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Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 1 of 52 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA Plaintiff, ) vs. ) Civil Action No. 06-544 (JR) UNITED STATES DEPARTMENT OF AGRICULTURE, ) and MIKE JOHANNS, IN HIS CAPACITY AS THE ) SECRETARY OF AGRICULTURE, ) Defendants. ) _________________________________________________ ) REPLY IN SUPPORT OF PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT AND OPPOSITION TO DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 2 of 52 TABLE OF CONTENTS SUMMARY OF ARGUMENT......................................................................................................................4 I. THIS COURT HAS JURISDICTION TO HEAR CREEKSTONE’S CLAIMS.4 A. Creekstone’s Claims Are Not Moot. B. Creekstone Has Standing To Present Its Claims. II. USDA’S EXPANSIVE INTERPRETATION OF THE VSTA TO APPLY TO DIAGNOSTIC TESTS AND TO THE USE OF BIOLOGICAL PRODUCTS IS UNPERSUASIVE AND NOT ENTITLED TO DEFERENCE.....................10 A. The VSTA Is Neither Ambiguous Nor Susceptible to USDA’s Interpretations...............................................................................................10 2. Regulation of Diagnostic B. USDA’s Expansive Interpretation of the VSTA Is Not Entitled to Deference. Authority.............................................................................................21 Explication..........................................................................................22 Contemporaneous or C. The Reenactment Doctrine Does Not Save USDA’s Unsupported Interpretation of the VSTA IN PARTICULAR B. BSE Test Kits Are Not, and Would Not Be, Used in the Treatment of Animal Disease IV. USDA’S RESTRICTIONS ON BSE TEST KITS ON ECONOMIC GROUNDS ARE OUTSIDE ITS AUTHORITY UNDER THE VSTA V. USDA IS NOT ENTITLED TO SUMMARY JUDGMENT ..............................45 CONCLUSION EXHIBIT 1 Supplemental Declaration of John D. Stewart EXHIBIT 2 Declaration of Boyd R. Oase of Kowalski’s Markets EXHIBIT 3 Declaration of James R. Kiley of Wild by Nature Markets EXHIBIT 4 Declaration of Darin Parker of Parker International Inc. EXHIBIT 5 Declaration of Kyu O Kim of NY-SK Trading, LLC EXHIBIT 6 Declaration of Steve Erdley of Penn Traffic Company EXHIBIT 7 Hearing before the Committee on Agriculture on the Estimates of Appropriations for the Fiscal Year Ending June 30, 1914, H.R. 28283, 62d Cong. 20-32 (1913) (testimony of Dr. A.M. Farrington, Asst. Chief, Bureau of Animal Indus., Dept. of Agric.) EXHIBIT 8 Declaration of Paul W. Brown, M.D. EXHIBIT 9 Report on the Monitoring and Testing of Ruminants for the Transmissible Spongiform Encephalopathy (TSE) in the EU in 2005 EXHIBIT 10 Declaration of Linda A. Detwiler, D.V.M. EXHIBIT 11 Supervie and Castagliola, “The Unrecognized French BSE Vet. Res. 349-362 (2004) iii Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 4 of 52 TABLE OF AUTHORITIES 1 FEDERAL CASES 62 Cases of Jam v. United States, 340 U.S. 593 (1951) AFL-CIO v. Brock, 835 F.2d 912 (D.C. Cir. 1987) *Adamo Wrecking Co. v. United States, 434 U.S. 275 (1978) American Fin. Servs. Ass'n v. FTC, 767 F.2d 957 ), cert. denied, 475 (1986 American Petroleum Institute v. EPA, 52 F.3d 1113 (D.C. Cir. 1995) *Animal Health Institute v. USDA, 487 F. Supp. 376 (D. Colo. 1980) Area Transp., Inc. v. Ettinger, 219 F.3d 671 (7th Cir. 2000) Arnold v. Intervet, Inc., 305 F. Supp. 2d 548 (D. Md. Babbitt v. Sweet Home Chapter of Communities for a Greater Oregon, 515 U.S. 687 *Barnett v. Weinberger, 818 F.2d 953 (D.C. Cir. 1987) Better Government Assoc. v. U.S. Dept. of Interior, 780 F.2d 86 (D.C. *Bowen v. Georgetown Univ. Hospital, 488 U.S. 204 Burlington Northern R.R. Co. v. Surface Transportation Bd., 75 F.3d 685, (D.C. Cir. 1996) 164 Lorillard v. Pons, 434 U.S. 575 (1978) Chevron. Public Citizen, Inc. v. U.S. Dept. of Health and Human F.3d 654 (D.C. Cir. Christensen v. Harris Cty., 529 U.S. 576 *City of Chicago v. Environmental Defense Fund, 511 U.S. 328 City of New Haven v. HUD, 809 F.2d 900 (D.C. Cir. 1987) Continental Airlines, Inc. v. U.S. Department of Transportation , 856 (D.C. Cir. 1988) Edward J. DeBartolo Corp. v. Florida Gulf Coast Building & Constr. Trades Council, 485 U.S. 568 (1988) Engine Mfrs. Ass'n v. EPA, 88 F.3d 1075 (D.C. Cir. Ethyl Corp. v. EPA, 51 F.3d 1053 (D.C. Cir. 1995) *ExxonMobil Gas Marketing Co. v. FERC, 297 F.3d 1071 (D.C. Cir. *FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) Federal National Mortgage Ass'n v. United States, 56 Fed. Cl. 228 (Ct. 2003) *Friends of the Earth, Inc. v. EPA, 446 F.3d 140 (D.C. Cir. 2006) *Friends of the Earth v. Laidlaw, 528 U.S. 167 (2000) *Garrelts v. Smithkline Beecham Corp., 943 F. Supp. 1023 (N. D. Ia. *General American Transp. Corp. v. ICC, 872 F.2d 1048 (DC Circuit 1989) 1 Asterisk denotes authorities principally relied on. iv Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 5 of 52 Gettman v. DEA, 290 F.3d 430 (D.C. Cir. *Grand Laboratories, Inc. v. Harris, 488 F. Supp. 618, 619 (D.S.D. on other grounds, 660 F.2d 1288 (8th Cir. Independent Insurance Agents of America, Inc. v. Hawke, 211 F.3d 638 International Union, UAW v. Brock, 816 F.2d 761 (D.C. Cir. Investment Co. Inst. v. Camp, 401 U.S. 617 (1971) *John Hancock Mut. Life Ins. Co. v. Harris Trust & Sav. Bank, 510 U.S. 86 (1993)..........................................................................................................................22 (1995)].........................................................................................................................17 Koszola v. F.D.I.C., 393 F.3d 1294 (D.C. Cir. Lorillard v. Pons, 434 U.S. 575 (1978) *Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) Lynn Martin v. Occupational Safety and Health Review Commission, 499 U.S. 144 F.3d 52 (D.C. Cir. *Michigan Citizens for an Independent Press v. Thornburgh, 868 F.2d 1285 (D.C. Cir. 1989) Michigan v. EPA, 268 F.3d 1075 (D.C. Cir. Miller v. AT&T Corp., 250 F.3d 820 (4th Cir. 2001) *Natural Resources Defense Council v. Reilly, 983 F.2d 259 (D.C. Cir. Pacific Power & Light Co. v. FPC, 184 F.2d 272 (D.C. Cir. PanAmSat Corp. v. F.C.C., 198 F.3d 890 (D.C. Cir. 1999) Pegram v. Herdrich, 530 U.S. 211 Public Citizen, Inc. v. U.S. Dept. of Health and Human Services, 332 662 (D.C. Cir. 2003) denied, 514 U.S. 1032 (1995) *Railway Labor Executives' Ass'n v. National Mediation Bd., 988 F.2d 133 Cir. 1993), aff'd on rehearing en banc, 29 F.3d 655 (1994), cert. U.S. 1032 Reno v. Flores, 507 U.S. 292 (1993) Rodriguez v. United States, 480 U.S. 522 (1987) *SEC v. Sloan, 436 U.S. 103 Sea-Land Serv., Inc. v. Dep't of Transp., 137 F.3d 640 (D.C. Cir. Sea Robin Pipeline Co. v. FERC, 127 F.3d 365 (5th Cir. 1997) *Sierra Club v. Morton, 405 U.S. 727 (1972) Solid Waste Agency of Northern Cook County v. U.S. Army Corps of Engineers, 531 U.S. 159 Texas & Pacific Railway Co. v. Pottorff, 291 U.S. 245 United States v. Mead, 533 U.S. 218 (2001) *Whitman v. American Trucking Ass'ns, 531 U.S. 457 Whitmore v. Arkansas, 495 U.S. 149 (1990) STATE CASES v Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 6 of 52 *Hall v. Nebraska, 100 Neb. 84, 158 N.W. 362 (1916) STATUTES Administrative Procedure Act, 5 U.S.C. § 706(2) Act of July 1, 1902, ch. 1378, 32 Stat. Agricultural Bioterrorism Protection Act of 2002, 7 U.S.C. § 8401 Virus Serum Toxin Act, 21 U.S.C. §§ 21 U.S.C. § 21 U.S.C. § 21 U.S.C. § 21 U.S.C. § 28 U.S.C. § 2680(b) 29 U.S.C. § 2611(11) P.L. 99-198, 99 Stat. Sections 211-213 of the Public Health Security and Bioterrorism and Response Act of 2002, P.L. 107-188, 116 Stat. 647 REGULATORY MATERIALS 9 C.F.R. Chapter I Subchapter 9 C.F.R. § 101.2(2) 9 C.F.R. § 102.5(d) 9 C.F.R. § 29 C.F.R. § 825.114(b) 62 Fed. Reg. 31,326 (June 9, 1997) 70 Fed. Reg. 460, 461 (Jan. 4, 2005) LEGISLATIVE MATERIALS Hearing before the Committee on Agriculture on the Estimates of for the Fiscal Year Ending June 30, 1914, H.R. 28283, 62d Cong. 20-32 (1913) (Reply Memo Exh. S. Rep. No. MISCELLANEOUS OIE Terrestrial Animal Health Code – 2005, Appendix 3.8.4, Surveillance for Bovine Spongiform Encephalopathy Report on the Monitoring and Testing of Ruminants for the Presence of Transmissible Spongiform Encephalopathy (TSE) in the EU in Supervie and Castagliola, "The Unrecognized French BSE Epidemic," 35 Vet. Res. 349-362 2B Sutherland Stat. Constr. § vi Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 7 of 52 SUMMARY OF ARGUMENT With hardly a word of analysis (prior to this case), the Department of (“USDA”) has interpreted a statute designed to keep companies from fraudulent vaccines and serums for treatment of diseases in animals as of authority to restrict or preclude activities related in any way to appropriate to uphold such an action on the basis of post hoc those rationalizations are inconsistent with basic principles of citation or plausible support, and in some instances simply do not make For example, USDA’s argument that this case is moot is based entirely on improper characterization of plaintiff Creekstone Farms Premium Beef’s attempt by Creekstone to export beef to Japan. Neither the Complaint, Summary Judgment, nor the Declaration filed by Creekstone’s founder and characterized Creekstone’s claims that narrowly. To the contrary, strong, valid reasons for wanting to use BSE test kits. USDA’s claim that Creekstone lacks standing rests on a similarly narrow this case is about and the relief Creekstone is seeking. Clearly benefits to its business of testing all its cattle for BSE warrants the testing, is suffering both economic and non-economic injuries from allow Creekstone access to BSE test kits, injuries that this Court striking down USDA’s restrictions on BSE test kit use. USDA’s defense of its regulations restricting the use of diagnostic actions concerning BSE test kits in particular, is based on a convoluted Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 8 of 52 language of the VSTA and on its observation that Congress did not from regulating BSE test kits. But the Supreme Court and the U.S. Court District of Columbia have consistently rejected such attempts to find from the absence of a prohibition. The VSTA on its face does not extend use of biological products, nor the restriction of access to diagnostic tests, like the BSE test kits at issue here, which do not operate immune system). USDA’s interpretation of the VSTA is not subject to expands the Department’s authority beyond the literal bounds of the contemporaneous interpretation of the statute but rather one that USDA (3) USDA’s regulations were not accompanied by any analysis of the or legislative history, or really by any explanation; and (4) at least and to