Why FSMA?

The FDA developed FSMA to enable faster identification and removal of potentially contaminated food from the market resulting in fewer foodborne illnesses and deaths.

The rule requires the maintenance of additional traceability records for high-risk foods as defined by the FDA.

Food Traceability List or FTL

The FDA’s FTL identifies the categories of foods, but not the individual foods that require additional traceability records.

Does FSMA 204 apply to you?

FSMA applies to the entire food supply chain (domestic and foreign) and companies that manufacture, process, pack, or hold foods on the FTL or foods containing an ingredient on the list unless an exemption applies. There are some complete and partial exemptions for certain entities and foods.

What seafoods are on the FTL?

• Finfish (fresh and frozen), specifically:
  • Finfish,histamine-producing species
  • Finfish, species potentially contaminated with ciguatoxin
  • Finfish, species not associated with histamine or ciguatoxin
• Smoked finfish (refrigerated and frozen)
• Crustaceans (fresh and frozen)
• Molluscan shellfish, bivalves (fresh and frozen)

Traceability Plans

Companies that must comply with the rule are required to establish and maintain a traceability plan. The traceability plan needs to include traceability procedures and operations. It must:

• Describe the procedures used to maintain the required records.
• Describe the procedures used to identify foods on the FTL that a company manufactures, processes, packs, or holds.
• Describe how traceability lot codes are assigned.
• Include a contact person for questions about your traceability plan and records.
• Show on the farm map for aquaculture farms, the location and name of each container (e.g., pond, pool, tank, cage) in which the seafood on the FTL is raised, including geographic coordinates and any other information needed to identify the location of each container.

Types of traceability records to keep

Traceability records must be maintained and provided for the following CTEs including KDEs and traceability lot codes linked to the product:

• Harvesting
• Cooling (before initial packing)
• Initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel)
• First receiving of seafood obtained from a fishing vessel
• Shipping
• Receiving
• Transformation of a food

Traceability lot codes

Traceability lot codes identify products moving through the supply chain, linking them to related records. Records for every CTE must include the traceability lot code and any KDEs linked to the product.

Recordkeeping timelines

24 hours. Records must be on paper or in electronic format. They must be available to the FDA within 24 hours after the request, along with information needed to understand them.

Two years. Update traceability plans as needed to ensure compliance with the requirements. You must keep your previous traceability plans for two years after a plan update. You must also maintain records for two years from the date they were created or obtained.