FDA Proposed Rule for Traceability—Are You Prepared?

Perishable items and nut butters will be among foods requiring increased traceability records under FDA proposed ruling expected later this year. Automation, increased due diligence, and additional staffing are in offing for affected food processors.

Joyce Fassl

Apr 1, 2022

It might seem to the average consumer that product recalls are on the rise. But for the past few years, there has actually been a downturn in recalls, according to Eric Edmunds, food safety director with The Acheson Group (TAG).

“That [consumer perception] could have been caused by COVID or a lack of investigational activities happening on the FDA side in particular,” Edmunds explains. “But the science is improving, and the ability to detect and tie illnesses to actual causes is definitely getting better.”

The food industry, in general, is doing a better job of controlling hazards, Edmunds says. Today’s scientific advancements, including whole genome sequencing, are able to identify the cause of many foodborne illness outbreaks, but mainstream news and social media have led to an increased awareness of food safety among consumers.

Social media has played a big role in recall awareness, notes Tiffany Donica, a continuous improvement coach at SafetyChain Software and former food quality director for some major manufacturers. “Before Snapchat, TikTok, and Facebook, you might have heard about a food safety incident in the news, if it was major. But now, at the drop of a hat, somebody can post something on one of those platforms,” she states. “It goes viral, and the whole world is in an uproar about something that we might have not heard about 10 years ago.”

While food manufacturing plants are already maintaining strict traceability records, traceability regulations for perishable foods and nut butters are expected to be announced later this year by the U.S. Food and Drug Administration (FDA). (For a list of the foods included under the proposed rule, see the chart to the left.)

The proposed rule is covered under the Food Safety and Modernization Act (FSMA) signed into law in 2011. “The underlying reason why Congress passed a law is there’s basically a slow response time to investigating certain outbreaks and foodborne illness events,” says Edmunds. “The idea was that by creating more records, especially for high-risk foods, it would facilitate quicker investigations and prevent illness overall. If the FDA’s able to find the problem quicker, they’re able to put out public notices faster, effectuate recalls, and prevent more people from getting sick.”

The proposed rule shows a proactive approach to food safety challenges, according to Pablo Coronel, director of food safety at CRB. “With the suppliers knowing that everything is going to be traced, they’re going to be careful to supply good ingredients,” he states. “It puts a lot more responsibility on the ingredient supplier and is a very big help in keeping the cold food supply safe.”

Enhancing traceability and recordkeeping is going to improve food safety, Donica says. “Now, is it going to require a lot more diligence? Absolutely. And it could also cost facilities a little bit more in capital,” she states. “It’s going to require a lot more diligence in the food industry, especially in regulatory, food safety, and quality initiatives.”

Combatting Foodborne Illness Inside and Outside of the Plant

Tech-enabled traceability is preferred, but not required

While some larger processors already have software and staff in place to adhere to the proposed rule, many plants are still using Excel spreadsheets or paper documentation for traceability. While these methods are still acceptable to the FDA, processors affected by the proposed rule should be aware that all traceability records involved in a recall incident must be sent to the FDA within 24 hours.

“While the FDA would prefer food processors have tech-enabled traceability, the statute actually doesn’t require it,” states Edmunds. “If the FDA is investigating a foodborne illness, or acting on recall-level activities, you must share a sortable spreadsheet with all of the required information for your critical tracking events [CTEs].”

The FDA website has several examples of CTEs and KDEs for products, such as soft cheese, seafood, and fresh-cut romaine lettuce.

For those companies still documenting traceability records on paper, Edmunds thinks an investment in automation is well worth the price. “From a business perspective, automation is going to save time in the long run,” he says. And he expects most companies to experience this kind of request at some point. “It’s not really an if, but when,” he adds.

Many mom-and-pop food operations currently do not have the knowledge to handle the additional requirements under the proposed traceability rule. Donica says these operations will see added costs for which they might not have budgeted. Software like SafetyChain can aid them in implementing some benefits, but it does come with a price tag, she explains. “It’s almost like you have to have a person solely [dedicated] to ensure that the documentation from beginning to end is being captured appropriately, and that it’s being validated.”