BSE test kits in particular, USDA’s regulations were not any similar formal pronouncement. But even if USDA’s regulatory authority under the VSTA extended to uses biological products, and for what purpose, and to regulating manner analogous to viruses, serums, or toxins, USDA cannot legally ban test kits. First, BSE test kits do not function as “analogous products;” used in the treatment of an animal disease. (In fact, USDA claims it can using BSE test kits precisely because they are not being used in the using BSE test kits to screen cattle slaughtered for human consumption them “worthless.” To the contrary, even USDA’s improperly limited view testing admits that testing can identify carcasses infected with this cattle would have any outward signs of BSE that might keep them out of - 2 - renowned BSE experts submitting declarations in support of this Reply the benefits of more extensive BSE testing, a practice adopted by almost world that has been exposed to BSE. Finally, even assuming that USDA’s regulations were authorized by the assuming also that USDA could, consistent with the VSTA, assert BSE test kits in particular, USDA’s filings in this case now make it really regulating BSE test kits in order to protect animal health or well-being of farmers and ranchers. Rather, USDA is trying to protect competition that Creekstone and others who want to test will pose. Put wants to deprive American consumers of the opportunity to buy beef from This goal not only is far beyond what Congress authorized in the VSTA, tenets about the role of government to protect competition and foster economy. For any one of these reasons, Creekstone is entitled to summary judgment that USDA’s actions preventing Creekstone from conducting BSE tests on slaughters are beyond USDA’s statutory authority. Moreover, even if the determine that Creekstone has not demonstrated that it is entitled to those claims, that still would not mean that USDA has carried its burden judgment for USDA on those claims. Nor, of course, would it mean that summary judgment on Creekstone’s third claim: that USDA acted even if it was within its statutory authority—a claim that has yet to be - 3 - ARGUMENT I. THIS COURT HAS JURISDICTION TO HEAR CREEKSTONE’S CLAIMS. A. Creekstone’s Claims Are Not Moot. USDA’s argument that Creekstone’s claims are moot is easily disposed of. USDA’s misreading of Creekstone’s Complaint, Creekstone’s desire to test is not limited to gaining access to Japan’s market. In addition to voluntary testing would enable Creekstone to enhance its brand and domestic and international customers will purchase more Creekstone beef, if Creekstone can assure those customers that its products come from BSE. Moreover, because of lingering concerns over the safety of U.S. U.S beef producers have not been able to recapture market share in the markets—making BSE testing still relevant for those markets. USDA mistakenly states that “plaintiff’s primary concern is with its the Japanese market.” USDA Consolidated Memorandum in Support of Motion for Summary Judgment and in Opposition to Plaintiff’s Motion for (“USDA Memo”) at 15. Creekstone’s Complaint and the Supplement CEO and current consultant John Stewart make clear that Creekstone is ban against voluntary testing for BSE, not a foreign government’s trade Supplemental Declaration, Exhibit 1 to this Reply, ¶¶ 2-3, 5, 8. “It is defendant’s voluntary cessation of a challenged practice does not power to determine the legality of that practice.” Friends of the Earth 189 (2000). Here, by contrast, there has been no cessation of USDA’s ban - 4 - testing, making mootness not even an issue. By definition, this case is Government Assoc. v. U.S. Dept. of Interior, 780 F.2d 86, 91 (D.C. Cir. legality of the standards utilized” by a government agency were not moot of the guidelines and the regulation . . . has continued,” even though was moot where agency had granted relief); City of New Haven v. HUD, 809 Cir. 1987) (same). Access to the Japanese market is but one component of Creekstone’s voluntary BSE testing. In addition to Japan, Creekstone wishes to gain other overseas markets as well as to expand its U.S. sales by offering Exh. 1 (Stewart Supp. Decl.) ¶ 2. And beyond access to markets, more beef at higher prices to both its foreign and domestic customers if tested for BSE. Id. ¶¶ 2, 6, 7; Creekstone customer declarations, of Japan’s lifting its ban, Creekstone could increase the demand for its In addition, Creekstone’s business model is to sell the finest Angus offering its customers beef from BSE-tested cattle, Creekstone intends for excellence, safety, and superior beef products. See Exh. 1 (Stewart concedes this point by admitting that one of its reasons for denying for BSE is USDA’s concern that Creekstone’s competitors would feel well lest they be at a disadvantage. See USDA Memo at 52 n.30. USDA’s allowing Creekstone to offer customers BSE-tested beef would boost provide a competitive edge alone defeats USDA’s mootness argument. Moreover, despite Japan and Korea lifting their respective U.S. beef (and other U.S. beef producers) still cannot sell as much U.S. beef as - 5 - Supp. Decl.) ¶¶ 2-6 and attachments. This is because Japanese and Korean concerned about the safety of U.S. beef. Exh. 1 ¶¶ 3, 4, 6 and beef, Japan requires all of its beef to be tested for BSE, and Australia BSE, putting Creekstone and other U.S. beef producers at a competitive ¶ 3 and Attach. A. Creekstone’s desire to test for BSE is motivated in effectively for overseas customers, again defeating USDA’s mootness In sum, there is absolutely nothing about Japan’s lifting its U.S. beef impossible to grant [Creekstone] effective relief.” USDA Memo at 15, Northern R.R. Co. v. Surface Transportation Bd., 75 F.3d 685, 688 (D.C. added). The relief Creekstone seeks from this Court is an order to open or keep open Japan’s beef market. Creekstone has set forth a to conduct voluntary BSE testing irrespective of Japan resuming U.S. mootness argument that “plaintiff’s alleged injury has disappeared” understood as an Article III standing challenge. But for the reasons set challenge also fails. B. Creekstone Has Standing To Present Its Claims. USDA claims that Creekstone lacks standing to pursue its claims because has not made a sufficiently concrete demonstration that Creekstone could and/or at a higher price were it not for USDA preventing Creekstone from BSE and (b) Creekstone has not “provided convincing evidence” that being for BSE would remedy that injury. USDA Memo at 17.1 USDA misstates 1 The weakness of USDA’s argument is exposed by its facially untenable “has creatively alleged” this injury in “an attempt to save its case - 6 - standing, misstates the legal standards for standing, and attempts to about consumer demand for Creekstone’s specific information. Creekstone’s basic injury is that it is prohibited from testing its enhance its brand and distinguish Creekstone beef in the marketplace and of its customers, many of whom will buy more beef at higher prices if it direct cause of that injury is USDA’s unlawful actions, restricting the BSE test kits, preventing the manufacturers of BSE test kits and the laboratory authorized to conduct BSE testing from cooperating with approve Creekstone’s proposed Hazard Analysis Critical Control Points voluntary BSE testing. Memorandum of Points and Authorities in Support for Summary Judgment (“Pl. Memo”) at 11-14. This Court can redress invalidating the USDA regulations and actions that prevent Creekstone ordering USDA not to interfere with Creekstone activities that are See Pl. Memo at 2. USDA argues that Creekstone must show a definite economic injury, and a economic benefit from a ruling in its favor, in order to have standing unlawful action. USDA Memo at 17-23. But the law is very clear that only kind of injury that establishes standing. See, e.g., Sierra Club v. (1972); Lujan v. Defenders of Wildlife, 504 U.S. 555, 562-63 (1992). that USDA principally relies upon in its mootness argument, McBryde v. Circuit Counsel and Disability Orders…, 264 F.3d 52 (D.C. Cir. 2001), Japan’s recent lifting of its ban against U.S. beef.” USDA Memo at 17. ban on U.S. beef 12 days after Creekstone filed its Motion for Summary Memo at 16) and four months after Creekstone described this basis for and 26 of its Complaint. - 7 16-17) held that Judge McBryde had standing to challenge a reprimand Circuit—clearly not an action to remedy an economic injury. Id. at argument, nor could it, that there is anything speculative about BSE testing on its cattle, or about USDA’s actions that are preventing If USDA’s position were the law, then businesses’ fundamental right to unlawful agency actions would be thwarted. Indeed, in USDA’s view, its new vaccine could not be subjected to judicial review because the not provide “convincing evidence” that it could sell the vaccine if it The law instead, as set down by the Supreme Court, is that a private government action directed at it has standing to challenge that action: challenging the legality of government action or inaction, the nature be averred (at the summary judgment stage) or proved (at the trial standing depends considerably upon whether the plaintiff is himself an forgone action) at issue. If he is, there is ordinarily little question caused him injury, and that a judgment preventing or requiring the 504 U.S. at 561. 2 Creekstone’s assertions of injury and redressability thus are not third parties, as USDA assumes. USDA Memo at 19, 22. The cases that USDA standing argument all involve indirect claims involving third parties, government action directed at the plaintiff. Whitmore v. Arkansas, 495 considered whether a third party could challenge a death sentence defendant. The injury in Area Transp., Inc. v. Ettinger, 219 F.3d 671, on whether, if the Federal Transit Agency issued the order to a that the plaintiff sought, the competitor would choose to forego future plaintiff in Gettman v. DEA, 290 F.3d 430, 435 (D.C. Cir. 2002) hoped consulting services to third parties who would use marijuana if the DEA is no comparison at all between Creekstone’s demonstrated interest in involving BSE testing and Mr. Gettman’s “at best reciting injury to his Id. at 435. - 8 - But even if economic injury were necessary to demonstrate standing, that Creekstone has suffered and is continuing to suffer economic Memo Exh. 1, at ¶¶ 3, 6, 17 (Creekstone has lost about 35% of its and is prepared to spend $6,000,000 per year to perform BSE testing lost demand); see also Stewart Supplemental Decl., Exh. 1 to this Reply, average sales to Japan in the past two months have been less than were prior to the discovery of BSE in the United States), ¶ 8. USDA’s contrary is both speculative and beside the point. The agency spends arguing about the accuracy or significance of polls that have consumers to be reluctant to purchase U.S.