How to Adhere to the FDA's New Food Traceability Regulations

The FDA released the FSMA Proposed Rule for Food Traceability, a 55-page document that standardizes traceability techniques for high-risk foods, in late September 2020. We've included several critical items to keep in mind for food and beverage facilities, such as new foods on the Food Traceability checklist, record-keeping standards, and compliance deadlines.

The Food Traceability List is a list of foods that can be traced back to their source (FTL)

The FDA's new traceability standards are aimed at high-risk foods, while the language mostly avoids mentioning them by name. This is most likely a way of avoiding any allergies to certain foods that have been designated as high-risk, as well as dispelling the assumption that any items that aren't on the list are automatically risk-free.

One of the proposed rule's challenges is that it must take into account not only FTL foods, but also meals that contain them as ingredients. Because many food and beverage firms have a diverse product range, employing an electronic food safety management platform can assist executives in tracking all of the goods that would be subject to the law and ensuring compliance.

Key data items and critical tracking events

The proposed rule's two pillars, Key Data Elements (KDE) and Critical Tracking Events (CTE), initially emerged in the Institute of Food Technologies' suggestions for enhanced product tracing in 2012. Important traceability data should be collected and communicated at essential points in the supply chain, according to KDEs (CTEs).

The FDA should adopt a comprehensive set of record-keeping criteria, including the use of standardized technology to capture KDEs, according to an advisory group. KDEs can be used to initiate investigations and shorten traceback timelines in the event of an outbreak or recall. This assumption was embraced by the FDA in the proposed regulation, which stated that traceability lot numbers and additional KDEs should be recorded and linked to allow for product tracking in the event of foodborne illness outbreaks or recalls.

The Food and Drug Administration (FDA) has ready an interactive reference to provide examples of CTEs and KDEs in the supply chain. KDEs change depending on the type of one's business: data requirements for growing, receiving, transforming, making, and shipping meals are all distinct. Here's how these tracking events are specified in more detail:

Creating: making a food on the FTL using ingredients from foods that aren't on the list. Peanut butter is an example; peanuts are not on the FTL, but peanut butter is.

Growing: an early phase in the supply chain that necessitates the creation of a traceability lot code and linking it to growing area coordinates (sprouts have proposed additional requirements, including seed lot codes)

Receiving: the act of receiving food by a client (other than the consumer) after it has been transported.

Transportation of food from one establishment to another is known as shipping.

Any food on the FTL can be transformed, including its package or label.

Rules for keeping records

Since the obligation of tracing "one step forward, one step back" was specified in the Bioterrorism Act of 2002, industry efforts have already increased. Despite this, the agency's response to foodborne illness outbreaks has been hampered by a lack of timely access to accurate and complete data. Links will become more defined as a result of synchronizing traceability processes across the industry, making it easier to trace the origin of contaminated items.

The FDA's proposed rule requires food and beverage firms to keep the following records in order to achieve this goal:

All FTL foods that have been shipped: Companies should keep a list that includes a description of all FTL foods that have been shipped, as well as a traceable product identifier.

Companies should have a definition of traceability reference records and how different pieces of information, such as purchase orders and bills of lading, are linked.

Companies must generate traceability lot codes that identify distinct types of food at any step in the production, creation, or transformation process. It's also necessary to include a description of how these codes are created and given.

As you might expect, this brings a lot of data into food, beverage, and consumer packaged goods firms, which are already struggling to keep up with the volume of data generated in their plants every day. SafetyChain is a consolidated solution for all of your regulatory and non-regulatory programs, including a program manager feature and a simplified document repository that simplifies record-keeping. It can help you develop and maintain a robust traceability program that meets FDA regulations, in addition to food safety, quality, and compliance procedures.

Additional information relevant to traceability records, including as acronyms and classification systems, must also be included in records, according to the FDA. Companies would also be required to employ either electronic records or legible paper records that could be swiftly converted into sortable spreadsheets and delivered to the FDA within 24 hours of a request. This would provide full traceability information for all foods in question, with specific date ranges.

At ReposiTrak Inc., Park City Group co-founded ReposiTrak, Inc. with Leavitt Partners, chaired by Michael Leavitt, former Secretary of Health and Human Services, to meet the predicted surge in regulatory requirements connected with the Food Safety Modernization Act of 2011. (FSMA).

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