On September 23, 2020, the FDA proposed a new Food Traceability Rule that would establish additional traceability recordkeeping for those who manufacture, process, pack, or hold foods that are included in the Food Traceability List (FTL). The proposed rule would impact retail food establishments, distributors, restaurants, and meal-kit delivery services. The goal of the rule is to mitigate foodborne illness outbreaks.
The following is the tentative list of foods on the FTL: soft cheeses, shell eggs, nut butter, cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits and veggies, finfish (including smoked), crustaceans, mollusks, and ready-to-eat deli salads.
Here are the requirements by distribution stage and food use:
- Grower (farms) – Grower must establish records for the growing area coordinates.
- First receiver – Person (other than farm) who purchases to takes ownership of food after the farm. This may be the distributer. Grown, raised, and caught food would have a first receiver. Location of catch needed for seafood.
- Receiver – This is when food is received by a customer other than a consumer. You must maintain records linking the traceability lot code for the food with the following information: location identifier and description, entry number, location identifier, quantity and unit of measure, traceability product identifier/description, reference record type and number, name of transporter.
- Records for transformation – This is the process of combining it with other foods or processing it to make a new product (e.g., using a head of lettuce to make a salad). You must maintain records linking the traceability lot code to the traceability lot identifier and description, quantity of each lot of food, etc.
- Records for creating a food – Make or Produce a listed food out of ingredients that are not on the FTL (e.g., manufacturing peanut butter/soft cheese).
- Shipping a food – Entry number assigned to food, quantity/unit of measure, traceability product identifier, location identifier, etc.
The FDA notes that waivers and exemptions are available for certain foods and economic hardship scenarios.
Records should be original paper or electronic copies and must be available upon request of the FDA within 24 hours, which includes an electronic spreadsheet of records. Electronic recordkeeping is strongly encouraged, and records should be kept for at least 2 years.
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This article was written by Emily Gamb, an Acuity Regulatory Analyst.