After first year, FDA ready to invest in New Era’s future | #education | #technology | #training


PHOENIX — Maybe you remember something about the New Era of Smarter Food Safety. You might think it was longer ago than it was, but it was only a year ago that FDA’s Frank Yiannas of shared his brainchild for future food safety.

The trouble is that what you’ve heard since has not told you much if anything about this “New Era.”

Well, today at the meeting of the International Association for Food Protection (IAFP), more details were filled in, leaving attendees with at least an understanding of what’s really going on.

The New Era is FDA’s “new approach to food safety, using technology and other tools to create a safer and more digital traceable food system.”

Okay, but what does that mean?

The IAFP offered up some experts to answer that question in a super-cooled ballroom at the Phoenix Convention Center.  They included Nathan Anderson and Andrew Kennedy from FDA’s campus in Silver Springs, MD, along with Aaron Asmus with Hormel Foods in Austin, MN, Derrick Bautista with Del Monte Foods in Walnut Creek, CA, and Pamela Wilger with Cargill Inc. from  Wayzata, MN.

As it turns out, FDA’s announcement a year ago was not like a corporate campaign roll-out that takes place in a fixed order. The panel of insiders from several of America’s largest food manufacturers admitted that during its first year the “New Era” was a “bootstrap” operation.  Part of that was due of course to FDA’s focus on the pandemic and the other was the project’s undefined purpose

And after that year, the New Era might be better positioned than it expected going in increased budget possibilities next year, according to FDA’s Anderson.

But as for what the New Era is all about, it was made clear. FDA wants the companies it regulates to go digital. And companies like Hormel, Del Monte, and Cargill were there to show how much they like to do that, but to spread a cautionary tale about how difficult and how long it is going to take.

Food manufacturers produce tons of paperwork. Until replaced with digital solutions, all that paper is going to slow down FDA’s move into the future with, for example, easy traceability.

As reported Tuesday, major food companies are working on the transition now, but the move from paper systems to digital could take five to ten years.   

When FDA announced it a year ago, it did predict New Era’s  “blueprint” would “take over the next decade to usher in the New Era of Smarter Food Safety.”  It did claim its goals were “achievable” to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures.  

Early on,  FDA said the COVID-19 pandemic “accelerated the need for actions called for in the blueprint, especially in times of crisis.”

For the applicable part of FDA’s budget, first-year “bootstrapping” involving the New Era has resulted s a $52 million budget submission from the Commissioner, up by $44 million, according to Anderson. “This increase in the budget is a real sign of confidence,” he said.

But it was unclear whether FDA is going to be able to help private companies adapting their new systems to the New Era with their costs. And as food safety functions are going to require help from informational technology and even cybersecurity personnel, those costs are only going to increase. “We have to hire IT people to become part of the food safety team,” said Cargill’s Wilger.

New attention is going to so-called “cybercrime” where there’s been the potential for actually hurting people, such as poisoning water systems or adulterating food.  Food defense against so-called “intentional adulteration” is required by the Food Safety Modernization Act of 2011. Added security, however, almost always means IT projects take more time, according to today’s panelists.

The blueprint for the New Era of Smarter Food Safety was announced in July 2020. In FDA Voices, Janet Woodcock, M.D., Acting Commissioner of Food and Drugs, and Yiannas, Deputy Commissioner for Food Policy and Response provided details.

Here are its major elements for2021.

Core Element 1: Tech-Enabled Traceability

  • Continue to advance food traceability fundamentals as FDA transitions from a proposed to final Food Traceability Rule, as required by FSMA Section 204.
  • Work with international regulatory partners to create a common global, harmonized food traceability language based on harmonized data elements and standards.
  • Hold a “Low- or No-Cost Food Traceability Challenge” to incentivize the development of tech-enabled solutions for food producers of all sizes.
  • Develop and pilot prototype to allow FDA to receive traceability data in digital form that can be used to create outbreak investigation diagrams and improve outbreak response.

Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response

  • The complete operational phase of a seafood artificial intelligence (AI)/machine learning (ML) pilot to see if AI can improve our ability to quickly and efficiently identify products that may pose a threat to public health.
  • Enter into domestic mutual reliance agreements with at least three states to further strengthen the federal-state food safety net.
  • Initiate a feasibility study on the use of remote regulatory assessments as an adjunct to compliance oversight for human and animal food firms.
  • Complete the pilot of assessing third-party food safety standards to determine if they align with certain FDA food safety requirements.

Core Element 3: New Business Models and Retail Modernization

  • Continue collaboration with national retail regulatory associations and the Centers for Disease Control and Prevention (CDC) to support the FDA’s efforts to advance the safety of foods sold in traditional retail establishments.
  • Convene a public New Business Model Summit in 2021 with food e-commerce stakeholders to identify a future courses of action to address potential food safety vulnerabilities.

Core Element 4: Food Safety Culture

  • Develop and launch internal training for FDA inspectional staff to introduce them to behavioral and organizational principles that make up food safety culture. Evaluate the feasibility of offering this training to state regulatory inspectors.
  • Conduct a literature review on challenges, barriers, and opportunities to influence attitudes and behaviors related to desired food safety practices.
  • In collaboration with the Partnership for Food Safety Education, support the modernization of consumer education materials to include delivery via new tech-enabled mediums and messaging on the safe handling of foods delivered to their homes.

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