Taking control of your produce safety future...

Bob Whitaker, Ph.D. Whitaker Consulting LLC

 This is the fourth article in a series entitled “Produce Safety – of this I am certain” (1) The future of produce safety: of this I am certain... | LinkedIn). The ten “certainties” we are exploring are restated in the table below. Today’s article focuses on certainty #2, “Produce companies need to control their own produce safety future”.

The certainty that produce companies need to control their own produce safety future seems like a fairly straightforward objective, but I am sure that not many truly do. Many producers feel caught in an ever-changing crossfire of customer demands and FDA regulations that leaves them shaking their heads in frustration.  Indeed, it is a safe bet to suggest that the majority of growers, packers, shippers and processors have produce safety programs that have been shaped by what they have been told to do by buyers, commodity groups and regulators. And it is our own fault. 

To understand the reasoning for that blunt assessment we have to go back nearly three decades. As illness outbreaks began to be traced to consumption of fresh produce in the mid- to late 1990’s, many in the produce industry simply did not know what to do in response while others simply chose to ignore the mounting evidence that fresh produce could be contaminated with human pathogens. This was not necessarily an overt act of malfeasance by growers, shippers or processors, but more of a natural reluctance to change long held production practices, a hesitancy to take on the costs of yet another customer inspired requirement and a recognition of the deficit of scientific knowledge that might support improved produce safety practices. Given those realities, push back against the need for produce safety programs was an understandable, if ultimately misguided reaction, and put the buying community, producers and the FDA in an untenable position where something had to be done to build consumer trust and protect public health. Retail and foodservice operations embraced third party audits as a way to push suppliers toward development of produce safety programs in the late 1990’s and they later added either raw or finished product testing for some commodities starting in the 2007. The United Fresh Fruit and Vegetable Association developed good agricultural practices or GAP guidance in the late 1990’s and expanded upon them with auditing guidelines and questionnaires in 2001 to help producers understand sources of contamination and how they might be managed. FDA built upon the original industry GAP guidance and issued their document in 1998. When illness outbreaks continued, commodity specific guidances for fresh market tomatoes, leafy greens, cantaloupes, green onions and herbs were added between 2006 and 2013 with other commodities voluntarily preparing GAP guidances that reflected specific challenges with their commodities, e.g., potatoes. In 2008, the Leafy Greens Marketing Agreement was born in California and later in Arizona, the Tomato or T-GAP program was launched in Florida and a bit later the California cantaloupe industry launched a GAP program. Each of these initiatives relied on state regulatory auditors to monitor compliance. Of course, the Food Safety Modernization Act (FSMA) was signed in 2011 and is still being fine-tuned and implemented today.

Even with all this activity to write guidance and eventually regulations by industry and FDA, the reality of the situation was that a relatively small sampling of industry companies were involved; generally, the larger grower/shippers and processors, a smattering of retailers and foodservice companies and regional and national trade associations. Efforts to develop guidances always started out enthusiastically with several attending and contributing thoughts and ideas, but as time went on, attendance at meetings began to dwindle and a relatively small group of industry professionals always ended up driving the completion of the effort. The net effect was that many in the industry simply had little ownership in produce safety guidances or even participated in commentary on FSMA regulations and only a rudimentary understanding of why they were important and how they could be leveraged in the own operations.

