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Stakeholder Teleconference Sponsored by the Food and Drug Administration to Discuss Product Tracing Pilots

More Information on Product Tracing under the FDA Food Safety Modernization Act (FSMA)

Moderator: Mildred Cooper
September 7, 2011
11:30 am CT

Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen only mode. During the question and answer session, please press star 1 on your touchtone phone. Today's conference is being recorded. If anyone has any objections, you may disconnect at this time. I would now like to introduce Mildred Cooper.

Mildred Cooper: Thank and good afternoon. Welcome to today's Stakeholder Teleconference sponsored by the Food and Drug Administration to discuss product tracing pilots. This is Mildred Cooper, senior advisor in the Office of External Relations. Joining us today to make brief presentations are Sherri McGarry, Senior Advisor, Office of Foods, FDA, and Jennifer McEntire, Senior Staff Scientist and Director, Institute of Food Technologists.

Also joining us are FDA technical experts Jenny Scott, Senior Advisor, Office of Food Safety, CFSAN, and Jim Gorny, Senior Advisor for Produce, CFSAN. These presentations will be followed by a Q&A session. Sherri?

Sherri McGarry: Thank you Mildred, appreciate that. As you've heard I'm Sherri McGarry and I'm the lead for the work group on product tracing within the Inspections and Compliance Implementation Team for the Food Safety Modernization Act. I'm very pleased to be on this call to share with you an important first step towards fulfilling the requirements under Section 204 of the statute. That section is called Enhancing Tracking and Tracing of Food and Recordkeeping.

It has two major requirements. First, FDA will work with the USDA and state agencies to establish pilot projects in coordination with the food industry. The pilot's will explore and evaluate methods and technologies for rapid and effective tracing of foods. Second, FDA must publish a notice of proposed rulemaking to establish record keeping requirements for high risk foods.

Today, FDA is very excited to be here joining with the Institute of Food Technologists to announce that we are moving forward with the first requirement, the product tracing pilot projects. IFT will carry out the pilots under an existing FDA contract. There are two pilots required under FSMA, Food Safety and Modernization Act, one, with the processed food sector and one with the produce industry, involving raw fruits and vegetables.

Product tracing is very important as you can all imagine especially as I can see there's quite a bit of interest and participation in this stakeholder phone call that we are having today. The pilot projects are an important step in helping us and I say us collectively to learn more about tracing food products back to identify a common source in the supply chain when a food contamination event occurs such as in a foodborne outbreak.

This can help FDA, and not just FDA, but those who sell the products and produce the products to more quickly and rapidly identify that product and more importantly remove it from the market place to prevent any additional illnesses. Improvements in product tracing will also allow us to have more focused messaging to consumers. Tracing helps us to determine not only what food may be the cause of the outbreak but also those foods that may be less likely to be involved in the outbreak itself.

As we proceed with these pilots we recognize the importance of taking into consideration the diversity of the food supply and practicality for small businesses. IFT will be soliciting input for the pilots and FDA has indicated it wants to include industries representing the entire supply chain from growers to restaurants and grocery stores. It's also very important to have some public input as well.

And we recognize the importance of stakeholders in this process. I want to assure you that multiple stakeholders will be involved throughout the process. IFT, as mentioned, will be obtaining input from processed food and produce industry sectors, consult with U.S.D.A, state agencies and consumer groups on proposed foods and ingredients on which these product tracing pilots will occur as well as looking at the various technologies for the pilots themselves.

FDA does not plan to recommend specific product tracing technologies as we move forward with the implementation of the Food Safety Modernization Act and specifically this section of the statute. Rather, the agency will focus on the elements of a product tracing system that will enable rapid and effective tracing of foods such as what data should be kept, ways to link food along the supply chain, and basically connect the dots along the supply chain, and how quickly the data can be provided to FDA, especially when we have an emergency situation and the risk of illness exists.

With respect to record keeping requirements for high risk foods, we do have quite a bit of work ahead of us to establish the pilot and to collect other information that's required under Section 204 of FSMA, Food Safety Modernization Act, specifically the record keeping requirements for high risk food. Once we complete the work on the pilots and additional data gathering we will move forward with developing record keeping requirements for high risk foods.

