In response to questions it has received since publishing its so-called egg rule last year, the U.S. Food and Drug Administration  (FDA) Tuesday published a draft guidance to give direction to egg producers.

The egg safety final rule — “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” — was intended to prevent Salmonella from contaminating eggs on the farm and from further bacterial growth during egg storage and transportation.

Salmonella is one of the leading causes of foodborne illness in the United States and shell eggs are a primary source of Salmonella infections. The FDA says it expects the new egg rule will prevent approximately 79,000 cases of illness and 30 deaths each year that are caused by the consumption of eggs contaminated with Salmonella.

Among other things, the egg rule requires shell egg producers to keep records and to register with the FDA. 

Tuesday’s draft guidance includes questions and answers about who is covered by the egg rule, compliance dates, definitions, cleaning and disinfection, refrigeration, sampling and testing for SE, registration, enforcement and compliance.

The draft guidance is available here. 

Electronic or written comments on the draft guidance can be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit electronic comments to  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding the draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1700.