The Federal Meat Inspection Act and the Poultry Products Inspection Act give USDA overall responsibility for ensuring the safety and wholesomeness of meat and poultry products that enter interstate commerce. Acting under these legislative authorities, USDA inspectors provide continuous government inspection of each and every meat and poultry carcass and its parts at slaughter plants throughout the United States. Within USDA, FSIS is responsible for inspections at all meat and poultry slaughter and processing plants and has inspectors positioned both on and off the slaughter line. FSIS inspectors positioned on the line are to inspect every carcass and its parts, including the viscera (e.g., hearts and liver) organoleptically—by sight, touch, and smell—for defects, and direct plant personnel to take appropriate corrective action when defects are found. According to a Federal Register notice, plants rely on FSIS inspectors to control and direct their production processes. For example, FSIS regulates the speed of the slaughter line based on its inspectors’ ability to perform proper inspection procedures. FSIS inspectors positioned off the line move freely about the plant to focus on areas of greatest risk and to perform collection of carcass samples for testing of microbial pathogens. Among other activities, these inspectors review plant records and live animals presented for slaughter. These inspectors are also responsible for ensuring plants’ compliance with regulatory requirements on a daily basis and for taking regulatory enforcement action when deficiencies are found. In 1997, FSIS announced the need to modify its meat and poultry slaughter inspection program to, among other things, make industry more responsible for identifying carcass defects. This approach is consistent with the agency’s previous adoption of the Pathogen Reduction: Hazard Analysis and Critical Control Point (HACCP) regulations. Under the risk- based HACCP approach, industry—rather than federal inspectors—is responsible for identifying steps in food production where food safety hazards, such as fecal material, are reasonably likely to occur and for establishing controls that prevent or reduce these hazards. As part of this approach, plants must identify the point (known as the critical control point) where they will establish control for a food safety hazard and take steps to prevent, eliminate, or control the hazard. FSIS had not extended the HACCP principles to slaughter inspections because the agency provides continuous inspection of each and every carcass. However, FSIS believed that changing its existing inspection systems would also reduce inspectors’ reliance on organoleptic inspections, allow for a shift to prevention-oriented inspection systems based on risk, and permit redeployment of its resources to better protect the public from foodborne diseases. Before making a permanent change to its slaughter inspection systems, FSIS developed the pilot projects in 1998 at young chicken, young turkey, and young hog plants to test whether such a change would achieve its intended purpose of deploying inspection resources more effectively in accordance with food safety and other consumer protection requirements. FSIS’ pilot projects at these plants are known as the HACCP-based Inspection Models Project (HIMP). FSIS developed food safety and quality performance standards for plants in the pilot projects to meet. FSIS set the performance standard for food safety defects at zero. An example of a food safety defect is a carcass contaminated with fecal material because ingestion of meat and poultry contaminated with fecal material poses potential harm to humans. FSIS’ performance standards for food quality defects vary, depending on the animal species and the type of defects. An example of a food quality defect is bruises on the carcass that, while not harmful if consumed, affects the wholesomeness of meat and poultry products. According to FSIS officials, the food quality performance standards are intended to be more stringent than the performance standards in place at plants that are not participating in the pilot projects. In May 1999, FSIS negotiated an agreement with the union representing its inspectors that limited the number of plants participating in the pilot projects to 20 young chicken plants, 5 young turkey plants, and 5 young hog plants. According to the agreement, the pilot projects for each species are to end when a final rule is published for that species. Before converting to the inspection systems under the pilot projects, participating plants modified their operations to meet certain requirements, such as installing a new workstation at the end of the slaughter line and before the chiller for the FSIS inspector positioned on the slaughter line at poultry Over the course of the pilot projects, some plants have dropped plants. out, and others have joined. As of July 2013, 29 plants were participating in the pilot projects in 18 states. Appendix II provides additional information on the location of plants in the pilot projects and the volume of poultry and hog slaughter in the United States. The chiller is the point when eviscerated carcasses—carcasses that have had internal organs and any processing defects removed—are chilled in order to inhibit microbial growth and meet the regulatory requirements of 9 C.F.R. § 381.66(b)(1). young chicken and turkey plants. Plants participating in FSIS’ pilot projects are required to participate in this program. The Salmonella