Improving Environmental Controls

Baseline/Target

Historical data (e.g., consecutive sampling results/data from the previous six to 12 months) is needed to establish a baseline/target. For example, if a site tests less than 50 cfu (colony-forming units) for a year with only two/three spike readings, then a 50 cfu would be set as the baseline. Justification for a baseline higher than 125 percent of the mean (e.g., seasonality adjustment) should be documented. The EMP and the target/baseline are unique for each plant and for each type of product. Also, it is different for different zones. Since the reasons for a positive finding are likely to be plant-specific, the corrective actions will differ from plant to plant based on final food products. The environmental monitoring team needs to consider variables that can impact the baseline (e.g., seasonality, geographic differences, and supplier sources).

Trends and Corrective Actions

The results of environmental monitoring samples should be tabulated in a way that they can be compared with previous results in order to highlight trends. It is important to compare sampling results against a target level or a baseline. Any increase in indicator microorganism or pathogen numbers should be addressed by corrective action, since these results are a signal that there is a deviation in the sanitary conditions. A suitable corrective action (e.g., identification and elimination of the source of contamination) should be initiated to bring the values close to or below the target/baseline.

If a positive result (or repeatedly high numbers) is found in any sampling zone, reassemble the team and initiate a root cause investigation. Restrict traffic in the affected zone(s) as much as possible. Examine the area thoroughly and use the team’s findings to improve operations, including: increase cleaning and sanitation frequencies, conduct repairs (water leakage, drains, etc.), change employee traffic patterns and practices, collect more swab samples, initiate corrective actions, verify the effectiveness of corrective actions, and monitor the results. Most environmental monitoring programs do not consider the corrective action to be successful until there are at least three consecutive negative results from the affected area after it has been verified that something was changed to address the microbial contamination.

Mapping

Every facility has several areas to map, and within each area, there will probably be two or three different zones. For example, a plant might have a couple of raw areas (coolers, blending rooms), fully processed areas (oven exit, cooling tunnel), and packaging areas (baggers, form-fill, packing tables). A map of all sampling locations should identify each area and the specific zones within each area that will be tested. This can be an effective way to identify hot spots to take appropriate corrective actions. Map the locations of negative results (green flag), increasing trends (orange flag), and positive samples/results (red flag) on a facility design diagram to help define the scope of the problem. Mapping helps identify harborage niches and hot spots in a plant that may act as a source of contamination.

Summary

An effective EMP is an essential component of a food processing system. FDA’s Food Safety Modernization Act advocates the importance of implementing an effective EMP in food manufacturing facilities as a preventive measure to detect areas of pathogen harborage and to verify the effectiveness of cleaning and sanitation programs. It is critical for food manufacturers to develop a science-based environmental sampling, testing, and verification program that effectively monitors the overall hygiene quality of the facility. An unscientific and improperly designed EMP can be expensive and wasteful. Every product, process, employee training, raw material, GMP, and pathogen of concern is different. EMP is specific to the individual food facility and to the individual operations within the facility.