Traceability in the “New Era of Smarter Food Safety”

The saying “When America sneezes, the world catches a cold” could not be truer when it comes to food safety management.  If we look at the history of food safety in the U.S., we can see how significant food safety regulatory events have impacted on the rest of the world.  From the creation of the Good Manufacturing Practices (GMP’s), through the development of Hazard Analysis Critical Control Point  (HACCP) food safety systems and more recently the Food Safety Modernization Act (FSMA), all have had a profound impact on the way that food safety is viewed and managed throughout the world.

“What is the future of food safety?” many ask. The US FDA is moving into what they have described as the “New Era of Smarter Food Safety”.  A new era that is sure to have a profound impact on the food safety around the world.  According to the FDA this new blueprint is centered around four core elements:

  1. Tech-enabled Traceability, with the aim to leverage technology to achieve end-to-end traceability throughout the food supply chain.
  2. Smarter Tools and Approaches for Prevention and Outbreak Response, with the aim to enhance and strengthen root cause analysis and predictive analytics to help the industry modify current practices to avoid identified risks and provide more robust data.
  3. New Business Models and Retail Modernization. Looking at more traditional business models, the FDA is exploring the best ways to further modernize and help ensure the safety of foods sold at restaurants and other retail establishments.
  4. Food Safety Culture is a prerequisite to effective food safety management. The FDA believes that in order to make dramatic improvements in reducing the burden of foodborne disease that more needs to be done to influence the beliefs, attitudes, and, most importantly, the behaviours of people and the actions of organisations.

The FDA believes that these core elements will help create a safer and more digital, traceable food system for the future and that tech-enabled traceability is going to have a big impact on the global food supply chain.

Current status of traceability in the food supply chain

Traceability or product tracing is defined by the Codex Alimentarius Commission as “the ability to follow the movement of a food through specified stages of production, processing and distribution”. Traceability within food control systems is applied as a tool to control food hazards, provide reliable product information and guarantee product authenticity.

 A typical food supply chain today is considered in theory to be linear from suppliers of raw agricultural commodities through producers and processors through distributors to retailers and finally consumers. However, the reality is a complex web of systems with interconnected networks of nodes and edges making up the value chain.

So why is food traceability considered by the FDA to be a core element in the new era of smarter food safety?

Food traceability is the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward. Traceability involves documenting and linking the production, processing, and distribution chain of food products and ingredients. In the case of a foodborne illness outbreak or contamination event, efficient product tracing helps government agencies and those who produce and sell food to rapidly find the source of the product and where contamination may have occurred. This enables faster removal of the affected product from the marketplace, reducing incidences of foodborne illnesses. Whether we are talking about food safety or food defence, traceability plays a key role in emergency planning for public health and can be broken into four phases:

Phase 1. Preparedness: When planning for an emergency situation, traceability provides greater visibility into a supply chain, thereby helping stakeholders be better prepared if something goes wrong.

Phase 2. Response: In case something goes wrong, traceability improves the agility of the response by all stakeholders.

Phase 3. Recovery: During the recovery phase, traceability allows the industry and regulators to maintain or rebuild trust with consumers into the safety and resiliency of the food system.

Phase 4. Prevention: Traceability allows for the determination of causality of the problem through root cause analysis, thereby preventing future issues.

Existing FDA regulations require much of the food industry to establish and maintain records that document one step forward to where food has gone and one step back to its immediate previous source. These requirements establish baseline traceability recordkeeping throughout much of the food system.

The Problem:  “One up, one back” traceability is no longer good enough. It does not provide enough visibility. It is time to implement more automation for greater efficiency, higher visibility and consumer protection.

The future of traceability

Current traceability records often prove insufficient to effectively and rapidly link shipments of food through each point in the supply chain. In addition, the existing FDA traceability requirements do not apply to farms and restaurants, meaning that a large part of the supply chain is excluded from keeping these important traceability records.  As a result, the food industry lacks a harmonised system of traceability from farm to fork that is universally understood and utilised. This means that during an outbreak investigation, the ability to rapidly track and trace food is often impeded by insufficient data identifying a food as it moves through the supply chain. A modern, coordinated approach to traceability that can be used and understood throughout all stages of the food supply chain will go further to reduce foodborne illness, build consumer trust, and avoid overly-broad recalls.

Traceability, or the  ability to track the food product through all stages of the supply chain , is now more of a demand rather than a request among many consumers today. Many consumers now want to know where all products and their ingredients, even the minor ones, come from.

This makes it important to have good data on food products and the supply chain. Having and sharing authentic information from each and every step of the food supply chain enhances food safety,  strengthens brand integrity, and increases customer loyalty.

