Final Report and Quarterly Summaries on FDA Inspections Under the Egg Safety Rule
Summary Period: September 2010 – December 2011
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 FDA.
When the Egg Rule was first implemented, FDA set a goal to inspect all farms subject to the rule by December 31, 2011. The initial inventory of registered large egg farms was 641. However, in proceeding with inspections, FDA discovered that several farms were no longer subject to the rule because they had ceased operations or canceled their registrations. FDA visited and performed “washout inspections” of these farms, and these reports are included in the cumulative number of inspectional visits. These “washouts” reduced the final inventory of farms subject to the Egg Rule to 533.
In September 2010, FDA implemented a risk-based inspection strategy to meet its goal, focusing first on inspections of 35 farms that had been associated with previous outbreaks and/or poor compliance history. The agency completed the first assignment by the end of 2010, with a total of 41 farm inspections (FDA identified and inspected six additional affiliated farms).
FDA then began its 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 determine whether to inspect farms using a comprehensive or targeted approach. Risk criteria included the number of laying hens, registration status, public health risk (whether or not the farm or company had been associated with previous recalls, outbreaks or consumer complaints), and other indicators that could impact how a farm implements food safety measures. In total, FDA and its state partners conducted a total of 663 inspectional visits, exceeding all goals set. FDA and its state partners shared the results of inspections throughout the course of these assignments.
Summary of Egg Farm Inspections 2010 - 2011
FDA Inspections 9/2010 - 12/2010
FDA Inspections 1/2011 – 12/2011
State Contract Inspections 2011
I. Comprehensive inspections required investigators to:
Inspect the establishment to assess compliance with the Rule in terms of the SE prevention plan, the egg laying operation, and the firm’s environmental testing;
Review a subset of relevant firm records;
Conduct environmental sampling;
Document findings and initiate compliance action as warranted.
Targeted inspections require all of the above except environmental sampling.
FDA conducted 41 inspections under the initial high-risk assignment, plus an additional 396 inspections under the FY-11 assignment. All of these inspections have received their final classification and are reported here. Ten states also entered into contracts with FDA and conducted 118 targeted inspections. The total number of inspections conducted from September 2010 – December 2011 was 555.
Inspection Types Conducted (FDA and State Contract)
Inspection (FDA) Classifications for FY-11 Assignment
Jan – Mar, 2011
Apr – Jun, 2011
Jul – Sep, 2011
Oct – Dec, 2011
NAI - 305 of these inspections were classified as No Action Indicated (NAI), meaning that there were no significant deviations from the egg rule observed during the inspection.
VAI - 195 of these inspections were classified as Voluntary Action Indicated (VAI), meaning that significant deficiencies were observed, but the establishments should be able to correct deficient practices without any official action by FDA.
OAI - 14 inspections were classified Official Action Indicated (OAI, meaning that the objectionable conditions observed are egregious and warrant an official action by FDA, such as a Warning Letter to these establishments. 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 is conducting follow-up inspections at firms receiving a Warning Letter approximately six months after issuance.
Significant deviations from the Rule included:
Lack of a written SE prevention plan or significant requirements of that plan;
Failure to environmentally test for SE during required time periods;
Failure to divert eggs or begin egg testing after a positive environmental sample;
Failure to implement the SE prevention plan;
Failure to maintain required records; and
Failure to monitor conditions required for implementation of the plan.
II. Results of Ongoing Egg Producer Inspection Assignment
As of December 2011, FDA had conducted comprehensive and targeted inspections of more than 550 producers of eggs for the table market. Of these, FDA conducted 55 comprehensive inspections, which included environmental sampling.
More than 100 FDA investigators conducted these inspections. Three to 5 investigators participated in the inspection at each farm. In some cases, state investigators accompanied FDA on these inspections.
Ten states (Arkansas, California, Georgia, Iowa, Indiana, Michigan, Minnesota, North Carolina, Ohio and Wisconsin) were awarded contracts to conduct 136 targeted inspections (with no environmental sampling). State inspectors completed 118 of the 136 contracted targeted inspections and FDA completed the 18 inspections that states were unable to complete due to insufficient resources available within the time allotted.
If state inspectors observed conditions during a targeted inspection that warranted expansion to a comprehensive inspection, the states notified the local FDA District Office, which then conducted the comprehensive inspection. States were able to continue their participation in the inspections during these expansions.
Environmental samples collected at comprehensive inspections during the FY-11 Assignment included 2030 swabs, with 51 (~2.5%) positive for SE. The 51 positive swabs were part of 22 samples collected at 11 different farms. All of the farms with positive environmental samples complied with the egg rule and implemented egg testing or diverted eggs from the table market.
III. Next Steps in the Inspection Strategy
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.
During calendar year 2012, FDA will inspect large egg farms that registered late, which includes approximately 73 farms. On July 9, 2012, the Egg Rule went into effect for producers with less than 50,000 but more than 3,000 laying hens. FDA and its state partners will begin inspection of these smaller farms in the fourth quarter of this calendar year.