FSMA 204 for shell eggs: who is covered and what egg packers must keep
Yes, shell eggs are on the FDA Food Traceability List, so egg producers and handlers must keep traceability records unless an exemption applies. FDA’s Food Traceability List defines shell egg as “the egg of the domesticated chicken” and says it includes fresh or frozen products that contain raw, unpasteurized eggs as ingredients.
This guide covers who is exempt, which egg products are in or out, what an egg packer keeps, and how long.
Are shell eggs covered by FSMA 204?
FDA’s Food Traceability Rule FAQs (item TFTL.25, updated August 2025) say shell eggs are on the list, so producers and handlers must keep key data elements, assign a traceability lot code, and keep a traceability plan. The rule text is in 21 CFR Part 1, Subpart S.
Which egg producers are exempt?
21 CFR 1.1305 lists two exemptions that matter most to egg farms:
- Fewer than 3,000 laying hens. The subpart “does not apply to shell egg producers with fewer than 3,000 laying hens at a particular farm,” for the eggs they produce at that farm (paragraph a.2). The FAQ says this mirrors the Shell Egg Rule.
- Eggs that will be treated. Shell eggs are exempt when all eggs produced at the farm receive a treatment as defined in 21 CFR 118.3, in line with 21 CFR 118.1(a)(2) (paragraph d.2). The FAQ says this applies even before the treatment happens.
The same section has other exemptions that may fit an egg business, such as farms selling directly to consumers and small retail food establishments and restaurants. Each has conditions. Check with FDA or a food safety professional before you decide you are exempt.
Which egg products are in or out?
FDA’s FAQ (item TFTL.26) answers this directly:
| Product | Covered? |
|---|---|
| Foods with shell eggs as an ingredient | Yes, they are covered |
| Pasteurized liquid eggs | No, they have already received a kill step |
| Frozen egg yolks | No, they have generally been pasteurized or otherwise treated |
| Powdered eggs | Not covered by the rule |
The List itself adds that pasteurized eggs may be fully exempt under 21 CFR 1.1305(d)(2) or (g), or may fall under the kill-step exemptions in (d)(3) and (d)(5).
What does an egg packer keep?
When you initially pack a traceability lot of a raw agricultural commodity, 21 CFR 1.1330 says you keep records linked to that lot. They include:
- The commodity and variety, if applicable
- The date you received the food
- The quantity and unit of measure received
- The location description for the farm where the food was harvested
- The business name and phone number for the harvester, and the date of harvesting
- The location of cooling and the date of cooling, if applicable
- The traceability lot code you assigned
- The product description and the quantity and unit of measure of the packed food
- The location description for where you initially packed the food (with the traceability lot code source reference, if applicable), and the date of initial packing
- The reference document type and number
Our key data elements guide shows the same fields for every event. How these fields apply to eggs, for example what counts as the harvest date, is a question to put to FDA or your food safety professional. Do not guess on it.
Egg farms also get one relief on the plan. The FAQs on farm records (TF.1 and TF.7) require a farm map for listed foods “(other than eggs).” So an egg farm’s traceability plan does not need the map that a produce farm keeps. The plan still has to cover your records. See our traceability plan guide.
What if I buy eggs from more than one farm?
FDA’s FAQ (item TFTL.27) says a partial exemption for commingled raw agricultural commodities can apply to eggs from a farm you own and a farm you do not own. It requires that the eggs meet the commingled definition, which depends on the food coming from farms under different company management. Owning one of the farms does not affect your eligibility. The partial exemption has conditions, so read paragraph (h) of 21 CFR 1.1305.
How long do I keep the records, and how fast must I share them?
Under 21 CFR 1.1455, you keep records for 2 years from the date you created or obtained them. You must make them available to FDA within 24 hours of a request, or within some reasonable time to which FDA has agreed. When FDA asks during an outbreak, a recall or another threat to public health, the covered information must be provided in an electronic sortable spreadsheet. Certain small farms, retail food establishments, restaurants and other small businesses may provide it in another form. Our guides on record retention and the 24-hour spreadsheet go further.
On timing, check FDA’s rule page. It says FDA proposed to extend the compliance date by 30 months to July 20, 2028, and that Congress directed FDA not to enforce the rule before that date. The original date was January 20, 2026. Retail buyers may ask for the data sooner, as our retailer guide explains.
Where Lotcrumb fits
Lotcrumb is being built to turn the packing logs, invoices and bills of lading you already have into lot-level records, and to produce a sortable spreadsheet when someone asks. Join the waitlist for early access.
This guide is general information, not legal or regulatory advice. Whether you are covered or exempt depends on your operation, so confirm it with FDA or a food safety professional.