In Part 1 of this series, published in the February/March 2023 issue of Food Safety Magazine, we reported on the reaction we received to the U.S. Food and Drug Administration's (FDA's) Final Food Traceability Rule that was released late last year.

We learned that food processors were certainly aware of the new Rule, but many were not sure how they would be affected by it. Roughly one-third of the people we heard from said that they produced products on the Food Traceability List (FTL) and, therefore, would be directly affected by the requirements of the Rule. We also found out that as many as two-thirds of those we heard from suggested that being directly affected by the Rule ultimately may not matter much, as they expect that the requirements of the Rule will come to apply to other foods not on the FTL.

Many of the comments and questions we received were largely along the lines of, "Exactly what does this mean for us, and what will we have to do to comply?" Due to the uncertainty of what exactly is required, we also heard many comments related to what help might be available for processors to better understand the requirements, as well as FDA's expectations and how we can hear those answers directly from the FDA. Processors want to know, "What is the impact on my company and my operations?"

Anticipating these comments, we asked in our survey, "What do you wish the FDA understood about the impact of the Food Traceability Rule?" (Figure 1).

In the direct answer to our question, roughly one-third of respondents mentioned that they had specific food processing issues that would arise or be impacted by the Rule (Figure 1). Twenty-eight percent said the agency needed to consider the impact of the Rule on small businesses, and the remaining one-third had questions for FDA about the agency's enforcement position, the training that may be needed, what resources and training assistance will be available from the agency, how the documentation requirements will work, and similar issues.

As to the first issue of specific food processing segments impacted, a food safety specialist at a fresh produce packager mentioned, "Most fresh produce products fall under the FTL, yet FDA does not have a solid grasp on how fresh produce is traced. In the proposed Rule, they seemed to be looking for case-level traceability, which is not doable."

Another packaging company director of quality mentioned the complexities when dealing with multiple suppliers in a production process. He said, "Supply chain availability can sometimes require a manufacturer to pivot to a different supplier. Subtle differences, like diced tomatoes versus whole tomatoes, often prevent us from being able to do so because the ingredient deck of the finished product must specify the tomato's form. Oftentimes, whole and diced are both used, and so both must be listed accordingly. It doesn't consider that during the manufacturing process, the whole tomatoes break down and become indistinguishable from the diced, essentially making the ingredient description irrelevant, not to mention misleading. Allowing for 'tomatoes' to be listed without identifying the form would allow more flexibility and keep production lines moving. Downtime often comes when we are waiting on ingredients."

Another quality assurance/quality control manager in a processed food facility echoed this complexity, saying, "Mixed production facilities such as ours use the same products across multiple streams in large quantities and need to have several suppliers for some production runs."

The impact on small businesses is another area where processors wish FDA had a better understanding. Many people indicated this concern with a concise, "We wish they understood the impact this will have on small businesses; we are already struggling to comply with existing requirements."

A key element of the Rule is for processors to have the ability to produce lot traceability records within 24 hours of a request for those records from FDA. Survey responses on readiness to comply with this element may be an indication of processors' confidence in their current abilities, with 90 percent of survey respondents saying they have that capability now (Figure 2).

One dairy quality assurance/quality control manager added, "I imagine, for some companies, meeting the new requirements in three years could be difficult to achieve. Some small companies might have trouble [affording the] software that would make traceability more efficient…" Another comment, also from a dairy specialist, reinforced this idea: "It will be difficult for smaller companies to produce required documentation."

So, what are companies using to gain this capability? We asked that too, of course!

Roughly one-third said they were using a commercial software program or an off-the-shelf module for their current enterprise resource planning (ERP) system (Figure 3). The next two responses saw 19 percent reporting that they were using spreadsheets, and 19 percent saying they had their records on paper. Together, these two categories of relatively "manual" recordkeeping accounted for the largest subset of systems reported being used.