The lack of traceability and transparency can also create blind spots in the supply chain and expose various stakeholders to unnecessary risk. It can weaken consumers’ brand trust, which can translate into lower sales and profits. It can even give rise to certain legal issues that can stall new product launches.

The lack of traceability in the food supply chain is typically caused by companies using outdated systems or traditional paper tracking and manual inspections. These introduce errors and delays into sharing information.

There are considered to be three key drivers of food traceability change:

  1. Emerging Technologies
  2. Consumer-Centricity
  3. The FDA blueprint for the “New Era of Smarter Food Safety

1. Emerging technologies

A technology on the forefront of changing the way we trace product through the supply chain is Blockchain.   Blockchain plays a critical role in creating more transparency in the supply chain to build consumer trust. The use of blockchain can lead to more accountability in the supply chain by creating an immutable ledger or audit trail of product events and transactions.

Many industry leaders are more strategically planning to use blockchain after learning from pilot programs over the past few years. Supply chain use cases are being evaluated for the criticality of the role blockchain played to solve a particular challenge. Many are asking “Did blockchain give us something better than what we’re using today?”

The results are mixed, but either way, the companies that pilot blockchain usually end up learning more about their systems’ ability to share data externally, as well as their trading partners’ data sharing capabilities. Blockchain programs have highlighted data quality issues and inconsistencies that need to be addressed. In fact, a recent Gartner study concluded that from 2020 through 2022, 80 percent of supply chain blockchain initiatives will remain at a pilot stage instead of emerging into broad-based applications. The main reason is that many supply chain use cases still rely on events that are stuck in the “analogue world,” such as events and data occurring across physical products, packaging layers, and transportation assets.

Blockchain can do a lot of things but it can’t magically make your data ready for the permanence of an immutable ledger or give you instant supply chain visibility. In the new era of smarter food safety, expect to see a more thoughtful approach to blockchain adoption that incorporates global data standards and more stringent data governance to ensure wise investments are made. 

2. Consumer-Centricity

Recent studies have shown that consumers increased spending in the fresh food category and further research shows that a large majority of consumers want to know more about where their food comes from. 

As consumers continue to diversify their diets, it will be increasingly important for food brands and retailers to provide trustworthy information, which leads to peace of mind. By prioritising food traceability, the industry can work together to close the gap between consumer demand for fresh, healthy food and the industry’s ability to meet that demand with assurance of safety.

In the new era of smarter food safety, look for increased collaboration between trading partners to more easily identify the location where a product was harvested and produced. This will help them complete the full picture of traceability for consumers. A key data standard that can help create efficiencies here is the Global Location Number (GLN), which uniquely identifies a company’s physical locations such as a store or a warehouse. This number can be universally accepted in trading partner systems and is a key part of traceability programs because they allow for more precise recording and sharing of supply chain events.

3. The FDA blueprint for the “New Era of Smarter Food Safety”

The FDA has proposed a new rule that lays the foundation for end-to-end food traceability to track a food at every step of the supply chain as part of the “New Era of Smarter Food Safety” initiative. This proposed rule would create a first-of-its-kind standardised approach to traceability recordkeeping, paving the way for industry to adopt and leverage more digital, tech-enabled traceability systems both in the near term and the future.

US Congress recognized the need for greater traceability in the FDA Food Safety Modernization Act (FSMA). FSMA section 204, Enhancing Tracking and Tracing of Food and Recordkeeping, instructs the FDA to develop additional recordkeeping requirements for certain foods to help establish clear tracing of a food product’s source when needed to address food safety risks. This proposed rule, when finalised, would implement this key component of the landmark food safety law. The FDA  recognises that to fully realise the public health benefits envisioned by FSMA, they need to continue to improve  ability to rapidly and accurately identify foods that may be causing illness, and this rulemaking is part of that.

The FDA wants to help protect consumers by more quickly identifying the source of contaminated products, limiting the scope of recalls, and reducing the risk of illness or death. Advancing traceability will also greatly facilitate timelier root-cause investigations to learn more about how contamination occurs in order to prevent future outbreaks.

A Game Changer for Prevention

More comprehensive traceability through access to records of key data elements associated with critical tracking events in food production and distribution has the potential to help the industry pinpoint the exact sources of foods involved in outbreaks. Not only does this help to remove potentially unsafe products from the market more quickly, preventing additional illness or death, but it also helps to conduct root cause investigations to figure out what went wrong leading to the outbreak. Without knowing the source of a contaminated food, it is extremely hard, if not impossible, to fully diagnose the problem and implement strategies to prevent similar issues in the future. Recent outbreaks of foodborne illness tied to fresh produce like leafy greens highlight the importance of better traceability.

