DocketNumber: Case No. 2:12-cv-04028-ODW(PJWx)
Citation Numbers: 223 F. Supp. 3d 1008
Judges: Wright
Filed Date: 12/14/2016
Status: Precedential
Modified Date: 7/25/2022
ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT [67] AND DENYING PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT [61]
I. INTRODUCTION
This is an action for judicial review of a final agency decision under the Administrative Procedure Act (“APA”). In 2009, the Food Safety and Inspection Services (“FSIS”)—which administers the Poultry Products Inspection Act, 21 U.S.C. §§ 451-72 (“PPIA”)—denied a rulemaking petition aimed at banning force-fed foie gras
II. FACTUAL BACKGROUND
Foie gras is a luxury food product made from the liver of a duck or goose. (Administrative Record (“AR”) at 138, ECF No. 18.) Before slaughter, the bird is force-fed a special mix of food using a feeding tube (a process also known as gavage). (AR at 143-45.) This causes a large buildup of fat in the bird’s liver, which gives the product its signature taste. (Id.)
A. The Petition
On November 28, 2007, several individuals and animal rights organizations (including some of the Plaintiffs in this action) petitioned FSIS to initiate rulemaking “to exclude force-fed foie gras from the food supply as an adulterated and diseased product that is ‘unsound, unhealthful, unwholesome, or otherwise unfit for human food.’ ” (AR at 5 (quoting 21 U.S.C. § 453(g)(3)).) The petitioners argued that (1) the force-feeding process causes hepatic lipidosis in ducks and geese, rendering the birds “unhealthful” under the PPIA, and (2) the consumption of force-fed foie gras may trigger the onset of secondary amyloidosis in humans. (AR at 10-23.) The petitioners state that hepatic lipidosis also causes “various secondary infections and illnesses” in poultry, but they did not develop those points further. (AR at 17, 20, 21.) The petition was accompanied by 65 exhibits, totaling 1150 pages. (AR at 32-1150.)
B. The Plaintiffs
1. Animal Rights Organizations
The four organizations bringing this action are Animal Legal Defense Fund (“ALDF”), Farm Sanctuary, Compassion Over Killing, and Animal Protection and Rescue League. ALDF “has spent over three decades focusing on issues involving animals and the law,” and “its main focus is preventing animal cruelty and advancing the protection of the interests of animals through the legal system.” (Wells Decl. ¶ 3, ECF No. 61-1.) To this end, “ALDF advocates concerning the health consequences of consuming animal products because the practices that exacerbate the harmful health effects of consuming animal products are the same practices that greatly contribute to animal cruelty in animal farming.” (Id. ¶5.) ALDF has spent resources “raising awareness about the health effects on ducks being raised for foie gras and the human health consequences of the force-feeding process,” including issuing press releases, initiating letter-writing campaigns, and petitioning administrative agencies. (Id. ¶ 8; see also id. ¶¶6, 7, 9-11.) According to ALDF, “had [it] not diverted these resources to combat force-fed foie gras, it would have suffered a loss of credibility, support, and organizational goodwill among its donors, its peers, and the legal community.” (Id. ¶ 12.) The parties generally agree that Farm Sanctuary, Compassion Over Killing, and Animal Protection and Rescue League are similarly situated to ALDF for standing purposes. (See generally Defs.’ Opp’n at 12, 14 n.10, ECF No. 67; Pls.’ Stmt, of Undisputed Facts 98, 101, ECF No. 61-6; Friedrich Deck, ECF No. 22-3 (Farm Sanctuary); Meier Deck, ECF No. 61-3 (Compassion Over Killing); Pease Deck, ECF No. 22-7 (Animal Protection and Rescue League).)
