Quick answer
What is the FDA egg safety rule?
It is 21 CFR Part 118, the federal rule that requires shell egg producers with 3,000 or more laying hens to run a written Salmonella Enteritidis prevention plan, test their houses and keep eggs at 45°F or below from 36 hours after lay. Separate FDA rules add refrigeration at retail and a safe handling statement on shell eggs.
The FDA egg safety rule is the main federal control on Salmonella in shell eggs, and it works on the farm, well before eggs reach your dock. Buyers rarely see it directly, but it shapes what a supplier can promise and what paperwork exists. This guide explains who the rule covers, what producers must do, the refrigeration and labeling rules around it, and what to ask a shell egg supplier. It is a plain summary, not legal advice.
The FDA egg safety rule in brief
FDA published the rule in July 2009 to prevent Salmonella Enteritidis (SE) in shell eggs during production, storage and transportation. FDA expected it to prevent about 79,000 cases of foodborne illness and 30 deaths each year (FDA Egg Safety Final Rule, page current as of August 10, 2022). The text in 21 CFR Part 118 was read in the electronic Code of Federal Regulations, current through November 3, 2026.
Who it covers:
- Covered in full: a producer with 3,000 or more laying hens at a farm, producing shell eggs for the table market, that does not sell all of its eggs directly to consumers.
- Covered in part: if all of a farm's eggs receive a treatment, such as in-shell pasteurization or processing into egg products, the farm must meet only the refrigeration and registration requirements.
- Holders and haulers: anyone who transports or holds shell eggs for processing or egg products plants must meet the refrigeration requirement, for eggs from farms of that size.
What covered producers must do
Each covered farm needs a written SE prevention plan, specific to that farm, with these measures at a minimum:
| Requirement | What the rule says |
|---|---|
| Pullets | Chicks from SE monitored breeder flocks; pullet house tested for SE at 14 to 16 weeks of age |
| Biosecurity | Limit visitors, prevent cross contamination between houses, keep out wild birds and other animals |
| Pest control | Monitor and control rodents and flies; remove debris that harbors pests |
| Cleaning and disinfection | Required before new hens enter a house that tested positive |
| Refrigeration | Eggs held and transported at or below 45°F ambient beginning 36 hours after lay |
| Environmental testing | Each house tested when hens are 40 to 45 weeks of age, and 4 to 6 weeks after a molt |
| Egg testing | After a positive house: four tests of 1,000 eggs at 2-week intervals, or divert eggs to treatment |
| Records | Plan, test results and monitoring records, kept for 1 year after the flock leaves production |
| Registration | Each covered farm registers with FDA |
The rule allows one equilibration step: eggs held cold may sit at room temperature for no more than 36 hours just before processing, to temper them.
Diverted eggs go to treatment
When an egg test comes back positive, the producer must divert that flock's eggs to treatment until four consecutive egg tests are negative. Treatment means a process that achieves at least a 5-log destruction of SE in the shell, or processing into pasteurized egg products under USDA inspection. Every pallet or case of diverted eggs, and its paperwork, must carry this statement: "Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f)."
That is one route by which eggs reach breaking plants; our guide to breaker eggs covers the others.
45°F refrigeration from farm to kitchen
Three rules keep shell eggs cold from the farm to the point of service:
| Stage | Rule | Requirement |
|---|---|---|
| Farm and transport to packing | 21 CFR 118.4(e) | 45°F ambient or below from 36 hours after lay |
| Packed for the consumer, storage and transport | 9 CFR 590.50 (USDA) | 45°F ambient or below, with safe handling instructions |
| Retail establishments | 21 CFR 115.50 | Placed under refrigeration promptly on receipt; stored at 45°F ambient or below |
FDA defines a retail establishment as any operation that stores, prepares, serves or otherwise provides food directly to consumers, which includes restaurants and institutional kitchens. Shell eggs specifically processed to destroy all viable Salmonella are exempt from the retail refrigeration rule. How to check temperature at the door, and when to reject a load, is covered in our guide to frozen food receiving temperature, which includes raw shell eggs.
The safe handling statement
Under 21 CFR 101.17(h), the label of shell eggs must carry this statement, set off in a box: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly."
Two details matter to foodservice buyers:
- Placement for foodservice. For eggs sold to foodservice establishments, or packed for repacking elsewhere, the statement may appear on the cartons or in labeling such as invoices or bills of lading, following trade practice.
- Pasteurized shell eggs. Eggs processed to destroy all viable Salmonella before distribution are exempt from the statement.
A grade on the carton is not part of this system. Grades measure quality, as our post on USDA egg grades explains.
What to ask a shell egg supplier
Covered farms keep records for FDA, not for customers, so frame questions around what the supplier can confirm in writing:
- Are the farms covered by 21 CFR Part 118, and registered with FDA?
- Is there a written SE prevention plan for each farm supplying my item codes?
- What happens to my supply if a house tests positive? Diversion can cut shell egg volume from that flock for weeks.
- How are eggs kept at 45°F or below from the farm through the delivery truck?
- Where does the safe handling statement appear on my shipments: carton or invoice?
- Are any eggs pasteurized in the shell? If so, which item codes, and by what process?
Where Echo Lake Foods fits
Part 118 governs shell egg farms. Echo Lake Foods makes precooked egg items from a blend of quality USDA inspected, pasteurized eggs, and has pasteurized eggs since 1964. For how the HPAI question fits alongside SE, see our post on avian influenza egg safety. For spec sheets on our heat and serve eggs, contact Echo Lake Foods.
FAQ
Who has to follow the FDA egg safety rule?
Shell egg producers with 3,000 or more laying hens at a farm that produce eggs for the table market and do not sell all their eggs directly to consumers. Farms that send all eggs to treatment follow only the refrigeration and registration parts, and anyone holding or hauling eggs for processing must keep them at 45°F.
What temperature must shell eggs be kept at?
At or below 45°F ambient. The FDA egg safety rule applies from 36 hours after lay, USDA rules apply to eggs packed for consumers in storage and transport, and FDA's retail rule applies once eggs reach a store, restaurant or institution. Pasteurized in-shell eggs are exempt from the retail rule.
Does the egg safety rule apply to egg products?
Not directly. Part 118 covers shell eggs on the farm and in transport. Liquid, frozen and dried egg products are made under USDA inspection and must be pasteurized. Eggs diverted under Part 118 can be sent to those plants for pasteurization, which counts as treatment.
Do restaurants need the safe handling statement on egg cartons?
The statement must accompany shell eggs, but for eggs sold to foodservice establishments FDA allows it on cartons or in labeling such as invoices or bills of lading. Check that it appears on one of them, and keep eggs refrigerated at 45°F or below after receipt.
Next step
Compare quality standards in USDA egg grades, check deliveries with our frozen food receiving temperature guide, or contact Echo Lake Foods about pasteurized, precooked egg items.
