Baking & Snack - March 2016 - 68

FOOD SAFETY

Unless handled and
processed under preventive
controls, any food can be
subject to contamination.
Adobe Stock

plained. "In some cases, it may be that their ingredient
supplier has preventive controls in place. But the key
thing is that the facility will need to document why they
chose this particular preventive control, how it is being
implemented and the results of applying it."
Mr. Steed observed, "Not all preventive controls will
need to be managed with the same level of rigor and
frequency." Considerable freedom is allowed to decide
monitoring methods, corrective actions, verification,
validation, frequency and documentation.
After undertaking a hazard analysis, it may be that the
food safety team determines a particular hazard requires
no preventive control. If so, "It has to document why
there is no need for control," Dr. Brackett observed. "In
other words, [explain] why this facility did what it did
regarding this particular hazard."
Such leniency has its limits, according to Cornelius
Hugo, manager, global innovation, AIB International. It
works for minor cGMP issues and corrections in documenting them. "However, for preventable recalls such as
undeclared allergens and controls for pathogenic bacteria in ready-to-eat food, there will not be flexibility for
documenting effective plant programs that prevent these
type of recalls," he noted.
There are pros and cons involved, too. "If I were a
baker, I would see this open-ended approach as encouraging," Mr. Payne said. "There is some risk, however,
because how I interpret something and how the FDA
inspector interprets the same thing may differ. That's
where a third-party inspector can help."

Bakery, snack challenges
Allergens throw the biggest food safety hurdle at bakers
and snack food manufacturers. These foods meet the
FSMA definition of ready-to-eat, and many of their ingredients qualify as allergenic to one or another segment
of the public. Thus, the new food safety rules demand
a more rigorous environmental monitoring program,

68 Baking & Snack March 2016 / www.bakingandsnack.com

especially after the kill step. "Under FSMA, the baking
industry can expect a lot more attention to be paid to
allergen controls," Dr. Brackett said.
More baked foods are recalled because of allergen labeling problems than for any other reason. "Cross-contact with allergens is too common
due to weak preventive actions and procedures,"
Mr. Steed said. He directed attention to the new
cGMPs outlined under 21 CFR 110. Part 117
identifies 24 instances where allergen crosscontact potential needs to be addressed and
controlled.
Allergen labeling plans are important to this
effort. Mr. Hugo explained, "If a company has
plant conditions for allergen cross-contact or different allergens in its products, it is required ... to prevent undeclared allergens through proper label control
programs from the inception of the label and into plant
operations from receiving through packaging."
Validation of kill steps will also be necessary to food
safety plans for bakery and snack operations. "Kill steps
can be important depending on the product risk and
must be determined through the preventive control process," Mr. Bremer said. "These need to be updated with
cGMPs that are current for the operations and the food
risk as past food safety programs must be updated."
It's common knowledge that the heat of the oven or
fryer destroys pathogenic microorganisms. But proving
that it works as a kill step - validating it - is another
matter. Mr. Hugo described AIB International's new tools
to help bakeries evaluate food safety preventive controls.
The AIB Kill Step Calculator evaluates pathogen risks for
production of buns, whole wheat bread and muffins, with
cookies the next to be added to the program. It relies on
information from data logging equipment that bakeries
commonly use to verify oven temperatures.
The design and equipping of food facilities plays a
significant part in FSMA compliance. "These are things
that are easier to work with early in the design of facilities than later on," said Richard Wiehe, PE, senior associate mechanical engineer, Burns & McDonnell.

The qualified individual
Getting started means allocating resources, and every
registered food facility needs to identify a preventive
controls qualified individual (PCQI) to manage the food
safety process and the team that will carry out FSMA
rules. "You look for a combination of experience and
training," Mr. Payne said.
Finding and training this person should be the first
thing a company does, Dr. Brackett noted. "Then assemble a food safety team to work with the qualified
individual to build a food safety program," he said.

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Baking & Snack - March 2016

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