FDA issues guidance for labeling and further processors

April 9, 2020

UEP staff and consultants have been in constant communication with the FDA, petitioning it to take actions to increase the supply of eggs at retail. As a result, FDA  issued the following  guidance:

Packaging and labeling

On April 3,  FDA released the guidance document, Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency. The guidance states, “FDA does not intend to object to the sale by retail food establishments of shell eggs in cartons or flats without labels, provided the following circumstances are present:”

  • The retail food establishment displays clearly at the point of purchase (for example, on a counter card, sign, tag affixed to the product, or some other appropriate device) the following information:
    • Statement of identity,
    • The name and place of business of the manufacturer, packer, or distributor, and
    • Safe handling instructions for shell eggs that have not been processed to destroy all viable Salmonella.
  • If shell eggs from multiple suppliers are offered for sale at the same time and in the same location, it is clear to consumers which point of sale labeling applies to which of the shell eggs that are offered for sale.
  • The shell eggs are sold by the complete carton or flat (for example, 30 eggs are sold in a flat designed to hold 30 eggs).
  • There are no nutrition claims at the point of purchase for the shell eggs. See “FDA Provides Temporary Flexibility Regarding Nutrition Labeling of Certain Packaged Food in Response to the COVID-19 Pandemic,” issued on March 26.
  • In many states, there may be additional labeling requirements and prohibitions for eggs.

Further processors  

On April 6, FDA released the guidance document, “Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency.” The guidance permits temporary flexibility to allow producers who currently only sell eggs to facilities for further processing (e.g.,  into “egg products”)  to sell to the table egg market, provided certain circumstances and requirements are met.

UEP commentaryThe Egg Safety Rule is specific in the requirement that if ANY eggs at a particular farm do not receive a treatment for Salmonella enteritidis, the farm must comply with all of the requirements of the rule for egg production on that farm. This guidance will allow for certain houses on a particular farm that have met all the requirements of the egg safety rule for the life of the flock, including pullet monitoring, to follow this guidance for a path to the table egg market. This guidance also requires that those houses on the farm that will remain in the products market to also immediately come into compliance with certain provisions of the rule. 

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 Egg 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.  Egg producers whose poultry houses have laying hens over 45 weeks of age that have been sending the eggs for further processing may continue to do so.”

These policies are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS). FDA encourages all shell egg producers to continue to comply with applicable requirements of 21 CFR part 118 (the Egg Safety Rule).