Rounding out the education sessions on Wednesday of the 2022 Food Safety Summit, Session 9 examined how to improve food recalls. Speakers included Steve Mandernach, J.D., Executive Director of the Association of Food and Drug Officials (AFDO); Lisa Hainstock, Food Safety Specialist with the Michigan Department of Agricultural and Rural Development (MDARD); Jennifer Pierquet, Project Manager at AFDO; Mitzi Baum, CEO of STOP Foodborne Illness; and Erik Mettler, Assistant Commissioner for Partnerships and Policy within the Office of Regulatory Affairs (ORA) in the U.S. Food and Drug Administration (FDA).
Ensuring food safety is a fundamental duty of regulatory agencies, including federal, state, and local government agencies. However, these agencies have not always been successful at working collaboratively to achieve success. FDA’s New Era of Smarter Food Safety ties together steps for innovation and more efficient approach for change, and FDA’s Blueprint for the Future is a focal point for recalls. AFDO recently released a whitepaper calling for modernization in the recall process to take unsafe food off of store shelves faster and reduce the number of consumers who become ill from contaminated food.
Communication is Key between States and FDA
After Mr. Mandernach introduced the panelists, Ms. Hainstock noted that some good relationships have developed between regulators and industry, but that FDA's policies and procedures "are neither agile nor quick." Increases in communication and information-sharing are required to remove product from the market more quickly.
Ms. Hainstock also shared that FDA and the Michigan Department of Agricultural and Rural Development (MDARD) do not always see eye to eye, such as when it comes to food sampling. MDARD prefers to inform companies immediately if a contaminated product is discovered, but FDA standards for laboratory work may require one to two days before FDA will assign an official to address the contamination issue. "Why does the review process have to add such a delay?" Ms. Hainstock hypothesized. "We're finding workarounds to help industry and protect our customers."
Another example of disagreement between FDA and MDARD concerns information-sharing and distribution lists. Ms. Hainstock used the example of the recent infant formula recall due to Cronobacter sakazakii contamination. MDARD knew that the formula had been widely distributed in Michigan, but the Department ran into difficulty in obtaining the distribution lists for the recall. "A lack of timely distribution information isn't always the fault of FDA, but it causes problems," Ms. Hainstock acknowledged. MDARD and FDA also sometimes disagree about whether or not a situation warrants a recall. "I would like very much for FDA to look at these situations a little closer, particularly the lab accreditation issue, so that recalls can happen a little faster," Ms. Hainstock said.
Getting Ahead of the Epi Curve
Ms. Pierquet next read aloud a passage from author Deborah Blum's book, The Poison Squad, which traced the evolution of food safety regulation in the U.S. and showed a pattern of reactive legislation, rather than proactive policy-making. "Why does this matter to recalls?" Ms. Pierquet posited, and went on to discuss the Peanut Corporation of America's massive 2009 recall as an illustration of a crisis that spurred foundational legislation, such as the 2011 Food Safety Modernization Act (FSMA). Although AFDO's recently published whitepaper on recall modernization and improvement is an analysis of the past, "We want to move forward into the future, because we want to avoid these kinds of doom-and-gloom scenarios," Ms. Pierquet said.
The AFDO whitepaper underlines the need for urgency around Class 1 recalls. "We need to move quickly with good data to get closer to a recall, so we can get on top of the epi[demiological] curve," she said. The whitepaper also stresses the need for better communication and information-sharing between FDA and state and local health agencies, as well as improved consistency in sharing recall data, such as the distribution lists discussed earlier by Ms. Hainstock.
Also, FDA and states do not currently train together for recalls, but Ms. Pierquet believes this should change. She also believes that FDA should reexamine the values around recall response and facilitate changes in food safety culture. "FDA needs to be 'all in' on fundamentally reevaluating and changing recall culture so we can move forward in a cohesive manner," she said.
Food Safety is Personal
Ms. Baum opened her remarks by saying, "It's really important that we ground ourselves in the one person who impacts us," and proceeded to tell the story of a man who visited the STOP Foodborne Illness office and shared with Ms. Baum's staff the story of his mother, a two-time cancer survivor, who passed away in 2009 from foodborne illness caused by Salmonella. Ms. Baum noted that food safety regulations, at their core, are created not for industry, but for consumers.
"Are we acting with a sense of urgency? I'm sure in many cases we'd say no, and I'm sure in FDA's case they'd say 'we're working as quickly as we can' … but public health is what we're talking about when we're talking about recalls, and we need to do recalls as quickly as we can," Ms. Baum said. She stressed communication as the most important element in recall modernization, as well as being an essential tool in many of the core elements of FDA's Blueprint for the New Era of Smarter Food Safety.
An Integrated Food Safety System
After joking with the audience, "You're probably wondering why I'm part of this panel," Mr. Mettler stressed the importance of cooperation in an integrated food safety system and the need to listen to one another. "We have to be open and looking for opportunities," he said. Mr. Mettler also thanked AFDO for sending its recall modernization whitepaper to FDA, which he commended as featuring "many good points."
"With an integrated food system, we really have to look at each other as partners in the system," Mr. Mettler said. "It can't be just regulatory, not just state or local, not just industry, and not just consumers. We all have to work together to achieve this."
The 2022 Food Safety Summit is taking place in person at the Donald E. Stephens Convention Center in Rosemont, Illinois from May 9–12. Stay tuned for more conference coverage!