2. Individual Plaintiffs
The individual Plaintiffs in this action are Sarah Evans, Caroline Lee, and Michelle Schurig. Evans previously consumed force-fed foie gras, but now “avoid[s]” doing so “due to the cruelty involved in the force-feeding process and the nature of the resulting diseased product.” (Evans Deck ¶2, ECF No. 61-3.) Evans continues to consume other types of duck and goose dishes, however, and is concerned that restaurants may inadvertently serve her force-fed foie gras. (Id. ¶¶ 6-9.) Lee, like Evans, also “avoid[s]” eating force-fed foie gras, and is likewise concerned about the possibility of eating force-fed foie gras unknowingly; however, unlike Evans, it does not appear that Lee has ever consumed foie gras. (Lee Deck ¶ 8, ECF No. 61-4.) In addition, Lee contends that she is ge
C. Procedural History
In May 2012, Plaintiffs filed this action. (ECF No. 1.) In March 2013, the Court dismissed the action for lack of subject matter jurisdiction, reasoning that an agency’s decision not to initiate rulemaking was not subject to judicial review under the APA. (ECF No. 45.) Plaintiffs appealed from the ensuing judgment. (ECF Nos. 46, 49.) In December 2015, the Ninth Circuit reversed, holding that the denial of a petition to initiate rulemaking is renewable under the APA. Animal Legal Def. Fund v. U.S. Dep’t of Agric., 632 Fed. Appx. 905, 908 (9th Cir. 2015). Defendants argued on appeal that Plaintiffs lacked standing to bring this action, but the panel declined to consider those arguments in the first instance. Id. Judge Chhabria, however, issued a concurring opinion expressing skepticism that the animal rights organizations could establish standing based solely on their “choice to spend money to counteract challenged conduct germane to [their] mission.” Id. (Chhabria, J., concurring) (emphasis in original). Following remand, both parties moved for summary judgment. (ECF Nos. 61, 67.) Those motions are now before the Court for decision.
III. LEGAL STANDARD
A court “shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Courts must view the facts and draw reasonable inferences in the light most favorable to the nonmoving party. Scott v. Harris, 550 U.S. 372, 378, 127 S.Ct. 1769, 167 L.Ed.2d 686 (2007). A disputed fact is “material” where the resolution of that fact might affect the outcome of the suit under the governing law, and the dispute is “genuine” where “the evidence is such that a reasonable jury could return a verdict for the nonmov-ing party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1968).
The district court “is not required to resolve any facts in a review of an administrative proceeding”; rather, “the function of the district court is to determine whether or not as a matter of law the evidence in the administrative record permitted the agency to make the decision it did.” Occidental Eng’g Co. v. I.N.S., 753 F.2d 766, 769 (9th Cir. 1985). As a result, summary judgment is an appropriate vehicle for deciding APA cases. Id.
IV. DISCUSSION
As previously noted, the parties raise three issues: (1) whether Plaintiffs have Article III standing; (2) whether the interests of the animal rights organizations fall within the zone of interests that the PPIA protects; and (3) whether the denial of the petition was arbitrary, capricious, or contrary to law.
A. Standing
Defendants argue that the organizational Plaintiffs assert only a generalized
The “irreducible constitutional minimum” of standing is comprised of three elements: (1) injury in fact; (2) causation; and (3) redressability. Lujan v. Defs. of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). “To establish injury in fact, a plaintiff must show that he or she suffered ‘an invasion of a legally protected interest’ that is ‘concrete and particularized’ and ‘actual or imminent, not conjectural or hypothetical.’” Spokeo, Inc. v. Robins, —U.S.-, 136 S.Ct. 1540, 1548, 194 L.Ed.2d 635 (2016) (quoting Lujan, 504 U.S. at 560, 112 S.Ct. 2130). For an injury to be “particularized,” it must have “affected the plaintiff in a ‘personal and individualized way.’ ” Preminger v. Peake, 552 F.3d 757, 763 (9th Cir. 2008) (citations omitted). Generalized grievances, which are harms of an “abstract and indefinite nature,” do not provide a basis for standing. Novak v. United States, 795 F.3d 1012, 1018 (9th Cir. 2015). As long as the injury is particularized, however, the injury can be “minimal.” Preminger, 552 F.3d at 763. “[A]n ‘identifiable trifle is enough to fight out a question of principle; the trifle is the basis for standing and the principle provides the motivation.’ ” Council of Ins. Agents & Brokers v. Molasky-Arman, 522 F.3d 925, 932 (9th Cir. 2008) (quoting United States v. Students Challenging Regulatory Agency (SCRAP), 412 U.S. 669, 689 n.14, 93 S.Ct. 2405, 37 L.Ed.2d 254 (1973)). “The party invoking federal jurisdiction bears the burden of establishing these elements.” Lujan, 504 U.S. at 560, 112 S.Ct. 2130.
