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Statement of Need: The actions being proposed are part of FSIS's regulatory reform effort to improve FSIS's 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 egg and egg products regulations as consistent as possible with the Agency's meat 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 shell eggs and processed egg products, FSIS now is considering (1) requiring all shell egg packers and 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 shell egg packers and egg products plants would reduce the occurrence and numbers of pathogenic microorganisms in egg products. FSIS inspection program personnel would be better able to ensure that shell egg packers and egg products processing plants have the flexibility needed to properly implement HACCP and Sanitation SOPs and encourage innovation in shell egg and egg products processing. The Agency will also propose to require that shell egg packers and 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 of 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 shell egg packers and 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 eventually 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.

Risks: None.