Quarterly Summaries on FDA Inspections Under the Egg Safety Rule
Summary Period: January 2011 – September 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 the U.S. Food and Drug Administration (FDA).
FDA intends to inspect all farms currently subject to the Egg Rule by December 31, 2011. The initial inventory of registered large egg producers was 604. However, because of finding firms out of business, cancelled registrations, etc., the agency was left with 517 registered large egg producers. In September 2010, FDA began implementing a risk-based inspection strategy to meet its goal. The agency first focused its inspections on 35 farms that had been associated with previous outbreaks and/or poor compliance history. The first assignment was completed by 12/31/2010 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, that 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.
I. Comprehensive inspections require 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.
Through September 30, 2011, FDA has conducted more than 295 inspections under the FY-11 assignment. Of the inspections conducted thus far, 295 have received their final classification and are reported here. 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. Ten states have also entered into contracts with FDA and will conduct 136 targeted inspections.
Inspection Types Conducted For FY-11 Assignment
Inspection Classifications For FY-11 Assignment
Jan – Mar, 2011
Apr – Jun, 2011
Jul – Sep, 2011
Compliance with the Rule:
- Details on classification for these 295 FY-11 Assignment inspections were available at the time of this report.
- 178 of these inspections have been classified as No Action Indicated (NAI). This means there were no significant deviations from the egg rule observed during the inspection.
- 111 of these inspections have been classified as Voluntary Action Indicated (VAI). This classification means that significant deficiencies were observed, but the establishments should be able to correct deficient practices without any official action by FDA.
- Six inspections have been classified Official Action Indicated (OAI). This classification means that the objectionable conditions observed are egregious and warrant an official action by FDA. These actions have included the issuance of 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.
Significant deviations from the Rule were defined as follows:
The below is a listing of the most significant violations
- 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 On-going Egg Producer Inspection Assignment
As of September 2011, FDA had conducted comprehensive and targeted inspections of over 300 producers of eggs for the table market. Of these, FDA conducted 82 comprehensive inspections, which included environmental sampling.
Inspections are being conducted across the United States in all states with producers that are required to comply with the egg rule.
More than 100 FDA investigators are conducting these inspections. More specifically,
- Between three (3) and five (5) investigators participated in the inspection at each farm.
- In some cases, State investigators are accompanying FDA on these inspections.
- Some states have been awarded contracts to perform inspections independently.
Several States have been awarded contracts to conduct targeted inspections.
- Contracts have been awarded to ten states: AR, CA, GA, IA, IN, MI, MN, NC, OH, WI
- Contracts are for a total of 136 inspections, with option to expand.
- Contract inspections will be targeted only, with no environmental sampling.
- If conditions are observed by state inspectors that warrant expansion to a comprehensive inspection, the states will notify the local FDA District Office who will conduct the comprehensive expanded inspection.
- States may continue to participate in the comprehensive expanded inspections.
Environmental samples were collected during comprehensive inspections.
- Of the 2056 swabs collected during the FY-11 Assignment, 52 (~2.5%) were positive for SE.
- Those 52 positive swabs were part of 22 samples collected at 10 different farms.
- All of these farms have complied with the egg rule and implemented egg testing or diverted eggs from the table market.
In the agency’s previous report on this effort, FDA reported the types of violations investigators were observing during our inspections. The same types of violations continue to be observed as we conduct this round of initial inspections.
III. Next Steps in the Inspection Strategy
Utilizing the agency’s risk-based approach to inspections, farms are being inspected using risk criteria that include 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 initial 35 farms inspected. Most of the planned comprehensive inspections have been completed, leaving the less resource-intensive targeted inspections to be conducted.
The remaining farms will receive a targeted inspection focused on compliance with the major provisions of the Rule. An evidentiary threshold based on initial inspectional observations was established for these sites, which will trigger comprehensive inspections that will include environmental sampling, if indicated. FDA and its state partners continue to be in communication throughout the course of this assignment to share the results of inspections.