Am. Federation Govt. Employee v. Glickman, AFL-CIO

• Decision Date: 30 June 2000
• Docket Number: No. 99-5320,AFL-CIO,99-5320
• Citation: 215 F.3d 7
• Parties: (D.C. 2000) American Federation of Government Employees,, et al.,Appellants v. Daniel R. Glickman, Secretary of the U.S. Department of Agriculture, et al.,Appellees
• Court: U.S. Court of Appeals — District of Columbia Circuit

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215 F.3d 7 (D.C. 2000)

American Federation of Government Employees, AFL-CIO, et al.,Appellants v. Daniel R. Glickman, Secretary of the U.S. Department of Agriculture, et al.,Appellees

No. 99-5320

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 11, 2000

Decided June 30, 2000

Appeal from the United States District Court for the District of Columbia(98cv00893)

Anne M. Wagner argued the cause for appellants. With her on the briefs was Mark Roth.

Alfred Mollin, Attorney, U.S. Department of Justice, argued the cause for appellees. With him on the brief were David W. Ogden, Acting Assistant Attorney General, William B. Schultz, Deputy Assistant Attorney General, Barbara C. Biddle, Attorney, and Wilma A. Lewis, U.S. Attorney.

Before: Edwards, Chief Judge, Randolph and Garland, Circuit Judges.

Opinion for the Court filed by Circuit Judge Randolph.

Randolph, Circuit Judge:

The Federal Meat Inspection Act ("FMIA"), 21 U.S.C. 604, and the Poultry Products Inspection Act ("PPIA"), 21 U.S.C. 455, require inspectors appointed by the Department of Agriculture ("USDA") to perform a "post-mortem inspection" of the carcasses and parts of all livestock and birds processed for human consumption. The question in this appeal from the judgment of the district court is whether the statutes permit federal inspectors to step back from the processing lines and perform their inspection duties by overseeing inspections conducted by plant employees.

I

Inspectors from the USDA's Food Safety and Inspection Service ("FSIS") generally conduct post-mortem inspections while stationed at fixed points along the slaughter processing line. Using organoleptic methods, that is, relying on sight, touch and smell, the inspectors examine the head, viscera, and exterior of each carcass for signs of adulteration, such as tumors, inflammation, parasites, and other diseases. See 9 C.F.R. pts. 310-11, 381.76-94. If the inspector detects no signs of adulteration, the carcass is passed and marked with the USDA legend. See 9 C.F.R. 310.8, 381.79. Under the FMIA, if the inspector finds any lesion or other condition "that might render the meat or any part unfit for food purposes, or otherwise adulterated," the carcass (and its parts) must be retained for veterinary disposition. 9 C.F.R. 310.3. A carcass or part found to "be unsound, unhealthful, unwholesome, or otherwise adulterated" is condemned and marked as such. Id. 310.5. Similar procedures apply to inspections under the PPIA. See id. 381.81-89.

The method of inspection just described had remained unchanged for decades. Then, in the mid-1990s, FSIS embarked on a comprehensive food safety initiative targeting the agency's resources at what it perceived as a serious health risk--foodborne pathogens, such as salmonella and E. coli, which cannot be detected by organoleptic inspection. At the same time it determined to make changes in the current inspection process to combat these microbial causes of foodborne illness, FSIS addressed what it considered to be another failure of the present regulatory system--that it provides processing plants with little incentive to detect and eliminate unacceptable carcasses before presenting them for inspection. For these reasons, FSIS decided to require "industry to assume responsibility for producing safe products, reducing foodborne pathogens, and ... to shift Agency inspection resources to those areas which present the greatest public health risk." John W. McCutcheon Decl. at p 10.

In July 1996, FSIS took the first step in implementing its new initiative by promulgating the Pathogen Reduction/ Hazard Analysis and Critical Control Points ("HACCP") final rule. See 61 Fed. Reg. 38,806 (1996). The rule "requires plants to implement science-based process control systems as a means of preventing food safety hazards, sets certain food safety performance standards, and establishes testing programs to ensure those standards are met." Food Safety and Inspection Service, HACCP-Based Inspection Models 1 (1998). It provides the industry with complete control over production decisions and execution, subject only to the performance standards set by FSIS. FSIS believes that heightening the industry's responsibility for safe meat and poultry products will increase "the incentives and flexibility establishments need to innovate and improve food safety." HACCP Final Rule, 61 Fed. Reg. 38,808.

Such advances, according to FSIS, cannot be achieved without substantial changes to its approach to inspection. As the agency put it, the roles of establishments and federal inspectors need to be "realigned to accord with the HACCP philosophy." Id. To design and test new inspection models, FSIS initiated the Inspection Models Development Project (the "Models Project"). Under the regulatory framework proposed in the Models Project, the task of separating normal from abnormal carcasses and parts will be carried out solely by industry personnel. Federal inspectors will be responsible for monitoring the plant's performance in sorting and for verifying its compliance with performance standards and regulatory requirements. Under the new model, a finding that a product is not adulterated will be based on FSIS's determination that the establishment's food safety and sanitation control systems are preventing adulteration.¹

Under the new inspection models, FSIS has said that "slaughter process control will be an industry responsibility subject to FSIS oversight and verification." HACCP-Based Meat and Poultry Inspection Concepts: In-Plant Slaughter Inspection Models Study Plan, 63 Fed. Reg. 40,381, 40,381 (1998). It explained, "[e]stablishment employees will conduct anatomical and pathological examinations of carcasses, and FSIS inspectors will oversee, evaluate, and verify the effectiveness and reliability of the establishments' slaughter process controls." Id. FSIS plans the transition to industry based inspection to occur in stages. At the outset, establishment employees will only be responsible for identifying and removing trimmable defects. They will later assume responsibility for generalized condemnable conditions. And at the final stage, employees will perform "all tasks related to slaughter control," with the inspectors' role limited to oversight and verification. Food Safety and Inspection Service, HACCP-Based Inspection Models Project In-Plant Slaughter 10 (1998).

Draft guidance put out by FSIS gives some indication of what oversight and verification entails. Though the descriptions vary slightly depending on the class of animals, oversight amounts to inspectors observing establishment personnel as they process carcasses and remove unacceptable products from the food supply. By verification, FSIS means that inspectors will...