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Saturday, 20 July 2013

FSMA-HARPC - A Ferocious Tiger or a Temporarily Confused Cat?

Update: February 24, 2016 - Training of FSMA Preventive Control Qualified Individuals (PCQIs)

As previously predicted, watch for "accredited" Tiger Tamers who will be offering hasty and superficial training for Preventive Control Qualified Individuals (PCQIs). They will issue certificates for participation instead of actually certifying the competence of the so-called trained PCQIs. One could almost guarantee that many of the training offered will only be for show (i.e. no significant new things will be learned by those "qualified" to take the training).  If the trainees are not already competent to manage preventive controls, any training in Preventive Controls that is completed within one or two days is highly unlikely to lead to the required competence but this is what the so-called trainers will be offering. Let's watch and see. Superficiality breeds superficiality. It's not really the fault of these tiger tamers. They are only taking advantage of a sustained superficiality within the industry to make a bit of money. Just know what you will be getting when they knock on your door.

Also watch for purveyors who will be offering and granting FSMA & HARPC certifications. If your company is seeking such certifications, make sure that the purveyors knocking at your door actually have the authority to grant such certifications. Otherwise, it is simply their word they will be granting to you. Such certification may not carry any weight with the FDA that actually has the authority to say yea or nay. 

Update: September 10, 2015
The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates forsome businesses begin in September 2016.
First published July 20 2013

Hazard Analysis and Risk-Based Preventive Controls (HARPC) is increasingly being discussed across the industry. In some instances, it appears to be presented as being over and above HACCP. Here are my questions and thoughts regarding the unmodified HARPC proposal as currently presented:

What exactly does the HARPC proposal mean by “Risk Based Preventive Controls”? Is this different from what HACCP already covers? If so, how is it different?

My question relates more to any technical, not enforcement, differences. Are there any substantial technical (i.e. functional) differences between HARPC and HACCP? If so, which is better functionally? On the other hand, if the only difference is the mandatory enforcement, why not simply make HACCP mandatory instead of introducing a new name for what is essentially the same and thereby creating confusion?

Although I agree that there are enforcement differences introduced by FDA for the United States, I see HARPC only as the way FDA has elected to implement the universal HACCP concept. Other countries are choosing to enforce HACCP differently. This does not make their systems less reliable.

I am quite aware that technical inefficiencies and inconsistencies exist in how the HACCP principles are applied by different establishments in different jurisdictions. This represents an application problem; rather than a problem with the HACCP principles. The known inefficiencies are not eliminated by the HARPC variety of HACCP. In fact, I see the introduction of ambiguities within the HARPC proposal that, predictably, will contribute other kinds of inefficiencies and inconsistencies. I have read several publications dealing with the HARPC proposal and this clip from information published by FDA sums up some of the ambiguities that are going to inevitably pose challenges in its implementation and enforcement:

Ambiguities - Providing Opportunities for Illusionary Promises by Spurious Tiger Tamers

I predict a lot of misinterpretations of the intentions of the FSMA-HARPC proposal, at least in the initial stages, until the community (industry and regulators) return to the fact that HARPC is really not anything new or different from a well implemented HACCP system. Modifications to the proposal are necessary and inevitable.

One immediate ambiguity under the proposed FSMA-HARPC relates to what constitutes sufficient training for the person who must “prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a re-analysis of the food safety plan (or oversee these activities), etc.” Even with stipulations for an acceptable training requirement, who is to say that every trainee becomes as competent as the other?

A second ambiguity relates to the subjectivity of identified risks. Who will determine the risk upon which to base the operation’s “preventive controls”? Will this be the operator’s personnel or the regulator? If it is the regulator, will regulatory inspectors be process authorities so as to have sufficient credibility to decide on the risks specific to each operation? If the operator’s personnel must determine the risks associated with their operation, how will an inspector be able to enforce more than the operator’s personnel have identified as the only risks? In this instance, suppose more risks than the operation has identified do in fact exist, what will force the operation to identify all of the risks that may have been deliberately ignored because of some perceived difficulties and/or anticipated high costs of controlling the ignored risks? In other words, who is to say that the risks identified by the operation are, or are not, the only risks associated with the operation? These ambiguities may eventually be resolved.

