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Statement of Need: The actions being proposed are part of FSIS's regulatory reform effort to improve FSIS's shell egg and egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the shell egg and egg products regulations as consistent as possible with the Agency's livestock and poultry products regulations. FSIS is also taking these actions in light of changing inspection priorities and recent findings of salmonella in pasteurized egg products.

Summary of the Legal Basis: This rulemaking is proposed under the authority of the Egg Products Inspection Act, as amended, 21 U.S.C. 1031-1056.

Alternatives: FSIS is engaged in a thorough review of its current regulations and, where possible, will eliminate overly prescriptive regulations and replace them with regulations that embody performance standards. Performance standards establish requirements in terms of the objective to be achieved. They specify, the ends, but do not detail the means to achieve those ends. Performance standards allow food processing establishments to develop and employ innovative and more effective sanitation or processing procedures customized to the nature and volume of their production. To address hazards that can be presented by egg products, FSIS now is considering (1) requiring all inspected egg products plants to develop, adopt, and implement written Sanitation SOPs and HACCP plans and (2) converting to a lethality-based pathogen reduction performance standard many of the current highly prescriptive egg products processing requirements. The implementation of HACCP and Sanitation SOP requirements by egg products plants would reduce the occurrence and numbers of pathogenic microorganisms in egg products. Further, with HACCP and Sanitation SOPs in place, FSIS would be better able to allocate its inspection resources to the areas of greatest risk; FSIS inspection program personnel, therefore, would be better able to ensure that egg products processing would grant plants the flexibility needed to properly implement HACCP and Sanitation SOPs and encourage innovation in egg products processing. In addition, such a performance standard for egg products processing would provide FSIS inspection program employees an objective measure of performance useful in processing, inspection, and enforcement. The Agency will also propose to require that egg products plants adopt sanitation SOP and HACCP plans. Plants will have significant latitude in identifying the Sanitation SOP and HACCP plan suitable for their process. The egg products industry has indicated its desire to adopt HACCP on an industry-wide basis. About 30 percent of egg products plants have already implemented HACCP or HACCP-like programs. The pathogen reduction performance standard that egg product plants will have to achieve under their HACCP plans would likely have a more economically significant impact than the requirement of Sanitation SOPs or HACCP plans.