The pilots are very important in that development process. Again, we will carry out this requirement with stakeholder input. The proposed rule that FDA develops will have a comment period and as FSMA states will have at least three public meetings that will be held during the comment period for input from various stakeholders. In closing we want - we look forward to working with IFT, our government partners and other stakeholders.

We have worked with IFT in the past and has been a very successful collaboration. FDA has also worked on product tracing for a period of time and we do have quite a bit of information that we have gathered already. But we look forward to this new endeavor with IFT and with our stakeholders. We have developed several information materials that are posted on the FDA Web site,

Posted there you'll find questions and answers, a one page overview of the pilots, a consumer update and I really encourage you to consult those materials on the Web site. At this point I'll turn it back to our moderator.

Mildred Cooper: Thanks Sherri. And I think at this point we'll turn it over to Jennifer for her remarks from IFT. Thank you.

Jennifer McEntire: Thank you very much. The Institute of Food Technologists is very pleased to be involved in these pilots. And feel that our past experience and contacts put us in good position to successfully execute these pilots for FDA. The pilots will be conducted in accordance with the requirements set out in the Food Safety Modernization Act. They'll focus on produce and processed foods that have been associated with outbreaks within the past few years.

They require minimal if any changes to existing business systems, and we'll also be looking at costs and benefits. The work will be done in a couple of phases. First we want to quantify where we are today, so that we can measure the improvements in being able to rapidly and effectively identify the recipients of food. Second, we'll examine the data that are shared between trading partners. In our 2009 report to FDA we introduced the concept of critical tracking events and key data elements.

These will be tested so that we can determine the points along the supply chain where data needs to be captured and the minimal amount of data necessary to link those products through the supply chain. We recognize the industry already collects a lot of data and will look at how to better to use and distill this data to make those connections. Once we've determined the data that needs to be collected and then upon a request shared we'll look in the next phase at how those data can be more rapidly analyzed.

I want to stress that while we are charged with exploring how collaboration platforms basically third party solutions can be used to enhance the speed and accuracy of tracing, we will not be endorsing any particular system or technology. Rather we may assess the characteristics of third party products that seem to offer improvements and product tracing.

In terms of timing our report will be issued to FDA in about nine months. The pilot studies themselves must be completed by early March, in about seven months. It'll be about another month or six weeks before the specific supply chain, specific food products selected for evaluation will be determined, that's not been determined at this time. FDA will make the final selection. But we'll be working with stakeholders and our industry and trade association contacts to provide FDA with some recommendations for potential products to be evaluated over the next few weeks.

If you're a food company interested in participating and you produce or handle a processed food or produce item that qualifies for this study I encourage you to get buy in from your supply chain partners and then contact Caitlin Hickey at IFT. Her contact information is on the IFT and FDA press release as well as our respective Web site. The technology providers who will participate have not been determined. There are way more technology providers out there than can possibly be involved in the actual pilot tests.

We'll be providing windows of availability to hear about potential solutions with preference given to those that are currently commercially available and that have existing customers in the processed food or produce industry. We do want to be inclusive and we'll be looking for other ways to capture the good information that technology providers can offer. And this will be reported back to FDA in our report.

In terms of soliciting input we have invited some really top notch individuals to serve on a core expert panel. They'll be providing us with insight, direction, and ultimately assist in developing the final report to FDA.

These individuals are Doug Bailey with USDA's AG Marketing Service. He's their chief information officer, Ben Miller with the Minnesota Department of Agriculture, Bruce Welt with the University of Florida, Brenda Lloyd with UFPC Yum Brands, Caroline Smith DeWaal with Center for Science in the Public Interest, Tom Breuer with Deloitte Consulting, and Jack Guzewich who's recently retired from FDA and is now IFT's Food Safety Strategist.

