FDA FSMA Traceability Rule: la nuova “Rintracciabilità” USA
Il nuovo Regolamento FDA “Food Traceability Final Rule” pubblicato a Dicembre 2021 ed entrato definitivamente in vigore il 20 Dicembre 2022, stabilisce nuovi requisiti di tracciabilità, oltre a quelli previsti dalle normative esistenti, per le persone che producono, trasformano, imballano o detengono alimenti inclusi in un primo elenco di comodities coinvolte chiamato Food Traceability Rule (FTL ). Il regolamento si applicherà a questo elenco di prodotti per poi essere gradualmente applicato a tutti i prodotti sotto la giurisdizione FDA. La norma finale è una componente chiave del progetto New Era of Smarter Food Safety Blueprint della FDA promosso dal direttore della Food Policy and Response Frank Yiannas nel Luglio 2020.
Gli operatori coinvolti dovranno sviluppare un Manuale di Tracciabilità definendo elementi chiave definiti “Key Data Element” (KDE) associati a specifici eventi critici di tracciamento “Critical Tracking Event” (CTE) sviluppando su un tipo di filiera pre-identificato da FDA una Anlisi del Rischio su n.7 FSMA Factors identificati dalla FDA.
Food Traceability List
La FDA ha stilato una Food Traceability List (FTL) in cui sono inseriti gli alimenti soggetti alle nuove regole – Requirements for Additional Traceability Records for Certain Foods. Tale lista comprende prodotti considerati vulnerabili, soprattutto dal punto di vista microbiologico (ad esempio molluschi, crostacei, formaggi, uova, germogli, frutta, etc.).
| Cheeses, other than hard cheeses, specifically: | |
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Includes soft unripened/fresh soft cheeses. Examples include, but are not limited to, cottage, chevre, cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna. Does not include cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged. |
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Includes soft ripened/semi-soft cheeses. Examples include, but are not limited to, brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, monterey jack, and muenster. Does not include cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged. |
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Includes all cheeses made with unpasteurized milk, other than hard cheeses. Does not include cheeses that are frozen, shelf stable at ambient temperature, or aseptically processed and packaged. |
| Shell eggs | Shell egg means the egg of the domesticated chicken. |
| Nut butters | Includes all types of tree nut and peanut butters. Examples include, but are not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters. Does not include soy or seed butters. |
| Cucumbers (fresh) | Includes all varieties of fresh cucumbers. |
| Herbs (fresh) | Includes all types of fresh herbs. Examples include, but are not limited to, parsley, cilantro, and basil. Herbs listed in 21 CFR 112.2(a)(1), such as dill, are exempt from the requirements of the rule under 21 CFR 1.1305(e). |
| Leafy greens (fresh) | Includes all types of fresh leafy greens. Examples include, but are not limited to, arugula, baby leaf, butter lettuce, chard, chicory, endive, escarole, green leaf, iceberg lettuce, kale, red leaf, pak choi/bok choi, Romaine, sorrel, spinach, and watercress. Does not include whole head cabbages such as green cabbage, red cabbage, or savoy cabbage. Does not include banana leaf, grape leaf, and leaves that are grown on trees. Leafy greens listed in § 112.2(a)(1), such as collards, are exempt from the requirements of the rule under § 1.1305(e). |
| Leafy greens (fresh-cut) | Includes all types of fresh-cut leafy greens, including single and mixed greens. |
| Melons (fresh) | Includes all types of fresh melons. Examples include, but are not limited to, cantaloupe, honeydew, muskmelon, and watermelon. |
| Peppers (fresh) | Includes all varieties of fresh peppers. |
| Sprouts (fresh) | Includes all varieties of fresh sprouts (irrespective of seed source), including single and mixed sprouts. Examples include, but are not limited to, alfalfa sprouts, allium sprouts, bean sprouts, broccoli sprouts, clover sprouts, radish sprouts, alfalfa & radish sprouts, and other fresh sprouted grains, nuts, and seeds. |
| Tomatoes (fresh) | Includes all varieties of fresh tomatoes. |
| Tropical tree fruits (fresh) | Includes all types of fresh tropical tree fruit. Examples include, but are not limited to, mango, papaya, mamey, guava, lychee, jackfruit, and starfruit. Does not include non-tree fruits such as bananas, pineapple, dates, soursop, jujube, passionfruit, Loquat, pomegranate, sapodilla, and figs. Does not include tree nuts such as coconut. Does not include pit fruits such as avocado. Does not include citrus, such as orange, clementine, tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and pomelo. |
| Fruits (fresh-cut) | Includes all types of fresh-cut fruits. Fruits listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e). |
| Vegetables other than leafy greens (fresh-cut) | Includes all types of fresh-cut vegetables other than leafy greens. Vegetables listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e). |
| Finfish (fresh and frozen), specifically: | |
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Includes all histamine-producing species of finfish. Examples include, but are not limited to, tuna, mahi mahi, mackerel, amberjack, jack, swordfish, and yellowtail. |
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Includes all finfish species potentially contaminated with ciguatoxin. Examples include, but are not limited to, grouper, barracuda, and snapper. |
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Includes all species of finfish not associated with histamine or ciguatoxin. Examples include, but are not limited to, cod, haddock, Alaska pollock, salmon, tilapia, and trout.[2] Siluriformes fish, such as catfish, are not included.[3] |
| Smoked finfish (refrigerated and frozen) | Includes all types of smoked finfish, including cold smoked finfish and hot smoked finfish.[4] |
| Crustaceans (fresh and frozen) | Includes all crustacean species. Examples include but are not limited to shrimp, crab, lobster, and crayfish. |
| Molluscan shellfish, bivalves (fresh and frozen)[5] | Includes all species of bivalve mollusks. Examples include, but are not limited to, oysters, clams, and mussels. Does not include scallop adductor muscle. Raw bivalve molluscan shellfish that are (1) covered by the requirements of the National Shellfish Sanitation Program; (2) subject to the requirements of 21 CFR part 123, subpart C, and 21 CFR 1240.60; or (3) covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish are exempt from the requirements of the rule under § 1.1305(f). |
| Ready-to-eat deli salads (refrigerated) | Includes all types of refrigerated ready-to-eat deli salads. Examples include, but are not limited to, egg salad, potato salad, pasta salad, and seafood salad. Does not include meat salads. |
La Food Traceability List (FTL) identifica gli alimenti per i quali sono richiesti i record di rintracciabilità aggiuntivi. I requisiti aggiuntivi si applicano agli alimenti specificatamente elencati nell’FTL e agli alimenti che contengono alimenti elencati come ingredienti, a condizione tale ingrediente rimanga nella stessa forma (ad esempio, fresco) in cui è indicato in lista.
ESI ha pianificato un webinar di approfondimento del nuovo Rule: a chi e come si applicano le nuove prescrizioni di tracciabilità, che cosa comporta per gli OSA e come procedere all’adeguamento richiesto.