In the white paper, which can be accessed here, the team starts by examining two basic problems associated with food recalls: No. 1, consumers continue to become ill from recalled products that are consumed after the issuance of a recall announcement, and no. 2, the issuance of a recall and communication around it is typically done too late in the outbreak investigation to prevent additional illnesses.
The paper goes on to say that while the Food and Drug Administration (FDA) has made efforts to address improvements around its recall activities, more is needed to adequately protect consumers. It also says that the release of the FDA’s New Era of Smarter Food Safety Blueprint calls for smarter tools and creative approaches for prevention and outbreak response, including recall modernization. AFDO is urging the FDA to do just that: creatively explore new perspectives, innovative policies and out-of-the-box approaches to implement the recommendations included in this paper.
We caught up with AFDO Executive Director Steven Mandernach for a Q&A about the white paper, his big takeaway, who should read it and more.
Quality Assurance & Food Safety: Why was this white paper something that was important for AFDO to publish?
Steven Mandernach: It goes back to the fact that we see that we continue to see illness after the point of a recall, and that is very concerning to us. In some of these recalls, we’re seeing a number of illnesses happen after the fact. And it makes you think that perhaps there’s some work that can be done to improve it.
The other challenge that I think we always see is that overall sharing of information and the timeliness of information both become a big challenge during a recall. First, you need that in order to make good decisions in a quick and prompt manner. And secondly, you need to be able to share it with the folks that can ensure that the product is indeed off the market. Those two things are areas that we continue to see challenges in. We’ve been discussing for the last decade and just haven’t quite got those resolved.
If you go back and look at some of the court documents, the OIG reports and the GAO reports, a lot of this isn’t rocket science. It’s been identified for over a decade, or in some cases almost 20 years, as needed improvements, particularly in the FDA recall system. We’re still not there.
Our work was happening pretty much simultaneously with STOP Foodborne Illness, who also did a pretty large amount of work in the recall space and has issued some beginning thoughts on what needs to happen on recalls.
We also did a pilot project that really changed how recall audits were done, automated that process and actually allowed for reporting all the way up. So once a recall audit was done, no matter what level was done, everyone through the system could see the metrics happening as they go and where there might be problem areas that the recall was not effective.
QA: Some of the charts in the white paper are really stark, showing how much illness happens before the recall starts.
SM: Absolutely. And that’s the thing: Even if you could move the recall ahead by four, five or six days, you’d really have the potential to impact who gets sick and who doesn’t.
There are some key things that I think you’ll see as you go through the white paper. One of the things that the USDA FSIS and FDA approach very differently is the classification of recalls. Once the recall was initiated, FSIS almost immediately classifies it because that impacts what the firm needs to do, how it needs to approach it and how FSIS will approach the recall. For the FDA, it is often weeks if not more than a month later. That puts it in limbo, and no one knows exactly where it’s going to be.
Everyone takes a guess, but there have been times where people were wrong and ended up with something that they thought was a class two, but it was actually a class one recall. That just shouldn’t happen.
The thought that it needs to take the overall regulatory system months to classify a recall is just wrong. Even weeks is too much. That’s something we should be able to figure out very, very quickly.
QA: How do the ideas and recommendations in this white paper address the disconnect when it comes to informing consumers?
SM: What an average consumer thinks is the responsibility of the FDA with a recall, and what their actual responsibility is, are two pretty different things. The current agency view is that their job is to measure whether the recall was effective, and if it was not, to take regulatory action. That’s a very after-the-fact activity, and that really, in all honesty, does not protect public health because it is ineffective. There’s nothing you can do to fix it at that point.
If we are truly a public health-centric food safety system, we have to move to the other direction of ensuring recalled products are off the market, which is really a little more similar to how FSIS overall approaches recalls. They’ve done a lot of really good things over the last decade. They’re modernizing their process and making it a much more effective process.
QA: Who should read this white paper?
SM: It really sort of it everybody. There are pieces of this that are definitely consumer oriented and at least would help those that are working in the consumer advocacy area to identify some things that they should be requesting, asking or demanding. I would argue demanding in some instances.
The industry is very much engaged in this process. There’s nothing in this report that would be a shock to a recall coordinator anywhere in this country, and it really does talk about some of their main pain points, classification being one of them. Waiting weeks or months does not work. That is not a good system.
The other thing that we face is the lack of information sharing, particularly if the FDA obtains a distribution list and is unwilling to share those elsewhere. Then that means you can end up with 20, 30, 40, 60 different jurisdictions contacting the firm when they’re in this emergency situation and really shouldn’t be dealing with all those requests. But they’re responding to requests for the same information that has already been provided to the federal government, and that’s not being shared with others. That just doesn’t make any sense. That’s not a good use of anyone’s time, and the American consumers deserve better.
QA: What’s your big takeaway from the white paper?
SM: I was a little disappointed that some of the key recommendations from previous reports were really not dealt with in a substantive manner. Whether you’re looking at the OIG or GAO reports, all of them are saying basically the same thing. Some of the key things from all the way back to over 20 years ago still remain as challenges. That just doesn’t seem like it’s effective and what we would expect out of the FDA.
QA: What do you expect reader takeaway to be?
SM: I think it’ll be that it’s time to work in this area, and it’s definitely an area that everyone can do better. I think all levels of government, the firms and consumers all have a role in this effort. All of us could perform better than we are today.
QA: Why is this white paper coming out at an important time?
SM: Having two major national organizations, AFDO and STOP, really focused on recalls at the same time over a three-year period of time, both with industry, consumers and our regulators engaged, that tells you something. Both have similar conclusions. (I would argue we might be a little more in the process weeds because we’re a little more engaged on the process side, and they might be a bit more on the consumer side because that’s who they represent.) But to have two major national organizations exert this much effort on recalls is a sign that something needs to be done.
We’ve spent a lot of time thinking about it and talking about it. We’re at the point where we’ve got to start taking some action. This is the right thing to do for consumers. There’s just no excuse for us not to do better.
As a person who’s been in public health for 20 years, the last thing I want to see is someone get sick after we know there’s a problem.