A scientist on the FDA’s Foodborne Parasitology Research Team works on a test for detecting foodbor ( Courtesy FDA )

The clock is ticking for the Food and Drug Administration’s determination of “high-risk” foods and what traceability/record-keeping standard those foods should meet.

In June last year, the Food and Drug Administration agreed in a consent decree to act by Sept. 8 this year to designate a list of high-risk foods and a proposed record-keeping rule for those same foods.

The consent decree was an outcome of a lawsuit filed in 2018 against the FDA by consumer groups Center for Food Safety and the Center for Environmental Health. Those groups said the FDA was in clear violation of complying with the Food Safety Modernization Act mandates in publishing the list of high-risk foods.

The FSMA legislation required FDA to designate high-risk foods by January 2012 and to propose recordkeeping requirements for facilities that handle those foods by January 2013.

The court’s consent decree deadline to produce a final rule, including record-keeping requirements for high-risk foods, is Nov. 7, 2022.

In creating the list of high-risk foods, the FDA will consider:

  • Known safety risks of a particular food;
  • Likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
  • The point in the manufacturing process of the food where contamination is most likely to occur;
  • Likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
  • Likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
  • Likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

Bill Marler, food safety lawyer with Seattle-based Marler Clark LLC, said in a 2019 blog post that he thinks the high-risk food list should include raw milk and products made from it, raw juice, raw sprouts, pre-cut fruit and vegetables (including leafy greens), raw shellfish and uncooked flour.

The FDA’s rulemaking process will be closely watched by the industry, said Trevor Suslow, vice president of food safety for the Produce Marketing Association.

While the FDA may designate higher-risk food basked on frequency of outbreak, Suslow said the distinction could just as easily be higher-risk practices.

“We need to very careful about no blanket categorization of high-risk foods,” he said. 

“Once something is on that list it will reside there forever, more likely than not.”

For Jennifer McEntire, vice president of food safety and technology for the United Fresh Produce Association, the FDA list should be considered a list of priorities.

“I don’t think anyone wants to call it high-risk foods, but that’s what it is, according to FSMA,” she said. 

McEntire said United Fresh will have web seminars in October and November to talk about the proposed rule and what is in it.

With the final rule not expected until November of 2022, there will be ample time for industry input, she said.

“I think many of us are hopeful that once we see the proposed rule, as long as it’s reasonable, the industry will begin to move towards (voluntary) compliance in preparation for the final rule.” 

McEntire said she doesn’t believe the FDA will require anything different than what’s already recommended today.

McEntire said Congress put some limitations on what the FDA could mandate, and the rule will reflect the agency’s New Era of Smarter Food Safety.

The FDA has said priority areas for the “New Era of Smarter Food Safety” include:

  • Tech-Enabled Traceability and Foodborne Outbreak Response: Looking at technologies, data streams and processes that will greatly reduce the time it takes to track and trace the origin of a contaminated food and respond to public health risks; 
  • Smarter Tools and Approaches for Prevention: Enhancing the use of new knowledge from traceback, data streams and tools for rapidly analyzing data;
  • Adapting to New Business Models and Retail Food Safety Modernization: Advancing the safety of both new business models, such as e-commerce and home delivery of foods, and traditional business models, such as retail food establishments; and 
  • Food Safety Culture: Promoting and recognizing the role of food safety culture on farms and in facilities. This involves doing more to influence what employees and companies think about food safety and how they demonstrate a commitment to this work. Strengthening food safety cultures also extends to the home and FDA is working to educate consumers on safe food handling practices.

Considering that it has been almost a decade since Food Safety Modernization Act has passed, McEntire said “new era of smarter food safety” will encourage voluntary adoption of the systems that are available today. 

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