The food system is rapidly evolving—from new foods, to new formulations, to new production and delivery methods. As a whole, the industry is pushing into untapped areas, facing supply chain challenges, and responding to unique market demands, including those that have quickly emerged as a result of the COVID-19 pandemic (e.g., e-commerce, new delivery models, virtual inspections).

To keep pace with all this change, the Food & Drug Administration (FDA) announced the New Era of Smarter Food Safety in April 2019. On July 13, 2020 (delayed from Spring 2020 due to COVID-19-related issues), the Administration subsequently published the New Era of Smarter Food Safety Blueprint. This blueprint outlines the approach FDA will take create a New Era of Smarter Food Safety that evolves along with food technologies and systems—and the impacts these changes will have on the food industry and consumers alike.

New Era: What to Expect

According to FDA, “The New Era of Smarter Food Safety represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” That being said, the Administration further notes that “smarter food safety is about more than just technology. It’s also about simpler, more effective, and modern approaches and processes. It’s about leadership, creativity, and culture.”

Correspondingly, the New Era is built on four core elements to support FDA’s ultimate goal of reducing foodborne illness:

• Tech-Enabled Traceability
• Smarter Tools and Approaches for Prevention and Outbreak Response
• New Business Models and Retail Modernization
• Food Safety Culture

Importantly, the New Era does not replace or negate the progress of the Food Safety Modernization Act (FSMA). Rather it builds on FSMA’s science and risk-based protections and uses them as the foundation for integrating more data, better analytics, and technological advancements going forward. FSMA’s full implementation remains a priority for the FDA. In FDA’s words, the New Era is “people-led, FSMA-based, and technology-enabled”.

Building the Blueprint

The New Era of Smarter Food Safety Blueprint is the roadmap FDA will follow to build its New Era and further food safety modernization under the FSMA rules. The blueprint includes goals to:

• Enhance traceability
• Improve predictive analytics
• Respond more rapidly to outbreaks
• Address new business models
• Reduce contamination of food
• Foster the development of stronger food safety cultures

Each of these goals is addressed by the core elements and the following actions, as outlined in the blueprint, which will be implemented over the next decade:

Core Element 1: Tech-enabled Traceability. Food traceability is the ability to track any food through all stages of the supply chain—production, processing, distribution—to ensure food safety and operational efficiency. The objective of Tech-enabled Traceability is to use technology to create traceability advancements, including implementing rapid tracebacks, identifying specific sources, and helping to quickly remove products from the marketplace when necessary. Beyond technology, part of this effort involves harmonizing efforts to follow food from farm to table by creating similar data standards across government and industry. As public health agencies increasingly rely on electronic data in outbreak investigations, quality and compatibility must be addressed to more quickly and accurately trace the origin of contaminated food. Blueprint actions include:

• Developing foundational components
• Encouraging and incentivizing industry adoption of new technologies
• Leveraging the digital transformation

Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response. One of the most powerful resources available to create this New Era is data. However, that power lies in collecting better quality data, conducting more meaningful analysis, and transforming data into more strategic, prevention-oriented actions. The blueprint seeks to strengthen procedures and protocols for conducting root cause analyses to identify how a food became contaminated and then for using predictive analytics to prevent future outbreaks. As under FSMA, the focus is on the preventive nature of modern food safety approaches. Blueprint actions include:

• Invigorating root cause analysis
• Strengthening predictive analytics capabilities
• Developing domestic mutual reliance
• Developing inspection, training, and compliance tools
• Improving outbreak response
• Implementing recall modernization

Core Element 3: New Business Models and Retail Food Modernization. How food is getting from farm to table is continually evolving. The recent pandemic is a prime example, as it has brought huge growth in distribution channels, including e-commerce and food delivery, carryout, and pickup. The FDA and industry must be prepared for new business models that continue to emerge with marketplace demands and consumer needs. The address this, blueprint actions include:

• Ensuring safety of food produced or delivered using new business models
• Modernizing traditional retail food safety approaches

Core Element 4: Food Safety Culture. According to the Safe Food Alliance, “Food safety culture refers to the specific culture of a facility: the attitudes, beliefs, practices, and values that determine what is happening when no one is watching. A strong culture of food safety helps a facility both to prevent and catch deviations in their processes that impact the safety, quality, and legality of their products.” Improvements in food safety, foodborne illness, and outbreaks depend largely on food safety culture, even more than technology. A strong food safety culture has always been a prerequisite to effective food safety management and that will continue in the New Era. Blueprint actions include:

• Promoting food safety culture throughout the food system
• Further promoting food safety culture throughout the Agency
• Developing and promoting a Smarter Food Safety consumer education campaign

Incorporating into Operations

As FDA has recognized, there is a real need for more “real-time, data-driven, nimble approaches to help ensure a strong and resilient food system”. The New Era of Smarter Food Safety Blueprint is FDA’s way to get there. It will be up to players in the food industry to take the core elements of the blueprint and begin to incorporate them into operations. As FDA rolls out this initiative, organizations should consider doing the following:

• Implement an information management system to help coordinate, organize, control, analyze, and visualize the information necessary to remain in compliance and operate efficiently.
• Conduct third-party assessments to provide an outside perspective of food safety systems and compliance/certification.
• Explore technological advancements that allow for further digitization and promote more timely and accurate collection and management of important data.
• Conduct root cause analysis, as needed, to identify underlying issues and ensure similar problems do not occur in the future.
• Build a strong food safety culture that focuses on changing from a reactionary to a preventive mindset that promotes safety and quality.