The main compliance date of September 2017 for the Preventive Controls Rule for Human Food is fast approaching. Facilities now have the daunting task of trying to amend their current food safety systems to meet the new requirements, which are becoming well known as HARPC (Hazard Analysis and Risk-Based Preventive Controls).
Need for a Combined System
Many facilities already have well-established Hazard Analysis and Critical Control Point (HACCP) or National Advisory Committee on Microbiological Criteria for Foods (NACMCF) based food safety systems. These sites will continue to be asked to comply with HACCP or NACMCF requirements by their customers, accreditation standards, and also by local legislation in the countries to which they export product.
At first glance, the requirements in HACCP or NACMCF and HARPC may look aligned, but facilities must be careful, as there are a number of fundamental differences, which need to be considered before making any alterations to their current food safety systems.
New HARPC requirements demand a new mindset, which many HACCP specialists are finding difficult to embody.
Although the Preventive Control Rule is very clear about what the food safety plan should achieve, it does not stipulate how it should be laid out and documented. Many of the understood practices from HACCP and NACMCF are not detailed in the rule (such as a scope, product description, intended use, intended user, or a process flow diagram). It could, thereby, be presumed that these elements are no longer required.
However, it would be naïve to think that these key elements could be excluded from any effective food safety plan. Gathering information about the product and process is essential to ensuring that the pertinent hazards are defined. If used properly, these tools can be advantageous to the HARPC system. Plus, facilities need to adhere to the current requirements for food safety because they will need to continue to include this type of information in their system if they want to continue to meet customers’ expectations and accreditation.
The Main Discrepancy
There is one fundamental difference between the HACCP and HARPC requirements that requires special attention.
Both systems require hazard analysis to assess the significance of the food safety hazards. Typically, in a HACCP system, the significant hazards would then be assessed to determine which need controlling through the application of a CCP. Contrarily, the FDA indicates that to meet the Preventive Control Rule, all food safety hazards must be assessed without taking any current controls into account.
Though this change seems slight, its consequences could be huge, requiring a different approach to ensure the manageability of the system.
With HACCP, the norm is to include all possible hazards, even those unlikely to occur, to make sure all eventualities are covered. During the risk assessment process, these hazards would then be knocked off the list by accounting for the controls in place.
By applying HARPC principles and assessing this number of hazards without taking the controls into account, the result would be that a high proportion of the hazards would become significant, and therefore, would require the application of a preventive control. The food industry would find itself in a similar situation to when HACCP was first introduced and many facilities, due to the lack of pre-requisites or Good Manufacturing Practices (GMPs), had numerous CCPs. This caused the system to be unwieldy and consequentially ineffective.
Importance of Scoping
The solution is to ensure that only pertinent hazards are channeled into the hazard analysis. To do this in a structured way, so that it can be explained at an inspection with confidence, a methodology is required.
As mentioned above, product description, intended use, intended user, and process flow diagrams can be used to your advantage at this stage. By detailing such information during the scoping section of the assessment, prior to the hazard analysis, the pertinent hazards that would affect the safety of the product from the inherent characteristics, components, storage conditions, shelf life, food safety treatments, and hurdles, can be extracted.
This method can be used to assess each process step individually and detail the pertinent hazards at that step.
For example, from where a product is chilled, the hazard of Listeria monocytogenes during preparation, packing, and storage may be extracted. Similarly, from where a product is packed with a modified atmosphere, the hazard of incorrect gas content at packing or the use of porous film at the development stage may be extracted. In addition, from where knives are being used to fillet meat or fish, the hazard of contamination from the knife tip during butchery may be extracted.
Hierarchy of Controls
Once the pertinent hazards have been extracted and risk assessed, without taking the current controls into account, a number of significant hazards will have been produced. Each significant hazard will require a preventive control. Those that have been deemed not too significant should be managed through pre-requisite programs (PRPs) or GMPs.
But where do CCPs fit in when a combined HACCP and HARPC system is required? To understand when to apply a CCP, the hierarchy of the controls needs to be understood.
Currently, there are three levels of control that are ordered as seen in Figure 1.
A PRP is a facility-wide generic control, which is applied to more than one step in the process. A preventive control (PC) manages a significant food safety hazard, as defined through the risk assessment.
It is essential to understand the difference between a PC and a CCP. Answering this question was one of the key aspects in the research and development of my book, Combine Your HACCP & HARCP Plan Step-by-Step. The following excerpts from the book are summaries of definitions.
- The FDA define a PC as: “risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”
- The agency also defines a CCP as: “a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.”
Extracting pertinent information from each summary, definitions of PC and a CCP can be devised:
PC: Procedures, practices, and processes to significantly minimize or prevent the hazard; and
CCP: Procedures, practices, and processes at which control can be applied and is essential to eliminate a food safety hazard or reduce such hazard to an acceptable level.
In summation, a PC recognizes when contamination has occurred and either corrects the error or stops the product from being released. A CCP is a control applied to a known contamination issue (such as cooking), which reduces that known contamination to a safe level.
Applying this theory to all the significant hazards generated from the risk assessment can help establish whether a PC or a CCP should be applied.
The Future of HACCP and HARPC
The principles of HACCP were originally published in the 1950s. Despite subtle changes and improvements along the way, its fundamental elements have stayed the same. This type of system has improved food safety over time, but today food safety recalls and withdrawals tend to be related to ineffective PRPs or GMPs.
HARPC is likely to turn HACCP on its head. However, the effects of this change can only be positive. The introduction of PCs as an additional tier of control will no doubt be an advantage. Perhaps in the future, requirements will be combined to produce one robust methodology for food safety risk assessment and control that can be used worldwide.
Marsh is the author of the recently released Combine Your HACCP & HARPC Plan Step-by-Step. She also co-authored Assessing Threat Vulnerability for Food Defence and co-authored Assessing Error Vulnerability for Food Integrity. Since starting her own consultancy business in 2012, she has become well regarded in the field of food safety risk assessment. Reach her at firstname.lastname@example.org.