1. Animal Rights Organizations
An organization can assert standing under two theories: (1) in a representative capacity, where there has been an injury to one or more of its members, Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 181, 120 S.Ct. 693, 145 L.Ed.2d 610 (2000); or (2) on its own behalf, where there has been an injury to the organization itself, Comité de Jornaleros de Redondo Beach v. City of Redondo Beach, 657 F.3d 936, 943 (9th Cir. 2011) (en banc). The organizational Plaintiffs here assert only the second type of standing.
An organization has standing on its own behalf if it can show (1) that the defendant’s actions have frustrated its mission; and (2) that it has spent resources counteracting that frustration. Id.) Fair Hous. of Marin v. Combs, 285 F.3d 899, 905 (9th Cir. 2002) (organization must show “a drain on its resources from both a diversion of its resources and frustration of its mission”); El Rescate Legal Servs., Inc. v. Exec. Office of Immigration Review, 959 F.2d 742, 748 (9th Cir. 1991) (“The allegation that the [defendant’s] policy frustrates [the organizations’] goals and requires the organizations to expend resources [that] they otherwise would spend in other ways is enough to establish standing.”). However, “standing must be established independent of the lawsuit filed by the plaintiff.” Comite de Jornaleros de Redondo Beach, 657 F.3d at 943 (citations and internal quotation marks omitted). Moreover, “[a]n organization ‘cannot manufacture the injury by ... simply choosing to spend money fixing a problem that otherwise would not affect the organization at all. It must instead show that it would have suffered some other injury if it had not
The Court concludes that ALDF meets both requirements. ALDF’s mission is to prevent animal cruelty, which includes eradicating the practice of force-feeding poultry. (Wells Decl. ¶¶ 3, 8.) FSIS frustrated ALDF’s mission by declining to initiate rulemaking that would ban force-fed foie gras from the food supply in the United States, which in turn would have dramatically reduced the market for force-fed poultry. This forced ALDF to continue expending resources to counteract the practice, including writing press releases and initiating letter-writing campaigns to educate the public about the danger to both human and animal health of force-feeding poultry, and filing other administrative petitions aimed at banning the practice. (See Wells Decl. ¶¶ 6-11.)
