In the Guidance, FDA explains that its purpose of the document is to provide guidance to egg producers on certain provisions contained in FDA’s final rule 'Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation' (74 FR 33030, codified at 21 CFR part 118), concerning the management of production systems that provide laying hens with access to the outdoors. Laying hens are provided outdoor access in some production systems, including certified organic production systems governed by the United States Department of Agriculture’s (USDA) National Organic Program regulations (7 CFR Part 205).

FDA stresses this is a guidance document and as such, it describes the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The document overviews the coverage of the so-called 'Egg Rule' and definititions as well as Salmonella enteritidis prevention measures for free-range systems and environmental sampling.

FDA issued the final rule ('The Egg Rule') on 9 July 2009, requiring shell egg producers and certain other persons to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation (21 CFR part 118). The egg rule became effective on 8 September 2009. The compliance date for the egg rule is 9 July 2010 for producers with 50,000 or more laying hens, and 9 July 2012, for producers with fewer than 50,000 but at least 3,000 laying hens. Producers with fewer than 3,000 laying hens and those that sell all of their eggs directly to consumers are exempt from the egg rule.

Further Reading

You can view the full FDA Draft Guidance by clicking here.