The FDA Traceability Rule Moves Industry into a New Era of Smarter Food Safety
The American government passed the Food Safety Modernization Act (FSMA) in 2011, but new regulations from this groundbreaking legislation are still coming down the pipeline. One of the big milestones is set to pass soon: the FDA Proposed Rule for Record Keeping for Food Traceability will be finalized in November and includes major enhancements to industry traceability practices and requirements.
Businesses in the food and beverage industry – including importers outside the United States – will need to meet an even higher challenge than they have seen so far from FSMA. The FDA is set to finalize traceability as one of its foundational rules to ensure the safety of the food supply, pressing the need for modern data management systems in all food production facilities.
Data Challenges: Extending “Modernization” in FSMA from Food Safety to Traceability
The Proposed FDA Traceability Rule is part of a broader initiative that began with FSMA in 2011, and is, in essence, the follow-up to the Final Rule for Preventative Controls for Human Food, which came into effect in 2015 and required all food facilities to have “a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards” (commonly known as a HACCP or PCP Plan).
These mandatory preventative controls came along with testing requirements, third party certifications, more systematic inspections and audits, new requirements for bioterrorism and fraud, greater controls over imported food, and the authority to require a recall (with accompanying punitive measures like suspension of registration or administrative detention of products) – just to name a few.
The first stage of FSMA’s paradigm shift also included early requirements for product tracing abilities, which are now being expanded in the upcoming Traceability Rule with a view to the broader supply chain. When the Proposed Rule was announced in 2020, FDA deputy commissioner for Food Policy and Response Frank Yiannis explained:
When we say traceability, what we are really talking about is the ability to track a food at every step of the supply chain. While limited to certain foods, this proposed rule would create a first-of-its-kind, standardized 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.
In other words, the major problem the FDA had to tackle to achieve modernized traceability is data management. To put the challenge in perspective, agriculture, food, and related industries in the US accounted for over USD one trillion of the national GDP in 2020 and employed almost 20 million people. Food and beverage processing establishments alone numbered over 30,000 in 2017. How many products, let alone data points, are hinted at in those figures?
Aware of this enormous challenge, the Proposed Rule is the result of extensive research by the FDA on the best ways to standardize data elements and information required by FSMA, centralizing the role of modern technology to address traceability for “the new era.” The goal is that any product in the entire food supply chain could be traced “one step forward, one step back” anywhere, any time.
In order to achieve this goal, the new FDA traceability rules require manufacturers, processors, and holders of foods on the Food Traceability List (FTL) to establish and maintain a reliable traceability system with detailed records containing Key Data Elements (KDEs) related to various Critical Tracking Events (CTEs). Once it goes into effect on Jan. 6, 2025, FSMA 204 will apply to all foods on the FTL.
Food Modernization Means Smart Food Safety and Traceability Software
The FDA Traceability Rule is a major step towards the modernization envisioned in FSMA in 2011, specifically in terms of technological adoption. The centrality of the link between traceability and technology is clear in the four core elements of the FDA’s vision laid out in “The New Era of Smarter Food Safety Blueprint: Modern Approaches for Modern Times” (released in 2021):
- Tech-enabled Traceability
- Smarter Tools and Approaches for Prevention and Outbreak Response
- New Business Models and Retail Modernization
- Food Safety Culture
What the “Blueprint” emphasizes is how integrated technology solutions for the food industry need to be for the “new era.” “Smarter food safety is about more than just technology,” the document says. “It’s also about simpler, more effective, and modern approaches and processes. It’s about leadership, creativity, and culture.” The Traceability Rule will indicate a bigger, necessary shift towards the adoption of advanced technologies in the food and beverage sector (as well as agriculture).
The costs associated with this transformation are significant, which the FDA recognizes in the Blueprint. One way they have tried to address this is through hosting a competition to create “low or no cost solutions” for end-to-end traceability. However, the winners of last year’s challenge were not determined on their ability to meet the Proposed Food Traceability Rule (so they may not be sufficient to meet the upcoming requirements), nor did the criteria include evidence that the solutions work in practice. The competition’s aim was to promote innovation rather than to present viable solutions to the industry, and so includes software that is not reliable enough to mitigate liability, let alone perform at a high enough level for most food businesses (such as modified Excel spreadsheets), or that present other obstacles like privacy concerns (see the ones that use Blockchain technology).
The good news is that existing and proven traceability solutions offer more than just compliance. The data you must collect for regulatory compliance is the same data that you need to manage sales and logistics. In other words, the solutions for traceability are also the solutions for food safety, for managing third-party certifications (like organic, allergen-free, Kosher, etc.), for production management, for warehouse management and inventory control, for business reporting and analytics, accounting, and more.
The US government and governments around the world understand that such technologies are now necessary to improve business outcomes in a sector with low-margins and major supply chain obstacles. The data management crisis posed by the new FDA Traceability Rule (all of the KDEs) is actually a crisis that already existed from a business standpoint, because retailers already demand higher standards of traceability from their suppliers. That’s why government agencies are offering grant programs to food businesses looking to modernize, innovate, improve safety and traceability programs, and open new markets.
