As a result of the COVID-19 pandemic, the U.S. Food and Drug Administration today released a guidance document, Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency, to provide producers of shell eggs that normally would be sent to facilities for further processing the flexibility to sell their eggs for distribution to retail locations, such as supermarkets, when certain conditions are present. This flexibility will help egg producers meet increased demand for shell eggs by consumers at retail locations.
The FDA rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, requires producers of shell eggs that are sold to the table egg market (e.g., sold directly to consumers in retail establishments) to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation. SE is one of the leading causes of foodborne illness from bacteria in the United States. The regulations also require shell egg producers to maintain records concerning their compliance with the rule and to register with the FDA.
Under the temporary policy, FDA does not intend to object if shell eggs from a poultry house consisting solely of laying hens up to 45 weeks of age are sold to the table egg market provided the following conditions are present:
For Poultry Houses Providing Eggs to the Table Egg Market:
· A producer complies and has been in compliance with all requirements of the Egg Safety Rule for the poultry house for the life of the flock, including SE monitored pullets, biosecurity, rodent and pest control, cleaning and disinfection, environmental and egg testing, refrigeration, and recordkeeping.
· Before sending any eggs to the table egg market, a producer simultaneously conducts environmental and egg testing (as described in 21 CFR 118.7 and 118.8) for the poultry house. Note that environmental testing would still occur when the laying hens are 40-45 weeks of age and subsequently if molting is induced.
· No environmental tests or egg tests are positive for SE in the poultry house.
· A producer processes eggs from the poultry house separately from eggs on the farm that are not going to the table egg market.
· A producer implements and maintains a written plan (e.g., use of dedicated equipment, change of personnel protective equipment between houses) to prevent cross-contamination between poultry houses whose eggs are going to the table egg market and any other poultry houses on the farm.
For Poultry Houses Not Providing Eggs to the Table Market:
· Before sending any eggs to the table egg market, a producer complies with all requirements of the Egg Safety Rule for poultry houses that are not sending eggs to the table egg market (e.g., biosecurity, rodent and pest control, cleaning and disinfection, refrigeration, and recordkeeping), except for testing and SE monitored pullets.
This policy does not apply to poultry houses with laying hens over 45 weeks of age at the time this guidance is issued. Laying hens older than 45 weeks of age are not included because environmental samples collected after 45 weeks are less likely to detect SE, if present, than samples collected at 40-45 weeks.
This policy is intended to remain in effect only for the duration of the public health emergency.
This guidance is one of several steps FDA is taking to address increased consumer demand for shell eggs at supermarkets. In addition, FDA has issued a Temporary Policy Regarding Packaging and Labeling of Shell Egg Sold by Retail Food Establishments During the COVID-19 Public Health Emergency. FDA is working closely with its government partners to monitor supply chains and identify additional solutions to address changes in consumer demand to help ensure that the food supply is safe and available.
