During the Food Safety Summit, held May 6 – 9, 2019 in Chicago, AFDO Executive Director Steven Mandernach was part of an interactive town hall discussion that included representatives from the USDA, CDC and FDA. What follows are Mandernach’s opening remarks in an effort to share this message with a wider audience.

Remarks for Town Hall Session

Food Safety Summit

May 9, 2019

Steven Mandernach, Executive Director, AFDO

Introduction

Good morning. It’s a pleasure to be visiting with so many passionate food safety professionals. AFDO greatly appreciates our strong partnership with the Food Safety Summit. Thank you for the opportunity to participate in the Summit and this session. Also, congratulations, to Joe Corby, my predecessor and mentor, on receiving the NSF Food Safety Leadership Award. I can’t think of a food safety professional more deserving. Like so many in the room, I think Joe has been an inspiring mentor.

Background about AFDO

The Association of Food and Drug Officials (AFDO) has existed since 1896, since that time advocating for uniform science-based food and drug laws including the establishment of the precursor to the FDA. In my role as the Executive Director of AFDO, I spend much of my time working with food safety stakeholders such as federal, state and local regulators; industry; consumer groups; and trade associations.

Introduce Theme of Recalls

Today, I’m going to focus on one of the themes that has emerged through these conversations: RECALLS. When I discuss recalls, we’re going to focus on what should be class I recalls -- those where there is a reasonable probability that eating the recalled food will cause serious adverse health consequences or death.

Let’s take a step back before we get too far and establish a common understanding. Until recently, I was a state regulator. In my mind, everyone in the food safety system had exactly the same purpose in recalls—ensuring the recalled product was removed from the market quickly to minimize the potential for additional bad outcomes for consumers.

Industry wants to get the product off the market as quickly as possible so additional customers aren’t potentially harmed and to limit potential liability and brand damage.

State and local regulators are typically working in their public health role. They are trying ensure where the product is known to be distributed, it has been removed from the market limiting the potential for adverse consequences for their residents and constituents.

The Federal agencies — FDA and FSIS — approach recalls a bit differently.

• · FDA recall policies suggest the FDA seeks to publicize the recalled product, evaluate whether the recall is effective, classify the recall, and verify the firm has corrected the circumstances that allowed for the recall to occur.

• · FSIS takes a bit different approach when you review their policies and procedures in that it has an added role of ensuring the product is no longer in commerce.

What do the food consumer’s expect? Don’t they simply expect the food they purchase is safe and not going to harm or kill them? It’s reasonable in the United States that should be the case.

From the public’s perception, perhaps we all need to focus on a little more is ensuring the product is removed from the market quickly. The food safety distribution system isn’t getting simpler. Every internet-user is a potential food marketer often with no understanding of food safety. As a former public employee entrusted with responsibility of food safety for a state, my nightmare was an individual getting ill from a product that had been recalled and was purchased after the recall was announced. This type illness is 100% preventable and should not happen if we have strong systems in place.

During this process of discussions with various groups, it became clear to me that the roles of parties involved in recalls were not always the same. For example, getting the lists of firms where recalled product was distributed to….for FDA this seems to be a function of getting information to find further distribution points and to determine if a recall has been effective normally well after-the-fact. For FSIS, state, and local agencies, they are seeking distribution lists for the public health purpose of quickly ensuring product is off the market in their states and communities.

I didn’t get these differing purposes until I read the federal agencies recall policies and procedures. Visiting with colleagues across the food safety system, it became clear this was not a commonly understood point. One of the pain points I learned from industry was in a national recall they were receiving upwards of 60 distribution list requests from regulatory agencies — some simply requesting the field or columns in a different order. Imagine, if all of us in the food safety system, could instead focus on the effort ensuring product was removed from market. Might this be more effective?

Additionally, for the many dual jurisdiction facilities and manufacturers with both FDA and FSIS oversight, the process varies significantly between the organizations, but why? Is this difference supporting the best public health outcomes? Could we get to a more unified and simplified process to limit the confusion in these high stress emergency events by and moving toward great consistency between the agencies?

In 2020, we are in an age of artificial intelligence. Our cell phones can know where we parked and guess where we are likely to uber to next, why can’t we get to the point where one regulatory/public health agency, perhaps the home state, could collect the distribution information nationwide, send it through an AI system and which results in notification of regulatory authorities across the country in minutes about recalled product that had been delivered to their jurisdiction. This system could also present the information in the manner the jurisdiction needs to take action, and perhaps even have incorporated an ability for public health regulators to record verification of product removal. Visiting with consumer groups and consumers, I believe this is their expectation and shouldn’t it be?

On the industry side, there are a few opportunities, too. Better abilities to track product….as a regulator dealing with many outbreaks, it was always frustrating that we couldn’t get to the point of knowing what lot went where? Why? Ironically, it was one of my smallest processors with a recall that we were best able to trace the produce….the lot number was on every invoice, it was amazing how effective this simple practice was. I suspect we might hear more about the concept of traceability in a few minutes.

During recall events, we hear concerns about confidentiality of distribution information—for example, industry involved are reluctant to share information and FDA and FSIS are restricted by federal confidentiality laws from distributing information to state and local officials. Does this really make sense? Would the American consumers that receive these products take the position that this is confidential information and we can’t provide information about distribution of this product? I am encouraged by the comments from former FDA Commissioner Gottlieb and others that we can move further in this area.

This year, AFDO has been bringing together groups of stakeholders from regulatory programs, processors, distributors, and retailers to further examine recalls and rethink and ultimately, by this time next year begin to demonstrate ways our collective food safety system can improve recall effectiveness and focus recalls as a public health measure.

Regretfully many of us will be involved in recalls over the next year, I want to encourage everyone at all levels to think what your organization’s role is in a recall and start refocus on a recalls primary purpose — to protect public health and prevent serious injury or death. AFDO will continue to work with stakeholders to advance, pilot, and improve this system.

Thank you again for allowing me to visit with you this morning.

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