Defendants make two main counterarguments. First, Defendants contend that the denial of the petition did not “force” ALDF to expend resources taking on the force-fed foie gras industry; rather, ALDF simply chose to spend money to combat a problem that would otherwise not affect it in a personalized way. (Defs.’ Opp’n at 13-15.) However, as both the Supreme Court and Ninth Circuit have made clear, the frustration of an organization’s mission is the personalized injury that “forces” the organization to spend money to alleviate the frustration; an organization is only “choosing” to spend money if the defendant’s conduct “does not affect the organization at all.” See Valle del Sol, 732 F.3d at 1018; see also, e.g., Havens Realty Corp. v. Coleman, 455 U.S. 363, 378-79, 102 S.Ct. 1114, 71 L.Ed.2d 214 (1982) (organization whose purpose was to ensure equal housing opportunity had standing to sue the owner of an apartment complex for racial steering, because the steering practices “frustrated [the organization’s] efforts to [provide] counseling and referral services” to prospective tenants and required it to “devote significant resources to identify and counteract the defendant’s racially discriminatory steering practices”); Valle del Sol, 732 F.3d at 1018 (organization offering transportation to undocumented immigrants had standing to challenge a law that criminalized such conduct, because the law would deter its volunteers and because it had diverted resources to educate its members about the law); Comité de Jornaleros de Redondo Beach, 657 F.3d at 943 (organization that supported day laborers had standing to challenge a law banning the congregation of day laborers in the street, because the law frustrated the organization’s mission to make known laborers’ availability to work and because it spent resources educating laborers about the law); Fair Hous. Council of San Fernando Valley v. Roommate.com, LLC, 666 F.3d 1216, 1219 (9th Cir. 2012) (organization whose purpose was to combat illegal housing discrimination had standing to sue for housing discrimination, because discrimination frustrated the organization’s goal and thus forced it to spend resources on an education and outreach campaign to counteract the defendant’s discriminatory conduct); Fair Hous. of Marin, 285 F.3d at 905 (same). While the “loss of credibility, support and organizational goodwill”
Second, Defendants argue that the denial of the petition does not truly “frustrate” ALDF’s mission, because the practice of force-feeding poultry is only one of the myriad animal welfare threats that ALDF seeks to eradicate. (Defs.’ Reply at 5-6.) The Court disagrees. Fighting force-fed foie gras clearly constitutes a substantial part of ALDF’s mission; indeed, ALDF has spent “over a decade ... pursuing] petitions, campaigns, lawsuits, and outreach efforts to address force-fed foie gras.” (Wells Decl. ¶ 6.) Thus, any substantial setback to ALDF’s goal of eliminating force-fed foie gras—which, as discussed, FSIS’s denial of the petition is—is fairly characterized as “frustrating” its mission, even if that is only one of several goals pursued by ALDF.
Finally, as both parties generally agree, Farm Sanctuary, Compassion Over Killing, and Animal Protection and Rescue League are similarly situated to ALDF in all material respects. (Friedrich Decl. ¶¶3-9, 11, 12 (Farm Sanctuary); Meier Decl. ¶¶ 3-8 (Compassion Over Killing); Pease Decl. ¶¶2-10 (Animal Protection and Rescue League).) For these reasons, the organizational Plaintiffs have standing to bring this action.
2. Individual Plaintiffs
The individual Plaintiffs, however, do not have standing. The Supreme Court has held that where, like here, a plaintiff relies only on threatened future injury (as opposed to a past or present injury), the “‘threatened injury must be certainly impending to constitute injury in fact.’ ” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 133 S.Ct. 1138, 1147, 185 L.Ed.2d 264 (2013) (citations omitted). “‘Allegations of possible future injury,’” on the other hand, are insufficient. Id. (citations omitted). Here, the individual Plaintiffs’ assertions of possible future injury are far too remote and speculative to confer standing. There is no evidence before the Court that consuming force-fed foie gras causes immediate injury to the consumer, and there is little, if any, evidence that it appreciably increases one’s chance of developing disease over time. Even if the Court credited the conclusions in the Solomon Study (see infra Section IV.C.3.ii), that study found at most that repeated consumption of foie gras over time may increase the risk of triggering secondary amyloidosis in genetically susceptible persons. Neither Evans nor Schurig are genetically predisposed to developing secondary amyloidosis, and thus the Court is at a loss as to what injury could befall them from eating force-fed foie gras. And while Lee may have more reason to be concerned given her genetic susceptibility,
B. Zone of Interest Test
Defendants contend that the PPIA is concerned solely with human welfare, and thus the organizational Plaintiffs’ concern for animal welfare falls outside the zone of interests that the PPIA- protects. • (Defs.’ Opp’n at 15-17.) Defendants also argue that the Court should discount any tangential concern those organizations may have for human welfare, which derives solely from their concern for animal welfare. (Id.) The Court is unpersuaded.
