FDA proposes tougher shell egg safety



ROCKVILLE, MD — An estimated 118,000 illnesses per year are caused by consumption of shell eggs contaminated with Salmonella Enteritidis (SE) bacteria. That's not acceptable, says the Food and Drug Administration (FDA;, which recently released details of proposed regulation to improve the safety of shell eggs while on the farm.

According to the FDA's 21 CFR Parts 16 and 118—Prevention of Salmonella Enteritidis in Shell Eggs During Production, a "biosecurity program" would require poultry houses to keep egg belts, manure-removing equipment and other similar equipment clean and ensure that they are not sources of SE contamination that can be spread from one poultry house to another. The program also limits visitors to the farm and poultry house and calls for proper hygiene of personnel who move among houses. The document explains that, "proper hygiene includes the use of protective clothing that is changed as employees move between poultry houses and foot sanitizing stations or other appropriate means to protect against contamination."

The proposal also calls for poultry houses to develop procedures for cleaning and disinfection. Further, under the proposed regulations, any poultry house that has had an environmental sample or egg test positive for SE would have to undergo cleaning and disinfecting procedures before new laying hens are placed in the house. These procedures include dry cleaning, wet cleaning (soaking, washing, rinsing), disinfection, and possible fumigation with formaldehyde.

"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 percent reduction in all salmonellosis and a 50 percent reduction in SE outbreaks by 2010," says Acting Commissioner Dr. Lester M. Crawford. Although there are other sources of SE, actions to improve egg safety are "the single most effective way to reduce the overall number of SE infections and outbreaks," according to the FDA.

The proposed regulation would affect all egg producers having 3,000 or more laying hens that produce shell eggs for retail sale, and who do not process their eggs with a food safety treatment, such as pasteurization. "There are a few processors who do in-shell pasteurization," reports Patricia Curtis, Ph.D., director of the Poultry Product Safety & Quality Program at Auburn University in Alabama. "However," she says, "not many consumers are willing to pay the difference in price for the pasteurized eggs."

The rule would not apply to producers who sell all of their eggs directly to consumers, or producers with fewer than 3,000 laying hens. In addition, if a producer has 3,000 or more laying hens and all eggs are to be given a treatment that will achieve at least a 5-log destruction of SE or processed into egg products, then only proposed refrigeration requirements would apply. According to the American Egg Board, there are approximately 260 egg producing companies with flocks of 75,000 hens or more. These companies represent about 95 percent of all the layers in the U.S.

"These measures have proven effective in research studies," says Hilary Shallo Thesmar, Ph.D., R.D., director of food safety programs at the Egg Nutrition Center in Washington, D.C. "Pennsylvania egg suppliers have administered a quality assurance program implementing such regulations over a 10-year period. The results have shown a significant reduction in SE in eggs when these guidelines are followed," she notes. Curtis agrees and notes that, "The industry has voluntarily introduced most of the best management practices, which made a significant reduction [in SE in eggs]." But she adds, "I am not sure how much more reduction will be seen without additional regulation on the retail end of the farm to table continuum."

Experts believe that, predominantly, eggs become contaminated with SE via the "transovarian" route, whereby SE infects the ovaries and oviducts of some egg-laying hens, permitting contamination of the interior of the egg while the egg is still inside the hen. The site of the contamination is usually the albumen (the egg white). "The FDA proposed regulation could significantly prevent contamination in the first place," predicts Shallo Thesmar. She also highlights the fact that the egg industry has sponsored other research studies, including some that focus on using vaccines to prevent hens from becoming infected with SE.

"I think the assumption that is made is that, by containing the spreading of SE from the environment from bird-to-bird transfer, transovarian contamination can be controlled," says Curtis. "I'm not sure how true this is. The best management practices will control horizontal spread and, to some extent, the transovarian. The key question is what causes the transovarian infection versus the intestinal infection? I'm not sure we have the answer to that question."

The proposed regulation is projected to cost $82 million annually to implement and is expected to provide total annual benefits of $580 million.

The FDA will accept comments on this proposed regulation until December 21.

A summary of the FDA's proposed ruling:

  • Provisions for procurement of chicks and pullets;
  • Biosecurity program;
  • Pest and rodent control program;
  • Cleaning and disinfection of poultry houses that have had an environmental sample or egg test positive for SE before new laying hens are added to the house;
  • 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 an egg test is positive, the eggs be diverted from the table egg market;
  • Identification of a person responsible for environmental and egg sampling and testing and for egg diversion.