`
`
`
`
`
`SYLVIA SHIH-YAU WU (CA Bar No. 273549)
`Center for Food Safety
`303 Sacramento Street, 2nd floor
`San Francisco, CA 94111
`(p) 415-826-2770 / (f) 415-826-0507
`swu@centerforfoodsafety.org
`
`RYAN D. TALBOTT
`(Admitted Pro Hac Vice on Jan. 28, 2020)
`AMY VAN SAUN
`(Admitted Pro Hac Vice on Jan. 28, 2020)
`Center for Food Safety
`2009 NE Alberta Street, Suite 207
`Portland, OR 97211
`(p) 971-271-7372
`rtalbott@centerforfoodsafety.org
`avansaun@centerforfoodsafety.org
`
`ZACHARY B. CORRIGAN
`(Admitted Pro Hac Vice on Jan. 28, 2020)
`Food & Water Watch, Inc.
`1616 P Street, NW, Suite 300
`Washington, DC 20036
`(p) 202-683-2451
`(f) 202-683-2452
`zcorrigan@fwwatch.org
`
`JAMES B. DOUGHERTY
`(Admitted Pro Hac Vice on Apr. 6, 2020)
`700 7th St. SW, Suite 805
`Washington, DC 20024
`(p) 202-488-1140
`jimdougherty@aol.com
`
`Counsel for Plaintiffs
`
`
`UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`SAN FRANCISCO DIVISION
`
` Case No. 4:20-cv-00256-JSW
`FIRST AMENDED COMPLAINT
`FOR DECLARATORY
`AND INJUNCTIVE RELIEF
`(ADMINISTRATIVE
`PROCEDURE ACT CASE)
`
`CENTER FOR FOOD SAFETY; FOOD &
`WATER WATCH, INC.; HUMANE FARMING
`ASSOCIATION; PETER VAN GORDER; and
`ROBIN MANGINI;
`
`
`Plaintiffs,
`
`
`
`
` 1
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 2 of 74
`
`
`
`
`
`v.
`
`
`SONNY PERDUE, in his official capacity as the
`Secretary of the U.S. Department of Agriculture;
`MINDY BRASHEARS, in her official capacity as
`the Deputy Under Secretary for Food Safety, U.S.
`Dept. of Agriculture; U.S. DEPARTMENT OF
`AGRICULTURE; and FOOD SAFETY AND
`INSPECTION SERVICE;
`
`
`
`
`
`Defendants.
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`INTRODUCTION
`The plaintiff non-profit organizations, Center for Food Safety (CFS), Food & Water
`1.
`Watch, Inc. (FWW); the Humane Farming Association (HFA); FWW member Peter Van Gorder;
`and CFS and FWW member Robin Mangini (collectively, Plaintiffs) bring this action against the
`above-listed Defendants (individually and collectively Defendants) for their issuance of new rules
`that vitiate this country’s food-safety inspection system for swine in slaughter plants, effectively
`turning it over to the slaughter companies themselves. Defendants’ New Swine Inspection System
`(NSIS) rules, at 84 Fed. Reg. 52300 (October 11, 2019), also lift prior limits on slaughter-line
`speeds, allowing plants to move swine carcasses past government inspection-program personnel
`(hereinafter, inspectors or Program employees) at speeds that neuter the mandatory government’s
`critical appraisal of swine carcasses and parts. Defendants approved these dangerous regulatory
`rollbacks, despite the fact that contaminated pork may cause as many as 1.5 million cases of
`foodborne illnesses, 7,000 hospitalizations, and 200 deaths in the United States each year.
`As a result of all of these changes—which will essentially eliminate much of the
`2.
`government inspection of ninety-three percent of the domestic pork supply—the health and welfare
`of the individual plaintiffs, as well as that of CFS, FWW, and HFA’s members, are seriously
`endangered by adulterated and unwholesome pork product. The individual plaintiffs and the
`groups’ members have already been forced to spend money and will continue spending money in an
`attempt to avoid pork from animals slaughtered in plants likely to switch to NSIS.