The Supreme Court has held that “a person suing under the APA must satisfy not only. Article Ill’s standing requirements, but an additional test: [t]he interest he asserts must be ‘arguably within the zone of interests to be protected or regulated by the statute’ that he says was violated.” Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak, 567 U.S. 209, 132 S.Ct. 2199, 2210, 183 L.Ed.2d 211 (2012) (quoting Ass’n of Data Processing Serv. Orgs., Inc. v. Camp, 397 U.S. 150, 153, 90 S.Ct 827, 25 L.Ed.2d 184 (1970)).
As the word “arguably” indicates, the inquiry ‘“is not meant to be especially demanding.’ ” Id. (quoting Clarke v. Sec. Indus. Ass’n, 479 U.S. 388, 399, 107 S.Ct. 750, 93 L.Ed.2d 757 (1987)). “[T]here does not have to be an ‘indication of congressional purpose to benefit the would-be plaintiff.’” Nat’l Credit Union Admin. v. First Nat. Bank & Trust Co., 522 U.S. 479, 492, 118 S.Ct. 927, 140 L.Ed.2d 1 (1998) (quoting Clarke, 479 U.S. at 399, 107 S.Ct. 750). Rather, “[t]he test forecloses suit only when a plaintiffs ‘interests are so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress intended to permit the suit.’ ” Pottawatomi Indians, 132 S.Ct. at 2210. The test is particularly lenient in APA cases, where there is a “presumption in favor of judicial review of agency action.” Clarke, 479 U.S. at 399, 107 S.Ct. 750; Lexmark Int’l, 134 S.Ct. at 1389; Bennett v. Spear, 520 U.S. 154, 163, 117 S.Ct. 1154, 137 L.Ed.2d 281 (1997) (“[W]hat comes within the zone of interests of a statute for purposes of obtaining judicial review of administrative action under the ‘generous review provisions’ of the APA may not do so for other purposes.”). As a result, “the benefit of any doubt goes to the plaintiff.” Pottawatomi Indians, 132 S.Ct. at 2210.
C. Merits
1. Standard of Review
When a petitioner seeks judicial review of final agency action, “[t]he reviewing court shall hold unlawful and set aside agency action, findings, and conclusions found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). “To determine whether an agency violated the arbitrary and capricious standard, this court .must determine whether the agency articulated a rational connection between the facts found and the choice made.” Arizona Cattle Growers’ Ass’n v. U.S. Fish & Wildlife, Bureau of Land Mgmt., 273 F.3d 1229, 1236 (9th Cir. 2001). The agency may not “rel[y] on factors which Congress has not intended it to consider, entirely fail[ ] to consider an important aspect of the problem, [or] offer[ ] an explanation for its decision that runs counter to the evidence before the agency[] or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983). Thus, the Court cannot “consider reasons for agency action which were not before the agency.” Id.
That said, judicial review of an agency’s denial of a rulemaking petition is “‘extremely limited’ and ‘highly deferential.’” Massachusetts v. E.P.A., 549 U.S.
2. The PPIA
The PPIA “provide[s] for the inspection of ... and otherwise regulate[s] the processing and distribution” of poultry and poultry products to prevent “adulterated or misbranded” poultry from entering the food supply. See 21 U.S.C. § 452. The PPIA prohibits the sale of “dead, dying, disabled, or diseased poultry,” id. § 460(d), and requires any “poultry products found to be adulterated [to] be condemned,” id. § 455(c). There are several grounds on which a poultry product is considered “adulterated,” including “if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food.” Id. § 453(g)(3). Condemnation of poultry products must be “supported by scientific fact, information, or criteria.” Id. § 452. The Secretary of Agriculture has the authority to promulgate rules and regulations “as are necessary to carry out the provisions of [the PPIA],” id. § 463(b), which the Secretary has in turn delegated to FSIS, 9 C.F.R. § 300.2(a), (b)(2).
3. Analysis
Plaintiffs challenge FSlS’s decision on three grounds: (1) its explanation for why hepatic lipidosis does not render the liver unfit for human consumption is “nonsensical and irrational”; (2) its conclusion that there was insufficient evidence of a connection between consumption of force-fed foie gras and the onset of secondary amyloidosis in humans “ran counter to the evidence before it”; and (3) FSIS entirely failed to consider other bases purportedly included in the petition that support a finding that foie gras is unfit for human consumption.
