FDA found food safety gaps in 40% of egg-farm inspections

Jul 10, 2012 (CIDRAP News) – The US Food and Drug Administration (FDA) found violations of its egg safety rules on about 40% of the farms it inspected in 2011, but only about 3% of the problems were serious enough to call for FDA action, according to an agency report released yesterday.

As it released the data, the FDA noted that rules to prevent Salmonella Enteritidis (SE) contamination of eggs took effect yesterday for medium-sized farms—those with 3,000 to 50,000 laying hens. The regulations became effective in July 2010 for farms with more than 50,000 hens.

The FDA said its own inspectors and state contract workers inspected 555 egg farms in 2011. Of those, 96 inspections were more comprehensive than the rest because they included environmental sampling.

On 14 (2.7%) of the inspections officials found problems that were considered "egregious" and warranted an official FDA response, such as a warning letter. "In large part, these inspections are the first inspection of the farm by FDA, and a warning letter is the appropriate administrative official action," the FDA said.

Another 195 (37.9%) inspections revealed "significant deficiencies" but ones that the operators "should be able to correct . . . without any official action by FDA," the agency said.

Significant problems included such things as the lack of a written SE prevention plan, failure to conduct environmental tests for SE, failure to divert eggs or begin egg testing after a positive environmental sample, and failure to keep required records.

In other findings, the FDA said SE was found in about 2.5% (51 of 2,030) of swabs taken in environmental sampling at the egg farms. The 51 positive swabs were among the 22 samples collected on 11 farms.

The agency used a risk-based approach to inspections, selecting farms on the basis of criteria that included the number of laying hens, registration status, and previous recalls and consumer complaints. The 50 highest-risk farms were picked for comprehensive inspections and environmental sampling, the FDA said.

The FDA's egg safety rule does not apply to farms that have fewer than 3,000 hens and those that sell all their eggs directly to consumers. Large operations (more than 50,000 layers) produce about 80% of the US egg supply, the agency said when it established the rules.

Under the safety rule, egg producers who don't use pasteurization must take a number of steps, including establishing pest-control and biosecurity measures, testing for SE in their poultry houses, cleaning and disinfecting houses that test positive, and refrigerating eggs during storage and transportation.

See also:

Jul 9 FDA notice on rules taking effect

FDA 2011 egg safety inspection report

Jul 9, 2010, CIDRAP News story on debut of egg safety rules

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