I had the chance to chat on Sept. 14 with Jennifer McEntire, senior staff scientist and director, Institute of Food Technologists.
11:45 a.m. Tom Karst: I wanted to ask you about IFT involvement in the FDA pilot traceability programs. Are you getting some good reaction in the industry about what you are doing? Are you excited about the task ahead?
11:45 a.m. Jennifer McEntire: For the most part, yes. It is a little overwhelming at times. We have definitely have gotten a lot of interest from the technology providers, which is not surprising. Since our first report in 2009, many of the technology providers have been in regular communication with IFT about what their doing, their developments. For the past several months, I’d say some of the food industry and trade associations have also expressed interest. I think a lot of people are a little bit nervous about how this is going to be conducted, how it will play out. We’re trying lend some clarity to the process now. Of course I see some of the comments on LinkedIn and overhear things that cause me a little bit of concern but I heard similar types of concern in 2009 and I think we did a good job and I’m pretty confident we can do a good job again.
11:47 a.m. Karst: Have we come close to identifying potential participants in the study or is that still a work in progress?
11:48 a.m. McEntire: It is definitely a work in progress. In terms of identifying the food products, the Food Safety Modernization Act does specify that the products need to be those associated with outbreaks over the last couple of years. So there is a finite list there. We just announced today that we will be having stakeholder input sessions - three of them at a minimum - and also offering people the opportunity for written comments. The meetings are Oct. 3 in Seattle, Oct. 5 in Washington, D.C. and then Nov. 2 in Chicago. For the earlier meetings in particular, we have not put out the questions that we want people to respond to you, but one of those questions does pertain how to select the product and how to select the factors that should be considered in selecting a product, how to select the participants and the technology providers. On the food side, the FDA has final say. But the participants will come from the food industry, and on the technology side, that is something that we at IFT handle.
11:50 a.m. Karst: You are only doing one produce pilot. Does that mean that their will be just one technology provider that you will be using?
11:51 a.m. McEntire: Not necessarily. We are going to be looking at many points in the supply chain and I think that we do need to seriously consider how to engage as many technology providers as possible while keeping things manageable. In one of our pieces of work in 2009, when we did do a mock tomato traceback, we worked with Microsoft and TIBCO. Long story there; they had been selected before we became involved, so we didn’t have a say as to who the technology providers were for that task. In this piece we do. I think that had we had a say in 2009, we may have been a little more inclusive. I don’t want people to assume that the technology providers we select for these products are the ones we are endorsing. FDA clearly can’t endorse a particular technology and we have no desire to endorse a particular technology, so we want to be very fair in how participants are selected and ensure we are able to perform a number of good tests.
11:53 a.m. Karst: What were the takeaways from the 2009 traceback exercise? What would you say IFT learned from that?
11:54 a.m. McEntire: From the 2009 tomato pilot. I call it a mock pilot. It used historical data. This was in the very early stages of PTI. So the data that were supplied, Microsoft had asked for the participants to fill in basically an Excel spreadsheet, not looking for standardized format of data, but definitely standardized fields. It took a few iterations to figure out what are the data that are needed to trace the product. So that was one key learning, just having that discussion back and forth. I’ve heard many people who participated in that study talk about it. From the regulatory side - we had state and federal regulators participating. From the industry side, including trade associations. Everyone calls it a success, but for very different reasons. My observation, from the outside looking in, was the most valuable thing about that study was that it was one of the first times that regulators, industry and other stakeholders came together to talk about some issues related to traceability, data, and records outside of an outbreak crisis situation. I think there was some real communication that occurred there, some real connections that were built, and a better understanding of what people’s roles and responsibilities were, and I that I think was the most valuable thing that came out of that task.
11:55 a.m. Karst: At the same time, it showed the industry had a ways to go, right?
11:56 a.m. McEntire: The data certainly were not perfect. One of the questions that was presented in that task was, ‘Does the industry have data?’ So the answer was ‘Yes, but...” It certainly was imperfect data that needed to be worked with. Microsoft did a considerable amount of Q and A on the data, if you will, to ensure that it could set into the system, which was a single database that software pulled from that database to do some visualization and graphics. But there was a substantial amount of work that had to be done to that data before we could get that stage in the process.
11:58 a.m. Karst: Do you think that a database concept in traceability is worth considering as far as what the ideal should look like, having a central database to record when product moves from one place to another?
11:59 a.m. McEntire: This question is often raised. There is an awful lot of valid concern I think about having a master database. Who is going to manage that. What are the controls associated with that data. If I had a crystal ball, I’m not sure that everybody is going to be putting all their data into a central database anytime soon.
12:00 a.m. Karst: How will the Produce Traceability fit into the produce pilot?
12:01 a.m. McEntire: One of the questions we are going to be asking of stakeholders is the extent we should consider initiatives like PTI. On the processed foods side, the Grocery Manufacturers Association hasn’t supported anything that would be analogous to PTI.
12:02 p.m. Karst: Will PTI influence the pilot to a big degree for produce? The pilot will have something to do with PTI, right?
12:04 p.m. McEntire: The answer to your question is probably, yes. There was a question about PTI in the stakeholder call and it is not our intention to undo any progress PTI has made. I hear critics or skeptics. I’m not sure the extent PTI is implemented and I’m not even sure that we want to evaluate the extent to which PTI has been implemented. We want to look at whatever produce item is chosen, we’ll give that to the supply chain and evaluate what the supply chain is doing. There may be players in that supply chain who have fully adopted PTI and others who have never heard of it. We need to assess the supply chain, where it is at, before we can say the extent to which PTI will play a role in the pilot.
12:06 a.m. Karst: Is assessing where the industry is at relative to PTI going to be the first stage of the pilot?
12:07 p.m. McEntire: It is part of our task, part of our charge from FDA. We will be conducting baseline studies and so for that we are actually going to be look at historical outbreaks, hopefully in the last couple of years. We will get the records that were obtained for those traceback efforts. We will get a traceback investigators together to look at these records and what made traceback more straightforward, what made some more difficult. What were some of the roadblocks, some of the obstacles. What are the things we can study, that we can test to try to trace it better.
12:08 p.m. Karst: When will the produce pilot start?
12:09 p.m. McEntire: We will be collecting input through the early part of December. The tests themselves need to be concluded in March. So we do have a multi-stage process. I would like to perform as many tests as we possibly can. The baseline study should be initiated pretty quickly. We are waiting on some data for that. The foods themselves will be identified over the next couple of weeks. As soon as we have the foods identified , then we will start looking for industry participants. Quite frankly, it may be that the food selected are those for which we have willing participants.
12:11 p.m. Karst: Anything else you might like to note about the process?
12:12 p.m. McEntire: There are an awful lot of skeptics and critics. We are looking for people who are open minded and cooperative to participate. There is still an awful right now that is unknown. There are some limitations associated with the task. The Food Safety Modernization Act was clear we are not to explore pedigree solutions, that we are not to explore case level tracking. Some of the issues associated with the pilot are outside of my hands. We are going to do the best job we can. The FDA has made it lear to us that they want stakeholder involvement, so there is not a whole lot has been predetermined, despite what some may think. Technology providers haven’t been selected. That’s probably one of my chief concerns, how to go about that selection process. If people want to offer input, comments and their experiences, it is more than welcome.