Plaintiffs argue that FSIS gives a “nonsensical and irrational” explanation for why fatty livers caused by disease are unfit for human consumption, but livers fattened through force-feeding are not. (Pls.’ Mot. at 19-21, 23-25, ECF No. 61.) First, they contend that the logic behind FSIS’s reasoning is scientifically unsound. (Id.) Second, they contend that neither the PPIA nor the relevant regulations distinguish between the causes of particular physiologic states (such as hepatic lipido-sis). (Id.) The Court disagrees.
As noted above, the Court must defer to an agency’s scientific judgments. FSIS reasoned that although force-fed livers contain excess fat and thus could be characterized as affected by hepatic lipido-sis, it is not a diseased or otherwise dangerous product because liver fattening is the normal and expected physiologic response to force-feeding.
Plaintiffs’ argument that the distinction is without basis in the statutory and regulatory scheme fares no better, because this is a classic case in which the Court should give Chevron and Auer deference to the agency’s interpretation of the relevant statutes and regulations, respectively. The PPIA explicitly requires that the condemnation of poultry be based on “scientific fact, information, or criteria,” and that such condemnation be achieved “through uniform inspection standards and uniform applications thereof.” 21 U.S.C. § 452. Despite this, the PPIA and its implementing regulations are filled with broad and ambiguous phrases describing the bases for condemning poultry or removing it from commerce. Indeed, § 453(g)(3) alone contains seven such words: “filthy,” “putrid,”
Here, there is nothing in the PPIA or the implementing regulations that renders FSIS’s distinction between causes of hepatic lipidosis unreasonable. Plaintiffs point, for example, to the requirement that FSIS condemn any poultry carcass that “show[s] evidence of an abnormal physiologic state,” 9 C.F.R. § 381.83, and argue that the phrase “abnormal physiologic state” precludes any consideration of what causes that state. (Pis.’ Mot. at 19-21.) However, this is far from the only reasonable interpretation of this phrase; indeed, the cause of the physiologic state may be exactly what makes it “abnormal.” (See Thaler Decl. ¶ 39 (“[AJbnormal physiology is the term used to describe situations where one or more steps in th[e] complex web of interacting body functions is not working as expected.”); ¶ 40 (“Fat storage is a liver function that is normal physiology.”).) Similarly, the Court sees nothing inherent in the word “diseased,” 21 U.S.C. § 460(d), that requires FSIS to totally disregard the cause of a physiologic state as a basis for condemnation (or, in this case, non-condemnation).
Finally, Plaintiffs point to a regulation enacted under the Federal Meat Inspection Act that requires FSIS to condemn “all carcasses showing signs of ... fatty and degenerated liver,” 9 C.F.R. § 311.16 (emphasis added), and argue that this discredits FSIS’s attempt to distinguish here between the causes of fatty livers as a basis for condemnation. See Kenney v. Glickman, 96 F.3d 1118, 1124 (8th Cir. 1996) (“The legislative history of the two Acts and subsequent amendments indicate a congressional intent to construe the PPIA and the FMIA consistently.”). ■ This is unpersuasive. Section 311.16 requires that the liver be both “fatty and degenerated” before being condemned; the regulation does not, as Plaintiffs suggest, categorically mandate the destruction of all carcasses with excess fat in the liver. Plaintiffs also give" no reason why the cause of the fatty liver should not inform whether the liver is “degenerated.”
