How HARPC Affects Frozen Food Manufacturers

Regulations on the food industry received a major overhaul when the Food Safety Modernization Act was signed into law. The key component of the plan for frozen food makers is to create and maintain a Hazard Analysis and Risk-Based Preventive Control plan.

Regulations on the frozen food industry received a major overhaul when the Food Safety Modernization Act of 2011 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.


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. 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)
  • Those who are under the new Standards for Produce Safety laws (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 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

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.

Mark Masterson is from with over 10 years of experience in the restaurant and bar industry. With an extensive background and entertaining writing style Mark is focused on providing quality information and advice to managers and contractors about the best practices on choosing the right type of ice machine.













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