FSMA Proposes New Rule for Food Traceability

There are additional food traceability requirements coming in November 2022. These requirements affect businesses that manufacture, pack, process or hold foods that the FDA has included on the Food Traceability List (FTL). As a business that works with foods on ...

FSMA Proposes New Rule for Food Traceability

There are additional food traceability requirements coming in November 2022. These requirements affect businesses that manufacture, pack, process or hold foods that the FDA has included on the Food Traceability List (FTL). As a business that works with foods on the traceability list, you must maintain records containing Key Data Elements (KDEs) that are associated with Critical Tracking Events (CTEs).

foodready.ai food safety software is here to help you meet the improved FSMA standards set by the FDA. Our software tracks supplier inventory does quality batch management and can keep required logs and records such as sanitation and time and temperature. We also offer an Enterprise plan which gives you access to our professional food safety consultants. 

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What Foods Are On the FSMA Food Traceability List?

      • Cheeses other than hard cheeses

      • Chicken eggs

      • Nut butters – not seed or soy butters

      • Cucumbers (fresh) – all varieties

      • Herbs and leafy greens (fresh) – all varieties

      • Melons (fresh) – all varieties

      • Peppers (fresh) – all varieties

      • Sprouts (fresh) – all varieties

      • Tomatoes (fresh) – all varieties

      • Tropical tree fruits – Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, starfruit, etc.

      • Fresh cut fruits and vegetables of all types

      • Finfish, including smoked fish – Includes all finfish species, such as cod, Alaskan pollock, tuna, mackerel, grouper, barracuda, salmon, etc.; except does not include siluriformes fish, such as catfish 

      • Crustaceans- includes all crustacean species such as shrimp, lobster, crayfish, crab, etc.

      • Mollusks, bivalves – includes all species such as clams, oysters, mussels, etc, but does not include scallops.

      • Ready-to-eat deli salads – includes all types such as pasta salad, egg salad, pasta salad, but does not include meat salads.

    What are Critical Tracking Events and KDEs?

    Critical tracking events are steps in your procedure that require tracking of KDEs (key data elements such as dates received, where the ingredient is from, etc.)

    Examples of CTEs

    Growing Food

    Sprout growers have additional KDEs to maintain that are specific to sprouts.


    Either the final link in the supply chain (consumer receives) or the “first receiver” is someone that receives a food from a farm to process or package into a product.


    The step at which the food is “created” from a single FTL food WITHOUT adding any other foods on the traceability list. For example, peanut butter is a created food.


    The process of changing an FTL food through its package, label, combining ingredients or processing. Transformation does not include single ingredient packaged foods or creating a food.


    Traceability program records must be kept for any shipping. The foodready.ai software is perfect for this application.

    Other Requirements

    Records must be maintained, legible, and stored properly to prevent loss or destruction.

    The traceability records must be given to the FDA within 24 hours after their request for them.

    You must keep traceability information in an electronic sortable spreadsheet when the FDA requests information during a recall, outbreak, or public health threat.

    Foodready is a food safety software and consulting company. Our software has a HACCP builder, food traceability, you can create your own checklists to manage your HACCP plan or track other items, ingredients, tasks, or events. With our Enterprise program you will have access to food safety quality assurance professionals who can help you with GFSI, SQF, GMP, SOP, BRC, CGMP, HACCP, gap analysis, or prepare for audits like the Costco audit, the Whole Foods audit, Publix audit, Kroger audit, Safeway audit, Meier audit, HEB audit and more.


    Food traceability is crucial for several reasons. It helps ensure food safety by allowing businesses and regulators to quickly trace and identify the source of a food product in the event of a contamination or outbreak. This capability is vital for executing effective recalls, thereby minimizing the impact on public health. Additionally, traceability supports transparency in the food supply chain, enhancing consumer trust and compliance with regulatory requirements.
    While the specific penalties can vary, non-compliance with FSMA traceability requirements can result in significant consequences, including FDA enforcement actions such as warning letters, mandatory recalls, and administrative detentions. In severe cases, businesses may face injunctions, fines, or criminal prosecution. Non-compliance can also damage a company’s reputation and lead to loss of consumer trust.
    International food suppliers exporting to the United States must also comply with the FSMA traceability requirements if they deal with foods on the FTL. This means maintaining adequate records of KDEs for CTEs and ensuring their traceability systems can provide necessary information in an electronic, sortable format upon request by the FDA. Compliance is crucial for maintaining access to the U.S. market and avoiding import refusals or other restrictions.
    Can small businesses seek exemptions from the new traceability requirements?

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    Saro Loucks

    Saro Loucks

    Saro Loucks is the Director of Content and a Food Safety Advisor for FoodReady. Saro is certified in HACCP and a trained SQF Practitioner. When Saro is not editing, writing, or advising new customers on what food safety goals they should pursue, she enjoys spending time with her family, baking gluten-free sourdough bread, and playing Mahjong.
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