Initiative Program permits plants to operate with an exemption (known as a waiver) from complying with certain regulatory requirements. For example, young chicken plants in the pilot project are exempt from meeting FSIS’ regulatory requirement that limits the slaughter line speed at young chicken plants and can operate the slaughter line at a faster line speed. Plants in the Salmonella Initiative Program must demonstrate to FSIS that results from their Salmonella testing consistently demonstrate that they maintain control over production processes. The goal of the Salmonella Initiative Program is to reduce and eliminate Salmonella before products reach consumers. In January 2012, FSIS published in the Federal Register a proposed rule to modernize poultry slaughter inspections based, in part, on the agency’s experience with the pilot projects at young chicken and young turkey plants. FSIS developed the proposed rule in response to an executive order directing agencies to review existing regulations that may have been outdated and modify them accordingly. According to the proposed rule, the modernization is intended to improve food safety and the effectiveness of poultry slaughter inspection systems, remove unnecessary regulatory obstacles to innovation, and make better use of the agency’s resources. The proposed rule further states that inspection systems currently in place at chicken and turkey plants (not in the pilot projects) are lacking in two important respects. First, the proper role of industry and FSIS is obscured. Specifically, FSIS inspectors are currently responsible for sorting acceptable carcasses from unacceptable carcasses, finding defects, identifying corrective actions, and solving problems in production control processes, but these are roles more appropriately the responsibility of the slaughter plants. Second, a significant amount of FSIS’ inspection program personnel resources are allocated toward inspection activities to detect defects and conditions that present minimal food safety risks. According to the proposed rule, this allocation limits the agency resources available for food safety-related inspection activities. Moreover, FSIS developed an economic cost and benefit analysis to demonstrate the merits of the proposed rule, which, according to USDA, is expected to have an annual impact on the economy of more than $100 million. FSIS’ proposed rule affects all poultry slaughter plants and includes mandatory regulatory changes. For example, the proposed rule requires all poultry plants to maintain written procedures to prevent contamination of carcasses and parts by fecal material and pathogens (e.g., Salmonella and Campylobacter) and to test for organisms (e.g., Salmonella) to demonstrate control over their production processes at a point before the carcass enters the chiller and at a point after the carcass exits the chiller. In addition, the proposed rule includes the optional new poultry inspection system for young chicken and turkey plants. According to the proposed rule, FSIS expects that the majority of young chicken and turkey plants will convert to the optional new poultry inspection system. The new poultry inspection system resembles the inspection systems at young chicken and young turkey plants in the pilot projects but also has some differences. Similarities between the pilot projects and optional new poultry inspection system include, among others: For each slaughter line, there would be one FSIS inspector positioned at the end of the line to perform a carcass-by-carcass inspection and one FSIS inspector positioned off the line to perform, among other things, food safety and quality checks on carcasses to verify that plant personnel (known as sorters) have effectively performed their duties, such as removing fecal material on carcasses. The FSIS inspector positioned on the slaughter line would visually inspect (observe) each carcass after the viscera are separated from it and after plant personnel have sorted carcasses, at a point near the end of the slaughter line. A difference between the pilot projects and the optional new poultry inspection system is that the new system would eliminate FSIS’ performance standards for food quality defects and replace them with a requirement that plants maintain records documenting that their products meet the regulatory definition of “ready-to-cook.” Ready-to-cook means that the products are free of such defects as feathers, oil glands, and diseases and are thus suitable for cooking without any further preparation. According to FSIS officials, plants could use the existing food quality standards—known as Finished Product Standards—to meet the regulatory definition of ready-to-cook. FSIS has not thoroughly evaluated the performance of each of the three pilot projects over time even though the agency stated that it would do so when it announced the pilot projects. Specifically, FSIS completed a report evaluating the pilot project at young chicken plants, but its data analyses have limitations. FSIS did not prepare a report evaluating the pilot project at young turkey plants and has no plans to do so because data from the five young turkey plants in the pilot project provide limited information due to the small sample size. While FSIS has begun drafting a preliminary report evaluating the pilot project at young hog plants, it used analyses similar to those presented in the report evaluating the pilot project at young chicken plants, suggesting similar limitations may apply.