Harmonising Approaches

Today’s food system is a complex and globally connected landscape. When we look at the current state of traceability across the food supply, we find that even though some food producers, manufacturers and retailers have adopted modern, effective traceability systems, rarely are these systems compatible with each other. And still, many other food companies have not adopted traceability systems at all. As a result, there lacks a harmonised system of traceability from farm to fork that is universally understood and utilized.

This means that during an outbreak investigation, the ability to rapidly track and trace specific food products through the supply chain is often impeded by a lack of data. The result can be millions of dollars in avoidable product loss by necessitating overly broad recalls and consumer advisories, a loss of consumer trust, and prolonged outbreaks of consumer illnesses and deaths.

The FDA conducted extensive research in developing the proposed rule and chose an approach that would standardise the data elements and information companies must establish and maintain, along with information they must send to the next entity in the supply chain. Consideration was given to existing standards that some firms and industry groups have already adopted, and when possible, the FDA have strived to make the proposed requirements compatible with those standards.

Benefits of Better Traceability

The proposed rule would allow the FDA to better establish linkages throughout the supply chain during a foodborne illness outbreak investigation and more quickly identify potential sources of contamination and prevent additional illness and death.

The availability of the traceability records that are set out in the proposed rule would also help limit the scope of recalls and in some instances, allow the FDA to better target consumer advice, avoiding blanket alerts on whole commodity sectors. For instance, in some past leafy green outbreaks, the FDA has had to call for all romaine lettuce to be removed from the marketplace when the available supply chain information could not pinpoint a specific entity that produced the lettuce linked to the illnesses. With this proposed rule, we’re hoping to avoid situations like this in the future.

How it will work?

At the core is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) (i.e., soft and semi-soft cheeses, shell eggs, nut butter, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruit and vegetables, finfish, crustaceans, molluscs, bivalves and ready to eat deli salads) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).  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. FDA would encourage the voluntary adoption of these practices industry-wide.

Critical Tracking Events (CTE’s)

The proposed rule identifies growing, receiving, transforming, creating, and shipping as the CTEs for which records containing KDEs would be required. The KDEs required would vary depending on the CTE that is being performed. The records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDEs.  Some of the more common KDE’s include but are not limited to:

  • Location identifier and location description of where the food was received/transformed/created, and the date and time
  • The quantity and unit of measure of the food 
  • Traceability product identifier and traceability product description for the food
  • Reference record type(s) and reference record number(s)
  • The name of the transporter who transported the food
  • CTE specific KDE’s

Traceability Program Records

In addition to requiring records of KDEs, the proposed rule would require persons who manufacture, process, pack or hold foods on the FTL to establish and maintain traceability program records. These records are intended to help regulators understand an entity’s traceability program, and include:

  • A description of relevant reference records
  • A list of foods on the FTL that are shipped
  • A description of how traceability lot codes are assigned
  • Other information needed to understand data provided within the required records

Additional Requirements

The proposed rule would also require that:

  • records be maintained as either original paper records, electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss.
  • traceability records be provided to FDA as soon as possible but no later than 24 hours after a request is made.
  • an electronic sortable spreadsheet containing relevant traceability information be provided to FDA within 24 hours of a request when necessary to assist FDA during an outbreak, recall or other threat to public health.


The future of traceability is in a revolutionary phase that is about much more than merely keeping track of foods. It will be about using collaborative ubiquitous artificially intelligent system of systems to transform the way we live our lives and sustain ourselves though the foods we eat.

We know that FDA cannot embark upon this journey alone and, to be successful, it’s equally important for food companies and technology firms, as well as government agencies and consumers, to join together in this effort.

Imagine how different our work and lives would be if we could leverage tools and technologies, as well as modern approaches, to fundamentally change how we keep food safe.

No matter whether you’re a food producer or a food regulator, or whether you are in the government, industry or academia, at the end of the day we’re all consumers.

In putting forth the concepts in the new era of smarter food safety, the FDA is not talking about things that can’t be done. They are encouraging the industry to work differently.

Working together and thinking outside the box, we’ll create a more digital, traceable and safer food system that advances food safety, improves the quality of life for consumers in the US and all over the world, and better prepare us for unexpected events that could impact the food supply.

While the “New Era for Smarter Food Safety” is currently a US driven initiative, if we look back at history, it would be my prediction that we are looking at a “New Global Era of Smarter Food Safety” and more globally collaborative food safety initiatives that embrace and leverage new technologies.