Anticipated Costs and Benefits: Costs The expected costs of the proposal will depend on a number of factors, including the following: Required Lethality. The level of lethality required in the pathogen reduction performance standard will have a significant impact on the cost of the proposal. The expected type performance standard may specify a uniform level of pathogen reduction for a target organism. Alternatively, different reduction levels may be specified for white, yolk, and whole egg products, or production processes, reflecting the relative level of risk. As the level of lethality increases, the ability to utilize the egg for different products and formulations is diminished. The Agency will investigate the level of lethality that provides an acceptable balance between risk and egg utilization. HACCP and Sanitation Standard Operating Procedures. Implementing a HACCP plan and Sanitation SOPs requires the preparation of a plan, employee training, documentation and recordkeeping, and testing procedures. The costs associated with HACCP implementation are reduced by the extent to which quality assurance or similar programs are utilized by egg products firms and the availability of off-the-shelf HACCP plans. The types of Sanitation SOPs being considered are essentially the same as those for meat and poultry, and costs would be similar. Plant Compliance/Enforcement. FSIS costs for monitoring and enforcement are expected to be lower than those for current comparable activities as the program moves from continuous inspection (inspector on duty throughout the entire shift) to being monitored on a patrol assignment. We are not aware of any estimates of FSIS costs for verifying process control and pathogen reduction for egg products. They would probably be similar in costs to those for meat and poultry inspection. The monitoring costs for some plants may increase, especially those reliant on the inspector to be the quality control expert. Benefits The types of potential benefits associated with this rule are: Improvements in human health due to pathogen reduction; improved utilization of FSIS inspection program resources; and cost savings resulting from the flexibility of egg products plants in achieving a lethality-based pathogen reduction performance standard. Once specific alternatives are identified, economic analysis will identify the quantitative and qualitative benefits associated with each. Human health benefits are based on changes from a baseline level of illnesses and the health cost per illness. FSIS egg products testing results indicate either some pasteurization processes are inadequate, or that egg products are being contaminated with salmonella after pasteurization, prior to, or during packaging. The results indicate a very low level of contamination. Pasteurized egg products have not been identified/associated with any known outbreaks; however, unpasteurized egg products have been implicated in foodborne outbreaks. Salmonella would principally be found in unpasteurized product. However, there have been a few instances when SE has been isolated from egg products found to be positive for the presence of salmonella. In the majority of these cases, the salmonella contamination can be attributed to post-pasteurization product contamination. Sanitation SOP and HACCP requirements could remedy this problem by enhancing the effectiveness of pasteurization by minimizing microbiological hazards before and after pasteurization. Two recent studies have raised questions about the efficacy of the current regulatory requirements for egg products pasteurization (9 CFR 590.570). The research suggests that for certain formulations of egg products, the required time/temperature combinations are not sufficient to destroy high numbers of salmonella (5 log 10), as originally projected by USDA research completed in the 1960s. A pathogen reduction performance standard requiring a specific reduction of salmonella in egg products would assist plants in ensuring that pasteurization of egg products is effective. FSIS has established an Egg Products Risk Management Analysis Team to better assess the information available on potential human health risks associated with egg products. The team is comprised of technical personnel from FSIS and other Federal agencies. The primary task is to fully characterize the hazard and identify potential risk mitigation alternatives for further analysis. The USDA Salmonella Enteritidis Risk Assessment and the CDC salmonella surveillance data provide estimates of the baseline level of risk. The egg products component of the risk assessment is being used to identify the expected reduction in illness attributed to the alternative identified in the proposed rule. Any new scientific or epidemiological information will be incorporated into the risk assessment model. The analysis will identify a range of estimated annual illnesses prevented. A standard methodology employed by the Economic Research Service will be used to calculate the health cost per illness, taking into account the severity of the illness. Sanitation SOPs would improve the utilization of FSIS inspection program resources by refocusing FSIS sanitation inspection on the oversight of establishment prevention and correction of conditions that cause direct product contamination or adulteration. If Sanitation SOPs are put in place, Agency inspection personnel will spend less time enforcing detailed sanitation requirements and directing the correction of problems after they occur. Instead, FSIS inspection program personnel will focus on oversight of an establishment's implementation of Sanitation SOPs and on taking appropriate regulatory action when an establishment?s Sanitation SOPs are not properly executed, or when product contamination or adulteration is imminent, directly observed, or probably had occurred. Under the current command-and-control based system, the inspector assumes responsibility for "approving" production-associated decisions. Under HACCP, industry would assume full responsibility for production decisions and execution. FSIS would monitor establishments' compliance with the pathogen reduction performance standard and HACCP requirements. The number of inspection tasks will be reduced, so inspection program personnel can focus more attention on areas of greatest risk in the production system within each establishment. Performance standards set forth requirements in terms of what is to be achieved by a given regulatory requirement. They represent a shift in focus from "command-and-control" regulations in that they specify the ends to be achieved but not the means to achieve those ends. The command-and-control provisions in the current regulations prescribe the means for producing safe egg products and do not account for the uniqueness of individual processing procedures and needs within different plants. FSIS command-and-control regulations require all establishments to produce egg products in the same manner. Such prescriptive regulations are burdensome and often conflict with HACCP and the new FSIS food safety strategy. As a general matter, command-and-control regulations are incompatible with HACCP and the new food safety strategy because they deprive plants of the flexibility to innovate-adopt new, more cost-effective production technologies, or develop new egg products. Potential technical innovations in improving product safety can be expected with the introduction of Sanitation SOPs and HACCP. In addition, with the elimination of prior approval requirements, the industry would be able to utilize computer integrated process controls and other technologies (currently used for other types of food processing). There is potential for the development of shelf-stable product which does not require refrigeration. Similarly, command-and-control regulations are incompatible with the proposed Sanitation SOP requirements because they often prescribe the exact means by which egg product plants must maintain sanitary conditions and do not allow the plant to assume responsibility for sanitation. Command-and-control regulations undercut the clear delineation of responsibility on which the food safety strategy is based. Analysis of the gains in resource productivity, technological change, and consumer choice will be largely qualitative.

Risks: None.