What is HARPC?

You may have heard the term ‘HARPC’ and wonder what it’s all about? Let us explain what it is, and how it will affect you…

What is HARPC?

HARPC stands for Hazard Analysis and Risk-Based Preventive Controls. Although it sounds similar to HACCP (Hazard analysis and critical control point) there are a few fundamental differences, which require a different approach.

Where has HARPC come from?

HARPC is an acronym that has been produced to meet part of the new Food Safety Modernization Act, in the US.

The FDA Food Safety Modernization Act (FSMA) was signed by Congress on December 21, 2010 and then became law when it was signed by President Obama on January 4, 2011.  The aim of the act is to better protect human and animal health by helping to ensure the safety and security of the food and feed supply.

The Act is made up of 5 new rules

The act proposes 5 additional rules to improve food safety, which are:

  1. Intentional adulteration
  2. Preventive controls for human food and separately for animal food
  3. Standards for produce safety
  4. Imports: The Foreign Supplier Verification Program for importers
  5. Imports: A program for the accreditation of third-party auditors (also known as certification bodies)

HARPC is part of the Preventive Controls for Human Food rule, which was published on 17th September 2015.

So, does HARPC affect me?

Generally, all food facilities in the US by law, now have to adhere to the Preventive Controls rule and so have to have a HARPC plan.  There are a few exceptions to this however, such as, farms do not need to comply and also food facilities who already have to have a HACCP plan by US law.

HARPC will also affect non-US based sites too.  Any business who is exporting food into the US will also need to comply.  Plus, they will need to comply, even if they have a HACCP system in place.

What is HARPC about?

HARPC as we’ve said, is hazard analysis and risk-based preventive controls.  It is a food safety plan, which determines preventive controls, based on risk.  HARPC does not recognise CCPs, but instead requires preventive controls to be applied, where there is a significant risk.

Because CCPs are not required, it does not use the typical CCP decision tree to determine CCPs.  It does however, as with HACCP, need a system of risk assessment to be applied to determine significant food safety risks using a severity and likelihood assessment.

When assessing the risks to determine significance, the FDA have been very clear that the assessment must be conducted without taking any controls into consideration.  This means that the number of significant hazards, if approached in the same way we typically would for HACCP, would be much, much higher.  If we were to then assess these for CCPs in the normal way, we would end up with loads of CCPs, which would be totally impracticable.

What do I do if I already have a HACCP?

Many sites, across the world, who already have a HACCP plan are therefore faced with a problem, they need to comply with both HACCP requirements and the FDAs HARPC preventive controls rule requirements.  HACCP is still going to be needed, by law in local countries (such as the UK), by their customers and also by their certification standards, such as BRC…

There is therefore a need for a combined HACCP and HARPC approach, but producing a system that complies with both, is difficult…

So, what is the solution?

As a HACCP specialist, when I heard about HARPC, I was obviously intrigued. I have spent many months now carrying out detailed research on the requirements of the preventive control rule and HARPC, to understand how it can be combined with the current HACCP approach.

To my knowledge (and through my extensive research) there is currently no methodology available which will meet both sets of standards.  To meet the need for a combined HACCP and HARPC approach, I have developed a step-by-step system that will explain the requirements for both and provide a methodology that can be used so you can get to work straight away.

Our new book, ‘Combine Your HACCP & HARPC plan’, we believe, is the first of its kind.  This practical book, explains the requirements and provides a methodology, taking you through each part step-by-step, using lots of examples and exercises for you to use.  We’ve even provided the exercises in a template pack, so you can print it out and have a go.  You can then use the templates for your own system, if you’d like to.HARPC Book

I’ve also created a unique stage in the assessment, to help pin-point the hazards that should be put into the plan – called the ‘Extraction Stage’.  Even in HACCP systems, I find that the product description, intended use and intended user sections are generally underutilised, as their purpose is not fully understood.  By using the method in the extraction stage, these parts of the process are fully utilised to get the most out of them and can be used for a combined approach, or even in your current HACCP systems.

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