The Food Safety Insights column was created to discover and report on changes and developments in food safety markets, along with the responses to these changes by food processors around the world. Our stated goal was to report on what is happening and what food processors are doing in actual practice—not what people expect, think, or assume is happening. To accomplish this goal, we regularly conduct surveys and interviews with food processors. To date, we have been in contact with and heard responses from tens of thousands of food safety professionals from around the world.

While reporting on what is happening in the food safety world is our main goal, every so often it is also fun to take what we have learned and make a few predictions about where the market is headed and what we expect to see over the next few years. Or, to paraphrase hockey legend Wayne Gretzky, skate to where the puck is going, not where it has been.

So, let's discuss a few trends and make a few predictions.

The Transformative Effect of Food Traceability

The coming implementation of effective food traceability systems has the potential to revolutionize supply chains and foodborne outbreak tracking in the same way that whole genome sequencing (WGS) and the PulseNet and GenomeTrakr databases have completely changed the game in identification and source tracking. These tools are credited with identifying and tracing contamination events that only a few years ago would have been invisible. Traceability will serve to illuminate the path from the individuals with foodborne illnesses to the production source—a link that is still missing from many foodborne outbreak investigations.

Effective food traceability will allow for faster and more targeted recalls that more precisely isolate affected products, minimize public health risks, and provide companies with better data. This will help them effectively find the root causes of contamination and develop permanent corrective actions to prevent recurrences.

The incidence of recalls will be reduced and shorter in duration. Those that do occur will be more targeted. Gone will be the day of blanket recalls—e.g., throw away and avoid eating [insert food product here] everywhere in the country. Better data delivered faster will also mean that more incidents will be caught in the distribution chain, before the affected product gets to the consumer. We have seen improvements over the past few years in the precision of recalls, but gaps remain. Closing these gaps will have a dramatic impact on the effectiveness of the system and, hopefully, an even more positive impact on the food-consuming public that seems to be losing trust in our food safety system.

Now, I know what you are thinking: "But the FSMA 204 compliance date has been delayed 30 months to July 2028!" This is true, and certainly unfortunate for the realization of any of these benefits. But a little more than two years ago, we published a two-part article on how the Food Traceability Final Rule will impact food processors.^1,2 The survey responses we received indicated that many small- and mid-sized processors were not prepared. Many were unsure of the requirements, unsure if FSMA 204 applied to them and/or the products they manufacture, and unsure of exactly what steps they needed to take to comply with FSMA 204. This uncertainty was even greater for international food processors (located outside of North America), which are also an essential element in the supply chain.

How much has changed in the past two years? Are these companies now completely prepared? We do not know for sure, but I have confidence that progress has been made, based on what we heard from surveys we conducted on FSMA readiness in 2017, 2019, and again in 2023. The responses clearly demonstrated that companies had been making considerable progress in other elements of FSMA compliance. I suppose it is reasonable to conclude that similar progress has been made with FSMA 204 compliance since 2023. But does progress alone result in the "chain with no missing links" that is required for an effective traceability program? In its public announcements, the Food and Drug Administration (FDA) has concluded that many companies are not ready, and that "all covered entities must be in compliance" for FSMA 204 to be effective.³ FDA plans to use the 30-month delay to coordinate across the supply chain and to work with "less-prepared partners."³

This may turn out to be a good plan. While keeping the compliance date in January 2026 may have served to force compliance, launching a traceability system with substantial holes could serve to handicap its effectiveness and further undermine the public's confidence in the food safety system—including the food safety professionals and government agencies running it.

The additional time does need to be seen as an opportunity to accelerate preparedness, and not as a reprieve that allows businesses to "sit back and relax." FDA needs to take actions to drive compliance and emphasize a sense of urgency.

Putting an effective traceability system in place will not be easy, even in 2028. There will undoubtedly be errors and problems in implementation that will need to be solved. Once an effective traceability system is in place, however, the food safety landscape will be forever changed. We will see dramatically faster identification of contaminated products and fewer potentially impacted lots. Mysterious, unsolved foodborne outbreaks will become increasingly rare. Less food will be unnecessarily wasted. Better data and the capacity for more rapid responses will minimize the duration and impact of foodborne illness outbreaks and greatly improve consumer confidence.

