As part of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration has issued a new rule requiring stricter controls over the monitoring of food products throughout the supply chain. In this conversation with SupplyChainBrain Editor-in-Chief Bob Bowman, Angela Fernandez, vice president of community engagement with GS1 US, explains the content and consequences of the rule.
SCB: What is the nature of this new rule by FDA with regard to high-risk foods?
Fernandez: The new proposed rule for additional traceability is part of section 204 of the FSMA. It's the last rule we've been waiting for from the Act, and it proposes three things to the industry. One is a food traceability list, specific to high-risk foods that trigger mandatory product-tracing requirements for review and annual updating. There's a multitude of items on this list, ranging from eggs to leafy greens to fruits and seafood. It's quite extensive from a high-risk perspective.
Second is that FMSA proposes detailed traceability requirements, beyond those we saw in the Bioterrorism Act of 2002. They speak about critical tracking events and key data elements. If you’re a stakeholder in the supply chain and you manufacture, process, pack, ship, hold, or receive any of the products or ingredients that are on that list, you would be required to capture and share the information that's been identified as key data elements — things like lot and batch number, and specific dates.
The third piece proposes possible exemptions for the additional traceability rule, which is quite broad in a couple of different categories.
SCB: How has the food industry been preparing for the rule?
Fernandez: It was working on this before FSMA came out in 2011. Remember the spinach recall in 2006. Then it was tomatoes and jalapeño peppers out of Mexico. This is when the produce industry said, "We've got a call to action here. We need to own this, to find a way to enhance our traceability processes as a commodity and a category, so that we’re able to handle these situations better as we move forward." That was the start of the Produce Traceability Initiative in 2008. The principles of that are very much inside this proposed rule.
The second piece I would highlight is the work that was tasked to the Institute of Food Technologists, to go out and do tracing exercises with the industry to provide insight into what we know today as the FSMA. That’s where the idea of critical tracking events and key data elements came from. GS1 was fortunate to be a part of that process, along with our industry players in food service, retail and the supplier base for fresh foods. We published the report from IFT in 2010, and the industry embraced it. So for the last decade, we’ve been talking about traceability and how we incorporate those key data elements and critical tracking events into our programs.
SCB: What do you mean by critical tracking events?
Fernandez: Critical tracking events are whenever there’s transformation of a food item. Say I’m a farmer, and I'm harvesting lettuce or some other commodity. That’s a critical tracking event, because I'm pulling food out of the ground, and need to be able to record that I'm harvesting my field at this state, and that this is my lot and batch. Secondly, I'm packing and putting it into a tote, maybe for further processing. That would be another event. It's any time the product has been transformed or processed for the next part of the supply chain.
SCB: What are the biggest issues and challenges with regard to food traceability today? Where in the supply chain does it become most difficult to ensure that?
Fernandez: That's something we've worked on with industry over the last couple of years. There are several areas of focus for us. First is around the data. That’s not as simple as it sounds, when you think about data being an asset, and how it needs to be created at the right point and stored in a way that can be understood by other trading partners. It’s also about being able to share it in a meaningful way, whether I'm pulling that commodity out of the ground, receiving it at the dock door of my distribution center, or receiving it in the back of the store and checking it into inventory. We haven’t had a consistent flow of the data through all of those steps.
SCB: Where are we right now with regard to establishing standards for food traceability? Is it a question of needing more development, or just gaining more acceptance of them?
Fernandez: What we've heard from our industry partners is that it’s the latter. It's more about how we work on the adoption of what's been defined. With all of the standards that are out there around traceability, I think it somewhat causes confusion. Some of the standards are more upstream, on the actual harvesting of products. I do believe they're there. Standards organizations have an opportunity to make sure we’re streamlining the process, making it easy to understand, and providing guidance and tools for companies to use those standards within their organizations, or work toward their use.
SCB: What’s the current role of blockchain in all this?
Fernandez: Blockchain is one of several technologies that companies in the food system are looking at, to provide more visibility around the electronic dataset. Trading partners involved in the purchasing, receiving and invoicing of products are writing to a distributed ledger. Anyone who’s a part of that transaction can go and see the real-time data. It streamlines visibility from end to end.
SCB: Blockchain seems helpful, but not absolutely essential to engaging in good food traceability.
Fernandez: That is correct. It’s one of many ways. The best traceability processes have a combination of technologies at play. First, you've got the dataset. Then technology automates the capture and flow of the data, and drives analytics so that we can take all of those inputs and be more proactive instead of reactive to what's happening in the supply chain.
SCB: What about radio frequency identification?
Fernandez: RFID is being deployed inside of food cases today, giving visibility to the tracking of items. Sometimes that’s done in combination with internet of things sensors, so that I know during transport that the temperature of a product has held steady, and I can accurately estimate its shelf life once it arrives. Or maybe the temperature fell a bit, so either I’ve lost some shelf life or shouldn't be accepting it. The datasets from those different technologies give us multiple views of what's happening in the supply chain, which helps us to make smarter and better decisions for the overall safety of our consumers.
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