonetheless remain[] entitled to a `degree of deference' under Skidmore v. Swift & Co., 323 U.S. 134, 65 S.Ct. 161, 89 L.Ed. 124 (1944). 517 F.Supp.2d at 14 (quoting Pub. Citizen, 332 F.3d at 662). Under Skidmore, `[t]he weight [accorded to an administrative judgment] in a particular case will depend upon the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control.' United States v. Mead Corp., 533 U.S. 218, 228, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001) (quoting Skidmore, 323 U.S. at 140, 65 S.Ct. 161) (second alteration in Mead ); see Am. Fed'n of Gov't Employees v. Veneman, 284 F.3d 125, 129 (D.C.Cir.2002) (under Skidmore USDA's view ... constitutes `a body of experience and informed judgment' to which we may properly resort for guidance (quoting Skidmore, 323 U.S. at 140, 65 S.Ct. 161)). USDA's promulgation of section 102.5(d) satisfies Skidmore's standard. As previously noted, section 102.5(d) provides that, once the APHIS Administrator determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a product, the product shall be subject to such additional restrictions as are prescribed on the license, including limits on the distribution of the product. 9 C.F.R. § 102.5(d) (emphases added). We believe regulation 102.5(d), which permits restrictions on the use of biological products, reflects considered agency deliberation, has been consistently applied since 1976 and is reasonably related to the purposes of VSTA, namely, to ensure the safety and efficacy of any product that is intended to be used in treating domestic animals. See, e.g., 21 U.S.C. §§ 151 (making it illegal to prepare, sell, barter, exchange, or ship ... any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals, unless ... [it] shall have been prepared, under and in compliance with regulations prescribed by the Secretary) (emphases added), 152 (requiring USDA permit to import  any virus, serum, toxin, or analogous product for use in the treatment of domestic animals ) (emphases added), 153 (authorizing Secretary to inspect  all viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, which are being imported or offered for importation into the United States) (emphases added), 155 (authorizing Secretary to issue permits for the importation into the United States of viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, which are not worthless, contaminated, dangerous or harmful ) (emphasis added); see Fed. Express Corp. v. Holowecki, ___ U.S. ___, 128 S.Ct. 1147, 1156-57, 170 L.Ed.2d 10 (2008) (according Skidmore deference to agency interpretive position that was reasonable, consistent with the statutory framework and consistently applied for 5 years). Accordingly, we find section 102.5(d) is authorized and is entitled to Skidmore deference. Creekstone also challenges USDA's interpretation of section 104.1. Section 104.1 provides that [n]o biological product shall be brought into the United States unless a permit has been issued for such product by the Administrator. Id. § 104.1. Although section 104.1 does not expressly provide that the Administrator can deny an import permit based on the product's intended use (in this case, sales to Creekstone), USDA so interprets the regulation. We believe USDA's interpretation of section 104.1 is not inconsistent with the regulation and therefore entitled to deference. See, e.g., Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512, 114 S.Ct. 2381, 129 L.Ed.2d 405 (1994) (We must give substantial deference to an agency's interpretation of its own regulations... unless it is plainly erroneous or inconsistent with the regulation. (quotation omitted)); Gardebring v. Jenkins, 485 U.S. 415, 430, 108 S.Ct. 1306, 99 L.Ed.2d 515 (1988). We are not persuaded by Creekstone's arguments to the contrary. Creekstone first invokes the expressio unius est exclusio alterius canon of statutory construction to assert that the omission of use from VSTA's provisions precludes USDA from promulgating a use regulation. With a statute like VSTA, however, which contains broad language authorizing the agency to promulgate regulations necessary to carry out the statute, we believe the doctrine has minimal, if any, application. See Cheney R.R. v. ICC, 902 F.2d 66, 69 (D.C.Cir.1990) (Whatever its general force, we think [ expressio unius ] an especially feeble helper in an administrative setting, where Congress is presumed to have left to reasonable agency discretion questions that it has not directly resolved.); Tex. Rural Legal Aid, Inc. v. Legal Servs. Corp., 940 F.2d 685, 694 (D.C.Cir.1991) (Whatever its usefulness in other circumstances ... this canon has little force in the administrative setting.); see also NLRB v. Beverly Enters.