-origin beef, and a poll of reporting that more than a third are “very concerned” about BSE. Compare with Pl. Memo Exh. 1 at ¶¶ 4-5. Yet one of USDA’s own exhibits confirms many Japanese consumers still have some doubts about the safety of the reluctant to buy” U.S. beef. USDA Memo Exh. 12. USDA even asserts, indicating that 75% of Japanese respondents were unwilling to eat has been found in the United States “does not necessarily suggest that will fail to return to the levels they were prior to the Japanese ban.” Creekstone’s standing to bring this lawsuit does not stand or fall on of those polls is that they support and confirm Creekstone’s own of BSE on U.S. and foreign markets. Whatever the accuracy of these influence the thinking of the distributors and retail chains to which and they supplement Creekstone’s personal communications with those consumers (and thus are not hearsay because they are offered to show - 9 - truth of the reported consumer sentiments). Cf. Exhibits 2-6 brokers and of supermarket chains). USDA’s speculation that demand for (and, apparently, will be totally unaffected by BSE concerns) cannot about the market obtained by Creekstone, which of course is an expert in demand for its products. See Pl. Memo Exh. 1 (Stewart Decl.) ¶¶ 4-5, Supplemental Decl.) ¶¶ 2-4.3 While Creekstone’s own declaration ought to declarations from Creekstone’s customers that they would purchase more would pay a higher price, if Creekstone could provide beef from defeat USDA’s speculations and arguments that Creekstone is not agency’s test ban. See Exhibits 2 -6. II. USDA’S EXPANSIVE INTERPRETATION OF THE VSTA TO APPLY TO DIAGNOSTIC TESTS AND TO THE USE OF BIOLOGICAL PRODUCTS IS UNPERSUASIVE AND NOT ENTITLED TO DEFERENCE. A. The VSTA Is Neither Ambiguous Nor Susceptible to USDA’s Interpretations. USDA claims that the VSTA authorizes it to control not only the a virus, serum, toxin, or analogous product (which USDA refers to as also who may use such biological products and for what purpose. USDA “biological products” that it can regulate the use of include kits. But those authorizations cannot be found in the plain language of USDA has taken a very simple statute, which gives the Department the manufacture and sale of specific products, and transformed it into a products and other kinds of activities. Some of USDA’s ostensible USDA’s assertion that information previously provided by Creekstone does improvements in the Japanese market is contradicted by Exh. 1 ¶¶ 3-4. the fact that access to the Korean market is still highly restricted. - 10 - to benefit public health and welfare – but that kind of generic goal blanche to regulate whatever it wishes. The law could not be more clear: “Agency authority may not be lightly courts to presume a delegation of power absent an express withholding of would enjoy virtually limitless hegemony, a result plainly out of likely with the Constitution as well.’” Michigan v. EPA, 268 F.3d 1075, (quoting Ethyl Corp. v. EPA, 51 F.3d 1053, 1060 (D.C. Cir. 1995). a delegation of power based solely on the fact that there is not an power.’” Id. (quoting American Petroleum Institute v. EPA, 52 F.3d 1113, 1995)).4 “Mere ambiguity in a statute is not evidence of congressional delegation Sea-Land Serv., Inc. v. Dep’t of Transp., 137 F.3d 640, 645 (D.C. Cir. there is not even ambiguity. The statute states very clearly what serum, toxin or analogous product used in the treatment of domestic It states clearly what activities are covered: the preparation, sale, of such products. Id. at §§ 151-152. And it states clearly when those prohibited: when such products are “worthless, contaminated, dangerous, “prepared, under and in compliance with regulations prescribed by the at an establishment holding an unsuspended and unrevoked license issued Agriculture”; or are imported without a permit. Id. 4 USDA’s reliance on Reno v. Flores, 507 US 292, 300-301 (1993), to say “demonstrate that ‘no set of circumstances exists under which the (USDA Memo at 23) is misplaced. In that case, the respondents were not regulation’s application in a specific instance, it had not yet been and there was no record concerning the INS’s interpretation of the a very different situation than is presented in the instant case. - 11 - The statute simply does not authorize USDA to regulate activities other preparation, sale, barter, exchange, or importation of biological USDA can prohibit or regulate the use of a biological product—in this for what purpose.5 Nor does the statute authorize regulation of are not analogous to a virus, serum, or toxin—just because they are used animals. Ignoring those simple, albeit inconvenient for USDA, truths, (illogical) claims that its actions promote public health and welfare ranchers, encouraging this Court to “simplistically…assume[e] that statute’s primary objective must be the law.” Rodriguez v. United (1987) (per curiam) (emphasis in original). 1. Regulation of the Use of Biological Products USDA asserts that its authority in 21 U.S.C. § 154 to issue regulations necessary to prevent the preparation, sale, barter, exchange, or contaminated, dangerous, or harmful virus, serum, toxin, or analogous treatment of domestic animals” “explicitly authorizes restrictions on serum, toxins, or analogous products may be prepared, sold, bartered, USDA Memo at 25. This contention is absurd on its face. Saying that USDA manufacture and sale of products intended for use in the treatment of same as saying USDA can regulate the use of such products. (And indeed, how to regulate the use of products when it wishes to do so. See Pl. 5 USDA’s assertion that “regulation 102.5(d) is not a direct use products” (USDA Memo at 25) is pure semantics (and irrelevant). Without authorization to regulate how and by whom biological products are used, USDA cannot indirectly do so through unlawful limitations in licenses biological product manufacturers. - 12 - Under USDA’s theory of how the statutory language should be read, if a to regulate seat belts, air bags, and other safety devices intended for would be authorized to regulate who may drive motor vehicles, and where, Not surprisingly, USDA offers no case law in support of its unorthodox VSTA, nor even any formal interpretation previously published by USDA. in the treatment of domestic animals” clearly limits, rather than analogous product.” Just as clearly, the phrase must have been used in from the Act of July 1, 1902, ch. 1378, 32 Stat. 728, which authorized to regulate any “virus, therapeutic serum, toxin, antitoxin, or prevention, treatment, or cure of diseases or injuries of man.” See USDA, 487 F. Supp. 376, 378-79 (D. Colo. 1980) (VSTA modeled after the Contrary to USDA’s theory of statutory construction, authority to class of activities, affecting vastly more businesses and individuals, statement of congressional delegation of that authority, not in a interpretation offered by the agency in litigation to justify its “Congress…does not alter the fundamental details of a regulatory scheme ancillary provisions—it does not, one might say, hide elephants in American Trucking Ass’ns, 531 U.S. 457, 468 (2001); see also FDA v. Tobacco Corp., 529 U.S. 120, 159–160 (2000). Remarkably, USDA also argues that 21 U.S.C. § 154, because it authorizes issue regulations “as may be necessary to prevent the preparation, sale, 6 Moreover, even if USDA were correct that the phrase “for use in the animals” allowed it to regulate how a biological product is used, that USDA to dictate who may use the product and for what purpose. - 13 - shipment” of worthless or dangerous biological products, “also expands regulate beyond just the ‘preparation, sale, barter, exchange, or Memo at 26. Once again, USDA offers no case law, legislative history, or statements or rulemaking interpreting the VSTA to support or explain contends that “clearly” restrictions on how a biological products may be what purpose “may be necessary to close loopholes and remove incentives regulations directed at the ‘preparation, sale, barter, exchange, or Apparently USDA believes that Congress made it a crime not only for a and sell a dangerous biological product, but for a farmer to continue to well. See id. Quite simply, it is not for USDA to decide to “close chose not to regulate. Even if there were such a need for this kind of “[n]eed for regulation cannot alone create authority to regulate.” Sea FERC, 127 F.3d 365, 371 (5th Cir. 1997). Over and over, courts have rejected interpretations of a series of words beyond the scope of the words in the series, as does USDA’s of authority to regulate the use of biological products parallels a rejected earlier this year: The plaintiff in Dolan v. United States (Feb. 22, 2006), relied on a provision concerning liability for “loss, transmission” of mail, 28 U.S.C. § 2680(b). The Court observed that, “miscarriage” “refer to failings in the postal obligation to deliver right address, it would be odd if ‘negligent transmission’ swept far injuries like those alleged here—injuries that happen to be caused by involved neither failure to transmit mail nor damage to its contents.” - 14 - Similarly, in this case it would be odd indeed if Congress intended, in the preparation, sale, barter, exchange, or shipment of dangerous or stimulate or enhance the immune system of animals, to regulate how such by whom, and for what purpose—activities carried out by the users of the their manufacturers, and after the products have already been prepared, Texas & Pacific Railway Co. v. Pottorff, 291 U.S. 245, 257-59 (1934), instant case, in that the Court both (a) refused to find that a national statutory authorization for “banking” to include pledging its assets to (b) also reasoned that, if that power had been authorized, there would amend the banking statute later to provide a limited power to pledge.7 enactment of the Agricultural Bioterrorism Protection Act of 2002, 7 USDA limited authority to regulate the possession and use of dangerous evidence that the VSTA should not be read to give broad authorization to biological products and for what purpose (as is the legislative history did not believe the VSTA empowered USDA to regulate the use of Memo at 24-25.8 USDA offers no response to that application of the canon construction, followed in Pottorff, to the history of the VSTA and 7 As the D.C. Circuit observed in Independent Insurance Agents of F.3d 638 (2000), “[t]he pre-Chevron vintage of Pottorff is irrelevant,” had already made clear at that time that decisions of the Comptroller of generally entitled to deference. Cf. Babbitt v. Sweet Home Chapter of Communities for a Greater Oregon, (1995) (fact that Congress in 1982 authorized the issuance of permits endangered species is strong evidence that Congress understood the prohibition on “take” of endangered species to include indirect as well - 15 - USDA does offer one reference to legislative history of the VSTA that biological products. USDA Memo at 31.9 But that mention of use, put into suggests that Congress meant to include regulatory authority over how a be used or by whom. Rather, the passage refers to “controlling the use” worthless viruses, serum, and analogous products “by preventing the products that may be manufactured within the United States. The focus of Senate Report, like the focus of the statutory language that Congress how biological products are used, or by whom, but on regulating the shipment of dangerous or worthless products.10 In any event, this phrase could not endow USDA with authority not set out forth the statute. 