`The rules cannot stand and should be permanently enjoined. They are ultra vires and
`3.
`contrary to the Federal Meat Inspection Act (FMIA or the act), 21 U.S.C. §§ 602-695 (2018).
`
`
`
` 2
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 3 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`Further, they are otherwise contrary to constitutional right, power, privilege, or immunity and
`arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with law in violation
`of the Administrative Procedure Act (APA), 5 U.S.C. §§ 551-559, 701-706 (2018).
`JURISDICTION
`This Court has jurisdiction under 28 U.S.C. § 1331 (2018), which grants federal district
`4.
`courts “original jurisdiction of all civil actions arising under the . . . laws . . . of the United States,”
`as well as the APA, 5 U.S.C. §§ 702 and 704, and 21 U.S.C. § 674 (2018), which establishes U.S.
`district court jurisdiction for all kinds of cases arising under the FMIA.
`VENUE AND INTRADISTRICT ASSIGNMENT
`5. Venue is proper in this Court under 28 U.S.C. § 1391 (2018) because this suit was filed in
`the district where Plaintiffs CFS, HFA, Peter Van Gorder, and Robin Mangini all reside, and there
`is no real property involved in the action. Plaintiff CFS resides in the County of San Francisco and
`has more than 15,500 members in Alameda, Contra Costa, Marin, Napa, San Francisco, San Mateo,
`and Sonoma counties. Plaintiff HFA resides in the County of Marin, with roughly 40,000 members
`in California and 12,000 residing in in Alameda, Contra Costa, Marin, Napa, San Francisco, San
`Mateo, and Sonoma counties.
`Plaintiff Robin Mangini resides in Alameda County. Peter Van Gorder resides in
`6.
`Sonoma County. FWW has on office in Oakland and more than 9,400 dues-paying members in
`Alameda, Contra Costa, Marin, Napa, San Francisco, San Mateo, and Sonoma counties.
` This Court may issue a declaratory judgment in this case pursuant to the Declaratory
`7.
`Judgment Act, 28 U.S.C. §§ 2201-2202 (2018), and may grant the requested relief pursuant the
`APA, 5 U.S.C. § 706, 28 U.S.C. § 1651(a) (2018), the Federal Rules of Civil Procedure, and
`pursuant to its inherent authority as a federal district court.
`PARTIES
`Plaintiff CFS is a national, non-profit, public interest and environmental advocacy
`8.
`organization that works to protect human health and the environment by curbing the use of harmful
`food production technologies and by promoting organic and other forms of sustainable agriculture.
`
`
`
`
` 3
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 4 of 74
`
`
`
`CFS has approximately 950,000 members in the United States, with nearly 67,000 in California,
`including Plaintiff Robin Mangini. CFS’s members were some of the hundreds of thousands of
`individuals that submitted public comments to the FSIS in 2018, urging the Defendants not to
`finalize the proposed NSIS rules.
`Plaintiff FWW is a national, non-profit, public interest, consumer advocacy organization
`9.
`that works to ensure safe food and clean water. FWW presently has approximately 284,000 dues-
`paying members in the United States, with 33,000 in California, including Plaintiffs Peter Van
`Gorder and Robin Mangini. Its members were some of the hundreds of thousands of individuals
`that submitted public comments to the Defendants in 2018, urging them not to finalize the proposed
`NSIS rules.
`10. Plaintiff HFA is a national, non-profit, animal protection and consumer advocacy
`organization—registered since 1985 as a tax-exempt charity under §501(c)(3) of the Internal
`Revenue Code—that works to advance the welfare of farm animals and protect the health of
`Americans who consume animal products. HFA’s programs focus on protecting farm animals from
`cruelty, protecting the public from the risks of consuming adulterated and unwholesome animal
`products produced in slaughterhouses, restricting the misuse of antibiotics, hormones, and other
`chemicals used on industrial farms, and protecting the environment from the impacts of
`industrialized animal farming. HFA currently has approximately 250,000 members in the United
`States. In 2018, HFA submitted comments to the Defendants urging against adoption of the then-
`proposed NSIS rules which are the subject of this lawsuit.