Coronel says it is mostly medium-sized companies that will have to implement software solutions and documentation on every ingredient they receive. The challenge for them, he says, is how to do the proposed recordkeeping. “They’re going to have to implement traceability systems,” he says.

“And at the beginning, they’re going to need people who are dedicated to do this all the time, until they understand what’s going on.”

Smaller organizations and emerging brands should reach out to food safety and food security experts for help, Donica says. “There are a ton of people that you can get resources from, and [you should] attend webinars to make sure you are up to date on exactly what is required,” she states. “Work with your networking group, ask questions, and get best practices from other industries, especially if you’re very new into the industry, as well as if you’re very small and just don’t have that bandwidth of resources to pull from.”

The proposed rule is not about additional data gathering, Edmunds says. “It’s a compilation or transmission of data to the FDA that is going to cause a little more legwork, especially in a crisis scenario,” he explains.

Recently, TAG has been presenting free webinars on the topic in its FSMA Fridays webinar series in collaboration with SafetyChain and has begun to perform assessments for clients covering the proposed rule. TAG suggests that processors know which CTEs apply to them, ascertain if they already have the key data elements (KDEs) in their records, and know where these records are located. Edmunds says TAG’s work will ramp up when the rule is final. “You don’t want to invest too much when it’s not set in stone yet,” he states.

Due diligence is mandatory

Even large companies could experience some headaches with the proposed rule, Donica says. In her experience, validation is extremely important, but is sometimes overlooked. She says processors should ask themselves questions such as: Is what we put in place functioning correctly? and Are we meeting all the guidelines?

In large facilities where many employees and departments are involved in traceability, due diligence is mandatory. Food processing facilities have a responsibility to ensure new guidelines get established, and that they are performed during the validation, Donica adds.

SafetyChain’s software platform handles traceability from the beginning to the end of the process. “Supplier compliance is one of the modules in our platform that enables you to better track and keep up with expiring documents, not keeping spreadsheets, and having everything in one spot where you can see what’s expiring, when it’s expiring, and to [store] documents from different suppliers,” she says.

If food processors need to change suppliers, or there are changes in growing regions, they must update their traceability documentation quickly and accurately. With the industry’s continuing labor challenges, a lot of plants are struggling, she says.

If your suppliers are not up to standards, SafetyChain allows processors to give direct feed-back to those suppliers and provide them with information on what they need to improve.

SafetyChain software can integrate with existing enterprise resource planning (ERP) systems, says Donica, but it will require some work on the food company’s IT side, as well as SafetyChain’s part. “We do require an internal IT person to do the IT work on their side, because it is their ERP system.”

Lot codes, suppliers, and incoming ingredients require attention

One area that might cause some confusion for affected processors is lot codes. “There’s a new legal definition of a traceability lot code,” says Edmunds. Processors must know how traceability lot codes interact with the existing lot codes they are receiving and producing. “Is it going to create a new data element, or will you be able to transfer your existing lot coding system into the legal definition of the traceability lot code?” Edmunds asks.

The FDA’s website provides an overall outline, with frequently asked questions, on what is on the proposed food traceability list and how lot codes come into play. For example, the site has farm-to-fork sample graphics showing where CTEs and KDEs would apply at each step along the supply chain.

While Edmunds believes audits won’t change much, bringing on new suppliers is an area to watch. He suggests establishing upfront documentation procedures for the information you need and how the new supplier is going to send it to you.

Coronel predicts FDA inspectors will find audits challenging until they understand how the new system works. He says they will need to understand how ERP works with traceability. He also believes audits will likely take more time.

Over the years, food safety consultant Paul Cordes has found traceability mistakes in his work with processors. “If I’m using salt that comes in with a tag on it from the manufacturer, that might be the Julian date when it was produced. You don’t necessarily use that,” he says, because the supplier might have assigned its own internal codes. Cordes also says processors should be careful with the extra traceability documentation if they are producing variety packs or prepared meals with different types of foods, such as a salad kit.

When bringing on new suppliers, if you have multiple ingredients that are coming in, you keep individual receiving records for each of them, says Edmunds. “But if you’re transforming or creating, [using ingredients] coming from multiple traceability lot codes, and you have multiple ingredients that are already on the list and creating something else, there are going to be some growing pains in that area, such as finding out exactly how to transfer that information through your production process.”

