FDA Traceability Rule: The Next Wave of Change

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Years of persistent food issues and crises led to the passage of the U.S. Food Safety Modernization Act (FSMA). And like with most major legislation, implementation dragged on for years while regulators listened to feedback and drafted the rules that supported FSMA. And as this process wore on, people stopped paying attention and had to play catch up. Suddenly, we’re faced with the prospect of history repeating itself with the looming implementation of the FDA’s traceability rule.

Focus on recalls

FSMA consists of a group of regulations with a context associated with it now, as we see what’s that evolving into and what the desired outcome is. So you need to be able to take these things and use this to create the next steps in your current supply chain issues.

So, what is a typical recall scenario? I know this from experience since I’ve been responsible for overseeing a few large Class One recalls. And I wouldn’t wish that on anyone.

Section 204 text that explains the food traceability rule.

The basic steps of a recall:

1. Identifying a potential issue. You can identify this internally, or a consumer can pick it up. One of your customers might find it. Or it could be random sampling in the marketplace by state health inspectors. There’s a myriad of different ways to identify a potential issue.

2. Investigating the potential issue. The identification should trigger an investigation. But this process is constantly evolving, and one of the rules you’ll learn in a recall scenario, especially a Class One, is that it’s never going to go the way you expect. It’s always going to be convoluted. People aren’t going to be available. Data’s going to be limited. It’s not going to go the way you think. So, there’s an internal investigation. And with that, there needs to be a decision made about whether this is, in fact, a recall situation.

So, for example, let’s say it’s a genuine recall situation. Then, the wheels begin to spin at that point. And that’s always an excellent way to look at this process:

  • What is your process for evaluating a potential food safety crisis?
  • And once that process is complete, and you decide there’s an issue, what’s the process for executing that recall?

3. Notifying the FDA. Once that decision’s been made, everything begins, and you must notify the FDA. So, of course, there’s the reportable food registry. You must put your information in there.

And I’d also recommend that you contact FDA directly. And this means that, in advance, you must understand who the district directors are in your area and who the recall coordinators within FDA are at those locations. That’s who you’ll be managing your issue with. So get to know who those people are ahead of time.

4. Executing the recall. Then the actual execution begins, which includes product identification, public messaging, product disposal, inventory reconciliation, media and internal communication, and all these things flying at you at the same time –that trace back and reconciliation process:

  • How many cases did we make?
  • How many cases did we find?
  • How many were consumed by people in the marketplace? Hopefully, no one has become ill or injured by these products. How are you managing those?

5. Closing it out. And then, of course, once this is all done, the question becomes, how do you close these things out? And one of the critical points in the closeout piece is, what did we learn? Make sure you do a post-op and go back through that process and ask, “Why did this happen? And how can we keep this from ever happening again?” This is your opportunity to make sure it doesn’t happen again.

Consider the FDA’s focus on traceability

That’s usually the process that a recall goes through. Now, look at this from FDA’s perspective. Traceback and chain processes remain incredibly challenging. You must take fast action in these cases. And from their side, there’s poor reconciliation of information. They have different varieties, different ingredients, four packs, six packs, dog bones at Costco, and multi-packs. Not to mention poor record keeping.

We have our ingredients, our manufacturing, our distribution, and our customers. But the FDA must look at it from the other direction. And because of that, things get complicated because the supply chain is extremely complex. Once the product leaves your facility, it can go to distributors, warehouses, brokers, or packagers, where they slap your brand on it before it gets moved along to various retail outlets.

We also have shipments coming from Amazon and other retailers arriving at your house. So the FDA must fight backward through that supply chain to get to the source. And I’m here to tell you this has been frustrating for the FDA. A lot of times, when you see extensive recalls, this reverse process of getting back to the source material and the ingredients associated with those issues is challenging.

The FDA has realized this doesn’t work well and it’s slowing things down. We all know that during a recall, speed is critical because we’re protecting public health, and we need to get that information out there. And we need to remove that product as quickly as possible.

Traceability rule questions

If we’re doing traceability exercises in our operations, there are several questions we need to ask, such as:

  • What ingredients went into these products?
  • What other products do these ingredients go into?
  • Can we find those, and where did we ship that product?

The FDA insists that’s not good enough anymore. You must be able to trace the origin of that product through your facility – backward and forward – all the way from the point of contact. And that brings us to the FDA’s proposed traceability rule, Section 204 of FSMA.

food traceability list definition

After months of consideration and public comment, the FDA’s finally scheduled the final rule publication for Nov. 7, 2022, which will go live 60 days later. Companies would then have two years to comply fully.

Despite what appears to be a long runway for compliance, we must keep in mind human nature’s tendency toward procrastination. And if you did that with FSMA, you should learn from that and avoid doing it with these traceability rules.

You need to start thinking about it now and how you manage this because this is a complex process. So, what do you need to know, first off, does this apply to you?

There are exemptions for these new recordkeeping requirements and some waivers, depending on the circumstances.

For example, raw agricultural commodities aren’t required to be part of this. Neither are charitable foods, foods for personal consumption with a kill step. So, if you can demonstrate through your food safety plan that you’re covered, then you’re fine.

High-risk foods and first receivers

The food traceability list covers high-risk foods. This is where the FDA decided to start: with high-risk items. And they’re probably right. And if this works, they’ll probably roll this out to other product categories and make this inclusive of everything that falls under manufacturing in FSMA. This is another reason why you need to pay attention.

One of the things you hear a lot about lately is first receivers. So, who is this first receiver?

Well, the first receiver is: The first person (other than a farm) who purchases and takes physical possession of a food on the Food Traceability List (FTL) that has been grown, raised, caught, or (in the case of a non-produce commodity) harvested.