11 USDA asks this Court to ignore the venerable principle expressio unius alterius, on the grounds that the “principle does not contemplate the 9 USDA also refers to “[s]ubsequent legislative commentary,” by which it description of the VSTA. USDA Memo at 31. But it is hard to see how the USDA Federal Register notice that USDA quoted, that the “main purpose of those who use veterinary products from products which are worthless, or harmful” in any way justifies USDA’s conclusion here that “[c]learly contemplated by regulation 102.5(d) are consistent with the purposes of Memo at 31. What should be clear from that passage instead is that the to protect those who use biological products from harmful or worthless and constrain those who use biological products. 10 Cf. Exhibit 7 at 23-25 (USDA official explaining request for authority with no mention of restricting who could use toxins and viruses or products); Hall v. Nebraska, 100 Neb. 84, 88-89, 158 N.W. 362, 363-64 understand that the federal government undertakes to regulate those who been disposed of by the manufacturer.”) 11 See City of Chicago v. Environmental Defense Fund, 511 U.S. 328, 337 Committee report included statement that “all waste management including the generation, transportation, treatment, storage and by the exclusion,” Court declined to find that waste generation was statute, and not the Committee Report, which is the authoritative statute prominently omits reference to generation.”). Moreover, the in the Senate Report relates only to domestic manufacture of products, imported into the United States, like Bio-Rad’s BSE tests. Cf. USDA Memo - 16 - the treatment of domestic animals’ or ‘as may be necessary to prevent’ items….” USDA Memo at 26-27. USDA offers no authority for this claimed principle, nor any further explanation why it would be that phrases that specific or otherwise qualify it would suggest that Congress did not to be limited to the enumerated list of items or activities. This Court unsupported attempts to expand its jurisdiction beyond the authorities just as other courts have consistently rejected agency claims that implies authority to regulate something else, because it would be stated or intended purposes of the statute. See, e.g., City of Chicago, Railway Labor Executives’ Ass’n v. National Mediation Bd., 988 F.2d 133, aff’d on rehearing en banc, 29 F.3d 655 (1994), cert. denied, 514 U.S. cannot assume duties not given to it by Congress); Michigan Citizens for Thornburgh, 868 F.2d 1285, 1293 (D.C. Cir. 1989) (canon of expressio can determine whether statute is clear, and therefore no need to resort Arrogating to itself regulatory authority over a whole different set of by a different group of people, is simply not the kind of necessary regulatory scheme that Chevron contemplated. Cf. USDA Memo at 36. The an agency does not give it the power to assert authority that Congress absurd to suggest that, under the second prong of Chevron, there is a 12 USDA disputes the relevance of Kelley v. U.S. EPA, 15 F.3d 1100 (D.C. denied, 513 U.S. 1110 (1995). USDA Memo at 27 n. 13. The citation Memo in Support was, unfortunately, incorrectly limited (citing to p. But the case indeed is relevant as an example of how courts look to the statute has authorized an agency to do and decline to find statutory regulate in additional areas (in that case, specifying who will be hazardous waste cleanup). - 17 - statutory ‘ambiguity’ to cure whenever a statute fails to specify some seeks to invoke. This cannot be the meaning of Chevron, for it would claim limitless authority except in those few circumstances where ‘thou shalt not’ exercise such authority.” Railway Labor Executives’ (Edwards, J., concurring). 2. Regulation of Diagnostic Tests USDA admits that the VSTA says nothing about regulating diagnostic Memo at 35), but “neither does it specifically exclude such tests from The latter is true, but it falls short of authorizing USDA’s regulation Supreme Court and the D.C. Circuit have repeatedly admonished regulatory statutory authority for an agency to act “may not be presumed based an express withholding of jurisdiction.” ExxonMobil Gas Marketing Co. v. 1071, 1088 (D.C. Cir. 2002). The interpretation of the VSTA that USDA advances for purposes of this “diagnostic products are certainly used in the treatment of animals, under section 154 of VSTA.” USDA Memo at 37. Again, USDA vastly of the qualifier “intended for use in the treatment of domestic anything broadly defined as “treatment” is therefore regulated under the if Congress had given USDA authority to regulate a product just because “treatment of domestic animals,” that would not include authority to used solely to detect a disease (and especially those, such as BSE test - 18 - infection in dead animals).13 The cases USDA cites (USDA Memo at 41) its position: Pegram v. Herdrich, 530 U.S. 211, 228 (2000) contains a actions by HMO administrators: “eligibility decisions,” which concern condition or medical procedure for its treatment is covered by the and “treatment decisions,” which “are choices about how to go about patient’s condition: given a patient’s constellation of symptoms, what response?” Id. Not only to did the Pegram court not define “treatment,” “diagnosing” and “treating” as if they are two different types of conjunction “and.” Nor does Miller v. AT&T Corp., 250 F.3d 820, 830-31 contain any independent analysis of the meaning of the word Family and Medical Leave Act regulation, 29 C.F.R. § 825.114(b), which include “examinations to determine if a serious health condition exists condition,” and defers to an agency determination that the statutory by a health care provider,” 29 U.S.C. § 2611(11), is broad enough to This is a far different question than whether Congress meant for “virus, analogous product used in the treatment of domestic animals” to include reagents used to determine whether an animal has (or had) a disease. Additionally, to be susceptible to regulation under the VSTA, a have to be both a “virus, serum, toxin, or analogous product” and “used domestic animals.” 21 U.S.C. §§ 151, 152, 154. Something is not USDA claims its open-ended regulation of diagnostic products is refers to viruses, serums, toxins, or analogous products “for use in the animals,” rather than “for treatment of domestic animals.” USDA Memo at explain how a biological product that is not “for treatment of domestic in the treatment of domestic animals.” Creekstone suggest that to the though it seems unlikely there could be, it is a distinction without a - 19 - or toxin just because it is “used in the treatment of domestic animals,” seems to assume. In USDA’s expansive view of the VSTA’s targeted even a thermometer could be regulated under the VSTA, simply because it treatment of domestic animals.” USDA’s attempt to turn a limiting congressional delegation of regulatory authority is simply not borne out legislative history of the VSTA.14 USDA regulations state that “biological products,” include vaccines, antitoxins, immunostimulants, “and diagnostic components, that are of or that are derived from synthesizing or altering various substances or substances….” 9 C.F.R. § 101.2. Read literally, a “diagnostic component” need not have anything to do with the defining characteristic of analogous products,” which is that they “act primarily through the supplementation, enhancement, or modulation of the immune system or Similarly, USDA defines “analogous products” to include either similar in function to biological products in that they act, or are stimulation, supplementation, enhancement, or modulation of the immune response, or [s]ubstances… which are intended for use in the treatment detection or measurement of antigens, antibodies, nucleic acids, or added). Thus, USDA has explicitly de-coupled these diagnostic tests from 14 It also conflicts with a number of more-specific statutory including the Food, Drug and Cosmetic Act, as noted in Pl. Memo at 15 9 C.F.R. § 101.2 (definition of “biological products”). USDA offers that USDA has, in other regulations, made a clear distinction between through an immune response—and are subject to regulation under the not, even if the same or similar components are involved. See Pl. Memo - 20 - they be similar in function to the viruses, serum, toxins, and analogous terms covers. Under the interpretation of “analogous product” advanced by USDA’s Congress authorized the Department of Transportation to regulate the distribution in commerce of automobiles, motorcycles, trucks, and could regulate the construction (and use) of highways or racetracks, as C.F.R. § 101.2 do not represent “gap-filling” of an ambiguous statute. in this case amounts to the bare suggestion that it possesses plenary given area simply because Congress has endowed it with some authority to See Railway Labor Executives’ Ass’n v. National Mediation Bd., 29 F.3d 1994) (en banc), cert. denied, 514 U.S. 1032 (1995). The D.C. Circuit reject[ed] that suggestion.” Id. B. USDA’s Expansive Interpretation of the VSTA Is Not Entitled to USDA claims that its interpretations of the VSTA as authorizing it to products and activities not addressed in the statute are entitled to cannot overcome the large body of precedent rejecting just such claims expand the authority granted to them by Congress. 