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What is FSMA 204 and
how does it affect me?

More demands on your time and effort
to avoid financial and reputation damages
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What is FSMA 204?

The Food Safety Modernization Act (FSMA) is a comprehensive reform of food safety laws in the United States, signed into law in 2011. Administered by the Food and Drug Administration (FDA), FSMA aims to shift the focus of food safety regulations from responding to contamination, to preventing it.

FSMA 204 is a section of FSMA that establishes additional traceability record-keeping requirements for certain foods. It aims to enhance the ability to track and trace food products through the supply chain to improve food safety and recall effectiveness.

We Follow Safe Food Practices label for restaurants and grocery stores.

How is my business affected?

If your restaurant/QSR/convenience/grocery store has an annual revenue over $250K, FSMA 204 regulations apply to you.

To be compliant, your business needs to:

  • Write, store and update a Traceability Plan
  • Collect and store traceability & related documents from your suppliers in a safe and organized way
  • Extract and digitize the required data from the above documents
  • Retain those records for two years
  • Train all staff in traceability activities and keep them trained through turnover and changes to the rule
  • Provide the FDA with any traceability information requested, within 24 hours of the request
 
That sounds like a lot of work. What if I’m not compliant?
Not being compliant can have many implications and costs. These range from paying for an FDA auditor at a rate of $250-$300 per hour, to costly fines that can reach hundreds of thousands, possible closure of the business until compliance is met all the way to criminal charges, in extreme cases. Beyond that, the financial and reputation impacts for any business involved in a food-borne disease event, can be devastating.

Key Points to remember

  1. Food Traceability List (FTL): The list of foods that need to be tracked according to FSMA 204. Includes certain fresh fruits and vegetables, cheeses, eggs, nut butters, and seafood. Download our FTL Made Easy booklet to get more detailed version of what the list includes and doesn’t include.
  2. Critical Tracking Events (CTEs): Specific events in a food’s journey:
    1. Harvesting
    2. Receiving
    3. Creating
    4. Transforming
    5. Shipping
  3. Key Data Elements (KDEs): Specific information must be recorded for each CTE, such as location identifiers, lot codes, and quantities.
  4. Traceability Lot Code: A unique identifier assigned to a food product for traceability purposes.
  5. Traceability Plan: A document that describes how your business handles traceability. The document needs to be kept up to date and all versions be available when requested.
  6. Staff Training: All staff need to be trained and stay trained in the correct processes of receiving, recording and retrieving traceability data.
  7. Electronic Records: The FDA requires electronic record-keeping for easier data sharing and analysis for any retail food business with annual earnings of $250K or more.
  8. Records Retention: Traceability records must be maintained for two years.
  9. 24-Hour Rule: Companies must provide the FDA with all requested traceability information within 24 hours of the request.

Ready to get started?

Request a demo of Delta Trace today
and see how we can help your food retail business
stay compliant with minimal disruption.

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