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 (FSMA), in the US.
The FDAs 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.
FSMA – The 5 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
HARPC is part of the Preventive Controls for Human Food rule, which was published on 17th
So, does HARPC effect 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, for example, farms do not need to comply and
also food facilities who already have to have a HACCP plan which is required by product
specific 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. To be clear, sites will need to comply to HARPC, even if they have a
HACCP system in place.
What is HARPC about?
HARPC 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 food safety risk.
What is HARPC about?
Because CCPs are not required, it does not use the typical CCP decision tree to determine
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.
What is HARPC about?
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, would be much, much higher.
If we were to then assess these for CCPs in the normal way, we would end up with a lot of
CCPs, which would be totally impracticable.
So, the methodology for the determination of CCPs needs to be adapted.
What do I do if I already have a HACCP?
Many sites, across the world, who already have a HACCP plan are now faced with a problem, if
they need to comply with both HACCP requirements and the FDAs HARPC preventive controls
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 not an easy task.
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
The solution – a practical method
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
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.
Get Your Copy Now!
We have created a free downloadable pdf which goes into detail about the specific
requirements of the HACCP principles and compares them to the Preventive Rule (HARPC) and
the BRC Global Standard for Food Safety (as a GFSI recognized scheme).
You can request your free copy of this pdf by visiting: http://www.techni-
Further FSMA Information
If you would like further information on the FSMA rules we have a FSMA community you can
join. Every fortnight we break down the elements of the rules for our community, to help you
If you would like to join us, you’re very welcome – just click the link below…