Opinion ID: 1363049
Heading Depth: 1
Heading Rank: 6

Heading: R-CALF's Allegations

Text: R-CALF initially brought five claims for declaratory and injunctive relief but appeals only on the basis of its first APA claim, in which it argues that the Final Rule is arbitrary and capricious because it is based on faulty assumptions about the efficacy of the American and Canadian feed and import restrictions. As we evaluate each argument under this claim, we will consider whether R-CALF's new evidence is relevant to our review. It is an established rule that the focal point for judicial review should be the administrative record already in existence, not some new record made initially in the reviewing court. Camp v. Pitts, 411 U.S. 138, 142, 93 S.Ct. 1241, 36 L.Ed.2d 106 (1973). Under limited circumstances, however, extra-record evidence can be admitted and considered. At the district court level, extra-record evidence is admissible if it fits into one of four narrow exceptions: (1) if admission is necessary to determine whether the agency has considered all relevant factors and has explained its decision, (2) if the agency has relied on documents not in the record, (3) when supplementing the record is necessary to explain technical terms or complex subject matter, or (4) when plaintiffs make a showing of agency bad faith. Southwest Ctr. for Biological Diversity v. U.S. Forest Serv., 100 F.3d 1443, 1450 (9th Cir. 1996) (internal punctuation omitted). R-CALF also relies heavily on one statement in the case law that extra-record information might be admitted if it tends to show that the agency relied on assumptions that were entirely fictional or utterly without scientific support. Ass'n of Pac. Fisheries v. E.P.A., 615 F.2d 794, 812 (9th Cir.1980). In Asarco, Inc. v. U.S.E.P.A., 616 F.2d 1153 (9th Cir.1980), the benchmark case on this issue in this circuit, the district court had held a four-day hearing, which included testimony from two experts who had not helped the agency make the challenged decision. This court disapproved because this testimony was plainly elicited for the purpose of determining the scientific merit of the EPA's decision. Id. at 1161. Considering evidence outside this record is inappropriate, we explained, because it inevitably leads the reviewing court to substitute its judgment for that of the agency. Id. at 1160. Under the APA, courts must refrain from de novo review of the action itself and focus instead on the agency's decision-making process. Id. at 1158. Under these principles, R-CALF's arguments can only carry the day if they show flaws in the USDA's approach, rather than in its predictions. We address each of R-CALF's arguments in turn below. 1) The BSE Incidence Rate in Canada: R-CALF argues that the agency relied on a Canadian report that used an insufficient sample size based on data collected in 2001, before the Canadian and American BSE-infected cows were discovered. The district court agreed, R-CALF I, 359 F.Supp.2d at 1065-66, but we held that the district court improperly substituted its judgment for the agency's, see R-CALF II, 415 F.3d at 1097. We found that the USDA had based its calculations on international standards, and that the World Organization for Animal Health had ranked Canada in its minimal risk range in 2003. Id. at 1098. R-CALF argues now that data not available during the preliminary injunction proceedings and appeal indicate, if anything, an increasing prevalence of BSE, with five of the nine cases in Canadian-born cattle having been diagnosed in just the past year. R-CALF argues that this post-decision empirical data shows that the USDA was relying on faulty assumptions that lacked scientific support. While these new incidents are certainly cause for concern, they do not suggest that the agency made an incomplete or unreasoned review of the evidence before it in 2004. The agency was entitled to rely on the reasonable opinion of its experts at that time, see Marsh v. Or. Natural Res. Council, 490 U.S. 360, 378, 109 S.Ct. 1851, 104 L.Ed.2d 377 (1989), and the agency continues to monitor BSE in Canada, see Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines, 72 Fed.Reg. 1102 (Jan. 9, 2007). Because the Final Rule does not anticipate an incidence rate of zero in Canada or the U.S., these subsequent BSE cases do little to impugn the agency's decision-making process. If recent cases have cast doubt on the agency's scientific predictions, the proper remedy is to petition to reopen rulemaking under 5 U.S.C. § 553(e), not to challenge the existing rule as arbitrary and capricious. [6] 2) The Effectiveness of the Canadian Feed Ban: R-CALF argues