Which shell-egg farms fall under FDA’s Salmonella prevention rule?

Short answer

Part 118 covers a shell-egg producer with 3,000 or more laying hens at a particular farm when the farm produces eggs for the table market and does not sell all of them directly to consumers.

If any eggs from that farm do not receive a treatment as defined in § 118.3, the producer must comply with all applicable Part 118 production requirements for that farm. If all eggs receive the defined treatment, § 118.1(a)(2) says the farm must comply only with refrigeration under § 118.4(e) and registration under § 118.11.

The regulatory text contains an additional record provision that should not be overlooked: § 118.10(a)(3)(viii) expressly lists records showing that eggs at an all-treated farm received the defined treatment. This page does not resolve the tension between that record paragraph and § 118.1(a)(2)’s word “only.” Retain the treatment evidence and confirm FDA’s current interpretation rather than assuming no treatment record is needed.

For Part 118, treatment means a process achieving at least a five-log destruction of Salmonella Enteritidis in shell eggs, or processing egg products under the Egg Products Inspection Act.

21 CFR 118.4

Covered untreated-egg farms need a written, farm-specific prevention plan

The producer must have and implement a written Salmonella Enteritidis prevention plan for each covered farm. At a minimum, the plan addresses:

• procuring SE-monitored pullets or raising pullets under monitored conditions;
• biosecurity, including visitor limits and cross-contamination controls between poultry houses;
• monitoring and controlling rodents, flies, and other pests;
• cleaning and disinfecting a poultry house after a positive environmental or egg test before new hens are added; and
• refrigeration.

One or more supervisory personnel must administer the plan. The responsible person must have completed recognized-equivalent training or possess job experience providing at least equivalent knowledge.

Refrigeration

The federal temperature rule begins 36 hours after lay

Section 118.4(e) requires eggs to be held and transported at or below 45 °F ambient temperature beginning 36 hours after the time of lay. When table eggs have already entered that cold-holding requirement but need tempering before processing, the regulation permits room-temperature holding for no more than 36 hours immediately before processing.

The refrigeration provision also applies to a person transporting or holding shell eggs for shell-egg processing or egg-products facilities, but § 118.1(b) limits that statement to eggs from farms with 3,000 or more laying hens.

Environmental and egg testing

Positive environmental results trigger plan review and either diversion or egg testing

For monitored pullets, the pullet environment must be tested when the birds are 14 to 16 weeks old. If that test is positive, eggs must be diverted for the life of the flock or egg testing must begin within two weeks after laying starts.

Part 118 also requires environmental testing when laying hens are 40 to 45 weeks old and again four to six weeks after the end of an induced molt. A positive environmental test requires review and any necessary adjustment of the prevention plan, followed by egg testing unless eggs are diverted to treatment for the life of the flock in that poultry house. When egg testing follows a positive 40-to-45-week or post-molt environmental test, the results must be obtained or available within 10 calendar days after notification of the positive environmental result.

The egg-testing route uses four tests at two-week intervals. Each test uses at least 1,000 intact eggs representative of a day’s production. A positive egg test requires diversion to treatment until the regulation’s negative-testing conditions are met. If a positive flock later satisfies those negative-test conditions and returns to table-egg production, it must receive one egg test each month for the life of the flock. Shipping containers and accompanying documents for diverted eggs must carry the exact statement required by § 118.6(f).

21 CFR 118.10

The prevention plan and implementation records must be retained

Required records include the written plan, monitored-pullet documentation, biosecurity, pest-control, cleaning and disinfection, refrigeration, sampling, test results, diversion, treatment, plan review, modifications, and corrective actions as applicable.

Records must identify the producer and farm, include the activity date and time, and carry the signature or initials of the person performing or recording the activity. The written plan must be dated and signed by its administrator. Records generally must be retained for one year after the flock leaves production. Offsite storage is allowed for most records if they can be retrieved onsite within 24 hours; the written plan remains onsite.

21 CFR 118.11

Covered farms register with FDA

A producer covered by § 118.1(a) must register each farm with FDA within 30 days after becoming an egg producer. Registration updates are due within 60 calendar days after covered information changes, and FDA must be notified within 120 days after egg production ceases, subject to the regulation’s temporary-cessation exceptions.

The regulation lists registration information and methods. Because agency forms, addresses, and electronic systems can change, use FDA’s current registration instructions rather than relying only on contact details embedded in older regulatory text.

Official authority

Read 21 CFR Part 118

21 CFR Part 118 — shell-egg production, storage, and transportation ↗

The retained official Part 118 XML is 46,560 bytes with SHA-256 709fbf6dbdf7c8946a52e1308eaefb59d8a1254eb8cc87941851bc1462b43185.