6 replies to this topic

[jamesy]

First off, I greatly appreciate the volume of useful information I have sourced from various discussions here. Namely, whether an effective HACCP plan can contain no CCPs. I would love additional insight into a situation currently being examined within our organization.

Our organization produces nuts for use as non-critical aggregates in food and confectionery products. We receive raw product directly from farmers, and proceed to remove a variety of foreign materials from this raw product in addition to segregating the product based on various characteristics. Finished goods product is either shelled or unshelled, classified based on characteristics, and has had foreign material minimized to levels within the specifications of our customers. In addition, finished product is sampled and tested for acceptable levels of aflatoxin and foreign material by an on-site USDA entity before it is allowed to leave the facility (with the passing label applied by the USDA being "Fit for human consumption").

Our dilemma arises in the nature of our product. Through a series of CPs, we reduce and minimize the level of foreign materials (such as rocks, metals, etc.). However, we still market our product as a raw agricultural product not intended for use as a critical ingredient, and not safe for end-user consumption without additional processing. This has caused myself and other personnel to disagree somewhat on how HACCP applies to our process. As we evaluate our process for CCPs, we have no ultimate processes that reduce or eliminate a hazard to a level fit for actual human consumption, despite the label attached to the finished product by the USDA grading system. For instance, we have no metal detector in our process, and rely on the elimination of nonferrous metals through a series of magnets. Similarly, rocks and stones are removed from the product through specific machinery designed to do so. No kill step exists to eliminate inherent microbial pathogens from the product (as this would alter the very nature of the product), yet we attempt to minimize the potential for occurrence or contamination by such pathogens in our process through GMPs. So, no CP exists where the product we produce will undergo no further processing for a particular hazard before end-user consumption. Thus, in my mind, we have a HACCP program containing no CCPs.

On the other hand, we have the argument that an intrinsic necessity of a HACCP plan is at least one identified CCP. Some personnel argue that the USDA sampling and testing of finished product for the presence of aflatoxin and foreign material provides us with a go/no go step in our process to control these hazards. I find fault in this due to the sampling method present, as even a very high confidence level and low confidence interval are still only monitoring a portion of the product, and that the USDA grading is simply a monitoring of our process similar to our own finished goods sampling.

We are not alone in our woe. Our entire industry seems to be in a similar situation to ours. Competitors consider their metal detectors as CCPs, something I fully agree with. In fact, the cleaned and sized product line includes a metal detector due to the increased quality demands from the intended use of the product. Some also consider their electronic sorting machinery as a CCP, which I do not agree with based simply on their unreliability in detection of foreign material. However, none of our peers have CCPs in place related to stones, sticks, or glass in their processes.

I apologize for the novel, but wanted to provide some level of detail as to our situation. Any thoughts?

[tsmith7858]

Jamesy,

You ask some interesting questions and being a user if raw nuts, I tend to agree with some of your points. My question on the foreign material is what are you specifying to your users? If you are stating it is free of foreign material to a certain degree, what is your verification method? Magnets are not a guarantee and I would think you would need a metal detector to prove or remove things that might get through. One could argue that if you have a proven track record you do not need to have it as a CCP, but if you have never used a metal detector, than you have no way to prove it. With other foreign materials, you are right, there is no reliable detection so calling it a CCP would be not be accurate (you would never be able to validate it).

As for the pathogens, I agree with what you say about not needing a CCP. You are not doing anything to reduce them and you state it. Being a user of raw nuts, we always assume nuts arrive with inherent pathogens unless we know they were treated and we have the responsibility to put in the kill step. That being said, you would need a good PRP or oPRP showing that you do not introduce or create an environment that could increase pathogens.

TS

[Tony-C]

Our organization produces nuts for use as non-critical aggregates in food and confectionery products.

In addition, finished product is sampled and tested for acceptable levels of aflatoxin and foreign material by an on-site USDA entity before it is allowed to leave the facility (with the passing label applied by the USDA being "Fit for human consumption").

Thus, in my mind, we have a HACCP program containing no CCPs.
Any thoughts?

Hi Jamesy

IMO this boils down to your defined intended use of your product. e.g. For further processing.

The question I would ask is what hazards may not be removed by your customer. This is where ISO 22000 does have it's benefits with the requirement for communication throughout the food chain.

So do your customers have processes to remove Aflatoxins or metal? If not then it is likely that these are CCP's.

Regards,

Tony

[jamesy]

tsmith:

I appreciate your perspective on the part of a raw nut consumer. In terms of specifications, we meet (or exceed, depending on the customer) the customer specifications presented to us. To preface, the USDA grading system I mentioned applies the misnomer of "Fit for human consumption". Statistically, it allows for only 1-2% foreign material in each lot. That is obviously unacceptable. Our finished product sampling is conducted on a piece-basis, with 8 pieces of foreign material acceptable in a 440lb. sample. Foreign material we deem hazardous (such as metals, glass, or hard plastics) have a zero-occurrence policy. If we locate such materials in our finished product, the process is immediately halted, the plant is thoroughly inspected to determine whether the contamination was internal or external, and all in-process product is reworked. The only validation on CPs that we have identified as possible are pull tests conducted frequently on our magnets. The product line that contains a metal detector (and which we would consider a CCP) is obviously subject to frequent validation. We are not in love with our current process, and I feel will be adding a metal detector to all product lines in the soon future. A notable lack of options exists in terms of verification, with our documented record of continuous improvement as the quality bar is raised being paramount.

