http://www.foodmanufacturing.com/articles/20...

Tue, 02/03/2015 - 11:00am

Marc Masterson, IceMachinesPlus.com

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now![1]

Regulations on the frozen food industry received a major overhaul

when the Food Safety Modernization Act of 2011[2] was signed
into law. This bill changed the position of the FDA from a passive
responder to food safety issues to a proactive one that seeks to
stop food spoilage incidents before they happen. By now, many of
you are very familiar with the law, but we thought it would be
good to go over the salient points.

HARPC

The key component of the plan for frozen food manufacturers is

to create and maintain a Hazard Analysis and Risk-Based
Preventive Controls (HARPC) plan[3]. The plan must identify food
safety and adulteration risks associated with their business,
implement controls to minimize them, verify that the controls are
actually keeping food safe, and to design and implement actions
to correct deviations from the controls. This plan must be
periodically reviewed and verification documents must be filed.

There are exceptions to who has to keep HARPC plans. Food

businesses that don’t have to comply with keeping a HARPC
plan include:
Those that are under regulation of the USDA (primarily animal
products)[4]
Those who are under the new Standards for Produce Safety

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laws[5] (primarily farmers that handle fresh foods and

vegetables)
Those who were complying with the older HACCP regulations
(seafood and juices)
Canned food processors (with some exceptions)
“Small” and “very small” businesses, which have yet to be
defined by the FDA.
Companies that have a three-year average product value of
less than $500,000

Thus, if you’re a frozen food processor of appreciable size and

you aren’t focused just on meats you will need to follow the new
HARPC regulations. Companies and owners can be criminally
charged by the FDA for not following HARPC. The FDA can also
send out a warning about the frozen food processor to the
public.

Fortunately, if you have voluntarily made and followed an older

HACCP plan, you’re already well on your way to making a
HARPC plan. The bill’s language states that the newer
regulations would be consistent with previous regulations.
However, the HARPC requirements are more stringent so some
changes may need to be made. The FDA is planning on providing
small firms with education on how to build and maintain a
HARPC plan, much like how the USDA offers training in
regulatory compliance to small meat and poultry firms.

Parts of a HARPC Plan

The first part of a HARPC plan is to identify the possible

hazards for your product. These include naturally, unintentionally,
and intentionally introduced hazards.

Naturally introduced hazards include natural toxins, allergens,

toxins introduced during decomposition, bacterial and viral
infections, and parasites.

Unintentionally introduced hazards include unsafe or untested

food dyes, unsafe food handling practices, and improper processing

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techniques.

Intentionally introduced hazards are bioterrorist attacks on the

food supply and may be one of the trickiest things that food
manufacturers will have to work with since it involves all aspects
of the plant’s operation.

Companies have to produce written documentation identifying and

analyzing the risks of these and how they pertain or could pertain
to the facility and the food they produce.

The second part of a HARPC plan is to find the critical control

points in the processing of a food and build a plan to minimize
potential hazards at those points. Critical control points are the
points in the manufacturing process where the identified hazards
can get their start. For instance, if you get cold produce from
your suppliers and can’t process it immediately or put it under
refrigeration, that’s a critical control point. A list of examples
from the law include:

Sanitation procedures at food surface contact points

Sanitation of utensils and equipment
Staff hygiene training
Environmental monitoring program (for pathogen controls)
Food allergen control program
Recall plan
Current Good Manufacturing Practices (cGMPs)
Supplier verification activities

The third part is to follow and document a monitoring program to

ensure that the preventative controls are being followed. The
fourth part defines corrective actions taken when deviations are
found and a description of why it happened, including:

Identification of weak spots in the controls

Identification of ineffective controls
Identification of new hazards
Performing necessary steps to reduce the likelihood of
recurrence
Evaluating the processed food for safety
Prevention of adulterated food from entering commerce

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The final three parts are to ensure that the above core steps are
being followed, that adequate documentation and records are
kept, and that the plan is updated every three years or when a
significant change happens at the facility. Notably, HARPC
documentation needs to be in place before the significant change
occurs.

Building and following a HARPC plan may seem burdensome, but

it is meant to reduce the number and severity of food poisoning
outbreaks. By following good manufacturing processes and thinking
ahead on what could go wrong in our frozen food plants rather
than reacting, we can make sure that our products remain safe
and avoid trouble with regulators and the general public.

[6]

1. http://subscribe.advantagemedia.com/fm_ods
/landing.aspx?cmpid=textadincontent

2. http://www.fda.gov/Food/GuidanceRegulation/FSMA/

3. http://www.harpc.com/harpc-requirements/

4. http://www.usda.gov/wps/portal/usda/usdahome?navid=LAWS_REGS&
navtype=SU

5. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm304045.htm

6. http://www.icemachinesplus.com/

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