Ctr. for Food Safety v. Perdue

• Decision Date: 30 September 2022
• Docket Number: C 20-cv-00256-JSW
• Parties: CENTER FOR FOOD SAFETY, et al., Plaintiffs, v. SONNY PERDUE, et al., Defendants.
• Court: U.S. District Court — Northern District of California

CENTER FOR FOOD SAFETY, et al., Plaintiffs,
v.
SONNY PERDUE, et al., Defendants.

No. C 20-cv-00256-JSW

United States District Court, N.D. California

September 30, 2022

ORDER RESOLVING CROSSMOTIONS FOR SUMMARY JUDGMENT RE: DKT. NOS. 65, 68

JEFFREY S. WHITE, United States District Judge.

Now before the Court for consideration are the motion for summary judgment filed by Plaintiffs Food & Water Watch (“FWW”), Center for Food Safety (“CFS”), the Humane Farming Association (“HFA”), and Robin Mangini (“Mangini”) (collectively, “Plaintiffs”) and the crossmotion for summary judgment filed by the U.S. Department of Agriculture (“USDA”), Secretary of Agriculture Thomas Vilsack, the Food Safety and Inspection Service (“FSIS”), and Deputy Under Secretary for Food Safety Sandra Eskin (collectively, “Defendants”). The Court has reviewed the parties' papers, relevant legal authority, and the record in the case, and it finds this matter suitable for disposition without oral argument.^[1] See N.D. Civ. L.R. 7-1(b). For the following reasons, the Court DENIES Plaintiffs' motion for summary judgment and GRANTS Defendants' cross-motion for summary judgment.

BACKGROUND

Plaintiffs are three non-profit consumer organizations and one of their individual members who bring this challenge to the USDA's Modernization of Swine Slaughter Inspection Rule. See 84 Fed.Reg. 52,300 (Oct. 1, 2019) (“Final Rule”). Plaintiffs allege that the new rule, which

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implements a new inspection system for swine slaughter, is contrary to the Federal Meat Inspection Act (“FMIA”) and violates the Administrative Procedure Act (“APA”).

Plaintiffs allege that the FMIA requires federal government inspectors to examine and inspect every animal prior to slaughter and every carcass and body part after slaughter. Plaintiffs contend, however, that the new inspection system established by the Final Rule transfers these federal inspection duties to the slaughter plant employees, which prevents federal inspectors from conducting an adequate appraisal of animals, carcasses, and parts as required by the FMIA.

Plaintiffs also allege that the rulemaking process was arbitrary and capricious in violation of the APA because the Final Rule (1) irrationally departs from prior inspection regulations and practices; (2) is based on a flawed pilot project; and (3) relies on a flawed risk assessment for which the public was not provided adequate time to provide notice and comment.

A. The Federal Meat Inspection Act.

Congress enacted the FMIA in response to unsanitary conditions in meatpacking plants. The FMIA authorizes the FSIS, a component of USDA, with protecting consumer health and welfare by ensuring that meat products are safe and unadulterated. 21 U.S.C. § 602. The FMIA authorizes FSIS to appoint inspectors and public health veterinarians (“PHVs”) to conduct antemortem and post-mortem inspections of carcasses intended for use as human food. Id. §§ 603604.

In furtherance of its mission of protecting consumer health and welfare, FSIS has promulgated regulations that govern ante- and post-mortem examinations at swine slaughter establishments. See, e.g., 9 C.F.R. pts 309 & 310; Swine Post-Mortem Inspection Procedures and Staffing Standards, 50 Fed.Reg. 19,900 (May 13, 1985); Cattle & Swine Post-Mortem Inspection Procedures and Staffing Standards, 47 Fed.Reg. 33,673 (Aug. 4, 1982).

B. The Traditional Inspection System.

The traditional inspection system established by the FSIS requires federal inspectors to inspect all swine before and after slaughter. During ante-mortem inspections, federal inspectors examine all livestock offered for slaughter while at rest and in motion and direct establishment employees to tag animals showing visible signs of disease or other condemnable conditions for

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further inspection by a PHV. See 9 C.F.R. § 309.1. During post-mortem inspections, establishments present the head, viscera, and carcass of each animal for inspection by FSIS. 9 C.F.R. § 310.1(b)(3). Federal inspectors look for disease through “organoleptic inspections” and by incising and palpating certain lymph nodes. Modernization of Swine Slaughter Inspection, 83 Fed.Reg. at 4780, 4783 (Feb. 1, 2018) (“Proposed Rule”). The traditional inspection system requires up to seven FSIS inspectors per evisceration line. Id. Under the traditional inspection system, establishment employees are not required to sort carcasses before the post-mortem inspection to identify or remove contamination or to flag potentially condemnable carcasses or parts for further scrutiny by FSIS. Id.