We are not alone is the difficulty of verification. A number of years ago, a multinational organization that became our customer conducted some initial in-house verification of our product to assure that it was within their specifications. This involved visually inspecting entire truck loads meticulously in order to establish a probability of future occurrences. If anyone is curious, visually inspecting tons upon tons of peanuts is not a thrilling experience.

Our stance on microbial pathogens is one of our process being noncontributory to contamination. We take quite seriously our commitment to effective PRPs so that we do not provide an environment conducive to any potential contamination.

Tony-C:

Your point is one that we are very concerned with. We attempt to meet or exceed our customer specifications in terms of foreign materials or hazards. Shipping product to a customer that does not conform to their specifications means that the foreign material present in our process is likely not to be removed in their further processing, and is a scenario we obviously wish to avoid.

We communicate with our customers about what foreign materials could be present, and that their processes can effectively mitigate such hazards were they to occur at specified levels. Our concern in this area mostly centers around potential improper use of our product as a critical ingredient by small manufacturers. That is, the regional manufacturers that may see fit to introduce our product to their process without an effective kill step or metal detector. Although some argue that this is not our direct concern since we provide accurate descriptors of the nature of our product, it is still not something we take lightly.

[Charles.C]

Dear jamesy,

I think there is a considerable confusion in this thread regarding food safety, product specifications etc, particularly as far as the primary thread topic is, I understand, supposed to be HACCP. Perhaps some return to basic HACCP principles or a reformulation of the problem in terms of FSOs might be advantageous. As an obvious example I see no appearance yet of the word "risk".

The ever-increasing overlap into the HACCP world of "regulatory" CCPs (thanks ISO 22000 et al) has also occasionally successfully clouded the fundamental issues involved IMO.

Rgds / Charles.C

[Tony-C]

I think there is a considerable confusion in this thread regarding food safety, product specifications etc, particularly as far as the primary thread topic is, I understand, supposed to be HACCP. Perhaps some return to basic HACCP principles or a reformulation of the problem in terms of FSOs might be advantageous. As an obvious example I see no appearance yet of the word "risk".

The ever-increasing overlap into the HACCP world of "regulatory" CCPs (thanks ISO 22000 et al) has also occasionally successfully clouded the fundamental issues involved IMO.

Rgds / Charles.C

Basic HACCP guidelines from CODEX:

GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM
Consideration must be given to the likely end-use of the product
APPLICATION
A full description of the product should be drawn up

Regards,

Tony

[Charles.C]

Sorry, perhaps I should hv been more specific –

It appeared to me that the significance of any product specifications was only meaningful in the current context when related to the risk of causing a health related incident.

I hope it is self-evident that any risk analysis will vary for scenarios where the product is directly consumed or not, eg a High Risk product or not.

Nuts not my direct area but it seemed from the text that the considered, potentially significant hazards were shell fragments, other (extraneous) foreign materials and aflatoxin.

From memory, I hv (very, very rarely) seen shell fragment removal appear as a CCP in a process HACCP plan but never risk-validated on a health related basis. A regulatory CCP would be a different matter of course. I presume the shell is classified as inert for allergenic purposes.

Removal of extraneous materials has been discussed at length many times here. The conclusion appears to be that for one final or an integrated set (but not both), the (acceptable audited) presentation can be either a CCP or not depending on yr risk analysis (and perhaps on yr auditor). And a similar comment about critical limits.

For aflatoxin, hv no idea if it is reduced during yr process (or even needs to be for safety reasons in yr case). If so, could be a CCP depending on the risk analysis.

To preface, the USDA grading system I mentioned applies the misnomer of "Fit for human consumption". Statistically, it allows for only 1-2% foreign material in each lot. That is obviously unacceptable

I presume this is an arbitrary categorisation, not specifically related to HACCP issues. The “ffhc” declaration has always IMEX been a favorite letter-of-credit phrase to protect buyers for items like foreign materials in agricultural products. I believe the "adulterated" tag is a similar favorite in USA.

ISO 22000 clearly states that a system may have zero CCPs. Auditors tend to be less happy IMEX hence the thriving business in (cheap/secondhand) metal detectors.

Rgds / Charles.C

added – the above comments were made from a pragmatic viewpoint. If one queries the reason for all these (acceptable) alternative conclusions it can get very confusing indeed. This is immediately obvious in the variable interpretations of risk matrices such that different operational conclusions are possible from the same input data. One reason (apart from simple subjective opinion) is that the basic technique is a 2+-dimensional version of a complex, ecological, multivariable situation. Unfortunately, AFAIK, any attempt to expand the variables rapidly gets quite heavy, eg FMEA and nomogram type solutions. The cfia approach does include a coarse adjustment by setting relative severities according to microbiological / physical origins of the hazard. Maybe there are other variations also.

ISO 22000 has attempted to refine/redirect certain fundamental aspects of HACCP within an auditable format. It appears to have generated an equal number of implementative options as compared to traditional HACCP, perhaps even more so via oprps. I suppose it has also inadvertently created PASxx. Refined interpretations of ISO 22000 / HACCP procedures exist but are certainly not for light reading.

Personally, all the current HACCP-type implementation techniques seem flawed to me but, so far, I find the flaws in the risk matrix approach more understandable and manageable.