9th October 2023
Food Safety Modernization Act (FSMA) Section 204 Update
The United States Food and Drug Administration (FDA) oversees the Food Safety Modernization Act (FSMA), a set of regulations aimed at addressing food safety issues occurring within the food system.
These requirements apply to all products in the United States, including those imported from overseas and all recordkeeping must be compliant by 20 January 2026.
Section 204 focuses on the Food Traceability List of FDA designated foods that require additional recordkeeping in order to protect public health. The list was developed using a risk ranking model for food tracing, applied to associated commodity-hazard pairs.
The risk ranking model for food tracing scores the commodity-hazard pair based on data relating to seven criteria. These criteria include: the frequency of outbreaks, severity of illness, likelihood of contamination, potential for pathogen growth, manufacturing process contamination probability, consumption rate and amount and cost of illness.
Fresh produce types included in the Food Traceability List are:
- Cucumbers (fresh)
- Herbs (fresh)
- Leafy greens (fresh)
- Leafy greens (fresh-cut)
- Melons (fresh)
- Peppers (fresh)
- Sprouts (fresh)
- Tomatoes (fresh)
- Tropical tree fruits (fresh)
- Fruits (fresh-cut)
- Vegetables other than leafy greens (fresh-cut)
Additional traceability requirements apply to the listed foods and also to foods that contain these products as ingredients.
Further details of the additional recordkeeping requirements for products on the Food Traceability List can be found here: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
FDA Food Traceability List: https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list
Deloitte Resource on Section 204: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/us-traceability-in-the%20food-value-chain.pdf
MPI Resource on FSMA compliance for NZ Suppliers: https://www.mpi.govt.nz/dmsdocument/33148-us-food-safety-modernisation-act-fsma-compliance-information-for-new-zealand-suppliers-and-united-states-importers