For these reasons, the Court concludes that FSIS acted within its discretion in rejecting .the petitioners’ arguments concerning hepatic lipidosis.
ii. Secondary Amyloidosis
Plaintiffs again attack the scientific reasoning, and the underlying statutory and regulatory constructions, behind FSIS’s conclusion that the study petition
FSIS provided a reasonable scientific explanation for its position. FSIS found that the Solomon Study did not evidence any connection between human consumption of foie gras and the onset of secondary amyloidosis because: (1) the experiments in the study were performed on mice, not humans, and humans are less susceptible than mice to developing secondary amyloidosis; (2) the mice were genetically engineered to have a pre-existing inflammatory process, making them even more susceptible to developing secondary amyloidosis; (3) the mice that developed secondary amyloidosis were injected or fed with “purified and concentrated amyloid fibrils extracted from foie gras,” and that the removal of the fat from foie gras “could have altered how a normal stomach ... would have handled the ingestion”; (4) the authors of the study themselves never concluded that the study evidences a definite connection in healthy humans between eating foie gras and developing secondary amyloidosis, only that “it would seem prudent” for those genetically susceptible to developing secondary amyloidosis to “avoid” eating foie gras; and (5) the study’s theory that persons with diabetes and Alzheimers may also be at an increased risk of developing secondary amy-loidosis after consuming foie gras was speculative and not even tested in the study. (AR at 1548; Hafner Deck ¶¶2-16.)
Plaintiffs also argue that it is irrational for FSIS “to (a) conclude that further study is necessary to ascertain human health risks of foie gras, yet (b) permit that product to enter the human food supply.” (Pls.’ Opp’n at 24; see also id. at 21 (“The PPIA nowhere mentions a “wait-and-see’ approach to a diseased and adulterated poultry product that may be unsafe for human health.”).) At bottom, this is a question of statutory construction: does the PPIA require FSIS to remove from the food supply any poultry product where it has not affirmatively ruled out any possible threat to human health, or does the agency have the discretion evaluate the likelihood and seriousness of the threat before banning the product?
The Court finds Plaintiffs’ absolutist approach untenable. As previously noted, the statutory scheme taken as a whole clearly points to affording FSIS discretion in carrying out the PPIA’s objectives, which must include reasonable discretion as to the quantum of evidence needed before taking agency action as drastic as banning a food product entirely from the market.
iii. Other Bases
Finally, Plaintiffs list a number of other conditions that the force-feeding process apparently produces,
“It is a hard and fast rule of administrative law, rooted in simple fairness, that issues not raised before an agency are waived and will not be considered by a court on review.” Nuclear Energy Inst. Inc. v. Envtl. Prot Agency, 373 F.3d 1251, 1297 (D.C. Cir. 2004); see also Marathon Oil Co. v. United States, 807 F.2d 759, 767-68 (9th Cir. 1986); Nat’l Parks & Conservation Ass’n v. Bureau of Land Mgmt., 606 F.3d 1058, 1065 (9th Cir. 2010); cf. Appalachian Power Co. v. E.P.A., 251 F.3d 1026, 1036 (D.C. Cir. 2001) (“‘[A] party must initially present its comments to the agency during the rulemaking in order for the court to consider the issue.’ ” (quoting Tex Tin Corp. v. EPA, 935 F.2d 1321, 1323 (D.C. Cir. 1991))). “An agency cannot be faulted for failing to address such issues that were not raised by petitioners.” Appalachian Power Co., 251 F.3d at 1036; Advocates for Highway & Auto Safety v. Fed. Motor Carrier Safety Admin., 429 F.3d 1136, 1150 (D.C. Cir. 2005) (“[T]he role of the court is to determine whether the agency’s decision is arbitrary and capricious for want of reasoned deci-sionmaking. Therefore, it is unsurprising that parties rarely are allowed to seek ‘review of a substantive claim that has
Here, Plaintiffs did not adequately raise in them administrative petition the other issues that they now contend could form a basis for initiating the rulemaking. The 25-page petition focused on two points: that “force-feeding induces liver disease [i.e., hepatic lipidosis] in ducks and geese” (AR at 14); and that consumption of foie gras could lead to secondary amyloidosis in humans (AR at 22-24). The petitioners made passing references to other ailments that the force-feeding process could cause (most of which were simply secondary to hepatic lipidosis), and did not mention any of the myriad regulations which Plaintiffs now cite. (AR at 17, 20, 21.) This cannot be fairly construed to “alert the agency” that each secondary ailment was a substantive and independent basis for the petition. Appalachian Power Co., 251 F.3d at 1036. For example, Plaintiffs now make much of the fact that the force-feeding process can cause toxemia or septicemia, yet the petitioners did not mention either condition in the petition or cite the relevant regulation (9 C.F.R. § 381.83). While this and the other issues may have been lurking somewhere in the 1,150 pages of exhibits that petitioners submitted to FSIS, the Court can hardly fault FSIS for not scouring the exhibits and addressing possible issues that Plaintiffs would later deem important enough to ferret out on judicial review. See Advocates for Highway & Auto Safety, 429 F.3d at 1150 (“[A] rulemaking cannot be found wanting simply because an agency fails to address every alternative ‘thought conceivable by the mind of man.’’’ (citation omitted)); McNair, 537 F.3d at 988 (the agency need not “explain every possible scientific uncertainty”).