One quality assurance/quality control manager of a dietary supplement contract manufacturer said that they would have no trouble tracking their raw materials and ingredients to their origin with their existing systems and programs. "We looked at existing systems and programs, and we found that each had gaps in what we needed. So, we worked with an independent design company, and we built our own system to meet our needs." Once that system is ready, he indicated that tracking their products back to the source would be possible even within the 24-hour time target set by the Rule. "We even purchase certain ingredients from domestic brokers, but we get all of the tracking data from them on the origin of the products." The main issue to overcome in their situation arises when they sell it to their customer—the brand owner. "The data on the distribution from our customer to the store and then to the end customer is not available to us," the manager noted.

Another director of quality assurance at a contract manufacturer mentioned that all of their current records are still on paper. "We have looked at a number of the commercially available options, and we think one of those—especially those that are a 'bolt-on' to our current ERP system—may work well for us." The issue he mentioned that is holding them up from fully implementing the new module is its cost. "Our issue is the not only the outright cost of the software and installation itself, but those costs combined with the continuing high costs we are facing in other areas—such as supply chain shortages and the high prices we are continuing to pay for logistics—makes it difficult to take on anything else. We keep waiting for our supply and logistics costs to return to normal, but it seems that once these costs went up during the supply chain crisis, there has been no incentive to reduce costs since, and that takes resources from other projects."

Other companies that have already implemented traceability systems and new software programs commented about the lack of standardization of the software packages and the form of reports expected by FDA. Although the specific requirements of the Final Food Traceability Rule are not yet in force, several said that they have had issues with explaining what their systems collected in terms of supply chain data and how some inspectors had trouble accepting the format of the reports they produced. This lack of standardization may make communication and meeting expectations of the Rule more difficult during an inspection.

These are just a few examples of what companies are doing to prepare for compliance. This still leaves open the question of "Am I covered by the Rule, and do I have to comply?" Recall in our February/March edition of Food Safety Insights that about one-third were not sure if the Rule applied to them. Furthermore, more than one-half expected that the Rule will ultimately apply to foods other than those on the FTL, expanding the applicability of the Rule and potentially impacting more processors than expected.

“FDA has released a decision-tree tool on its Food Traceability Website that allows companies to go through a series of questions to determine if they are entitled to an exemption to the Rule."

As part of its outreach and education on the requirements of the Rule, FDA has released a decision-tree tool on its Food Traceability Website that allows companies to go through a series of questions to determine if they are entitled to an exemption to the Rule. Using what I learned in my interviews, I decided to try out this program. Now, certainly a caveat is in order. I took the information I was given in the interviews and applied that to the decision tool. I understand that what I learned in a 30-minute interview does not make me well versed with the particulars of any processor's or distributor's operations. In many cases, I had to estimate the correct input for the tool. These examples should be viewed as an illustration of the use of the decision tool and not as a definitive answer for anyone's particular situation. Nonetheless, this exercise was an interesting experience.

In the case of the processor mentioned earlier that works with both whole and diced tomatoes, they reported that they used a validated thermal process to treat the incoming product. Assuming that their validated process meets the Rule's requirement to comply with 21 CFR 112.2(b) to reduce the presence of microorganisms, and that process is used on all of their products, the FDA decision-tree tool seems to suggest that they should qualify for an exemption because of this kill step. This does not solve their labeling issue, but it may offer the possibility of a simpler option for compliance with the Rule.

In the February/March column, we also discussed the case of a nonprofit food bank distributor. In describing their operation, they said, "We are a nonprofit food bank distribution center… and we do not change or process the food while in our possession."

In running this case through the decision tool, it takes about five steps to arrive at the answer that this nonprofit distributor may not qualify for an exemption if they distribute any products on the FTL. Since they "take physical possession" of the food and it is for distribution and not "personal consumption," the decision tool reports that they are not qualified for an exemption under "personal consumption, holding food for specific consumers." On the other hand, the distributor may be eligible for an exemption if all of the foods that they distribute are "rarely consumed raw," as defined in the Rule. This illustrates another of the complications of determining whether an entity qualifies for an exemption—there may be multiple paths to explore.

This exercise was used only as an illustration of how many questions may arise in determining which companies are subject to the Rule and much will depend on their specific situations. It does, however, illustrate that you will need to do your homework on your own, using all of the details of your specific operation to find out what you will be required to do to comply.

It is probably a good thing that we have three years.