So why the walk down memory lane? Because it provides a window with which to view where industry priorities have been for the last three decades. The guidances provide value in that they identify potential risk factors which can serve as a roadmap for any operation to begin their own hazard analysis and risk assessment. Only rarely during the course of the hundreds of meetings I attended over the time GAP guidances were being developed and later during the regulatory process around FSMA did I see a produce industry C-level executive participating. Simply put, the decision makers were not there. In many instances, aside from deciding what the risk factors were (e.g., water, animals, etc.), industry meetings to develop best practices for managing risk factors often devolved into groupthink and took on the characteristics of a race to the minimum that might be required or be acceptable to most companies; not necessarily what needed to be done to control a specific contamination risk. Always in the background was the unsaid concern that any significant changes would simply not be accepted by most producers if they significantly altered accepted growing practices, added costs, or offered opportunities for competitive advantages for growers that might not face a specific risk and could avoid its management. The produce rule was no different; it really became a minimum baseline for growers, shippers and packers and the politics of federal regulation omitted the need for hazard analysis and risk assessment and provided relief or even freedom from coverage based on grower size though it seems unlikely that pathogens recognize the same boundaries. Don’t misunderstand, the groups that devoted their time and efforts to develop guidance documents and provide insightful comments to FDA on proposed rules were sincere and worked hard, but they were limited in the end, resistant to stretch too far and unable to influence the mindset of the target audiences for their work product. Hindsight is 20/20 but given the continuing struggles the industry has with illness outbreaks; did we really do the industry the best service by trying to protect against significant changes? What might our industry look like today, if industry executives had actively and consistently engaged in produce safety, recognized the potential disruptions, the public health impacts and loss of trust outbreaks bring about and accepted the need for real change to address specific risk factors? 

In parallel to guidance and regulation evolution, third party audits became the “greens fees” for suppliers to serve retail and foodservice buyers. Buyer demands for audits were largely facilitated by larger shippers and processors who took on the role of helping their grower/suppliers and other vendors develop the basic programs and documentation to pass field, harvest or facility third party audits; a strategy that seems valid on the surface. During the time I was in Salinas, CA, I vividly remember working with contracted growers that my employer relied on to supply commodities and raw products for processing to help them develop hazard analysis and risk assessments and build programs that permitted them to “pass” third party audits our customers required. I was not alone, the trend to “do for” growers, harvesters and cooling vendors was pretty much universal (and still is in many areas across the country) and it was not an easy task. It seemed there was push-back at every turn and acceptance was only grudgingly achieved and had to be constantly reinforced. 

In effect, with good intentions, many growers, harvesters, third party cooling and distribution vendors were insulated from truly taking charge of their own produce safety programs. They essentially put their produce safety future in the hands of the larger grower/shippers who in turn often took on a “tell me what to do” posture and shaped produce safety programs around requirements from retail and foodservice buyers, generalized produce guidance from FDA and trade groups and third-party audits modeled after available produce safety guidances. Effectively the buy side of the industry, third-party certifiers, trade groups and FDA filled a vacuum; absent growers, harvesters and processors stepping up to address produce safety needs. Unfortunately, they were not as familiar with specific on-farm operations and growing environments as growers were and, in some cases, often did not possess sufficient produce specific scientific expertise and resulting requirements were sometimes conflicting, scientifically unsupportable and often reflected “solutions” to suspected outbreak causative factors though those factors were often only suppositions to begin with. But with “passing” third party audits remaining the de facto measuring stick for produce safety, the emphasis in the industry was to qualify suppliers by passing the third-party audit and meet buyer requirements. However, the most heated industry conversations on produce safety in the mid-2000’s were always around the multitude of audits required by buyers and the costs associated with those audits. No meeting could stir emotions more than a meeting on the subject of third-party audits and the producers desire to settle on a single audit that could be used and trusted by buyers. Eventually, the Global Food Safety Initiative (GFSI) developed a benchmark standard attempting to standardize the plethora of food safety standards and have had some success, but the issue of producers having to undergo several audits on the same operations yearly still exists today. 

Make no mistake, third party audits are valuable tools to measure compliance to standards and communicate with suppliers who cannot visit supplier locations routinely. However, produce safety cannot be practically advanced by passing an audit. One can meet the requirements of an audit but not necessarily have a comprehensive produce safety program. For example, all produce safety audits ask about equipment sanitation and want to see the master sanitation schedule, check the chemicals used, the frequency of sanitation, methods of sanitation verification testing and sanitation worker training. However, even if these elements are present and documented critical pathogen harborage areas might not be properly identified and therefore addressed each day resulting in a cross-contamination risk. This indeed has been the case in the industry where generic Listeria testing was exclusively limited to non-contact food surfaces and conducted monthly. In has only been recently that generic Listeria testing frequencies have been increased and sampling has been extended to critical zones in the operation. Similarly, a common audit requirement is to sample surface-sourced irrigation water five times during a season using in generic E. coli as an indicator of its pathogenic cousins. This equates to about once a month to earn compliance on the audit. However, compliance to the audit requirement does not account for microbial water quality every time water might be used or the validity of generic E. coli as an indicator for pathogens in surface water sources. Other examples of achieving audit compliance that does not actually reflecting day to day or even hour to hour safety status can be readily identified. Just ask yourself, how many times have illness outbreaks occurred and the responsible company reports having received passing audits prior to the outbreak? 

