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GUIDANCE DOCUMENT

Guidance for Industry: Questions and Answers Regarding the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House) August 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2000-N-0190
Issued by:
Guidance Issuing Office
Human Foods Program

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), that reference the “poultry house.” Specifically, this document provides guidance to shell egg producers whose production systems provide laying hens with access to areas outside of a “poultry house” as that term is defined in 21 CFR 118.3.  

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, 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.

Under 21 CFR Part 118 (Part 118), which is a regulation that was promulgated by FDA and is administered by FDA, certain requirements apply only to the “poultry house” as that term is defined in 21 CFR 118.3. As discussed above, this document provides guidance to shell egg producers regarding compliance with Part 118, specifically in the context of production systems that provide laying hens with access to areas outside of a “poultry house.” As part of this guidance, FDA has identified which areas FDA considers to be outside the “poultry house,” as that term is defined in 21 CFR 118.3. This document does not address the requirements of the United States Department of Agriculture (USDA) National Organic Program (NOP). FDA is aware that certified organic egg production systems must comply with the relevant legal requirements associated with the NOP, including requirements relating to “outdoor access.” However, FDA does not play any role in interpreting or enforcing such provisions. Nothing in this document should be read as interpreting any of the NOP’s requirements. For example, when FDA interprets 21 CFR 118.3 to mean that a certain type of housing style is “outside the poultry house” for the purposes of Part 118, that interpretation does not have any bearing on whether this type of housing style meets the requirements for “outdoor access” under the NOP. To avoid confusion, FDA has changed the terminology used in this guidance from “outdoor access” to “access to areas outside the poultry house.”   

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2000-N-0190.

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