5 replies to this topic

[QCQA4ME]

Hello all,I am in the process of drafting our first productspecification and find myself going in circles trying to decide if micro limitsshould be included. We are a processor of raw tree nuts that are commonly sentto processors in North America that have and will apply a validated kill step(roasting, steam, etc.) and export markets that do not require this product tobe pasteurized prior to receipt.

As mentioned we handle only raw nuts and have no kill step in our process, ourrole is to remove FM, establish or make grade, size separation and packaging.We do have systems to prevent or control the spread of microorganisms thru PMP,GMP's PRP's. Furthermore has previously been established through industry andscientific studies that Salmonella can be expected in low levels within theentire crop, considering all this would it be appropriate to exclude microlimits within a product specification.

Thanks in advance for the help.

[Charles.C]

Hello all,

I am in the process of drafting our first productspecification and find myself going in circles trying to decide if micro limitsshould be included. We are a processor of raw tree nuts that are commonly sentto processors in North America that have and will apply a validated kill step(roasting, steam, etc.) and export markets that do not require this product tobe pasteurized prior to receipt.

As mentioned we handle only raw nuts and have no kill step in our process, ourrole is to remove FM, establish or make grade, size separation and packaging.We do have systems to prevent or control the spread of microorganisms thru PMP,GMP's PRP's. Furthermore has previously been established through industry andscientific studies that Salmonella can be expected in low levels within theentire crop, considering all this would it be appropriate to exclude microlimits within a product specification.

Thanks in advance for the help.

Dear QQM,

Are there any microbiological legislative requirements for import control, eg Salmonella?

Seems probable. If so, >> Conclusion.

Rgds / Charles.C

[MKRMS]

 Sapers, G.M., Solomon, E.B., Matthews, K.R., The produce contamination problem, Elsevier, 2009 p 255.pdf   38.96KB   102 downloads Dear QCQA4ME,

I would not encourage you to eliminate micro specifications. This could lead to you having to market all nuts as potentially contaminated, regardless if they actually are. Imagine the impression this gives to your customers in the light of recent events (i.e. Salmonella in peanut butter and subsequent recalls).

Do you have a sampling plan and microbiological analysis at receipt? Introducing a CCP (or at least oPRP) here can help to control potential contamination. Contaminated batches can then be rejected or at least processed separately and singled out for sale to heat-processing facilities only (if they want them). Beware of cross-contamination, though. Contaminated batches, if accepted, should be processed last and all line equipment thoroughly disinfected before uncontaminated batches are processed again.

It is also important to work with suppliers to get them to reduce contamination, if this is possible at all.

I have just found the following interesting hint in Sapers, G.M., Solomon, E.B., Matthews, K.R., The produce contamination problem, Elsevier, 2009 p 255. I'll include the snippet as pdf. The author states that from 2007, nut producers are required to implement a kill step that achieves at least a 4log reduction. All handlers that handle nuts for sale seem to come in under this regulation.

 Sapers, G.M., Solomon, E.B., Matthews, K.R., The produce contamination problem, Elsevier, 2009 p 255.pdf   38.96KB   102 downloads

Regards,

Matt

Edited by MKRMS, 29 December 2011 - 11:26 AM.

[QCQA4ME]

Thank you for the resposnes however while Pasteurizationis mandatory when supplying almonds within North America, there are exemptions;

· road side stands

· Handlers that ship unpasteurized almonds to a handler/processor thatwill then pasteurize the product through a verified/validated method (we are inthis category).

· Or handlers that ship to areas outside the US, Canada and Mexico arealso exempt and in both of these scenarios product must be and is, labeled “unpasteurized” (wealso ship outside US, Canada and Mexico)



Ourprocess includes cleaning (removal of FM and sizing only) we are not requiredto pasteurize as we fall into the 2nd and 3rd exemption categories noted above,nor do we have a kill step in our process. Our product is sold and shipped as"Unpasteurized".

Our suppliers are growers so we are very near the beginning of the supplychain, while growers take measures to reduce the likelihood of contamination, there is still the possibility of some level of contaminationwithin the entire crop.

I guess my questionis, if have systems in place to control the spread or growth of microorganismsin our environment, but have no means to reduce microbial levels that may bepresent in our raw product how can we then provide a finished productspecification that includes specified limits or “Negative” for any appropriate organism?

[Charles.C]

Dear QQM,

As per MKRMS's comments, it is rather unlikely that any product specification will be taken seriously if it does not include reference to possible BCP safety-related contaminants. At a minimum, legislative requirements are usually nominally expected by customers, regardless of their subsequent intentions, or exemptions as you mentioned (I find this option rather strange in view of USA's normal import viewpoint on items such as Salmonella ).

You will usually see a, representative, legislatory answer to yr question (ie what result is interpreted as “negative”) if you study the details of the (normal) import requirements.

A typical answer is that “Negative” is interpreted as testing a given lot by taking a defined number of samples and doing a microbiological analysis on a portion of each sample to test for “detection” (if referring to a Zero Tolerance species like Salmonella spp.).

Obviously if a positive detection is obtained, the result is a failure. Pragmatically, people usually re-test, this is mostly satisfactory unless there is gross contamination. (although you will know that the contamination definitely does exist and you hv proven the limitation due to sampling ).

More of a problem is that if all samples are negative, ie Salmonella is not detected, this does not guarantee that a further test will also be negative. The extent of the guarantee (ie confidence level) is measured by statistical formulae associated with yr sampling plan and the actual degree of contamination / homogeneity in the lot. However, if such risks are not a problem for you, you can select any typical sampling plan for a possible contaminant as appropriate /lot, for example, ( n=5, c=0, mM =0) is often used for Salmonella.

But you should be aware that for many products, the USA customarily takes a much larger sample than the above if they do inspect yr cargo for Salmonella, and they will probably hv far more sophisticated technology than yourself, ie they will have a much better chance than you of finding any contamination if it actually exists. (And, as you previously noted, it is in practice quite likely to exist).

Ideally, if you wish to maximise yr chance of preventing any contamination in yr shipped cargo, it is necessary to control all the growing/harvesting steps (eg by GAP type requirements). This situation can be documentarily proven by” GAP certification”. Many organisations which approve manufacturer’s processes based on GAP standards will (very) happily assist in such matters (at a price). I predict the procedure will also involve microbiological analyses.

Rgds / Charles.C

[DAVE84]

Hello QCQA4ME

I agree with MKRMS reply. i encourage you to not to remove micro specs. Upto my knowledge US regulation does not require micro specs for raw material which will go under heat treatment or cooking for ex wheat flour.. Tree nuts are harvested in such way that you will most likely have salmonella in them. But having micro specs will give you idea of bacterial load in each received load and how you handle them. In the case of hight bacterial load you can always communicate with your cusomer (processor) about the issue and i doubt they will have problem. Infact they must have calculated lethality validation and up to my microbiology knowledge this process are desinged for atleast 12D kill (12 log reduction). In my whole life i have not seen population more than 9 log (unless you do some special process to get more than 9 log).

If you get lot of push back, you can try to monitor bacterial population in each load for few months and based on history you can develop random testing guidline (not recommended but sometimes you have to go for this because of cost).

Regards
Dave