Oct 27, 2020

New FDA Food Safety Regulation Drives Digital Transformation of Food Supply Chain

This article was originally published on ARC Web.


To comply with a proposed new US Food and Drug Administration (FDA) rule for traceability of high-risk foods (mainly those that are consumed raw), the supply chain will undergo digital transformation from farm to retail outlet.  This includes the MES and control systems in food processing and packaging plants. supply chain digital transformation

The proposed FDA rule for traceability was released for comment in September 2020.  The schedule could require compliance as early as 2023.  With one in six people in the US getting sick from foodborne diseases yearly, ARC anticipates that any delays should be limited.

With the extensive impact on technologies, business processes, and workflows, food companies and their technology providers need to start planning now for implementation.

Ensuring Food Safety Drives Supply Chain Digital Transformation

The Food Safety Modernization Act (FSMA), which became law in January 2011, instructs the FDA to develop recordkeeping requirements for clear tracing of a food product’s source to tackle food safety risks.  This is considered the first major piece of federal legislation addressing food safety since 1938.  On September 21, 2020, FDA formally released for comment the proposed traceability rule for FSMA section 204. 

Food Safety Issues

According to data from the Centers for Disease Control and Prevention, about 48 million people in the US (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases.  This significant public health burden is largely preventable with near real-time supply chain traceability.  The new regulation should make the food we consume become much safer from pathogens permeating the food supply chain.

Proactive Food Safety

FSMA shifts the focus of federal regulators from responding (via massive recalls) to prevention (by quickly shutting down the source) when contamination occurs.   Current traceability methods, with each company tracking one step back and one forward, take far too long to prevent injury and deaths.  Hence, the broad recalls, with losses averaging $9.5 million each.   The new traceability approach requires near real-time visibility through multiple nodes of the supply chain to identify and isolate the source of a problem quickly. 

Food Supply Chain Digital Transformation

Companies involved in the food supply chain now have a deadline to meet.  This involves:

  • Digitization (converting from paper-based systems)
  • Digitalization (electronic workflows) likely involving blockchain
  • Digital transformation (new business processes and business models)

Food industry applications and solutions will need significant changes to the software and applications to achieve compliance.

Food Traceability

The FDA defines food traceability as the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward.  

Rapid Response Reduces Illnesses and Deaths

When a foodborne illness outbreak or contamination event occurs, rapid product tracing helps government agencies and those companies that produce and sell food to find and contain the source.  This traceability enables faster removal of the specific bad items from the supply chain and retail outlets.  The rapid response reduces incidences of foodborne illnesses.

Scope of the Traceability Rule

The new FDA rule requires traceability multiple steps back to the farm and forward to the retail outlet i.e., “farm to table” and requires response within one day.  The food supply chain from the farm to consumers consists of four basic steps: production, processing, distribution, and preparation.  Each step has multiple participants.  Cocoa beans have over 15 transactions from farmer to plant for conversion into chocolate – many more to the retail outlet.  

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