This group will be supplemented by sub panels working specifically on the produce study, the processed foods study, and the cost benefit evaluations. The cost benefit work will be led by Deloitte Consulting and we're also subcontracting with Auburn University to support that effort. IFT has worked with - we've organized a traceability improvement initiative. It's funded by the BASF Health and Nutrition, Underwriters Laboratory, and the Fishery Scholarship Fund at the National Fisheries Institute.

And this initiative has allowed us to gather input on product tracing from over 70 stakeholders just within the past two months. These individuals representing industry, government, technology providers, academics and other stakeholders continue to work together and I expect to see some working documents from them over the next few months. This group's effort is separate from the pilot studies but we'll certainly consider the recommendations developed by this group as well as many others in our report to FDA.

Essentially we want to hear from you. It's difficult to meet everyone face to face but IFT is committed to insuring that all voices are heard and all perspectives are considered in our analysis and recommendations. Let Caitlin Hickey know if you want to be notified or if you want to get involved. Caitlin can be reached at 202-330-4985. Her email address is available in the press releases. And you can visit our Web site for more information on the pilot.

If it's not up-to-date it will be posted within a couple of days. IFT will speak at food safety and supply chain conferences on this topic but we will not be providing the results until after FDA has seen them and approves the release. We will describe the approach as I've laid it out here and we will certainly be focusing the approach as we gather information from stakeholders over the next couple of months.

Again, we at IFTfeel really privileged to work on this important industry changing project with the FDA and we look forward to engaging all stakeholders in the process. Mildred, turning it back to you.

Mildred Cooper: Great, thank you, Jennifer. At this point let's open up the call to your questions. So that we can get to as many of your questions as possible please limit yourself to one question with one follow up. Stacy, can we take the first question please?

Coordinator: Certainly. Again, a reminder if you would like to ask a question, please press star 1 on your touchtone phone. Let's hold a moment for any questions. Our first question is from Nancy Donely) of STOP Foodborne Illness.

(Nancy Donely): Hi. Thank you very much. I was wondering when will these public meetings be convened and where will they be convened?

Sherri McGarry: Yes, hi, this is Sherri McGarry and with respect to the public meetings, there's three that are required and those will occur during the proposed rule making when FDA puts that in the Federal Register. So we're a little bit too soon for that so that will be coming up further down the line.

(Nancy Donely): So that's after the pilot studies are conducted?

Sherri McGarry: Absolutely because the pilot studies as well as additional data gathering are going to be used to inform FDA’s rule making process. We need all that stakeholder input to develop the best proposed rule that’s going to be practical and feasible and protect public health.

(Nancy Donely): Thank you.

Coordinator: Our next question is from Sam LaBinjo, Consumer Safety Officer with the Chicago district.

Sam LaBinjo: Hey, how are you doing? My question is what type of way can the field help out with some of the new regulations and understanding some of the new rules? Because it seems like sometimes the field's kind of not really in the loop and, you know, we're the first line people and we see a lot of the, you know, we interact with the - we interact with industry a bit more than the centers do.

Sherri McGarry: Well thank you for those insightful comments. This is again Sherri and we are very much interested in hearing from our own folks as well as additional external stakeholders in this process. Because you have some of the hands on experience that we need to hear from and so the best way to do that is work through your district office and our contact and lead of the compliance and inspection workgroup is Barbara Cassens.

And you may contact her as well as me directly after the call or at any time. Thank you.

Sam LaBinjo: Thank you.

Coordinator: Our next question is from Barry Eisenberg, United Fresh Produce Association.

Barry Eisenberg: For the past few years, the Produce Association has been working on the produce traceability initiative. Could you outline how you plan to take advantage of the work that’s been done in the system put in place?

Sherri McGarry: This is Sherri, I think I’m going to ask Jennifer to address that and I’ll maybe add if there’s anything further.

Jennifer McEntire: Yes, this is Jennifer McEntire, and we’re very appreciative of the relationship, the valued relationships that we built with the Produce Marketing Association, the United Fresh Produce Association, and others over the past couple of years. We included elements and information about the produce traceability initiative in our 2009 report and we’ve seen the progress made in the implementation of the PTI over the past couple of years.