Icicle ERP: Effective FDA Traceability Compliance Software for the Modern Food Industry
As we’ve discussed, the Proposed FDA Traceability Rule requires food business in the US and importing into the US to begin tracking a huge amount of KDEs (or data points). What is expanded from previous FSMA requirements is the scope of what must be tracked, which is now truly from seed to sale. Beginning at the farm (and for some products like sprouts, individual seeds), food processors will need to track data-rich, traceability lot codes on a granular level from Receiving through every step of the production process (transformations and creation) to Shipping.
Proven Data Management for FDA Traceability KDEs
While raising the bar for traceability, the new FSMA requirements are not reinventing the wheel. Instead, they are based on established industry best practices, as codified by the Global Food Safety Initiative (GFSI) as that organization has worked to standardize food safety procedures using data-based decision making and in consultation with industry stakeholders. GFSI-recognized certification programs are among the most recognized and valued globally for the high standard of safety and quality they offer. Major retailers like Walmart and Sam’s Club require their suppliers to meet GFSI and traceability standards. Audit-readiness is a key consideration for Costco suppliers, who are required to maintain GFSI Scores of 85% and higher, alongside unannounced third-party GMP audits clearly outlined under supplier requirements.
The technology to meet this challenge already exists in Icicle’s automated traceability software, which supports GFSI compliance (through SQF, BRC, ISO, etc.). The cloud-based system automatically creates labels at Receiving that includes all of the information required by the FDA and more, and is seamlessly integrated into the supply chain (from your suppliers to your customers) through standardized, global GS1 barcode technology. Those barcodes can be scanned using Icicle, on any secure, internet-enabled device (scanners, mobile devices), as inventory moves through production to Shipping – just as the FDA demands – to deliver a complete warehouse management and logistics system.
But Icicle doesn’t just store that information in a centralized system; it uses it for your business. For example, that barcode you generated at Receiving includes the information that the system can use to generate a best-before date as well. As inventory moves into the warehouse, Icicle will automatically sort and prioritize ingredients, packing, and materials to be used in production in the most efficient order, maximizing shelf life and product quality while minimizing waste.
Recall Prevention with Integrated FDA Traceability Compliance
The new FSMA regulations stress prevention: fast and effective traceability has become crucial for tracking non-compliance and preventing or mitigating the spread of food-borne illnesses. The proposed regulation estimates that measuring these data points in a standardized traceability system will make identifying the sources of foodborne illnesses 84% faster.
What that means for food manufacturers is that the FDA will be requiring all data to be collected and readily available to react quickly in the event of a recall. Manual systems are not up to this task. With thousands of KDEs to track, automation technology is essential to maintain accurate traceability records in a way that is manageable for businesses.
Like with data management, Icicle delivers benefits far beyond document storage in the cloud. When your KDEs are tracked alongside Critical Control Points (CCPs) from your food safety program in the same system, traceability and food safety are fully integrated. That means that, not only do you have a more complete picture of your facility at any time, but you can respond to problems quickly and develop proactive solutions with confidence.
With Icicle, a measurement out of range (whether deviance or nonconformity) automatically sends an alert to initiate immediate corrective actions. Icicle guides users to develop complete SOPs intuitively based on specific food safety prerequisite programs, easily setting up automatic notifications through assigned tasks for team members with the appropriate training records. Afterward, your staff can use Icicle to conduct a root cause analysis to prevent future issues when possible.
Integrated traceability doesn’t just make recalls less likely in the first place, it also streamlines compliance significantly. Instead of spending months preparing for audits, with Icicle’s integrated and automated ERP system, recordkeeping is seamlessly folded into daily operations using digital tools and data-driven workflows. Auditors and inspectors can be given remote access to regulatory documents and overall, the time spent on preparation as well as in audits themselves, is reduced dramatically.
Adapt to the New Era of Food Safety and Traceability with Icicle ERP
The biggest challenge to food manufacturers in the “new era of food safety” is not the transition into the modern world of automation technology, but developing the ability to adapt easily to changing requirements from both regulators and customers.
FSMA’s last major paradigm-shift for the food industry (i.e., the adoption of preventative food safety programs) presented the same challenge. At the time (2015), Icicle was a smaller software solution mostly focused on food safety alone. Even so, when an Italian olive oil manufacturer called us up for emergency assistance in meeting FSMA requirements to keep their US business, we got them up and running in six weeks to pass their inspection with flying colours.
Icicle helped them meet the next unexpected challenge too:
When the FDA notified the local authorities that they had conducted an inspection, we were immediately notified that we were going to get a local inspection as well. Unlike the FDA, it did feel like they were trying to catch us. It was a complete opposite of our earlier experience. But everything was ready at the tips of our fingers and the Italian inspection also went according to plan.
Steven Crutchfield, Villa Cappelli Head of Production and Product Innovation
Today, Icicle has grown exponentially to cover the entire production process and deliver compounded benefits to our users. Built with food safety at its core, Icicle was designed for the highest levels of compliance according to industry gold standards, and so provides the instructure you need to adapt and grow your business.
Whether it’s this new FDA Traceability Rule or something else down the road, Icicle’s intuitive and comprehensive platform, expertly developed templates, hands-on customer support, and seasoned consulting services can help you weather big changes the right way and thrive.
Steven from Villa Cappelli explained it best: when facing the regulatory challenges of FSMA, “Icicle simplified things and made me feel like I could do this.”
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