“In the past few years, we have seen an increasing number of responses indicating that more people are reducing their environmental monitoring test volumes.”

Reduced Environmental Monitoring

One of the questions we ask frequently in our surveys is about the types and volumes of analytical testing done by food processors. We focus on microbiological testing and, in particular, environmental monitoring (EM).

In the past few years, we have seen an increasing number of responses indicating that more people are reducing their EM test volumes. Among the reasons we have heard for these reductions is companies have accumulated a large dataset of historic results that allows them to make more effective risk assessments and validations of preventive controls, which reduces the need for sampling data. Many have also put this is simpler terms, saying, "We see a lot of negative results, so there is no reason to continue to test at those levels."

We still see most respondents report that they are conducting "about the same" number of tests as they have been—i.e., no increases or decreases. While the number of people that indicate they are increasing their EM test volumes is a minority of responses, that number is nonetheless larger than those making reductions, suggesting growth in overall EM test volumes, but at a far slower rate.

Over the past few decades, with increases in food plant capacity and production volume and an increasing number of facilities, increases in EM test volumes were common.  But this is changing. As an example of the pace of this change, in surveys we conducted in 2020 in the U.S., Canada, and Europe, respondents who indicated they would be increasing their EM test volumes outnumbered those indicating reductions by a ratio of 20:1 in the U.S./Canada and 15:1 in Europe. In recent surveys, however, these ratios have dropped to less than 5:1 in the U.S./Canada and less than 2:1 in Europe. This market will show a significantly lower growth. More importantly, a growing number of facilities are conducting fewer EM tests.

For those companies who have scientific justifications to use their datasets for better risk assessments and to validate their preventive controls, this reduced level of testing may not have an effect. However, almost every expert I know counsels that if you are testing and not finding positives, that is not a signal to have confidence and relax, but rather a wake-up call to test until you find the risk organisms that are certainly hiding in your plant somewhere.

While this change may indeed have a scientific justification for many companies, inevitably reduced costs (since fewer tests equal lower costs) may be the stronger driver, and one that is difficult to reverse until there is a problem.

This trend has been having an impact on diagnostic test markets, but more importantly, it will eventually backfire and result in contamination events that otherwise would have been detected by a robust EM program. As these contamination events become well known, we expect to see a resurgence in EM volumes in a correction that should not have been needed.

Hitting the Limits of Outsourcing?

The fact that far fewer microbiological samples than ever are analyzed at in-plant labs will be no surprise to any reader of this column. The level of outsourcing in sample analysis has been steadily growing for more than a decade. Seven years ago, we reported that about three-quarters of the processors in our surveys had an in-plant lab, and 55–60 percent of them used that lab for some or all of their pathogen samples. Eleven years ago, in 2014, Strategic Consulting Inc.'s data showed that this figure was closer to 75 percent. In more recent surveys conducted within the past 2 years, we see that this ratio has flipped and now 78 percent of U.S. processors report that they no longer have an in-plant lab. Of those processors that maintain an in-plant lab, only 8 percent allow the analysis of pathogens in-plant. This is a substantial shift.

These data indicate that over the past decade, a large volume of samples has been outsourced to commercial labs. This has been apparent in the growth of the commercial laboratory business, especially in North America and Europe, where the commercial laboratory market for microbiology test analysis has been growing as much as two times the rate of overall sample growth. Of course, this rate of outsourcing cannot continue since, at some point, the market will be saturated as it runs out of samples to outsource. Based on what we hear from food companies and commercial labs, we are already at that point of saturation. This will cause the growth of the lab market to regress to the level of the overall growth of sample volumes—well below the double-digit growth that labs have seen.

Saturation will stoke the already intense price competition in the commercial lab market. Commercial labs, adjusting to lower growth rates and looking to maintain their margins, will also negotiate lower prices from their test suppliers, putting more downward pressure on already squeezed pricing in the diagnostic test market.

“As outsourcing has grown dramatically with fewer in-plant labs, we are hearing from food processors that they miss having the capability for rapid analysis that allows them to make faster decisions.”