The industry jumped ahead of itself by its reliance on audits before developing validated strategies to manage potential contamination risks. GAP guidances gave us the hazards and risk factors and the produce rule expanded on them and provided management strategies but the hard work of addressing actual in-operation risks can only really be done by growers, packers and processors in their operations. Only then can preventive controls be developed and assessed for efficacy. From a 2021 perspective it seems clear that our overwhelming reliance on audits has bordered on the absurd. I can remember working with spot market commodity suppliers and asking about their produce safety programs and they would invariably send me a copy of a produce safety audit; often for a different commodity than what my company was interested in. In more recent years as I visited companies in the produce industry and asked about their produce safety plans, they often would take me out to their lobby and show me a copy of an audit certificate, generally 5-years old.  But from a 2000 perspective, third party audits offered an immediate solution to the increasingly alarming occurrence of outbreaks and recalls, and they represented a way for consumer-facing retail and foodservice operations to reassure themselves of the safety of the products they were selling. Certainly, there was a deficit of scientific knowledge on produce safety that really wasn’t properly addressed until 2007 when the Center for Produce Safety was formed and that limited development of real science-based solutions, but while not diminishing the critical importance of science, common sense can often serve as an important factor in risk assessment and management. It was understood in the early 2000’s that cattle were the major source for E. coli O157:H7 in growing environments, logic would lead one to believe that contaminated irrigation water was likely to transfer pathogens to crop plants, wild animals could vector pathogens to production fields, Listeria monocytogenes could be an important issue in packing and processing environments and so on. Therefore, without the science one could conclude that production fields located next door to cattle feeding operations, irrigation methods where open-sourced water contacted edible tissues on crops, or incomplete cleaning and sanitation strategies could be problematic. So, one is left to ask, if producers had embraced their role is meeting their legal obligations for the safety of their products instead of leaving it to others to tell them what to do or tacitly do the minimum to pass the audit might we as an industry be in a better position today? Might we simply have taken our eyes off the ball in some instances by focusing solely on audits instead of seeking out specific operational safety issues proactively and recognizing and addressing potential sources of pathogen contamination like, microbial quality of agricultural inputs like organic fertilizers and soil amendments, animal intrusion, adjacent land use, efficacy of sanitation practices, equipment design, and employee education? 

It is encouraging to see the old paradigm is being rethought as recent actions by the California Leafy Greens Marketing Agreement (LGMA) to reimagine adjacent land use and irrigation water sources to search out risk and science-based solutions and then modify their audit requirements. It is an example of how crisis often provides the energy to break inertia and commit to real change. Clearly the leadership at LGMA has a renewed commitment to move to a new phase of learning and changing practices based on science.

