9 replies to this topic

[swmalone]

Hello all.  I have been a lurker on these forums for some time but I decided to post and see if any of you have some input on a HACCP plan I am working on.  First a bit of background.  I am consulting for a small Co-packing facility that is looking to get approval from the USDA to begin receiving large totes of jerky and then package it into smaller retail packages.

 

The question I have is that with prerequisite programs in place including approved suppliers (which in this case is also the customer of the co-packer) the risk is very low.  The product goes through no equipment, it is segregated from allergens.  The only concern is when the tote is open exposing the product to the environment and the employees wearing gloves transfer it to smaller bags before sealing.

 

It is this step that is the CCP but the question I have is how best to monitor and control this.  At the moment I have two thoughts.

 

1.  Place all product on hold and collect samples of retail sized bags throughout the lot and have them sent to a lab and tested for water activity.  If below 0.85 release product to customer, if above follow deviation program.

 

2. Same as above but sample for L. monocytogenes.  I would rather only rely on this as an occasional verification of the HACCP plan and would prefer to rely on the water activity and good prerequisite programs.

 

I look forward to hearing what you have to say.  The issue I have been running into with my conversations with the USDA is that since this falls into the Heat Treated, Shelf Stable category they are looking at is more like a jerky processor as opposed to this company just receiving the RTE jerky and packaging it.

 

Thanks in advance.

[Charles.C]

Hi swmalone,

 

I deleted yr haccp sub-forum duplicate topic since >1 invariably causes confusion. Thks.

 

Not in USA but i would anticipate that you (or someone) will need to validate to USDA that the product being repacked is safe to eat. From USDA's POV, I imagine this would also involve a hazard analysis of the jerky manufacturing process.

 

I am curious as to the critical limit you are using as associated with a CCP of  "unpacking/transferring/repacking product". Low temperature ?

[swmalone]

The product in question is shelf stable and does not require refrigeration.  The jerky manufacturing process is a different company and they have a USDA validated HACCP plan for the Heat Treated, Shelf Stable product.  That company places the product in large sealed totes and then ships it to the co-packer.  They then take it into a segregated room and open the tote and transfer the jerky by hand into smaller bags.  Since it is a shelf stable product that does not require refrigeration the room is maintained at room temperature, in this case the low to mid 60's in degrees F.  The primary concern is exposure to the environment and the employees.  There are personnel practices in place as well as SSOPs and an environmental monitoring plan to reduce the potential risks.  The current plan that I have to validate the HACCP plan and that the re-packaged product is safe to consume is to conduct water activity on a composite sample from each lot.  

 

I was just hoping that someone on here has had experience working with the USDA as a co-packer as opposed to a manufacturer.

 

I appreciate the response.  Thanks.

[Charles.C]

The product in question is shelf stable and does not require refrigeration.  The jerky manufacturing process is a different company and they have a USDA validated HACCP plan for the Heat Treated, Shelf Stable product.  That company places the product in large sealed totes and then ships it to the co-packer.  They then take it into a segregated room and open the tote and transfer the jerky by hand into smaller bags.  Since it is a shelf stable product that does not require refrigeration the room is maintained at room temperature, in this case the low to mid 60's in degrees F.  The primary concern is exposure to the environment and the employees.  There are personnel practices in place as well as SSOPs and an environmental monitoring plan to reduce the potential risks.  The current plan that I have to validate the HACCP plan and that the re-packaged product is safe to consume is to conduct water activity on a composite sample from each lot.  

 

I was just hoping that someone on here has had experience working with the USDA as a co-packer as opposed to a manufacturer.

 

I appreciate the response.  Thanks.

 

Hi swmalone,

 

thks for clarifications.

 

IMO (and perhaps USDA's) there are 2 independent processes from a Regulatory, HACCP, POV unless you can demonstrate a continuous control chain from the end of the original validated process.

 

I appreciate USA's blanket fixation/sampling theses with L.mono for RTE goods. If relevant (=contamination risk), this would presumably be a regulatory type CCP (=GMP?)  for yr specific type of operation. No idea on that one. (Could include other pathogens also of course depending on yr environment.)

