I’ll take your 1-mile setback and raise you 3. 

Balancing Science and Assumptions in Food Safety 

First attempts are rarely the best. That applies to just about everything—including writing and food safety practices. This document has been edited many times, and that doesn’t make the first version wrong or useless—it’s simply part of the iterative process of finding the best way to communicate a message. The same principle holds true in food safety. 

In produce food safety, we often manage “known unknowns.” Environmental conditions change constantly, usually beyond the control of the grower. Decisions are made based on the best available information at the time—what we might call educated guesses. While well-intentioned, these guesses can resemble hopeful assumptions more than science-based risk management. 

The solution? Invest in research and data collection to better understand the risks and refine practices accordingly. It’s a natural progression: we start with a best guess, we collect data, we reassess. But what happens when new evidence contradicts that original guess? 

That’s where things get complicated. If the original guess aligns with new data, it’s easier to validate and formalize. But more often, early assumptions fall short. This introduces a challenge: how do we justify changing an accepted industry standard that was originally based on a guess? 

This is the danger of “the first requirement”. By being “first,” it becomes the default, and soon it’s embedded in systems, policies, and contracts. Over time, it gains weight that may outweigh newer, more accurate information. Even if new research data shows the original approach was flawed or incomplete, shifting away from it becomes difficult. As a result, tension grows between established practices and emerging science. 

This situation is particularly visible in the fresh produce sector, where food safety risks are both serious and extremely complex. One example is the management of risks from adjacent land uses—animal operations, composting facilities, and wildlife habitat. These areas are known sources of microbial pathogens like Salmonella and pathogenic E. coli. Setback distances (buffers) are established to manage the potential for contamination, sometimes based on data, but often grounded in the logic that “more distance must be better.” 

But are those distances really effective? Maybe—but maybe not. And each year, the market tendency towards continuous risk reduction is to increase setback distance requirements, reinforcing the idea that more distance must be better. However, growing research shows that while distance matters, it is far from the only factor that matters, and many other factors, often unique to a specific location, are interacting that drive heightened risk.  

Recent work by Dr. Mohit Verma at Purdue University, funded by the Center for Produce Safety, measured fecal indicators, Bacteroidales, in air samples taken in fields near animal operations. The findings showed that setback distance alone could only predict airborne contamination with Bacteroidales from animal operations with 12–54% accuracy. That’s a very wide and uncertain range. The takeaway here isn’t that setbacks are unnecessary—but that setback distances alone are insufficient to effectively manage risk. In short, on the topic of setback distances, the appropriate setback distance is very much “IT DEPENDS!”  

So, what should the industry do? 

We need to listen, understand and appropriately apply the science to drive pragmatic food safety requirements specific to certain locations. Risk is multifactorial. Distance is only one part of the equation. Rather than defaulting to single-variable design requirements, we should be developing strategies that account for the full range of contributing factors for a site. That’s not easy, but it’s necessary. 

When best guesses harden into standards without reassessment, they can slow progress. They consume resources, create ineffective systems to manage, and limit exploration of more sustainable or effective solutions. Continuing to support research, collecting high-quality data, and being willing to revise practices when the evidence points to a better path—this is how we must move forward.  

The true cost of sticking with flawed assumptions is stagnation and creating non-sustainable food safety systems. We owe it to growers, consumers, and the broader food system to stay open to change and invest in better ways to manage risk. Let’s listen to the science and use it to drive targeted, customized risk management solutions appropriate for each situation and site.  

The Western Growers Science team recently completed a real-world study comparing different methods for verifying harvest bin sanitation in produce operations. Their findings are now available in a new whitepaper that looks at how tools like Adenosine Triphosphate (ATP), traditional microbial tests and the CytoQuant® flow cytometer perform under field conditions.  

The paper provides practical insights into what is measurable in the field, and how verification methods can support stronger sanitation programs. Read the full report here.  