`11. Plaintiff Peter Van Gorder is a resident of Sebastopol, California. He is a dues-paying
`member of FWW. Before the challenged NSIS rules became effective, he has been a regular
`consumer of pork, and he intended to continue consuming unadulterated USDA-inspected pork
`product.
`12. Plaintiff Robin Mangini is a resident of Piedmont, California. She is a dues-paying
`member of FWW and a member of CFS. Before the NSIS rules became effective, she has been a
`
`
`
`
` 4
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 5 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`regular consumer of pork, and she intended to continue consuming unadulterated USDA-inspected
`pork product.
`13. Defendant Sonny Perdue is the Secretary of the U.S. Department of Agriculture (USDA)
`and is given authority to administer or delegate the administration of the FMIA. 21 U.S.C. §§ 621,
`601(a).
`14. Defendant Dr. Mindy Brashears is Deputy Under Secretary of Food Safety for the
`USDA, which has been delegated the administration of the FMIA by the USDA Secretary. 7
`C.F.R. § 2.18(a)(1)(ii)(B) (2019).
`15. Defendant USDA is the U.S. department that houses Defendant FSIS.
`16. Defendant FSIS’s staff and senior management wrote and approved the final NSIS rules.
`The agency is responsible for ensuring that the nation’s commercial supply of meat, poultry, and
`egg products is safe, wholesome, and correctly labeled and packaged for human consumption.
`STATUTORY BACKGROUND
`The Administrative Procedure Act
`17. The APA governs federal agency actions, including but not limited to its rulemaking.
`The purpose for the APA is to improve the administration of justice by prescribing fair
`administrative procedure.
`18. Under the APA, a court is empowered to hold unlawful and set aside agency action for
`findings and conclusions that, among other reasons, are “contrary to constitutional right, power,
`privilege, or immunity[,] . . . arbitrary, capricious, an abuse of discretion, or otherwise not in
`accordance with law[,]. . . in excess of statutory jurisdiction, authority, or limitations, or short of
`statutory right[,] . . . and without observance of procedure required by law.” 5 U.S.C. § 706(2).
`B.
`The Federal Meat Inspection Act
`19. When Congress passed the FMIA in 1907 it declared that “[i]t is essential in the public
`interest that the health and welfare of consumers be protected by assuring that meat and meat food
`products distributed to them are wholesome, not adulterated, and properly marked, labeled, and
`packaged.” 21 U.S.C. § 602. To achieve this goal, Congress authorized the Secretary of
`
`A.
`
`
`
`
` 5
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 6 of 74
`
`
`
`Agriculture to issue regulations “to protect the health and welfare of consumers” from
`“[u]nwholesome, adulterated, or misbranded meat or meat food products[.]” Id. The reason was
`that “unwholesome, adulterated, mislabeled, or deceptively packaged articles can be sold at lower
`prices and compete unfairly with the wholesome, not adulterated, and properly labeled and
`packaged articles, to the detriment of consumers and the public generally.” Id.
`20. Regulations promulgated under the FMIA establish an exhaustive scheme (detailed
`further below) requiring the federal government inspection of animals, or “amenable species,”
`including swine, before they are slaughtered (ante-mortem) as well as inspection of the carcasses
`after slaughter (post-mortem). Congress was so concerned with the need for federal oversight of
`slaughterhouses that it made it a criminal activity to slaughter animals or prepare or sell, transport,
`offer for sale or transportation, or receive for transportation, in commerce, products intended for
`food without a federal inspection of the animals and meat and meat products as prescribed by the
`law. Id. § 610.
`
`GENERAL ALLEGATIONS
`21. As detailed more fully below, this case involves a radical transformation of the federal
`government’s food-safety inspection of swine and swine carcasses, affecting the pork product that
`ends up in grocery stores and restaurants around the country. Prior to the NSIS rules that are the
`subject of this suit, each and every swine was to first receive a mandatory government “inspection”
`prior to slaughter. As part of this process, federal government inspectors critically appraise animals
`for disease and food-safety issues. They must tag those animals with symptoms of disease so that
`they receive a more careful inspection, both before and after they are slaughtered separately from
`other animals. Federal inspectors also flag animals for residue and drug tests where necessary.
