FDA Announces Enhanced Egg Safety Initiatives

The FDA has announced a new regulation which it expects to prevent approximately 80,000 cases of food-borne illness (and 30 deaths) caused each year by Salmonella Enteritidis in eggs.

The final rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (74 FR 33030), requires manufacturers to employ additional preventive measures during the production of shell eggs in poultry houses, and mandates subsequent refrigeration during storage and transportation. Click on the follwing link to view a copy of the FDA Final Egg Rule.  According to the FDA, the implementation of such measures could potentially reduce the number of Salmonella infections from eggs by nearly 60 percent.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”

Salmonella Enteritidis can be found inside eggs that appear perfectly normal. Eggs in the shell can become contaminated on the farm, primarily because of infection in the laying hens. If the eggs are subsequently eaten raw or undercooked, the bacterium can cause illness.

The new rules requires that measures designed to prevent Salmonella be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.

Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.

Under the rule, egg producers must:

  • Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria;
  • Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment;
  • Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use;
  • Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis; and
  • Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.

Egg producers whose eggs receive treatments such as pasteurization must still comply with the refrigeration requirements. Similarly, certain entities such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration mandates.

To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan and associated records documenting compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. In turn, the FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

The FDA has estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.

The new rule is part of a coordinated strategy between the FDA and the FSIS. The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.

In addition to the new safety measures being taken by industry, consumers can also reduce their risk of food-borne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, to make sure eggs in the carton are clean and not cracked, and to cook eggs (and any foods containing eggs) thoroughly.