How to Set Up Environmental Monitoring Programs

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.