Risk-based management has been the on-trend phrase of the past decade within the food safety community. Globally, numerous regulations and food safety standards have adopted language that requires food-producing entities to assess their process and product, and then apply risk-based measures appropriate for the risk. This is a logical and scientifically supported theory – it makes complete sense to apply the most time and resources where gaps are identified and where our opportunity to minimize risk is the greatest.

I have spent my academic and industry career chasing, supporting and helping execute this concept, supported by science and the best-informed guesses when available. I am an ardent believer that when risk-based programs are truly developed and implemented, we will find a more manageable and sustainable system of food production.

The transition to risk-based management is a passion, and I work diligently to support the produce and food industry in incorporating those practices. However, one of the observations I have made throughout my career is that risk-based management and measures are straightforward only in textbooks, and the true application of risk-based management for food safety represents a quagmire of scientific and social complexity.

The shift to risk-based regulations and standards has been rapid from a regulation perspective, leading to numerous updates and forms being produced to aid the industry in assessing and documenting their risk to meet compliance requirements. While new forms and checklists were made and training developed, it appears the root cause impeding the shift to true risk-based management is that no concerted effort to shift to a fundamentally different management or regulation style occurred at the same time.

With the introduction of risk-based language in the regulation, the industry acted effectively the same, albeit with more paperwork and different terms used. Customers required the same information and had the same expectations of suppliers while regulators used similar decision-making and actions reminiscent of the prior regulatory era.

In effect, the transition to risk-based food safety happened on paper, but food safety culture remained more-or-less entrenched in an era of zero-hazard tolerance.

The paradigm shift to true risk-based management ultimately requires some amount of risk to be acceptable, and it recognizes that different systems, producers and products will have variable levels of risk.

In a risk-based system, it does/will not matter how many risk assessment forms are completed since risk-based management only truly begins when we permit the food industry and food regulators to recognize that there is some acceptable amount of risk.

Without acknowledging that not all risks can be eliminated or controlled – especially for fresh produce and foods without microbial kill steps – there will continue to be little incentive or benefit for risks to truly be identified. Risk identification and characterization are generally still perceived as evidence of failure rather than evidence of proactive risk management.

One illness is too much, but zero is unrealistic.

Allowing for risk in the food system seems counterintuitive to our goal to reduce foodborne illnesses. The food industry should have a goal of zero risk to consumers, and that must always be the target. However, while one illness will always be too many, zero illness is also unattainable and building systems that only tolerate pass/fail or good/bad outcomes prevents identifying realistic ways to manage risk.

This binary risk outcome is an enormous roadblock in the path to continuous improvement since there is rarely any advantage for a company to characterize its true risks within the system. For example, while we openly discuss and recognize that seasonal or geographic factors may influence risk in fresh produce production, what benefit do individual growers gain from fully characterizing that risk when customers and regulators view such identification in isolation—often discrediting the fact that sufficient efforts and programs may already be in place to manage it at an acceptable level?

In effect, guilt is easy to prove while evidence of control (or innocence) is almost impossible to defend.

Taking a recent real-life event as an example, a pathogen-positive sample originating from a routine sampling event for Salmonella led to a grower losing a multi-million-dollar customer who chose to terminate a contract due to the pathogen finding. This reactive decision was made despite that this positive was in isolation and not associated with any illnesses or process failure evidence. This isolated pathogen result ultimately led to a drastic reaction by the customer and reinforced for the grower that there is little incentive to build systems to identify and monitor for risk. Additionally, there is even less incentive to be transparent with external stakeholders about when risks may be present.

In the prior example, we saw a customer interpret a pathogen detection incompletely and with what seems a disproportionate reaction. It is understandable that no one wants food/systems with risk and would naturally reject it. However, believing that a successful strategy is to sever ties with any supplier, farm, product or process once a positive is found from a random test is misguided. More importantly, it is counterproductive and destructive since it reinforces to the food producer that a smarter strategy would be to build food safety programs that always return negative results, regardless of whether that outcome truly reflects the situation. As with all risk, the scariest type is the type you do not know you have. If we interpret each finding of a pathogen, and sometimes even indicator/index organisms, to be viewed as evidence of systematic/gross/preventable failure, then that only further reinforces that identifying risk to optimize managing it is not a sustainable food safety or business strategy. Conversely, this supports a strategy opposite of risk-based management since we are not allowing food producers to investigate risk to manage it without then using that same information as evidence against them.

