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FDA Publishes Final Guidance on the Egg Safety Rule


Constituent Update

December 27, 2011

The Food and Drug Administration today published final guidance for egg producers to help them further comply with the FDA egg safety rule. The guidance entitled: “Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” was initially published as draft for comment on August 12, 2010.

The guidance provides recommendations on the following provisions of the final rule: Salmonella Enteritidis (SE) prevention measures; environmental testing for SE; egg testing for SE; sampling methodology for SE; and recordkeeping requirements for the SE prevention plan. While the rule lists the measures producers must take to comply with the rule, the guidance offers more specific recommendations and options for several of the measures. The final guidance differs from the draft guidance in that it addresses environmental sampling plans for a variety of poultry house styles, as requested by commenters.

The FDA issued the egg safety rule in July 2009, requiring egg producers to have preventive measures in place on the farm during the production of shell eggs and subsequent refrigeration during storage and transportation.

On July 9, 2010, the new food safety requirements became effective for egg producers having 50,000 or more laying hens, which represents about 80 percent of production. Producers with at least 3,000 but fewer than 50,000 laying hens must comply with the new rule by July 2012.


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