Baking&Snack - June 2014 - 69

"The main issues will be the additional time that will be required
to make sure food safety is built into
the finished product and having the
additional resources available to accomplish this," said Charlie Moon,
vice-president of technical services/
quality assurance/regulatory for
Flowers Foods, Thomasville, GA.
"The benefit of FSMA is that ingredients and all foods will be safer for
consumers."

Reactive out, preventive in
The biggest change FSMA has sent
hurtling toward the industry is
the departure from the country's
reactive tradition of food safety
implementations. From the start of
its rulemaking process, FDA emphasized the change to preventive
controls.
Everyone from farmers to food
processors will now bear significant
responsibilities when it comes to
contamination prevention. In the
past, government inspectors have
been relied on to catch tainted food
after production and before it made
its way into public consumption.
It will be the first time that com-

prehensive, science-based preventive controls will be required across
the entire food chain.
"The primary challenge that
food manufacturers will face under
FSMA is that the burden of proof
with regard to food safety lies with
the manufacturer," said Stephanie
Lopez, vice-president for food
safety services innovation at AIB
International. "Evidence will need
to be obtained to demonstrate that
the product will be safe, and this
evidence cannot be based solely on
finished product testing. It must be
based on proof that the combination
of raw materials and process steps
will continually result in safe food."
That burden of proof, naturally,
comes in the form of documentation. And product developers, in
addition to providing proof of their
preventable controls, must be sure
the ingredients they are using can
offer that same assurance and paper
trail. As Ms. Lopez pointed out, formulators will continue to look for
confirmation that the supplier has
well-developed and implemented
prerequisite programs and hazard
analysis and risk-based preventive

Inspection in times of emergency
Companies will see an influx of records and inspections during normal production periods. What may be overlooked is that FDA could
implement expanded record access during times of emergency. If a
situation is deemed to be an issue of public health, FDA can enter a
facility and request to see its records.
Currently and under proposed FSMA rules, the food facility pays
no fees for routine inspections. But if problems are found that
warrant re-inspection, stiff hourly fees will be charged. Actually
re-inspection fees have been on the books since 2001, according
to Chengboey Lau, principal scientist for regulatory compliance/
food safety at Mondelez International. When FDA shows up for reinspection, a facility is charged $237. Although these fees have yet to
stick, they are certain to be unavoidable under FSMA regulations.
"Even though this has been instituted for the last three fiscal
years, we haven't seen FDA send an actual invoice to a company for
a re-inspection fee, Ms. Lau said. "They're trying to come up with
"
a small business exemption, because that fee is pretty harsh on a
small business.
"

Baking&Snack - June 2014

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