As I mentioned in my comments, in the first stage we’ll be looking at some of the data elements and I think that here is where this study is very much aligned with looking at the data that’s being collected by the PTI, the information on the labels that are being required by PTI, and so, that certainly will be part of the study.

And I don’t think that we at IFT intend to do anything that would discourage industry from moving forward on the path that they’ve already started to go down with the PTI. So, we’ll continue to work with the trade associations in ensuring that these pilot studies capture and assess the good work that’s already being done in the produce industry.

Sherri McGarry: And this is Sherri from FDA’s perspective, I think I would just add that the PTI has really shown industry leadership in improving product tracing and I commend them for those efforts. And, again we will certainly be looking at those initiatives that are in the forefront and that will be practical and feasible for the industry. Jim, did you want to add anything to that?

Jim Gorny: No, I think you did it.

Sherri McGarry: Thank you.

Coordinator: Our next question is from Barbara Blakistone of National Fisheries Institute.

Barbara Blakistone: I was wondering at this point are - do you know how many products will be involved in the studies, in the pilots?

Sherri McGarry: This is Sherri and the requirement under FSMA is to have at least two pilots, one for processed food and one for produce. So, to get any more detailed than that is going to be a little bit difficult right now. However, under FSMA it does say that we should be looking at food that has been involved in significant outbreaks in the last about five years.

So, we will hone in according to the statute on those foods that have been involved in a significant outbreak in last about five years I believe it is. Jennifer, anything to add?

Jennifer McEntire: No, nothing.

Barbara Blakistone: Thank you.

Coordinator: Our next question is from Iain Green of Picarro.

Iain Green: Good afternoon everybody. As far as I understand it I think a lot of the pilot program work is going to be focused on a lot of the traceability initiatives that are currently planned with the mechanical tools such as bar coding and RFID.

Is it going to be possible that the molecular tracking folks are going to be able to kind of mirror some of the samples and available information so that some of tools that have become available in the last year of two, not originally perhaps considered as part of FSMA might be able to show they may be able to help in future programs?

Jennifer McEntire: Hello, Iain this is Jennifer McEntire at IFT. Right now we have not selected the technology providers or the types of technologies that will be used to perform the pilot. But I think when we look at the Food Safety Modernization Act and the requirements, we probably will focus on those technologies that are in current use expecting that those will be the ones that may be the most readily adopted in terms of actually doing the pilot.

That said, I am familiar with a number of newer technologies, tracing technologies that are not related to bar codes, not related to what’s seen in use today, and we certainly will make sure that FDA is aware of all the types of tracing technologies that exist, all the methods that are out there in development and in commercial use. So, that there will be opportunities even for those who are not participating in the actual pilot to make sure that their voices are heard and that that information is passed forward to FDA.

Iain Green: Thank you, Jennifer.

Coordinator: Our next question is from Patty Lovera of Food and Water Watch.

Patty Lovera: Yes, I have a question that’s kind of related to earlier ones about defining the risk and I guess the question I have is in addition to figuring out, you know, if foods were involved in an outbreak in the last five years, do you have any thinking about the type of supply chain and if that impacts your definition of risk? So, you know, a sure supply chain, direct sales, that kind of thing - you’re thinking about how you define what foods to do in the pilot?

Sherri McGarry: Hello, that’s a very good question, I appreciate that. There’s two components to answer that, the first is that we want to stay within the Food Safety Modernization Act and there’s certainly some points in the supply chain that are not as well covered as others. So, we’re going to focus on the context within the Food Safety Modernization Act.

But, from a public health standpoint it is really important to be able to track foods both back in the supply chain and forward. So, it’s very important in these pilots that we can demonstrate that tracking process and so - but that is a very good question and those are kind of the parameters that we’re going to be looking at all along - what’s covered under the Food Safety Modernization Act and then being sure that we can connect as many dots along the chain as we possibly can to potentially find that common source. Jennifer did you want to add anything to that?

Jennifer McEntire: No, I think that for the next couple of weeks we be considering the types of products and the types of supply chains that should be evaluated and so input is certainly welcome in that process.

Sherri McGarry: I think we have time for two more questions.