1. No Deference for Interpretations Expanding the Scope of the Agency’s Authority 16 USDA cites an opinion of the District Court for the District of USDA as having “plenary authority granted by Congress to regulate the vaccines.” USDA Memo at 27, quoting Arnold v. Intervet, Inc., 305 F. Md. 2003). But the question there was whether USDA’s regulatory regulate the manufacture of animal vaccines preempted state tort law manufacturers, not whether USDA has authority to regulate everything vaccines. Even “plenary authority” to regulate the field of animal imply authority to regulate tests for detecting animal diseases. - 21 - USDA virtually ignores the extensive precedent declining to accord any agency interpretation of a statute that gives itself expanded authority. also John Hancock Mut. Life Ins. Co. v. Harris Trust & Sav. Bank, 510 Natural Resources Defense Council v. Reilly, 983 F.2d 259, 266 (D.C. simply “may not ‘avoid the Congressional intent clearly expressed in the that its preferred approach would be better policy.’” Friends of the 140, 145 (D.C. Cir. 2006), quoting Engine Mfrs. Ass’n v. EPA, 88 F.3d 1996); see also Ethyl Corp. v. EPA, 51 F.3d 1053, 1060-61 (D.C. Cir. interpretation that added factors to a list of factors to be considered, policy justifications for the additional factors, observing “Congress implicitly delegated discretionary authority to the Agency to consider interest’….” Id. at 1060.). 2. No Deference for Statutory Interpretations Not Accompanied by Further Explication Creekstone has established that USDA’s interpretations of the VSTA are little or no weight because they were announced with virtually no derived. Pl. Memo at 26-27, 30-31, 41. USDA does not deny this. Rather, response is to assert that one of the cases Creekstone cited, Adamo States, 434 U.S. 275, 287 (1978), was decided before Chevron and is law. USDA Memo at 34 n.16. Unfortunately for USDA’s argument, the Creekstone cited Adamo Wrecking, that an agency’s statutory explanation or analysis is entitled to little weight, has been relied and the D.C. Circuit many times since Chevron. - 22 - For example, Public Citizen, Inc. v. U.S. Dept. of Health and Human 654, 662 (D.C. Cir. 2003) discusses the inapplicability of Chevron the agency has not provided any explanation for its interpretation. contains no reasoning that we can evaluate for its reasonableness, the contemplated in Chevron’s second step is simply inapplicable.” Id., well as SEC v. Sloan, 436 U.S. 103, 118 (1978) (reaching the same can only speculate as to the Commission’s reasons for reaching the because the agency’s orders did not “address[ ] in any detail the which it took [the] action”).17 Barnett v. Weinberger, 818 F.2d 953, 960-64 (D.C. Cir. 1987), another decision, declined to accord Chevron-like deference to the Department of interpretation of a statute under circumstances quite similar to the In sum, the regulations in question were issued after what appears to have been cursory consideration, were accompanied by neither explanation justification, and were given a breadth that does not comport with the animating the statute purportedly interpreted. These elements buttress our conclusion that the regulations are not entitled to significant weight in delineating the scope of the statute’s “custodial care” provision. Id. at 963 (footnote omitted). The Court considered it important that explanation or discussion of the regulations providing the issued, “nor was any attempt made to support the regulations by an history underlying the statute.” Id., citing Adamo Wrecking, 434 U.S. at 436 U.S. at 117-18, and Investment Co. Inst. v. Camp, 401 U.S. 617, 627 See also Federal National Mortgage Ass’n v. United States, 56 Fed. Cl. Claims 2003) (noting that United States v. Mead, 533 U.S. 218 at 228 deference is due to an IRS interpretation for which “no reasoning is Wrecking)). - 23 - defer to an agency “in significant part because agency failed to opinion or other supportive statement,” 818 F.2d at 963). The interpretations of the VSTA USDA relies on to prevent Creekstone cattle for BSE were all announced by USDA with virtually no explanation represent permissible and reasonable interpretations of the targeted See Pl. Memo at 26-27, 30-31, 41. USDA’s argument now that it has those interpretations in subsequent Federal Register notices related to VSTA regulations would make no sense even if those explanations were Memo at 39 (apparently claiming that recent developments in genetic and other “advances in scientific knowledge” somehow justified USDA the passage of VSTA that it should regulate the use of biological health and welfare and that diagnostic tests are analogous to vaccines from the fact that these would be post facto rationalizations in any cited do not even state, much less purport to explain, that scientific USDA’s regulations under the VSTA to address use of biological products diagnostic products. If general scientific advancement were sufficient regulating outside the terms of a statute, the words and choices of meaningless with each new discovery or invention. 18 In its opposition to Creekstone’s Motion for Summary Judgment, USDA interpreting comprehensive, far-reaching statutes, like the securities Congress delegated to administrative agencies broad authority to economy or aspect of commerce. USDA Memo at 27, 33. Such statutes broader authority for the agency and greater leeway to adopt statute like the VSTA, enacted to address specific concerns about particular uses. - 24 - Moreover, USDA’s interpretation of the VSTA’s provisions for permitting the importation of biological products, 21 U.S.C. §§ 152-153, as regulation of the use of those products once they have been imported, is the USDA regulations implementing those provisions, much less supported explanation.19 See Pl. Memo at 19-20. For that reason, it is entitled to under Christensen v. Harris Cty., 529 U.S. 576 (2000). In fact, the only explanation that we have for USDA’s interpretations of under the VSTA to regulate the use of diagnostic products like BSE test USDA’s counsel in this litigation. Pursuant to well-established reject such post hoc rationalizations of counsel. See, e.g., Bowen v. Hospital, 488 U.S. 204, 212-13 (1988); PanAmSat Corp. v. F.C.C., 198 Cir. 1999). This Court also should not accord any deference to USDA’s USDA asserts that Creekstone is barred from requesting that the Court 104.1—which on its face says nothing of restricting the manner in which product can be used, or by whom, or for what purpose—if, contrary to Court finds that that particular regulation does authorize such not include a demand in its complaint that 9 C.F.R. § 104.1 be 30; cf. Pl. Memo at 19-20. Creekstone’s Complaint did, however, state regulations implementing the VSTA, at 9 C.F.R. Chapter I Subchapter E cover the BSE test kits as described above, then those regulations are rulemaking authority granted to USDA in the VSTA.” Complaint Count 1 ¶ regulation on import permits, 9 C.F.R. § 104.1, is contained in 9 C.F.R. The prayer for relief in the Complaint also asks the Court to “Enter USDA lacks authority to restrict the use of BSE rapid test kits or to production of such test kits that limit to whom they may be distributed and to enjoin USDA “from implementing or enforcing any prohibition on or using USDA-approved BSE rapid test kits for purposes of routinely that Creekstone processes (including any restriction on the sale of such Creekstone does not believe that 9 C.F.R. § 104.1 authorizes diagnostic tests like the Bio-Rad BSE test kits, and so it does not need Court concludes that it does give that authority to USDA, then provisions of the Complaint noted here provide a sufficient request for hold the regulation ultra vires and vacate it in this summary judgment - 25 - authority under the VSTA, consistent with Adamo Wrecking and subsequent conduct its own analysis of the breadth of the VSTA provisions, using statutory construction described above and in Creekstone’s Memorandum in 3. Little Deference for Statutory Interpretations that Were Far from Contemporaneous or Consistent As Creekstone established, agency interpretations that are not statutes’s enactment and that do not reflect long-held positions of the entitled to less deference than more contemporaneous interpretations. USDA’s primary response is to claim—again without any citation—that this statutory interpretation no longer applies after the Supreme Court’s USDA Memo at 38-39. In fact, this principle has been applied repeatedly post-Chevron: “It is well established that the prestige of a statutory depends crucially upon whether it was promulgated contemporaneously with statute and has been adhered to consistently over time.” Barnett v. 961-62 (footnote omitted) (giving little weight to an interpretation after enactment of statute). See also Continental Airlines, Inc. v. U.S. Transportation , 856 F.2d 209, 216-217 (D.C. Cir. 1988) (relying on an contemporaneous interpretation of applicable statute rather than a more Martin v. Occupational Safety and Health Review Commission, 499 U.S. 144 that the consistency of application of interpretations bears on the agency’s position under Chevron); Railway Labor Executives, 29 F.3d at “telling” that the Board had not asserted its claim that it had latent allow carriers or the Board itself to initiate investigations for the statute’s 60-year history). - 26 - USDA has given virtually no explanation for why the Department failed, two-thirds of the life of the VSTA, to recognize that it had the authority to regulate who may use biological products and for what diagnostic tests as well as biological products themselves. In fact, so been able to determine, the instant case is the first time ever that purported authority to prevent a company from performing tests on its on the carcasses of animals it has already slaughtered). See also Exh. C. The Reenactment Doctrine Does Not Save USDA’s Unsupported VSTA. Finally, USDA claims that its interpretation of the VSTA as authorizing restrict who may have access to biological products and for what purpose has been blessed by Congress and must be deferred to under the USDA Memo at 28 n.14. Under that doctrine, courts “have frequently reenactment of a statute after promulgation of an agency interpretation or otherwise communicated to Congress may be regarded as ratification by Barnett v. Weinberger, 818 F.2d at 963 n.89. But the VSTA was not amended in 1985; rather, Congress simply expanded a few of the primarily to eliminate a dichotomy that had existed between regulation shipped across state lines and those manufactured and used within the 99 Stat. 1654-56; S. Rep. No. 99-145, Sept. 30, 1985, at 338-39, 20 USDA seems to make that claim only with respect to its asserted biological products, and not its claim that diagnostic tests are regulation under the VSTA. See USDA Memo at 28 n.14. Presumably that is expansion of the definition of “analogous