One of the linchpins of the FDA’s Food Safety Modernization Act (FSMA) is that some foods need to be tracked to a greater degree than other foods to help prevent foodborne illnesses and deaths.
“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL),” says the FDA. “The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.”
Those that manufacture, process, pack, or hold foods on the FTL must maintain records containing:
- Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs)
- Provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.
Risk-Ranking Model for Food Tracing Creates the FTL
Foods do not randomly end up on the FTL but are selected based on a risk-ranking model for food tracing.
“The FDA developed a Risk-Ranking Model for Food Tracing (RRM-FT) as a data-driven science-based decision support tool to assist the Agency in the process of designating a Food Traceability List as required by FSMA Section 204,” says the FDA.
The semi-quantitative risk-ranking model uses the following criteria:
- Criterion 1 (C1): Frequency of outbreaks and occurrence of illnesses,
- Criterion 2 (C2): Severity of illness,
- Criterion 3 (C3): Likelihood of contamination,
- Criterion 4 (C4): Growth potential, with consideration of shelf life,
- Criterion 5 (C5): Manufacturing process contamination probability and industry-wide intervention,
- Criterion 6 (C6): Consumption, and
- Criterion 7 (C7): Cost of illness.
Food Traceability List: Foods Ranked by Risk
The FDA assigns a commodity risk score to foods on the Food Traceability List so we can rank them in terms of how important it is to trace the foods (the higher the score, the higher the risk for the food):
- Cheese (made from pasteurized milk), soft-ripened or semi-soft 490.
- Shell Eggs 450.
- Cheese (made from pasteurized milk), fresh soft, or soft un-ripened 430.
- Crustaceans 430.
- Cucumbers 430.
- Leafy Greens 430.
- Melons 430.
- Finfish, histamine-producing species 430.
- Tomatoes 430.
- Vegetables other than leafy greens (fresh-cut) 430.
- Nut Butters 420.
- Sprouts 420.
- Cheese (made from unpasteurized milk), other than hard cheese 410.
- Leafy Greens (fresh-cut) 390.
- Molluscan Shellfish, bivalves 380.
- Finfish, species not associated with histamine or ciguatoxin 370.
- Fruits (fresh-cut) 370.
- Peppers 370.
- Tropical Tree Fruits 370.
- Smoke Finfish 360.
- Finish, species potentially contaminated with ciguatoxin 330.
- RTE Deli Salads 330.
- Herbs (fresh) 240.
Listeria and Salmonella Top List of Commodity-Hazard Pairs
The FDA also lists FTL foods in regard to commodity-hazard pairs to show what illnesses can be associated with the consumption of the food.
The top 25 on the commodity-hazard pairs list (the higher the rank, the more the risk):
- Cheese (made from pasteurized milk, soft-ripened or semi-soft: Listeria monocytogenes.
- Melons: Listeria monocytogenes.
- Vegetables other than leafy greens (fresh-cut): Listeria monocytogenes.
- Leafy Greens: STEC 0157
- Cucumbers: Salmonella spp.
- Nut Butters: Salmonella spp.
- Cheese (made from unpasteurized milk), other than hard cheese: Listeria monocytogenes.
- Leafy Greens: Salmonella spp.
- Finfish, species not associated with histamine or ciguatoxin: Listeria monocytogenes.
- Fruits (fresh-cut): Listeria monocytogenes.
- Finfish, histamine-producing species: Salmonella spp.
- Melons: Salmonella spp.
- Smoke Finfish: Listeria monocytogenes.
- Crustaceans: Salmonella spp.
- Finfish, species not associated with histamine or ciguatoxin: Vibrio parahaemolyticus.
- Finish, species not associated with histamine or ciguatoxin: Salmonella spp.
- Finfish, species potentially associated with ciguatoxin: Ciguatoxin.
- Crustaceans: Aeromonas spp.
- Finish, histamine-producing species: Aeromonas spp.
- Leafy Greens (fresh-cut): Cyclospora cayetanensis.
- Leafy Greens (fresh-cut): Shigella spp.
- Fruits (fresh-cut): Salmonella spp.
- RTE Deli Salads: Hepatitis A virus.
- Crustaceans: Hepatitis A virus.
- RTE Deli Salads: Salmonella spp.
Establishing a Food Traceability Plan
The FSMA requires those subject to the requirements of the final rule, to establish and maintain a traceability plan containing the following information:
- A description of the procedures you use to maintain the records you are required to keep under this rule, including the format and location of these records.
- A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold.
- A description of how you assign traceability lot codes to foods on the Food Traceability List, if applicable:
- A statement identifying a point of contact for questions regarding your traceability plan and records; and
- If you grow or raise food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
o The farm map must show the location and name of each field (or other growing area) in which you grow food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
o For aquaculture farms, the farm map instead must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.
The final rule also requires that:
- Records must be maintained as original paper or electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss. Electronic records may include valid, working electronic links to the information required to be maintained under the rule.
- All records required under this rule, along with any information required to understand the records, must be made available to the FDA within 24 hours after a request is made (or within a reasonable time to which the FDA has agreed).
- Unless exempt from this requirement, an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.