`Second, after slaughter, federal inspectors must critically appraise each animal’s head, viscera, and
`carcass on the lines where prepared. Third, federal inspectors condemn those animals and carcasses
`that are found to be adulterated. Finally, federal inspectors supervise the disposal of such
`condemned animals and carcasses.
`
`
`
`
` 6
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 7 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`22. Defendants’ new NSIS rules, quite to the contrary, prevent federal inspectors from
`performing crucial inspection activities of swine prior to slaughter and of carcasses afterwards. The
`new rules thus curtail the ability of federal inspectors to detect serious food-safety problems, and
`they expose those who consume such pork products to serious health threats. Under this new
`regime, it is slaughter-plant employees rather than federal inspectors that are charged with
`identifying those animals with food-safety conditions, such as septicemia, before and after
`slaughter. Septicemia is linked to pathogens including Salmonella, a serious human pathogen in
`contaminated pork that Defendants estimate annually sickens 69,000 people.
`23. Likewise, after slaughter, under these new rules, plant employees without minimum
`education or training (an estimated average of four hours’ worth, according to the Defendants’ cost-
`benefit analysis) are now solely charged with trimming carcasses that may have problems such as
`bruises from drug injections (thus avoiding the detection of illegal drug use) and parts contaminated
`with fecal material, ingesta, or milk. Fecal matter, ingesta, and milk can contain infectious agents
`that can be transmitted to humans. Under- or un-trained plant employees are now charged with
`identifying and notifying federal inspectors when swine carcasses show serious diseases such as
`pork measles, a rare but fatal disease caused by a tapeworm that is transmittable to humans. The
`rules also preclude inspectors from preventing the release of swine infected with animal diseases,
`such as Foot-And-Mouth Disease and African Swine Fever, back into the animal supply, thereby
`substantially increasing the risk of wide-spread mortality and increased prices, threatening the
`health and welfare of consumers.
`24. This Complaint outlines how the new NSIS rules violate the FMIA and APA as follows.
`Section I details the comprehensive manner in which federal inspectors are required to perform
`their mandatory FMIA inspection duties by critically appraising all swine prior to slaughter. It also
`details how federal inspectors follow the FMIA’s mandates to ensure that those animals showing
`symptoms of disease are slaughtered separately so that they receive a careful inspection when
`slaughtered. Federal inspectors also condemn those animals found adulterated and supervise their
`disposal pursuant to the FMIA. Section II details how federal inspectors under the former,
`
`
`
`
` 7
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 8 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`traditional inspection system followed the FMIA by critically appraising all carcasses and parts of
`swine after slaughter and condemning and supervising the disposal of carcasses and parts found to
`be adulterated. This section also details the training that allows federal inspectors to perform such
`critical and complicated tasks.
`25. Section III details how the new NSIS rules abrogate the FMIA’s mandatory ante-mortem
`inspection, separate-slaughter, and post-mortem inspection duties. The NSIS rules prevent and
`preclude federal inspectors from critically appraising animals prior to slaughter, and carcasses and
`parts afterwards. Section IV details how the NSIS rules also eliminate the act’s condemnation and
`disposal-supervision requirements for federal inspectors. Section V details how the Defendants
`have rolled back pathogen standards at the same time, despite the fact that the NSIS rules amount to
`a massive change in the way inspections will be carried out in swine plants.
`26. Section VI demonstrates how the Defendants have failed to provide any adequate basis
`whatsoever for the NSIS rules. The chief documents upon which the Defendants have relied were
`prepared in response to two 2013 reports by the USDA Office of Inspector General (OIG) and U.S.
