FDA Egg Rule
The U.S. Food and Drug Administration says that as many as 79,000 illnesses and 30 deaths due to consumption of eggs contaminated with the bacterium Salmonella Enteritidis may be avoided each year with new food safety requirements for large-scale egg producers. The new food safety requirements will become effective on July 9, 2010, through a rule for egg producers having 50,000 or more laying hens – about 80 percent of production. Among other things, it requires them to adopt preventive measures and to use refrigeration during egg storage and transportation.
Large-scale egg producers that produce shell eggs for human consumption and that do not sell all of their eggs directly to consumers must comply with the refrigeration requirements under the rule; this includes producers whose eggs receive treatments such as pasteurization. Similarly, those who transport or hold shell eggs must also comply with the refrigeration requirements by the same effective date.
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. Salmonella Enteritidis can be found inside eggs that appear 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.
“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “Today's action will help prevent thousands of serious illnesses from Salmonella in eggs.”
The rule requires egg producers with fewer than 50,000 but at least 3,000 laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to comply with the regulation by July 9, 2012. Producers who sell all their eggs directly to consumers or have less than 3,000 hens are not covered by the rule.
Under the rule, egg producers whose shell eggs are not processed with a treatment, such as pasteurization 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 eight-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 F during storage and transportation no later than 36 hours after the eggs are laid (this requirement also applies to egg producers whose eggs receive a treatment, such as pasteurization).
To ensure compliance, egg producers must maintain a written Salmonella Enteritidis prevention plan and records documenting their compliance. Egg producers covered by this rule must also register with the FDA. The FDA will develop guidance and enforcement plans to help egg producers comply with the rule.
During the 1990s, the FDA and the U.S. 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.
The new rule is part of a coordinated strategy between the FDA and the USDA’s Food Safety and Inspection Service (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 reduce their risk of foodborne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, make sure eggs in the carton are clean and not cracked, and cook eggs and foods containing eggs thoroughly.