Dairy Processing - September/October 2023 - 64

FOOD SAFETY
things like call the FDA,
provide them with
the information
that you're
required to
provide to them,
the more they're
thinking you
don't have your
act together, "
Wagner warned.
Looking back
at her long tenure at
the FDA, she said a lack
of swiftness would make her
suspicious and lead her to think
someone from the FDA needed to visit the facility from which
the recalled product originated.
The primary reason to give a recall response top priority
is to keep a potentially dangerous product out of consumers'
pantries and refrigerators. Wagner said the majority of recalls
are not associated with an outbreak, but even if a company
is recalling a product as a precaution, acting with urgency
should be a prime concern.
And she said the majority of companies take that
approach. Through her years of working with the industry,
Wagner discovered that companies often execute on a recall
before the FDA has even officially classified it.
Actually doing mock recalls
and implementing that recall plan,
I think, is really important. "
Roberta Wagner, IDFA
" If they know it's likely a Class I situation because they
can look at past precedent, what the agency has recalled,
they just act, " she said. " They want to make sure they're being
protective of consumers. "
She also encouraged companies to not wait around to find
their key contacts at the FDA. Wagner has told IDFA members
to be sure they identify the FDA recall coordinator for each of
their facilities. If a larger company operates plants in different
states, it's likely that it would have to deal with different
coordinators, depending on the location of the outbreak.
" Make sure you know who those people are, and that list
is always current, " she cautioned. " Introduce yourself, do a
quick call. It's better to develop that relationship before you're
in a crisis situation. "
64 SEP-OCT 2023 | DAIRYPROCESSING.COM
'CONTINUAL IMPROVEMENT'
While dairy products are inherently different than other readyto-eat
foods, it doesn't make going through an outbreak or
recall response different for dairy processors.
Just like any ready-to-eat food maker, a dairy processor
reacting to a recall or outbreak will have to examine the
operation at the facility where it occurred and determine
exactly what went wrong.
Any time a Class I recall becomes necessary, Wagner
explained, a company needs to reassess its food safety
plan, identify where the blame lies and put solutions and/or
corrective actions in place to prevent the recurrence of that
type of event.
" FSMA is all about continual improvement, " she said. " I
think recalls are an opportunity for industry to learn. "
The first thing a company involved with a recall has to do
is get products off retail and digital e-commerce shelves, and
out of homes. But Wagner said assessing the specifics of what
went wrong should be concurrent with that.
" Why did this happen? And then think about what kinds of
controls are needed or corrections to beef up the food safety
system and make sure it doesn't happen again. "
Thorough evaluations of this type can become
immediately beneficial, as well. Wagner explained that while
responding to a recall, being forthcoming with information for
the FDA can help the process along.
" One of the biggest problems when I was at the agency
was getting facilities or companies to clearly articulate
how and why they scoped the recall, " she shared. " How did
they make the determination of what was in versus what
was out? "
If a facility deals with cheddar cheese that is made every
day, she offered as an illustration, it must be determined how
many days of production need to be part of the recall - that's
where batch and lot numbers come into play - and a company
has to be able to explain why just a couple of days are in a
recall but not a whole month.
" And it needs to be risk-based, science-based, " Wagner
said of the explanation.
When she worked at the FDA, she said one of the
biggest roadblocks the agency encountered was coming
across companies that couldn't tell the agency how that
determination was reached.
A facility should be able to identify a clean break in
the production, show that a complete clean of the facility
happened on a given day or be able to pin down another
factor, such as a corrected labeling issue, that accounts for
the product range, Wagner said.
" Make sure you can explain that very clearly, as to how
you're making those judgments. "
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Dairy Processing - September/October 2023

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