`Government Accountability Office (GAO). They found the pilot program for the NSIS rules
`lacking in oversight and usable data. This section of the Complaint painstakingly charts how the
`Defendants’ 2014 evaluation of the pilot program and revised 2018 risk assessment demonstrate
`that little has changed since these two audits. Defendants’ data supporting the NSIS rules remains
`seriously lacking. Defendants misrepresent the data that they have made public. Defendants also
`fail to address numerous comments including those from expert peer reviewers. This section also
`shows that the changes in the inspection system under NSIS will not be as protective of, much less
`better for food safety compared to traditional inspection. This is perhaps no surprise, as Section VII
`shows how the rulemaking is very much the product of Defendants’ undue bias.
`27. Last, Section VIII of this Complaint details how Plaintiffs have been, are being, and will
`be harmed by the NSIS rules, before ultimately presenting Plaintiffs’ seven claims for relief and
`relief requested.
`
`
`
`
`
`
` 8
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 9 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`STATEMENTS OF FACT
`I. ANTE-MORTEM INSPECTION UNDER THE FMIA
`A.
`Inspection
`28. The FMIA plainly and simply requires the “examination and inspection of all amenable
`species” before the animals are allowed to be slaughtered. 21 U.S.C. § 603 (emphasis added).
`An “inspection” is a critical appraisal by a federal inspector. Am. Fed’n of Gov’t
`29.
`Emps. v. Glickman, 215 F.3d 7, 11 (D.C. Cir. 2000) (AFGE); 21 U.S.C. § 622 (including inspectors
`in a list of officers and employees “of the United States authorized to perform any of the duties
`prescribed by this chapter”).
`30. Under traditional inspection, federal inspectors perform ante-mortem inspection to
`remove obviously-diseased animals from the food supply prior to slaughter and to identify animals
`that require a more extensive post-mortem examination by a government Public Health Veterinarian
`(PHV). Defendants consider it the first line of defense in protecting the public from potentially
`harmful meat products.
`Inspectors observe all livestock at rest and in motion. FSIS Directive 6100.1 Rev. 2
`31.
`(7/24/14) (FSIS Directive 6100.1) at X(B). This allows federal inspectors to catch certain abnormal
`signs, such as labored breathing, which are easier to detect while the animals are at rest, and others,
`such as lameness, which may not be detected until the animals are in motion.
`Inspectors are supposed to observe the overall condition of each animal, including the
`32.
`head—with attention to the eyes—legs, and body; the degree of alertness, mobility, and breathing;
`and whether there are any unusual swellings or any other abnormalities. Id. at X(C).
`Inspectors are to “pass” for slaughter the livestock that do not show signs of diseases or
`33.
`abnormalities and thus are fit for slaughter for human consumption. Id. at X(D).
`34. When inspectors find animals showing signs of abnormalities or diseases, they direct the
`establishment to set the affected animals apart into separate “U.S. Suspect” pens for further
`inspection by the PHV. Id. at X(E).
`
`
`
`
`
` 9
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 10 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`Suspect Animals
`B.
`35. The FMIA also addresses how inspectors are required to treat animals showing symptoms
`of disease: “all amenable species found on [ante-mortem] inspection to show symptoms of disease
`shall be set apart and slaughtered separately from all other [amenable species], and when so
`slaughtered the carcasses . . . shall be subject to a careful examination and inspection, all as
`provided by the rules and regulations to be prescribed by the Secretary, as provided for in this
`subchapter.” 21 U.S.C. § 603 (2018).
`36. USDA’s existing regulations require that “[a]ny livestock which, on ante-mortem
`inspection, do not clearly show, but are suspected of being affected with any disease or condition
`that . . . may cause condemnation of the carcass on post-mortem inspection, and any livestock
`which show, on ante-mortem inspection, any disease or condition that . . . would cause
`condemnation of only part of the carcass on post-mortem inspection, shall be so handled as to retain
`its identity as a suspect until it is given final post-mortem inspection, when the carcass shall be
`marked and disposed of . . . .” 9 C.F.R § 309.2(a) (2019).
`37. Such animals are physically tagged with a “U.S. Suspect” tag because they are
`“suspected of being affected with a disease or condition which may require [their] condemnation, in
`whole or in part, when slaughtered, and [are] subject to further examination by an inspector to
`determine [their] disposal.” Id. § 301.2.
`“Each animal required . . . to be treated as a U.S. Suspect shall be identified as such by or
`38.
