Baking & Snack - March 2016 - 65

FORMULATION
Food Safety

The Prevent Defense
Food safety regulations under FSMA
permanently replace reactive hazard
control with rigorous hazard prevention.
Is your company ready?
by Laurie Gorton

The clock is ticking. Most food facilities face a September
deadline for complying with regulations set out by the
Food and Drug Administration (FDA) that enforce the
Food Safety Modernization Act (FSMA).
Actually, FDA's final rule covering preventive controls
for the safety of human foods is effective now, having
been published in the Federal Register of Sept. 17, 2015.
And now means now.
"I would hope that most food facilities are on the way
to compliance already," said Jack Payne, vice-president,
product management and solutions consulting, Aptean
Inc., a provider of enterprise resources planning systems. "The scope of the rules has been known for three
years or more, even if the actual regulations were only
recently finalized and published. Documentation of preventive control plans should be in place now."
Food safety experts such as Len Steed, manager, global innovation, AIB International, urge immediate action.
"Companies should establish a team responsible for a
successful transition to FSMA on time," he said. "Every
plant should set up a Gantt chart or project schedule to
ensure they are in compliance on or about Sept. 17. This

will allow them to prioritize what needs to be done by
set dates in order to achieve compliance in the most efficient and logical path and manage the progress."
Mr. Payne added, "If I'm a food manufacturer and
don't have a plan by now, then I'm in trouble."

FSMA rules emphasize
thorough testing and
record-keeping as part of
any food safety plan.
Adobe Stock

A different approach
FSMA marks a sweeping change for FDA. It places the
job of preventing foodborne illness on the shoulders of
food processing facilities, and its rules are different than
those of past FDA regulations. "It takes the function of
Hazard Analysis Critical Control Points (HACCP) and
makes it law," said Justin Hamilton, senior project engineer/project manager, foods and consumer products
group, Burns & McDonnell, a civil engineering firm
with a practice among consumer packaged goods clients. "HACCP is the foundation of preventive controls."
It takes many HACCP components - for example,
implementation of prerequisite programs, current Good
Manufacturing Practices (cGMPs), analysis of potential
problems and documentation - but shifts control measures into a prevention mode called Hazard Analysis
and Risk-Based Preventive Controls (HARCP).
"FSMA compliance with its emphasis on risk prevention is different than HACCP," said Robert Brackett, PhD,
vice-president and director of the Institute for Food Safety
and Health (IFSH) at Illinois Institute of Technology.
Food facilities are required to implement written preventive controls plans. To establish the plan, the facility must evaluate hazards that could affect food safety;
identify what preventive steps, or controls, will be put
in place to minimize or prevent the hazard; describe

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