Next Steps for the FSMA Act: Food Traceability Proposed Rule

December 7, 2020
By Marc Digiorgio

Since 2011, the Food and Drug Administration (FDA) has created a series of rules and regulations to help food growers and producers be more proactive in terms of food safety. These rules were created as part of the Food Safety Modernization Act (FSMA). Rather than waiting until a foodborne pathogen causes widespread illness, the FSMA re-examines how perishable food is produced and transported in order to identify potential weaknesses in the chain and resolve them. We have already shared some insights regarding allergen identification and prevention of cross-contact, as well as how to prepare your food safety plan for future inspection.

Taking the Next Step

The next phase for implementation with the FSMA is the recently-published Food Traceability Proposed Rule. This proposed rule applies to any business that manufactures, processes, or distributes foods on the Food Traceability List. Items on this list are food products that:

  • are known to frequently cause illnesses, some of which may be severe and/or expensive to mitigate;
  • have a higher likelihood of contamination;
  • have a higher potential for pathogen growth, often related to shelf life;
  • have a higher probability of process contamination;
  • have a high rate of consumption

Specific types of foods on the Food Traceability List include:
Food Traceability Proposed Rule

  • most soft cheeses
  • eggs
  • nut butters
  • cucumbers
  • fresh herbs
  • leafy greens
  • melons
  • peppers
  • sprouts
  • tomatoes
  • tropical tree fruits
  • fresh-cut fruits and vegetables
  • finfish, crustaceans, and mollusks
  • ready-to-eat deli salads

In order to treat these products with proper care and attention, the Food Traceability Proposed Rule establishes additional recordkeeping requirements that would help the FDA identify consumers who might have received tainted products, prevent or mitigate foodborne outbreaks, and address threats of foods which might have been intentionally adulterated.

What The Proposed Rule Includes

The core requirement for the proposed rule is to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While this is currently being developed in reference to high risk foods, this rule can be applied to all perishable food producers and handlers as a matter of good manufacturing practice. Basically, the proposed rule sets a series of CTEs for which KDEs would be tracked. Naturally, these would vary depending on the type of food product.

Below is a list of CTEs along with examples of the relevant KDEs to be tracked:

Growing
This is the point of origin for items like fresh fruits and vegetables; the first step on the supply chain.

  • Coordinates of the growing area(s) would be considered KDE.

Receiving
This addresses food products received by a customer other than the consumer, after being transported from another location.

  • location identifiers and descriptions
  • quantity and unit of measure of food received
  • name of transporter
  • point of contact for traceability lot code generator

Creating
Creating is considered separate from growing or transforming; it is the making of a food product through the manufacturing process.

  • location description of food created, and date of creation
  • quantity and unit of measure of food created

Transformation
Transformation involves changing a food product, its packaging and/or its label by combining ingredients or processing a food.

  • product description for foods used in transformation
  • location identifier and description for where food was transformed and the date of completion
  • quantity produced through transformation

Shipping
Shipping is defined simply as transport of a food product from one specific location to another. This can be applied to transport anywhere in the food supply chain, not just when a food product arrives at its final destination.

  • quantity and unit of measure of food transported
  • location identifiers (departure and arrival)
  • name of transporter

Looking Ahead

The FDA will be accepting feedback on the Food Traceability Proposed Rule through January 21, 2021. Additional questions related to this rule may be sent to the FSMA Technical Assistance Network. The proposed rule would go into effect 60 days after publication in the Federal Register. Food producers would have two years to come into compliance.

At Harvest Food Solutions, we take food safety seriously. If you have questions about how the Food Traceability Proposed Rule would affect your business operations, just give us a call or fill out our contact form. We would be happy to help.

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