21 CFR Part 118 - Production, Storage and Transportation of Shell Eggs

What it says

Part 118 requires shell egg producers with 3,000 or more laying hens to put in place measures to prevent Salmonella Enteritidis from contaminating eggs on the farm during production, and to keep eggs refrigerated during storage and transportation. Measures include a written SE prevention plan, procurement of chicks and pullets from suitable sources, biosecurity, rodent and pest control, cleaning and disinfection, testing, and refrigeration.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The rule targets the farm, where preventive measures give the best chance of controlling the hazard.
• Environmental testing is used to check whether the controls are working.
• Refrigeration of eggs after laying limits growth if any contamination is present.

What FDA inspectors look for

• Whether a written SE prevention plan exists and is carried out.
• Whether testing and follow-up are done and recorded.
• Whether refrigeration requirements are met.

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