C. The HIMP Pilot Program.

In the 1990s, FSIS proposed changes to the inspection process. FSIS acknowledged that the FSIS's inspection procedure had not kept up with advancements in the control and eradication of animal diseases. See HACCP-Based Meat and Poultry Inspection Concepts, 62 Fed.Reg. 31,553 (June 10, 1997). FSIS also found that the traditional inspection method failed to efficiently use its resources, including failing to adequately target foodborne pathogens such as Salmonella and E. coli. Id.

As a result, FSIS began to look for ways to modernize and increase the efficiency of the inspection process. As a first step, FSIS required establishments to develop a system of preventative controls designed to ensure their products are safe. See Pathogen Reduction/Hazard Analysis and Critical Control Point (“HACCP”) Systems, 61 Fed.Reg. 38,806 (1996). With these measures, FSIS adopted a new approach that required establishments to play a larger role in ensuring product safety. See 83 Fed.Reg. at 4787; 61 Fed.Reg. at 38,808.

To assess the efficacy of the new approach, FSIS developed the HACCP-Based Inspection Models Project (“HIMP”) pilot, which was designed to test the new inspection models in volunteer meat and poultry slaughter establishments. See HACCP-Based Meat and Poultry Inspection Concepts, 62 Fed.Reg. 31,553 (June 10, 1997). Under the HIMP pilot, plant employees performed the task of separating normal from abnormal carcasses and parts; federal inspectors monitored the plant's performance and verified the plant's compliance with

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performance standards and regulatory requirements.

The D.C. Circuit struck down the initial HIMP pilot program as contrary to 21 U.S.C. section 604 (“Section 604”) of the FMIA, finding that the proposed model impermissibly “[d]elegat[ed] the task of inspecting carcasses to plant employees” and relegated federal inspectors to an oversight and verification role in violation of the clear mandate of the FMIA. Am. Fed'n of Gov't Emps., AFL-CIO v. Glickman, 215 F.3d 7, 11 (D.C. Cir. 2000) (“AFGE I”).

Following AFGE I, FSIS modified the HIMP pilot to comply with the D.C. Circuit's ruling. The modified pilot program placed federal inspectors at up to three fixed locations along the slaughter lines with the responsibility of examining the head, carcass, and viscera of all hogs; other federal inspectors would be assigned to plants to verify the effectiveness of the plant's process control systems. The D.C. Circuit held that the modified HIMP pilot program satisfied the FMIA because it required “federal inspectors in participating hog plants to inspect all hog carcasses, heads and viscera, as the statute demands.” Am. Fed'n of Gov't Emps., AFL-CIO v. Veneman, 284 F.3d 125, 130 (D.C. Cir. 2002) (“AFGE II”). However, the court noted that because the program was a test program, were Defendants to undertake rulemaking “to adopt [it] as a permanent change,” the opinion in that case “may not necessarily foreshadow the outcome of judicial review of such future regulations.” Id. at 130-31.

In 2000, the revised HIMP pilot program was initiated in five large, high-volume hog slaughter establishments. See 83 Fed.Reg. at 4787-88. Under the HIMP pilot, establishment employees remove and dispose of animals that are dead, moribund, or display condemnable conditions before federal inspectors conduct ante-mortem inspection. Id. at 4788. The establishment employees also sort animals that appear to be healthy into “Normal” pens and sort animals that appear to have condemnable diseases or conditions into “Subject” pens. Id. Federal inspectors then examine, at rest, all animals deemed “Normal”, and they examine five to ten percent of those animals in motion. Id. If any of the animals exhibit signs of condemnable conditions, federal inspectors direct establishment employees to move the animals to “U.S. Suspect” pens for final disposition by a federal PHV. Id. The federal PHVs examine all animals in the “Subject” pen and direct the plant employees to move the animals to the “U.S. Suspect”

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pens for final disposition by a federal PHV. Id. The federal PHV determines if any animals must be identified as “U.S. Condemned” and disposed of in accordance with 9 C.F.R. section 309.13. Id.

During post-mortem inspection, establishment personnel sort carcasses and parts and trim dressing defects and contamination (e.g., hair, bruises, feces, ingesta, and milk), mark with ink localized pathology defects intended for removal under FSIS supervision, and identify carcasses and parts intended for disposal under FSIS supervision. Id. Subsequently, FSIS online inspectors visually inspect the head, viscera, and carcass of each hog at fixed locations on the evisceration line. Id. FSIS represents that the plant employees' pre-sorting permits the federal online inspection to occur much more efficiently under HIMP than under the traditional inspection system. Id. As a result of the increase in online efficiency, FSIS states federal inspectors conduct more offline, food safety related verification inspection activities under HIMP than under the traditional inspection system. Id.

In 2013, the U.S. General Accountability Office (“GAO”) and the USDA's Office of the Inspector General (“OIG”) evaluated the HIMP pilot program. 83 Fed.Reg. at 4781. The GAO report identified...