Your A to Z FSMA 204 glossary

Food identified as potentially contaminated or otherwise implicated during an outbreak or recall investigation, defined by its traceability lot code and distribution.

A shipping document that can serve as a reference record, linking a shipment of an FTL food to its traceability lot code and key data elements.

An FTL raw agricultural commodity (other than certain fruits and vegetables) combined from different farms so the source lots can no longer be distinguished; subject to modified requirements.

Active temperature reduction of a raw agricultural commodity before initial packing, using a method such as hydrocooling, forced air or vacuum cooling, as defined by FDA.

Any food on the Food Traceability List, including foods that contain an FTL food as an ingredient, that is subject to the rule's additional recordkeeping.

A point in a food's journey where the FDA requires traceability records: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation.

Points in the supply chain closer to the consumer relative to a given node: the direction product moves and a forward trace follows.

A category of persons or foods the rule fully or partially excludes, such as certain small producers, farms selling directly to consumers, and foods that receive a kill step.

The first person (other than a carrier) to take possession of a food obtained from a fishing vessel; responsible for originating key seafood traceability records.

The FDA's list of foods for which additional traceability records are required, including leafy greens, fresh-cut produce, shell eggs, nut butters, certain cheeses, and specified seafood.

The FDA Food Safety Modernization Act of 2011, which shifted food-safety regulation from responding to contamination toward preventing it.

Section 204 of FSMA and its Final Rule on additional traceability records for certain foods, establishing standardized recordkeeping across the supply chain.

Activities that produce a food on a farm. Growing is context for the rule's farm records and map; it is not itself one of the seven named Critical Tracking Events.

A Critical Tracking Event for farm activities that remove a raw agricultural commodity from where it was grown or raised and prepare it for use as food.

The first packing of a raw agricultural commodity other than food obtained from a fishing vessel; a Critical Tracking Event at which a traceability lot code is assigned.

The specific pieces of information recorded for each Critical Tracking Event, such as traceability lot code, product description, quantity, location, and reference documents.

A process such as cooking, pasteurizing, or retorting that significantly minimizes pathogens; applying a kill step can exempt an FTL food from further traceability requirements.

A key data element capturing a supply-chain location, business name and physical address, associated with a traceability event.

A definite quantity of food produced or handled under uniform conditions, identified for traceability by its traceability lot code.

Operations that transform an FTL food, cutting, cooking, blending, or packaging, captured under the Transformation Critical Tracking Event.

Any point in the supply chain, farm, packer, processor, distributor, or retailer, where an FTL food is grown, transformed, shipped, or received.

The firm that assigns a traceability lot code at a required assignment point, such as initial packing, first land-based receiving or transformation.

A provision that relieves certain entities, for example some small retailers or farms, from part, but not all, of the rule's requirements.

The person identified in a covered firm's traceability plan for questions about its plan and records.

A key data element describing the food, including product name and packaging and, where applicable, brand, commodity, and variety.

A key data element recording how much of an FTL food is tied to an event, expressed in a defined unit such as cases, pounds, or kilograms.

The removal of a food from the market to protect public health; FSMA 204 records are designed to make identifying and scoping a recall faster.

A Critical Tracking Event created when an entity takes possession of an FTL food after it has been shipped, linking the received lot to the shipper's records.

The requirement to keep traceability records for two years from the date each record was created.

A covered firm must make requested traceability records available to FDA within 24 hours, or a reasonable time FDA agrees to. A sortable spreadsheet can also be requested in specified public-health circumstances.

A document, such as an invoice, bill of lading, or bill of sale, that contains or supports the key data elements required for an event.

An establishment that sells food directly to consumers, such as a grocery store or restaurant; subject to specific provisions and some exemptions.

A Critical Tracking Event created when an FTL food is arranged for transport from one location to another, requiring the traceability lot code and related KDEs.

Traceability information that can be provided to the FDA within 24 hours as an electronic sortable spreadsheet during an outbreak, recall, or other threat.

The full sequence of nodes an FTL food passes through from origin to consumer, connected end-to-end by traceability lot codes.

A descriptor, often alphanumeric, that uniquely identifies a traceability lot of an FTL food, the thread that links records across the supply chain.

A key data element identifying the location that assigned the traceability lot code, so records can be traced back to their origin.

A written record describing how a firm maintains its traceability records, including procedures, points of contact, and how lot codes are assigned.

An investigation that works backward through supply-chain records from the point of illness toward the source of contamination.

A Critical Tracking Event involving manufacturing, processing or changes such as commingling, repacking or relabeling when the output remains an FTL food. TLC treatment depends on the specific scenario.

Points in the supply chain closer to the origin relative to a given node: the direction a traceback moves toward the source.

A recall a company initiates itself, often coordinated with the FDA rather than mandated; the most common type of recall.