  • Any entity except a farm.
  • Must maintain Key Data Elements (KDE) and Critical Tracking Event (CTE) data.
  • If a farm sells FTL foods, it must identify as a farm for those downstream.

If a farm sells traceability list foods, it must identify as a farm for those downstream. A first receiver might need to establish a traceability lot code for a food if they receive it from an originator without one.

One of the things we see in our supply chain, in many cases, are lot codes on your products that might go to someone else, and maybe they put a different code outside of that.

Now you’ve got two codes, and how do you know which one’s the right one? Well, the FDA says that through that chain, there needs to be a traceability lot code that allows for easy backward access. So they want to quickly track back through the system from the retailer to the manufacturer. And that traceability lock code is critical to that. And when they get to your facility, they’ll want to see critical data and tracking events associated with those products.

Examples of first receivers

The FDA’s provided several examples to help:

With fresh-cut romaine lettuce, you have the grower. And they’re exempt. On the farm, it’s packed off. It goes to a produce processor. And they’re the first receiver. Let’s say they’re washing it before packaging. Then they send it along to a distributor and then a retailer. We need to have processes that track that path from the retailer to the distributor to the processor. That way, if someone identifies a problem at retail, the FDA can quickly go back to the processor.

What about finfish? You have a vessel out there that catches some finfish. That fisher sells their catch to a buyer. Logic might suggest that the seafood processor is the first receiver, but the FDA insists the buyer is that first receiver and that seafood is processed, distributed, and sold at retail. So just like the previous example, working backward, if you’re that buyer and you don’t understand these requirements, you could be in a world of hurt.

In one final example, the FDA looks at shell eggs. You have a farmer who produces the eggs and then washes and packs them on the farm. They then send it to a distributor before moving on to a retailer. In this scenario, the distributor is the first receiver. These things aren’t static. They’re contextual based on the industry.

The potential problem is that if you have these different industries establishing different ways of managing this process, and deciding on different first receivers, then it will be chaos.

First receiver responsibilities

To start, the first receiver must identify and create a lot code for traceability. Then, that code will move forward with the product. And that means it must travel through that entire chain with the product, not just to the next step, so the FDA has visibility.

Next, you must identify critical tracking events (CTEs), each of which demands documentation. These events might include steps such as growing, receiving, transforming, creating, and shipping.

Finally, the first receiver is responsible for establishing the key data elements (KDEs), which must be documented for the CTEs.

Again, that lot code stays the same as the product moves through the supply chain. That is, until a transformation occurs. Again, this enables the FDA to skip some points in the process that minimally handle the product.

As you look at that supply chain, the end retail point, the manufacturer, and the first receiver are the critical points. What FDA is saying is that – in a crisis – they don’t have time to go to the distributor. They don’t have time to go to the warehouse. They’re irrelevant to the food safety operations, assuming they’re doing their jobs correctly.

They want to go to the first receiver as quickly as possible. So the FDA is looking for speed and accurate traceability using a lot code that goes through the entire process.

Creation and transformation

Once you understand these concepts, there’s another layer associated with this, and this is creation and transformation.

For clarity, the FDA defines creating as “making or producing a food on the FTL using only ingredients not on the FTL.” Creating does not include originating or transforming a food. Additionally, the FDA defines transformation as “an event in a food’s supply chain that involves changing a food on the FTL, its package, and/or its label such as by combining ingredients or processing a food.” This excludes the original packaging, a single-ingredient food, or creating a food.

You must ask yourself:

  • Do you have products or ingredients on the food traceability list?
  • What in that supply chain requires tracking?
  • What records do I need?
  • How will I maintain traceability of that lock code in the supply chain?
  • Who else needs to know this in the supply chain?

The FDA offers some examples here, too.

The first is potato salad. This starts with three elements not on the FDL: potatoes from a farm, onions from a farm, and then mustard and vinegar used in the processing step to make the finished good. In this case, that’s the potato salad.

They chop all this stuff up, and they make the potato salad. The FDA classifies that as a deli salad, which is on the FTL. So, in this example, the potato salad processor is the first receiver. So, they need to document key data elements and everything we’re talking about. Then, they need to provide that traceability lock code that goes through the distributor and the retailer and maintains that traceability through the system.

Then there’s peanut butter, which is a relevant example right now. With peanut butter, you’re working with ingredients such as peanuts, salt, sweeteners, and emulsifiers – all of which aren’t on the FTL, but the finished product, a nut butter, is. So far, this is like the potato salad.

However, you can also make peanut butter sandwich crackers, where you’re using the peanut butter, which is on the FTL, and other ingredients, such as crackers, which aren’t on the FTL. But you still must provide traceability information because the risk isn’t mitigated by a kill step. So that risk goes downstream. But if you have a product with a kill step and have those records, the FDA doesn’t need recordkeeping for traceability.

Let’s say you’re making cheese and have a pasteurization step. And you have a food safety plan in place. Then you’re compliant.

Our final example here covers jars of salsa. This is another example we see quite a bit as well. To start, you’re dealing with farms, which provide the tomatoes, peppers, and cilantro, and farms aren’t covered. But then, to make the salsa, you’re transforming those ingredients. But you produce it with a kill step, so further records aren’t required after that transformation.

As you can see from these examples, these things can go in different directions. What exemptions might apply within this process? Well, we know farms are exempt. But if you’re the first receiver, it triggers all kinds of stuff. You must understand your critical tracking events and your key data elements. You need to set up a transferable lot code. And you need to figure out if you created or transformed the product within this process.

For more about his critical issue, check my conversation with TraceGains here.

Bryan Armentrout has worked in food safety for more than 20 years and was highly involved with the development of the FSMA recommendations to the FDA as part of the Foreign Supplier Verification Team at the Grocery Manufacturer’s Association. Based on his knowledge, he’s created food safety plans for leading companies in the United States and abroad.