Baking&Snack - June 2014 - 72

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wants to see the same from its suppliers. This focus on
safety was key even before FSMA came into the mix, and
when the rules become enforceable, it will only grow.
Even more documentation and planning will need to
be in place. Mr. Moon said that could affect some vendors early on. "Some ingredients from smaller-sized
vendors may be impacted since they will not immediately have the resources available to develop the required
food safety, preventive control and record maintenance
that will be required," he said.
The same can be said for ingredient importers. If
those companies can't immediately provide the documented, preventive proof that its product will routinely
be deemed safe, bakers will look for other options.
"Much of the burden for validating ingredient safety
and verifying that preventive controls are in place will
fall upon the importers," Mr. Moon said. "For bakers,
more thought will likely be given to procuring ingredients from a domestic source when possible."
Ms. Lopez pointed out that this could affect some
bakers greatly. "Some bakers may not be affected at all
by import requirements under FSMA, and some may
be significantly affected," she said. "While the proposed
rule has responsibilities for the importer of record, anyone further down the supply chain may be affected by a
loss of suppliers or delays of shipments."

Inspection changes

Solutions for Today's Consumer

* Organic & Non-GMO

The records and trails of paper aren't just coming from
amped-up operations procedures and new preventive
measures. Ms. Lau pointed out that at the same time
FDA inspections are increasing, they are also becoming
more enforcement-oriented. In the past, the discovery
of a minor infraction might result in a command from
FDA to get it cleaned up and move on. Now, FDA is issuing more 483s - the documentation given to a firm's
management at the conclusion of an inspection when an
investigator has observed any conditions that, in their
judgment, may constitute violations.
"When you look at the FDA database from fiscal year
2013, which is the most available data right now, they have
given 47% of their 483s to the food sector," Ms. Lau said.
"And that's an increase in the past five years."
When the company receives the 483, it has a set
number of days to respond with corrective actions and
a timeline of when they will take place. So the verbal
commands from yesterday are now replaced with letters
from FDA and documentation from the company on
how the problem has been handled.

Finding solutions
ingredients@sunopta.com * www.sunopta.com

72 Baking & Snack June 2014 / www.bakingandsnack.com

Everyone is dealing with and preparing for all of this in
their own way, but Mr. Herzog pointed out that regard-

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Baking&Snack - June 2014

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