product” in 9 C.F.R. § 101.2 “which are intended for use in the treatment of animals through the antigens, antibodies, nucleic acids, or immunity” did not occur until 31,326 (June 9, 1997). - 27 - U.S.C.C.A.N. 2004-2005; Garrelts v. Smithkline Beecham Corp., 943 F. (N. D. Ia. 1996) (legislative history of 1985 amendments indicates amendments); see also Pl. Memo at 22-23; cf. Babbitt v. Sweet Home, 515 J., dissenting) (subsequently enacted provision authorizing permits for endangered species does not implicate reenactment doctrine for agency prohibition on “take” of endangered species). Moreover, for the reenactment doctrine to apply, Congress must have been of the agency interpretation at issue. See, e.g., Barnett v. Weinberger, particular, “application of the legislative reenactment doctrine Congressional awareness and ‘express congressional approval of an interpretation if it is to be viewed as statutorily mandated.’” General v. ICC, 872 F.2d 1048, 1053 (DC Circuit 1989) (quoting AFL-CIO v. Brock, (D.C. Cir. 1987)); accord, International Union, UAW v. Brock, 816 F.2d 1987) (finding no “affirmative step taken by Congress that indicates an agency’s interpretation” (emphasis in original)); accord, Koszola v. (D.C. Cir. 2005); see also Pacific Power & Light Co. v. FPC, 184 F.2d 1950) (“before a mere reenactment can be given conclusive effect as a of an administrative interpretation, it must be shown that Congress was doing so.”); 2B Sutherland Stat. Constr. § 49.09 (reenactment doctrine nothing indicates that the legislature had its attention directed to the interpretation upon reenactment.”).21 USDA offers no evidence to this Cf. Lorillard v. Pons, 434 U.S. 575, 581–85 (1978), the case relied on Congress’s familiarity with the statute and judicial interpretations of of Congress’s intention to incorporate a contemporaneous construction of - 28 - regulation that USDA claims authorizes restrictions on the use of an product, and which was promulgated prior to the amendment of the VSTA in make any mention at all of such restrictions. Cf. 9 C.F.R. § 104.1; see n.11 (no mention of regulating diagnostic tests in legislative history amendments). USDA also implies that its interpretation of the VSTA as authorizing private BSE testing must be deferred to because of a vote by the House Committee not to adopt a rider to an appropriations bill that would have allow Creekstone and others to conduct private BSE testing. USDA Memo at negative vote by Congress on a bill is “a particularly dangerous ground interpretation of a prior statute.” Solid Waste Agency of Northern Cook Corps of Engineers, 531 U.S. 159, 169-70 (2001). Accord, Central Bank of First Interstate Bank of Denver, N.A., 511 U.S. 164, 187 (1994); Brown & U.S. at 155. A failed committee vote on an appropriations rider lacks III. USDA LACKS STATUTORY AUTHORITY TO REGULATE BSE TEST KITS IN PARTICULAR. To be subject to USDA’s regulatory authority under the VSTA, something both a “virus, serum, toxin, or analogous product” and “used in the animals.” 21 U.S.C. §§ 151, 152, 154. And for USDA to “prevent the 22 In contrast, USDA offers no response to Creekstone’s demonstration, legislative history of the Agricultural Bioterrorism Protection Act of the Public Health Security and Bioterrorism Preparedness and Response 116 Stat. 647, that Congress did not believe USDA’s regulatory authority may use biological products. See Pl. Memo at 24-25; see also Brown & 133 (“the meaning of one statute may be affected by other Acts, spoken subsequently and more specifically to the topic at hand.”) - 29 - exchange, or shipment” of such a product, it must be “worthless, harmful.” Id. at § 154. As Creekstone showed in its Pl. Memo at 34-40, screening of apparently healthy cattle at slaughter do not meet any of A. BSE Test Kits Are Not “Analogous Products.” The commonsense meaning of “virus, serum, toxin, or analogous product” analogous products are other products that, similar to the viruses, specifically in the VSTA, are given to animals to supplement the the animal’s immune system to generate more of its own antibodies, to effects of disease. USDA itself has expressed that understanding of what means. See Pl. Memo at 29, 38 n.14. Creekstone has demonstrated that “analogous products” is also consistent with the legislative history of USDA’s own regulations contemporaneous with and extending for decades VSTA, and is similar to the way courts have interpreted virtually therapeutic serum, toxin, antitoxin, or analogous product” in the human USDA attempts to narrow the scope of this argument by distinguishing USDA’s authority to regulate diagnostic tests extends as a general “whether USDA was required to make an exception to license restrictions BSE test kits for purposes other than government surveillance testing, to conduct private testing for its own marketing purposes.” USDA claims subject of Count 3 of the Complaint and therefore not covered by the for summary judgment. USDA memo at 40 n.21. To the contrary, the issue raised is whether the VSTA authorizes USDA to prohibit the sale of BSE than government surveillance testing. That is a question of whether and other actions regarding by whom BSE test kits may be used and for excess of statutory jurisdiction, authority, or limitations, or short of of 5 U.S.C. § 706(2)(C)—the subject of Counts 1 and 2 of the Complaint. - 30 - Act of July 1, 1902, ch. 1378, 32 Stat. 728, on which the VSTA was 25, 27-30.24 Even if USDA is correct that “[d]iagnostic test kits frequently rely on antibodies and antigens to stimulate, modulate, or detect the immune products made with viruses, serums, or toxins” (USDA Memo at 36), that such test kits are “analogous products” to vaccines and similar products diseases. See pp. 19-21, supra. But in any event, as Creekstone has recognized that certain products made from microorganisms may be some settings and products unregulated by the VSTA in others. Pl. Memo diagnostic test kits “frequently” involve the stimulation or modulation an animal, as USDA maintains, that does not suggest that all diagnostic test kits, must be “analogous products” subject to USDA’s regulatory For example, EPA provided this description of substances that may or may “analogous products,” depending on how they are used: It is now recognized in the scientific literature that the generation or of an immune response involves both antigens and certain protein regulatory factors referred to as cytokines. Some cytokines (e.g. interleukins) essential components in the generation and expression of an immune without which the vaccine would be worthless…. Cytokines are also many body tissues and act on cell types other than those of the immune Cytokines of natural or synthetic origin can be prepared as products for administration to animals. Because of the diverse biological activity of cytokines, not all products consisting of these substances would be under the VSTA. Many of these cytokines intended to be used as drugs under the jurisdiction of the Food and Drug Administration. In such the VSTA would not apply. USDA tries to dismiss the cases cited by Creekstone as irrelevant interpreting the VSTA. USDA Memo at 36 n.18. But, as Creekstone the human version of the VSTA is almost identical, and courts have held interpreted similarly. See p. 13, supra; Pl. Memo at 30 n.10 - 31 - Both cytokines and immunomodulators are analogous to biological products when they are used to stimulate, supplement, enhance, or modulate the of animals in the treatment of disease. Products consisting of these that work through the immune mechanisms in the treatment of specific appropriately fall within the definition of “biological products.” 62 Fed. Reg. 31,326, 31,327 (June 9, 1997) (emphasis added.) BSE test determine whether an animal carcass is infected with a disease that does animal’s immune system, are not a product that works through the immune specific disease, and therefore should not be considered an “analogous rulemaking precedent. USDA’s declarant, Dr.Rippke (whose declaration provides no information training and qualifications other than that he has worked at USDA for 20 implementation of the VSTA—which addresses hundreds of products besides BSE—for the last 10 years), provides only the barest of analysis to BSE test kits are analogous to viruses, serums, and toxins. Cf. USDA contrast, in Exhibit 8 to this Reply, Paul W. Brown, M.D., a real expert transmissible spongiform encephalopathies in particular, explains that the immune system of the animal that is tested. There is a sharp immunological means to prevent foreign pathogen infections (e.g., active immunization) and the use of an immunologic reagent (e.g., an antibody) prion proteins obtained from the body of an infected host. The use of whatsoever to do with the immune system of the infected (and now dead) fact, USDA has already acknowledged that BSE itself does not even work system of the cattle it afflicts: “The BSE agent does not evoke any response or inflammatory reaction in host animals.” 70 Fed. Reg. 460, - 32 - Dr. Brown says, “USDA thinking on this point is very confused.” Exh. 8 ¶ conclusory statements notwithstanding, there is nothing about BSE test the immune system of cattle and in fact can only be administered to dead analogous to vaccines and therapeutic serums administered to animals to disease.25 B. BSE Test Kits Are Not, and Would Not Be, Used in the Treatment of Animal Disease. USDA sets out a circular argument: BSE test kits are “intended for use domestic animals,” even though there is no treatment for BSE and USDA testing of normal-appearing cattle at slaughter has no BSE mitigation 40-44. USDA then claims authority to prevent access to BSE test kits for it alleges, they are worthless for the treatment of domestic animals in reject this attempt to “have it both ways.” USDA’s claim that a test which is used to determine whether meat from a animal might be infected is “intended for use in the treatment of nonsensical, especially given that there is no known treatment for the USDA also relies on its regulation (which, as Creekstone has already with the VSTA in any case, Pl. Memo at 29-31), 9 C.F.R. § 101.2(2)(ii), “analogous products” to include substances that do not even act on the are used for “the detection or measurement of antigens, antibodies, USDA asserts that BSE test kits fall under that definition and are any event because they are tests for “antigens.” USDA Memo at 41 n.22. for that contention, ¶¶ 7-8 of the Rippke declaration, refers to BSE immunological detection of specific antigens found in animal tissue though it also states that “antigens” are materials “that, as a result appropriate tissues