FDA proposes rules to reduce Salmonella in eggs

Sep 22, 2004 (CIDRAP News) – The Food and Drug Administration (FDA) is proposing a set of regulations to reduce Salmonella enteritidis (SE) contamination of eggs on poultry farms, with a goal of reducing human SE infections by about 28%.

In announcing the proposal this week, the FDA said it estimates that about 118,000 people get sick each year from eating SE-contaminated eggs that have not been fully cooked. The incidence has been fairly steady in recent years, officials said.

"The implementation of this rule would reduce the number of SE-related illnesses by 33,500 and is a major step in realizing our pubic health goal of a 50% reduction in all salmonellosis and a 50% reduction in SE outbreaks by 2010," FDA Acting Commissioner Lester M. Crawford said in a news release.

The regulations apply to poultry farms that have at least 3,000 layer hens and don't already pasteurize their eggs or use a comparable safety step, the FDA said. Such large farms account for more than 99% of eggs produced in the United States. The regulations cover:

  • Procurement of chicks and pullets
  • A biosecurity program to prevent the spread of SE from the environment into poultry houses or between poultry houses
  • Cleaning and disinfection of poultry houses where an environmental sample or egg has tested positive for SE
  • Refrigerated storage of eggs on the farm
  • Producer testing of environmental samples from poultry houses for SE and follow-up steps when a sample tests positive
  • Designation of a person responsible for SE prevention at each farm

SE contamination of eggs "occurs as a result of infection of the hen's reproductive tract, and so the Salmonella are transferred to the inside of the egg," Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition (CFSAN), told reporters in a Sep 20 teleconference. "The proposed measures are designed to reduce the likelihood that this transovarian contamination would occur."

The cost of implementing the proposed rules is estimated at $82 million per year, or from 19 cents to $1 per hen, depending on the size of the farm, according to Louis J. Carson, deputy director of CFSAN's food safety and security staff, who also spoke at the news conference. He said the rules are expected to pay about $490 million in annual benefits, mainly from reduced hospitalization costs and fewer cases of chronic arthritis and other long-term effects of salmonellosis.

The proposed regulations are published in the Federal Register today, marking the beginning of a 90-day comment period. Carson said he couldn't predict when the rules will take effect, but said, "We would think that certainly by the end of '05 or the beginning of '06 we'd have a final rule out."

Transovarian SE contamination of eggs has been recognized as a problem since the 1980s, Carson reported. "It's taken us a while to try and identify this and to recognize that the contamination is inside the egg and what we might be able to do to reduce the contamination," he said.

Carson said the poultry industry has recognized since the early 1980s that on-farm measures to prevent SE contamination are important. "Many producers today participate in quality assurance programs, and those quality assurance programs may have one or more of these measures already in there," he added.

The development of the proposed regulations began in 1999, according to Carson. CFSAN spokesman Sebastian Cianci told CIDRAP News the FDA implemented two rules aimed at SE in 2001. One requires restaurants, retail stores, foodservice operations, and institutions to refrigerate eggs at 45ºF or lower; the other requires that egg cartons bear a label stating that eggs should be refrigerated until used and cooked until yolks are firm.

In developing the new regulations, the FDA consulted the US Poultry and Egg Association, state veterinarians, and consumer groups, Carson said.

Cianci said the proposal focuses on large poultry farms because they account for most egg production and because smaller farms have not been implicated as sources of Salmonella in any recent egg-related outbreaks. But he added, "We're soliciting comment on whether or not it [the proposed rule] should be required for the smaller farms."

The FDA also said it is aware of illness outbreaks linked with undercooked eggs served in restaurants and is seeking comments on whether to propose new requirements to prevent those cases.

See also:

Full text of proposed regulations (278 pages)

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