Oct 19, 2010 (CIDRAP News) The US Food and Drug Administration (FDA) has authorized one Iowa company tied to a recent nationwide Salmonella Enteritidis (SE) outbreak to resume egg production for the retail market, while officially warning the other company of possible enforcement action if it doesn't correct problems inspectors found in August.
In addition, today the Centers for Disease Control and Prevention (CDC) increased its estimate of cases involved in the outbreak to 1,813, compared with 1,608 in the last update on Sep 20.
The two egg companies recalled a combined total of 550 million eggs in August because of the farms' suspected link to the SE cases reported nationwide since May.
In an Oct 15 letter released yesterday, the FDA gave Hillandale Farms of West Hampton, Iowa, permission to resume production for the "table market" at its poultry houses in West Union, Iowa. The agency said its inspectors last week confirmed that the company had corrected problems as promised and that Salmonella tests of eggs and the environment at the farm have consistently been negative.
At the same time, the FDA released an Oct 15 letter to Austin DeCoster, owner of Quality Egg LLC of Galt, Iowa, that details biosecurity problems found at the company's farms in August and warns of possible enforcement action if the conditions are not corrected. The problems were publicized when the FDA released its Form 483 inspection reports on Aug 30. The letter represents the FDA's official notification of the company concerning the findings.
The letter urges Quality Egg to "take prompt and aggressive action" to eliminate Salmonella contamination and biosecurity gaps. "Failure to take prompt corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice," it states. "These actions may include, but are not limited to, seizure and/or injunction."
The letter acknowledges that the FDA received a letter from DeCoster on Oct 5 reflecting the firm's "ongoing discussions" with the agency about corrective actions. "We acknowledge your commitment to correcting the deviations and will verify your corrections via inspection," the FDA told DeCoster.
Hinda Mitchell, a spokeswoman for Wright County Egg, owned by Quality Egg, said yesterday that the company has already addressed the problems the FDA found, according to a Bloomberg News report yesterday. "There's nothing new here," she told Bloomberg. "We responded swiftly and had expeditious completion of the issues that were raised."
The problems at the Wright County Egg farm in Clarion, Iowa, included rodent infestations, wild birds in poultry barns, and massive buildups of chicken manure, among other things detailed in the letter and the 483 inspection reports.
Wright County Egg is still allowed to sell eggs, but they must go to a facility where they are broken and heated to kill any pathogens so they can be used in prepared foods, USA Today reported today.
Concerning Hillandale Farms, the FDA letter said the company submitted information on Sept 20 and Oct 1 about the steps it took to correct objectionable conditions and about the results of Salmonella testing. On the basis of that information and the FDA's inspection of the firm's West Union facility Oct 13 to 15, the agency said, "FDA finds your corrective actions to be adequate."
The agency authorized resumption of egg production for the table market at three of the West Union henhouses. For four other houses, the company has committed to withholding shipments of eggs to the table market until it completes four rounds of egg testing as recommended by the FDA, the letter says. Also, the company has agreed to clean and disinfect two other henhouses before repopulating them.
Today's CDC update on the Salmonella investigation notes that the outbreak involves SE with the pulsed-field gel electrophoresis pattern JEGX01.0004the most common pattern. From May 15 to Oct 1, 3,182 illnesses involving SE with this PFGE pattern were reported, but some of them may not be related to the outbreak, the CDC says. On the basis of the previous 5 years of reports, about 1,369 such cases would normally be expected during this period. Therefore, the CDC estimates that about 1,813 cases are related to the outbreak.
As reported previously, investigators in 11 states found 29 restaurants or event clusters where more than one person sickened with the outbreak strain had eaten, according to the CDC report. Wright County Egg was an egg supplier in 15 of the restaurants and event clusters. Other investigative findings identified Hillandale Farms as another potential source of contaminated eggs contributing to the outbreak.
At a September congressional hearing on the outbreak, lawmakers said SE had been found in eggs and in samples from chickens from the implicated farms. The FDA previously reported finding SE in some environmental samples from the farms but has not confirmed finding the outbreak strain in eggs.
Oct 18 FDA statement about Hillandale authorization to ship
Oct 15 FDA letter to Hillandale
Oct 18 FDA statement about letter to Wright County Egg
Oct 15 FDA letter to Wright County Egg
Oct 19 CDC update on outbreak investigation
Aug 30 CIDRAP News story on FDA inspection reports
Sep 22 CIDRAP News story on congressional hearing revealing that tests found Salmonella in eggs and samples from chickens
Oct 19 USA Today story