Wednesday, October 20, 2010

Unscrambling The Egg Mess: The Latest Developments

CDC updates numbers; FDA "warns" Wright County Egg, gives green light to Hillandale

Two weeks ago, CDC told me that it planned – "by the end of the week"– to release an update to its report on the Salmonella Enteritidis outbreak investigation. Yesterday, they delivered.

From May 1st to October 15, 2010, CDC estimates that 1,813 illnesses are likely to be associated with the consumption of Salmonella Enteritidis-contaminated eggs from Wright County Egg (also known as Quality Egg LLC) and Hillandale Farms of Iowa.

CDC typically receives approximately 1,369 reports of illnesses due to this very common strain of Salmonella during the May 1st to October 15th timeframe (based on a five-year average). This year, the agency has received 3,182 reports. The estimate of 1,813 illnesses represents the difference between this year's reports and the five-year average.

This graph, taken from the CDC investigation report, profiles the outbreak on a week-by-week basis. The solid line represents the five-year average number of cases.

The outbreak numbers appear to tail off during the last four weeks, but this is not necessarily the case. As the graph explains, the area in grey represents a time period during which new illnesses may have occurred but have not yet been diagnosed and reported to CDC.

What can we deduce from this graph?
  1. The outbreak did not start on May 1st. It likely began much earlier – perhaps in February/March. The number of cases per week appears to start tracking noticeably above the baseline average as early as the last week of January.
  2. The outbreak peaked in June/July. CDC identified the outbreak in July, when it was already at its peak. The number of cases began to drop off in August, even before the first recall was initiated.
  3. The outbreak did not end with the August recalls of eggs from Wright County Egg and Hillandale Farms. Even in mid-September, the number of reported cases continued to track well above the 5-year average baseline.

What has FDA been doing?

Hillandale Farms of Iowa:- FDA performed a follow-up inspection of Hillandale's West Union facility from October 13 to 15th, and has permitted Hillandale to resume the distribution of shell eggs, based on the following understanding:
  • Hillandale's agreement to clean and disinfect houses 1 & 2 prior to repopulation;
  • Hillandale's commitment to comply with the requirements of the Egg Safety Rule, including egg testing from houses with environmental Salmonella-positives;
  • FDA's confirmation of the corrections to the problems noted in the agency's August 2010 inspection (see FDA-483 report)
  • Consistent negative Salmonella Enteritidis test results from the environment and from eggs at houses 3, 5 and 7 in the West Union facility.
  • Commitment not to ship table eggs from houses 4, 6, 8 & 9 until they go through four rounds of egg testing. These eggs will be held and shipped once all four rounds of testing are completed satisfactorily.
  • Monthly environmental testing of houses 4, 6, 8 & 9 for the life of the current flock.

Wright County Egg (Quality Egg, LLC):- FDA issued a Warning Letter to Austin Decoster, the owner of Quality Egg LLC on October 15th, based on the agency's inspection report and its subsequent discussions with the Company. It's clear from the Warning Letter that FDA is not yet satisfied with Decoster's response to the agency's findings. After reciting a summary of the deviations noted in its FDA-483 report, FDA closed with the following statements:
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the shell egg regulation, and the PHS Act. You also have a responsibility to use procedures to prevent further violations.

You should take prompt and aggressive actions to eliminate the Salmonella Enteritidis contamination and the observations described in this letter. Failure to take prompt corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and/or injunction.

FDA is in receipt of your response dated October 5,2010, to the FDA-483 and additional information you submitted reflecting ongoing discussions with the agency of your corrective actions. We acknowledge your commitment to correcting the deviations and will verify your corrections via inspection.

As for the rest of the shell egg industry, FDA has begun its first round of "routine" inspections under the new Egg Safety Rule. I reported two weeks ago, that the first inspections were completed in Maine in late September. The focus then shifted back to the Midwest. FDA has not indicated any plans to release the results of these inspections – unless, of course, they result in recalls or warning letters.

Until FDA decides to release the results of its inspections, our household is sticking with Eggland's Best!

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