that BSE may be transmitted through blood and saliva, not just contaminated feed, that one of the BSE-infected cows was rendered into feed, and that the recent diagnoses of BSE show that the feed ban is not working because of alleged non-compliance. The district court credited this argument, see R-CALF I, 359 F.Supp.2d at 1066-67, but we held that the agency had properly considered and rejected these alternative theories of transmission. R-CALF II, 415 F.3d at 1098. We also held that it was appropriate for the agency to assume the longer incubation rates for BSE in Canada to explain the more recent cases of infected cattle. Id. R-CALF now argues that the recent incidents of BSE in cows born after the feed ban prove that the feed ban is ineffective. It also argues that a government study on the U.S. feed ban shows some noncompliance. See United States Government Accountability Office, Mad Cow Disease  FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness, Feb. 2005. It also refers to a statement by Secretary Johanns suggesting that there are questions that must be answered about the number of BSE incidents in Canada and remarking that South Korea has continued to close its borders to American beef. These post-decisional statements are far outside the record and of little persuasive weight. Though these recent incidents in younger cattle certainly cast doubt on the effectiveness of the feed ban, the agency  at the time it made its decision  properly relied on studies from both the World Organization for Animal Health and the Harvard Center on Risk Analysis finding that feed bans were the most effective way to prevent the spread of BSE, see 70 Fed. Reg. at 463, 467, and, again, considered them as a part of a system of safeguards, not as a sole preventative measure. It bears repeating that the agency did not assume 100 percent effectiveness of its measures. See 70 Fed.Reg. at 511. In a related argument, R-CALF claims that the agency incorrectly assumed that the Canadian feed ban, which exempted products made from animal blood or fat, would be as effective as the European feed ban, which does not have these exemptions. The agency expressly considered this argument and rejected it because Canada's feed ban was equivalent to the feed ban in the United States, which also allowed these products. 70 Fed.Reg. at 491. The agency's research showed that about 96% of the infectivity of any given cow was contained in certain tissues, and that the only examples of blood transmission of BSE occurred in blood transfusions. Id. As we noted in our preliminary injunction ruling, the agency properly relied on studies rejecting the idea of transmission through tallow, and we held that the district court erred when it criticized the gaps in the Canadian feed ban. See R-CALF II, 415 F.3d at 1099. R-CALF does not offer any evidence or arguments to support a different result at this phase. In light of the science available at the time, the agency's partial reliance on the feed ban was justified. [7] Finally, R-CALF argues that the agency showed its own lack of confidence in the feed ban when it suspended the part of the Final Rule allowing meat products from cattle over 30 months old. This argument fails as well. While the Final Rule prohibited importing cattle over 30 months of age, see 9 C.F.R. §§ 93.436(a)(1), (b)(1), and banned the use of specified risk materials from cows over 30 months of age, see 9 C.F.R. 310.22(a)(1), it allowed meat products from cattle of any age, see 70 Fed. Reg. at 494. The Final Rule, however, stated that international guidelines recommended allowing meat from cattle of any age as long as there were measures in place to segregate highly infective tissues from the nervous system. Id. [8] Two months after issuing the Final Rule, the agency decided to suspend this part of the rule and continue to ban beef derived from older cattle. See 70 Fed. Reg. 12,112. It essentially left in place the pre-2004 practice of allowing in meat from cattle under 30 months of age. See 70 Fed.Reg. at 536. R-CALF argues that this change of heart shows the agency's lack of confidence in its initial assumptions about the effectiveness of the feed ban, the ban on specified risk materials, and the BSE incubation period. To be considered by the courts, however, this evidence would have to show a lack of reasons for the parts of the rule that are currently being challenged, rather than a subsequent lack of confidence in them. R-CALF has failed to make a connection between the uncertainty about this provision and the lack of justification for any other provisions of the Final Rule. 3) Blood Transmission : R-CALF claims that the agency incorrectly assumed that the ban on specified risk materials in products for human consumption would eliminate the risk of BSE in spite of information that BSE can also be transmitted by blood that affects other tissues. R-CALF points out that the agency continues to ban fetal bovine serum, see 70 Fed.Reg. at 502-03, but, it argues, inconsistently permits the use of tallow in cattle feed, see id. at 500-01. The agency's commentary in the Final Rule explains that fetal bovine serum might pose a risk for livestock if used in certain applications such as bovine vaccine production or bovine embryo transfer, or for other products brought into direct exposure with ruminants. 