FSMA Traceability Rule Impacts Importers, Food Retailers and Wholesalers

FSMA Section 204 Requires Lot Codes to Be Tracked for Many Varieties of Foods

On November 21, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register the final rule on traceability requirements for certain foods. The traceability requirements are mandated by the Food Safety Modernization Act – FSMA. The final rule requires new records to be kept for foods FDA has determined to have higher food safety risk. The final rule imposes significant new requirements on importers, manufacturers, distributors, warehouse operators and retailers and wholesalers. The new requirements also apply to shipments from retail distribution centers to store locations.

Who is Subject to the FSMA Section 204 Rule?

The rule regulates:

1. Farms
2. Packers
3. Food Manufacturers (including packagers)
4. Food Wholesalers
5. Food Warehousers
6. Food Retailers

What Foods are on the Food Traceability List (FTL)?

The foods subject to the final rule are:

• Cheeses, other than hard cheeses
• Shell eggs           
• Nut butter          
• Cucumbers (fresh)
• Herbs (fresh)    
• Leafy greens (fresh), including fresh-cut leafy greens      
• Melons (fresh)
• Peppers (fresh)
• Sprouts (fresh) 
• Tomatoes (fresh)        
• Tropical tree fruits[1]        
• Fruits and Vegetables (fresh-cut)             
• Finfish, including smoked finfish
• Crustaceans      
• Mollusks, bivalves           
• Ready-to-eat deli salads
• [1] Includes fruit such as guava, papaya, starfruit, mango, lychee. Does not include citrus or non-tree fruits such as bananas or pineapple. See the final rule for more details.

What Records Must be Kept?

Importers, Retailers and Wholesalers When Receiving Product

1. Lot code-which a retailer or wholesaler must assign if a lot code does not exist for a food.
2. Quantity and unit of measure
3. Product description
4. Location of immediate previous source (other than transporter)
5. Location of where food was received
6. Date food was received
7. Location of lot code source issuer or reference to the location of the lot source code issuer (e.g., link to a website, food facility registration number)
8. Reference document type and number (e.g., a purchase order, ASN, BOL, packing list, commercial invoice that contains the above information). For example, if commercial invoice contains information for 1-7 above and has a specific identifying number (i.e. invoice number) then the commercial invoice is the record that satisfies this #8 requirement. A separate record need not be kept that the reference document is “invoice #12345.”

Importers, Wholesalers and Others When Shipping Product

1. Lot code-which a retailer or wholesaler must assign if a lot code does not exist for a food.
2. Quantity and unit of measure
3. Product description
4. Location of immediate previous source (other than transporter)
5. Location of where food was received
6. Date food was received
7. Location of lot code source issuer or reference to the location of the lot source code issuer (e.g., link to a website, food facility registration number)
8. Reference document type and number (e.g., a purchase order, ASN, BOL, packing list, commercial invoice that contains the above information). For example, if commercial invoice contains information for 1-7 above and has a specific identifying number (i.e. invoice number) then the commercial invoice is the record that satisfies this #8 requirement. A separate record need not be kept that the reference document is “invoice #12345.”

Written Traceability Plan

All businesses subject to the regulation must write and implement a traceability plan. The plan must include:

1. The procedures used to maintain records including the format and location of records
2. The procedures used to identify foods on the FTL
3. If applicable, a description of how lot codes are assigned
4. Point of contact for traceability compliance
5. The plan must be updated as needed

Small Business Exemption for Retailers and Restaurants

The exemption is limited to retailers and restaurants with less than $250,000 in annual food sales.

USFI Sales has compliance solutions for the FSMA Traceability Rule. Please contact us for additional information.