We have already discussed certainty #1 delving into the likelihood of future produce-related illness outbreaks, the underlying reasons for that certainty (Of this I am certain: it is not a question of if your company will face a produce safety event, but when. Part 1. | LinkedIn) and the near-term things you can do today to limit that reality (What can you do right now to avoid a produce safety crisis? | LinkedIn). We intuitively know that continued illness outbreaks are likely unless risk and science-based changes are made across the industry. We also know that there are multiple considerations to controlling your produce safety future. This very complexity is a contributing factor in long-standing producer frustration and the adoption of “tell me what to do” philosophies described above. Some factors that can impact a company’s ability to control its produce safety future include basic human behavior and a natural resistance to change, financial ramifications and competitive factors, the degree of comfort with science, environmental situations or adjacent land use issues near company operations, market acceptance and product uses and public perception. While the question of controlling a company’s produce safety future is admittedly complex, I am reminded of one of Dr. Seuss’ (that’s right the guy who wrote Cat in the Hat) famous quotes, “sometimes the questions are complicated, but the answers are easy”. The thing is, when you boil it all down, in order to control your produce safety future, the first step is to make up your mind to do so. You have to move from considering produce safety a “greens fee” to enable produce sales to committing to developing produce safety as a core competency of your company. It is a big change in mindset for many. I know the perfectionists and nay sayers will pooh pooh the simplicity of that answer. They will point to the aforementioned factors and add confusing and still incomplete FDA regulations, the spectrum of customer requirements, lack of scientific data, limited access to expertise and their limited scope within the monolith of the produce industry as nearly insurmountable. They will lament that their company can only do so much. 

I disagree with these tired excuses for inaction. The truth is that we cannot begin to solve produce safety outbreaks unless we decide we need to. It is obvious that what we are doing today, is not working. We are in a “one step forward and two steps back” loop that has to be changed. The first step is accepting that change is needed, and we need to create awareness within our companies that ongoing produce safety issues and the specter of outbreaks and recalls is not sustainable. If the task seems too large, break it down to smaller pieces. Focus on what you and your company can do. Start simple; near-term, what are the things your company can do to manage the safety of your company’s products? What produce safety knowledge does your company currently possess and where are the company’s knowledge gaps? Who or what can help the company bridge these gaps? In the end, I believe if a company takes a careful, comprehensive, risk-based approach to defining what you can do to make your products safe, it will help the company:

•  Identify avenues to access emerging science and learnings that can be leveraged to make produce safety programs company and operation specific.
•  Realize value of publicly available research data and the internal data your company generates daily to drive produce safety decisions and permit the development of a roadmap that puts the company in position to improve produce safety performance.
• Better understand knowledge, organizational, and leadership gaps and what measures to take to fill those gaps including evaluation of external knowledge resources available from your trade associations, third party solution providers and universities. 
• Engage customers, service providers, suppliers, regulators and trade groups to identify where common values exist and opportunities where your company’s voice needs to be heard.
• Build insights and strategies to give your company a proactive and creative voice with customers, consumers and regulators on future produce safety issues.
• Look inward at the roles and educational and training needs various employees need to be able to effectively execute the company’s produce safety efforts starting with the CEO and moving through sales and marketing, operations, HR, IT and even influencing the foundation the company must build to attract future STEM-trained employees to meet produce challenges down the road.

At the end of the day, you can either actively take control of your company’s produce safety efforts or accept that your company will remain in a purely reactive mode at the mercy of folks that do not know your operations. Think about it for a minute, when companies are implicated in an illness outbreak and products are recalled, who can you rely on to come to your defense? Buyers generally back away and hold your company responsible for recall costs and inventory that cannot be sold, let alone liability issues associated with consumers. Regulatory agencies are oriented to investigate and when appropriate build legal cases to hold the company responsible for public health impacts. Trade associations and commodity groups are most likely to be helpful in addressing the impact of an outbreak and recall, but they are limited to how far they can go as they have to balance their actions against their equally important responsibility to protect the whole sector and help restore customer and consumer trust. So, what choice do you really have? Does it make sense to leave produce safety decisions and directions to entities that do not know your operations like you do when if something goes wrong, it’s your company that has to carry the vast majority of the burden?  Indeed, it is time for producers to take the initiative and own their responsibility for produce safety and their future. Remember, just get started. Do not try to be perfect. Know that you will make mistakes, but seek out knowledge and expertise, correct problems and move forward. Produce safety is ultimately a continuous process.

I saw a quote recently in a LinkedIn post attributed to Jon Gordon that said, “culture drives behavior, behavior drives habits, habits create future”.  It stood out to me as I was thinking about writing this article because it connects behavioral changes that prioritize produce safety to establishing beneficial employee and business habits that promote a desirable produce safety future. In my next post, we will discuss produce safety culture and how a company’s culture is predicated on owning its produce safety future. Till then…