Another potential problem area has to do with the proposed "certain exemptions". The emphasis should be on "applicable enforcement" instead of "exemptions". Even with that change in focus, the task of determining what constitutes "applicable enforcement" for the different types and sizes of operations is not easy.

I am still baffled that restaurants and retail food establishments are not included in the definition of "facility" under FSMA and HARPC. I see these as some of the weakest links (food safety assurance links) in the food supply and consumption chain: 

For now, we wait to see how the modifications go. Meanwhile, the ambiguities of the HARPC proposal provide sufficient impetus for opportunists who are ready with spurious tiger-taming promises. Different outfits are already capitalizing on the artificial confusion. Armed with hurriedly prepared training programs as well as cut-and-paste consulting schemes, the self-styled magic workers are already offering their services to rescue confused operations from the claws of the supposedly threatening FSMA-HARPC tiger. Operators beware! You need to wisely use your financial resources and carefully choose your training providers and consultants.

HACCP - A Veritable Safeguard

The proper application of HACCP principles remains indisputably as a sensible engagement for any food operation. The FSMA-HARPC is technically not a new concept. It is merely an interpretation of how to implement HACCP with an introduced degree of ambiguity. The introduction of some identified hazards that are not specifically named in the usual literature or guidelines dealing with HACCP (e.g. radiological and naturally occurring hazards, etc.) may be seen as differentiating HARPC from HACCP. This is technically not the case. The CODEX definition of a hazard mentions the “condition of food”. According to CODEX, a hazard is: “A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.” An astute food safety and HACCP expert understands the "condition of food" as covering any identifiable condition such as the presence of radiological contamination, naturally occurring hazards, etc. 

The “condition of food” consideration (in conjunction with “biological” considerations) also covers even the intrinsic hazards present in food - allergens, etc. Also implicit in the last part of the CODEX definition ("...with the potential to cause an adverse health effect.”) is the understanding of "anything". In other words, anything with the potential to cause an adverse health effect is a hazard. Even with the FSMA naming of radiological hazards, etc., we have not seen the end yet of things that could be directly named as possible hazards.

A true hazard analysis under HACCP cannot be done without considering the risks associated with the operation. “Risk-based” has always been a consideration within HACCP. It is not a new idea. As well, the HACCP concept is already inherently pro-active and preventive therefore the supposedly new proposal of “preventive controls” is not really new. Critical control points and other supportive measures such as pre-requisite program controls are understood to be preventive controls by anyone with a good knowledge of HACCP.

Irrespective of the confused appearances, a veritable safeguard is for operations to proceed according to the 12 steps of HACCP as outlined by CODEX long before the introduction of “HARPC”. Any operation that properly implements a genuine HACCP system (with no window-dressing antics) will be much further ahead. The first step is crucial, as are all of the 12 steps. Employ knowledgeable staff to set up and manage the system. Secondly, to avoid any regulatory infractions and associated consequences, the food safety team needs to sufficiently understand the regulations in order to properly address the requirements. One thing to keep in mind is this: If you properly, completely and effectively implement a HACCP system that pertains to your operation, you will meet the HARPC requirements. An excessive focus on HARPC, on the other hand, may do more harm than good since a clear definition of "risk-based"is not readily or easily established and will never be. Risk is not a constant by any definition or under any consideration. The notion of “risk-based” exemptions makes matters worse as it introduces a degree of confusion about which operations are to be granted exemptions. For example, where restaurants are granted exemptions in spite of recorded food-borne illness outbreaks that are linked to restaurants, one wonders about the wisdom in granting such exemptions.

Posted by Felix Amiri
Felix Amiri is the Food Industry Chair of GCSE-Food & Health Protection

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