`under the supervision of a Program employee with an official device . . . . No such device shall be
`removed except by a Program employee.” Id. § 309.2(m).
`39. Such animals “shall be set apart and . . . slaughtered separately from other livestock at
`that establishment unless disposed of as otherwise provided[.]” Id. § 309.2(n).
`“When any animal identified as a U.S. Suspect is released for any purpose or reason, . . .
`40.
`the official identification device shall be removed only by a Program employee and he shall report
`his action to the area supervisor. When a suspect is to be released . . . for a purpose other than
`slaughter, the operator of the official establishment or the owner of the animal shall first obtain
`
`
`
`
` 10
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 11 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`permission for the removal of such animal from the local, State or Federal livestock sanitary official
`having jurisdiction.” Id. § 309.2(p).
`In accordance with these provisions, when inspectors find animals showing signs of
`41.
`abnormalities or diseases under traditional ante-mortem inspection, they direct the slaughter
`establishment to set the affected animals apart into separate pens, called “U.S. Suspect” pens, for
`further examination by the government PHV. FSIS Directive 6100.1 at X(E). Government PHVs
`are to examine and take the temperature (or direct establishment employees to take the
`temperature), as necessary, of abnormal or diseased livestock. Id. at XII(A). PHVs are to designate
`livestock as “U.S. Suspect” by applying or directing establishment employees to attach a serially
`numbered “U.S. Suspect” tag to livestock that:
`
`1. Have any disease or condition that may cause the PHV to condemn the carcass or part
`of a carcass when inspected post-mortem; and
`2. Are presented as non-ambulatory disabled.
`Id. at XII(B).
`Inspectors are also responsible for the detection and reporting of Foreign Animal
`42.
`Diseases (FADs) and reportable conditions. FSIS Directive 6000.1 Rev. 1 (8/03/06) (FSIS
`Directive 6000.1) at VII(A)-(B). FADs can significantly affect human health or animal production
`and can be costly to the livestock growers to control and eradicate, and thus also for consumers.
`Diseases such as classical swine fever (hog cholera), Foot-And-Mouth disease, and African Swine
`Influenza can cause high death rates or severe illness and production losses. This loss of
`productivity can increase the cost of food products obtained from those animals. Also, the
`quarantine required to control any disease outbreaks can stop all animal movement and trade for a
`significant period of time.
`43. A few of the signs when observed during ante-mortem inspection pointing to a FAD
`include sudden lameness and the existence of central nervous system conditions. Id. at VI(C).
`Inspectors are to deem such animals “U.S. Suspects” or “U.S. Condemned,” as
`44.
`appropriate, and report them to the FSIS District office if reportable or a FAD. Id. at VII(A)-(B).
`
`
`
`
` 11
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 12 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`45. When animals are identified as U.S. Suspect for chemical residues, the PHV is to collect
`required samples (of muscle, liver, and kidney) and test these animals for chemical residues during
`post-mortem inspection. FSIS Directive 10,800.1 Rev. 1 (3/3/14) (FSIS Directive 10,800.1) at Ch.
`4. I(A). Also, such testing for drug residues is required when post-mortem findings may indicate
`antimicrobial treatment or violative chemical use or exposure, even if the carcass and its parts have
`been condemned. Id. at Ch. 3. I(B).
`46. Such testing is required because chemical residues and antimicrobial use can affect the
`plant’s entire swine supply, regardless of whether an individual carcass is condemned.
`47. Some of the pathologies and conditions that are supposed to merit the retention and
`testing of carcasses for chemical residues include the presence of injection sites, injury, or
`inflammatory conditions, even if these are not condemnable conditions. Id.
`48. Under the agency’s existing regulations, livestock suspected of having been treated with
`or exposed to any substance that may impart a biological residue which would make the edible
`tissues unfit for human food or otherwise adulterated shall be identified at official establishments as
`“U.S. Condemned.” 9 C.F.R. § 309.16(a). All carcasses and edible organs and other parts thereof,
`in which are found any biological residues which render such articles adulterated, shall be marked
`as “U.S. Condemned” and disposed of in accordance with 9 C.F.R. §§ 314.1 or 314.3. Id. §
`309.16(b).