-Mass., 174 F.3d 13, 32 (1st Cir.1999); Ragsdale v. Wolverine World Wide, Inc., 535 U.S. 81, 97, 102, 122 S.Ct. 1155, 152 L.Ed.2d 167 (2002) (O'Connor, J., dissenting) (arguing that  expressio unius ought to have somewhat reduced force in th[e] context of statute authorizing agency to `prescribe such regulations as are necessary to carry out' the Act (quoting 29 U.S.C. § 2654)). Nevertheless, Creekstone argues that section 154's otherwise to carry out language cannot support the use regulations because, as previously noted, the otherwise to carry out language was not added to section 154 until almost ten years after USDA first asserted the authority to regulate the use of biological products. As the district court correctly noted, however, the argument cuts both ways. 517 F.Supp.2d at 13 n. 6. Because section 102.5(d) was already in effect when the Congress amended VSTA in 1985, it had the opportunity to alter the regulation but did not do so. See Doris Day Animal League v. Veneman, 315 F.3d 297, 300 (D.C.Cir.2003) (`[W]hen Congress revisits a statute giving rise to a longstanding administrative interpretation without pertinent change, the congressional failure to revise or repeal the agency's interpretation is persuasive evidence that the interpretation is the one intended by Congress.' (quoting Commodity Futures Trading Comm'n v. Schor, 478 U.S. 833, 846, 106 S.Ct. 3245, 92 L.Ed.2d 675 (1986) (quotation omitted))). But Creekstone asserts that the 1985 amendment does not satisfy the requirements of the legislative reenactment doctrine because the application of the legislative reenacement doctrine requires a showing of both congressional awareness and express congressional approval of an administrative interpretation if it is to be viewed as statutorily mandated. Gen. Am. Transp. Corp. v. ICC, 872 F.2d 1048, 1053 (D.C.Cir.1989) (quotation omitted). Even assuming the 1985 amendment does not satisfy the legislative reenactment doctrine, however, the Congress's 1985 decision to leave section 102.5(d) undisturbed is persuasive evidence that it is consistent with congressional intent. See NLRB v. Bell Aerospace Co. Div. of Textron, Inc., 416 U.S. 267, 274-75, 94 S.Ct. 1757, 40 L.Ed.2d 134 (1974) ([A] court may accord great weight to the longstanding interpretation placed on a statute by an agency charged with its administration. (footnote omitted)). [10] Creekstone also argues that VSTA's legislative history demonstrates that the Congress intended to regulate manufacturers and importers of biological products, not users like Creekstone. Creekstone cites the 1913 testimony of A.M. Farrington, Assistant Chief of the Bureau of Animal Industry, before the House Committee on Agriculture, to the effect that VSTA was meant to allow USDA to regulate the preparation and marketing of biological products. See Agriculture Appropriation Bill: Hearings Before the Senate Comm. on Agric., 62d Cong. 23-24 (1913) (testimony of A.M. Farrington, Asst. Chief, Bureau of Animal Indus., USDA). We are not persuaded. The legislative history of VSTA is extremely sparse, Animal Health Inst. v. USDA, 487 F.Supp. 376, 378 (D.Co.1980), and the history that does exist does not conclusively support either interpretation. See, e.g., S.Rep. No. 62-1288, at 2 (1913) (VSTA is intended to control[] use [] by preventing the interstate shipment[] of dangerous drugs. (emphasis added)). In any event, whether a use regulation was contemplated by the Congress in 1913, we believe the Congress subsequently endorsed the same in 1985. Finally, Creekstone argues that the Agricultural Bioterrorism Protection Act of 2002 (ABPA) [11] supports its claim that VSTA does not authorize a use regulation. ABPA gives the Secretary authority to regulate each biological agent and each toxin that [he] determines has the potential to pose a severe threat to animal or plant health. 7 U.S.C. § 8401(a)(1)(A). The House Conference Report accompanying ABPA noted that the legislation was needed, in part, because of the inadequacy of the penalty provisions of [VSTA] enacted in 1913 and under which USDA currently regulates these dangerous agentsas well as the lack of authority for the Secretary of Agriculture to regulate possession of biological agents and toxins that pose a severe threat to plant or animal health. H.R.Rep. No. 107-481, at 124 (2002), U.S.Code Cong. & Admin.News 2002, pp. 464, 481 (Conf.Rep.) (emphasis added). According to Creekstone, the Report shows the Congress did not believe that VSTA gives USDA the authority to regulate the use of biological products. We disagree. First, ABPA governs only those substances that pose a severe threat to plant or animal health. VSTA, by contrast, encompasses all biological products intended for use in the treatment of domestic animals. 21 U.S.C. §§ 151, 152. Further, the Congress effectively refuted Creekstone's interpretation by specifically exempting from ABPA products already regulated under VSTA. See 7 U.S.C. § 8401(g)(1)(C).