Getting Candid about Environmental Monitoring Programs

Many companies will expand the swab site following a positive environmental sample. This vectoring-out concept will keep reaching further away from the initial positive until the positive detections are no longer found. In many cases, this can be several feet to several yards from that original finding, but this is the definition of Seek and Destroy.

One effective tool in eliminating pathogens is the use of silver ion-containing compounds. I find PURE Bioscience is helpful in eliminating Listeria and Salmonella from environmental niches.

RS: Should companies routinely do air testing of any sort? Do you have suggestions for the best means to do so?

CC: Air testing should be an integral part of an effective environmental program. All air sampling programs should include a sample of the environmental air outside the facility as a baseline. Granted, it will vary day to day and season to season, but when it is done in conjunction with the samples being taken in the production area, it will give a perspective as to how effective the air filtration system is.

Similar to the swab results, air sampling is telling you something. If you investigate, you might find the excessive counts in the facility in comparison to outside air indicate that the PM for changing filters is not occurring at the frequency the plan requires. Maybe there is a tear in the filters or there are no filters; I encountered both situations during plant visits to determine the high rate of mold contamination of finished products. The air sample program also indicated that access doors directly across from the filling lines were left open far too long or too often, and the dust and debris from a neighboring non-food manufacturer were infiltrating into the food plant’s production areas.

The very best method for air sampling is to purchase equipment that actually pulls definable volumes of air into the unit and impinges the targeted microorganisms onto differential growth media. The results can be expressed as count per “X” liters of air or converted to counts per cubic foot.

Many companies continue to rely on air exposure plates. While it can be a reasonable indicator of air quality, realize the downside to the method is that results are obtained only when a random spore or microbe happens to settle on the open plate of growth media. Not very scientific, but if the plates are exposed in areas of high pedestrian or vehicular traffic, or directly under an air exhaust vent, the data can still be valuable and indicative of a need to initiate corrective actions.

RS: What steps should companies take to develop an EMP? Should they do it in-house or go outside?

CC: The steps companies need to take before designing the EMP start with a comprehensive risk assessment of the process, the raw materials being used, the product being manufactured, and an assessment as to whether the “category” of the product has been recalled or implicated in a foodborne outbreak. The entire management team needs to be on board with the program, the implications, the responsibilities of each department, and the fact that FSMA requires the environment be monitored. This is not just another “Oh there goes QC again!” program. A proactive environmental program requires every level of management from the very top down to be engaged in the goals and execution of a sound EMP. It is also not a bad time to engage the corporate or outside legal counsel with the intent of the program and how Zone 1 swabs are handled or not conducted at all.

Does the process have a kill step? Should it and could it have a kill step? Does it have something that could be or should be a kill step? Blanching might be considered a reduction step or in some corners a kill step. If you are applying a heat step to the product and the product still contains pathogens, there’s a problem. You have re-contaminated the product through the environment, unclean equipment, handling practices, or whatever. If the product is manufactured under conditions whereby it may become contaminated, FDA and other regulatory agencies will hold you accountable.