Pathogenic microorganisms can find a number of ways to enter your facility. Incoming ingredients, packaging and pallets are potential sources. How about personnel, including visitors and contractors? Do any employees keep animals at home or on a farm they visit before coming to work? Do you restrict access to areas where finished ready-to-eat (R.-T.-E.) products are exposed, such as packing areas? What has changed since your facility conducted its last risk assessment?

Section 103 of the Food Safety Modernization Act (FSMA) requires “an environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.” Nearly three years after the compliance deadline, your program may still be effective; then again, perhaps it’s a good time for a reboot.

A foundational practice in FSMA is to perform and periodically update a risk assessment and take reasonable steps to reduce or manage the identified risks. When there is a risk that pathogenic microorganisms can enter the facility, an effective program to find and eliminate them is required. This usually means swabbing and testing suspected surfaces in the plant.

Consider the different zones in your facility. Zone 1 includes areas in direct contact with finished R.-T.-E. product. The Food & Drug Administration recently expanded its interpretation of Zone 1 to include areas that are directly over the product. If a sample from Zone 1 yields a positive result for a pathogen, it could trigger a recall. Zone 2 includes areas, such as the sides of conveyors, that are adjacent to Zone 1. Testing samples can confirm that Zone 2 areas are free of pathogens and, therefore, cannot contaminate Zone 1 surfaces or the product.

Zone 3 includes areas such as the floor under equipment, drains or walls that are away from the line but in the same room. These swab tests confirm that pathogens are not in this area. Zone 4 includes places that are isolated from the production area but in the same building.

The F.D.A. places the responsibility of how to test for pathogens on the food manufacturer. Review your testing protocol to ensure that it includes relevant test organisms, actionable test limits, efficacious test locations and frequency. Are you getting negative results all the time? This is not necessarily good. It may mean that you are not testing in the right locations or are testing for the wrong organisms. The test should be sensitive enough to find something so that data can help improve cleaning and sanitizing practices.

A standard plate count will detect the presence of coliforms, which are not pathogenic but a good indicator organism that is prevalent in the environment. Listeria species is another non-pathogenic organism that is everywhere in soil, making it a good marker for assessing sanitizing practices. In your program, consider such pathogens as listeria monocytogenes, salmonella and E. coli.

Ensure that the procedure, findings, corrective actions and training are accurately documented and up-to-date. When F.D.A. inspectors arrive at your facility, be prepared to demonstrate that your program is comprehensive, up-to-date and well implemented, or they may decide that they need to do it for you.

Len Heflich is a contributing editor for Baking & Snack and the president of Innovation for Success. Connect with Mr. Heflich at