of an animal body, stimulate an immune response.” Laboratories, Inc. v. Harris, 488 F. Supp. 618, 619 (D.S.D. 1980), rev’d F.2d 1288 (8th Cir. 1981) (referring to “antigen” as “the biological produce an immune response”). Given that BSE does not involve an immune (see text supra), Dr. Rippke’s description of BSE test kits as prion proteins believed to cause BSE, is internally inconsistent and - 33 - only be used on cattle that are already dead. See USDA Memo at 41-42. its regulations that the determination of whether a product is intended of domestic animals is to be based on objective criteria indicating the 9 C.F.R. § 101.2(1); see USDA Memo at 43 n.24. Here, BSE test kit Rad, market millions of BSE test kits a year to countries that conduct of all animals presented for slaughter (mandatory above a certain age in USDA’s assertion that BSE test kits are ineffective for BSE disease applied to targeted cattle with symptoms that might be indicative of test kits for other purposes provides an incontrovertible objective the manufacturer intends them to be used and as intended to be used by “intended for use in the treatment of domestic animals,” despite USDA’s contrary. Cf. id. Thus, USDA’s actions dictating that BSE test kit cannot sell the test kits for purposes other than treating BSE in cattle C. BSE Test Kits Are Not Worthless, Contaminated, Dangerous or Harmful. Having asserted authority to regulate the use of BSE test kits by meat producers because BSE test kits are intended for use in the USDA turns around and claims (for the first time in writing, cf. Pl. 5, 7, and 10) that BSE test kits are “ineffective…and essentially measure when used, as proposed by plaintiff, to diagnose the disease in normally-looking cattle.” USDA Memo at 42. Since Creekstone never - 34 - BSE testing would be valuable as an animal human health measure and to diagnose BSE for the purpose of treating animals, this is really a In any case, USDA’s claim that the VSTA authorizes it to ban private use because they are worthless when applied to brain tissue from cattle” is contradicted by a wide array of facts and indeed even USDA’s countries of the European Union performed BSE tests on almost 9 million healthy-appearing at slaughter in 2005 alone. Report on the Monitoring Ruminants for the Presence of Transmissible Spongiform Encephalopathy 2005, European Commission, 20 June 2006, p. 12 Table B1, available at http://ec.europa.eu/food/food/biosafety/bse/annual_reps_en.htm (attached significant portion of the BSE cases found in the EU in 2005 (114 of 491 looking cattle tested at slaughter. Id. at p. 18 Chart B3. France, all cattle over 24 months of age, and Germany allows voluntary testing younger. Id. at p. 8 Table 2. Japan currently tests cattle of all ages officials consider BSE testing a measure for “ensuring the safety of Exh. 5 at 2-3. While most cattle slaughtered in the U.S. are under 30 been detected in cattle younger than that, although infrequently. Detwiler, D.V.M. (Exh. 10) ¶ 22; Ferguson Decl. (USDA Memo Exh. 1) at ¶ at 2 (BSE in 21 and 23 month old cattle in Japan). In addition, the age of cattle, dentition, is inherently inaccurate. Exh. 8 (Brown Decl.) USDA does not contend that BSE test kits are “contaminated, dangerous, U.S.C. § 151. USDA’s claim that BSE test kits as proposed to be used by “misleading” (USDA Memo at 42) does not relate directly to any criterion the VSTA. In any event, USDA does not suggest that BSE test kits are whether concentrations of BSE prions above the detection limit of the tissue. Thus there is nothing inherent about the test itself that is - 35 - Under these facts, USDA cannot simply declare that BSE test kits are used on healthy-looking cattle under 30 (or 24) months of age (which “slaughter-age”). USDA’s arguments do not hold up to even cursory asserts that BSE test kits applied to healthy-appearing cattle at normal BSE-infected cattle—but only because the BSE infection in the animal has enough for the BSE tests to detect it. USDA Memo at 43. But if no BSE slaughter-aged, healthy-appearing cattle, then 100% of those infected chain. Catching even a few such cases of this fatal, incurable disease value. Exh. 8 (Brown ) ¶ 11; Exh. 10 (Detwiler) ¶ 21. In fact, neither that BSE testing would be worthless; the closest they come is to say “is the most efficient method” of monitoring for BSE. USDA Memo Exh. 1 ¶ USDA asserts that BSE can only be detected ‘two to three months before a demonstrate clinical signs of the disease.” USDA Memo at 43. Even that USDA describes its targeted testing of a fraction of the cattle most BSE as testing “to accurately diagnose the presence or absence of the 49), and a negative inference could be made from Dr. Ferguson’s targeted testing can “be interpreted to mean that the animal is Decl. ¶ 6). But in fact, the testing USDA is conducting, just like the for its cattle, will only diagnose the presence of BSE if the disease Ferguson Decl. at ¶ 6 (“there is a long period in the life of an would not detect the disease”). Thus, even USDA’s “targeted” testing can negative” test results, if infected animals that are non-ambulatory or BSE-tested at a time when infectious prions are not concentrated enough identified in available tests. Only if cattle fall into one of the (because, e.g., they are having trouble walking, or have died of unknown BSE which has spread to the point where the animal will die of BSE testing USDA is conducting identify BSE-infected cattle. USDA’s emphasis results in tests that Creekstone proposes to perform, when USDA’s own in false negative results, is additional confirmation that USDA’s claim “worthless” is just that—an assertion unsupported by the facts. - 36 - course, but it seriously understates the value of BSE testing.28 USDA information that demonstrates the inaccuracy of its “2-3 months” August 24, 2006 the Canadian Food Inspection Agency (CFIA) issued a cow from Alberta, Canada that was confirmed to be BSE-infected on July (Detwiler Decl.) Attach. B. The conclusion of the CFIA (which has dealt many BSE cases as USDA), was that “in this instance, had the cow not unrelated disease and had a brain stem sample submitted for BSE testing, been four to eight months longer before the cow would have displayed caused it to be tested because of suspicion of BSE.” Exh. 8 (Brown Moreover, it is undisputed that, when countries have gone from testing outward signs that might indicate BSE to testing all cattle above a many more cases of BSE. Analysis of the experience in France as it went only of suspect animals, to testing of all cattle over 30 months of age, months, shows that passive surveillance was picking up only a fraction infection that were detectable with BSE rapid tests. Supervie and Unrecognized French BSE Epidemic,” 35 Vet. Res. 349, 351-52, 358, 361 Exhibit 11). This may be in part because the clinical signs of BSE are Memo Exh. 26 at Article 3.8.4.2 ¶ 1. In fact, both of the indigenous the U.S. were in cattle with ambiguous or no clinical features. Exh. 8 28 The OIE Terrestrial Animal Health Code – 2005, Appendix 3.8.4, Spongiform Encephalopathy, on which USDA relies in part (USDA Memo Exh. that cattle where BSE is detectable but clinical signs have yet to those showing clinical signs. Id. at Article 3.8.4.1 ¶ 2.c. - 37 - USDA also ignores the growing data about “atypical” BSE infection, which not accompanied by any outward signs even at an advanced state of and Attach. C. “Thus, some cattle that on visual inspection appear fact negates any argument about a limited window of ‘pre-clinical’ there are no signs leading to a suspicion of infection. The only way identified as BSE-infected is through testing.” Exh. 8 (Brown Decl.) ¶ 8 from making BSE testing of asymptomatic cattle worthless, it makes such an understanding of this aspect of the disease. Id. ¶ 14. In short, “[p]reventing voluntary testing while at the same time government testing does not make any sense for the protection of animal is further indication that voluntary BSE testing is not ‘worthless.’” USDA’s statutory authority under the VSTA to prevent the sale or products extends only to those that are “worthless, contaminated, U.S.C. § 154. When USDA acts to prevent distribution of BSE test kits to contractors because USDA believes that it is not cost-effective to use on all healthy-looking, slaughter-age cattle (or because USDA believes will have economic consequences for beef producers or national and confidence in beef, as discussed in the following section), USDA is not “worthless” product, and therefore it is acting outside its statutory Administrative Procedure Act, 5 U.S.C. § 706(2)(C). Much of the declaration of Lisa Ferguson (USDA Memo Exh. 1) seems to be convincing the Court that BSE is a dwindling, not-very-serious problem. that is in any case beside the point, since nothing about the VSTA would - 38 - prevent the sale or shipment of a vaccine or a diagnostic test for a were developed to treat a rare but invariably fatal disease, which only herd of 90 million head may contract, could USDA prohibit the vaccine because USDA decided the disease was not important enough to purchasing the vaccine? IV. USDA’S RESTRICTIONS ON BSE TEST KITS ON ECONOMIC GROUNDS ARE OUTSIDE ITS AUTHORITY UNDER THE VSTA. As Creekstone has explained, USDA acts outside of its statutory of section 706(2)(C) of the Administrative Procedure Act when it BSE test kits for reasons outside of the purposes and criteria expressed Memo at 41-43. In particular, since USDA is banning access to BSE test unrelated to the purposes of the VSTA, such as promoting domestic and confidence in beef, controlling costs of meatpackers, and the like, USDA statutory authority. Pl. Memo at 42, 44.30 USDA asserts that this issue goes to whether USDA acted in an arbitrary manner (Count 3 of the Complaint), and not Counts 1 and 2, which are the Creekstone’s current Motion for Summary Judgment. But to the extent that promulgated regulations that it now asserts authorize it to restrict the 29 The declarations of Drs. Brown and Detwiler (Exhibits 8 and 10 to very clear that (1) much of what Dr. Ferguson states as unqualified fact educated guess and (2) BSE is far from eliminated and indeed recent Dr. Ferguson’s declaration) make voluntary BSE testing even more Exh. 11 at 357 (referring to “animals slaughtered in the late stage of hypothesized that infected tissues are infectious” (emphasis added); Memo Exh. 3 at 91 (Dr. Prusiner explaining why the feed ban will reduce 30 Creekstone also noted that, if the reference in USDA regulations at 9 protection of domestic animals or the public health, interest, or authorize restrictions on biological products