FSMA Fridays: High-Risk Food Methodology (Part Two Of Four)

Safety Chain’s Barbara Levin discusses the FDA’s proposed methods for handling high-risk foods under FSMA with the Acheson Group’s David Acheson and Jennifer McEntire

On the last Friday of every month, Barbara Levin of SafetyChain, a leading provider of food safety and quality assurance automation and compliance solutions, hosts FSMA Fridays™, the leading online forum for the food and beverage community to learn the latest information about the FDA’s Food Safety Modernization Act (FSMA). Featuring Dr. David Acheson, the popular monthly interactive pod/webcast is sponsored by SafetyChain Software and The Acheson Group.

In the first portion of FSMA Fridays: High-Risk Food Methodology, Safety Chain’s Barbara Levin discussed the use of the FDA’s proposal to determine high-risk foods and the factors that go into determining what a high-risk food with the Acheson Group’s David Acheson and Jennifer McEntire. Here, in part two of high-risk foods, the panel addresses questions about FDA practices for analyzing high-risk foods, the concerns about the scoring system for high-risk foods, and some of the steps that will be taken moving forward with them.

Barbara: David, let's come back to you. Is the FDA going to do this analysis, that Jennifer was just speaking to, for every single food product, and if they're going to do that, where are they going to get the data?

David: Well, good question. There's no way that the agency can do this for every single food product. As Jennifer's gone over in the previous answers, they're looking at a lot of parameters. I just don't see how they can possibly do this for every single food product. I do see them trying to bunch food products, commodities together in the context of risk profiles, so I think that there's going to be buckets of food, so to speak, that will be put together in terms of the higher risk and the non-higher risk. They just need to see how they actually navigate through this.

In terms of where they're going to get the data, again, as Jennifer said, they want to look at a whole lot of parameters. In terms of the parameters that the regulators are looking at, I think they're good parameters, but let's face it. The data available on many of them is really, really thin.

It's going to be a real challenge, and it floats us back to the perennial problem, is that often, the private sector has data that would help inform the agency. But there is this reluctance to share it, particularly if you would voluntarily share data that might fit the food that you make into the high-risk category. You wouldn't want to do that. The incentives for producing that data are not exactly robust, to say the least. I think there's a big challenge, and one of the messages, from all of this high risk food-type work is it is absolutely going to need to be a work in progress, and I hope that none of it gets set in stone, moving forward, because the data's going to change, the information's going to change.

What is designated as high-risk/low-risk will change, certainly, as we've seen. Low-risk food becomes high-risk food when certain things happen, and outbreaks occur in products that we've never seen cause a problem before or haven't recognized as being a problem, and everybody on the phone is going to recognize that peanut butter is a classic example of that one, over the last five or ten years. I think this is going to have to be fluid. There is a complete absence of data for much of this stuff, and that's going to be one of our challenges, no question about it, which means that they're not going to be able to do it for every single food. That's the thought for now, Barbara.

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