 

As you say, (other) experience is valuable 

 

i think there are several other USA meat processors on this forum so here's hoping.

[swmalone]

Hopefully all of the US meat processors are just having a nice weekend and maybe someone will respond on Monday.  As for the other pathogens they will be included as part of the occasional micro testing of finished product.  I am hoping to just be able to rely on water activity as the per lot verification.  Their process has absolutely no water in the packaging areas.  The only water in the facility is in their cleaning room and all equipment is disassembled and cleaned in there.  The nice thing about this is I think we can demonstrate a continuous control chain from the end of the validated product.  The RTE product is shipped directly by the customer to the co-packer and they are only a few miles apart.  I think what it is going to come down to is doing the best we can with the HACCP plan and letting the USDA inspector make the decision and hopefully provide some guidance if they aren't happy with what we have put together.

 

Thanks again.

[Charles.C]

Hi swmalone,

 

JFI these documents which you probably are familiar with already seemed relevant to yr current queries although not directly adressing a (separate) repack-only operation. Some of the most complex L.mono permutation requirements/options i hv ever seen.

 

 bj1 - FSIS Compliance-Guideline-Jerky-2014.pdf   852.11KB   34 downloads

 bj2 - Post Lethality Exposed RTE meat - L.mono control,2014.pdf   1.03MB   23 downloads

 9cfr part 430,control L.mono in rte meat products - 2015-13507.pdf   257.55KB   21 downloads

[swmalone]

Thanks Charles.  I have a heck of a time trying to find USDA documentation compared to FDA stuff, I appreciate the links.

[PSC]

Hello.

 

I work for a jerky manufacturer in the US. We produce and package, so I am not too familiar with how a packing facility must operate, but I can do my best to help you with your question.

 

My thoughts would be that it's not a bad idea for you to test for aW if you fear the manufacturer is not doing their job. However, their HACCP plan should cover this area and I would think you shouldn't have to monitor aW. 

 

Since your facility is or will need to be approved by USDA to handle meat products, you will be required to do monthly tests of L. Mono. I believe the minimum requirement is three per month. We generally test food contract surfaces, while USDA will take a monthly product sample to test. Depending on how much product you are packaging per month should be assessed with deciding how often you test for L. Mono.

 

Your SSOP's, GMP's and HACCP plan should cover you for your environmental risks. If these three things are in order and your people are properly trained, you should have little worry about product contamination. Since you are dealing with RTE foods, I would assume that the policy is all employees in RTE areas are required to wear gloves and face masks. 

 

The main testing you'll want to do, apart from regular ATP tests after cleaning, is on your finished bags. You'll want to retain at least one bag from each batch and then do random tests of the bag seal to make sure there are no leaks. The retained samples may be used if there is a customer complaint to test to see if your product is fine as well as testing at the end of its shelf life, or any other reasonable cause to test the product. I'm surprised USDA has not required you to have metal or xray detection. However, if the manufacturer already does this, that may be sufficient. 

 

I hope this helps.

[swmalone]

There is a metal detector in the packaging area but I see no reason to assign it CCP status since the manufacturer has metal detection and the co-packer will not be using anything metal in the packaging process.  I suppose I could just assign it as a CCP to be on the safe side, but I hate assigning CCPs if I feel that prerequisite programs will do the job.

 

This does seem so low risk since they are receiving the product as RTE and just opening a large tote and transferring the product to retail size bags.  The Aw was just a thought I had to confirm that the jerky wouldn't support growth of Lm even if there was exposure.  From the standpoint of food contact surface swabbing the FDA is good with Listeria spp., I will have to make sure I am familiar with the USDA requirements for when they are packaging jerky.

 

I appreciate all of the assistance.

 

Thanks again.

[swmalone]

Oh and by the way, they are requiring the employees to wear gloves, but I hadn't considered face masks.  I will have to do more research on that one.

 

Thanks again.