Food safety programs have depended on hazard analysis and critical control points (HACCP) programs to ensure the safety and quality of food products. Processors start by conducting an analysis of potential hazards, whether that be contamination by pathogens, allergens, or other contaminants that could compromise the integrity of the product, and then work to identify a specific critical control point (CCP) for any given hazard of concern. The specific parameters that allow for effective control of the target hazard at the given CCP are firmly and clearly established and then are monitored on a defined timeline.
As most food safety professionals are well aware, HACCP has long required “prerequisite programs” be in place to ensure that the food safety and quality systems being implemented are working correctly. These prerequisite programs can include anything from proper sanitation procedures to good employee hygiene practices to pest control. If even one of those prerequisite programs relied on to keep food safe isn’t applied correctly, however, or if the system of prerequisite programs in a processing facility is not designed comprehensively or verified to be effective, this leaves a window open for food contamination.
The food industry and consumers have become increasingly concerned with food safety and quality. As a result, the food industry and its regulators have more recently heightened their emphasis on environmental monitoring programs (EMPs). Conceptually, environmental monitoring may serve as either validation or verification of specific prerequisite programs or may be more generally seen as a strategy to monitor the environment for unhygienic conditions.
The increasing importance of EMPs is particularly well illustrated by recent changes to regulatory approaches to food safety. The U.S. FDA Food Safety Modernization Act (FSMA) and similar regulations in other countries have elevated the importance of prerequisite programs. For example, in the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (PC Rule), many of the specified “preventive controls” represent programs that would have previously been classified as prerequisite programs. However, FSMA preventive controls include a requirement for verification of the preventive controls, which was not in place for prerequisite programs.
Additionally, the FSMA PC Rule includes a specific recognition of environmental monitoring as a key verification strategy for certain nonprocess preventive controls such as sanitation. The rule states: “Environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples.” This provision demonstrates the growing consensus on the importance of environmental monitoring programs as an essential part of food safety and quality systems.
Effective Environmental Monitoring Programs
Exactly how EMPs should be designed and executed—from the frequency and process of sampling to which test method or technology is fit for the purpose to how results are reported and acted upon—is highly variable depending on each facility, the prerequisite programs used, the product(s) produced, and other factors. Regardless of the specifics of the program, the effectiveness of any environmental monitoring program and, by extension, a total food safety program, is most often determined by a company’s willingness, engagement, and commitment to taking a preventive mindset toward food safety.
John Butts, PhD, a member of the FQ&S editorial advisory panel, president of FoodSafetyByDesign. and advisor to the CEO of Land O’Frost, has described a model for control of Listeria monocytogenes in meat processing called “seek and destroy” and an overarching concept of microbiological or environmental process control. Environmental process control contains three steps: elimination of the resident organisms of concern from the processing environment, management of the vectors and pathways within that environment, and use of process control methodology to measure and predict loss of control.
Environmental process control uses environmental monitoring as a key tool. Environmental monitoring measures the risk present in the processing environment and also assesses the hurdles established to control entry of pathogens. This requires multiple sites in the processing environment to be sampled individually and in conjunction with one another. These results indicate the level of control in the facility and help identify when failures occur or when interventions or additional actions are required to bring the process back with control parameters.
However, achieving a high level of environmental process control is not an easy task and requires full cooperation throughout the organization. The relationship between effective EMPs and an organization’s culture is more significant than most food safety practitioners and business leaders realize.
As such, concern can spread quickly throughout a food company when positives are detected through verification activities, especially in cultures where food safety activities are largely completed by food safety professionals. Food safety in these stages is crisis management driven, with leaders stressing the importance of “doing things right” while conducting investigations that fail to get to the root cause.
The development of such effect-driven behaviors that wait for a crisis to engage operations professionals is harmful to consumers, brands, and overall company financial performance. No matter the industry, for an EMP to be as successful as possible, organizational alignment from the food safety experts all the way to the C-suite should ensure that the primary goal of any monitoring program is to proactively and transparently find, correct, and verify problems before they happen, and positive tests are a necessary part of that process. Linking EMPs to organizational and food safety culture can create a “line of sight” to the corporate vision and values, down to individual behaviors, enabling a preventive mindset to help protect consumers, brands, and financial performance.
Effective EMPs, particularly those linked to specific goals such as sanitation validation and verification, can significantly reduce the risk of contamination and associated recalls. For example, good environmental monitoring data are often essential to allow companies to limit recalls to a single lot, production day, or production week. Without appropriate validation and verification data, it is challenging to sufficiently prove that finished product contamination on a given day could not have been transferred to subsequent lots. In addition to food safety hazards, spoilage issues (including problems caused by organisms introduced from the environment in processing plants) represent a growing business risk for food companies. Consumers often use social media platforms to communicate food spoilage issues and pressure companies into action.
Therefore, the business needs for EMPs represent another benefit to food companies. It’s widely known that recalls are extremely costly for companies; despite this given, quantification of the benefits of EMPs is still often considered challenging. As foodborne disease surveillance systems continue to improve, companies are being placed at an increased risk of being identified as the source of an outbreak.
However, food companies have also seen that effective EMPs can facilitate extended run times, thereby improving production efficiency. For example, environmental monitoring may identify difficult-to-clean areas that can be eliminated through equipment redesign, which will subsequently allow for longer production runs.
With renewed industry focus on the programs underpinning HACCP and a greater understanding of the important role environmental monitoring plays in delivering safe products to consumers, it is imperative that food manufacturers regard EMPs as critical and invest the resources necessary to ensure effective execution. Once implemented, it is also vital that the programs evolve with the organization to continuously improve and to foster an effective and positive company culture surrounding food safety.
For more detailed guidance, Cornell University and 3M recently partnered to develop the first comprehensive Environmental Monitoring Handbook for the Food and Beverage Industries, a free resource to guide any processor on how to create a rigorous environmental monitoring program that’s mindful of employees, regulators, and consumers in this safety-conscious time.
David is the global scientific affairs leader for 3M Food Safety. Reach him at email@example.com.