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GUIDANCE DOCUMENT

Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation July 2015

Final
Docket Number:
FDA-2011-D-0398
Issued by:
Guidance Issuing Office
Office of Food Safety

REVISED JULY 2015

This document provides guidance to egg producers and other persons who are covered by FDA’s final rule “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” (74 FR 33030 (July 9, 2009) (codified at 21 CFR part 118)). The guidance document revises our previous guidance (regarding questions FDA has received on the final rule since its publication) by removing text pertaining to Competitive Exclusion Products, providing citations for regulatory requirements, and making a few editorial changes.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our 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 regulations at 21 CFR part 118 require 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.  The rule also requires shell egg producers to maintain records concerning their compliance with the rule and to register with FDA.  FDA took this action because SE is among the leading

bacterial causes of foodborne illness in the United States, and shell eggs are a primary source of human SE infections.  The final rule will reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE.

This guidance document contains questions and answers relating to the requirements contained in 21 CFR Part 118, “Production, Storage, and Transportation of Shell Eggs,” including (1) compliance dates; (2) coverage; (3) definitions; (4) SE prevention measures; (5) sampling and testing for SE; (6) registration; and (7) enforcement and compliance.

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Submit Comments

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:

Dockets Management
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-2011-D-0398.