@prefix rdf: . @prefix rdfs: . @prefix owl: . @prefix xsd: . @prefix gs1: . @prefix fsma: . @prefix dcterms: . @prefix skos: . @prefix vann: . # ============================================================================= # Ontology Declaration # ============================================================================= # # This module is intentionally MINIMAL. # # Per GS1 US "EPCIS Recommendations for FSMA 204 Critical Tracking Events" R2.0 # (May 2025) and "Application of GS1 System of Standards to Support FSMA 204" R3.0 # (Dec 2025), every FSMA 204 Key Data Element maps onto a NATIVE EPCIS 2.0 or # GS1 Web Vocabulary field: # # - Traceability Lot Code -> GS1 Digital Link GTIN+Batch/Lot in # quantityList.epcClass / outputQuantityList.epcClass / childQuantityList.epcClass # - Location KDEs -> /414/{GLN} URIs in readPoint / bizLocation / sourceList / destinationList # - Party KDEs -> /417/{GLN} URIs in sourceList (type=owning_party) / destinationList # - Dates -> eventTime # - Reference documents -> bizTransactionList # - Seafood KDEs -> ilmd with gs1:catchZone / gs1:harvestDateStart / gs1:harvestDateEnd / gs1:fishType # - CTE identification -> combination of EPCIS event type + bizStep (NO RDF class needed) # # There are therefore no CTE classes, no "TraceabilityLotCode" class, and no # event-level fsma: properties in this vocabulary. The only concept that GS1 US # does NOT already cover is the Food Traceability List categorisation of a # trade item — and that is the sole thing this module contributes. # ============================================================================= a owl:Ontology ; dcterms:title "OpenEPCIS FSMA 204 Vocabulary"@en ; dcterms: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: - fsma:FoodTraceabilityList — enumeration of the 23 FDA-defined food categories - fsma:foodTraceabilityListCategory — 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 fsma: 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-food-traceability - 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"""@en ; dcterms:creator "OpenEPCIS" ; dcterms:license ; dcterms:created "2026-04-17"^^xsd:date ; dcterms:modified "2026-04-17"^^xsd:date ; owl:versionInfo "0.1.0" ; owl:versionIRI ; vann:preferredNamespacePrefix "fsma" ; vann:preferredNamespaceUri "https://ref.openepcis.io/extensions/us/fsma204/" ; rdfs:seeAlso ; rdfs:seeAlso ; owl:imports . # ============================================================================= # Food Traceability List enumeration (FDA FTL as published 2022) # ============================================================================= fsma:FoodTraceabilityList a owl:Class ; rdfs:label "Food Traceability List category"@en ; rdfs: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."@en ; dcterms:source ; owl:oneOf ( fsma:LeafyGreens fsma:LeafyGreensFreshCut fsma:CheesePasteurizedFreshSoft fsma:CheesePasteurizedSoftRipenedOrSemiSoft fsma:CheeseUnpasteurizedOtherThanHard fsma:ShellEggs fsma:Sprouts fsma:Cucumbers fsma:Melons fsma:Peppers fsma:Tomatoes fsma:FruitsFreshCut fsma:VegetablesOtherThanLeafyGreensFreshCut fsma:HerbsFresh fsma:TropicalTreeFruits fsma:FinfishHistamineProducing fsma:FinfishCiguatoxinAssociated fsma:FinfishOther fsma:SmokedFinfish fsma:Crustaceans fsma:MolluscanShellfish fsma:ReadyToEatDeliSalads fsma:NutButters ) . fsma:LeafyGreens a fsma:FoodTraceabilityList ; rdfs:label "Leafy greens (excluding fresh-cut)"@en . fsma:LeafyGreensFreshCut a fsma:FoodTraceabilityList ; rdfs:label "Leafy greens, fresh-cut"@en . fsma:CheesePasteurizedFreshSoft a fsma:FoodTraceabilityList ; rdfs:label "Cheese, pasteurized, fresh soft or soft unripened"@en . fsma:CheesePasteurizedSoftRipenedOrSemiSoft a fsma:FoodTraceabilityList ; rdfs:label "Cheese, pasteurized, soft-ripened or semi-soft"@en . fsma:CheeseUnpasteurizedOtherThanHard a fsma:FoodTraceabilityList ; rdfs:label "Cheese, unpasteurized (other than hard cheese)"@en . fsma:ShellEggs a fsma:FoodTraceabilityList ; rdfs:label "Shell eggs"@en . fsma:Sprouts a fsma:FoodTraceabilityList ; rdfs:label "Sprouts"@en . fsma:Cucumbers a fsma:FoodTraceabilityList ; rdfs:label "Cucumbers (fresh)"@en . fsma:Melons a fsma:FoodTraceabilityList ; rdfs:label "Melons (fresh)"@en . fsma:Peppers a fsma:FoodTraceabilityList ; rdfs:label "Peppers (fresh)"@en . fsma:Tomatoes a fsma:FoodTraceabilityList ; rdfs:label "Tomatoes (fresh)"@en . fsma:FruitsFreshCut a fsma:FoodTraceabilityList ; rdfs:label "Fruits, fresh-cut"@en . fsma:VegetablesOtherThanLeafyGreensFreshCut a fsma:FoodTraceabilityList ; rdfs:label "Vegetables other than leafy greens, fresh-cut"@en . fsma:HerbsFresh a fsma:FoodTraceabilityList ; rdfs:label "Herbs (fresh)"@en . fsma:TropicalTreeFruits a fsma:FoodTraceabilityList ; rdfs:label "Tropical tree fruits (fresh)"@en . fsma:FinfishHistamineProducing a fsma:FoodTraceabilityList ; rdfs:label "Finfish, histamine-producing species"@en . fsma:FinfishCiguatoxinAssociated a fsma:FoodTraceabilityList ; rdfs:label "Finfish, ciguatoxin-associated species"@en . fsma:FinfishOther a fsma:FoodTraceabilityList ; rdfs:label "Finfish, other species (not histamine, not ciguatoxin)"@en . fsma:SmokedFinfish a fsma:FoodTraceabilityList ; rdfs:label "Finfish, smoked"@en . fsma:Crustaceans a fsma:FoodTraceabilityList ; rdfs:label "Crustaceans"@en . fsma:MolluscanShellfish a fsma:FoodTraceabilityList ; rdfs:label "Molluscan shellfish, bivalves"@en . fsma:ReadyToEatDeliSalads a fsma:FoodTraceabilityList ; rdfs:label "Ready-to-eat deli salads (refrigerated)"@en . fsma:NutButters a fsma:FoodTraceabilityList ; rdfs:label "Nut butters"@en . # ============================================================================= # The single property this module contributes # ============================================================================= fsma:foodTraceabilityListCategory a owl:ObjectProperty ; rdfs:label "Food Traceability List category"@en ; rdfs: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."@en ; rdfs:domain gs1:Product ; rdfs:range fsma:FoodTraceabilityList ; dcterms:source .