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FDA Issues Draft Guidance on Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation

Constituent Update

July 12, 2011

The U.S. Food and Drug Administration (FDA) today published draft guidance that provides direction to egg producers and other persons who are covered by FDA’s final rule “Prevention of Salmonella Enteritidis in Shell Eggs During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). The guidance document responds to questions FDA has received on the final rule since its publication.

On July 9, 2009, FDA issued a final rule that requires 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.

The draft guidance document contains questions and answers relating to the requirements contained in Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118),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.

Submit comments electronically to the docket through

To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All submissions must include the docket number listed in the notice of availability that publishes in the Federal Register.

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