Milling & Baking News - October 11, 2016 - 21

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longer than expected. The road forward will not be easy, he said.
"Developing all the regulations was
hard, but actually now translating that
into implementation and compliance
is going to be even harder than that,"
he said. "All of these rules have staggered implementation dates, and you
need a kind of scorecard to figure out
when they all get started."
Also of interest to the food industry
are supplemental rules under FSMA

related to accrediting laboratories, the
Reportable Food Registry (a portal
for the industry to provide consumers with information when there is a
reasonable risk a food product may
make people ill) and the imposition
of traceability requirements for food
commodities.
One of the major 2016 flour recalls,
initiated due to traces of peanut contamination, has triggered intense milling industry interest in the sanitary
transportation rule.
"This rule was developed based
on assessing risks in transport of
foods, especially as it relates to microbial contamination and based
on experience that has to do with
what was in the conveyance prior to
loading food commodities, issues of
cross contamination and also issues
related to temperature control when
in transport," Dr. Ostroff said. "This
rule was meant to build upon best
practices within the industry, and
so there was a lot of work that was
done to gather information. We put
out the proposed rule. We got a lot of
feedback, including a lot of feedback
from many of you in the room, and
we made a number of changes based
on feedback that we received from
groups like these."
Changes to FSMA include a shift toward focusing the rules on food safety

Industry Activities

risk rather than quality. Intended use
of the food now determines sanitation
requirements, he said.
Closer look at transportation
Dr. Ostroff elaborated further on
transportation and FSMA.
"While there were a fair number of
changes made to the sanitary transportation bill, I think the one that's been
most challenging and difficult for us,
especially in terms of discussions with
this group, has to do
with the issue that the
final version of the rule
places the responsibility
on the shipper for the
sanitary conditions of
transport unless there's
been a written agreement with the carrier,"
he said. "And I can
tell you that I've had a
number of discussions
with the folks who
developed the rule. I
know that you all have
been in discussions
about this issue. We are
aware of your concerns,
and all I can say at this
point is we're very closely examining
what the options happen to be."
Eye on inspections
Another significant change in the
F.D.A. approach toward food safety
relates to inspection work.
"By and large over the years (this
system) has been based on (inspectors)
being generalists, and so the inspector
that may come to your particular facility on a particular day next week may
be examining a pharmaceutical company," he said.
What is involved in conducting an
F.D.A. inspection has become much
more sophisticated than in the past,
Dr. Ostroff said.
"In the old days ... you could get
away with being a jack of all trades
and master of none, but it doesn't
work really well these days," he said.
"So what we have decided is that we
will specialize our inspection workforce. We will have inspectors who
only work on food. We will have inspectors who only work on pharmaceuticals. We will have inspectors who
will only work on medical devices and
inspectors who will only work on import-related activities."
This transition together with an organizational restructuring of field offices will begin in 2016 and continue
into 2018, Dr. Ostroff said. MBN

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Baking News XOctober 11, 2016 / 21

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Milling & Baking News - October 11, 2016

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