instore - July 2017 - COMM - 6

Operations:

Are you ready for
FSMA inspections?
by Anna Wiber

rmed with clipboards, swabs and
a keen eye, the Food and Drug
Administration (FDA) has slowly begun assessing bakery operations
across the country. Under the Food
Safety Modernization Act (FSMA), baking facilities will undergo inspections
verifying that preventive controls are in
place. And while being prepared for an
unannounced inspection is at the top of
many companies' agendas, what should
they expect when the investigators
walk through the door?

Shawn Stevens, FDA consultant and attorney at FoodIndustry Counsel, LLC,
says there are five enforcement priorities for the agency. These include
critical review of food safety plans
and verification records, extensive microbiological sampling, recall require-

ments for samples that test positive for
pathogens exceeding FDA thresholds,
comparing pathogens found in the facility against human isolates stored in the
Centers for Disease Control's PulseNet
database, and initiating broader investigations - including criminal - of food
companies whose products are found to
have caused human illness.
With this in mind, bakers must ensure
their records are up-to-date, staff is
properly trained and preventive controls are established, all before investigators arrive.

For the record
Under FSMA, a company's food safety
plan should have been established in
September 2016, but many bakeries

are still struggling to develop an effective document that encapsulates its approach to identifying food safety hazards. It's even harder to establish one
that can be updated easily. Many facilities are creating overcomplicated plans,
leaving room for questions they may not
be able to answer during an inspection.
Len Heflich, former co-chair of the
American Bakers Association (ABA)'s
Food Technical Regulatory Affairs
Committee (FTRAC) and current president of the Center for Food Integrity,
witnessed this pattern within the field.
"The industry doesn't grasp the concept of a food safety plan because FDA
doesn't spell it out - and we don't want
them to," Heflich says. "We want to take
the lead on this and define it ourselves."
So, Heflich developed a model for food
safety plans, which he shared with ABA
members. The two-page report outlines
the policies and programs that a facility
should have in place and contains brief
information about them. The policy and
program specifications are then detailed
in a separate document specific to plant
processes and products. This model allows baking companies to break down
the plan and detail how they manage,
control and minimize risk.
Plant operators must also remember
to update plans accordingly. In the report, "Hazard Analysis and Risk-Based
Preventive Controls for Human Food:
Draft Guidance for Industry," the FDA
expressed the plan must be reanalyzed
at least every three years. This includes
when changes are made to systems or
equipment, when new information is
discovered about potential hazards associated with the food or facility, when
there is an unanticipated food safety
problem, or when a preventive control,
combination of preventive controls -
or the plan itself - is ineffective.

COMPANIES ARE REQUIRED TO KEEP AT LEAST TWO YEARS OF RECORDS ON FILE.
PHOTO: © TRAIMAK FOTOLIA-STOCK.ADOBE.COM

6 * JULY 2017

commissary INSIDER

"It's an evergreen document and process," says Rasma Zvaners, vice-president of regulatory and technical services at the ABA. "If you change something
in your operations, revisit your food
safety plan and update it accordingly.
The food safety plan should not live on
the bookshelf collecting dust."

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Table of Contents for the Digital Edition of instore - July 2017