Baking & Snack - August 2016 - 102

Securing Safe
FSMA forces bakers to soon
respond to FDA's classification
of it as a 'high risk' industry.

Although it may be out of necessity that so much has
been written about the new Food Safety Modernization
Act (FSMA) rules, such commentary now borders on
overload. So, what are the salient points you need to
know? In this final installment of my series on "government regulations," I tackle that question and others involving FSMA.
It seems quite unlikely that the baking industry could
be classified as high-risk, but it is. The extent of recalls,
the frequency of their occurrences and the potential
severity associated with them prompted the Food and
Drug Administration (FDA) to classify the baking industry as a "high risk" industry. Just scan our industry
magazines and daily papers to understand the cause for
this classification. From May 1 to June 30 this year, FDA
posted 68 recalls for the baking industry.
The reasons included products that either had or possessed the potential to contain one or more of the following contaminants: Listeria monocytogenes, potential
or actual presence of small metal fragments, plastic
pieces, E. coli O121 and undeclared milk, peanut, egg,
walnuts, coconut and wheat allergens.
What is the upshot of all this? The baking industry
will see more inspections. FDA is required by law to
inspect bakeries, and all other registered food manufacturing facilities, every three years. And that leads right
into FSMA, for when FDA inspects, FSMA will be the
guidance its inspectors will be using.
Let's start by being clear on the "when" of FSMA,
which includes compliance dates tied to publication
of the final rules on Sept. 17, 2015. Very small busi-

102 Baking & Snack August 2016 / www.bakingandsnack.com

nesses - averaging less than $1 million annually in
sales - have three years to comply (September 2018);
businesses with fewer than 500 employees have two
years (September 2017); and all others have one year
(September 2016). And in all cases, compliance means
FSMA-certified ... no ifs, ands or buts!
FSMA requires establishing a documented food safety
system that covers hazard analysis, preventive controls,
oversight, and management, verification and thorough
training of employees.
Hazard identification, the first step in the system,
considers known or reasonably foreseeable biological,
radiological, chemical and physical hazards. It doesn't
matter if these hazards occur naturally, are inadvertently
introduced or are intentional - they must be addressed.
Then, for each hazard, be it a process step, a food allergen or a sanitation requirement, preventive controls are
required to minimize or prevent the risk.
FSMA standards also require that bakers design
procedures to ensure the preventive measures are performed and corrective actions are taken when needed.
Food facilities must then put in place a verification
step that validates the required preventive controls are
consistently implemented and effective as a part of the
facility's food safety system. Lastly, the program requires a defined recall program also be a component
of the system.
There will need to be a "preventive controls qualified individual" who will be responsible for your food
safety plan; validating your preventive controls; ensuring required recording, collection and adequacy of the
records; reviewing corrective actions; and documenting
that the training requirements of your program are met.
Management is required to ensure that all employees
who manufacture, process, pack or hold food are qualified to perform their assigned duties. Employees must
have the necessary combination of education, train-

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