`C.
`The Condemnation of Animals
`49.
`In addition to the inspectors’ ante-mortem-inspection duties to examine and inspect
`animals and ensure that suspect animals are identified as such, slaughtered separately, and given a
`“careful” post-mortem inspection, federal inspectors must condemn and dispose of animals that are
`found to be dead, dying, or diseased.
`50. Under existing regulations, “[l]ivestock found to be dead or in a dying condition on the
`premises of an official establishment shall be identified as U.S. Condemned and disposed of in
`accordance with § 309.13.” 9 C.F.R. § 309.3(a) (2019). “Livestock plainly showing on ante-
`mortem inspection any disease or condition that . . . would cause condemnation of their carcasses
`
`
`
`
` 12
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 13 of 74
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`on post-mortem inspection shall be identified as U.S. Condemned and disposed of in accordance
`with § 309.13.” Id. § 309.3(b)
`“U.S. Condemned” means “the livestock so identified has been inspected and found to be
`51.
`in a dying condition, or to be affected with any other condition or disease that would require
`condemnation of its carcass.” Id. § 301.2(b).
`52. According to FSIS directive, “[i]n accordance with 9 CFR 309.3(a)-(e), PHVs are to
`identify livestock as ‘U.S. Condemned’ by directing that a serially numbered metal ‘U.S.
`Condemned’ ear tag . . . be applied to each animal that is condemned on ante-mortem inspection.”
`FSIS Directive 6100.1 at XIV(A).
`53. PHVs do not have to apply the “U.S. Condemned” tag but are to observe that the “U.S.
`Condemned” tag is applied by an establishment employee. Id. at XIV(B).
`54. Federal inspectors may identify and tag dead animals as “U.S. Condemned.” Id. at
`XIV(C). Only government PHVs may condemn live animals. Id.
`“U.S. Condemned” tags are placed on:
`55.
`
`a) Livestock that are dead or in a dying condition when offered for slaughter on the
`premises of the official establishment;
`
`
`b) Livestock that are plainly showing on ante-mortem inspection any disease or condition
`that would cause the PHV to condemn the carcass when inspecting postmortem; and
`c) Any swine have a temperature of 106°F or higher.
`Id. at XIV(D).
`56. Only federal inspectors may remove U.S. Condemned tags. 9 C.F.R. § 309.13(a) (2019).
` “Livestock identified as U.S. Condemned shall be killed by the official establishment, if
`57.
`not already dead.” Id. “Such animals shall not be taken into the official establishment to be
`slaughtered or dressed[.]” Id. “The official U.S. Condemned tag shall not be removed from, but
`shall remain on the carcass . . .” until it is disposed of. Id.
`
`
`
`
`
`
`
` 13
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF, CASE NO. 4:20-cv-00256-JSW
`
`
`
`
`
`Case 4:20-cv-00256-JSW Document 26 Filed 04/06/20 Page 14 of 74
`
`
`
`II. POST-MORTEM INSPECTION UNDER THE FMIA
`A.
`Inspection
`58. The FMIA similarly requires that all amenable species’ carcasses receive inspection after
`slaughter:
`
`For the purposes hereinbefore set forth the Secretary shall cause to be made by inspectors
`appointed for that purpose a postmortem examination and inspection of the carcasses and
`parts thereof of all amenable species to be prepared at any slaughtering, meat-canning,
`salting, packing, rendering, or similar establishment in any State, Territory, or the District of
`Columbia as articles of commerce which are capable of use as human food[.]
`21 U.S.C. § 604. The FMIA defines the term “prepared” to mean “slaughtered, canned, salted,
`rendered, boned, cut up, or otherwise manufactured or processed.” Id. § 601(l). Thus, when each
`swine is slaughtered and its carcasses and parts are prepared, it needs to be examined and inspected.
`59. Under Defendants’ still existing regulations, “[a] careful post-mortem examination and
`inspection shall be made of the carcasses and p