WASHINGTON—A new U.S. Food and Drug Administration (FDA) report issued in July found violations of its egg safety rules on about 40% of the farms it inspected in 2011; however, only about 3% of the problems were serious enough for agency action.
On July 9, the final group of egg producers—shell egg producers with at least 3,000 but fewer than 50,000 laying hens—were required to comply with FDA’s Egg Safety Rule requiring egg producers to have preventive measures in place on the farm during the production of shell eggs and subsequent refrigeration during storage and transportation.
The Egg Safety Rule, finalized in 2009, is designed to prevent thousands of illnesses and dozens of deaths each year from consumption of eggs contaminated with Salmonella Enteriditis. The requirements for industry compliance with the regulations were phased in over a 3-year period based on the number of laying hens in each operation.
According to the report, FDA 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," 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 cited in the report included 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. Salmonella Enteriditis was found in about 2.5% of swabs taken in environmental sampling at the egg farms.
Utilizing the agency’s risk-based approach to inspections, farms are were inspected using risk criteria that included number of laying hens, registration status, public health risk (whether or not the farm/firm has been associated with previous recalls, outbreaks or consumer complaints), and other indicators that could impact how a farm implements food-safety measures. The 50 highest-risk farms were identified for comprehensive inspections and environmental sampling, as was the case with the initial 35 farms inspected.