Coordinator: Thank you, our next question comes from Tom Karst of Packer Newspaper.

Tom Karst: Yes, I was wondering relative to the high risk commodities is it anticipated that small growers of these high risk commodities would be subject to record keeping requirements that FDA will develop?

Sherri McGarry: This is Sherri, at this time we are continuing to look at the language in the Food Safety Modernization Act in this section to really get a better understanding as to what is being covered under the act and what is being excluded. So, I think at this time we’re probably still in those deliberations. The focus will likely be more on the receipt of those products from the growers.

But, at this point, again we continue to be under deliberations and looking at that further in the language of the statute. But I can tell you that we still would like to have your input even if you were excluded or might be excluded, we would very much like for you to work with IFT as well as other stakeholders to see how we can make the best connections along the supply chain to enhance product tracing..

Tom Karst: Thank you.

Sherri McGarry: Thank you and I think we have time for one more question.

Coordinator: Our final question comes from Ali Kashani of Washington State Department of Agriculture.

Evan Evans: Yes, actually this is Evan Evans Washington State Department of Agriculture. I wanted to find out with the increased emphasis on recycling and reuse of beneficial waste products will your tracing pilots and traceability include what be - for the food processor becomes waste but maybe utilized downstream as feed or even food, so that the traceability will extend to that as well?

Sherri McGarry: I think as many folks know with some of the previous outbreaks that we’ve been involved in and those that were also a very large food contamination event that may not have caused human illness, but may have caused some animal related illnesses. Those are very significant issues and have created some significant product tracing challenges for us.

We believe at FDA that it is important to be able to trace products both food and feed in the supply chain, but when we focus on the language of the statute we’re, again continuing some deliberations to the extent which feed and secondary products might be addressed. So, I think we’re still under deliberations for that but the experience that we’ve had tracing those products it can very difficult. So, we’d like to see improvements in that area as well.

Evan Evans: Thank you.

Mildred Cooper: Okay, thank you so much for all your questions. Sherri or Jennifer do you have any closing remarks you’d like to make before we end today’s session?

Jennifer McEntire: This is Jennifer McEntire. I would again like to express our thanks and appreciation that FDA’s entrusted us with this very important work. We are a science society and we have thousands of members throughout the world and we look to engage not only our members but other stakeholders who are involved in the public health community and the food community and the technology community to make sure that we are able to provide FDA with the most complete information regarding improvement and product tracing possible.

With that I would invite you to visit our Web site or contact Caitlin to get more information about what we’re doing and ensure that you’re involved in what we’re doing. I think that’s critically important in order to have a really successful pilot project and a very useful report to FDA. Sherri.

Sherri McGarry: Thanks Jennifer and again from FDA perspective being able to trace a food product back to identify a common source to help FDA and those that produce and sell food more quickly identify and remove that product from the marketplace to prevent illnesses during a foodborne outbreak is really critical. And with what we’re doing here and the start of these pilots, working with IFT and all of our stakeholders is one important step to enhancing that product tracing system and improving our public health protection while keeping in mind practicality and feasibility as we move forward. I’d also like to emphasize that there will be many opportunities for stakeholder input throughout this process of implementing the Food Safety Modernization Act, in particular this section.

As additional opportunities become available they will certainly be posted on FDA’s Web site, the FSMA related Web site, and of course we’ll be reaching out to let folks know about those opportunities as well and we look forward to working with IFT again. And just to remind folks to get in touch with the contact that Dr. McEntire has provided you if there’s interest in those pilot studies.

I appreciate all of your time today. We appreciate you taking time out of your day for this important message and we look forward to continue collaborations. Mildred?

Mildred Cooper: Thanks Sherri. Thanks to everybody who participated today in this discussion and just to remind you, if you would like to hear this call again, a replay will be available about one hour after the call ends and will remain available until September 14th. You can access the replay by calling 866-434-5270 and the pass code for the replay is 332.

And with that, let me thank you once more for joining us today to on our call. Thank you.

Coordinator: This concludes today's presentation. Thank you for your participation. You may now disconnect.


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