70 Fed.Reg. at 502. In R-CALF II, we noted the special risk posed by the serum because it is injected directly into the bloodstream. R-CALF II, 415 F.3d at 1099. The agency's ban on fetal bovine serum represents caution in the face of unknown risk. It does not imply a more general finding of risk from feed products that may have come into contact with cattle blood. As the agency explains in the Final Rule, cattle blood only appears to pose a risk when it is directly transfused into other cattle. See 70 Fed.Reg. at 491. Regarding the agency's decision to allow imports of tallow, the agency was entitled to follow international standards and previous practices requiring that the tallow be protein-free and accompanied by certification. See id. at 501. In light of our previous endorsement of the feed ban, we find that the agency has justified its different treatment of tallow, fetal bovine serum, and cattle feed. R-CALF, in a similar vein, argues that the agency's subsequent rule prohibiting imports of pregnant cattle shows that it has since come to recognize the possibility of other types of BSE transmission. See Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Technical Amendments, 71 Fed.Reg. 12,994 (Mar. 14, 2006). However, we previously adopted the agency's interpretation that the Final Rule, even before the amendments, banned breeding cattle. See R-CALF II, 415 F.3d at 1099. Moreover, the amendments specifically state that the agency is merely clarifying the Final Rule. 71 Fed.Reg. at 12,994. R-CALF is therefore incorrect that the Final Rule did not ban breeding cattle. The agency fully considered the possibility of other types of BSE transmission and gave reasons for banning some products and not others. Its analysis satisfies our review. 4) Ban on Specified Risk Materials. R-CALF argues that more recent science shows that the ban on these cattle parts will be less effective than the agency assumed. We previously endorsed the agency's reliance on this ban because its decision was based on the Harvard-Tuskegee Study. See R-CALF II, 415 F.3d at 1099. [9] As R-CALF's summary judgment motion points out, the study's authors have since revised their certainty about the ban from 95% to 80%. The agency has also acknowledged the scientists' downward adjustment. See Substances Prohibited From Use in Animal Food or Feed, 70 Fed.Reg. 58,570, 58,587 (Oct. 6.2005). This post-decisional revision, however, does not show that the agency, at the time it made its decision on the Final Rule, failed to consider relevant factors or rested its decision on completely baseless assumptions. [10] 5) Other Arguments : R-CALF argues that the agency assumed that non-ambulatory cattle (who are more likely to have BSE) will not be slaughtered for human consumption, but the agency stated in the Final Rule that Canada does not allow non-ambulatory cattle to be slaughtered for export, 70 Fed.Reg. at 491, and R-CALF offers no reason to distrust that statement. R-CALF also argues that the agency relied on the Harvard-Tuskegee study's findings of low risk without considering the risk of errors and mislabeling. We find that the agency considered these risks and found them covered by existing regulation and monitoring by the USDA. See 70 Fed.Reg. at 499. Finally, on summary judgment, R-CALF contends that, overall, the agency's actions were contrary to the purposes of the Animal Disease Risk Assessment, Prevention and Control Act of 2001, Pub.L. No. 107-9, 115 Stat. 11, which requires the Secretary of Agriculture to submit a report to Congress on the USDA's plans to research and monitor BSE and gauge the effectiveness of its prevention measures. This argument was not pled in the complaint, and in any event is unavailing. The Act merely requires a report on these factors, and the USDA continues to provide these reports. Therefore, under the APA standard of review, none of the claims as stated in R-CALF's complaint warrant remand to the agency.