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Statement of Need: FDA is proposing regulations as part of the farm-to-table safety system for eggs outlined by the President's Council on Food Safety in its Egg Safety Action Plan. FDA intends to propose these regulations because of the continued reports of outbreaks of foodborne illness and death caused by SE that are associated with the consumption of shell eggs. The agency believes these regulations can have significant effect in reducing the risk of illness from SE-contaminated eggs and will contribute significantly to the interim public health goal of the Egg Safety Action Plan of a 50 percent reduction in egg-related SE illness by 2005.

Summary of the Legal Basis: FDA's legal basis for the proposed rule derives in part from sections 402(a)(4), and 701(a) of the Federal Food, Drug and Cosmetic Act (the Act) ((21 U.S.C. 342(a)(4) and 371(a)). Under section 402(a)(4) of the Act, a food is adulterated if it is prepared, packed, or held in insanitary conditions whereby it may have been contaminated with filth or may have been rendered injurious to health. Under section 701(a) of the Act, FDA is authorized to issue regulations for the efficient enforcement of the Act. FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease. Scientific reports in published literature and data gathered from existing voluntary egg quality assurance programs indicate that measures designed to prevent SE from entering a poultry house (e.g., rodent/pest control, use of chicks from SE-monitored breeders, and biosecurity programs) can be very effective in reducing SE-contamination of eggs and related foodborne illness.

Alternatives: There are several alternatives that the agency intends to consider in the proposed rule. The principal alternatives include: (1) no new regulatory action; (2) alternative testing requirements; (3) alternative on-farm prevention measures; (4) alternative retail requirements; and (5) HACCP.

Anticipated Costs and Benefits: The benefits from the proposed regulation to control Salmonella Enteritidis in shell eggs on the farm derive from better farming practices. Improved practices reduce contamination and generate benefits measured as the value of the human illnesses prevented. FDA has produced preliminary estimates of costs and benefits for a number of options. The mitigations considered include on-farm rodent control, changes in retail food preparation practices, diversion of eggs from infected flocks to pasteurization, record keeping, refrigeration, and feed testing. The actual costs and benefits of the proposed rule will depend upon the set of mitigations chosen and the set of entities covered by the proposed rule.

Risks: Any potential for contamination of eggs with SE and its subsequent survival or growth must be considered a very serious risk because of the possibility that such contamination, survival, and growth could cause widespread foodborne illness, including some severe long-term effects and even loss of life. FDA made a decision to publish a proposed rule that would include SE prevention measures, based on a considerable body of evidence, literature, and expertise in this area. In addition, this decision was also based on the USDA risk assessment on SE in shell eggs and egg products and the identified public health benefits associated with controlling SE in eggs at the farm and retail levels.