FDA Regulations to Improve Egg Safety, Reduce Salmonella Illnesses

The Food and Drug Administration on July 7 announced a regulation expected to prevent each year 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella enteritidis.

The final rule requires preventive measures during the production of shell eggs in poultry houses and requires subsequent refrigeration during storage and transportation.

Egg-associated illness caused by Salmonella is a serious public health problem. Infected individuals may suffer mild to severe gastrointestinal illness, short term or chronic arthritis, or even death. Implementing the preventive measures would reduce the number of Salmonella enteritidis 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. If the eggs are eaten raw or undercooked, the bacterium can cause illness. Eggs in the shell become contaminated on the farm, primarily because of infection in the laying hens.

The rule requires that measures designed to prevent Salmonella enteritidis 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 (four tests at two 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
  • 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 still must comply with the refrigeration requirements. Similarly, certain persons such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration requirements.

To ensure compliance, egg producers must maintain a written Salmonella enteritidis prevention plan and records documenting their 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. FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

FDA 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 one cent per dozen eggs produced in the United States.

During the 1990s, FDA and the Department of Agriculture implemented a series of post-egg production safety efforts such as refrigeration requirements designed to inhibit the growth of bacteria that may be in an egg. While these steps limited the growth of bacteria, they did not prevent the initial contamination from occurring.

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