By John Butts, Ph.D., Principal, Food Safety By Design LLC

Recent, high-profile Listeria outbreaks, product recalls, and the tragic loss of lives have spotlighted an urgent issue in the processed meat industry, prompting intensified regulatory action. Change is inevitable, but the pace and scale of transformation in Listeria control are now unique.¹ The advent of whole genome sequencing (WGS) has revolutionized microbiological oversight, enabling regulatory agencies to link product and environmental samples with patient data in the GenomeTrakr database with unparalleled precision. This heightened analytical capability significantly increases the likelihood of identifying "residents"—persistent Listeria strains within facilities—which can lead to findings of "unsanitary conditions" under the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS) standards. As the agency broadens its scope by including Listeria species in routine analysis and enforces stricter policies, producers (particularly those employing the Alternative 3 Listeria control strategy) face heightened scrutiny. The rules are evolving, the tools are more sophisticated, and the stakes for compliance have never been higher.

Another critical factor is the continual infusion of new employees into our professional industrial workforce. As inexperienced management and technical staff enter our industry, it becomes essential to recognize and address educational needs to continuously improve microbiological process control. Insights suggest that, as an industry, we are likely following behind that curve.

In 1989, FSIS initiated ongoing Listeria surveys of products in the marketplace. Through the early to mid-1990s, we moved forward with discoveries of harborage and microbiological movement in our facilities. In 1998 and 1999, the tables turned with the first major outbreak detected by a new public health detection system. Regulation followed, with risk assessments placing processed meats, such as deli meats and hot dogs, in the highest risk category of all 22 classes of food products. Next came regulatory food safety assessments, tighter regulations, and more sensitive sampling and analysis. Over time, sampling size, methods, and detection abilities have continuously improved.

Food safety is non-competitive in the meat industry. The Meat Institute (formerly known as the North American Meat Institute, or NAMI) has sponsored initiatives such as:

• Listeria workshops
• A Sanitary Design Facility Task Force
• A Sanitary Design of Equipment Task Force.

The Listeria Workshop was launched in the year 2000. It is still going 25 years later, sharing proven preventive controls. The Sanitary Design Task Forces have effectively defined the risks encountered, along with how to design out those risks. Other preventive measures include product pasteurization and growth inhibitors formulated into the products to prevent Listeria growth. Many companies have been highly successful in environmental microbiological process control.

From 2003, the U.S. saw numerous years without illnesses or outbreaks associated with federally inspected processed meats. Unfortunately, that has changed. Public health data tells us that we are behind the curve and need to address our ability to prevent product contamination.

In 2017, I shared the following chart (Figure 1) during a presentation at the Global Food Safety Forum.

The steady decline in testing, as shown in Figure 1, has stabilized at under 0.5 percent. In 2018, four confirmed illness cases from ready-to-eat (RTE) pork patty rolls were linked through WGS. Since that time, outbreaks associated with Listeria have occurred.

Since the inception of solutions like lactate and diacetate, developed by Dr. Andrew Milkowski and his team at Oscar Mayer and subsequently shared with industry, we have yet to see an illness or outbreak associated with federally inspected processed meats using growth inhibitors. However, outbreaks associated with cooked chicken meat, products produced for deli slicing, and meat and poultry entrées effectively demonstrate why inhibitors need to be included in product formulations. Unfortunately, in those outbreak-associated cases, environmental monitoring failed and preventive actions were not employed.

An unintended consequence we face is the failure to evolve beyond a minimum level of compliance in Global Food Safety Initiative (GFSI) audits (e.g., SQF, BRC) that began in 2007. While GSFI has defined and brought forth great initiatives to support food safety, these audits today merely serve as a "check-the-box" exercise. Substantial evidence now shows that an excellent audit rating for a plant may not have a true relationship to the production of food-safe products. The audits measure the existence of programs without measuring effectiveness. Unfortunately, management's perception of these audits is that the manufacturing process is producing safe food. This may be true, if the audits have been fully implemented; however, reality is an empty box that can be easily checked. Company leadership must expect and challenge their organizations to raise the food safety bar.

Embedding food safety professionals within leadership teams is a critical strategy to drive proactive risk management and strengthen accountability from the top down. Similarly, boards of directors must take ownership of food safety systems, as failure to do so jeopardizes not only public health but also organizational integrity. The industry now stands at a pivotal crossroads—either embrace a values-driven approach to food safety, or risk falling behind in an era of heightened scrutiny and evolving regulatory expectations. A strong food safety culture is the pathway for companies to continuously produce safe products. Food safety culture can be objectively measured, and what is measured can be improved. The culture movement must be top-down and value-driven, with the CEO, leadership team, chiefs, vice presidents, directors, and managers serving as catalysts for driving a culture within their organizations. Recent outbreaks and recalls define the need to separate quality assurance and food safety at the plant level, at a minimum. In medium to large operations, each function has its own technology and purpose.

The bar has been raised by many companies who have effectively implemented programs based on risk and supported with validated controls. Unfortunately, plants can still receive a high audit score because they have the programs, although they may be ineffective at controlling food safety. Our industry has many proven preventive controls. The non-competitive nature of food safety has made these available through many educational resources. Dr. W. Edwards Deming has been quoted as saying, "It is not necessary to change. Survival is not mandatory."

The model in Figure 2 provides an example of some of the dimensions and characteristics measured in Listeria control.

Critical to this discussion is where regulatory and GFSI compliance fit into the model. GFSI compliance is defined as an "excellent" score. Regulatory compliance is defined as no repetitive noncompliance records, as well as passing food safety assessments and routine, risk-based Listeria monocytogenes sampling results, without progressive enforcement activities. Compliance is at the doorstep of food production. Compliance is just beyond "Doubt." Failure to comply with regulations and achieve excellent scores on audits puts the plant into the "Doubt" or early "Awareness" stage shown in Figure 2. Plant personnel are firefighting while hurriedly preparing for an upcoming audit.

Our job is to create measurement systems that correctly identify risks and measure them, while developing and applying preventive practices and interventions. A robust food safety culture must embody the preventive practices that enable the production of food-safe products while driving continuous improvement.

John Butts, Ph.D., is Principal at Food Safety By Design LLC and advisor to the CEO at Land O' Frost. He is also a member of the Editorial Advisory Board of Food Safety Magazine.