The Food and Drug Administration proposed a regulation today to further improve the safety of shell eggs on the farm. When implemented, the production changes defined by the regulation will significantly reduce the number of illness caused by eggs contaminated with Salmonella Enteritidis (SE).

An estimated 118,000 illnesses per year are caused by consumption of SE-contaminated eggs. If an individual eats an SE-contaminated egg that is not fully cooked the individual may suffer mild to severe gastrointestinal illness, short term or chronic arthritis, or death.

“The implementation of the provisions of this rule would reduce the number of SE-related illnesses by 33,500 and is a major step in realizing our public health goal of a 50% reduction in all salmonellosis and a 50% reduction in SE outbreaks by 2010,” said Acting Commissioner Dr. Lester M. Crawford. “Today’s action builds upon the safe consumer handling labeling and egg refrigeration and retail rule of 2000.”

The proposed regulation would require implementation of SE prevention measures for all egg producers with 3,000 or more laying hens that produce shell eggs for retail sale and do not process their eggs with a treatment, such as pasteurization, to ensure their safety. The proposed rule’s SE prevention measures include:

Provisions for procurement of chicks and pullets
A biosecurity program
A pest and rodent control program
Cleaning and disinfection of poultry houses that have had an environmental sample or egg test positive for SE
Refrigerated storage of eggs at the farm
Producer testing of the environment for SE in poultry houses–if the environmental test is positive, FDA proposes that egg testing for SE be undertaken, and that, if the test is positive, the eggs be diverted from the table egg market
Identification of a person responsible for SE prevention at each farm

Through these proposed measures, FDA believes SE prevalence will be reduced in the poultry house environment and consequently in the eggs themselves. Most SE contamination of eggs is a result of SE infection in the laying hen’s reproductive tract, known as transovarian contamination). The proposed prevention measures are designed to reduce the likelihood of transovarian contamination.

To fully implement this proposed rule will cost an estimated $82 million annually for the more than 4,100 farms that have 3,000 or more hens. The actual cost will vary with the number of poultry houses and layers under production and will range from a low of 19 cents per layer to $1.00 per layer per year.

While today’s proposal focuses primarily on the farm, FDA is aware of illnesses and outbreaks associated with serving undercooked eggs at retail establishments. Therefore, FDA is soliciting comment on whether to propose potential retail establishment requirements to address their concern.

The proposed rule is part of a joint and coordinated strategy by FDA and the Food Safety Inspection Service (USDA) to more effectively deal with egg safety for both shell eggs and egg products. FDA and FSIS will continue to work closely together to ensure that our egg safety measures are consistent, coordinated and complementary.

A comment period of 90 days will be provided on the proposal. Written comments can be submitted to FDA at: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers lane, Room 1061, Rockville, MD 20852 . It is important to include docket numbers 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN Number 0910-AC14.