Coronel has seen companies that can’t get certain products, so they replace them. “A few companies have called me and said, ‘Is it OK if we substitute this for this for food safety?’ And that goes back to having some flexibility,” he says. “But I think, for traceability, it can be a nightmare because everything will change. But if those ingredients or those intermediate products have the electronic token and have been traced back, then it shouldn’t be that much more difficult.”

The key for affected processors right now is to identify whether they’re holding or processing something on the food traceability list. “Food processors must look at their supply chain to see which CTE applies to them, and they’ll need to start immediate discourse with their suppliers to determine if they already have the pertinent information,” says Edmunds.

It is important to note that if food processors apply a kill step, the requirements do not apply to their subsequent shipping. If a processor receives a food that has been subject to a kill step, the requirements also do not apply to its receipt or subsequent transformation and/or shipping of food.

Making traceability more effective

Co-packers or co-manufacturers also need to increase their awareness of traceability. They must have all the documents and be able to trace back any components of the food they are processing, says Cordes. “It’s their responsibility. They’re selling it as a final product. It is going to be different for variety packs, co-packing, or co-manufacturing of someone else’s goods,” he says. “Sometimes, you’re not the holder of all the information, but you’re go-ing to have to be now.”

Cordes says the FDA is trying to make the system more effective. “For some businesses, I think it’s going to be a little trickier than [for] others because it will cost them money in the end,” he says. “You have to track what goes into a product and be able to retain that information in the event that there is an issue.” It just means the FDA has a little bit more power to do things than what they have in the past, Cordes concludes.

FDA’s Recent Work on Prevention and Outbreak Response

According to FDA statistics from December 2021, foodborne pathogens are estimated to sick-en one in six Americans each year, resulting in an estimated 128,000 hospitalizations and 3,000 deaths. The agency says foodborne outbreaks require multidisciplinary efforts and, often, multijurisdictional coordination.

The FDA’s Foodborne Outbreak Response Improvement Plan (FORIP), introduced in 2020 as part the agency’s New Era of Smarter Food Safety Blueprint, is an operation the agency is undertaking to improve the speed, effectiveness, coordination, and communication of outbreak investigations.

FORIP focuses on multistate outbreaks that require significant engagement coordinated by the FDA’s CORE Network. This plan is intended to complement two of the blueprint’s core elements: “Tech-enabled Traceability” and “Smarter Tools and Approaches for Prevention and Outbreak Response.”

Last summer, the FDA launched its Low- or No-cost Tech-enabled Traceability Challenge as part of the America COMPETES Reauthorization Act of 2010. The act asks companies to invest in innovation through R&D to improve U.S. competitiveness. The goal was to encourage stakeholders—from technology providers to public health advocates and innovators—to develop traceability hardware, software, or data analytics platforms that are low or of no cost to end users.

Out of 90 submissions from countries around the world, the FDA announced 12 winners from the U.S., Canada, and New Zealand. Some commonalities between winners include alignment with GS1 standards, multilingual options, and label generation. The following are some of the winners.

Atma.io, Avery Dennison’s connected product cloud—a platform for creating, managing, and assigning digital identities for individual items—is one of the components that provides item-level traceability to each participant in the food supply chain, from source to store and from farm to fork, using Avery Dennison systems and proprietary blockchain technology through Mastercard Provenance. Each item-level event is tracked in atma.io and subsequently written to Mastercard Provenance, allowing producers to automatically feed in product attribute information for each SKU—for example, weight, price, and shelf life.

Mojix uses industry standards to link traceability events for each individual item and/or lot throughout the food supply chain to enable a low-cost, collaborative open data network. Each item has a universal ID, and when an item is separated into parts, all key data elements (KDEs) and critical tracking events (CTEs) remain associated with the original ID. Distribution centers, processors, and wholesalers can attach information to an item through a digital link. The Mojix network synchronizes data from multiple sources and acts as a global repository.

Rfider from Rfider Ltd is software-as-a-service that simplifies capturing, securing, and sharing critical event data along supply chains, all the way to consumers. This system includes a mobile application with an intuitive interface for data collection, a platform for data management, and a data sharing system for easier sharing capabilities. The mobile app is further designed to present users with the tasks that are relevant for a product at any given step in the supply chain.