Commercials labs seeking other avenues of growth will expand into additional analytical services, other markets (e.g., pharmaceuticals), and other services. In a move that will further intensify diagnostic test competition, these labs will offer their own commercial diagnostic tests. All of these things are already happening, but they will continue to intensify and result in a more intensely competitive market, lower margins for many businesses, and perhaps even more significant business risks.

Potential Shifts in Analytical Techniques

As outsourcing has grown dramatically with fewer in-plant labs, we are hearing from food processors that they miss having the capability for rapid analysis that allows them to make faster decisions. Outsourcing has returned them to the days of 2- and 3-day sample turnaround, and this is becoming unacceptable. This may be driving some analysis back into plant labs.

Early in their introduction in the market, rapid microbiological methods (RMM) were employed at in-plant microbiology labs to produce faster results for product release testing. Since decisions to ship products were held pending lab results, faster results meant faster and more efficient logistics and less need for finished product inventory and storage. In-plant labs also gave them the ability to make faster operational decisions about cleaning and sanitation and product switchovers based on their EM data. Today, with less (if any) lab capacity and a large volume of their microbiological tests being outsourced to commercial labs, food companies seem to be regretting the loss of RMM to provide real-time data enabling faster internal operational decisions. Many processors are now telling us they would like to have that capability back and are considering bringing some lab capacities back in-house by having RMM available for analysis of EM samples.

The tests they will likely adopt may look different than the popular tests of the past, however. Those who return to the use of RMM for in-plant EM applications will not be utilizing technologies like PCR or instrument-based ELISA that require trained lab technicians. Since companies have had limited in-plant lab capabilities for some time and they will not be looking to hire lab technicians, they will want tests that are very easy to use, with only a few steps, so that plant employees without laboratory experience can conduct them. Companies will also demand tests that are fast. Most tell us that less than 24 hours will be considered "useful," while a test with results in less than 8 hours will be "nice to have." They are also looking for tests that are very easy to use, with only a few steps, so that plant employees without laboratory experience can conduct them. We anticipate surface tests for the detection of non-pathogenic indicator organisms, or instrument-based tests for bioburden for product screening applications, to be the most in-demand tests. Screening tests for pathogens will also become more popular, but any need for sample pre-enrichment will still be met with resistance from many companies. Successful ones will have a limited need for pre-enrichment, and the enrichment step will need to be conducted in a sealed container for in-plant safety.

This article has outlined just a few of the trends that will affect food safety in the coming years and be impactful to our markets. Food safety, like every other market, will be affected by other trends such AI, digitization, data security, globalization, inter-connected supply chains, and many others. Food Safety Insights will be keeping an eye on how you are dealing with these issues, as well as the changes that affect our specific food safety markets.

References

1. Ferguson, B. "How the Food Traceability Rule Will Impact Food Processors—Part 1." Food Safety Magazine February/March 2023. https://www.food-safety.com/articles/8334-how-the-food-traceability-rule-will-impact-food-processorspart-1.
2. Ferguson, B. "How the Food Traceability Rule Will Impact Food Processors—Part 2." Food Safety Magazine April/May 2023. https://www.food-safety.com/articles/8490-how-the-food-traceability-rule-will-impact-food-processorspart-2.
3. U.S. Food and Drug Administration (FDA). "FDA Intends to Extend Compliance Date for Food Traceability Rule: Constituent Update." March 20, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-intends-extend-compliance-date-food-traceability-rule.

Notes

^a For chicken, the serotypes are Salmonella Enteritidis, S. Typhimurium and S. 4,[5],12:i.

^b For turkey, the serotypes are Salmonella Hadar, S. Typhimurium, and S. Muenchen.

^c These were the terms of the proposal at the time of our survey and the writing of this article. The comment period for the proposal was scheduled to end on January 17, 2025, and changes to these terms and the proposed regulation may be in process.

^d In the survey, we specifically asked the question, "If you could ask any question or make a request to USDA Deputy Under Secretary for Food Safety Sandra Eskin, what would that be?" Since the time of our survey, Sandra Eskin has left her position at USDA and, as of this writing, a successor has not yet been named.