Food Protection Trends - May/June 2020 - 204

GENERAL INTEREST PAPER

Proceedings of 2019 IFSH/FRI Joint Symposium:
Managing Microbiological Testing as a Preventive
Control Veriﬁcation
Wendy Bedale*
Food Research Institute, University of Wisconsin-Madison, 3159 Microbial Sciences Bldg.,1550 Linden Drive, Madison, WI 53706, USA

SUMMARY
In 2015, the U.S. Food and Drug Administration (FDA)
published the final rule for Current Good Manufacturing
Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food (PCHF). Food manufacturers are now
required to comply with this regulation and others related to
the Food Safety Modernization Act (FSMA). In the transition from the former "reactive" stance to the more "proactive" approach to food safety that FSMA has prescribed, how
should food manufacturers use microbiological testing within
food safety programs? The flexibility built into the preventive
controls regulations shifts responsibility from regulators to
manufacturers, who must decide when, where, and how to
utilize microbiological testing. Although numerous helpful
resources are available, simple, cookbook-style instructions
for conducting food safety-related microbiological testing do
not exist, challenging manufacturers and sometimes regulators. Among the organizations from which food manufacturers have sought assistance are the Institute for Food Safety
and Health (IFSH) and the Food Research Institute (FRI) of
the University of Wisconsin-Madison. Recognizing an unmet
need, these groups co-hosted a meeting on October 24,
2019, at which food manufacturers, regulators, scientists, and
others shared knowledge and resources while discussing the
best uses of microbiological testing in managing food safety
under the FSMA.
OVERVIEW
Robert Brackett (Director of IFSH) provided background
for the meeting in his introductory remarks. Among the
most confusing elements of the preventive controls (PC)
rule for food manufacturers are the validation and verification requirements, especially when microbiological testing is
required. Ready-to-eat (RTE) foods, in particular, may require
microbiological testing to be part of their preventive controls
verification strategies, because such foods will not receive a
subsequent "kill step" (e.g., cooking) by the consumer before
the foods are eaten. The goal of the meeting, as explained by
Brackett, was to discuss how microbiological testing could
most effectively be used to verify preventive controls.

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Food Protection Trends May/June

The need for microbiological testing under the
preventive controls rule
Fittingly, the first main presenter of the day was the technical
lead for the FDA's PCHF rule. Jenny Scott (Fig. 1) reminded
the audience that the underlying premise for both HACCP and
FDA's preventive controls rule is that prevention of hazards is
more effective than pathogen testing for ensuring food safety.
Microbiological testing is inherently "probabilistic" in nature:
you cannot prove that a pathogen is not present unless you
test the entire lot of food. As discussed by Scott and echoed
by numerous other speakers throughout the day, testing of
finished product is therefore of limited usefulness in proving
lot or batch safety; you cannot test the entire lot and still have
product left to sell.

Figure 1. Meeting speakers Jenny Scott and Robert Buchanan.

Microbiological testing is still important, however, even if
the built-in flexibility of FSMA's rules means that no particular
tests are explicitly required. Under the PCHF rule, a facility
that has identified hazards requiring a preventive control
must verify that the preventive controls (PCs) are effective at
significantly minimizing or preventing a hazard. If that hazard
is a microbial pathogen, microbiological testing of finished
product may be used initially to validate a preventive control.

http://www.foodprotection.org/files/food-protection-trends/may-jun-20-bedale.pdf

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