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Statement of Need: FDA is adopting regulations as part of the farm-to-table food safety system for shell eggs that would establish refrigeration requirements for shell eggs held at retail and labeling requirements instructing egg preparers and consumers on safe handling of shell eggs. FDA intends to adopt 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, and because the agency believes that these measures can have an immediate effect in significantly reducing the risk of foodborne illness due to consumption of SE-contaminated shell eggs. Further, these measures can be implemented while FDA and FSIS continue to develop their comprehensive farm-to-table food safety system.

Summary of the Legal Basis: FDA's legal basis to require refrigeration of shell eggs derives from sections 402(a)(4), and 701(a) of the Federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C.342(a)(4) and 371(a)) and sections 311, 361, and 368 of the Public Health Service Act (PHSA) (42 U.S.C. 243, 264, and 271) that relate to communicable disease. 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. Numerous scientific reports describe how refrigeration helps to maintain the egg's natural defenses against degradation and slows the growth of any SE present. Under section 701(a) of the act, FDA is authorized to issue regulations for the efficient enforcement of the act. Thus, a regulation that prohibits food from being held under insanitary conditions would provide for efficient enforcement. FDA's legal authority to require label statements on food products derives from sections 201(n), 403(a)(1), and 701(a) of the FDCA (21 U.S.C. 321(n), 343(a)(1), and 371(a)), and sections 311, 361, and 368 of the Public Health Service Act (PHSA) (42 U.S.C. 243, 264, and 271) that relate to communicable disease. Under section 403(a)(1) of the FDCA, a food is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FDCA provides that in determining whether labeling is misleading, the agency shall take into account the extent to which the labeling fails to reveal facts that are material with respect to consequences that may result from use of the product under conditions of use prescribed in the labeling or under customary or usual conditions. The fact that shell eggs may contain illness-causing bacteria and that there are measures that consumers can take to protect themselves from illness is material information and, therefore, must be provided in labeling to ensure that the product is not misbranded.

Alternatives: There are several alternatives to requiring refrigeration and safe handling instructions for shell eggs. The five principal alternatives include: (1) No new regulatory action, (2) labeling only, (3) refrigeration only, (4) Hazard Analysis Critical Control Point (HACCP) for shell eggs, and (5) in-shell pasteurization. FDA had concluded, based on information available at this time, that relying on current safeguards (option 1) would not greatly reduce the number of illnesses from SE in shell eggs. Even though the benefits from either labeling alone or refrigeration alone (options 2 and 3) exceed the costs, the combined benefits of refrigeration and labeling are much greater than either taken separately. FDA believes that a HACCP-like program (option 4) is currently not feasible. However, FDA is evaluating whether in the future, a HACCP-like program including possibly in-shell pasteurization, may be necessary to further ensure the safety of shell eggs. In-shell pasteurization (option 5) would greatly reduce SE, but FDA believes other interventions between farm-to-table could reduce SE at lower cost.

Anticipated Costs and Benefits: The benefits from requiring safe handling labeling and the refrigeration of shell eggs at 7.2 degrees C (45 degrees F) come from reducing SE-related illness. FDA used the results of the USDA SE risk assessment for one estimate of the baseline risk and the CDC Salmonella surveillance data for another estimate of the baseline. FDA also used the risk assessment model to estimate the expected reduction in illnesses attributed to the requirements. The range (5th to 95th percentile) of estimated annual benefits for the USDA SE risk assessment baseline was $87 million to $6.6 billion, with a median of $700 million. The range (5th to 95th percentile) of estimated annual benefits for the CDC surveillance baseline was $50 million to $1.7 billion, with a median of $300 million. The benefits are large, although FDA estimates that 95 percent of shell eggs are already held at ambient temperatures of 7.2 degrees C (45 degrees F) or less. The costs of the proposed rule are the sum of the costs of changes in manufacturing practices--labeling and refrigeration--and changes in consumer practices--egg preparation and consumption. The costs of labeling are the sum of administrative compliance, inventory disposal, and label redesign costs. FDA anticipates that the total labeling cost for a 6-month compliance period to be a one-time cost of approximately $18 million. The total cost included administrative costs of $280,000, inventory disposal costs of $3 million, and label redesign costs of $15 million. The refrigeration costs will be the cost of the additional equipment required for all establishments to maintain an ambient temperature of 7.2 degrees C (45 degrees F). The anticipated costs per establishment range from close to zero for small equipment upgrades to $6,000 for a large new refrigerator. For all establishments, the range (5th to 95th percentile) of anticipated one-time refrigeration costs was $7 million to $228 million, with a median of $31 million. FDA also considered as a part of the cost the change in consumer behaviors. The anticipated annual costs to consumers to change the way eggs are prepared and consumed ranged (5th to 95th percentile) from $2 million to $20 million, with a median of $10 million. The median total costs of the proposed rule--the sum of the costs of labeling, refrigeration, and changes in consumer practices--are about $60 million in the first year and $10 million per year thereafter.

Risks: Any potential for growth of SE in shell eggs must be considered a very serious risk because of the possibility that such growth could be widespread, affecting whole segments of the population, causing some severe long-term effects and even loss of life. FDA made a decision to adopt refrigeration and labeling requirements for shell eggs based on a considerable body of evidence, literature, and expertise in this area. This decision was also based on the USDA Risk Assessment and the identified effects associated with refrigeration and labeling.