Baking & Snack - May 2019 - 75

TECHNICALLY SPEAKING
Len Heflich
heflichfoodsafety@gmail.com

REASSESS AND

REDUCE

Periodic risk assessments ensure that food safety risks are minimized.

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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 (RTE) 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 RTE product. The Food & Drug Administration (FDA) has 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 sam-

ples 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.
FDA 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 upto-date. When FDA 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.

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Baking & Snack - May 2019

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