Risk-based management requires that we design systems that consistently and efficiently identify risk so that appropriate measures can be implemented to reduce it. Preventing the first step of identification impedes much hope of executing risk-based management across the food industry.
To illustrate what risk-based management and risk permission in food production could look like, here’s a non-food example. We all accept that sharks are a risk to human health when swimming in the ocean. However, our means to manage that risk is not to set out to remove all sharks from the ocean.

Instead, we as a community, have designed education, alerts, monitoring and sometimes physical barriers like nets to protect humans in the ocean environment from a potentially hazardous encounter. Extending the metaphor, we not only authorize the risk to exist, but we design systems to know when the risk is elevated and when too much risk is seen. If sharks are too close, we take measures to get people out of the water and close beaches.

In agriculture, we grow our food where pathogens live and must accept and authorize that occasional encounters with foodborne pathogens are not unexpected. If we build our pathogen monitoring systems appropriately, we will allow for systems to alert food producers when risks are no longer acceptable (i.e., too many sharks) due to current measurements being above what baseline measurements would expect.

Due to the complexity and diversity in agricultural and in food-producing ecosystems, risk is expected to be variable and needs to be monitored per producer and system. Once established, these risk-based monitoring systems must also be recognized and trusted as functional (i.e., we cannot abandon fields/processes simply because a non-zero-risk baseline is established). With understanding and authorization that the status quo has some inherent risk, we permit the establishment of systems being built to be able to identify and manage risks when they elevate.

Once we can understand the increased risk, science can help design appropriate mitigations to reduce risks back to acceptable levels. True risk-based systems offer the ability to allocate resources where risks are elevated and minimize limited resources being applied inefficiently across supply chains.

Transitioning to risk-based management starts with culture. 

As much as this risk-obsessed microbiologist loves the concept and science of microbial risk management, I have come to recognize that the first system to be built to achieve that goal is dependent on individual and societal psychology. As a collective food industry, we must focus efforts on shifting to a culture of risk acceptance if we want to truly usher in a more sustainable means to reduce foodborne illness. While it does sound somewhat counterintuitive to allow for risk when trying to reduce it, the lack of doing so regrettably leads to situations where far more risk remains unknown and unintentionally accepted. Permission to identify risk without fear of losing customers, ranch land and products is a critical first step to designing sustainable risk-based systems in the future.

Culture is discussed frequently both in business and the food safety community, but rarely do we intentionally collaborate to design systems to cultivate it. This is especially true when building culture requires connecting a diverse community representing different stakeholders and geographies. Any culture-building effort, including one for food safety, takes strategic design and constant support.

These efforts will often take more time and be more difficult than the food safety measures themselves. But, as with all great innovations and efforts, the first step is to truly identify the challenge at hand and to socialize the immediate need across all stakeholders.

The unlock for the food industry on real risk-based management starts with these two related and distinct questions:

1. What actions can we take to curate the culture of our broad food safety community to understand the need and adapt behavior to authorize risk identification and management throughout the supply chain?

2. What monitoring systems can we build to effectively evaluate risks within the industry so preventive and proactive actions are taken to remove pathogens from the food system, ultimately reducing risk to consumers?

With a collective commitment across all stakeholders to truly transition to risk-based management, we offer the opportunity to flip strategies, collaborations and mitigations. We can begin to design the monitoring systems we need to optimize both food safety and business outcomes within and across food segments.

A sustainable system of food production is within our grasp, but we must recognize it will not come to us without our collective efforts to build a bridge between two disparate food safety systems – one of hazard management to one of risk management.

The bridge between where we are at, and where we need to go, relies on the collaborative belief that we can change the food safety paradigm. A truly sustainable food safety system is attainable, but we need to choose to constantly cultivate it.