While the first half of 2020 has seen a decline in product recalls due to the FDA’s lax of regulation pressure during the pandemic, the FDA recently released its “New Era of Smarter Food Safety: Blueprint for the Future” as a warning that the pressure will soon return with greater force.

New FDA Strategy

This blueprint outlines how the agency plans to achieve Recall Modernization in the midst of a food revolution—a time where we will see more changes in the food system over the next 10 years than we have over the past several decades. The FDA planned to unveil the blueprint in the spring of 2020, but the strategy was paused to focus on COVID-19 pandemic response efforts. The pandemic challenges, however, have emphasized a greater need for this modern approach to ensure our food supply remains safe, now more than ever.

In the strategy document, the FDA indicates that while they have made advancements in food safety over the past decade, rates of foodborne disease in the U.S. have not changed significantly. The FDA’s ultimate goal is to bend this curve by reducing the number of illnesses. “This will be achieved by building on the current work to create a modernized food safety regulatory framework while leveraging the use of new and emerging technologies and approaches to strengthen predictive capabilities, accelerate prevention, speed outbreak response, and enhance adaptability to crises that could affect the food supply.”

Also, the FDA plans to “engage a broad expanse of stakeholders in industry, academia, trade associations, and consumer groups, as well as our state, federal, international and other regulatory partners, and groups…such as technology companies.”

Four Core Strategic Elements

The strategy includes four core elements that will help the FDA modernize the recall process, these include:

  1. Tech-Enabled Traceability: Many records in the supply chain are still paper-based and this is considered an “Achilles heel” that hinders significant progress in rapid trace-back efforts. This strategy will encourage companies to adopt tracing technologies and will also harmonize efforts to follow food from farm to table. While the FDA cannot mandate that companies adopt a technology-based system, they want to encourage and incentivize industry adoption of new technology, such as blockchain, to enable more effective processes to rapidly trace contaminated food to its source – in “minutes, not days, weeks, or even longer.”
  2. Smarter Tools and Approaches for Prevention and Outbreak Responses: Enhancing and strengthening root cause analyses and predictive analytics capabilities through expanded use of AI and machine learning tools while using remote, virtual, and/or component inspections of foreign and domestic firms. Improving consumer notification processes through web, social media, text messaging, email, alerts, digital prompts and a USG app.
  3. New Business Models and Retail Modernization: Looking to address how to protect foods from contamination as new business models emerge, including online shopping or delivery services like UberEats. Also, identify new vulnerabilities, provide educational resources, encourage technology automation to monitor product risk factors, and increase risk-based inspection approaches.
  4. Food Safety Culture: Increasing efforts to influence beliefs, attitudes and behaviors of people and the actions of organizations—on farms, in food facilities and in homes. Some initiatives include implementing an FDA food safety culture social marketing plan and using tech-enabled popular tools, such as Smart Home devices, smart phones and digital platforms to reach consumers with Smarter Food Safety messages.

As the FDA drives to modernize our food system through enhanced technologies, new protocols and procedures, and a better means of public awareness, we can only expect that companies will be more vulnerable to product recalls and public scrutiny. As a result, product recall and contamination insurance coverage will be even more of a necessity.  

RESOURCE

Stephen M. Hahn M.D., “FDA Launches New Era of Smarter Food Safety Initiative, Releases Blueprint and Pilot Study”, July 13, 2020, https://www.fda.gov/news-events/press-announcements/fda-launches-new-era-smarter-food-safety-initiative-releases-blueprint-and-pilot-study

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