December 22, 2011


US FDA on track to complete egg rule inspections



The US Food and Drug Administration (FDA) has stated that it is on track to complete new egg rule inspections of all 517 American egg producers with 50,000 or more laying hens by December 31.


In July 2010, shell egg producers with 50,000 or more laying hens became subject to the Egg Safety Rule (referred to as the Egg Rule from this point forward), which requires producers to implement measures to prevent Salmonella Enteriditis (SE) from contaminating eggs on the farm and during storage and transportation. It also requires producers to maintain records to document their compliance with the Rule and to register with the US Food and Drug Administration (FDA).


In a summary of its progress, FDA disclosed that it has more than 100 of its own inspectors carrying out egg rule inspections and that it has signed up 10 states that are providing additional expertise to get the job done.


In September 2010, FDA began implementing a risk-based inspection strategy to meet its goal. The agency first focussed its inspections on 35 farms that had been associated with previous outbreaks and/or poor compliance history. The first assignment was completed by December 31 2010 with a total of 41 farms being inspected (additional affiliated farms were identified through our inspections and inspected). The agency followed that with a second assignment, termed the FY-11 Assignment, which covered the remaining farms subject to the Egg Rule, again using a risk-based inspection strategy to identify farms that will be inspected using a comprehensive or targeted approach.


Through September 30, FDA has conducted more than 295 inspections under the FY-11 assignment.  Of the inspections conducted thus far, 295 have received their final classification.  Adding the 41 inspections previously reported, FDA has conducted more than 336. Moreover, most of the inspections planned as comprehensive inspections had been completed by September 30, leaving the less resource-intensive targeted inspections to complete between October 1 and December 31, 2011.

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