New Food Safety Modernization Act Requirements And How To Reduce Risk As A Manufacturer

The Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination of the food supply to preventing it. The law applies to human food as well as to food for animals, including pets.

Food Safety Modernization Act

Government regulation is good for the protection of citizens and animals in the USA but, just like any regulatory requirements, processes need to be established in manufacturing enterprises to ensure compliance, lest both criminal and civil penalties be incurred. In fact the government has specified mandates for Preventative Controls that should be implemented in plants and the manufacturing value chain as a whole.

These requirements are specified as:

A written food safety plan (FSP).
Hazard analysis.
Preventive controls.
Monitoring.
Corrective actions.
Verification; and
Associated records.

One control example is heat treatment in process control within food production to prevent bacteria contamination. This is also an example of a process value that needs to be stored and associated with batches, lots and shipments that go out.

New Requirements Require Traceability across The Supply Chain

On January 21, 2021 the FDA also proposed to establish additional traceability record keeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods. At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The specific list includes cheeses, other than hard cheeses, shell eggs, nut butter, and fresh cucumbers, herbs. leafy greens, melons, peppers, sprouts tomatoes, tropical tree fruits, fruits and vegetables, finfish, including smoked finfish, crustaceans, mollusks, and ready-to-eat deli salads. While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. The FDA would encourage the voluntary adoption of these practices industry wide.

Electronic Record Keeping And AI Can Help Provide Compliance

This is one of the first regulations that states that information on food from the original source, the farmer, to the customer must be maintained for compliance. Also, the government is looking for an ability to search these records as quickly as possible, so paper-based systems of record are a problem. This information is stored in many different data silos, but what if there was a way to electronically transfer all the needed data automatically and then search and account for information using tools, like an accounting system, to drill into any information needed. What if AI could be deployed behind the scenes to discover hidden meaning and correlations in the data? What if this was a cloud-based service that could span across multiple companies ands supply chain members?

Material Traceability And How ThinkIQ Can Help

ThinkIQ, a pioneer of Digital Manufacturing Transformation SaaS and delivers unprecedented material traceability and insight into ways to improve yield, quality, safety, compliance, and brand confidence. Our fact-based granular and data-centric contextualized view of material flows, and related provenance attribute data integrates into existing IoT and OT infrastructures and crosses supply chains to manufacturing processes and beyond. Our customers have saved $10’s of millions by identifying waste and underperforming assets, as well as reducing warranty reserves for quality and safety issues.