for purposes unrelated to such products, then that regulation should be struck down as ultra - 39 - for reasons other than for animal health and has issued product communications concerning BSE tests for purposes that have nothing to do authority in the VSTA, USDA has acted “in excess of statutory limitations, or short of statutory right,” in violation of 5 U.S.C. § Counts 1 and 2 of the Complaint.31 (Of course, if the Court believes appropriately falls under Count 3 of the Complaint, then the Court could this particular argument until it is briefed in connection with a Count 3 (should Creekstone be denied summary judgment on both Counts 1 USDA’s substantive response is to assert (1) that its actions preventing from BSE testing further the purposes of the VSTA by protecting animal regulating BSE test kits to achieve various economic or market ends is “purpose” of the VSTA. Neither of these arguments makes sense. USDA has said or implied numerous times that its policy of preventing healthy-appearing cattle at slaughter (i.e., those least likely to have health. See, e.g., USDA Memo at 48. But USDA has never explained how because BSE testing of healthy-appearing younger cattle is unlikely to does not mean that such testing would be harmful to animal health. A (which USDA in any case would expect to be extremely rare, since it seven or fewer BSE-infected cattle in the U.S., Defendants’ Statement of Facts ¶ 5) could not be more “harmful” to animal health than not testing 31 In contrast, Creekstone would be presenting an argument covered by if it were arguing here that, even if USDA were authorized by the VSTA biological products for reasons other than to protect domestic animals owners) from ineffective or harmful biological products, it was USDA to exercise that authority in order to protect Creekstone’s themselves or for other unreasonable reasons. - 40 - USDA’s illogical pretext for banning private BSE testing is further that virtually every developed country with BSE tests 100% of cattle age, and Japan tests all cattle presented for slaughter. See Section large-scale testing is reinforced by the statements of internationally and the management of BSE and similar diseases, Dr. Paul Brown and Dr. (Exhs. 8 and 10), that it is important to perform a greater amount of States and that any data on the presence or absence of BSE in cattle States is of value. Since Creekstone’s proposed voluntary testing would government testing for BSE, but would only provide supplemental data, reason to conclude that Creekstone’s proposed use of BSE test kits would animal health.32 USDA does not even attempt to explain its bald voluntary testing would interfere with USDA’s efforts “to accurately absence of the disease” and, “through its surveillance testing, to Memo at 49. Cf. Rippke Decl. (USDA Memo Exh. 2) (stating that current “will contribute to the knowledge of the disease and may increase the therapies or potential cures for the disease in the future,” but of voluntary BSE testing as proposed by Creekstone); Ferguson Decl. (stating that USDA’s testing of targeted animals is “the most efficient presence of BSE” (¶ 6), but never even claiming that Creekstone’s interfere with USDA’s “surveillance testing” for BSE). 32 Perhaps an argument could be made to that effect if Creekstone’s laboratory capacity or test kit manufacturing capacity that otherwise priority BSE testing. But USDA has not made such an argument, and in constructed its own laboratory for BSE testing and there is no shortage manufacturing capacity (especially now that USDA has reduced its BSE - 41 - If there was any doubt before, it is clear after reading the USDA Memo prohibition of the manufacture and sale of BSE test kits, except for use testing program, is an action to further USDA’s views of what is good markets for beef and for the financial health of U.S. meatpackers, manufacture and sale of a worthless or harmful biological product as the therefore is an action “in excess of statutory jurisdiction, authority, statutory right.” 5 U.S.C. § 706(2)(C). USDA openly acknowledges that it purposes of “maintaining domestic and international confidence in U.S. products,” “protecting consumers from paying more for privately BSE “correcting market deficiencies and information asymmetries pertaining BSE test kits.” USDA Memo at 51-52. Tellingly, for the first time USDA motivation that prohibiting private BSE testing “also prevents beef incur increased costs of conducting the BSE testing, which, although and food safety purposes, might otherwise be necessary to remain testing were permitted.” Id. at 52 n.30. USDA’s defense of its actions is to claim that, although not directly the provisions of the VSTA, they are “consistent with VSTA’s purpose.” Creekstone does not dispute that Congress enacted the VSTA in part to interests of livestock owners from biological products that would harm be worthless. But a regulatory action is not authorized by a statute with the statute’s purposes. A specific grant of authority from Congress v. United States, 480 U.S. 522, 526 (1987); American Fin. Servs. Ass’n 965), cert. denied, 475 U.S. 1011 (1986)); Railway Labor Executives’ - 42 - (“However sensible the Board’s view that stability in labor relations challenged regulation] …, Congress has not so provided.”) If USDA’s then USDA could also, for example, dictate to biological products amount they could charge for each product, because keeping prices low economic interests of livestock owners and beef producers. See also 62 States, 340 U.S. 593, 600 (1951) (“In our anxiety to effectuate the protecting the public, we must take care not to extend the scope of the where Congress indicated it would stop.”) A biological product is not “worthless, contaminated, dangerous, or in the treatment of domestic animals,” 21 U.S.C. § 151, because USDA would put others at a competitive disadvantage or would interfere with and international confidence in U.S. cattle and beef products.”33 This particularly cautious about inferring in the VSTA authority to restrict products for purposes of preventing competition among meat grounds that USDA believes would be inappropriate—or consumer access to Other government agencies are charged with regulating competition and representations to consumers. Imposing such limitations on speech Constitutional constraints. And action by USDA—or indeed any government specifically designed to favor one set of competitors (large meatpackers 33 USDA Memo at 51-52. In any event, USDA provides no explanation for which is counterintuitive, especially given that 100% testing (of all over 24 months in France and Germany, and over 30 months in the 35, supra) is already the norm in many of those international markets, have been seeking testing for imported beef. This Court should not unsupported assertion that more testing for BSE would make consumers safety of U.S. beef. See also Exhibits 1-6. - 43 - others (Creekstone and other high-end meatpackers with an interest in inappropriate as a matter of policy, it likely is unconstitutional. The interpreting the “VSTA’s purpose” as authorizing such potentially See Edward J. DeBartolo Corp. v. Florida Gulf Coast Building & Constr. U. S. 568, 575 (1988) (courts should construe a statute to avoid such construction is plainly contrary to the intent of Congress”). In any event, USDA’s argument is that its restriction of access to BSE consistent with the VSTA’s purpose to protect farmers and ranchers from associated with harmful or ineffective biological products. USDA Memo at this broad, vague claimed authority does not support USDA’s claim that consumers from paying more for BSE-tested beef (USDA Memo at 52) are VSTA’s purpose “to protect the economic interests of livestock owners (id.), since actions to protect consumers of meat do not relate to the farmers and ranchers per se at all. (Instead, USDA now makes the VSTA authorizes it to “regulate the economic condition of [the beef] authorization to ban private use of BSE test kits could be derived the VSTA, none of those purposes supports USDA actions ostensibly accurate information to beef consumers or protecting beef producers from Contrary to USDA’s assertion (USDA Memo at 51 n.27), Garrelts v. Corp., 943 F. Supp. 1023 (N. D. Ia. 1996), is very relevant to this analysis of the 1913 enactment of the VSTA and its amendment in 1985, concluded that in both instances “Congress’s concern was regulation of contamination, dangerousness, or harmfulness of animal vaccines to duties of product manufacturers…to safeguard human users of their (emphasis in original); see also id. at 1066-67. Obviously, the economic processors and consumers are even further removed from that - 44 - V. USDA IS NOT ENTITLED TO SUMMARY JUDGMENT. USDA has offered almost no argument directed specifically to its summary judgment, apparently believing that, if its arguments against judgment motion are successful, then USDA will be entitled to summary is, of course, not the way the law works. First, as USDA has noted, by agreement Creekstone has only moved for judgment on Counts 1 and 2 of its Complaint, leaving Count 3 for a record if the Court should conclude that Creekstone is not entitled to either Count 1 or Count 2.35 See Pl. Memo at 1 n.1; USDA Memo at 13 n.7. Court could decide that Creekstone has not qualified for summary without finding that USDA has met its burden of demonstrating that there as to any material fact and that USDA is entitled to judgment as a (which USDA certainly has not). See Fed. R. Civ. P. 56(c). CONCLUSION For the reasons explained above and in Creekstone’s Memorandum in Motion for Summary Judgment, Creekstone is entitled to summary judgment 2 of its Complaint, and for the relief sought therein. Dated: November 3, 2006 Respectfully submitted, __/s/ Russell S. Frye _ Russell S. Frye (D.C. Bar No. 331124) 35 The only argument that USDA has even asserted that could apply to complaint is that the Court lacks jurisdiction to hear Creekstone’s or do not present a redressable injury. As Creekstone has demonstrated memorandum, those arguments are misguided and unavailing. - 45 - FryeLaw PLLC P.O. Box 33195 Washington, DC 20033-0195 (202) 572-8267 rfrye@fryelaw.com __/s/ William L. Miller ________ William L. Miller (D.C. Bar No. 443191) The William Miller Group, PLLC 1666 Connecticut Avenue, N.W. Washington, DC 20009 (202) 256-2306 wmiller@williammillergroup.com __/s/ Peter C. Choharis ________ Peter C. Choharis (D.C. Bar No. 444787) 2771 Woodley Place, NW (202) 422-8312 Washington, D.C. 20008 pchoharis@yahoo.com Attorneys for Plaintiff CREEKSTONE FARMS PREMIUM BEEF, LLC - 46 -
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