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Quarterly Summary on FDA Inspections Under the Egg Safety Rule; Summary Period: September 2010 - December 2010
Summary Period: September 2010 - December 2010
Field Assignments are issued to the FDA Field Offices to respond to unique situations. Field Assignments contain guidance and instructions to the FDA Field Offices for the inspectional activities (investigations, sample collection) to be conducted in a particular Industry. Field Assignments have a start and end date. They also provide guidance pertaining to the Agency's regulatory/administrative policy when applicable.
In September 2010, a field assigment on egg safety was issued: Inspection of Egg Farms for Monitoring Compliance with Egg Safety Rule - Phase I (PDF: 152KB).
In February 2011, a second field assigment on egg safety was issued: Inspection of Egg Farms for Monitoring Compliance with Egg Safety Rule - Phase II (PDF: 175KB).
(February 3, 2011; Updated February 4, 2011; Amended February 8, 2011 Amended (pages 8-11: revised sampling instructions & page 15: revised information on waste disposal))
In July 2010, shell egg producers with 50,000 or more laying hens became subject to the Egg Safety Rule (referred to as the Rule from this point forward), which requires producers to implement measures to prevent Salmonella Enteritidis (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 600 farms currently subject to the Egg Safety Rule by January 2012. 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, issuing what is called an “assignment” to its field force.
The assignment 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;
Conduct laboratory analyses of environmental samples; and
Document findings and initiate compliance action as warranted.
The assignment indicated that Warning Letters should be considered for egg producers with significant deviations from the Rule. It also requires all violations to be documented on the Form FDA 483 (Inspectional Observations), and discussed with firm management.
Significant deviations from the Rule were defined as follows:
- 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.
Results of First Egg Producer Inspection Assignment
FDA conducted comprehensive inspections and environmental sampling at 35 shell egg farms under this assignment.
Inspections were conducted in the following six (6) States by six (6) of FDA’s 19 District Offices:
- Ohio – Cincinnati District Office (DO)
- Maine – Northeastern DO
- Pennsylvania -- Philadelphia DO
- Washington -- Seattle DO
- South Carolina -- Atlanta DO
- Utah -- Denver DO
Approximately 50 FDA investigators conducted these inspections. More specifically,
- Between three (3) and five (5) investigators participated in the inspection at each farm.
- In some cases, State investigators accompanied FDA on these inspections.
Environmental samples were collected at all farms.
- Of the 1,796 swabs collected, 76 (4%) were positive for SE.
- All of the positive environmental swabs were collected from the farms of one egg producer.
- FDA conducted follow-up inspections at the farms with positive environmental swabs and FDA verified that corrective actions, including egg testing, had been implemented.
Compliance with the Rule:
- All of the farms inspected had an SE Prevention Plan, Rodent and Pest Control Plan, and Biosecurity Plan in place.
- Deviations from the Rule were, in large part, related to the failure to completely implement and/or consistently follow these plans and/or maintain all required documentation/records.
- Eleven (11) farms received a final inspection classification of “No Action Indicated.”
- Twelve (12) farms received a final inspection classification of “Voluntary Action Indicated.”
- The final inspection classifications for the remaining 12 farms are pending. The majority of these inspections were conducted by inspectors in Washington State who were subsequently needed to investigate firms linked to two recent foodborne illness outbreaks associated with sprouts and cheese; the completion of the inspection reports for the shell egg producers was therefore delayed. The remainder of the inspections pending final classification are receiving a technical review to determine the appropriate classification and whether or not further FDA action is indicated.
|Observation Area||Failure to:|
|Records *Most citations on the Form FDA 483s fell in this category.||
|Rodent and Pest Control||
Next Steps in the Inspection Strategy
Utilizing the Agency’s risk-based approach to inspections, the remainder of the farms to be inspected are being ranked using criteria that include whether or not the farm/firm has been associated with previous compliance issues; number of laying hens, and participation in state egg quality programs. The 50 highest risk farms have been identified for comprehensive inspections and environmental sampling, as was the case with initial 35 farms inspected.
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 is being established for these sites, which will trigger comprehensive inspections that will include environmental sampling, if indicated. FDA and its state partners will be in communication throughout the course of this assignment to share the results of inspections.
To view the 483s issued under Phase I of the inspection, go to http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/ucm243505.htm.
To view warning letters associated with egg inspections, go to http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/default.htm.
 Nine firms consisting of 35 farms were inspected under this first assignment (note that a single egg production firm is typically comprised of multiple farms in different physical locations and sometimes in multiple cities). A single farm often has a number of houses, ranging from 6 – 30.