Header graphic for print
Animal Law Update Commentary on Animal Law and Legal Issues

Egg Producers – Avoid FDA Scrutiny

Posted in Animal, FDA, Legal liability

Since 2011, FDA has issued at least 21 warning letters notifying egg producers that they have violated regulations governing the safety of shell eggs. Failure to comply with these regulations is a violation of the Public Health Service Act, enforced by the FDA.

Shell eggs produced while in violation are considered adulterated. Producers with 50,000 or more laying hens have been subject to FDA’s regulations to prevent Salmonella Enteriditis (SE) since July, 2010.

Producers with less than 50,000 but more than 3,000 laying hens had to comply with these regulations as of July 9, 2012.

The rule “requires producers to implement measures to prevent Salmonella Enteriditis (SE) from contaminating eggs on the farm and during storage and transportation. It also requires producers to maintain records to document their compliance with the rule and to register with FDA.”

Written SE plans must include: pullet requirements, biosecurity measures, rodent, fly, and other pest control measures; cleaning and disinfection procedures; and refrigeration procedures.

Targeted or comprehensive inspections have identified the following violations which resulted in the issuance of warning letters.

  • Failure to register the farm with the FDA by the compliance deadline;
  •  Inadequacy of written SE plan;
  •  Failure to fully implement SE plan;
  •  Failure to document implementation of SE plan;
  •  Failure to secure interior of poultry house from entry by wild birds, cats, rodents, and pests;
  •  Failure to maintain records documenting pest and rodent control;
  •  Failure to monitor for rodents by appropriate methods;
  •  Failure to monitor for flies by appropriate methods;
  •  Failure to perform environmental testing for SE as required;
  •  When environmental testing for SE incorporates a sampling protocol not specifically recommended, those protocols should be submitted for approval that the testing methodology is equivalent in accuracy, precision and sensitivity in detecting SE, as those specified by FDA;
  •  Temperature controls policies should maintain the temperature of shell eggs within specified parameters.

Response to warning letters should indicate how all identified inadequacies have been addressed, with documentation of all implemented management adjustments.

Failure to respond adequately to these letters may result in regulatory action including: seizure, injunction, or the initiation of enforcement procedures.