OpenEPCIS FSMA 204 Vocabulary
type: Ontology
description: Minimal OpenEPCIS vocabulary for the U.S. FDA Food Safety Modernization Act §204 Final Rule on Food Traceability (21 CFR Part 1 Subpart S). All FSMA 204 Key Data Elements ride on native EPCIS 2.0 / GS1 Web Vocabulary fields per GS1 US R2.0 / R3.0. This module therefore contributes only the single concept that GS1 US does not already cover: the FDA Food Traceability List categorisation of a trade item, via: - usfsma:FoodTraceabilityList: enumeration of the 23 FDA-defined food categories - usfsma:hasFoodTraceabilityListCategory: object property on gs1:Product EPCIS event examples in this module's epcis/ directory are transcribed verbatim from GS1 US R2.0 and use only native EPCIS/GS1 fields. They do not reference any usfsma: class or property; the extension namespace exists purely for the master-data FTL categorisation. References: - FDA Food Traceability Final Rule: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods - 21 CFR Part 1 Subpart S: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S - Food Traceability List: https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list - GS1 US EPCIS Recommendations R2.0: https://documents.gs1us.org/adobe/assets/deliver/urn:aaid:aem:0c934e38-7cd7-4a86-aac3-c54b4c9ef293/EPCIS-Recommendations-FSMA-204-Critical-Tracking-Events.pdf - GS1 US Application Guideline R3.0: https://documents.gs1us.org/adobe/assets/deliver/urn:aaid:aem:8037d451-b557-4b0f-9fa8-fc94f94e4547/GS1-US-Application-of-GS1-System-of-Standards-to-Support-FSMA-204-Guideline.pdf
creator: OpenEPCIS
license: LICENSE-2.0
created: 2026-04-17
modified: 2026-06-19
version info: 0.9.9
version IRI: https://ref.openepcis.io/extensions/us/fsma204/0.9.9
preferred namespace prefix: usfsma
imports: voc

Food Traceability List category
type: Class
comment: FDA-defined categories of foods subject to FSMA 204 per the Food Traceability List (21 CFR 1.1300). The FDA list enumerates distinct food types with explicit splits (leafy greens non-cut vs fresh-cut; three cheese pasteurisation classes; individual produce items; four finfish classes). The FDA updates the list periodically; this enum reflects the 2022 publication.
source: food-traceability-list
one of: Leafy greens (excluding fresh-cut)
one of: Leafy greens, fresh-cut
one of: Cheese, pasteurized, fresh soft or soft unripened
one of: Cheese, pasteurized, soft-ripened or semi-soft
one of: Cheese, unpasteurized (other than hard cheese)
one of: Shell eggs
one of: Sprouts
one of: Cucumbers (fresh)
one of: Melons (fresh)
one of: Peppers (fresh)
one of: Tomatoes (fresh)
one of: Fruits, fresh-cut
one of: Vegetables other than leafy greens, fresh-cut
one of: Herbs (fresh)
one of: Tropical tree fruits (fresh)
one of: Finfish, histamine-producing species
one of: Finfish, ciguatoxin-associated species
one of: Finfish, other species (not histamine, not ciguatoxin)
one of: Finfish, smoked
one of: Crustaceans
one of: Molluscan shellfish, bivalves
one of: Ready-to-eat deli salads (refrigerated)
one of: Nut butters
note: FDA Food Traceability List categories per FSMA 204 (21 CFR 1 Subpart S). US food-safety scoping concept with no GS1, SEMICeu, or schema.org equivalent.

Leafy greens (excluding fresh-cut)
type: Food Traceability List category

Leafy greens, fresh-cut
type: Food Traceability List category

Cheese, pasteurized, fresh soft or soft unripened
type: Food Traceability List category

Cheese, pasteurized, soft-ripened or semi-soft
type: Food Traceability List category

Cheese, unpasteurized (other than hard cheese)
type: Food Traceability List category

Shell eggs
type: Food Traceability List category

Sprouts
type: Food Traceability List category

Cucumbers (fresh)
type: Food Traceability List category

Melons (fresh)
type: Food Traceability List category

Peppers (fresh)
type: Food Traceability List category

Tomatoes (fresh)
type: Food Traceability List category

Fruits, fresh-cut
type: Food Traceability List category

Vegetables other than leafy greens, fresh-cut
type: Food Traceability List category

Herbs (fresh)
type: Food Traceability List category

Tropical tree fruits (fresh)
type: Food Traceability List category

Finfish, histamine-producing species
type: Food Traceability List category

Finfish, ciguatoxin-associated species
type: Food Traceability List category

Finfish, other species (not histamine, not ciguatoxin)
type: Food Traceability List category

Finfish, smoked
type: Food Traceability List category

Crustaceans
type: Food Traceability List category

Molluscan shellfish, bivalves
type: Food Traceability List category

Ready-to-eat deli salads (refrigerated)
type: Food Traceability List category

Nut butters
type: Food Traceability List category

Food Traceability List category
type: ObjectProperty
comment: Declares that a trade item (gs1:Product) falls under a specific FDA Food Traceability List category. This is the only FSMA KDE that GS1 US's guidance does not already cover via native GS1 master-data attributes; the FTL category is what determines whether the food is in scope of the rule at all.
domain: Product
range: Food Traceability List category
source: section-1.1300
note: The one FSMA 204 KDE not covered by native GS1 master-data attributes: the FTL category determines whether a food is in scope of the rule (21 CFR 1.1300).
broad match: category