Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)
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Guidance Issuing OfficeOffice of Food Safety
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2367.
The purpose of this document is to provide guidance to egg producers on certain provisions contained in FDA’s July 9, 2009, 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's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
FDA issued a final rule (“the egg rule”) on July 9, 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 September 8, 2009. The compliance date for the egg rule is July 9, 2010, for producers with 50,000 or more laying hens, and July 9, 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.
The USDA National Organic Program regulations require that organic poultry have year-round access to the outdoors. Birds must have access to the outdoors, shade, shelter, exercise areas, fresh air, clean water for drinking, and direct sunlight (7 CFR 205.239(a)(1)). Poultry are allowed to be temporarily confined in some circumstances, such as inclement weather or conditions under which the birds’ health, safety, or well-being could be jeopardized (7 CFR 205.239(b)). However, continuous total confinement indoors is prohibited by USDA’s regulations (7 CFR 205.239(a)(1)).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2000-N-0190.