reductions in the test volumes. Those
large companies that have been doing
fewer samples will be dramatically increasing their test volumes from perhaps
tens to up to hundreds of samples per
week. Many of these companies include
a few large companies with multiple
locations.
We spoke to several of these processors to get more information. One
processor that indicated that they were
planning to reduce their EM sample
volumes told us that they were changing
their program to take a more focused
approach. They had been taking several
hundred samples each week throughout
the plant, but this changed about 2
years ago. At that time, they adjusted
their EM program to collect fewer
samples for pathogen analysis in key
problem areas, or, as they indicated,
they adjusted from a “shotgun” to a
“rifle” approach. The sample sites were
developed using data collected over
previous years; this approach allowed
them to identify key problem areas and
reduce the sampling they conducted
in those areas, which were shown to be
under better control.
Intensifying Efforts against Listeria
In other interviews, processors told
us about their plans to dramatically
increase their Listeria sampling, particularly
their EM sample volume. One company reported that they are dramatically
changing their program, with an aim
to find and eliminate Listeria harborage sites and as a response to the FDA
guidance released in 2017. Their plan
will include increasing their overall EM
sampling volume approximately twofold. They reported that all EM testing
will increase, including tests for other
pathogens, but the primary driver of the
increase will be Listeria, mentioning that
“we had been doing hundreds of Listeria
samples per month and will now be
doing hundreds of samples per week.”
They also mentioned that end-product
testing will increase somewhat, but less
than 10 percent, and routine microbiology will be unchanged.
Another company we spoke with
reported a similar plan: Later this year,
they will be increasing their EM test
volume significantly, but the numbers
of samples for Listeria that they collect
at each plant will increase from tens to
hundreds of samples each week.
Another company planned to take
a somewhat different approach. A few
years ago, in anticipation of regulatory
and inspection changes, they increased
their EM sampling and doubled the
number of samples that they were collecting for both Salmonella and Listeria.
Although they were regularly collecting
EM samples, most of the increase in
their sample numbers came from “seek
and destroy” sampling programs that
they conducted three times per year.
They found this to be an effective way
to hunt for difficult areas that may have
been missed by routine sampling. Following their FSMA compliance date,
they received an FDA inspection that
included a “swab-a-thon.” They were
happy to report that the FDA sampling
found no positive samples, but they
nonetheless increased their sampling
projects to quarterly, further increasing
their overall volumes another 10–15
percent.
Many will be wondering where
these samples will be analyzed. As we
have seen in the past, where companies
send their samples for analysis largely
depends on their sample volumes. As
shown in Figure 2, smaller and midsize
users overwhelmingly send their samples out to a commercial lab, but above
the 100-samples-per-week threshold, the
balance tends to favor using a centralized corporate lab or an in-plant lab.
This figure shows the selection based on
the number of facilities, but when the
data are weighted for volume, the number of samples being sent to commercial
labs is roughly 50–55 percent of the total sample volume in the survey. This is
expected, as the few, very large facilities
with high sample volumes tend to have
access to a central lab or in-plant lab,
whereas the higher-number-but-smaller-volume users are much more likely to
send their samples to an outside lab.
This is consistent with the data we re-
ported in December-January 2017, in
which approximately two-thirds of pro-
cessor locations will primarily outsource
sample analysis, but this results in a
50/50 split in terms of overall pathogen
sample volume.
An Opportunity for Testing Labs
Based on the data from this survey,
as well as data that we have collected
for other projects, we anticipate that
sample analysis for Listeria will be the
fastest growing category in food safety
microbiology for the next few years. As
the largest companies set the standard,
others will follow, and we would expect
this trend to continue for the next 2 to
3 years until companies have completed
the adjustments of their programs and
growth levels off at this increased level.
This increase in demand for
Listeria tests will drive competition in the
diagnostic and laboratory market, and
we can expect to see new products and
offerings emerge to capture this new
demand.
Processors are clearly attacking the
Listeria issue. It is now up to the diagnostic companies and laboratories to
help them meet the challenge. n
Bob Ferguson is the managing director of Strategic
Consulting Inc. and can be reached at
foodsafetyinsights@gmail.com or on Twitter at
@SCI_Ferguson.
FOOD SAFETY INSIGHTS
Figure 2. Where are your EM samples
analyzed?
Outside commercial lab
Central corporate lab In-plant lab
Number of samples analyzed per week
100%
82.1%
6.6%
11.3%
65.0%
11.7%
23.3%
32.0%
40.0%
28.0%