Substantive source review: October 7, 2026. Shell egg producers outside the United States do not universally need two FDA registrations. Decide which requirements apply to each actual farm or facility; registration does not approve eggs or guarantee shipment release.
Who is covered by Part 118?
Part 118 defines a shell egg as an egg of the domesticated chicken. Its producer requirements concern a particular farm with 3,000 or more laying hens producing table-market eggs, unless all its eggs are sold directly to consumers. Duck or quail eggs are not brought into Part 118 by this chicken definition; other safety, registration and import requirements may still apply.
If any eggs at a covered farm do not receive the defined treatment, all Part 118 production requirements apply. If all receive treatment achieving at least a 5-log destruction of Salmonella Enteritidis (SE), or processing under the Egg Products Inspection Act, the farm still has Part 118 registration and refrigeration duties. Holders and transporters of eggs from farms with at least 3,000 hens have the applicable refrigeration duty under 118.1(b), not an automatic producer-registration duty. Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-118/section-118.1
Prevention, refrigeration and positive-test decisions
For covered untreated production, implement the farm-specific SE prevention plan and applicable pullet sourcing, biosecurity, pest control, cleaning and testing measures. Under 118.4(e), hold and transport covered eggs at no more than 45°F ambient temperature beginning 36 hours after lay; a narrowly described tempering allowance applies before table-egg processing. Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-118/section-118.4
A positive environmental test is not a universal instruction to test eggs within two weeks. Review and adjust the prevention plan. For the 40–45-week and post-molt environmental tests, divert eggs to defined treatment for the flock’s life or obtain egg-test results within 10 calendar days of the positive-test notification. A positive pullet-environment test has the separate two-weeks-from-start-of-laying rule. Sources: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-118/section-118.5 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-118/section-118.6
The testing route uses four egg tests at two-week intervals with the prescribed sampling and methods. An SE-positive egg test triggers diversion upon notification; after qualifying negative tests allow return to table-egg production, monthly testing continues for that flock. Diversion requires the statement specified in 118.6(f) on shipping containers and accompanying documents. Apply the actual pathway rather than an invented automatic refusal or import-alert outcome.
Records: retention measured from the flock, not the filing date
Keep the required prevention plan, implementation, testing, diversion and corrective-action records for one year after the relevant flock permanently leaves production. The written prevention plan stays at the business. Other required records may be stored offsite if retrieved and provided at the business within 24 hours of an official-review request; electronically accessible onsite records count as onsite. Record actual observations, time, location and responsible signatures/initials as applicable. Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-118/section-118.10
SEPRM registration and maintenance are separate from FFRM
A covered producer registers within 30 days of becoming an egg producer. Correct information that was wrong at filing immediately; update later changes within 60 calendar days. Notify FDA within 120 days of ceasing egg production; the seasonal or specified temporary-cessation exceptions in 118.11(g) apply. Submit registration information in English using the Latin alphabet. Preserve the confirmation and applicable permanent registration number; follow current FDA registration instructions. Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-118/section-118.11
The Shell Egg Producer Registration Module (SEPRM) number is not a food-facility registration number. FDA’s April 2024 SEPRM guide, PDF pages 6–7, expressly permits “No” to whether the site has FFRM registration. A food-facility UFI, currently accepted DUNS, and a foreign facility’s registration US Agent requirements belong to the separate FFRM applicability assessment; FEI does not replace that UFI. A commercially included US Agent service is not a universal standalone Part 118 legal requirement. https://www.fda.gov/media/177489/download
Applicability decision: a recommended working table
| Chicken farm, at least 3,000 laying hens at that farm, table eggs not all sold directly to consumers: assess Part 118 producer registration and the treatment-dependent duties. A farm exemption from food-facility registration is a separate question. A holder or transporter of eggs from covered farms may have refrigeration duties without being the producer required to register under Part 118. | |
| Farm with only activities within the farm definition: | assess the food-facility farm exemption. A farm mixed-type facility with activities outside that definition must assess registration for its non-exempt activities. An off-farm packing or holding site must assess its own activities and exemptions; it is not automatically a farm or automatically required to make both filings. |
|---|---|
| Liquid, frozen or dried egg-product plant: | determine FSIS jurisdiction and the actual species, process and composition. Under 21 CFR 1.226(g), the FDA food-facility exemption applies only when USDA regulates the entire facility exclusively under the Egg Products Inspection Act or the other listed statutes. Mixed activities require a separate assessment. Registration never establishes import admissibility. Sources: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/section-1.226 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/subject-group-ECFRef316bd359c83c7/section-1.227 |
Preparation worksheet — recommended workflow, not an FDA form
Create one row per site and product. Record product/species and origin; shell, liquid, frozen, dried or composite food; actual farm, processing, packing, holding or transport activities; hen count at the particular farm and sales route; treatment and supporting evidence; applicable jurisdiction and exemption basis; responsible owner and backup; registration record type and private record location; authorized account access; required import documents and their current status; submission/completion evidence; unresolved questions, reviewer and next action.
Keep registration numbers and supporting records in an access-controlled record, not public examples. Never share an FDA account username or password. Use supported individual authorization/account arrangements. Do not put PINs or account credentials on shipment paperwork. Share correct registration information privately with an authorized Prior Notice filer when required, rather than treating all registration information as prohibited to share. Source: https://www.fda.gov/food/hfp-constituent-updates/fda-advises-human-and-animal-food-facilities-protect-their-food-facility-registration-information
Separate 2026 food-facility renewal check
Only where food-facility registration applies, an existing registration must be renewed between October 1 and December 31, 2026. Registration or an update before October 1 does not replace that renewal. This is separate from Part 118 registration maintenance. FDA charges no government food-registration or renewal filing fee; professional charges and annual US Agent coverage are separate. Use the reviewed renewal guide and food checklist, not registration as proof of safety or permission to import. https://fdabridge.com/blog/fda-food-facility-registration-renewal-2026 and https://fdabridge.com/checklists/food.pdf
Service scope and next steps
The $249 shell-egg service covers the Part 118 producer filing and commercially included first-year US Agent coverage; it excludes the separate food-facility filing. The $599 Egg Producer Bundle lists DUNS assistance, food-facility and shell-egg producer filings, and first-year US Agent coverage. Assess whether those filings are needed before choosing the bundle. Filing assistance does not establish an implemented SE program, laboratory testing, USDA eligibility or guaranteed release. See https://fdabridge.com/shell-egg-registration and discuss the actual site at https://fdabridge.com/contact
For product classification and import-document preparation, read https://fdabridge.com/blog/fda-registration-egg-products-liquid-dried-and-shell-eggs . Primary FDA explanatory guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-prevention-salmonella-enteritidis-shell-eggs-during-production
Shell Egg Producer Registration: Part 118 Applicability, Records and Separate Food-Facility Duties
Assess the farm, hen count, sales route and treatment before choosing egg filings. Part 118 registration, refrigeration and food-facility registration are distinct obligations.