Industrial Automation - It Doesn't Have To... Be Untraceable

Industrial Automation – It Doesn’t Have To…

In September 2020, the Food and Drug Administration (FDA) announced a new proposed rule regarding food traceability. This rule, which would be part of Section 204(d) of the FDA Food Safety Modernization Act (FSMA), establishes event tracking requirements for specific foods and ingredients throughout the supply chain.
Comments for the proposed rule have been extended until February 22, 2021, after which the FDA is expected to issue a final rule which would go into effect 60 days after its publication in the Federal Register. The compliance date would be two years after that.
The new requirements will have a significant impact on the food industry, especially for companies that rely on manual processes.
What is the Food Safety Modernization Act (FSMA)?
Prompted by a rash of produce recalls in the early 2000s, the original act was implemented in January 2011 to help the FDA respond and control foodborne illnesses. FSMA gave the FDA more authority over recalls and also required the agency to create rules and guidance to help businesses comply. Section 204 pertains to the plans that would enhance food tracking and tracing that includes a requirement for “Additional Recordkeeping Requirements for High-Risk Foods” also known as the New Proposed Food Traceability Rule (subsection d).
What is the New Proposed Food Traceability Rule?
It sets new recordkeeping requirements for foods that are considered “high risk” for foodborne illness. Here are the basics.

The rule establishes a Food Traceability List (FTL) that lists which foods will need additional recordkeeping. These foods were chosen based on their level of risk for carrying foodborne illnesses. The proposed requirements would only apply to the foods on the FTL. The FDA encourages the voluntary adoption of these practices industry-wide.

Secondly, the rule identifies five Critical Tracking Events (CTEs) throughout the food supply chain: Growing, Receiving, Transforming, Creating, and Shipping.

Each of these “events” has several Key Data Elements (KDEs) that need to be reported on.

In addition to the KDE records, the proposed rule would require businesses that manufacture, process, pack or hold foods on the FTL to establish and maintain Traceability Program Records. These records help the FDA regulators understand the terminology, methods, and systems a business uses in its traceability operations.

Lastly, businesses would need to make required records available to the FDA no later than 24 hours after a request. When necessary, a business would be required to provide the FDA with an electronic sortable spreadsheet containing traceability information on foods that are the focus of an FDA investigation.

During this episode, we discuss the FSMA, Food Traceability List, Critical Tracking Events, Key Data Elements, and give examples.
It isn't all doom and gloom, there are solutions that can help businesses navigate these proposed traceability rules which we discuss along with the ISO 22005 traceability standards. ISO the International Organization for Standardization
Learn more about elliTek's solution.