V. CONCLUSION
For the reasons discussed above, the Court GRANTS Defendants’ Motion for Summary Judgment (ECF No. 67), and DENIES Plaintiffs’ Motion for Summary Judgment (ECF No. 61).
IT IS SO ORDERED.
, That is, foie gras derived from the livers of force-fed poultry.
. Lee’s son was diagnosed with secondary amyloidosis. (Lee Decl. ¶ 5.)
. Loss of donor support is unquestionably an Article III injury. See ACLU of Idaho, Inc. v. City of Boise, 998 F.Supp.2d 908, 914 (D. Idaho 2014). Moreover, despite Defendants’ argument to the contrary, it appears that rep-utational loss can also constitute an Article III injury. See Meese v. Keene, 481 U.S. 465, 475, 107 S.Ct. 1862, 95 L.Ed.2d 415 (1987) (“[T]he
. Defendants erroneously label this test as a "prudential standing" inquiry. Lexmark Int'l, 134 S.Ct. at 1387 (" ‘[P]rudential standing’ is a misnomer as applied to the zone-of-interests analysis, which asks whether 'this particular class of persons has a right to sue under this substantive statute,’ ’’ (quoting Ass’n of Battery Recyclers, Inc. v. ERA, 716 F.3d 667, 675-76 (2013) (Silberman, J., concurring))).
. Plaintiffs object to portions of two declarations that Defendants submit in support of
. The bird is typically slaughtered before the fat deposits overwhelm the liver’s ability to function. (Thaler Decl. ¶ 40.)
. And if a fatty liver was per se ⅜ degenerated state, there would be no need to separately require that the liver be both "fatty” and "degenerated.” Cf. Asadi v. G.E. Energy (USA), L.L.C., 720 F.3d 620, 622 (5th Cir. 2013) ("In construing a statute, a court should give effect, if possible, to every word and every provision Congress used.”)
. "[A] district court [may] consider extra-record evidence to develop a background against which it can evaluate the integrity of the agency’s analysis.” San Luis & Delta-Mendota Water Auth. v. Locke, 776 F.3d 971, 993 (9th Cir. 2014).
. The only language that Plaintiffs point to for support is the PPIA’s statement of Congressional purpose, which expresses that the PPIA was enacted to ''assur[e]” that poultry products are not adulterated. 21 U.S.C. § 451. However, as with their other arguments,
. Plaintiffs contend that FSIS failed to address the fact that force-fed birds: (1) exhibit systemic inflammatory processes including arthritis and bacterial infections; (2) suffer from an abnormal physiologic state, caused by the liver expanding to 6 to 10 times its original size, restricting the birds’ ability to move and breathe; (3) are unable to walk due to liver enlargement and use of nutritionally deficient feed; (4) are dying because of the ailments caused by force-feeding; (5) suffer from septicemia, including due to the presence of E. Coli and other bacteria; and (6) suffer from toxemia, i.e., the presence toxins in the blood due to the failing liver. (Pis.’ Mot. at 22.)