The first FDA inspections under the new Egg Rule began in the Northeast and Midwest sections of the country in September 2010. Over 15 months, FDA inspectors visited about 600 facilities nationwide that produce about 80 percent of the country's eggs to determine if they are in compliance with the Rule, which went into effect in July, 2010.
Producers with 50,000 or more layinghens are now subject to the Rule, which requires them to implement measures to prevent Salmonella Enteriditis (SE) from contaminating eggs on the farm and from growing in the eggs during storage and transportation. Producers are also required to maintain records concerning their compliance with the Rule, including SE testing, and to register with the FDA.
Mike Taylor, FDA's Deputy Commissioner for Foods, says the Rule sets safety standards intended to head off outbreaks of Salmonella Enteriditis like the one that led to a recall of more than 500 million eggs in less than three weeks.
"We think that the industry's compliance with this rule will significantly reduce the risk of SE infections and outbreaks in the future," Taylor said. "These inspections will help ensure high rates of compliance and in turn improve the safety of eggs."
Field Assignment Issuance on Egg Safety
Field Assignmentswere 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.
- Inspection of Egg Farms for Monitoring Compliance with Egg Safety Rule - Phase I
September 20, 2010; updated September 28, 2010
- Inspection of Egg Farms for Monitoring Compliance with Egg Safety Rule - Phase II
February 3, 2011; updated February 4, 2011; Amended February 8, 2011
Egg Rule Assignment FY 2011 Amended (pages 8-11: revised sampling instructions & page 15: revised information on waste disposal)
Reports and Quarterly Summaries
Final Report and Quarterly Summaries on FDA Inspections Under the Egg Safety Rule
Multi-Criteria Decision Analysis Methodology Used to Prioritize Inspection of Egg Farms for Monitoring Compliance with the Egg Safety Rule (PDF: 40KB)
August 9, 2011
- Quarterly Summary on FDA Inspections Under the Egg Safety Rule September 2010 - December 2010
- Quarterly Summaries on FDA Inspections Under the Egg Safety Rule January 2011 – September 2011