Milling & Baking News - November 24, 2015 - 30

Industry Activities X

Andre Biane outlines FSMA
requirements for milling
PHOENIX - Under the Food Safety
Modernization Act, flour milling
companies will be legally required to
have a deeper understanding of the
intended end use of the flour than in
the past, said Andre Biane, president
and chief executive officer of AIB International Inc., Manhattan, Kas.
Mr. Biane discussed the implications of FSMA for milling during the
annual meeting of the North American Millers' Association held Oct. 2325 at the Royal Palms Resort and Spa
in Phoenix.
Regulations around raw materials
also have grown as part of FSMA,
Mr. Biane said.
"It does require better understanding of your supply chain from

bakery that has a kill step, labeling, other than for allergens, may
not change. Under
FSMA a mill will
need to start labeling whether or not
flour is applicable
for a ready-to-eat
use. If you are producing flour that
is going directly
into a ready-to-eat
product, you will
need to provide
a couple things - verification that
the ready-to-eat flour is safe from
pathogens, and that the appropriate
labeling is carried downstream for
your customers users. It isn't only

'It is really, really important to understand
what's happening to your product
downstream and what is coming into your
facility.'
- Andre Biane,
AIB International

incoming ingredients, raw materials
and products going downstream,"
he said.
Regarding incoming materials,
FSMA requires the development
and implementation of a risk-based
control program to show that a mill
is buying from suppliers capable of
minimizing potential hazards, Mr.
Biane said. Mills will be required to
verify, through a number of avenues
(including third-party auditors) that
their suppliers meet the government's standard.
Maintaining records is key, Mr. Biane said.
"They need to match up to show
that you are receiving from an approved supplier," he said.
In the case of end use, a major distinction for flour producers is whether the ingredient will end up in a
product like bread with a kill step or
in a ready-to-eat product without a
kill step. Labeling requirements may
be determined by the difference, a
distinction that is not always easy to
address, Mr. Biane said.
"On the downstream side, FSMA
also requires knowing where your
output is going," he said. "So in
the case of most flour going into a
30 / November 24, 2015 XMilling & Baking News

flour that is going into cookie dough.
Think also about flour that is used
as dusting flour, or that is used post
baking by your clients downstream.
Also think about grains and grain
mixes (including wheat germ) that
you produce that could be used in
salad bars and similar retail or food
service venues. That's something
that falls into the category.
"On the non-ready-to-eat side, if
you're making flour that is going to
a processor that is using it in mixes
and blends, labeling must explain
that this particular product has not
had a validated kill step. This labeling also has to carry through to the
next level in the supply chain. That's
important for you to know and ask
the right questions if downstream a
processor is making your flour into a
cake mix, or flour mix or donut mix
... what's happening at the next step.
"If it's going into a bakery that has
to have a kill step, and there's that
kind of verification you will need
to understand. If the flour is going
into packages that are going on the
consumer's shelf, that presents other
challenges. These are some of the
nuances that are coming out related to the supply chain and applied

control. It is really, really important
to understand what's happening to
your product downstream and what
is coming into your facility."
Mr. Biane also described heightened rules around the training of
front-line individuals, supervisors
and what are being called preventive control qualified
individuals
(P.C.Q.I.). Training
programs for each
level are now mandatory and must
be
documented,
he said.
During training, the F.D.A. will be
holding the preventive control qualified individuals to a high standard.
"The F.D.A. is going to assess
whether the P.C.Q.I. is really qualified, not based only on the documentation of what this person has
completed, rather based upon the
observations of what the inspectors
see when they are in a facility and
are talking to that individual," he
said. "That's very different from 'execute the training, check the box and
move on.' This is trying in their way
to connect what's happening on the
shop floor versus the training people
do."
The importance of documentation
rises to an entirely new level during
routine inspections or if problems
occur, Mr. Biane said.
"If they don't see a clear match
with walking and talking to people,
versus what you show as your programs, that may trigger that the facility may be vulnerable to the 'reason to believe' that sanitary conditions are not being met and product
might become adulterated," he said.
Such a conclusion would be based
on dialogue with staff and what they
see during the inspection.
"Should they reach this conclusion, this opens their authorization to
inspect and investigate much deeper
than the original intent at your facility," he said. "From what we've seen
from recent F.D.A. inspections is that
they are sending 3 to 4 inspectors to
a site. You have to be ready."
Satisfactory record keeping means
keeping them complete, clear, accurate for plant conditions, free from
errors, and where appropriate include proper signatures. They need
to reflect the real conditions under
which food is being manufactured
and distributed. MBN
bakingbusiness.com / world-grain.com

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Milling & Baking News - November 24, 2015

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