( Courtesy FDA )

The Food and Drug Administration's New Era of Smarter Food Safety and corresponding “blueprint” that guides the process are not a quick fix to outbreaks that led regulators to seek new answers.

The FDA, which released the New Era details and blueprint on July 13, said it’s a 10-year plan. As expected, it leans heavily on technology, particularly in traceability and outbreak responses.

Former FDA Commissioner Scott Gottlieb, whose tenure included several E. coli outbreaks linked to romaine lettuce, voiced concerns about the lack of technology hampering investigations, and said it would be a priority for the FDA.

In introducting the New Era plan, FDA Commissioner Stephen Hahn on July 13 said it’s important the technology is used “to build and put in place more effective approaches and processes.”

The blueprint plan has four core elements:

  • Tech-enabled traceability;
  • Smarter tools and approaches for prevention and outbreak response;
  • New business models (such as e-commerce) and retail food modernization; and
  • Food safety culture.

Hahn said the blueprint to implement the New Era builds on the work the FDA has taken with the Food Safety Modernization Act, and is the next stage in the process. 

Each of the core elements are assigned leaders from the FDA’s foods program.

“We want to explore ways to encourage companies to adopt tracing technologies and also to harmonize efforts to follow food from farm to table,” Hahn said in his statement. 

“We should strive to speak the same language, by espousing similar data standards across government and industry for tracking and tracing a food product.” 

'No surprises'

Jennifer McEntire, the United Fresh Produce Association’s vice present of food safety and technology, said the blueprint doesn’t include any surprises, and is a “solid outline of where food safety should be headed.”

Questions, McEntire said, include:

  • Will early adopters be rewarded by customers/consumers for embracing some of these initiatives?
  • What will incentivize those who lag behind?
  • And who is going to measure progress over these next 10 years?

“The blueprint covers a lot of ground and I’m curious to see the areas that move quickly and the ones we’re still talking about a decade from now,” she said.

Trevor Suslow, vice president of produce safety at the Produce Marketing Association, said the blueprint has few unanticipated, but all generally welcomed framework elements to advance food safety. Trade associations will continue to be involved in the process, he said.

“One key opportunity for the produce industry is to respond to the oversight management incentives described by FDA by moving beyond mere baseline compliance with investment in broad advancements in food safety systems, including end-to-end traceability and verifiable food safety culture,” Suslow said.

Preventing outbreaks

Inside the FDA, plans include strengthening procedures and protocols for conducting root cause analyses to understand how food becomes contaminated in the hopes of preventing it in the first place.

“Another example of the kinds of new tools we’re developing for prevention can be seen in a pilot program we’re conducting that will leverage artificial intelligence and machine learning to strengthen the agency’s review of imported foods at ports of entry to help ensure that they meet U.S. food safety standards,” Hahn said in the statement.

Hahn said the FDA was days away from announcing the blueprint details in March when the pandemic delayed it and work turned to address COVID-19. 
“In the months that have followed, it has become even clearer — from our experiences with the pandemic and the lessons we have been learning as part of the FDA’s response to it — just how essential the actions outlined in this blueprint are and, if anything, that they are more important now than ever,” Hahn said in his statement.

According to the blueprint, the FDA plans to engage members of the industry, academics, trade associations, consumer groups and regulators agencies and groups it traditionally has not worked with before, including technology companies.

“We recognize that building on our food safety approach in a rapidly evolving and interconnected world will require resources and innovation,” according to the blueprint. 

“Continued investments throughout FDA and the food safety system will be critical to improving public health and reducing supply chain disruption.”

The FDA has a FAQ list  on its New Era for Smarter Food Safety website.

A 10-year plan

In a July 13 media call, Frank Yiannas, deputy commissioner for food policy and response for the FDA, said some of the document’s aspects will be addressed by the end of the year, but the FDA sees the blueprint as a decade-long pursuit with evolving activities.

One of the issues the agency is working on right now is Section 204 of the FSMA: Enhancing Tracking and Tracing of Food and Recordkeeping, a component of which requires the FDA to designate high-risk food that would require additional recordkeeping.

During the media call, Yiannas said the “one step forward, one step back” model of traceability is no longer the goal, and although Section 204 doesn’t address technology or set an end-to-end traceability standard, that’s the desired goal.

“We are approaching that rule with what we call a 21st-century mindset,” he said. 

“We are limited by what we can say about rulemaking, but what I can say to you is that we are being thoughtful and thinking about what our key elements for traceability purposes are.”

The blueprint doesn’t ban paper records, but it is becoming increasingly difficult to meet expectations, and retail partners are becoming more aware of supplier’s methods and exerting more pressure on growers to modernize. 

He said the concept of a linear “supply chain” doesn’t apply to the food supply, and he prefers “food system.”

“The idea or notion that everybody can get into a central database and track foods easily is just too simplistic, so what we’re trying to do is to be very intentional and strategic,” Yiannas said.

Many outbreaks are linked to foods bought at retail and not foodservice, he said, and the FDA is interested in a retail food safety summit to address the issue.

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